Speech Generating Devices

There are three fundamental points with regard to Medicare coverage of SGDs we bring to your attention:

1. Every American has a right to enjoy the freedoms of life, liberty and the pursuit of happiness, a constitutional affirmation reinforced by the Americans with Disabilities Act. To limit disabled persons’ access to communication on the basis that non-disabled persons could use the same devices or software is a denial of that right. Concerns about unintended or fraudulent use of covered devices or software can be addressed by measures other than throwing the baby out with the bath water.

2. The Affordable Care Act provides that patients must communicate with their physicians via a portal, which is always internet-based. Furthermore, State laws governing professional practice and conduct by licensees in the health professions also require them to communicate with their patients, including those with communication disorders. Such a requirement becomes critical in the case of licensees in the mental health professions whose primary therapy is verbal communication. Therefore, CMS guidelines shouldn’t disallow internet connectivity from SGDs as it may controvert law.

3. Life evolves over time as does technology, an increasingly pervasive part of modern life. Since the technology supporting SGDs has advanced substantially over the past decade, the guidelines for addressing that technology should reflect, not restrict, that evolution.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

All people should have the method of communication available to them that is appropriate for them. All people also should have the right and ability to choose their method of communication for each specific situation. The representatives for the people who can easily access their own methods of communication need to ensure that the people they are representing have the ability and option to choose their method of communication.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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To Whom it May Concern:

I request that you QUICKLY approve the proposed restoration the scope of SGD coverage that had existed from 2001-2013, both in regard to the types of devices that can be used as SGDs – both computers and purpose built devices; and in regard to the capabilities or features of SGDs.

Also, please support funding of eye-tracking access AND repeal of the capped rental regulation that could put some people at risk of losing their system if they had extended hospitalization.

Thank you,
Jennifer Abramson

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enable remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please remove the capped rule on SGDs to allow our patients to communicate.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

Less

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);

Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and

Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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December 4, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please don't take away the only voice many of my clients have! This funding source is needed. Without it, many of them could not afford a communication device.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Speech generating devises make a major difference in a person's whole life. Let's not make people who need them do without these essential devises. Let's allow them to change as the person's ability communicate changes too. These devises are the person's whole way of interacting with the world. Without them, they are voiceless & powerless.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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December 3, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

To anyone who has ever had a loved one to lose their voice is understanding how important SGD' s are to living a quality life. I ask that you accept the proposed changes recommended by ASHA. Sincerely, Rebecca Adams

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA’s proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

Sincerely,
Rhoda Agin, Ph.D.

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A group that included policy experts from ASHA, the Amyotrophic Lateral Sclerosis Association (ALSA,) and representatives from SGD manufacturers has discussed and agreed on edits to the NCD 50.1 to submit to CMS as a united stakeholder group. The recommended edits are the result of several meetings, revisions, and discussions and include:

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On behalf of the Institute on Disabilities at Temple University, we thank you for this opportunity to comment on Medicare's (CMS) reconsideration of its National Coverage Decision (NCD) for Speech Generating Devices (SGDs). For more than 40 years, the Institute on Disabilities at Temple University has served as Pennsylvania’s University Center for Excellence in Developmental Disabilities (UCEDD) Education, Research, and Service, established under the federal Developmental Disabilities Assistance and Bill of Rights Act. The Institute also serves as Pennsylvania's Assistive Technology Act program established under the Federal Assistive Technology Act. As the Commonwealth's UCEDD and AT Act program, we interact with tens of thousands of people with disabilities every year, many of whom use or need SGDs. In addition, we provide communication assessments for adults with intellectual and developmental disabilities (ID/DD), following protocols established as a result of the 2001 NCD on SGDs, and have seen the way SGDs provide people with ID/DD a way to control their health – and their world.

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including:

- Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
- Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
- Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

- Providing users the ability to access medical alerting systems to call for help
- Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

- Enabling users to be left alone
- Enabling independent access to care at home
- Providing the ability to maintain family and parental roles
- Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

- The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
- Managing communication about health care appointments and transportation to health care appointments
- Enabling users to receive information about disasters and emergency actions
- Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

- Calling for help in an emergency using a text-to-911 or instant message relay service
- Enabling users to receive and respond to safety and emergency alerts
- Sending an instant message to a caregiver in another room to request assistance
- Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
- Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
- Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
- Accessing online user guides and technical support for training or troubleshooting with the SGD
- Enabling remote technical support, trouble shooting and device repair.
- Downloading page sets for use with the SGD’s communication software
- Keeping in touch with family and friends who live far away or are otherwise unable to visit
- Participating in online support groups

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

- Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
- Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

- Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
- Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
- Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
- Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

Thank you for you consideration of these comments. If you have any questions or would like further information, please contact Amy Goldman at amy.Goldman@temple.edu or 215-204-1356.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

It is my hope that this correspondence will enhance your understanding of what speech generating devices are AND what they can mean in the lives of so many around us. We have the power and the resources to give a voice to the subaltern, to enhance the quality of life for those otherwise unable to communicate with loved-ones and strangers alike, and to facilitate language-based communication (rather than needs-based communication). There is no good reason to limit or restrict anyone's RIGHT to communicate 1) exactly what they want to say, 2) as efficiently as possible.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please do not limit the types of devices available to Medicare beneficiaries, or their ability to functionally communicate with others. Thank you.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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As an AAC specialist, I provide people without speech a “voice.” Communication is imperative to social and medical well-being. I want to thank Medicare for addressing key concerns which were in the 2014 proposed Medicare National Coverage determination for Speech Generating Devices. Most of us use electronic devices to communicate via text such as text messages and e-mail and most people have access to a phone. Allowing people with speech disabilities to access the same means of communication is imperative for their ability to function as close to their peers as possible. These days, doctors’ offices text appointment reminders, physician’s communicate with patients using e-mail, and many employers only offer applications via e-mail or online. It is essential that the revised NCD for SGDs be signed as soon as possible to expand “speech” to include these means of communicating as an option that can be made available. The sooner this is adopted, the sooner people with a need will have access and confusion over the matter will be eliminated. It is also of extreme importance that eye tracking accessories be addressed in NCD for SGDs as this is the only means of access some people with disabilities would have to independent message composition. The issue of capped rentals is also in need of resolution. One specific point is that “Standard” devices rented would only include the ability for face-to-face communication and would not allow for access for other communicative options such as phone use, texting, and e-mail—as noted previously these are imperative for functioning in today’s society. With the capped rental policy as is, these would be unavailable and would be an issue. I also asked that there be further clarification between “functional speaking needs” and “functional speaking communication needs.” In the field of speech-language pathology, we utilize the term “functional communication needs” as there is far more to communication than speaking. Congruence of terms is crucial in eliminating confusion and misunderstanding. Please consider these imperative points for the NCD for SGDs. Again, thank you for revising some of the key issues. I hope that the remaining concerns of the AAC community can be resolved as well.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Support access to the SGD for patients with neurodegenerative diseases. Don't prevent it's important use for patients. Do what is necessary to allow for accessibility.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please make these changes as soon as possible. There are patients with progressive diseases like ALS that are being severely affected by these rules. To think that someone that is having all of their human abilities taken away slowly be given a device that can improve their quality of life. But then that new device is either limited via the inability to use email etc or taken away completely via the capped rental system if they have to receive hospice care or go in skilled nursing is just illogical and inhumane! Nobody would think it reasonable if it happened to one of their own family members!

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

As a speech-language pathologist for over 10 years, I have worked with many individuals who use SGDs.

I urge you to accept ASHA’s proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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December 6, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

These patients and students have the right to communicate in the way that best suits their needs.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please allow those in need the eligibility to obtain an SGD covered through medicare. SGD's are essential and paramount for the communication of those who cannot speak verbally or are limited verbally. SGD's allow social abilities, communication of wants/needs, and for the utmost dignity in life. Please advocate and allow SGD's as a covered service to medicare beneficiaries.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I am writing to urge you to keep coverage of eye tracking accessories for speech generating devices.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

As a speech pathologist, I have trained patients to use this technology when they have no other volitional movements to access their communication devices. Taking away coverage for this technology takes away one's ability to communicate needs, wants, thoughts, and even goodbyes to loved ones.

Thank you for your reconsideration to the coverage policy.

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[PHI Redacted] has this device and it is the only voice my kids know from him. If he didn't have it the would not be able to get to know the man i know. He would be a memory before he even is dead. It has also been the only way he can communicate his needs. Without the device [PHI Redacted] has to say each letter of the alphabet and wait till [PHI Redacted] blinks to acknowledge the letter he is thinkibg. Imagine doing that for 30 minutes just to get a simple sentence spoken. ALS has taken away pretty much everything [PHI Redacted] use to be able to do. This device gives him back one of the most important things he lost. His ability to communicate with family and friends. Without it he would be a sitting duck. It is his only interaction with the world.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Thank you for time and understanding.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA’s proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

I urge you to accept ASHA’s proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

Sincerely,
Janice Andersen

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I have worked as a speech language pathologist in a medical setting for 36 years with consumers who have lost their ability to talk. Only paper and pencil or cardboard pages were used as compensations for loss of speech. Through the years, technology has exploded to restore talking skills for these consumers through the invention & evolution of Speech Generating Devices (SGD). SGD’s are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.  

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs.  The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.  

Some of these device features are not within the client’s control, and none add costs to Medicare. 
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients. 

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders
  These capabilities also promote independent living by:
• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare. 

Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD.  From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered. 

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage.  These choices must be maintained.
For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency.   This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate.  To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I have witnessed first hand how important these devices can be to help students connect socially with others and convey messages more effectively.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Please continue funding speech generated devices:

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).
SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electonic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities which do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. The availability of this feature results in no additional cost to CMS. Instead, the ability of an SGD to perform environmental control functions requires substantial additional expense – in the form of home and appliance modifications – by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enable remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access thier SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage.

These choices must be maintained. For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

Less

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

For children with severe communication deficits, to deny them access to basic ability to communicate effectively is truly punitive beyond the burden they already are subjected. Would you deny this to Stephen Hawkings; one of the greatest minds of our times? Would you deny your child, your parent or sibling the ability to tell someone they are sick, sad, hurt or want to share a joke? Please, do not disallow the very basic needs of communication.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Dear Dr. Duggirala,

Please consider and include the revisions and recommendations submitted by ASHA concerning "speech-generating devices." These devices empower our most vulnerable citizens to communicate their basic needs and to engage with others whereas in the past these individuals were relegated to silence.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Good morning. I am writing this comment to you on the internet, participating in a public policy discussion over medical issues based on communications I received through social media from individuals involved with caring for ALS sufferers. They've let me know that your recent policy changes with regard to speech generating & communication technology would take away the ability of individuals in advanced stages of ALS to communicate in the way I am communicating right now, as well as with their family members, doctors, and to generally interact with the world around them.

ALS, and other terrible medical conditions that rob people of the ability to communicate, are devastating enough. But if the technology exists that can lessen the impact and allow these individuals to continue to interact with the world around them, I feel that should continue to be supported and expanded, not taken away or limited. I hope you will address this in your policies going forward.

Thank you for taking the time to read this public comment.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs). I am currently a Masters student in Speech-Language Pathology at Boston University and will be graduating in May 2015. I hope to work with individuals with complex communication needs, such as those who may require the use of SGDs as their primary mode of communication, and I find the potential for future lack of coverage troubling.

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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I have met a person who uses eye-gaze technology as his only means of communication and I have spoken with several people who support others who are in the same position.

Such speech-generating devices, and the ability to use such devices through the Internet, are essential to such persons' standard of living and essential for that person health.

They are essential for communicating with health professionals and essential for informing others about their symptoms and health needs.

Also, the use of both such devices and the Internet together is specifically necessary for those who have rare conditions such as ALS to discover, contact, and interact with ALS support groups and other individuals living with ALS about matters essential to their health, about the unique health-related choices with which they are faced, and about options they might not otherwise learn about directly from their specific health care providers.

Finally, the destructive force of rare conditions such as ALS, which cause the deficiencies speech generating devices are meant to alleviate, includes the harsh psychological trauma which results from forced solitude and an oftentimes bleak terminal diagnosis; empowering those who suffer from such diseases to communicate with the world outside their rooms' - both about themselves, about their conditions, and about their thoughts as well as about the world outside - is one of the surest and best means to counteract that trauma.

I urge you to consider carefully and compassionately the comments that are made in favor of permitting such Internet-accessible speech generating devices to those suffering from diseases like ALS and I urge you conclude this period of review in their favor.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease that took my sister's life. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

Thank you!

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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The use of communication technology is becoming more and more intimate with all members of society. Nowhere is this more evident than within communities of individuals who use this technology to share and connect with the rest of the world. The devices human beings use to communicate, when other avenues are lost, must have the ability to be tailored to their specific needs.

The terms of the capped rental category put the individual at risk of losing his or her method of communication at the most crucial and vulnerable of times – extended hospital stays, assisted living facilities, hospice care. Medicare provided SGDs need to be owned by the recipient in order for the devices to be customized so they are a valid and USABLE method of communication, adapted to the unique needs of the individual, and protected to insure the device can not be taken away when needed most.

I work for people who live with ALS. This disease takes away a tremendous amount from a person – a family – a community. However – it does not take away the person’s right to participate in decisions that directly affect his or her life. Devices with the ability to be unlocked allow a person living with ALS to remain in control of medical decisions, appointment scheduling and cancelling, and participating in telemedicine if and when travel to medical appointments becomes impossible.

It is crucial that people with disabilities severe enough to require these devices have access to assistance – from notifying a person within the same house but outside the immediate room that help is needed up to being able to connect with 911 services. Dialing 9-1-1 is the most familiar and effective way Americans have of finding help in an emergency. The Americans with Disabilities Act (ADA) requires all Public Safety Answering Points (PSAPs) to provide direct, equal access to their services for people with disabilities who use alternative methods of communications. Under Title II Emergency centers have to be able to get calls from TDD/TTY and computer modem users without relying on third parties or state relay services. As technological capabilities continue to expand to improve quality of life, so must our access laws.

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December 4, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please accept the proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.
Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained. For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Communication is imperative to the health and quality of life of every person in any form.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

Less

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

Less

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as "dedicated speech devices." As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client's control, and none add costs to Medicare.

The Medicare "coverage reminder" (Feb. 2014) specifically referred to "wireless" capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the "coverage reminder" was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as "environmental control" or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.
Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare "coverage reminder" (Feb. 2014) specifically referred to "environmental control" capability as disqualifying for Medicare coverage and payment. Although the "coverage reminder" was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.
Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare "coverage reminder" (Feb. 2014) specifically referred to "cellular communication" capability as disqualifying for Medicare coverage and payment. Although (1) "phone control" is not "cellular communication" capability, (2) SGDs typically do not include "cellular communication" capability, and (3) the "coverage reminder" was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 - 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device's role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.
Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD's communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS "codes" that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person's communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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There are many ugly diseases out there but 1 main one that has affected both [PHI Redacted] is ALS. Their ONLY form of communication was through the devices that help them to communicate. It should be a vital part of their life and "necessary" so they can maintain communication with their family members not only as a means of telling them their wishes or thoughts, but telling them necessary vital information about thier physical needs as well. It's their only form of communication when nothing else is functioning body wise. It should definitely covered as is any other medical necessity is to their disease. Thank you.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

The ability to verbally communicateis a basic human need. Speech- Generating devices will allow persons with limited ability to verbally communicate to indicate their wants and needs.

Persons who have a problem verbally communicating are frustrated because they are unable to say what is on their minds. This also affects family members and friends who find it difficult to communicate with them as they are often forced to quess what their loved one needs.

Speech-Generating devices will also allow some persons with limited ability to verbally communicate to continue working.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.
In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.
The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.   
Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs.  The 2001 NCD did not restrict any of these operational characteristics of SGDs, including
Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.  
Some of these device features are not within the client’s control, and none add costs to Medicare. 
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.
SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients. 
Environmental control capabilities provide important benefits to clients. They aid safety by:
Providing users the ability to access medical alerting systems to call for help
Allowing users to control access to the home, for example to allow access to the home for emergency responders
These capabilities also promote independent living by:
Enabling users to be left alone
Enabling independent access to care at home
Providing the ability to maintain family and parental roles
Enabling the ability to pursue volunteer or community activities
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.
A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare. 
Examples of why phone control is essential include:
The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.
Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD.  From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.
Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.
Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:
Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enabling remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.
Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered. 
Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.
The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.
Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.
The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:
In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage.  These choices must be maintained.
For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency.   This option also is cost-efficient for Medicare.
However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.
Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.
For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate.  To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

The ability to communicate one's basic wants and needs is a fundamental human right. With the advanced capabilities of technology these days, we need to take advantage of what is available to help everyone exercise this right to communicate. I've personally seen how these devices help those with communication impairments escape the personal prison of isolation that neurodegenerative diseases trap them in. A device with the ability to access people outside of the immediate environment (via internet capability for Skype or email transcription or telephone use) helps people stay healthier and happier. Being able to communicate their wants and needs with caregivers and medical professionals helps them stay ahead of the disease process and reduce risks of frequent re hospitalizations. Please please please accept these revisions to stay on the front line of communication access for Medicare recipients.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please allow people with catastrophic illnesses to communicate through the use of speech generating devices.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I have been working in the field of augmentative and alternative communication for more than thirty years. When I heard about Capped Rental, I suspected that it was likely to have significant impact on the field. When I learned some of the details, I was confused, surprised, and then worried. I am going to discuss only one of its provisions: the withdrawal of equipment during hospital or rehabilitation center stays.

Communication disabilities, in many ways, are like sensory impairments. The person with communication disabilities may have difficulties talking, making telephone calls, buying things at stores, banking, writing messages, etc. A person with sensory impairments (vision and hearing) has trouble talking, using phones, buying things, banking, etc. The two sets of disabilities are in certain ways parallel.

Suppose CMS regulations would require that eye glasses and hearing aids be returned to their manufacturer when their users went in for a hospital stay. The general public would be able to see immediately how strange such a requirement would be.

It is as though, when entering a hospital, a person would need to send back to a manufacturer his or her eye glasses and hearing aids.

A communication aid is personal and non-generic as hearing aids and eye glasses. Having to send it back when going to the hospital or rehab center makes as much sense as sending back prescription glasses and hearing aids.

How many Medicare users would like to relinquish their eye glasses and hearing aids for a hospital stay? The absurdity of this situation is an exact parallel with relinquishing one's speech-generating device (SGD).

I hope I have made myself clear

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December 3, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I work with students with severe autism and these devices are helping so many children communicate their wants, needs, thoughts, and feelings. They are a vital tool for so many and they need to be funded.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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ALS patients cannot communicate except with their eyes after not that long. When this happens, studies show that they often enter a downward spiral that leads to death fairly soon. I mean, how would you handle it if you had a perfectly good mind trapped inside a failing body that could not communicate with the outside world?

This dilemma is inevitable, however. ALS patients can still use their eyes for a long time after they can't use their voice or control a keyboard or joystick. However, in order to utilize this, they need a computer (tablet most likely) to do eye tracking.

This computer needs to be part of what Medicare gives someone with ALS. Further, almost anyone today uses the internet to communicate with, via email and social media and the like. Ergo, Medicare really needs to cover internet access for ALS patients.

In case you want to see some more street creds from this commentator, check out teamgleason.eecs.wsu.edu.

THINK ABOUT THIS ..... and then do the right thing!!!!

Dave

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PROPOSED COMMENTS

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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[PHI Redacted] passed away from ALS in September of 2012, and speech generating devices are imperative for communication between the patient and their caregivers. Imagine yourself being locked into your body, but your mind fully active and you need to tell someone that you need your arm moved because it is throbbing in pain and you cannot communicate your need. No one would ever know if these patients need medical attention without this device. Please, please, please give people with these needs this device. It helps to alleviate suffering for all involved in the care of patients. Thank you for putting patients' care first and foremost. Sincerely, Pam Balch

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The current situation, created by CMS in the Spring of 2014, is causing real and serious harm to Medicare beneficiaries with severe communication disabilities. The combination of changing to the 13 month rental system adding to the pressure on SGD vendors (resulting from the coverage "reminder") has led to a situation where beneficiaries have been renting speech-only devices that cannot be upgraded. Clear and poignant evidence of the harmful effect that CMS is currently causing on beneficiaries can be seen in the following videos:

http://www.bostonherald.com/news_opinion/local_coverage/2014/09/medicare_shushes_als_sufferers

http://fox6now.com/2014/07/02/not-having-these-locks-you-away-from-the-world-how-you-can-help-als-patients-get-the-speech-generating-devices-they-need/

http://www.frequency.com/video/speech-generating-device-helps-als/192853792?cid=5-5338

2. SGD manufacturers will continue to proceed with extreme caution regarding upgrades until CMS publishes a new national coverage decision. CMS is directly responsible for this, because of clear pressure on the manufacturers to conform to the so-called "coverage reminder," as is evidenced by the statement from a prominent member of the Chronic Care Policy Group at the Centers for Medicare & Medicaid Services: "I thought the SGD “coverage reminder” issue was on its way to resolution and that manufacturers pledged to come into compliance. I’m wondering why ITEM coalition was hired to approach CMS on something that 90 percent of the manufacturers understood they needed to address and were in the process of doing so?”

3. Many beneficiaries who need help immediately are individuals with ALS whose hospitalizations often increase in frequency as their disease progresses, and who are facing a premature death. Capped rental necessitates that they literally lose their ability to communicate with each hospitalization.

4. There are immediate solutions to the current situation. Several groups have already submitted comments with viable options. For example, allowing individual beneficiaries to pay for upgrades to their SGD from the first day of rental or easing the unworkable rules regarding hospital stays. Consider that hospitals have a bevy of wheelchairs available for use however rarely have any SGDs available to provide a method of communication. Indeed, SGDs provide individualized communication that is often the sole means of access to essential messages for individuals with severe communication impairments. The currently proposed changes to SGD funding increase the vulnerabilities of already extremely vulnerable people.

CMS must take responsibility for the harm it is currently causing to people whose situation is already extremely vulnerable. CMS can no longer pretend that the direct harm being done to people, the reluctance on the part of beneficiaries to replace old and fragile SGDs with the new SGDs they are entitled to and the amazing level of fear and anxiety among people who currently possess devices with upgrades that are wearing out and becoming more difficult to repair does not exist.

Please consider alternate options to this policy.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I support all the above revisions and recommendations as proposed by ASHA.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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PROPOSED COMMENTS

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Medicare (CMS) currently is reconsidering its National Coverage Decision (NCD) for Speech Generating Devices (SGDs). As part of that process, CMS will allow interested members of the public to submit comments about future Medicare SGD coverage until December 6, 2014. The information that follows was prepared by the Medicare Implementation Team, an ad hoc group of AAC clinicians, researchers, advocates, educators, manufacturers, etc., many of whom worked on the 2001 NCD.

FOLLOW THESE 5 SIMPLE STEPS TO SUBMIT A COMMENT TO CMS.

1. Review the 8 PROPOSED COMMENT AREAS below that are critical to include in a revised NCD for SGDs.

2. Copy the Comment Areas so you can PASTE them to the Comment Section on the CMS website. We recommend pasting the 8 comments to a Word Document first so you can add personal information and experiences that strengthen your submission and then paste those into the comment section. (Of course, you may also chose to select fewer of these comments, or only one, if you wish to concentrate your personal comments on a particular point. Also, you can submit several times, each with the focus on one comment, or just a few comments.)

3. Click here to visit the CMS website in a new window. Note: Before you will be allowed to enter any text, you will need to click the link to view the "CMS PHI Posting Policy" and then check the box next to the statement: “I have read and understand the CMS policy regarding redaction of PHI”

4. Fill in the form on the CMS website and PASTE your comments to the "Comment" box. The fields with the red asterisks are mandatory!

5. When you are satisfied with your comments, click the orange SUBMIT button at the lower right corner of the page. Your comments will not be recorded until you click SUBMIT!

DEADLINE FOR COMMENTS IS DEC. 6, 2014

Copy the following into your document and then paste into the Comment box on the CMS site

PROPOSED COMMENTS

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.
Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

Providing users the ability to access medical alerting systems to call for help
Allowing users to control access to the home, for example to allow access to the home for emergency responders
These capabilities also promote independent living by:

Enabling users to be left alone
Enabling independent access to care at home
Providing the ability to maintain family and parental roles
Enabling the ability to pursue volunteer or community activities
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
Managing communication about health care appointments and transportation to health care appointments
Enabling users to receive information about disasters and emergency actions
Enabling users to receive and respond to safety and emergency alerts
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Calling for help in an emergency using a text-to-911 or instant message relay service
Enabling users to receive and respond to safety and emergency alerts
Sending an instant message to a caregiver in another room to request assistance
Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
Accessing online user guides and technical support for training or troubleshooting with the SGD
Enabling remote technical support, trouble shooting and device repair.
Downloading page sets for use with the SGD’s communication software
Keeping in touch with family and friends who live far away or are otherwise unable to visit
Participating in online support groups or patient communities such as PatientsLikeMe
One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.
The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.
For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Please continue to support speech-generating devices (SGDs) as a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Thank you for the opportunity to provide input on Medicare policy regarding speech generating devices (SGD’s).

We have not only witnessed changes in technology itself, but also in how technology has molded and changed our everyday lives, but has become integral to it. The internet and access to it is no exception .Nearly every business has a web address, every person, including the homeless have an e-mail address. Banking, now rarely done in person, is now handled on-line, via the web for nearly all transactions. The preferred method of contact for most medical providers is e-mail and many offer appointment scheduling on their websites.

Statistically, the disabled are at a higher health risk as is. Acting as their own advocate, researching treatment options and advancements in their disease is not only productive, but and basic human right and part of their innate dignity.

Through the internet, one can now call 911 in life-threatening emergencies.

All of this can be accomplished on a computer ‘tablets’, used by many of those afflicted with ALS. However, current protocol, does not allow for such usage, requiring that these useful tools be ‘locked out’. . By doing so, the Medicare NCD Manual (Pub. No. 100-3, Ch. 1, Part 1), section 50.1 put the disabled, once again , specifically those afflicted with ALS, at a marked and distinct disadvantage with the rest of society and restricting any useful and meaningfully type of communication with the outside world.
I urge you to carefully consider allowing full usage of tablets. Access to the internet is a part of everyday, normal functioning life for each and every American. The disabled must be included in this number.

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Thank you for the chance to contribute to the discussion of Medicare policy governing Speech Generating Device (SGD) funding.

SGDs are a means of communication for individuals with complex communication needs (CCN). Because of hereditary or acquired disability their natural speech does not meet their communication needs and they require augmentative or alternative communication (an SGD) to facilitate personal safety and independence, and participation in family, social, community, and vocational roles.

As a speech-language pathology graduate student completing my coursework regarding individuals with CCN and augmentative/alternative communication, and as a clinician preparing to enter the workforce and provide services to these individuals, I would offer the following comments on the National Coverage Decision:

1. Diagnoses that would render an individual eligible to receive an SGD should not be limited. Individuals with a variety of disorders including cerebral palsy, traumatic brain injury, amyotrophic lateral sclerosis, autism, and apraxia of speech can benefit from an SGD. Individuals should qualify based on their communication diagnosis and needs (and recommendations of qualified professionals), rather than their general medical diagnosis.
2. Patients should have access to phone control and non-speech functions (email, web browsing, etc.) through their SGD. Individuals who need SGDs already face barriers to communication and life participation because of their CCN. Additionally, many may have concomitant physical disabilities that further impede their independence and mobility. Locking devices from internet access and preventing phone control willfully imposes another (unnecessary and avoidable) obstacle to these individuals’ ability to access their world. Phone and internet access on devices reduces individuals’ limitations on communication partners and access to societal and vocational roles (especially considering the increasingly technology-centered nature of our society).
3. Finally, funded SGDs should be customizable and contain outcome monitoring software. As future clinician, this is particularly important to me because it will allow me to provide individualized treatment shaped directly by quantitative outcomes from therapy. As an SLP my goal is to facilitate the most effective communication possible for my patients, and these features and abilities are integral to fulfilling that goal.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I have worked with adults with many of these conditions, helping them to use a speech generating device changed their world for the better. It allowed many of them to communicate with their family and their medical care givers when they could no longer physically do it independently.

I urge you to accept ASHA’s proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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On behalf of Reliance Mobility LLC DBA RM Speech, thank you for the opportunity to submit comments regarding the reconsideration of the CMS benefit category National Coverage Decision (NCD) for Speech Generating Devices (SGDs) currently described in section 50.1 of the Medicare NCD Manual (Pub. No. 100-3, Ch. 1, Part 1) and Section 1861(n) of the Social Security Act.

As is noted in the CMS Issue statement, SGDs and other related technologies that assist individuals to meet their speech needs has changed significantly since the 2001 NCD. I understand that CMS is seeking to redefine the appropriate benefit category(ies) for the range of devices and programs and the coverage policy.

I urge CMS to recognize that as technology has advanced, a larger spectrum of patients and with various speech generation needs can be accommodated. However, it is important to maintain a benefit category and coverage for dedicated SGDs and the beneficiary who needs a dedicated SGD.

• An individual with no speech capability or means of communication may require a dedicated SGD in which the software is programmed by a professional speech pathologist who can ensure that the language needs of the individual (age-appropriateness- many users are children, level of cognitive and physical disability, etc.) are appropriate, that the device performs the function of a speech for the patient, and that the patient interface accommodates the individual speech needs. Once the speech generation software is customized, the speech therapist “locks” the software to prevent the patient or caregiver from accidently allowing age inappropriate language or from reconfiguring speech. Allowing such devices to configure the function to generate a spoken communication or a text communication would expand and modernize a dedicated communication device.

Therefore,

• A DME benefit category and coverage policy must assure that individuals who require a dedicated SGD (with or without text/email communication capability) have access to such devices.
• Coverage policy must recognize that technology advances for both hardware and software allow dedicated SGDs to be built on familiar hardware and software operating system “brands” (i.e. Apple, Windows, Android, etc.)

Benefit Category

• Dedicated SGDs that serve as an individual’s prosthetic “voice” and/or source of spoken and written communication include a dedicated hardware and software component. They meet the definition of durable medical equipment because they are medical in nature, solely perform a medical and therapeutic function of speech generation, and can withstand repeated use. These devices are also registered with the FDA. Therefore, they should continue to be assigned to a DME benefit category.

Coverage: Dedicated Speech Generating Devices

• CMS should continue to cover dedicated SGDs that are comprised of a hardware and software component that serve as an individual’s prosthetic “voice” and/or primary source of spoken and written communication.
• The availability of hardware platforms from Original Equipment Manufacturers (OEMs) has allowed companies that develop dedicated speech generating devices to purchase the hardware rather than build unique hardware as was commonly done in the past.
  • For example, OEMs such as Apple and Samsung sell their hardware (i.e. iPads, etc.) with only the operating system such as Apple®, Android®, or Windows®. This is different than the “off the shelf” devices sold to the public. The speech generating software is written for the specific operating system.
• Dedicated SGDs, when connected to a computer wirelessly or using a wire, are unrecognizable. It is impossible for any other software applications to be downloaded onto the device or for the device to access the internet. Even the speech generation software upgrades, battery replacements, and other maintenance are typically done by the manufacturer.
• The software on a dedicated SGD must be configured by a professional speech therapist who must customize it for the individual, to assure that cognitive ability, language capacity, and development/function is appropriate. This is particularly important for children whose development changes. It requires continual attention by the professional to assure that the child’s needs are met. We urge CMS to keep in mind that Medicare policy will inform state Medicaid policies and those of private insurers and to consider the broad population of individuals who may need a dedicated SGD.

Thank you for your consideration of these comments.
Sincerely,
Albert Baxter, ATP, RRTS
PRESIDENT

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December 3, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

As a speech pathologist in the public schools, my goal is to have my students who use SGDs be as independent as possible. Please accept ASHA's proposed revisions to the National Coverage Determination 50.1:Speech Generating Devices.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Renee Beaird
1849 CR 322
De Berry, TX 75639

December 3, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

These devices greatly increase quality of life for the user. They are not isolated because of their inability to communicate verbally.

I urge you to accept ASHA’s proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

The gift of communication is one that many of us take for granted; until we lose it. Please do all you can to ensure that no one has to lose this gift.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).
SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

Less

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

Less

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enable remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.
Deborah Bell, MA/CCC

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Communication is an important part of out daily life. Please don't rob anyone of the ability to communication their wants and needs with family, friends and medical staff.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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December 4, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I work directly with this patient population, and it is life changing from two years of age to adults. These patients are unable to acquire spoken communication due to genetic issues or have lost communication due to acquired neurologic issues. Either way, being able to functionally communicate in single words or full length sentences means being "human." This is, by definition, what defines humans from other animals. Please support this initiateive.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I am a speech-language pathologist who works in a multidisciplinary ALS clinic where a majority of our patients develop communication difficulties over the course of the disease and many lose all ability to communicate. Concomitant with changes in communication most of our patients also lose the ability to move volitionally. There are many SGDs available at this time that are of great benefit to communicate and additionally to control the user's environment allowing for some maintenance of independence. The development of eye gaze technology has been wonderful for this community and has seen benefit for other patient populations such as cerebral palsy, MS, etc.

The capped rental rule for SGDs is a serious hindrance to the already severely limited autonomy of our patients. Given their diagnosis, there is an obvious lifetime need for an SGD and the provision in the ruling regarding return of the device upon protracted hospitalization in any facility is cruel in a situation that is already very unfortunate. Many rely on these devices and without them won't even be able to communicate basic needs such as toileting, pain, or emotional state.

Additionally, in this digital age communication is not just about face to face or over the phone communication. Our electronic medical record system allows for patients to email their physicians or other care providers with questions between visits. Many of our patients also participate in social networking related to their diagnosis and report a high degree of satisfaction in the ability to network with other individuals with similar diagnoses in other parts of the country and to keep in touch on a more regular basis with other, more local patients. The provision to "lock" these communication devices is archaic at this point and should be revisited in light of the large leaps in computing technology.

In this high-tech world augmentative and alternative communication (AAC) comes in many forms including software on tablets and smart phones which only increases the ability for patients that are still mobile to interact in the most natural fashion within their community. Many free applications are available, but are not robust or nearly as customizable as more expensive programs. Unfortunately, even the less expensive applications are not affordable for many of our patients given all the other medical expenditures they are incurring. Additionally, the purchase of a portable device on which to use the application is out of reach financially for most of our patients. I strongly urge consideration of coverage for portable communication systems (device and software) to meet the needs of our diverse population.

I appreciate the opportunity to comment on this matter as assisting people to communicate in the least restrictive manner is my job and my mission in life. I believe it is time to again revisit the legislation surrounding coverage for SGDs and would like serious consideration to be given for the following:

1. Removal of the rental cap so that consumers own the devices once they receive them.
2. Allowance for full use of the computing power of the SGD as a computer for electronic communication in any form and environmental control for independence.
3. Coverage for portable communication devices (smart phones, tablets, etc.) and software to improve quality of life and allow for least restrictive independence for as long as possible.
4. Coverage of eye gaze technology as a stand-alone purchase for continued computer access.
5. Coverage for communication software if a device is already owned.
6. Allowance for upgrades to software on a frequent basis as operating systems and computers change.

Thank you, Kiera

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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December 8, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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To: Laurence Wilson
Director, Chronic Care Policy Group

Joel Kaiser
Director, Division of DMEPOS Policy

Subash Duggirala, MD
Lead Medical Officer

[PHI Redacted] who experiences a profound developmental disability and cannot speak verbally, [PHI Redacted] access to a speech generating device that allows for remote speech in the form of both audible and written communications is the essence to human life regardless of the type and/or severity of communication, linguistic, social, cognitive, motor, sensory, perceptual, and/or other disabilities she may present and has the right to communicate to the fullest extent possible as a means of affecting how she lives. My family and I live in Mont Vernon, NH and we commend the efforts on behalf of CMS to broaden coverage and we agree that a written message or phone message from an individual lacking the ability to speak serves the same purpose in communicating with individuals not in close proximity to the patient as generation of speech does in communicating with individuals who are in close proximity to the individual. I am writing on behalf of the NH Council on Developmental Disabilities (NH CDD) and as a parent in support of the proposal and to also urge CMS to expand the proposal further.

The NH CDD consists mostly of volunteer members appointed by the Governor to represent and advocate for people with developmental disabilities. The Council supports programs and policies to further our mission of dignity, full rights of citizenship, equal opportunities and full participation in all areas of life for all NH citizens with developmental disabilities. Access to hardware/software/devices that allow individuals with identified speech challenges is essential to maximize a person’s ability to communicate within all social contexts in all aspects of life including the virtual world.

The current proposal falls short in two particular areas. First we believe it is appropriate and necessary to further broaden this coverage in the current proposal under the DME benefit category to include coverage for hardware and software used to create documents and spreadsheets, to play games and music, and to make video calls should. In addition this proposal should also include provisions of the Steve Gleason Act relative to rent and eye tracking given the pattern of denials that have been identified. People with disabilities who work and volunteer may need access to them. Utilizing documents and spreadsheets are also useful in developing home/personal budgets and managing everyday household activities.

Having access to games allows individuals like [PHI Redacted] and others who experience a disability that limits speech and communication to provide critical opportunities to learn and increase their abilities to express themselves. The proposal needs to provide access to these tools for her and others to work toward achieving increased abilities to use language and communicate. Recently [PHI Redacted] CCC SLP recommended we begin using WordToob, which is an iPad app that combines text, pictures and videos for learning. It is effective to teach the meanings of words, teach social skills, to share your day, for visual schedules and for learning to communicate on an AAC device for individuals of all ages. We ask that the proposal include games that support learning.

Secondly, with advances in technology our society has significantly expanded and shifted our methods of communication over the last two decades. If we are going to assure full and equal access to and participation for individuals who experience speech and communication challenges we must also expand and include access to social media such as Instagram and Facebook. These new advances and societal changes have nearly replaced phone calls and voice communications. Providing equal access to the devices, technology and applications that serve to enable and support effective communication in all different aspects of our lives is essential so that individuals with speech and communication challenges can fully participate, be as self sufficient, and independent as possible in all aspects of life like any other American.

Sincerely,

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I request you to kindly reconsider limiting the use of SGD's for our disabled community. Sit down on a chair for 10 minutes in total silence unable to move one inch. Not able to talk, move your head, or move any limbs. Now imagine someone asks you if you are in pain and where. How would you respond? For many people suffering from debilitating diseases such as ALS and Cerebal Palsy these speech generating devices are the only way to communicate a person's basic, human needs. Just try it for 10 minutes. Now imagine living like this for years and months one end. Please don't take the ability to communicate from those that are suffering enough already. [PHI Redacted] is one of them and we need our SGD every second of every day. It literally saves lives. Thank you.

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To Whom It May Concern:

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

As a speech pathologist with 35 years of clinical experience in working with adults with neurological disorders, I am pleading with you to reconsider to make no changes to the definition of a Speech Generating Device (SGD) or how one qualifies for one. [PHI Redacted] of individuals who suffer from debilitating multiple sclerosis where hands could no longer function adequately and verbalization is impaired, I can attest to my personal use of SGD's on a daily basis. It is imperative to consider the actual small number of people in our nation who will ever need to fully rely on these devices. Does that mean they should not be available? Instead, the committee needs to realize that elimination of these devices will do little to increase savings in our Medicare system or to "balance a budget" but will have severe consequences for already finally over-taxed and over-stressed families dealing with severe, chronic, debilitating diseases. In most cases, these SGD's speak to a "quality of life" issue where little else exists for these individuals and their families. NOTHING is worse in chronic illness than being isolated from others. 10 years ago, the cost of these devices was exorbitant. With today's technology, the opportunity for significant savings is available. The opportunity to make a difference for those suffering with debilitating neurodegenerative disease is critical.

Thank you for considering the consequences of this action.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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How many ways do you communicate with others in one day? Talking, lecturing (if you have a teenager), texting, email, facebook, twitter, web blogging, web comments, instant messages, Skype, telephone and writing are ways in which we communicate with others. Now imagine that you have a significant disability that affects your ability to speak, type or write. A speech generating device that is limited to speech output (it speaks) is only addressing on component of communication. How would you get through your day if your only means of communication is speaking to others face to face. You cannot write, type, text or call another person. The 20 year old definition of a speech generating device is this limiting. Comprehensive communication gives people with significant disabilities opportunities to live richer lives. Many are able to complete their education, gain employment and live independently because they have comprehensive communication. They can call someone if help is needed. They can write a paper for class and submit it online. They can design a website and get paid for their work. This is just a small example of the many things people with significant disabilities can do when they have comprehensive communication.

I'd also like to address the issue of Capped Rental. In April 2014, HCPCS codes for E2502-E2510 were reclassified as Capped Rental. People with significant disabilities who qualify for a speech device don't just need them when they're well. If they are hospitalized, enroll in hospice or are admitted to a skilled nursing facility you have to give your communication device back. Under Capped Rental, Medicare won't pay for the device so the patient has to return it to the DME. It is incomprehensible to me that people who are ill or dying will lose their ability to communicate with loved ones and caregivers at a time when they need it most. Unlike hospital beds and oxygen machines, communication devices are customized and personalized for the patient. There are rigorous requirements for obtaining a SGD including an evaluation by a Speech Language Pathologist. It is unlikely a hospital or nursing home can provide a comparable alternative for the patient.

Please consider changing the definition from Speech Generating Devices to Communication Devices and include all forms of communication. Also, please consider excluding HCPCS codes E2502-E2510 from the capped rental program or making provisions to continue the rental for clients in a hospital, SNF or hospice.

Thank you for your consideration.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

As a Speech/Language Pathologist, I see clients everyday that have lost their ability to communicate and rely on an SGD to be able to speak to their friends and family. These devices are very important toward their well being.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Speech generating devices (SGDs) provide individuals with complex communication needs (CCN) because of developmental disabilities, acquired neurological disabilities, and degenerative neurological disabilities access to home, school, work, and community.

Please authorize manufacturers to unlock SGDs and allow upgrades to provide access to nonspeech functions. Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

Please authorize manufacturers to unlock SGDs and allow upgrades to provide access to nonspeech functions.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

As a speech-language pathologist, I have worked with many children and adults whose lives have been changed from one of isolation and hopelessness through the use of SGDs. Those who have been most successful are those who have been able to be provided with an SGD that is customized to meet their specific motor, visual, cognitive, linguistic and situational needs . For instance, through access to a highly customized SGD, I saw a young adult with severe cerebral palsy be able to use Morse Code via pressing a single switch to access a SGD. With a means to communicate with others, this young man was able to start his own small printing company and end up paying taxes rather than receiving SSDI. Or, a young 4-year-old girl with severe disabilities was able to use a highly customized SGD to interact with peers and teachers at school and went from requiring one-to-one instructions to fully integrated in a 5th grade classroom, earning good grades, on her way to a fruitful career and taxpayer as an adult, being able to give back to the country that helped her meet her potential through the use of a customized SGD that gave her access to the world.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Speech-generating devices (SGDs) are a vital means of communication for patients with speech and language impairments. These individuals almost always have co-occurring severe physical impairments related to their ALS. SGDs enable these individuals with complex communication needs to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions.

With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.
2. Keep access to capabilities, features and functions that support device function as an SGD.
3. Continue to allow SGD manufacturers to include environmental control capability.
4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.
5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Internet and email access has been a lifeline for nearly all of our patients at Cedars Sinai ALS Clinic, particularly given that many are unable to communicate over the phone due to their severe speech impairments.

Other reasons this feature is vitally important include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

Again, this eye gaze access feature of SGDs is absolutely critical to patients with ALS. Without eye gaze access, many patients would have little to no ability to communicate with their friends, family, caregivers, or healthcare providers.

7. Update the SGD HCPCS codes.

8. Keep the option for coverage of either a dedicated SGD or for SGD software.

Thank you for this opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

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I submit this comment on behalf of Amanda Hynan, PhD. Senior Lecturer, Speech and Language Therapy, Leeds Beckett University, United Kingdom. It’s gratifying to the community that people around the globe are engaged in this effort. Dr. Hynan is, of course, quite accurate in detailing the value of video as an method of distance communication. And, I think we all can agree it too should be available to people who use SGDs. Indeed, her research and so many others have shown that critical communication information is exchanged through gestures, facial expressions and body language.

I shall write her. As I understand the NCD draft, the NCD does not exclude people from using video technologies, but rather states that Medicare will not PAY for them (e.g., webcam or software or subscription that enables videoconferencing). In fact, telemedicine is becoming especially important for people who rely on SGDs. It can be both life and cost saving for those with significant physical challenges who have difficulty getting to and from essential appointments, as well as those who live in rural areas, lack transportation, and/or have very limited resources.

Video technologies are making a life-saving difference as well as enhancing quality of life on a day-to-day basis. Thank you for your consideration of Dr. Hynan’s comment (and my two cents on top of it).

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This comment includes a specific request that arises from the agency’s use of terminology.

The community appreciates the NCDs focus on function rather than features of hardware or software, which we know will continue to change. The draft refers to “functional speaking needs” and “functional speaking communication needs” in the same paragraph.

Inconsistent use of terminology leads some to paranoia and others to confusion. In any case, the term “functional communication” (of which speech is one method) is a familiar term used within the profession of speech-language pathology as well as other allied health professions.

A consistent use of terminology certainly poses no threat to the NCD process, only to understanding what is meant. The qualifying population is clearly defined as is the process for evaluation/prescription, which requires the professional expertise of a speech-language pathologist and a physician within their codes of ethics. The expanded definition of “speech” to include communication by texting, email and phone recognizes the effect that technology has and will continue to have on people communicate today. I see absolutely no reason to confuse or confound by apparently saying the same thing in two different ways in the same paragraph. The intent is to provide people who have limited speech with access to communication so they can live their lives as fully and independently as possible.
Thank you

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Reduce Proposed Timeline for Issuance of new NCD on SGDs

There are many stories (told and untold) about why and how the NCD Reminder (issued by CMS in April 2014 and rescinded in November 2014) has negatively impacted Medicare beneficiaries in 2014. Denials, uncertainty, lack of access to critical communication options, a new “capped rental” policy, and so on….each edict managed to create confusion, anger, and bewilderment. Each has resulted in real harm to people who are severely disabled. These beneficiaries have needs that have been documented through extensive assessment and prescription procedures conducted by licensed professionals. As far as I know (as my colleagues were able to discover), this group (and the community of stakeholders that supports them) have never attempted to defraud or misuse Medicare SGD benefits.

When CMS rescinded the NCD reminder and called for a review of the NCD on SGDs, it acknowledged that the times have changed, the way people communicate has changed and technology has changed.

The community has responded to a large extent by agreeing…YES, it’s 2014 not 2001, and the times have changed. However, until the coverage “reminder” the 2001 NCD on SGDs was working (with some tweaking to it over time). No one was complaining, expenditures were minimal and benefits were maximal. In fact, the “reminder” changed both policy and practice….it did far more than “remind.”

After 8 months of angst, are we really asked to wait another 8 months to “fix” the existing NCD?
AAC stakeholders representing multiple organizations, groups, family members and individuals have all said….NO need to start from scratch; NO need to reinvent. What we need is to restore CMS’s commitment to providing access to communication for people who are severely speech impairment recognizing that speech is only one of the many ways people communicate every day to meet their basic needs, medical and otherwise. This requires clarification and tweaking. Thus, the new NCD on SGD should be issued as soon as possible.

Perhaps the group most profoundly affected by CMS’s actions has been people with amyotrophic lateral sclerosis. Data show that these individuals are more apt elect to “unlock” their dedicated SGDs than other groups so they can use email, text, access a phone, environmental controls. These individuals are often “locked in” and unable to move anything except their eyes as their disease progress so they require “eye gaze technologies” to access their SGDs. Also, these individuals are more apt to be hospitalized, go into hospice or nursing homes as their care needs increase so they need access to communication in environment outside of their homes.

The irony of 2014 for this group in particular is that as their rights to communicate were being denied by CMS, the “ice bucket challenge” went viral. Suddenly, people around the world were learning they existed and cared. Simultaneously, Medicare recipients faced losing a benefit they had grown to depend on and that we (speech-language pathologists, physicians, AAC manufacturers and the U.S. Government) had promised would be there for them. CMS had “decided” that SGDs would from now on “only speak”, taking away the ability to communicate with family, friends, employers, medical personnel who were not in the same room. Also, people who were undergoing assessments suddenly faced “capped rental” so that even if a physician prescribed an SGD that could be unlocked, they couldn’t modify their personal equipment for 13 months.

In short, the CMS “reminder” actually changed what had been existing policy and practice for the past 13 years. By doing so, it, CMS inadvertently and naively (I believe), affected the lives of people for whom SGDs are essential by limiting features and functions that enable these individuals to be independent (phone, environmental controls, internet access), by denying eye gaze technologies as accessories, by imposing a capped rental policy on SGDs.

Please issue a new NCD on SGDs that clarifies and corrects and do so as soon as possible.
Thank you very much.

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Access to phone, environmental control and functions that enable SGDs to be used should continue to be allowed.
Functions and features currently available to people who use SGDs since 2001 should continue to be available. The ability to use a phone, use environmental controls in one’s home/office, access information and support services through the internet are essential to individuals who require SGDs and should NOT be excluded from coverage. When drafting a “new” NCD for SGDs, these features need to be specifically allowed. They are essential to the daily function of individuals with severe speech impairments, and as such, a component of the assessment process undertaken by speech-language pathologists and prescribed by physicians. By denying access to any of these features, Medicare negatively impacts the safety, health, well-being, and independence of people with severe physical disabilities and precludes technical assistance support by manufacturers. And I, for one, wonder just how patients with severe speech impairments are supposed to be “engaged” in their own care (new healthcare laws/policies) if they are simultaneously being denied access to communication options which enables them to do so and which are increasingly being used by everyone else?”

Phone alerts, an ability to call 9-1-1, phone conferencing with medical personnel, scheduling of appointments, email, tele-medicine, online training, online upgrades for software, back up of personal data, online technical assistance and so on were available to Medicare beneficiaries until the “coverage reminder” was issued this year—at no cost to Medicare. Environmental controls allow people to receive alerts, call for help, remain safe in their homes, be far more independent, be alone and so on.

People without physical disabilities can access phones, send email, text, etc. using their hands. They do NOT want or benefit from these features. Thus, these features are not useful to individuals without illness or injury and should be allowed.

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As noted on the CMS website, “…changes in technology and use of devices that generate speech” has changed significantly since 2001….generating a reconsideration of this NCD to address coverage of devices that generate speech as well as other forms of communication.”

The Joint Commission defines effective communication as "Effective communication is the successful joint establishment of meaning wherein patients and health care providers exchange information, enabling patients to participate actively in their care from admission through discharge, and ensuring that the responsibilities of both patients and providers are understood. To be truly effective, communication requires a two-way process (expressive and receptive) in which messages are negotiated until the information is correctly understood by both parties. Successful communication takes place only when providers understand and integrate the information gleaned from patients, and when patients comprehend accurate, timely, complete, and unambiguous messages from providers in a way that enables them to participate responsibly in their care (The Joint Commission, 2010, p.1)"

This definition recognizes communication as a complex human behavior, which includes speech. It specifically identifies “effective communication” as a two-way process during which meaning is negotiated. New technologies have changed how people communicate, and perhaps have most dramatically affected and improved the lives of people with severe speech impairments.

Since 2001, Medicare beneficiaries with diagnoses of dysarthria, apraxia, aphonia and aphasia have been eligible for speech-generating devices funded by Medicare. As a result, thousands of individuals have been able to participate more actively in their daily lives, manage their medical conditions, express opinions, make decisions, work, engage with their communities, take care of their families, and so on and so forth. Since 2001, no evidence of fraud, misuse, or overuse of this benefit has ever been shown. Speech-language pathologists have followed a lengthy evaluation process for each client/patient, physicians have written prescriptions for their patients, and SGD manufacturers have provided SGDs to individuals…devices that meet their daily communication needs as determined by a licensed SLP and physician).

The 2001 National Coverage Decision for Speech Generating Devices (along with the clarification regarding “unlocking” dedicated devices) and a few other tweaks along the way, has enabled a few more people with severe speech impairments each year to communicate using SGDs. SGDs are highly personalized communication devices (and have always contained features that extended beyond speech at no cost to Medicare) to meet the needs of patients/clients. The Coverage Reminder significantly curtailed access to these SGDs without known or justified cause. Not everyone is the same. People who require SGDs may or may not have physical disabilities; they may or may not be able to read and write; they may or may not have cognitive limitations. The 2001 NCD enabled individuals to gain access to the features that meet their needs. It needs to be updated, but not significantly changed as soon as possible. I support the following suggestions:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.
2. Keep access to capabilities, features and functions that support device function as an SGD.
3. Continue to allow SGD manufacturers to include environmental control capability.
4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.
5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.
6. Keep coverage of eye tracking accessories.
7. Update the SGD HCPCS codes.
8. Keep the option for coverage of either a dedicated SGD or for SGD software:

Thank you for your consideration

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In this comment, I would like to draw CMS staff’s attention to the materials posted at the www.patientprovidercommunication.org website.

This information is pertinent to your consideration of a NCD on SGDs. Developed by the currently active Medicare Implementation Team, an ad hoc group of stakeholders, these materials will also supplement the longer document you will receive from our group.

I ask that you consider the examples and data sources when reviewing the NCD on SGDs.
Go to http://www.patientprovidercommunication.org/article_43.htm

Click for Examples Personal Statements. Testimonials from people who use SGDs about their needs, uses of SGDs in meeting their daily needs, and the impact of limiting their access to communicative functions they need, depend upon, and have relied on for years.

Click for Research that Supports SGD Use: Examples of recent studies that demonstrate SGD usage among Medicare recipients.

Click for Video Testimonials: People who use SGDs talk about how they use their SGDs to meet daily communication needs and why the NCD Reminder was, in some cases devastating, and in others cases how it made communication even more difficult for them.
Thank you,
Sarah W. Blackstone, PhD, CCC-SP

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I am a speech-language pathologist who has worked in the area of augmentative communication for more than 40 years. I was a member of the Rehabilitation Engineering Research Center (AAC-RERC) for the past 12 years and was also part of the group working with Medicare staff to develop the 2001 NCD on SGDs during 1999-2001.

Most recently, I have edited/authored a book entitled “Patient-Provider Communication: Roles for Speech-Language Pathologists and Other Health Professionals” with co-editors, Drs. David Beukelman and Kathryn Yorkston. In the book, esteemed authors/consultants include speech-language pathologists, nurses, psychologists, disability specialists, physicians, etc. Each chapter addresses the critical role that effective communication plays across healthcare settings. The book is replete with data that specifies the enormous costs (both financial and in terms of human suffering and sentinel events) when communication breakdowns occur because patients/providers. People who rely on SGDs are the MOST VULNERABLE population and access to their personal technologies is critical. The book is due out in 2015 (publisher Plural Publishing, Inc.)

I was also among the working group to develop The Joint Commission’s Road Map that was published to support the 2012 Standard on Advancing Effective Communication, Cultural Competence, and Patient-and-Family-Centered Care. http://www.jointcommission.org/roadmap_for_hospitals/

With support from Augmentative Communication Inc., USSAAC and the AAC-RERC, I have co-hosted the patientprovidercommunicaiton.org and its website for more than 4 years.

In this comment, I would like to draw your attention to the materials posted at the www.patientprovidercommunication.org website. This information is pertinent to your consideration of a NCD on SGDs. Developed by the currently active Medicare Implementation Team, an ad hoc group of stakeholders, these materials can supplement the longer document you will receive from our group.

I ask that you consider the examples and data sources when reviewing the NCD on SGDs.
Go to http://www.patientprovidercommunication.org/article_43.htm
Click for Examples Personal Statements. Testimonials from people who use SGDs about their needs, uses of SGDs in meeting their daily needs, and the impact of limiting their access to communicative functions they need, depend upon, and have relied on for years.

Click for Research that Supports SGD Use: Examples of recent studies that demonstrate SGD usage among Medicare recipients.

Click for Video Testimonials: People who use SGDs talk about how they use their SGDs to meet daily communication needs and why the NCD Reminder was, in some cases devastating, and in others cases how it made communication even more difficult for them.

Thank you,
Sarah W. Blackstone, PhD, CCC-SP

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SGD manufacturers need to be able to use off-the-shelf technology as SGD hardware for multiple reasons.

Personal computers and computer-based devices can be modified to function as dedicated speech devices. Mainstream technology will continue to change, becoming more available, more powerful, and containing some build-in features that may benefit people who require SGDs.

Why would Medicare restrict the use of these devices as long as the devices meet the other requirements for coverage stated in the May 2001 interpretive clarification to the May 2001 interpretive clarification to the 2001 NCD?

Data show that depending upon the individual (and their diagnosis) only some people have chosen to “unlock” their devices (at a small cost to themselves ~ $100). For example, data from a recent chart review of 64 patients (from 2001-2008) with ALS (a group most likely to “unlock” their SGDs) revealed the following: 19% of the SGDs (n=13) remained dedicated and 81% of SGDS were unlocked after purchase at no cost to Medicare. The authors concluded that “SGDs provide a vital link to communication for persons with ALS (a group that uses multiple means of access and demonstrates a clear preference for unlocking features to enable access to common communication interfaces, such as Facebook, Twitter, and email…” (Ball, Pattee, & Beukelman, 2014, in preparation)

A simple modification to the existing NCD would be easy to do and enable the “new” NCD to be released soon…. Many people already negatively impacted by the Coverage Reminder despite it being withdrawn. Uncertainty persists and for some, time is running out. Please consider adding the following:

? Being a dedicated speech device, used solely by the individual who has a severe speech impairment;
? May be a dedicated personal computer or computer based device and may be based on off-the-shelf hardware or purpose built hardware;

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Capped rental takes away a person’s ability to communicate – to say I love you – to say good bye – to express pain or even an itch.
The person has no internet access, therefore no way to contact 911, no emergency alert system, no method of staying in touch with family members or the community in which they live. The person has no method of being in charge of their own medical appointments – no staying up to date on world events.

In addition – they can’t comment on the very issue we are talking about….

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS and other Motor Neuron Diseases (MND) have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

Many of our patients use these devices when they are no longer able to speak and unable to move their hands, arms and legs. These devices are critical for communication.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Imagine losing your ability to share your thoughts and feelings. SGD gives people a voice, an ability to engage in conversation and be useful as a thinking and communicating family and community member and citizen.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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December 5, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

SGD's are necessary to give people voices Huey would not have otherwise. Communication is not only a human right but also link to the rest of the world. Please accept ASHA's proposals so that individuals who need this technology to communicate are not denied that right and remain connected.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Kathy Boada
12278 E LaSalle Pl
Aurora, CO 80014

December 3, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions—submitted by ASHA—to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson’s, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I strongly urge:
Please allow speech generating devices to no longer be rentals but to be purchased items for patients.
Please allow the coverage of medically necessary accessories for access including but not limited to eye technology.
Please allow the ability to use functions such as email and text messaging for individuals with that need.

I urge you to accept ASHA’s proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

Sincerely, Kathy Boada

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Thank you for the opportunity to provide comments to the Centers for Medicare and Medicaid Services (CMS) regarding the benefit category determination for Speech Generating Devices. America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.

AHIP and our member plans support CMS’s efforts to ensure that Medicare beneficiaries living with serious conditions such as cerebral palsy, amyotrophic lateral sclerosis (ALS), muscular dystrophy, and multiple sclerosis, among others, have access to speech generating devices that are critically important to beneficiaries’ ability to communicate. Since January 2001, speech generating devices have been categorized as a durable medical equipment (DME) benefit and have been covered for patients suffering from a severe speech impairment that warrants the use of such a device. At the time of the 2001 National Coverage Determination (NCD) for Speech Generating Devices, the functionality of such devices was typically dedicated to speech generation and, as such, the NCD was limited to dedicated speech devices. Technological advancements have vastly expanded the functionality of speech generating devices such that they are now able to assist patients in generating text and email messages to communicate with their caregivers and physicians. There has been some concern that beneficiaries with severe speech impairments would see reduced access to speech generating devices — even though “unlocking” these expanded functionalities would continue to be paid for directly by beneficiaries — because the device is not dedicated to speech generation.

We commend CMS for its intention, as stated in the solicitation of public comment and on its website, to “internally generate a reconsideration of the benefit category NCD addressing Medicare coverage of augmentative and alternative communication devices” in anticipation of developing an updated NCD by July 31, 2015. We urge CMS to recognize the integral nature of technology and health care and continue to provide beneficiaries with access to SGDs through Medicare coverage of speech functions while still providing them with the flexibility to privately pay for additional SGD functions. CMS’ reconsideration of the NCD should support a policy that is consistent with Medicare’s DME definition and, thus, prevents the potential for fraud and abuse. Specifically, while SGD software installed on a personal computer or other device is a covered benefit when all other coverage criteria in the SGD Local Coverage Determination (LCD) and related Policy Article (PA) are met, the device that runs the SGD software (i.e. laptop computer, table, smartphone) is not a covered item, as it is not primarily medical in nature, and thus, does not meet the definition of DME.

Thank you for the opportunity to provide these comments.

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To whom it May Concern,

Thank you for the opportunity to provide comments on the Medicare policy regarding speech generating devices. As an agency that provides Augmentative Alternative Communication (AAC) devices and services to individuals with disabilities, we see first-hand the challenges these individuals face every day. Speech Generating Devices (SGDs) provide an essential method of communication for individuals with speech language disabilities. Regarding the National Coverage Decision, please respectfully consider the recommendations of the American Speech Language Hearing Association (ASHA), the Rehabilitation Engineering Research Center on Augmentative Alternative Communications (RERC-ACT) and the Rehabilitation Society of North America (RESNA) in supporting the following:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware
2. Keep access to capabilities, features and functions that support device function as an SGD
3. Continue to allow SGD manufacturers to include environmental control capability
4. Continue to allow SGD manufacturers to provide phone control as an SGD feature
5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions
6. Keep coverage of eye tracking accessories
7. Update the SGD HCPCS codes
8. Keep the option for coverage of either a dedicated SGD or for SGD software

Thank you for your consideration of this important information.

Sincerely,
Cathy Bodine and the clinical team at Assistive Technology Partners
The faculty and staff of the Colorado Assistive Technology Program

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

As a speech language pathologist, I have seen how SGDs can change and greatly improve the lives of patients and their families. The SGD gives a voice to a patient who otherwise would not have one, allowing them a basic human right- the ability to communicate with others.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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December 4, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I am a speech pathologist in a VA Medical Center. We have many patients with ALS, and have a special clinic to try to meet their needs. In many cases, these Veterans lose the ability to speak early on in the disease progression, while continuing to have full cognitive abilities. Having a speech generating device (SGD) is imperative for them to continue to communicate with health care workers and with their own families and friends. Many times these patients also lose the ability to use their arms and hands as well, making it necessary for them to use more advanced means of access such as eye-tracking systems, with which they are able to use eye-gaze to operate the speech device, and therefore continue to be able to communicate. Although the VA is funded differently than Medicare, I feel that from my experience I can speak up for the many sufferers of neurodegenerative diseases that DO depend on Medicare for their ability to communicate. In my 18 years of being a medical speech pathologist, I have seen how devastating it is for someone to lose their ability to communicate, and how transforming it is for them to have a device to restore that ability.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Not having access to the devices needed as aneeded SLP would be devastating to the quality of life to our clients.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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December 4, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please read this letter and support what it says.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I appreciate the opportunity to provide input on Medicare policy regarding speech-generating devices. I have been a Special Education Teacher working with multiply handicapped children for the past 31 years. For the past 12 years I have worked as an Assistive Technology Specialist. I have also had experiences with individuals with ALS and PSP in my personal life.

SGDs are very important and life changing for so many individuals. They provide a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions.

With respect to the National Coverage Decision (NCD), CMS should:

1.Keep the option for coverage of either a dedicated SGD or for SGD software:

These options are important to allowing for unique customization and save money by allowing for resources to be used more efficiently. For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

2. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

3. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

4. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders
  These capabilities also promote independent living by:
• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

5. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.
Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

6. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

7. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.
Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

8. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please do not limit the availability/selection of communication devices for my patients. This will place limitations on their communication which has a direct impact on their quality of life.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I have experienced the heart breaking process of watching a dear friend being diagnosed with ALS and lose her speech and verbal communication abilities in a very short amount of time. Without a speech generating device to help her continue to be able to express herself and remain connected with those around her, this process becomes even more hopeless and dehumanizing. All of those dealing with such medically complex conditions are entitled to having their needs met in a realistic, affordable and individualistic way.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Until a few years ago, I had no idea what a Speech Generating Device was. I suppose when I saw images of renowned Physicist, Stephen Hawking, I never considered his computer tablet mounted on his chair enabled him to not only speak to people in his presence, but was the conduit for him to challenge the world of science.

Now that my life has been profoundly affected by far too many people with ALS, I am more than aware of the need for Speech Generating Devices and for them to be available with their full technological abilities.

I won't address the rules "reminder" points (capped rental, eye gaze, locked devices, etc), but instead simply want to point out that this rule sets up a number of barriers that prohibit the patient for what the former Secretary of HHS outlined as "Person Centered Planning". Not only are these rules barriers, but they also create an unsafe environment and prevent the patient in many cases from managing their own care. While it's not pertinent to these comments specifically, the rule, if enforced likely costs much more over time than if the patient had full technological access with the SGD and could manage their own care and environment vs having another human complete those tasks.

We strongly believe the efforts toward Person Centered Planning (PCP) is most appropriate for a person living with ALS or any other physically restrictive condition where the patient's cognitive abilities have not changed. In ALS, most often the patient's cognition is even sharper than before diagnosis. What was written: "PCP must be implemented in a manner that supports the person, makes him or her central to the process, and recognizes the person as the expert on goals and needs. In order for this to occur there are certain process elements, consistent with statutory or regulatory provisions."

A patient who has the full ability of their SGD can better manage their care, contact and connect with CMS, speak to their physician or care services representative and function as their own, The device would expand their abilities beyond the bedside, making them the central focus on every level in their care plan.

Additionally, their are safety issues when locking the devices. We've already seen a few people who needed emergency assistance outside of earshot and their locked devices could not connect with 911 or a caregiver for help.

Finally, I want to add that these devices are not just computers to those who use them. They are an extension of the person. The device allows them to communicate in the same ways we all do in the 21st century. Sit in a single chair for a week, take away your phone and keyboard and you will learn on a basic level what it is like for someone living with ALS and using a locked device. The SGD for many is as important as any medicine. With ALS, there is no treatment, but in most cases, the SGD acts as a medicine or even a prosthetic, allowing them to continue living with purpose, dignity and in centered on their own care.

People like Stephen Hawking are changing and challenging the world with their minds through their SGD's. CMS is in a unique situation to review old standards and move toward more innovative solutions for patients utilizing current technology, while also leaving the door open for new advances. Let's not miss another Stephen Hawking in the thousands of people who use or will use these devices.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

No one should be left with NO WAY to communicate. Try putting yourself in their shoes.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Accept the proposed revisions for speech generating devices

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I have personally seen the positive impact a SGD can have on a person's quality of life in my practice as a speech pathologist. Please do not restrict a person's access to communication.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I have personal experience with the problems of inadequate devices being available for patients I knew in the 1980s who were no longer able to speak or write because of ALS. The tragedy of this disease is often that the mind stays acutely aware of its inability to communicate adding additional stress and frustration of being trapped in a useless body and utterly alone with one's thoughts. I am writing to urge CMS to establish a coverage policy that ensures people with ALS have access to speech generating devices (SGDs), including the ability to upgrade devices and access additional functionality such as email, internet access and environmental controls. I also urge CMS to ensure coverage for access technologies like eye tracking, which people with ALS need in order to utilize an SGD if they have lost mobility in their hands and arms.

ALS is a fatal neurodegenerative disease that robs people of the ability to walk, stand, move their arms and even wink an eyelid — to do the everyday things most Americans take for granted. For many people, ALS also takes away their ability to speak. To even say hello or I love you. However, SGDs provide people with ALS a voice. Many of the SGDs needed by people with ALS also have features that enable people with ALS to communicate in other ways, such as through email, texting and online through social media. Moreover, some SGDs provide people with the option to access other features such as environmental controls so that they can continue to live as independently as possible as their disease progresses. SGDs are so critical to living with ALS. They are the window to the world for a person with ALS. Without them, a person with ALS is trapped, isolated and alone in a body they no longer can control and unable to communicate or interact with their loved ones or the outside world. SGDs are essential to living with ALS.

ALS is a horrific disease. Medicare policies should not make it worse. I again urge CMS to establish an SGD coverage policy that provides people the option of accessing additional SGD communications and non-communications functions, including while they are renting devices. I also urge CMS to establish policies that provide coverage for access technologies such as eye tracking. In doing so, Medicare can help improve the health and lives of the people that the program was created to serve.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).
SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.
The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.
Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders
  

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare. Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.
Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.
However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I fully support the SGD community. SGD is an important part of communication system for those patients who no longer have the ability to fully verbally express themselves. The various types of SGD should continue to be made available to patients who have limited ability to communicate verbally.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Communication is MORE THAN SPEECH and a computer is MORE THAN A SPEECH GENERATING DEVICE! Communication comes in many forms, texting, emails, etc. and the spoken word wether by a person or a device is NOT the only form of communication.

COMMUNICATION is a right & NOT a privilege. The ability to communicate SIGNIFICANTLY improves the quality of life not only for the person affected, but their family and caregivers as well.

However, this right is being threatened by the proposed CMS policy changes. Therefore, I support the following measures:

1) No changes to the definition of SGD.

2) Deletion of any disqualifying characteristics.

3) Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility.

4) The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions.

5) The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

I have had some patients who are appropriate for a SGD, and it is very frustrating to have a denial. At times, they have no other option for communication.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Communication is a vital to life! Please support these proposed revisions to ensure that individuals who require alternative means to communicate have the technology and funds to do so. Thank you.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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December 4, 2014

Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

[PHI Redacted] was diagnosed with ALS this past August. She is 42 years old, married for 20 years with three kids- ages 17, 15, and 10. She will benefit from a SGD in the near future. Quality of life is all ALS and other MND patients can hope for. Being able to communicate effectively is life sustaining for these patients and their families. It is imperative we ensure that persons with expressive and receptive communication limitations are not further limited by regulations. Please support all ASHA has proposed. As a [PHI Redacted] of a patient with ALS and a provider of Speech and Language services, thank you!

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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As a young college student in the 1960’s I visited what was then called a hospital for the retarded. Over 3000 people lived in that facility. Some were chained to the cement floor. Others lived in crib wards their entire lives. As a society, we decided that we could do better for these vulnerable people and that facility is long gone. By looking at the needs of each patient, it was discovered that many people in the facility had no cognitive issues at all. In the process, we also discovered that many people who were presumed to be incapable of communication were, in fact, able to express themselves—with the help of technology. First there were simple things like picture boards for those who could point and ‘yes/no’ switches. With the development of the personal computer, augmentative and alternative communication devices were created. Using a communication device, a person with serious disabilities who cannot speak can effectively communicate, even if he or she doesn’t have the physical ability to point at a picture. Children with congenital conditions as well as other non-literate individuals need devices with language systems that can convey abstract thoughts (“I am sorry”; “I am sad”), not just nouns and verbs. Adults with acquired disabilities, such as brain injury or ALS, need devices that do not require many hits of a key to generate language. And everyone needs the ability to communicate with different communication partners and in different settings. A person may talk one on one with a caregiver, but that is not her only communication partner. She will have peers at school or work and needs to be able to speak clearly and audibly in a group. She may have a specialist who monitors her via the camera in her device. She may use a text message to call for help. She will use a telephone to call for medical appointments. She sends emails to many communication partners, and may use social media to send messages to her government officials. The technology in her device permits all of these things. But technology changes. She may use Twitter or Skype today, but next year there may be a better tool. We should not look at the tool; we should look at the person. What is required to make clinically meaningful health outcomes for her? What is her condition? Her prognosis? What are her motor skills? What muscles can she control? Can she see? Can she hear? What are her language skills? Who are her communication partners? Is the device durable medical equipment that is subject to FDA regulations controlling safety and durability? Is adequate training included in the price of the device? How are outcomes measured?

Technology has changed the lives of people who use communication devices in many positive ways. Thank you for making this discussion about the future and not the past. As a society, we can continue to do better for people with disabilities.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

As a future speech language pathologist ensuring future clients will have access to SGDs is crucial to their recovery. Knowing I will be able to offer gold-standard care without the stress of worrying about SGDs being covered under insurance will be vital to not only my success as an SLP but more importantly the success of my clients who require a SGD for communication purposes.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

These revisions will greatly impact my own patients and allow them to have a higher quality of life, something that everyone should be able to access when possible.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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I am writing to provide public comment regarding the SGD NCD and proposed revisions. In addition, I will address changes in SGD funding that have been implemented since April 2014.

I have been a practicing SLP since 1993, which was prior to the SGD NCD implemented in 2001. The implementation of the SGD NCD was a significant improvement to the treatment options for those with severe, irreversible speech impairment and motor neuron disease. Prior to the rule, medically necessary speech devices to replace the non-functioning speech system were not available to these individuals. Traditional speech therapy was not effective in treating the severe dysarthria and speech impairment. With the 2001 SGD NCD, these individuals were able to regain the ability to independently communicate in an appropriate method commensurate with their intelligence and language abilities. This policy functioned extremely well from 2001 through 2013.

Beginning in October 2013, access methods required by those who had lost the ability to use their arms, hands and fingers were denied as not medically necessary. The access methods, such as head mouse tracking and eye tracking are extensions of the SGD and are required in order to use the device and without these accessory devices, the SGD would be worthless. These devices are not beneficial to individuals other than those intended to interact with the SGD in cases of severe physical disabilities. The updated NCD should include various access methods as required by those who cannot use standard limb movements.

Beginning in April 2014, SGDs were denied coverage if they could be upgraded at the users' expense to include other forms of communication besides audible speech. This change does not benefit CMS and does not reduce cost. In fact, suppliers had been in compliance with the dedicated device requirement and delivered devices that were locked in "speech only mode". After the client met the co-payment for the SGD they were then able to upgrade the device to allow alternative communication forms such as email. Again, this was at their own expense. Data supplied by the vendors demonstrates that very few devices were actually upgraded (unlocked) to allow other forms of communication. The updated SGD NCD should allow upgrades (unlocking) at the client expense.

Beginning in April 2014, restrictions were placed on funding of SGDs, specifically requiring ALL devices to be rented for a 13 month period. This makes no sense. SGDs are required for those with severe speech impairment, for whom no other form of traditional therapy will restore natural speech, for those with a permanent and irreversible speech disorder. These individuals are not going to get better. Their speech is not going to return. Why make them rent a device for 13 months? Furthermore, requiring a capped rental period of 13 months is restrictive and discriminatory against those with quickly progressing motor neuron disease which could result in a change of living situation to a setting such as nursing facility and/or hospice care. In these situations, those who must move to long term care wound lose access to SGD. In a disease which renders its victims completely paralyzed and trapped in a non-functioning body, access to SGD coverage is imperative in all living and care situations, including personal, private residential home through long-term care and even to hospice care. Removing access to communication devices for those at the end of life is inhumane and cruel punishment. The updated SGD NCD should allow for purchase of SGD and not require capped rental, or at the very least, allow coverage through out residential setting and care programs.

Finally, the changes that are in effect since April 2014, such as capped rental, do not address the ability of the device to be upgraded or unlocked at the users expense. Prior to April 1, 2014, clients could self pay upgrades to unlock the SGD to add features and functionality. If the SGD NCD will not be updated until July 2015, what is preventing those who have received a SGD under capped rental since April 2014 from unlocking/upgrading the device to allow alternate forms of communication such as email? At the present time, clients are being forced to pay their non-covered share for a device that does not meet all of the medically required communication modalities including spoken voice, email and other written forms of communication. I urge CMS to allow unlocking and upgrading of SGD supplied since April 2014 at the clients' expense.

Due to the changes in coverage implementation, many clients have been forced to purchase sub-par devices that attempt to meet their TOTAL communication needs at their own expense despite insurance coverage that would have paid for the appropriate technology during the years 2001 - 2014. Not only do they have a disease that has rendered them speechless, they have also been robbed of their voice. These are individuals who have worked entire careers and paid into the social security system who have now been let down - failed by a program that was supposed to help them in their time of need.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Thank you for helping us better help others.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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PROPOSED COMMENTS

Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

1. Continue to allow SGD manufacturers to use off-the-shelf technology as SGD hardware.

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

2. Keep access to capabilities, features and functions that support device function as an SGD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

• Enabling the SGD manufacturers to connect wirelessly to devices to provide technical support, troubleshooting, and software corrections and upgrades (independent of unlocking);
• Enabling photographs to be installed onto the device display, either through transfer from another device, or through a built-in camera; and
• Enabling copying and storing of device contents to protect against loss if the device malfunctioned or was sent for repair.

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

3. Continue to allow SGD manufacturers to include environmental control capability.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

• Providing users the ability to access medical alerting systems to call for help
• Allowing users to control access to the home, for example to allow access to the home for emergency responders

These capabilities also promote independent living by:

• Enabling users to be left alone
• Enabling independent access to care at home
• Providing the ability to maintain family and parental roles
• Enabling the ability to pursue volunteer or community activities

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

4. Continue to allow SGD manufacturers to provide phone control as an SGD feature.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

• The person who uses an SGD needs immediate means to call (send information) for medical emergencies, personal safety, and in case of disaster
• Managing communication about health care appointments and transportation to health care appointments
• Enabling users to receive information about disasters and emergency actions
• Enabling users to receive and respond to safety and emergency alerts

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

5. Authorize manufacturers to unlock SGDs: Allow upgrades to provide access to non-speech functions.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

• Calling for help in an emergency using a text-to-911 or instant message relay service
• Enabling users to receive and respond to safety and emergency alerts
• Sending an instant message to a caregiver in another room to request assistance
• Accessing medical records, schedule appointments, and communicate with healthcare providers via secure online healthcare portals
• Participating in tele-health visits with healthcare providers when travel to a clinic is impossible
• Using email to communicate with paid caregivers about scheduling, clarification of caregiving tasks, or other topics
• Accessing online user guides and technical support for training or troubleshooting with the SGD
• Enabling remote technical support, trouble shooting and device repair.
• Downloading page sets for use with the SGD’s communication software
• Keeping in touch with family and friends who live far away or are otherwise unable to visit
• Participating in online support groups or patient communities such as PatientsLikeMe

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

6. Keep coverage of eye tracking accessories.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

7. Update the SGD HCPCS codes.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

• Incomplete because no mention ever was made of the codes for SGD mounts or SGD accessories.
• Incorrect because one of the digitized speech output device codes was split into 3. Instead of 4 device codes, there are now 6.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

8. Keep the option for coverage of either a dedicated SGD or for SGD software:

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

• Dedicated built-for-purpose SGDs are configured and engineered to provide specific features that meet the needs of a variety of communication challenges not satisfied by SGD software alone.
• Dedicated SGDs are built to be durable, more easily heard in loud environments with high output speakers, easily mounted on wheelchairs and tables, and provide robust language representation options.
• Dedicated SGDs are adaptable for alternative access methods, such as head control, eye control, or switch scanning. Many people with communication impairments have co-occurring severe physical disabilities that leave them unable to use a standard mouse, keyboard, or touch screen. These individuals would be unable to use SGD software on a computer or tablet without alternative access options.
• Dedicated SGDs arrive ready to use as a packaged DME product, whereas SGD software requires the purchase of hardware that may be unaffordable or stress the financial resources of many Medicare beneficiaries.

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1. Users of SGDs have multiple disabilities.
2. People who use devices need to communicate with different communication partners, in different settings, and use many ways to do that!
3. The communication device should:
   • Be compliant with the FDA regulations for safety and effectiveness
   • Be durable enough to last for 5 year
   • Be supported with effective communication training as part of the purchase price
   • Contain outcome monitoring tools
   • Be customizable

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Thank you for considering my comments. I have seen the value of SGDs in the lives of clients, who are also becoming more and more technologically savvy. As one example only consider Steve Gleason, the former New Orleans Saints player coping with ALS. His SGD, which includes eye scanning allows him to communicate with friends, family and the larger world, to email, to talk to his young son, to express medical concerns, etc. It is his only means of communication as his body fails. Sadly many people with ALS lose their SGDs when they go to hospice and have NO voice at the time they may need it the most. Please support ASHA recommendations to help people without the means to talk. There is no more important population.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Dear Subash Duggirala,

As a speech-language pathologist and member of the American Speech-Language-Hearing Association (ASHA), I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

Please consider these revisions in support of the vital need for this vulnerable population those who rely on speech generating devices as the only effective means of communication.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.

In the 2001 NCD, Medicare recognized that both a dedicated SGD and SGD software that would be loaded onto a device the client already owned were appropriate for coverage. These choices must be maintained.

For some clients, SGD software, not a fully dedicated built-for-purpose SGD, satisfies a person’s communication needs. The SGD software may run on existing consumer computing products that a Medicare beneficiary already owns, allowing for unique customization and resource efficiency. This option also is cost-efficient for Medicare.

However, other Medicare beneficiaries with speech impairments can only get their communication needs met with a dedicated SGD. This funding benefit should also be maintained.

For these Medicare beneficiaries, who have physical impairments that now or that may progress to require use of mounting systems and access aids, and who lack the resources to purchase necessary hardware with their own funds, covering only SGD software and not dedicated SGDs would result in an inability to communicate. To avoid these harmful restrictions, CMS must continue to allow funding options for both dedicated SGDs and SGD software.

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I strongly agree with the reconsideration of this NCD to look at the devices that are more than just speech generating. Our older students depend on the multi-faceted use of their devices to communicate their needs past the person who is within ear shot of their device. These devices become very individualized and should be dedicated to the person who is setting up and using their device for all aspects of communication in this day and age of technology/communication.

Approval for speech devices with all communication capabilities, not just speech generation, is imperative for the population who needs them to meet their medical needs.

I appreciate this opportunity to comment.

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May 29, 2015

The Consortium for Citizens with Disabilities Technology and Telecommunications Task Force is pleased to provide the following comments to the Centers for Medicaid and Medicare Services (CMS) regarding speech generating devices (SGD). The Consortium for Citizens with Disabilities is a coalition of more than 100 national disability organizations working together to advocate for national public policy that ensures the self-determination, independence, empowerment, integration and inclusion of children and adults with disabilities in all aspects of society. The Telecommunications and Technology Task Force focuses on ensuring national policy on matters of telecommunications and technology, including assistive technology, helps move society toward our ultimate goal of full inclusion of all people with disabilities.

The CCD Technology and Telecommunications Task Force would like to thank CMS for their work on the NCD reconsideration. The CCD Technology and Telecommunications Task Force supports CMS’ newly proposed Medicare benefit category determination that would recognize remote speech in the form of both audible and written distance communications as legitimate communication functions for a SGD. This is an important step in the right direction for beneficiaries of SGDs. SGDs are necessary to the well-being of many Americans who require them to participate in society.

The Task Force strongly urges CMS to reconsider its position that a laptop computer, desktop computer or a personal digital assistant (PDA) cannot be covered as a SGD. It is clear these devices can primarily serve as an assistive technology for an individual who has a severe speech impairment and can be procured in many instances at a lower cost than other SGDs on the market.

The Task Force appreciates the removal of the word “dedicated” with respect to the function of a SGD. We also recommend that CMS incorporates the following sentence from the analysis portion of the Decision Memorandum into the text of the NCD: “As long as the speech generating device is limited to use by a patient with a severe speech impairment and is primarily used for the purpose of generating speech, it is not necessary for a speech generating device to be dedicated only to speech generation to be considered DME.”

Furthermore, given the history of misinterpretation by the CMS contractors, the Task Force is concerned about the absence of a statement addressing mounting technologies and/or accessories. We strongly encourage CMS to add the following language to ensure continued coverage:

Finally, the Task Force recommends that CMS issue the revised NCD for SGDs in final form as soon as possible. The uncertainty and confusion that arose in 2014 regarding SGD coverage and allowable features will not be resolved until this revised NCD is adopted as final administrative guidance.

The CCD Technology and Telecommunications Task Force appreciates the opportunity to provide these comments. If you have any questions, please feel free to contact one of the CCD Technology and Telecommunications Task Force Co-Chairs: Eric Buehlmann, eric.buehlmann@ndrn.org; Mark Richert, 4justice@concentric.net; Audrey Busch, audrey.busch@ataporg.org; Sara Rosta, sara.rosta@PPSV.com; or Michael Brogioli, mbrogioli@resna.org

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May 28, 2015

Comments on Speech Generating Devices

The Association of Assistive Technology Act Programs (ATAP) is pleased to provide the following comments to the Centers for Medicaid and Medicare Services (CMS) regarding speech generating devices (SGD). The Association of Assistive Technology Act Programs (ATAP) is a national, member-based organization, comprised of 54 state Assistive Technology Act Programs funded under the Assistive Technology Act (AT Act). ATAP was established in 1997 to maintain and enhance a strong, effective and efficient national network of Statewide Assistive Technology Programs which enables individuals with disabilities, service providers and others to learn about, access and acquire assistive technology (AT) needed for education, employment, and community living.

ATAP supports CMS’ newly proposed Medicare benefit category determination that would recognize distance communications as legitimate communication functions for a SGD. This is an important step in the right direction for beneficiaries of SGDs.

ATAP, however, strongly urges CMS to reconsider covering a laptop computer, desktop computer or a personal digital assistant (PDA) as a SGD. It is clear these devices can primarily serve as an assistive technology for an individual who has a severe speech impairment and can be procured at a much lower cost (in some instances) than other SGDs on the market.

ATAP appreciates the opportunity to provide these comments. Access to speech generating devices is a serious concern for our members. Please feel free to contact Audrey Busch, ATAP Director of Policy and Advocacy, at 202.344.5674 or audrey.busch@ataporg.org with any questions.

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December 5, 2014

SUBMITTED ELECTRONICALLY via CAGinquiries@cms.hhs.gov

Laurence Wilson
Director of the Chronic Care Policy Group
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
Attention: NCD 50.1: Speech-Generating Devices
P.O. Box 8016
Baltimore, MD 21244

RE: Joint DME MAC Coverage Reminder for Speech Generating Devices

Dear Mr. Wilson:

On behalf of the undersigned members of the Consortium for Citizens with Disabilities (CCD), a coalition of more than 100 national disability organizations, we would like to thank CMS for the opportunity to submit comments regarding the National Coverage Determination (NCD) 50.1: Speech Generating Devices (SGD). CCD works together to advocate for national public policy that ensures the self-determination, independence, empowerment, integration, and inclusion of children and adults with disabilities in all aspects of society. One focus of CCD includes assistive technology, inclusive of durable medical equipment and the role that technology and related services play in moving society toward our ultimate goal of full inclusion of all people with a disability.

Based on conversations with CCD members and other stakeholders in the disability community, the undersigned organizations of CCD support and request the following points be adopted by CMS:

• The original language defining SGDs does not require significant change;
• The language regarding disqualifying characteristics of SGDs needs to be removed;
• Device access technologies, including those that utilize eye gaze, must be recognized as essential, medically necessary accessories for patients with limited or no mobility;
• Other methods of communication, such as email, can be encompassed in the patient’s right to “upgrade” their devices at their own expense, without sacrificing the integrity of the SGD benefit; and,
• Maintain coverage of devices that include features that allow increased functionality and operation, e.g. blue tooth, telephone access, and infrared capabilities, where those features do not add to the cost of the device for Medicare;
• Update the SGD HCPCS codes to reflect today’s technologies;
• Maintain the option for coverage of either a “dedicated” SGD or SGD software, depending on the alternative that is appropriate and medically necessary for the beneficiary.

Although it is not a part of the original NCD or the February “clarification”, capped rental is a major barrier to comprehensive access to SGDs and communication devices. Capped rental causes significant problems pertaining to device upgrades and access to necessary features even those at the beneficiary’s own expense. The inclusion of SGDs as capped rental devices is inconsistent with recent references and decisions made by CMS. It is impractical to rent a speech-generating device and because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades. Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Clients who elect to unlock their devices impose no additional costs to Medicare. Many Medicare recipients use unlocked devices to support their health and independence.

It is clear, according to CMS text in a proposed rule, that capped rental leads to “complicated administrative procedures” that requires increased tracking for payment, replacements, and repairs, and additional claims processing system edits for counting rental months and non-continuous use. CCD, therefore, reiterates its request to exempt SGDs from the capped rental rule.

If you should have any questions, please contact any of the CCD Technology and Telecommunications Task Force Co-Chairs listed below.

Sincerely,

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December 2, 2014

Comments on Joint DME MAC Coverage Reminder for Speech Generating Devices

The Association of Assistive Technology Act Programs (ATAP) is pleased to provide the following comments to CMS regarding the National Coverage Determination (NCD) 50.1: Speech-Generating Devices. We appreciate the opportunity to provide comments. ATAP represents 54 state Assistive Technology Programs funded under the Assistive Technology (AT) Act of 2004. Assistive Technology Act Programs assure people with disabilities have access to and acquisition of the assistive technology services they need to live, work, and attend school in their communities.

State Assistive Technology Programs support the following points and additionally support the revisions in Attachment 1:

• The original language defining SGDs does not require significant change;
• The language with disqualifying characteristics needs to be removed;
• Device access technology must be recognized as essential, medically necessary accessories for patients with limited or no mobility;
• Other methods of communication, such as email, can be encompassed in the patient’s right to “upgrade” their devices without sacrificing the integrity of the SGD benefit; and,
• Capped rental continues to be the primary barrier to comprehensive access to SGDs and communication.

With respect to the capped rental issue, this payment decision appears to be an overarching issue that prevents device upgrades and exacerbates problems with access to communication devices. The inclusion of SGDs as capped rental devices is perplexing and inconsistent with recent references and decisions made by CMS. In proposed rules, CMS cites key statutes that verify the Secretary’s discretion in implementing the capped rental rule on certain devices. Specifically, § 1834(4) of the Social Security Act states:

Payment with respect to a covered item that is uniquely constructed or substantially modified to meet the specific needs of an individual patient, and for that reason cannot be grouped with similar items for purposes of payment under this title, shall be made in a lump-sum amount.

In addition, § 1834(2)(a)(ii) of the Social Security Act specifies that DME acquired by purchase at least 75% of the time can be exempt from capped rental. As indicated in 2012 PDAC data, SGDs were purchased 99.7% of the time. A recent announcement by CMS retroactively added an accessory code to the purchase list, demonstrating that CMS can provide a purchase option under their authority.

ATAP appreciates the opportunity to provide these comments and urges CMS to support these revisions. Please feel free to contact Audrey Busch, ATAP Director of Policy and Advocacy at 202.344.5674 or audrey.busch@ataporg.org with any questions.

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Dear Subash Duggirala,

As a supporter of the American Speech-Language-Hearing Association (ASHA) and citizen concerned about access to speech generating devices for Medicare beneficiaries, I am writing to request that you accept the proposed revisions-submitted by ASHA-to the National Coverage Determination 50.1: Speech-Generating Devices.

Speech-Generating Devices (SGDs) are used by patients with severe speech production impairment, such as dysarthria, apraxia, and aphasia as a result of neurodegenerative disease, traumatic brain injury, or stroke. For Medicare beneficiaries, the process for obtaining an SGD includes a recommendation from a physician and a comprehensive evaluation by a speech-language pathologist. The policy changes in 2014 related to SGDs have limited the types of devices available and limited the abilities of patients to communicate.

The revisions and recommendations submitted by ASHA include:

• No changes to the definition of SGD
• Deletion of any disqualifying characteristics
• Inclusion of device access technology, such as eye-tracking and infrared pointers, for patients with limited or no mobility
• The allowance of upgrades to include other forms of communications (such as e-mail) and other features necessary for patients with severe neurogenic conditions
• The removal of SGDs under the capped rental rule, so that patients can directly purchase the highly customized devices

Patients who require SGDs have medically complex conditions, including those with unstable progressive and degenerative diseases. Individuals who require SGDs often have multiple disabilities. The largest population requiring SGDs are patients with neurodegenerative disease (e.g., ALS, Parkinson's, multiple sclerosis), conditions where cognitive function and the need for communication remain intact, but the physiological ability to speak diminishes. SGDs are the only effective communication means for these patients, offering greater control of their health and their lives. SGDs are durable and customizable medically purposed technologies that allow the physician, speech-language pathologist, caregiver, and family to communicate with the patient/loved one.

thank you for your attention to this matter.

I urge you to accept ASHA's proposed revisions to the National Coverage Determination 50.1: Speech-Generating Devices. Doing so will ensure Medicare beneficiaries have access to the communication services they need. Thank you for your time and consideration regarding this important issue.

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Thank you for the opportunity to provide input on Medicare policy regarding speech-generating devices (SGDs).

SGDs are a vital means of communication for individuals with speech and language impairments, often with co-occurring severe physical impairments. They enable people with complex communication needs (CCN) to live more safely and independently, maintain important societal and family roles, and communicate important personal and medical decisions. With respect to the National Coverage Decision (NCD), CMS should:

In the May 2001 interpretive clarification to the 2001 NCD, Medicare expressly authorized coverage of computer-based SGDs as long as they were modified to function as “dedicated speech devices.” As Medicare reconsiders its SGD coverage and guidance, it is important that this option continue. Presently, several important SGDs make use of off-the-shelf or consumer computer based technologies. As required, these devices have been modified to meet Medicare requirements for coverage.

The size, weight, shape and access method are all important factors in the evaluation process for an SGD and off-the-shelf technologies provide additional options. SGD coverage should continue to extend to devices that are computer based, including those that rely on off-the-shelf hardware and components, as long as the devices meet the other requirements for coverage stated in the NCD.

Medicare covered SGDs: dedicated speech devices, used solely by individuals with severe speech impairment, require several capabilities, features, and functions to operate effectively and efficiently as SGDs. The 2001 NCD did not restrict any of these operational characteristics of SGDs, including

Some of these device features are not within the client’s control, and none add costs to Medicare.

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “wireless” capability as disqualifying for Medicare coverage and payment and its text raised questions about other similar features. Although the “coverage reminder” was withdrawn on November 6, Medicare should state clearly and confirm that any capability, feature or function that enhances or supports device operation as an SGD will continue to be covered.

SGDs have had the capability to enable users to operate external systems that can control lights, appliances, door openers, and home electronic devices, and access external alarm systems since before the 2001 NCD was developed and have continued to include these capabilities. These capabilities are generally referred to as “environmental control” or "electronic aids to daily living". The 2001 NCD does not restrict these environmental control capabilities that do not affect the primary or customary use of an SGD, and are not useful to an individual in the absence of an illness or injury. This capability is available at no additional cost to CMS. Instead, the ability of an SGD to operate environmental control functions requires home and appliance modifications, at substantial additional expense, paid for by clients.

Environmental control capabilities provide important benefits to clients. They aid safety by:

These capabilities also promote independent living by:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “environmental control” capability as disqualifying for Medicare coverage and payment. Although the “coverage reminder” was withdrawn on November 6, the NCD should state clearly and confirm that environmental control capability will continue to be covered.

A number of SGDs have the capability of connecting to telephone systems so that voice and text messages can be sent and received automatically through SGDs. Access to this capability enables telephone use by individuals who cannot place, answer or end calls physically or by voice. Like environmental control, the 2001 NCD does not restrict this SGD capability and accessing it does not result in any additional cost to Medicare.

Examples of why phone control is essential include:

The Medicare “coverage reminder” (Feb. 2014) specifically referred to “cellular communication” capability as disqualifying for Medicare coverage and payment. Although (1) “phone control” is not “cellular communication” capability, (2) SGDs typically do not include “cellular communication” capability, and (3) the “coverage reminder” was withdrawn on November 6, the NCD should clearly confirm that phone control capability will continue to be covered.

Medicare should allow users to unlock an SGD to allow access to non-speech capabilities, such as email and web browsing. Unlocking is consistent with the 2001 NCD. From 2001 – 2014 unlocking was allowed because the devices were client-owned equipment and Medicare policy allows modifications to client-owned equipment as the client chooses. Because of the payment rule change to capped rental, effective April 1, 2014, access to unlocking must now be based on other authority, such as DME upgrades.

Clients who elect to unlock their devices impose no additional costs on Medicare. Also, unlocking provides benefits in addition to, not instead of the device’s role as a speech generating device. A recent survey conducted by the Medicare Implementation Team, an advocacy group committed to maintaining SGD access for Medicare beneficiaries, found that Medicare recipients with unlocked SGDs use face-to-face communication (speech) more frequently than internet-based communication. Speech is still the primary and customary use of SGDs, even when they are unlocked.

Many Medicare recipients use unlocked devices to support independence and family and social roles. Examples include:

One outcome of the reconsideration process is that the NCD should state that SGDs can be upgraded at client expense to provide access to non-speech generating capabilities.

Eye tracking technologies have been available since before the 2001 NCD was written, and have been covered uniformly from 2001 when the NCD went into effect until late 2013. Since then Medicare decision makers have been denying eye tracking accessory claims, stating they are not covered.

Eye tracking technologies should not be considered different from other accessories needed by people with physical limitations. Eye tracking modules are only used by people with significant physical disabilities who are unable to use other access methods. Denying coverage of eye tracking technology leaves such individuals unable to communicate.

The 2001 NCD text describes the HCPCS “codes” that were initially assigned to SGDs and were used by Medicare (and other funding programs) for payment purposes. However, since 2001, the SGD codes have been changed and the NCD text is now both incomplete and incorrect.

The reconsideration process gives Medicare the chance to update and correct the SGD code descriptions and to insert the omitted code descriptions for SGD mounts and SGD accessories. These mounts and accessories are crucial to ensuring that individuals can consistently access their SGDs to communicate in all environments.