Sleep Testing for Obstructive Sleep Apnea (OSA)

January 22, 2009

Comments re: CAG-00405N Sleep Testing for Obstructive Sleep Apnea (OSA)

The Sleep Manufacturers Alliance (SMA) membership includes major manufacturers of diagnostic and therapeutic devices in the sleep disorder landscape. Our members include Cardinal Health, Covidien, DeVilbiss, Fisher Paykel Healthcare, ResMed and Respironics. We welcome the opportunity to comment on the proposed Decision Memo CAG-00405N that modifies the current categories of devices recognized by Medicare for use in home sleep testing for diagnosis of obstructive sleep apnea.

Obstructive sleep apnea is a dangerous disorder and is thought to be widely underdiagnosed. Patients who are suspected to have this disorder need prompt diagnosis and treatment, so alternative diagnostic pathways are welcomed. Since the therapy of choice is CPAP, a safe and effective therapy with no known clinical risks, it is appropriate to channel discrete resources to home diagnostic methodologies and more comprehensive resources to therapy.

We support adoption of this additional category of devices, but we raise several important questions that we believe CMS could easily address in its final posting on the proposed decision memo.

1. We believe there is some confusion as to how this Decision Memo correlates to the current NCD for diagnosis of sleep apnea that includes diagnostic device definitions. In order to ensure consistent application of the new Decision Memo as well as application of the existing NCD, we urge CMS to delineate clearly how the two decisions interact or meld together.

2. As manufacturers of diagnostic and therapeutic devices, SMA members are eager to hear the Agency's views about new technologies in the developmental pipeline that may not fit precisely into the current and proposed device categories. While we fully understand that CMS would review the scientific data that would accompany a new technology before making a determination, it does appear that the process associated with the pending Decision Memo signals somewhat of a product specific approach rather than a purely clinical approach. We ask CMS to comment on the possibility that an extended period of time will be required for NCD policy adjustments every time a genuine new technology measuring parameters not included in current definitions appears in the marketplace.

   We do recognize that the proposed Decision Memo has no direct mention of the WatchPat diagnostic device by Itamar, but we expect possible confusion by contractors/payors who might cite segments of the existing NCD as well as the DME MAC LCDs that implement the corollary facet of the broader obstructive sleep apnea coverage rules. Therefore, we urge CMS, as noted above, to specifically clarify in any final Decision Memo that directly or indirectly impacts the current NCD or corollary LCDs the need for contractors to adjust their policies accordingly.

3. In the event that the Decision Memo is adopted as proposed, we strongly urge CMS to promulgate appropriate coding parameters for the approved devices to ensure consistent and appropriate application of the decision by Medicare contractors.

We are willing to clarify any of these matters if you believe that would be helpful, and of course, we are glad to offer our expertise and resources to the Coverage and Analysis Group as you consider all the information provided related to this proposed Decision Memo.

The SMA would be glad to offer its resources to CMS in any capacity the Agency believes is appropriate, and would be willing to clarify or amplify any of these comments if requested. We can be reached at 703-752-4353 or ExecOffice@sleepalliance.org.

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Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Drs. Phurrough, Jacques, and Brechner and Ms. Stiller:

I strongly support the NCD for Sleep testing for OSA,(CAG-00405N), issued on Dec. 23, 2008. Ihave read it carefully, along with previous NCD''s related to OSA, CPAP and sleep testing. I have also carefully reviewed the two part technology assessment in August and December of 2007 as well as the literature describing HST and the use of peripheral arterial tonometry and specifically the WATCH-PAT device. I urge you to adopt the determination promptly.

I am a Board certified Sleep Specialist and AASM member. I have used several different home testing devices including the WATCH-PAT, and recently concluded a pilot feasibility study teaching primary care physicians to diagnose patients with HST''s, as well as treat OSA patients and make appropriate use of referral to sleep specialists and to sleep labs when medically necessary. This program has furhter convinced me that high quality primary care based programs are not only feasible but reperesent the future model of cost effective practice of sleep medicine in the US. This is strongly supportred by CMS''s decision regarding findings with repsect to HST devices, including the WATCH-PAT. I further support the distinction between devices based on PAT, such as the WATCH-PAT, and level 4 devices. The science supporting the diagnostic value, and clinical utility of the PAT technology for diagnosis of OSA is strong.

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January 22, 2009

Steve Phurrough, MD
Director Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Office of Clinical Standards and Quality
Mailstop: C1-09-26
7500 Security Blvd
Baltimore MD 21244

RE: Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N)

Dear Dr. Phurrough:

The American Academy of Otolaryngology - Head and Neck Surgery (Academy) represents approximately 10,000 physicians in the United States who diagnose and treat disorders of the ears, nose, throat, and related structures of the head and neck. The medical ailments treated by this specialty are the most common that afflict all Americans, old and young, including hearing loss, balance disorders, chronic ear infection, rhinological disorders, snoring and sleep disorders, swallowing disorders, facial and cranial nerve disorders, and head and neck cancer.

We have evaluated the aforementioned decision memo for sleep testing for Obstructive Sleep Apnea. The proposal states:
1. Type I Polysomnography (PSG) is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have clinical signs and symptoms indicative of OSA if performed attended in a sleep lab facility.
2. A Type II or a Type III sleep testing device is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.
3. A Type IV sleep testing device measuring three or more channels, one of which is airflow, is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.
4. A sleep testing device measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

Although we support this proposal, we would like to emphasize that otolaryngologists are well qualified to interpret level III and IV sleep studies due to their extensive training and board certification requirements. Our rationale is that Level III and IV home sleep tests are cardio-respiratory studies that are easily interpreted by any physician. These studies generally have 3-4 channels of data including oxygen saturation, pulse rate or EKG and air flow and respiratory effort tracings. Oxygen saturation and pulse rate/EKG are routinely evaluated by most licensed physicians and interpretation of these values is part of all general medical education. Furthermore, we believe that the effort and flow channels for these sleep studies are easily understood and do not require additional subspecialty board certification.

The American Board of Otolaryngology, an ABMS certifying body, certifies resident candidates’ comprehension of disorders and diseases that affect the head, ears, neck, upper respiratory and alimentary systems is a member of the conjoint Board of Sleep Medicine. As a part of this board, Otolaryngology has requirements for education in sleep medicine as part of its residency and Continuous Medical Education (CME). Hence, otolaryngologists who are board certified by this ABMS and ACGME approved board have sufficient knowledge to interpret Level III and IV home sleep tests. Consequently, regarding the criteria that you mentioned for Level I studies, we posit that additional subspecialty board certification, which encompasses all aspects of Sleep Medicine, is not necessary to interpret a Level I study. Currently, many physicians are interpreting Level I polysomnograms after pursuing additional training in this area. Further, active staff membership and privileging is specific for the skills and training of the physician applicant.

The interpretation of sleep studies by otolaryngologists is instrumental in the diagnosis of sleep disorders such as obstructive sleep apnea. Otolaryngologists have adequate training to interpret Level III and Level IV sleep tests. Consequently, it is our view that the requirement of a subspecialty to interpret these Level III and IV studies will limit access to optimal care rather than improve it. According to the Institute of Medicine’s report Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem only about 20% of patients with obstructive sleep apnea are diagnosed and treated. Further, it cited a lack of care for patients with Obstructive Sleep Apnea particularly as more patients are identified and seek treatment. In this report, the IOM recommended “Substantially upgrading access to medical services to prevent and manage sleep disorders by improving diagnostic and therapeutic technologies, especially portable technologies.”

We thank you for your consideration and we welcome the opportunity to discuss this issue further with you. If you have any questions regarding our recommendation, please contact Udo Kaja, Program Manager of Health Policy at (703) 535-3727 or via e-mail to Ukaja@entnet.org.

Sincerely,

David R. Nielsen, MD, FACS
Executive Vice President and CEO

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January 22, 2009

Dear Dr. Phurrough,

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) proposed coverage decision, Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N). America's Health Insurance Plans (AHIP) is the national trade association representing the private sector in health care. AHIP's member companies provide health benefits to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

General Comments
We encourage CMS to ensure that all patients receive the most safe, effective and appropriate treatments. AHIP and our members concur with CMS's proposed decision to provide coverage for Type I Polysomnography (PSG) for beneficiaries who have clinical signs and symptoms indicative of obstructive sleep apnea (OSA) if performed in a sleep lab facility. In addition, we recommend that CMS help enhance the quality of diagnosis provided by sleep laboratory testing by limiting testing to studies at sleep centers that are accredited according to the standards set by the American Association of Sleep Medicine (AASM), which has been accrediting sleep laboratories and sleep disorders centers since 1977.

AHIP has significant concerns with CMS's proposed coverage of home sleep tests, as home testing is less comprehensive than PSG, and is more susceptible to patient operator error and the misinterpretation of results. In regards to what may be the appropriate criteria to determine which beneficiaries would qualify for any home sleep test, AHIP concurs with the AASM's recent update of their clinical guidelines for home sleep testing that use should be limited to those beneficiaries whose physicians have determined them to have a moderate to high pre-test likelihood of OSA. Beneficiaries who have central sleep apnea, periodic limb-movement disorder, insomnia, parasomnia, circadian rhythm disorder, or narcolepsy, should not qualify for coverage of home sleep tests, nor those with co-morbid conditions that could affect the outcome of the test, such as congestive heart failure or stroke. In addition, portable monitoring should not be used to screen beneficiaries who have no signs or symptoms of a sleep disorder, even if they are in a high-risk group.

AHIP supports the coverage of unattended Type II, Type III, and Type IV (three or more channels) sleep testing devices only for beneficiaries who cannot access sleep laboratories within an appropriate time frame due to geographic limitations or clinical urgency. In addition, we only support coverage of these tests when the above patient criteria are applied, when patients are educated on the use of these tests prior to home testing, and it is accompanied by a complete sleep evaluation, which includes supervision and reading of the portable monitor by a physician who is board certified or board eligible in sleep medicine.

At this time, there is a lack of evidence demonstrating that actigraphy, the recording of body movement during sleep, is effective at evaluating and/or diagnosing OSA. Therefore, AHIP does not support coverage for those home sleep tests that include actigraphy. In addition, current evidence does not support the use of home pulse oximetry alone for the use as a screening or diagnostic test for sleep apnea; therefore, AHIP does not support coverage of any home sleep test that contains this singular modality.

Thank you for the opportunity to comment on these important issues.

Sincerely,

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The American Thoracic Society (ATS) welcomes the opportunity to provide comments regarding the Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N).

The ATS represents over 18,000 physicians, researchers, and allied health professionals. As stated in its mission statement, “the ATS is committed to the prevention and treatment of respiratory, critical care and sleep disorders through research, education, patient care and advocacy.” Members of the ATS are actively involved in fulfilling the society’s mission in the rapidly developing field of Sleep Medicine. Indeed, 60% of the CPAP services to Medicare beneficiaries are provided by pulmonary physicians. Training in the diagnosis and management of patients with OSA is part of the ATS’ official standards for training of pulmonary specialists – even those without formal specialization in Sleep Medicine. In addition the American Board of Internal Medicine’s Pulmonary Subspecialty examination includes sleep related breathing disorders and these specific domains in their testing.

The ATS endorses the CMS decision to expand testing for the diagnosis of OSA to include the use of portable monitoring devices in those adult beneficiaries with clinically suspected OSA. This decision complements the recently issued revision of CMS National Coverage Decision (CAG-00093R) that expanded coverage of CPAP treatment to include those patients diagnosed not only with polysomnography (Type 1) but also portable monitortesting (Types 2, 3, and 4, the latter requiring at least 3 channels).

The expansion of testing for the diagnosis of OSA to include the use of portable monitoring devices will allow greater patient access to testing. This decision will also stimulate the development of new diagnostic strategies for OSA that include sleep testing as part of clinical decision making and outcome rather than as an isolated event. A qualification to this position is that since the use of portable monitoring is not yet well validated in patients with underlying complex pulmonary, cardiologic or neuromuscular disorders, we recommend that, these patient groups should not have portable diagnostic studies, at least until this evidence becomes available.

To implement this decision and help ensure quality control, the ATS recommends:

1) CMS should work with the FDA to develop specific standards for validation and signal display of patient-based devices proposed to establish the diagnosis of OSA for the purposes of CPAP or for other treatments, including standards for outcome studies.

2) Physicians responsible for the performance and interpretation of attended and unattended polysomnograms (Type 1 and 2 studies) provide evidence for training and expertise in in-laboratory and portable technology for polysomnography and physicians responsible for the performance and interpretation of Type 3 and 4 portable monitor testing provide evidence of training and expertise in the unattended monitoring of cardiopulmonary variables over time with training and experience in referrals for polysomnography and assessment for non-cardiopulmonary disorders of sleep. The ATS believes that individuals certified in Sleep Medicine and/or Pulmonary Medicine (with appropriate and recommended training) should meet this requirement. While other physicians may receive such training, and should be trained to care for these patients in the future, at present there is not sufficiently widespread training of other groups for them to be considered as having adequate expertise a priori. We recommend that credentialing of such providers and/or laboratories should not necessarily be limited to only one accrediting body.

3) Interpretation of portable studies and laboratory-based polysomnograms must include the review of the raw, originally collected data.

4) The expansion of coverage of CPAP to include those beneficiaries with a diagnosis of OSA made using a combination of a clinical evaluation and portable sleep monitoring using a Type 2, 3 and 4 device should include all such devices. We believe that the emphasis should be placed on the available clinical evidence obtained with diagnostic devices using standardized equipment rather than embracing a device based on its classification. That is, the number of channels is less critical than the sensitivity and specificity of the diagnostic test.

5) Guidelines are needed on when in-laboratory testing should be performed and reimbursed when a portable monitor study in a symptomatic patient is negative or non-diagnostic. The ATS believes that there are times when it is essential to perform a complete polysomnographic study when portable monitoring is not adequate and that these studies should be reimbursed. The ATS, in concert with other scientific societies, should define the technological requirements and standards of practice for the clinical management pathways using these devices. These practice parameters should be published, subjected to testing and quality improvement, and updated as new technologies and evidence-based outcomes emerge.

6) The ATS believes that additional research is urgently needed to determine the appropriate role of portable monitors in clinical practice and develop a more holistic approach to the management of sleep apnea. We need to identify the signals that are essential for the “ideal portable monitor” and determine if any standardization is needed of sensors, signal conditioning, and scoring Our current method of diagnosing sleep apnea is too reliant on just one number – the apnea-hypopnea index. We need prospective research studies comparing clinical management pathways that include in-laboratory and home testing in diverse patient populations based on CPAP adherence, functional outcomes, and cost effectiveness. Federally funded clinical trials and practice-based networks could serve as the platforms for such research. In CAG-00093R, CMS promoted this initiative by approving CPAP coverage for patients participating in an approved clinical research study that uses portable monitor testing to diagnose OSA that does not comply with the accepted devices (Type 2, 3, and 4, the latter with 3 signals). We believe that this “Coverage with Evidence Development” opportunity should be reiterated in the current decision.

The ATS congratulates CMS on this important NCD providing coverage for portable monitor testing for the diagnosis of OSA. This disease is a major public health issue and we know that CPAP treatment in these patients reduces the symptoms of daytime sleepiness, lowers arterial blood pressure, and reduces the risk of motor vehicle accidents. Furthermore, growing evidence indicates that CPAP treatment for OSA reduces the rate of cardiovascular adverse events and death. CMS decision CAG- 00405N, in combination with CAG-00093R, means that patients with OSA will no longer be denied adequate care because of the expense and limited availability of polysomnography. The ATS believes that these decisions will have far reaching effects. By increasing the opportunity of its beneficiaries to be diagnosed and treated for OSA, CMS will improve their health status and reduce the devastating and costly consequences of undiagnosed and untreated OSA.

We thank you for providing the opportunity to present these comments.

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January 22,2009

Steve Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Room Cl-13-18; Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Proposed Coverage Decision Memorandum/or Sleep Testing/or Obstructive Sleep Apnea (OSA) (CAG-00405N)

Dear Dr. Phurrough:

Liberty Healthcare Group, Inc. ("Liberty") submits the following comments in response to the Proposed Coverage Decision Memorandum for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N), published December 23,2008 (the "Proposed Coverage Decision"). We submit these comments in accordance with § 1862(l) of the Social Security Act, and 68 Fed. Reg. 55634 (September 26, 2003).

Liberty is a wholly-owned subsidiary of Medco Health Solutions, a leader in managing prescription drug benefit programs that are designed to moderate the cost and enhance the quality of pharmacy health care. Medco provides pharmacy benefit management services for approximately 1 in 5 Americans.

Liberty is one of the nation's leading suppliers of Continuous Positive Airway Pressure ("CPAP") supplies to Medicare beneficiaries. Presently, Liberty serves over 1,000,000 Medicare beneficiaries nationally, including beneficiaries with obstructive sleep apnea ("OSA"). The Proposed Coverage Decision directly impacts Liberty. Therefore, Liberty is a stakeholder in this matter.

Liberty comments here on two aspects of the Proposed Coverage Decision. First, Liberty is concerned that the Proposed Coverage Decision is not consistent with Medicare coverage determinations regarding CPAP. Second, Liberty supports CMS's determination reflected in the Proposed Coverage Decision that diagnosis of OSA not be restricted to particular categories of physicians. We address each ofthese in turn below.

A. Consistency with CPAP Coverage Determinations.

Liberty is concerned that the Proposed Coverage Decision is not consistent with the recent National Coverage Decision ("NCD") regarding coverage of CPAP for treatment and management of OSA, and the related Local Coverage Determinations ("LCDs") regarding the coverage of CPAP and other respiratory assist equipment and supplies for the treatment of OSA. This lack of consistency is likely to lead to circumstances in which a test use to diagnose a Medicare beneficiary's obstructive sleep apnea ("OSA") is covered, while the appropriate therapeutic intervention for management of the OSA is not covered.

Minimally, the inconsistency will lead to confusion in the furnishing of tests to diagnose OSA and in the furnishing of CPAP, and may require the use of additional testing after an initial test is used to diagnose OSA, in order for CPAP to be covered by Medicare. This will result in unnecessary Medicare program expenditures, or if the additional testing is denied as not reasonable and necessary, additional beneficiary expense because the testing will be furnished under Advance Beneficiary Notices.

Specifically, the recent CPAP NCD extends Medicare coverage of CPAP to circumstances in which the beneficiary's OSA diagnosis is based on an unattended home sleep test using one of three types of monitoring devices, designated as Type II, Type III and Type IV in the NCD (being in addition to the previously covered polysomnography performed in a sleep laboratory). See CMS Trans. 96, CR 6048 (October 15, 2008) (modifying Medicare National Coverage Determinations Manual, ch. 1, § 240.4 (CMS Pub. 100-03)). Following the promulgation of this NCD, LCDs have been promulgated which parallel the NCD and extend CPAP coverage where an unattended home sleep test is provided with a Type II, Type III or Type IV device. See, e.g., Noridian Administrative Services, LCD for Positive Airway Pressure Devices for the Treatment of Obstructive Sleep Apnea, L171 (rev. eff. January 1, 2009) (the preceding NCD and LCDs are referred to as the "CPAP Coverage Determinations").

The Proposed Coverage Decision makes it clear that unattended sleep tests performed with Type II, Type III or Type IV devices are covered by Medicare (where certain conditions are met).

However, the Proposed Coverage Decision also extends Medicare coverage to tests performed with a Watch-Pat device, which is not a Type II, Type III or Type IV device. The Proposed Coverage Decision states that "a sleep testing device measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility." Proposed Coverage Decision at 1.

Therefore, a beneficiary might obtain a covered test used to diagnose OSA using a Watch-Pat device, and if the beneficiary has OSA, the therapeutic intervention necessary to treat the OSA, e.g., CPAP, will not be covered. The CPAP Coverage Determinations do not cover CPAP unless the test used to diagnose OSA is either an in-facility, attended polysomnogram or an attended or unattended test using a Type II, Type III or Type IV device. The CPAP Coverage Determinations do not cover CPAP where the test used to diagnose GSA was perfonned with a Watch-Pat device.

Liberty does not oppose coverage of sleep tests perfonned with the Watch-Pat device. However, Liberty points out that the coverage inconsistency between the Proposed Coverage Decision in its present fonn and the CPAP Coverage Detenninations is not in the interest of Medicare beneficiaries or the Medicare program.

Liberty urges that CMS eliminate this inconsistency. CMS can rectify the coverage provisions in a couple of ways, assuming CMS believes it appropriate for Medicare to cover sleep tests perfonned with the Watch-Pat device. First, the definition of a Type IV device could be modified to include the device, in addition to the types of devices already included in this category. CMS could make it clear that the revised definition applies to the CPAP Coverage Detenninations as well as to the coverage of testing.

Alternatively, either the GSA tests that support CPAP coverage in the CPAP Coverage Detenninations could be expanded to include tests using the Watch-Pat device, using the same wording as in the Proposed Coverage Decision, or the CPAP Coverage Detenninations could be simplified so that CPAP is covered where GSA is diagnosed based on a Medicare covered sleep study.

We believe that harmonizing the coverage of GSA tests and CPAP devices and supplies will benefit both Medicare beneficiaries and the Medicare program, for the reasons stated above, and will eliminate unnecessary cost and confusion.

B. Diagnosis of GSA.

The Proposed Coverage Decision states that "the evidence is sufficient to detennine that the results of the sleep tests identified below [in the Decision] can be used by a beneficiary's treating physician to diagnose OSA and prescribe CPAP therapy." Proposed Coverage Decision at 1 (emphasis added). Nothing in the Proposed Coverage Decision restricts the coverage of sleep tests or CPAP to where it is ordered, interpreted or prescribed by a subcategory of physicians, or physicians with particular specialty certification.

Liberty strongly supports this detennination by CMS. Recent LCDs for CPAP require that home sleep tests be interpreted by physicians who are board certified in sleep medicine, board eligible (except for taking the examination), or are members of the active staff of a sleep center or lab accredited by the American Academy of Sleep Medicine or The Joint Commission.

This kind of coverage restriction is not consistent with coverage requirements elsewhere in the Medicare program, and to the knowledge of Liberty is unprecedented. As an example, Medicare coverage of chemotherapy is not restricted to where it is prescribed by a Board certified oncologist. It is not consistent with Medicare program policy in general that CPAP be covered only where it is prescribed by certain categories ofphysician specialties.

Moreover, the restriction in the LCDs has a negative impact on access to appropriate therapeutic intervention for beneficiaries who suffer from GSA. This is a particularly pronounced problem in view of the fact that sleep medicine certification is relatively uncommon, and is a particularly pronounced problem in rural areas. We urge that the Proposed Coverage Decision be implemented without modification of the provision that diagnosis of OSA and prescription of CPAP may be by the "beneficiary's treating physician," without restriction to specialty. We also recommend that CMS make it clear that it does not intend Medicare coverage of sleep tests and CPAP to be restricted based on physician specialty certification.

Thank you for your time in considering these comments and suggestions. Liberty appreciates and supports CMS' efforts to improve access to and the delivery of needed, quality healthcare to the beneficiaries of the Medicare program. We welcome the opportunity to work with CMS in addressing the issues contained in this document. Please feel free to contact me directly at the following phone number (201) 269-6810 with any questions that you may have.

cc: Louis Jacques, M.D.
Director, Division of Items and Services

Jean Stiller, M.A.
Lead Analyst

Ross Brechner, M.D., M.S., M.P.H.
Lead Medical Officer

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January 22, 2009

Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

CMS: Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N)

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

On behalf of Itamar Medical, Inc. (Itamar) I submit these comments in support of the proposed National Coverage Determination (NCD) for sleep testing for obstructive sleep apnea (OSA) (CAG-00405N). We are very appreciative of the time and deep consideration the Coverage and Analysis Group (CAG) has dedicated over the past several years to the issue of coverage of sleep testing for obstructive sleep apnea. We agree with the findings of the proposed Decision Memorandum and the proposed NCD language and ask that CMS finalize the NCD as proposed with two minor clarifications. We believe that these clarifications, discussed below, will help to better describe the diagnostic capabilities of the five types of devices that would be covered by the new NCD. We also offer a brief discussion in response to some issues raised by other commenters, and make note of the need of an additional G code to describe the devices and tests to be covered.

I. Brief Background

The Watch-PAT family of portable sleep testing devices have been cleared by the Food and Drug Administration (FDA) and each is labeled for use in the diagnosis of obstructive sleep apnea. Watch-PAT devices are in widespread use throughout the United States. Over 40,000 diagnostic tests using the Watch-PAT have been performed in the United States, and tens of thousands of studies have been performed outside the U.S. The Watch-PAT is considered standard of care by Kaiser Permanente, the Veterans Health Administration, hospitals, sleep labs, and hundreds of sleep specialists throughout the country.

The VHA Field Advisory Committee for Sleep, which is charged with establishing clinical best practices, evaluated Watch-PAT and determined that it performed as well as any Type III device, had a low failure rate, and was easy for both patients and physicians to use. Similarly, Northern California Kaiser Permanente selected Watch-PAT as its preferred home sleep testing device for diagnosing and managing patients with OSA. Like the VHA physicians that evaluated Watch-PAT, the Kaiser physicians have concluded that Watch-PAT is accurate, performs as well as any Type III device, has a low failure rate, and patient-friendly. The Northern California Kaiser centers have completed more than 15,000 Watch-PAT studies and continued expansion through the Kaiser system is expected.

It is clear that the Watch-PAT devices have been vetted not only through the FDA clearance process, but also through actual clinical use. It is among the sleep testing devices physicians choose for their patients.

1. Test Classification

Itamar agrees with Medicare's proposed decision to cover sleep testing using Type I devices, Type II devices, Type III devices, Type IV devices with three or more channels and devices that measure three or more channels that include actigraphy, oximetry and peripheral arterial tone, whether such studies are performed in an attended or an unattended setting. The CMS proposal acknowledges and respects the existing categorization system (Type I-IV) of sleep testing devices established 15 years ago by the American Academy of Sleep Medicine, while at the same time recognizing that technology has evolved since 1994 and the classification system simply no longer describes all the types of sleep testing that has been cleared by the FDA for the diagnosis of obstructive sleep apnea. Furthermore, the classification system was not developed to be, nor is it today, an indicator of the type or quality of evidence available about any particular type of devices or a particular device within a class. It is a nomenclature only.

Because of the limitations of the classification system, CMS has articulated two new "Types" of devices that are used by sleep physicians to assist in their diagnosis of OSA. One new category indentifies devices that have an airflow channel, but that do not measure as many clinical elements as a Type III device; yet, they provide more comprehensive diagnostic data than standard Type IV devices. CMS coined the term "Type IV with 3 or more channels" to describe this group of devices. It was necessary to create this category so that devices that are more sophisticated than the recognized Type IV devices are not unfairly grouped in a category with devices that provide less clinical information. CMS has taken a similar approach with the Watch-PAT devices that use technology different from the technology that underlies the devices in categories I, II, III, IV, and IV (3+ channels). In the CPAP NCD, CMS sought to use the category of Type IV (3+ channels) as a "catch-all" or "miscellaneous" group, and grouped the Watch-PAT devices in the Type IV (3+ channel) class. Since that time, it has become clear that the Watch-PAT devices do not belong in this category as the Watch-PAT technology differs from those devices accurately described by the term of Type IV (3+channels) and because the Watch-PAT devices provides more diagnostic information than the Type IV (3+ channel) devices. In fact, if the Watch-PAT devices were to be grouped according to the type of information available to the treating physician, the devices should be group as Level II.

Coverage for devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Type II devices. While the ability of Type III devices and Type IV devices (3+ channels), which do not measure sleep time or sleep architecture, to diagnose sleep apnea has been well-evidenced (as properly described in the Draft Decision Memo CAG-00450N), it is important to recognize that for certain patients, proper diagnosis and management of therapy requires an accurate determination of AHI, which entails an actual measurement of sleep time, rather than an 'estimated time', as is the case when using Type III or Type IV (with 3 channels) devices. Furthermore, information about sleep states, including deep sleep and REM provide valuable information about the quality of sleep and help assess the efficacy of a treatment, ensuring that the therapy does not only reduces AHI but also helps patients benefit from the restorative and cognitive performance associated with such sleep stages.

We suggest that the NCD separate Type II and Type III, listed together in paragraph 2 of the Draft Decision Summary, and that a "sleep" element be added (underlined below) to the description of the respective devices (Type I, Type II and the PAT-based devices) in the following or similar manner:

Type I Polysomnography (PSG) is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) and the assessment of sleep in beneficiaries…

A Type II sleep testing device is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) and the assessment of sleep in beneficiaries…

A sleep testing device measuring three or more channels that include actigraphy, oximetry and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) and the assessment of sleep in beneficiaries…

The description for Type III and for Type IV measuring three or more channels would remain as currently worded in the proposed decision memorandum.

We also ask CMS to add language to the actual NCD (as opposed to only in the final Decision Memorandum) that makes clear that the coverage policy provides coverage for portable studies performed in any site of service a treating physician determines is appropriate. We recognize that the proposed decision memorandum states that sleep tests using these devices will be covered "if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility," and while this language seems clear, there has been confusion regarding covered sites of service following the publication of the revised CPAP NCD. To avoid any new issues, we suggest that a parenthetical be added to each of the statements regarding CMS's coverage of unattended sleep studies such that they read (by way of example) "[a] sleep testing device measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone is covered when used to aid the diagnosis . . . in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility (e.g., home, hospital, skilled nursing facility) or attended in a sleep lab facility."

III. Response to Commentary

1. Utilization

We understand that a commenter raised concern that coverage of unattended sleep testing could result in improper utilization of sleep tests. The examples provided suggested that physicians might over utilize home sleep testing because it is more convenient for patients or use home testing as a way to support coverage of an otherwise non-covered cosmetic procedure (e.g., repair of the nasal septum), or use unattended testing as a screening tool. Another commenter suggested that an explosion of unnecessary testing that will ensue from the proposed coverage policy. Of course, there was no data offered to support these allegation. Moreover, many of these allegations involve behavior likely to be considered abusive, if not fraudulent, and thus could only result from the unethical behavior of hundreds of physicians, sleep labs, hospitals and others who treat patients with OSA. We certainly, from our experience in health care and with the physician community, find it hard to believe that such behavior is as rampant as implied.

The issue of utilization was fully vetted during the NCD process for the revised CPAP NCD, and there was no evidence that coverage of unattended sleep testing necessary will lead to overutilization. In fact, the proposed NCD policy for sleep testing mirrors the sleep testing policy articulated in the CPAP NCD Decision Memorandum. CMS itself noted that it has "no evidence that physicians refer 'normal' patients, i.e. patients who manifest no symptoms or signs of a sleep disorder, for sleep testing." Even if misutilization was documented, the proposed coverage policy limits coverage to test performed on patients who have been clinically evaluated for OSA and present with signs and symptoms suggestive of the problem. We agree that this is the cornerstone of the care of the patient who may be suffering from OSA. Sleep testing, like any diagnostic test, is but only one piece of information used by a physician treating a patient. What is more, the proposed NCD merely gives treating physicians the ability to choose the right test for a particular patient. The is no one sleep test meets the needs of all patients.

In addition, the system is set up to deal with potentially misuse of any diagnostic test or physician service through a panoply of means such as the monitoring of physician utilization by the Medicare Administrative Contractors, random audits performed by several other contractors of the Medicare program, and investigations by the enforcement arms of the federal government. Questionable physician ordering patterns, whether related to improper use of a test as a screening tool or intention misuse, will, upon examination of claims data, appear as outliers and would be subject to review. If any type of sleep study was not medically necessary, the physician and the provider of the test would be subject to recoupment of the moneys paid for medically unnecessary sleep studies, and possibly civil and criminal fines.

Two commenters suggested that the proposed NCD not be adopted because it not consistent with American Academy of Sleep Medicine guidelines for portable monitors used in the diagnosis of OSA in adults. The focus was the coverage of the Watch-PAT devices. We agree that the proposed NCD is not the same as the AASM guidelines. Unlike the AASM Practice Guidelines, the NCD review involved a detailed analysis by a third-party of all types of portable monitors and a complete review of the available peer reviewed literature as well as a comprehensive technology assessment by AHRQ, testimonies to a Medicare Coverage Advisory Committee, and solicitation of public comments.

The AASM guidelines, on the other hand, focused on Type III devices. The guidelines also were not based on a complete evaluation of the published peer-reviewed medical literature, especially literature on devices measuring peripheral arterial tone. According to the guidelines, only four articles presenting data on the Watch-PAT were reviewed. CMS reviewed three of these four studies, along with another 6 papers. Thus, the CMS coverage analysis was far more exhaustive and complete than the analysis performed by the AASM Portable Monitoring Task Force. Consequently, while the AASM guidelines may be a benchmark tool in relation to Type III devices, it is not, by the authors own admission, a thorough review of all types of sleep testing devices.

A commenter suggested that the Watch-PAT devices should not be covered because it does not allow a physician to differentiate whether a patient has obstructive, mixed or central sleep apnea. Central sleep apnea (CSA) is a different disorder that is not the subject of the current coverage process, nor has there been any claims made that the proposed policy should be extended to central sleep apnea. However, in clinical circumstances in which OSA is suspected and CSA is not suspected, diagnostic testing such as provided by the Watch_PAT and other portable sleep testing has been shown to provide all the data available to demonstrate that it can make an accurate diagnosis of OSA. Again, we are confident that physicians will use their clinical acumen in choosing a diagnostic test based on patient clinical presentation.

A commenter suggested that coverage of unattended sleep studies will increase total Medicare spending thereby depriving patients of other health care and, therefore, such studies should be non-covered. We could not disagree more. Extensive experience by major healthcare networks, including Kaiser Permanente and the Veteran Affairs Health Administration has demonstrated that by using a combination of various types of sleep diagnosis methods including PSG, Type III devices and devices using peripheral tonometry (to also provide sleep data), whether for conducting an initial diagnosis or managing patients post initial intervention, has resulted in an overall lower costs for those systems, better utilization of resources and enhanced outcomes.

IV. G Codes

We understand that CAG is not the office within CMS delegated the task of developing G codes needed to implement new coverage decisions. Nevertheless, because clear and easily understood coding is as important to the smooth and proper implementation of a coverage policy as the National Coverage Determination itself, we raise here the need to revisit the G codes that describe sleep testing that were developed at the time the CPAP NCD was revised. These G codes do not capture the coverage category established for devices that use that use actigraphy, oximetry, heart rate and peripheral arterial tone to detect and measure apnea/hypopnea events and diagnose OSA. As a result, another G code needs to be established. We suggest the G code descriptor language be the same as, or similar to language recently developed by a workgroup designated by the CPT Editorial Panel and charged with considering new codes for sleep testing.

Adoption of a G code using this language would make the eventual transition to a CPT code easier.

We also recognize that this NCD may lead to additional G codes describing similar studies when performed in attended settings.

We hope these comments were useful, and that you will consider our suggested modifications. If you have any questions, please do not hesitate to contact me.

Respectfully submitted,

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Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group

Louis Jacques, MD
Director, Division of Items and Devices

Jean Stiller, MA
Lead Analyst

Ross Brechner, MD, MS (Stat.), MPH
Lead Medical Officer

Re: Proposed Coverage Decision Memorandum for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N)
December 23, 2008

We are in support of the proposed NCD as it provides clarification that homes sleep testing is reasonable and necessary to aid in the diagnosis of obstructive sleep apnea (OSA).

The proposed NCD is appropriate as it drawn from the same extensive evidence base that drove the March, 2008 NCD: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2). This new proposed NCD clarifies that the testing itself is reasonable and necessary when used in patients in whom there is clinical suspicion of OSA.

Home sleep testing has much to offer the Medicare program, as it allows for greater access to testing that is less expensive and less intrusive. This is particularly important given the high prevalence of OSA and the fact that the majority of patients with this condition remain undiagnosed and untreated. Patients with OSA who are not treated are at increased risk for a variety of problems including stroke, heart failure, myocardial infarction, and accidents. The consequences of undiagnosed and untreated OSA are significant to the Medicare program. Home sleep testing is an important option for confirming the diagnosis of OSA.

Sincerely,

Jon Freudman, MD
On behalf of Sleep Solutions Inc.

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January 21, 2009

Steve E. Phurrough, M.D., MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Louis B. Jacques, M.D.
Director, Division of Items and Devices
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Jean Stiller, MA
Lead Analyst
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Ross Brechner, MD, MS, MPH
Lead Medical Office
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Re: Proposed Coverage Decision Memorandum for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-)

Dear Drs. Phurrough, Jaques, and Brechner and Ms. Stiller:

The American Academy of Sleep Medicine (AASM), an organization composed of over 8,300 Sleep Medicine practitioners and more than 1,600 accredited sleep facilities, greatly appreciates the opportunity to submit comments on this Proposed Coverage Decision Memorandum that effectively will recognize coverage for a new sleep testing device. The proposed coverage expansion will have the effect of restructuring the types of sleep tests and recognizing a new category of sleep testing device that may be used to aid in the diagnosis of obstructive sleep apnea (OSA) as follows:

1. Type I Polysomnography (PSG) is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have clinical signs and symptoms indicative of OSA if performed attended in a sleep lab facility.

2. A Type II or a Type III sleep testing device is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

3. A Type IV sleep testing device measuring three or more channels, one of which is airflow, is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

4. A sleep testing device measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

Test Classification

The AASM has serious concerns with these non-specific and overlapping definitions for the sleep tests that currently are classified as Type I, II and III. This is inconsistent with the established definitions for these three types of tests. This direction does not provide any differentiation between the Type II and III testing devices and only distinguishes the Type I test through the reference to PSG. We are hard pressed to imagine that this full scale redefinition of testing modes is the intent of the proposed decision memorandum. Such a radical restructuring is not supported by any of the information provided in the proposed decision memorandum or in the formal request from Itamar Medical that initiated the request specifically to develop “an NCD that will address coverage for home sleep testing devices that diagnose OSA by measuring the peripheral arterial tone (PAT) signal, heart rate, blood oxygen saturation and sleep time.”

If there are any modifications being proposed to the established definitions of Type I, II, or III tests, we expect to see a reasonable and detailed rationale that supports such wholesale changes. If the presented is direction is anything other than “writer shorthand” to facilitate presentation, we hereby request that the comment period be extended to address the series of questions and concerns that this substantial modification will engender. Assuming that CMS does not intend to propose changes to the established definitions of what constitutes a Type I, II, or III test, we expect to see a clarification at your earliest convenience.

In looking at the proposed language for a Type IV test, the AASM supports the clarification that one of the three channels has to be airflow. This addition eliminates the guesswork previously associated with what constitutes a Type IV test by establishing that this test must take into account a central element that must be addressed in effectively identifying and treating a patient with OSA.

The AASM also has concerns with how an actigraphy, oximetry, and peripheral arterial tone sleep testing device should be classified. Without the proposed and reasonable modification that a Type IV test includes airflow, it is our understanding that such a testing mechanism falls into the Type IV classification. This understanding is based on both how the test operates and how Itamar has advertised its Watch-PAT family of devices as being reimbursable through “Medicare Approved Code: G0400” (please link to the publication cover and the Itamar advertisement). As the device indeed does not measure airflow, it now would fall outside of the Type IV category. Given the potential problems of overutilization and our very real patient care concerns that could arise from the inappropriate application of the testing information from an actigraphy, oximetry, and peripheral arterial tone device, the AASM recommends that this device be classified as a Type V device if coverage is allowed for this mechanism.

Coverage and Clinical Guidelines

A portable monitoring (PM) device that supports an OSA diagnosis based on a combination of actigraphy, oximetry, and peripheral arterial tone fails to meet many of the pertinent Clinical Guidelines for the Use of Unattended Portable Monitors in the Diagnosis of Obstructive Sleep Apnea in Adult Patients (please see the link to the Guidelines). The Guidelines point out that these devices simply are not appropriate to be used for the diagnosis of OSA in patients with significant co-morbid medical conditions where those conditions may corrupt the accuracy of information generated by the device. To provide an adequate level of information to contribute to an OSA diagnosis, portable devices must: record (at a minimum) airflow, respiratory effort, and blood oxygenation; and allow for a display of raw data with the capability of manual scoring or editing of automated scoring.

One of the concerns with PM equipment as a tool in making an OSA diagnosis is the perceived simplicity in connecting the test results with the diagnosis. This is especially true with the simple to use device where peripheral arterial tone and the associated “black box” algorithm serves as the basis for the test result. Without a corresponding require-ment, such as the one established in the DME MAC LCDs where the test needs to be interpreted by a qualified physician as a criterion for CPAP coverage, we are concerned that there will be an explosion of unnecessary testing. According to the Guideline:

“Comprehensive clinical assessment ensures several important facets of care:

1. Appropriate health care utilization. By providing skilled assessment prior to study, sleep medicine clinicians ensure that use of portable monitoring is appropriate for a given patient, thereby avoiding overutilization or application of PMs when attended study or alternate diagnostic assessments should be performed.

2. Comprehensive diagnostic assessment. Patients undergoing portable monitoring for suspected OSA frequently present with co-morbid medical and psychiatric conditions as well as other sleep disorders. Comprehensive evaluation is necessary to ensure that these co-morbid conditions are reliably identified and addressed in a comprehensive therapeutic approach.”

In addition to this serious concern over inappropriate utilization, the absence of a physician qualifications requirement presents the unfortunate situation where a patient will be tested by a physician where the testing services will be reimbursed by Medicare Part B and yet the patient will not have Medicare coverage for the associated CPAP.

The Guidelines also point to scenarios where use of the actigraphy, oximetry, and peripheral arterial tone devices would not be appropriate:

January 21, 2009

SUBJECT: Proposed Decision Memo, Sleep Testing for Obstructwe Sleep Apnea (USA) (CAG-00405N)

Dear Sir:

We are writing to express serious medical and administrative concerns that are raised by the proposed Decision Memo for Obstructive Sleep Apnea.

First, we are concerned that the data for WatchPAT and HSTs in the Medicare population are far less credible than the draft NCD implies. This is brought into sharper focus by the emphasis on WatchPAT in this NCD. Many of the articles cited by Itamar and a number of those cited by CMS are either irrelevant or extremely weak in support of CMS’s proposed position.

Second, it is crucial that the NCD not give blanket HST coverage, completely disregarding patient condition, physician training, type of equipment, or quality of test result. While Itamar asserts that LCDs are “confusing,” chaos would result if there is no guideline for patient selection, for physician training and for other test features. (The NCD mentions nothing about standards, and LCDs cannot be more restrictive than NCD5.) In addition, “least costly alternative” can be applied both by LCDs and postpay review. A for-profit recovery audit contractor could run wholesale through all Medicare polysomnography claims by asserting that the NCD covered wristband HST for each patient, with the NCD as bulletproof protection for his audits. USA diagnosis and treatment in complex elderly patients does not remotely approach “cookbook” medicine and national associations and Medicare carriers should be commended, not criticized, for their efforts to ensure quality clinical care for OSA.

Third, the NCD raises conflicts (with existing manual instructions, federal regulations for IDTFs, the CPAP NCD, and LCD5).

CMS’s general grounds for coverage is that technologies must be
(a) ordered and furnished by qualified personnel
(b) meet the patient’s medical need and be
(c) at least as beneficial as an existing and available medically appropriate alternative.¹

HSTs are consistently inferior to PSG, especially in regard to specificity, as found in paper after paper reviewed in the TA and NCD. In the AHRQ accuracy model used for the most recent CPAP MedCAC, false diagnoses were predicted over 30% of the time for HSTs in the Medicare population.² While the proposed NCD describes the lack of a “gold standard” for OSA diagnosis, there is no question that PSG is the gold standard for assessing apneic episodes in the complete context of sleep stage, body movements, and comprehensive physiological monitoring. CMS appears to accept the A}{RQ model that conventional PSG forces a six-month delay in apnea treatment in the U.S., which sounds absurd.³

There is no standard at all for defining “arterial tone” as new devices of dubious reputation and inadequate data enter the marketplace. New devices may be cleared by the FDA based on loose analogies to predicates and no published clinical data at all. Are contractors required to cover any new device claiming to be an HST? Regarding the specific NCD request, direct physiologic measurement of apneic episodes is abandoned and replaced by a wristband device measuring “arterial tone.” In support of their application, the requestors note seven additional articles in “peer-reviewed” journals (including journals of extreme obscurity), many of which are wholly irrelevant to the question at hand, test coverage for complex clinical syndromes in the elderly. For example, Pittman et al. (2006) is based on pre-diagnosed patients with well-characterized OSA. This has nothing to do with correct diagnosis of new patients. Pang et al. (2007), Berry et al. (2008), and Hedner et al. (2004) were all based in professional advanced sleep centers.4 Pang et a!. documented a non-specificity rate of 20%, even in a much younger population (age 50). Herscovici et al. (2007) studied REM versus non-REM sleep staging, which is irrelevant to the question of accurate OSA diagnosis in the elderly, and so on. Based on Medicare’s own published requirement that new technologies must be at least as beneficial as existing ones, the WatchPAT device fails by a consistent margin.

HST has a high rate of false positives, especially in the Medicare population. While CMS assumes that an unnecessary CPAP trial causes little harm, the NCD states that HST always provides a CMS-approved diagnosis of OSA. Therefore, contractors will have no recourse if potentially dangerous palatopharyngoplasty is conducted based on HST alone. In contrast, many private insurers specify that HST diagnosis cannot justify palatopharyngoplasty, and a true PSG with failure of a CPAP trial is needed.

While the requestor trumpets that Medicare’s CAC advisory boards and regional carriers have only “created confusion” it is far more likely that they did understand the real clinical issues at hand and responded appropriately.5 Sleep local coverage decisions received extensive local discussion and review during 2008.

CARRIER-ENFORCED CREDENTIALING REQUIRED BY REGULATION FOR IDTFs; APPROPRIATE FOR OTHER ENTITIES

The existing CPAP NCD, in its March version, wisely allows carriers to determine appropriate clinical evaluation and appropriate clinical experience and use of HSTs. As made clear by the background paragraphs of the Proposed Decision Memo, there is no “magic road” to accurate diagnosis of obstructive sleep apnea nor to its treatment. Professional training and deep clinical experience are critical, and this is particularly true in the elderly, who have a higher index of comorbid disorders than the younger population studied in most clinical trials. ⁶

The accuracy of a test is not intrinsic to the test, but is highly sensitive to spectrum effects, the base rate of different disorders in a population. This includes not only the main disorder in question but the prevalence of other disorders which may confound test results.7 In a real-world disorder, where patients have multiple comorbidities such as congestive heart failure or intrinsic lung disease as well as other sleep disorders, the accuracy of HSTs may be much lower than under ideal conditions.⁸

Therefore, it is critical that carriers be allowed to set medically reasonable criteria for the quality of sleep medicine diagnostics and therapy, just as for other areas of medical care. A number of carriers have required AASM or Joint Commission-based accreditation for sleep studies or studies adequate for CPAP dispensing, and this is a standard we strongly support. In fact, non-professional evaluation, best reflected by Haponik et al. (1984), has a 40% non-specificity rate as cited in the proposed NCD.

CONFLICT WITH IDTF REGULATIONS

In addition, many sleep studies may be performed under the IDTF model. TDTF regulations, found at 42 CFR 410.33:

Surely the NCD does not purport to withdraw these credentialing regulations by making any sleep test a covered test, regardless of contradictory regulations. But the NCD simply states flatly that HST “is covered when used to aid in the diagnosis” and one could argue that no matter how poor the quality of the HST or how marginal its value in diagnosis, it is “covered” by the proposed NCD. The NCD makes no comment at all about training for the HST, and since LCDs cannot be more restrictive than an NCD, it is unclear whether any patient instruction in the HST usage can be required by LCDs, or whether carriers can review just when an HST would be so poor in quality as to be uncovered.⁹

Assuming Medicare regulations require credentialing for sleep tests given by IDTFs, and the requirement at 410.33 is not overridden by the NCD, there is no reason that similar quality measures be withdrawn for sleep tests paid by carriers in other settings.

Congressional intent is clearly in favor of demonstrated quality measures, such as the requirement of credentialing for imaging facilities enacted in the July 2008 MIPPA legislation. MEDPAC has similarly urged CMS to use quality criteria on many occasions. CMS restated its drive for quality-driven care in the fee-for-service program as recently as January 16, 2009, and quality care requires setting standards.¹⁰° Reliability and quality is unquestionably an issue for PAT HSTs, with failure rates reported across a range of up to 20%.¹¹

The American Association for Sleep Medicine provides these guidelines for home sleep testing:

An HST may be adequate, under a set of boundary conditions as shown above. Such nationally endorsed consensus criteria are what your carriers have aimed for. Therefore, carrier LCDs which now describe quality controls, clinical preconditions or credentialing in regard to HSTs are not creating “great confusion” (as stated in Itamar’s letter) but rather, following clear published, peer-reviewed guidelines of the AASM. Elsewhere, CMS has relied on major clinical guidelines in its national coverage decisions and Administrator’s Rulings. The program manual instructs its carriers to do so as well. ¹²

CMS may be taking the position that clinical diagnosis alone could be adequate’¹³, and if so, the quality of either PSG or HST testing is irrelevant. The assumption that clinical diagnosis is adequate is a serious misreading of the studies CMS cites. Most of these involve small cohorts and commit the obvious error of “curve fitting”, where a series of parameters can be over-fitted to a small population and cannot be extrapolated to different population sets or clinically different populations (striking examples of this error category include Crocker et al. and Deegan et al., which amazingly were cited uncritically by CMS. Clinical diagnosis fails badly in larger studies, such as Hoffstein et al.) CMS also seems to devalue the PSG, in noting that PSG or All! are not fully predictive of CPAP response. This is to confuse apples and oranges. CPAP response is a complex phenomenon, which depends on the patient’s individual vulnerability, precise anatomy, physiologic tone during sleep, co-morbidities, tolerance for CPAP of adequate pressure, and other factors. The response to therapy obviously brings in many factors entirely separate from the factors that define the AHI, so the AHI cannot be a perfect predictor of response to CPAP, nor to palatopharyngoplasty, nor to other interventions.

In closing, CMS’s final NCD should either incorporate criteria such as those of the AASM or clearly provide for contractor discretion in doing so. Otherwise, the NCD will be misread to require payment, and deny recoupment, for any so-called “HST” regardless of device, quality, or clinical setting, which is the worst possible outcome.

Respectfully Submitted,

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January 21, 2009

Stephen Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group
Center for Medicare and Medicaid Services
Cl-13-18
7500 Security Boulevard
Baltimore, Maryland 21244-1850

RE: Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N)

Dear Dr. Phurrough,

I have reviewed the proposed decision memo referenced above. As a resident physician: I write to express my full support of the proposed decision. From my experience with patients who present to the UCSD Head and Neck Surgery Sleep Apnea Clinic, seniors prefer home sleep study as transportation is often difficult. They also prefer the comfort of their own homes.

Sincerely yours,

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January 20, 2009

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Louis B. Jacques, MD
Director, Division of Item and Devices
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Jean Stiller, MA
Lead Analyst
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Ross Brechner, MD, MS, MPH
Lead Medical Officer
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Re: CAG-00405N - Proposed Coverage Decision Memorandum for Sleep Testing for Obstructive Sleep Apnea (OSA)

Dear Drs. Phurrough, Jaques, and Brechner and Ms. Stiller:

The American Academy of Neurology Professional Association ("AANPA" or "Academy") is the premiere medical specialty society for neurology, representing more than 21,000 neurologists and neuroscience professionals dedicated to providing the highest quality patient-centered neurologic care. The Academy greatly appreciates the opportunity to submit comments on CMS' Proposed Coverage Decision Memorandum (CAG-D0405N) that would recognize coverage for a new device to test for Obstructive Sleep Apnea (OSA). The AANPA agrees with the first two proposals outlined in the proposed decision memo; and wishes to comment on the final two of the proposals involving:

• Type IV sleep testing devices
• A device that includes actigraphy, oximetry, and peripheral arterial tone

1. The AANPA agrees with CMS that airflow ought to be one of the three channels covered in a type IV sleep testing device.
2. The AANPA notes that the American Academy of Sleep Medicine (AASM) has proposed guidelines to identify patients for whom this is an appropriate diagnostic test. Appropriate patients may be identified by age restrictions, presence of high pretesting probability for having sleep apnea, and lack of associated co-morbid medical conditions; where appropriate patients for this testing have previously undergone a complete sleep medicine evaluation. The AANPA recommends that these requirements should be incorporated into CMS' Final Decision to identify patients for whom such testing would be covered.
3. Current use of Level III unattended studies - as cited by CPT@ code 95806 (Sleep study, simultaneous recording of ventilation, respiratory effort, ECG or heart rate, and oxygen saturation, unattended by a technologist) and developed by the Relative Value Update Committee of the American Medical Association (AMA), with acceptance by CMS-require that a trained technician administer the test and also require that the raw data be reviewed by a physician. The AANPA believes that these requirements are even more important for unattended home studies with fewer channels, and that these requirements should be incorporated into the Final Decision to identify tests to be covered.

1. The AANPA notes that the absence of airflow means that this device does not meet the CMS criteria of a Type IV device. The Academy believes that testing of airflow should be required for a device to diagnose OSA, a clinical disorders of airflow. Rather, this device uses indirect technology with a proprietary algorithm. Used without careful patient screening, the device cannot well distinguish OSA from central or complex sleep apnea. The Academy believes that its approval is premature, and that CMS should await the results of a prospective controlled study of diagnosis and treatment outcome, such as the study currently in progress by AASM on a Type IV device, that includes respiratory airflow.
2. As for CPT@ code 95806, any unattended test should be administered by a trained technician, and a physician should be required to review the integrity of the raw data. The AANPA recommends that these requirements should be incorporated into the Final Decision to identify tests to be covered.

The Academy applauds The American Academy of Sleep Medicine (AASM) for using its own funds to conduct a prospective study that is currently underway to evaluate the use of home studies in both the diagnosis and outcome for evaluation of OSA. The Academy anxiously awaits the results of the study, as we believe that the results will give a great deal of guidance to health professionals and CMS in the use of home studies to diagnose and treat OSA.

Because a very high percentage of Medicare beneficiaries snore, and a similarly high percentage complain of fatigue, we believe that home sleep testing might be ordered in 20% or more of the Medicare population, unless patients are carefully clinically screened. When diagnosed, OSA patients require treatment over many years, and should undergo a robust diagnostic evaluation- including the physician evaluation, testing with appropriate device type, treatment, and follow up.

The AANPA believes that the use of Level IV devices to diagnose OSA, or the use of devices with actigraphy, oximetry, and peripheral artery tone without respiratory airflow are premature, and that further prospective studies are needed to clarify their place in the diagnosis and treatment of OSA and other sleep apnea syndromes. The Academy would further urge CMS to consider conducting a prospective controlled study of these devices, similar to the one currently being performed under the direction of AASM for a Type IV device, which includes airflow measures.

Thank you for your careful attention to the comments above. The AANPA appreciates this opportunity to provide input. Should you have questions or require further information, please contact Katie Kuechenmeister, AANPA staff, by phone at (651) 695-2783 or by email atkkuechenmeister@aan.com.

Sincerely,

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January 19, 2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Drs. Phurrough, Jacques, and Brechner, and Ms. Stiller:

I submit this comment letter in strong support ofthe proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (CAG-00405N) issued by the Center for Medicare and Medicaid Services on December 23, 2008. As a physician who cares for patients with obstructive sleep apnea, I know the importance ofchoosing the right diagnostic testing modality for my patients. It is critical that I have the ability to choose between polysomnography and home sleep testing, including studies using peripheral arterial tonometry. Allowing physicians who manage patients with suspected sleep apnea the various diagnostic options listed in the proposed NCO allows them to best match the diagnostic test with the particular clinical and physical needs of patients. Thus, I urge CMS to finalize, as soon as possible, the important issue ofclarifying and ensuring coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment.

I am Board Certified in Pulmonary, Critical Care, Internal, and Sleep Medicine and a member ofthe American College ofChest Physicians and the American Academy ofSleep Medicine. I have treated patients with obstructive sleep apnea for 25 years. As a sleep professional, I follow the peer reviewed literature regarding home or portable sleep testing (HST) and have had the opportunity to use a number of different HSG devices, including the Watch-PAT device. I agree with CMS's findings that the evidence is sufficient to conclude that all HSG devices listed in the NCO are reasonable and necessary and when properly used, lead to improved health outcomes by assisting physicians, ),ike myself, in diagnosing patients accurately and in a timely manner.

Coverage for HST devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level IT devices. There are a number of patients in whom obtaining total sleep time, as opposed to total time in bed, is critically important in making an accurate diagnosis ofsleep disordered breathing. Therefore, I believe it is important for CMS to add the "sleep" element to the description ofthe Watch-PAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by descriptor. This change would fully capture the data provided at the device and which I use in my clinical assessment.

In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV (using three or more channels), and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is a clear distinction among the groups and devices using PAT, and that these PAT devices not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD.

The descriptor could then read, for example:

A sleep testing device measuring three or more channels that include actigraphy, oximetry, sleep time, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative ofOSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

In conclusion, I support CMS's Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (CAG-00405N) and urge CAG to finalize the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.

Respectfully submitted,

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January 19, 2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Drs. Phurrollgh, Jacques, aed Brechner, and Ms. Stiller:

I submit this comment letter in strong support ofthe proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (CAG-00405N) issued by the Center for Medicare and Medicaid Services on December 23, 2008. As a sleep professional who cares for patients with obstructive sleep apnea, I know the importance of choosing the right diagnostic testing modality for the patients entrusted to my care. It is critical that I have the ability to choose between polysomnography and home sleep testing, including studies using peripheral arterial tonometry. Allowing physicians who manage patients with suspected sleep apnea the various diagnostic options listed in the proposed NCD allows them to best match the diagnostic test with the particular clinical and physical needs of patients. Thus, I urge CMS to finalize, as soon as possible, the important issue ofclarifying and ensuring coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment.

I am a Registered Pulmonary Function Technologise and a Registered Polysomnographic Technologist and a member of the American Association of Sleep Technologists and the American Academy of Sleep Medicine. I have worked with patients with obstructive sleep apnea for 35 years. As a sleep professional, I follow the peer reviewed literature regarding home or portable sleep testing (HST) and have had the opportunity to use a number ofdifferent HSG devices, including the Watch-PAT device. I agree with CMS's findings that the evidence is sufficient to conclude that all HSG devices listed in the NCD are reasonable and necessary and when properly used, lead to improved health outcomes, assisting in diagnosing patients accurately and in a timely manner.

Coverage for HST devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level II devices. There are a number ofpatients in whom obtaining total sleep time, as opposed to total time in bed, is critically important in making an accurate diagnosis of sleep disordered breathing. Therefore, I believe it is important for CMS to add the "sleep" element to the description ofthe Watch-PAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by descriptor. This change would fully capture the data provided at the device and which I use in my clinical assessment.

In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV (using three or more channels), and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is a clear distinction among the groups and devices using PAT, and that these PAT devices not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD.

The descriptor could then read, for example:

A sleep testing device measuring three or more channels that include actigraphy, oximetry, sleep time, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative ofOSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

In conclusion, I support CMS's Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (CAG-00405N) and urge CAG to finalize the proposal. I appreciate CMS clarifYing its coverage policy for sleep testing for OSA.

Respectfully submitted,

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January 18, 2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I am submitting this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As a Doctor specializing in Otolaryngology for over 22 years, I have worked closely with patients suffering from obstructive sleep apnea and understand the value of matching the right diagnostic test with a particular patient. I have been utilizing the Watch-PAT devices since October 2008 and have had considerable results. Part of my job is to provide my patients with a device that is simple to use and apply without difficulty thus allowing them the greatest degree of comfort. The goal is to ensure that the patient has as "normal" a night sleep as possible while achieving a more accurate record of sleep activity. Therefore, it is imperative that patients have access to the various home sleeping devices available, including the Watch-PAT devices.

My patients have found the Watch-Pat devices easy to use and are relieved to learn that the Watch-PAT does not require them to wear an uncomfortable nasal canula or thoracic band which allows them to be at a more relaxed state as they sleep. It is important to clear up the confusion and misinformation that has been circulating among the sleep community and to have the proposed coverage policy that ensures the Watch-PAT devices are covered to be finalized as soon as possible. I applaud the efforts being made by CMS.

Respectfully,

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January 16, 2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore Maryland 21244-1850

RE:

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:
I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As a physician who cares for patients with obstructive sleep apnea, I know the importance of choosing the right diagnostic testing modality for my patients. It is critical that I have the ability to choose among polysomnography and home sleep testing, including studies using peripheral arterial tonometry. Providing physicians managing patients with suspected sleep apnea the various diagnostic options listed in the proposed NCD allows them to best match the diagnostic test with the particular clinical and physical needs of patients. Thus, I urge CMS to finalize, as soon as possible, to clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment. I am a Board Certified in Oral & Maxillofacial Surgery and Dental Sleep Medicine and a Diplomate of the American Board of Oral & Maxillofacial Surgery, the American Board of Dental Sleep Medicine, and member of the American Academy of Sleep Medicine and American Academy of Dental Sleep Medicine. I have treated patients with obstructive sleep apnea for sixteen years. As a sleep expert, I follow the peer reviewed literature regarding home or portable sleep testing (HST) and have had the opportunity to use a number of different HST devices, including the Watch-PAT devices. I agree with CMS’s findings that the evidence is sufficient to conclude that all HST devices listed in the NCD are reasonable and necessary and when properly used, lead to improved health outcomes by assisting physicians, like myself, diagnose patients accurately and in a timely manner. Coverage for HST devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level II devices. There are a number of patients in whom obtaining total sleep time, as opposed to total time in bed, is critically important to making an accurate diagnosis of sleep apnea. Therefore, I believe it is important for CMS to add the “sleep” element to the description of the Watch-PAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by descriptor. This change would fully capture the data provided by the device and I use in my clinical assessment. In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV using three or more channels, and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is clear distinction among the groups and devices using PAT not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD. Thus, the descriptor could read:A sleep testing device measuring three or more channels that include actigraphy, oximetry, sleep time, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

In conclusion, I support CMS’s Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) and urge CAG to finalizes the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.

Respectfully submitted,

Kent E. Moore, M.D., D.D.S.

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January 16, 2009

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As a physician who cares for patients with obstructive sleep apnea, I know the importance of choosing the right diagnostic testing modality for my patients. It is critical that I have the ability to choose among polysomnography and home sleep testing, including studies using peripheral arterial tonometry. Providing physicians managing patients with suspected sleep apnea the various diagnostic options listed in the proposed NCD allows them to best match the diagnostic test with the particular clinical and physical needs of patients. Thus, I urge CMS to finalize, as soon as possible, to clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment.

I am a Board Certified in Otolaryngology and a member of the American Board of Otolaryngology Head & Neck Surgery. I have treated patients with obstructive sleep apnea for 12 years. As a sleep expert, I follow the peer reviewed literature regarding home or portable sleep testing (HST) and have had the opportunity to use a number of different HST devices, including the Watch-PAT devices. I agree with CMS’s findings that the evidence is sufficient to conclude that all HST devices listed in the NCD are reasonable and necessary and when properly used, lead to improved health outcomes by assisting physicians, like myself, diagnose patients accurately and in a timely manner.

Coverage for HST devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level II devices. There are a number of patients in whom obtaining total sleep time, as opposed to total time in bed, is critically important to making an accurate diagnosis of sleep apnea. Therefore, I believe it is important for CMS to add the “sleep” element to the description of the Watch-PAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by descriptor. This change would fully capture the data provided by the device and I use in my clinical assessment. In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV using three or more channels, and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is clear distinction among the groups and devices using PAT not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD.

Thus, the descriptor could read:

A sleep testing device measuring three or more channels that include actigraphy, oximetry, sleep time, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

In conclusion, I support CMS’s Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) and urge CAG to finalizes the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.

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01/14/2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD, 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong opposition of the proposed National Coverage Determination for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008.

The request to broaden coverage to Level IV devices with 3 or more channels, and devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone (Watch-PAT). I strongly oppose devices that do not directly measure any aspect of airflow or chest and abdominal wall movement. Unfortunately, the Watch-PAT devices are unable to differentiate central apnea from obstructive apnea due to the fact that the device does not monitor those parameters. The Medicare population, more than most, is more apt to exhibit central sleep apnea. This could lead to misdiagnosis and mistreatment of our patients.

As a sleep professional with 24 years of experience in Sleep Medicine, I urge you to NOT approve the proposal to provide coverage for the Watch-PAT device.

Very truly yours,

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January 13, 2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore Maryland 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:
I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. I am a Board Certified in Obstetrics and Gynecology and have a particular interest in evaluating and treating sleep disorders in pregnant women. Home testing is particularly desirable in this patient population. It is critical that I have the ability to choose among polysomnography and home sleep testing, including studies using peripheral arterial tonometry. Providing physicians managing patients with suspected sleep apnea the various diagnostic options listed in the proposed NCD allows them to best match the diagnostic test with the particular clinical and physical needs of patients. Thus, I urge CMS to finalize, as soon as possible, to clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment. I agree with CMS’s findings that the evidence is sufficient to conclude that all HST devices listed in the NCD are reasonable and necessary and when properly used, lead to improved health outcomes by assisting physicians, like myself, diagnose patients accurately and in a timely manner. Coverage for HST devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level II devices. There are a number of patients in whom obtaining total sleep time, as opposed to total time in bed, is critically important to making an accurate diagnosis of sleep apnea. Therefore, I believe it is important for CMS to add the “sleep” element to the description of the Watch-PAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by descriptor. This change would fully capture the data provided by the device and I use in my clinical assessment. In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV using three or more channels, and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is clear distinction among the groups and devices using PAT not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD. Thus, the descriptor could read:A sleep testing device measuring three or more channels that include actigraphy, oximetry, sleep time, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.In conclusion, I support CMS’s Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) and urge CAG to finalizes the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.
Respectfully submitted,

Francesca Facco, MD

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January 12, 2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore Maryland 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As a physician who cares for patients with obstructive sleep apnea, I know the importance of choosing the right diagnostic testing modality for my patients. It is critical that I have the ability to choose among polysomnography and home sleep testing, including studies using peripheral alterial tonometry. Providing physicians managing patients with suspected sleep apnea the various diagnostic options listed in the proposed NCD allows them to best match the diagnostic test with the palticular clinical and physical needs of patients. Thus, I urge CMS to finalize, as soon as possible, to clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment.

I am a Board Certified in Pulmonary, Critical Care and Sleep Medicine and a member ofthe the American Academy of Sleep Medicine. I have treated patients with obstmctive sleep apnea for12 years. As a sleep expelt, I follow the peer reviewed literature regarding home or portable sleep testing (RST) and have had the oppoltunity to use the Watch-PAT devices I agree with CMS's findings that the evidence is sufficient to conclude that all HST devices listed in the NCD are reasonable and necessary and when properly used, lead to improved health outcomes by assisting physicians, like myself, diagnose patients accurately and in a timely manner.

Coverage for RST devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is ofparticular impOltance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level II devices. There are a number of patients in whom obtaining total sleep time, as opposed to total time in bed, is critically important to making an accurate diagnosis of sleep apnea. Therefore, I believe it is important for CMS to add the "sleep" element to the description of the Watch-PAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by descriptor. This change would fully capture the data provided by the device and I use in my clinical assessment.

In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV using three or more channels, and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is clear distinction among the groups and devices using PAT not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the cunent draft NCD.

Thus, the descriptor could read:

A sleep testing device measuring three or more channels that include actigraphy, oximetry, sleep time, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

In conclusion, I support CMS's Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) and urge CAG to finalizes the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.

Respectfully submitted,

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January 10, 2009

Coverage and Analysis Group
Office of Coverage Standards and Quality
for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Drs. Phurrough, Jacques, Brechner and Ms Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2009. I understand the importance of matching the right diagnostic test with each patient. As the marketing and sales representative at Progressive Medical my job is to educate physicians and train patients how to use home sleep testing devices therefore I have first-hand experience with the criticalness of choosing a diagnostic device that a patient will be able to use without difficulty and will provide the greatest comfort and reliability. We have used flow-based diagnostic units in the home to diagnose OSA and the cannula has slipped on several instances and a false positive or a false negative was obtained. A flow-based diagnostic unit is much better to be used in a laboratory where a sleep technician is observing the patient. The goal of home sleep testing is to ensure the patient has as "normal" a night sleep as possible so we can see the real study. Thus, it is important for our patients to have access to a variety of home sleep testing devices, including the WatchPAT devices which work on peripheral arterial tone.

I urge CMS to finalize the proposed coverage-policy ensuring that the Watch-PAT devices are covered, as soon as possible. Our physicians and patients find the Watch-PAT easy to use and the studies correlate with a full polysomnography performed in a laboratory. I feel strongly that this technology is ideally suited for diagnosing OSA in the patient's home and I applaud CMS's efforts to take action to include this device in the arsenal of home sleep testing devices.

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Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As a physician who cares for patients with obstructive sleep apnea, I know the importance of choosing the right diagnostic testing modality for my patients. It is critical that I have the ability to choose among polysomnography and home sleep testing, including studies using peripheral arterial tonometry. Providing physicians managing patients with suspected sleep apnea the various diagnostic options listed in the proposed NCD allows them to best match the diagnostic test with the particular clinical and physical needs of patients. Thus, I urge CMS to finalize, as soon as possible, to clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment.

I am a Board Certified Otolaryngology Head & Neck Surgery and have been practicing sleep medicine for almost ten years. As a sleep expert, I follow the peer reviewed literature regarding home or portable sleep testing (HST) and have had the opportunity to use a number of different HST devices, including the Watch-PAT devices.

Coverage for HST devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level II devices. There are a number of patients in whom obtaining total sleep time, as opposed to total time in bed, is critically important to making an accurate diagnosis of sleep apnea. Therefore, I believe it is important for CMS to add the “sleep” element to the description of the Watch-PAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by descriptor. This change would fully capture the data provided by the device and I use in my clinical assessment.

In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV using three or more channels, and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is clear distinction among the groups and devices using PAT not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD.

The Watch PAT device is reliable, easy to administer and accurate. I have had many cases where a false negative PSG was confirmed by a grossly positive Watch PAT test. I is also useful for patients that have refused to return for second PSG for CPAP titration. Patients prefer this device that has no contact on the face.

In conclusion, I support CMS’s Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) and urge CAG to finalizes the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.

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01/09/2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD, 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong opposition of the proposed National Coverage Determination for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23,2008.

The request to broaden coverage to Level IV devices with 3 or more channels, and devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone (Watch-PAT). I strongly oppose devices that do not directly measure any aspect of airflow or chest and abdominal wall movement. Unfortunately, the Watch-PAT devices are unable to differentiate central apnea from obstructive apnea due to the fact that the device does not monitor those parameters. The Medicare population, more than most, is more apt to exhibit central sleep apnea. This could lead to misdiagnosis and mistreatment of our patients.

As a sleep professional with over 8 years of experience in Sleep Medicine, I urge you to NOT approve the proposal to provide coverage for the Watch-PAT device.

Very truly yours,

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I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00404N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As a respiratory therapist who has worked for many years with patients suffering from OSA, I understand the value of matching the right diagnostic test with a particular patient. In 2003 the number of our veterans requiring sleep studies was increasing far beyond the capacity of our affiliated sleep laboratory. Patients were forced to wait months before having a sleep study. In response to this crisis, Dr Katherine Rice and Dr Jeffery Rubins developed a strategy to more quickly evaluate patients at high risk for sleep apnea. The approach involved using unattended sleep study devices; Watch Pat and Embletta devices. The Watch Pat device became our device of choice due to ease of patient application and comfort as well as providing accurate and clinically effective diagnosis of OSA. Using this approach, we have reduced our wait time from the initial physician request to time of diagnosis and treatment from months to a few weeks and in some cases days.Currently our sleep program can conduct 8 unattended studies per night, or 32 studies per week at a fraction of the cost.I urge CMS to finalize, as soon as possible, the proposed coverage policy ensuring that the Watch Pat devices are covered. Our staff and patients find the Watch pat easy to use and patients are relived to learn that the Watch Pat does not require them to wear an uncomfortable nasal cannula, thoracic bands and wires on their head. It has been difficult to know whether Medicare beneficiaries could be offered the Watch Pat. This new policy is important to clear up a great deal of confusion and misinformation that has been circulating among the sleep community. I applaud CMS''s efforts to take action to eliminate this confusion.

Respectfully submitted,

Shannon McGaughey, CRT
Sleep Program Coordinator
Minneapolis VA Medical Center

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January 8, 2009

RE: Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N)

Dear Dr. Phurrough,

I have reviewed the proposed decision memo referenced above. I find it excellent in every regard and fully support the proposed decision. I offer no new or additional evidence other than the continued patient feedback, particularly from seniors who present to the UCSD Head and Neck Surgery Sleep Apnea Clinic with signs and symptoms of sleep apnea, but who, when asked to obtain a sleep test and discover that it is an in-laboratory test, decline to do so or simply do not follow-up with the sleep test. The most common reasons are twofold:

1. They do not drive at night and therefore have no means of transporting themselves to the testing facility.
2. As individuals age, they prefer to sleep at home and simply refuse to sleep in a bed not at home.

As a practitioner who diagnoses and treats patients with sleep apnea, and an advocate for my patients, I fully support the proposed decision memo for sleep testing for obstructive sleep apnea.

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January 8, 2009

Coverage and Analysis Group
Office of Coverage Standards & Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Drs. Phurrough, Jacques, Brechner and Ms Stiller:

I submit this comment letter in strong support of the proposed National Coverage Detennination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2009. As a respiratory therapist who has worked for the past 20+ years with patients suffering with OSA I understand the value of matching the right diagnostic test with a particular patient. Part of my job is to train patients how to use home sleep testing devices thus I have first-hand experience with the importance of choosing a diagnostic device that a patient will be able to apply without difficulty and that will provide the patients with the greatest degree of comfort and reliability. I have used flow- based diagnostic units in the home to diagnose OSA and the cannula has slipped on several instances and a false positive or a false negative was obtained. A flow-based diagnostic unit is much better suited for use in a laboratory where a sleep technician is observing the patient. The goal of home sleep testing is to ensure the patient has as "nonnal" a night sleep as possible. Thus, it is important for our patients to have access to a variety of home sleep testing devices, including the Watch-PAT devices which work on peripheral arterial tone.

I urge CMS to finalize the proposed coverage policy ensuring that the WatchPAT devices are covered, as soon as possible. Our patients find the Watch-PAT easy to use and the studies correlate with a full polysomnography performed in a laboratory. I feel strongly that this technology is ideally suited for diagnosing OSA in the patient's home and I applaud CMS's efforts to take action to include this device in the arsenal of home sleep testing devices.

Respectfully submitted,

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01/08/2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD, 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong opposition of the proposed National Coverage Determination for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23,2008.

The request to broaden coverage to Level IV devices with 3 or more channels, and devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone (Watch-PAT). I strongly oppose devices that do not directly measure any aspect of airflow or chest and abdominal wall movement. Unfortunately, the Watch-PAT devices are unable to differentiate central apnea from obstructive apnea due to the fact that the device does not monitor those parameters. The Medicare population, more than most, is more apt to exhibit central sleep apnea. This could lead to misdiagnosis and mistreatment of our patients.

As a sleep professional with 10 years of experience in Sleep Medicine, I urge you to NOT approve the proposal to provide coverage for the Watch-PAT device.

Very truly yours,

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Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore Maryland 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment lener in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (eMS) on December 23, 2008. As a physician who cares for patients with obstructive sleep apnea, I know the importance of choosing the right diagnostic testing modality for my patients. It is critical that I have the ability to choose among polysomnography and home sleep testing. including studies using peripheral arterial tonometry. Providing physicians managing patients with suspected sleep apnea the various diagnostic options listed in the proposed CD allows them to best match the diagnostic test with the particular clinical and physical needs of patients. Thus,l urge CMS to fmalize. as soon as possible, to clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment.

I am a Board Certified in pulmonary and sleep medicine and a member of the and the American Academy of Sleep Medicine. I have treated patients with obstructive sleep apnea for 12 years. As a sleep expert. I follow the peer reviewed literature regarding home or portable sleep testing (I-1ST) and have had the opportunity to use a number of different HST devices, including the WatchPAT devices. I agree with CMS's findings that the evidence is sufficient to conclude that all HST devices listed in the NCO arc reasonable and necessary and when properly used_ lead to improved health outcomes by assisting physicians, like myself, diagnose patients accurately and in a limely manner.

Coverage for HST devices utilizing actigraphy. oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level 11 devices. There are a number of patients in whom obtaining total sleep time, as opposed to total time in bcd. is critically important to making an accurate diagnosis of sleep apnea. Therefore. 1 believe it is important for CMS to add the "sleep" element to the description of the WatchPAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by descriptor. This change would fully capture the data provided by the device and I use in my clinical assessment.

In addition, the proposed coverage policy makes the important distinction between Level II, Level JII (the difference between these levels is the ability of Level II devices to record sleep information), Level IV using three or more channels, and HST devices including peripheral arterial tone, whicn do not fit any of the above categories. It is important that there is clear distinction among the groups and devices using PAT not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD.

Thus, the descriptor could read:

A sleep testing device measuring three or mOTC channels that include actigraphy, oximetry, sleep time, and peripheral arterial tone is covered when used 10 aid the diagnosis of sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or oul of a sleep lab facility or attended in a sleep lab facility.

In conclusion, I support eMS's Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSAl (CAG-00405N) and urge CAG to finalizes the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.

Respectfully submitted,

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Drs.Phurrough, Jacques and Brechener and Ms.Stiller:

I submit the comment letter in strong support of the proposed NCD for sleep testing for OSA issued by the CMS on 12/23/2008. As a Respiratory Therapist, who has worked for the past 36 years with patients suffering with OSA, I understand the value of matching the right diagnostic test with a particular patient. Part of my job is to train patients how to use home sleep testing devices and to answer telephone questions, thus I have first-hand experience with the importance of choosing a diagnostic device that a patient will be able to apply without difficulty and that will provide the patient with the greatest degree of comfort. After all, the goal is to try to ensure the patient has as "normal" a night sleep as possible. Thus, it is important for our patients to have access to the various home sleep testing devices available, including the Watch-PAT devices.

I urge CMS to finalize, as soon as possible, the proposed coverage policy ensuring that the Watch-PAT devices are covered. Our patients find the Watch-PAT easy to use and they generally are relieved to learn that the Watch-PAT does not require them to wear an uncomfortable nasal canula or thoracic band. It has been difficult to know whether Medicare beneficiaries could be offered the Watch-PAT. This policy is important to clear up the great deal of confusion and misinformation that has been circulating among the sleep community. I applaud CMS''''s efforts to take action to eliminate this confusion.

Respectfully submitted,

Joe Dougherty, RRT, MS, MBA

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Coverage and Analysis Group
Office of Coverage~ Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD, 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong opposition of the proposed National Coverage Determination for Obstructive Sleep Apnea (GSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008.

The request to broaden coverage to Level IV devices with 3 or more channels, and devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone (Watch-PAT). I strongly oppose devices that do not directly measure any aspect of airflow or chest and abdominal wall movelnent. Unfortunately, the Watch-PAT devices are unable to differentiate central apnea from obstructive apnea due to the fact that the device does not monitor those parameters. The Medicare population, more than most, is more apt to exhibit central sleep apnea. This could lead to misdiagnosis and mistreatment of our patients.

As a sleep profcssional vith 24 years of experience in Sleep Medicine, I urge you to NOT approve the proposal to provide coverage for the Watch-PAT device.

Very truly yours,

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I am a board certified sleep specialist and member of the American Academy of Sleep Medicine. I strongly support the approval of Watch-PAT for ambulatory monitoring and coverage under CMS. I have personally conducted research on the Watch-PAT and we currently use it in our clinical practice to assess sleep apnea. The Watch-PAT does not fit neatly into the category system for home testing and is an entirely unique testing mechanism. I support PAT as a ligitimate and entirely seperate category of testing for sleep apnea.

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January 5, 2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore Maryland 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2009. As a respiratory therapist who has worked for the past year with patients suffering with obstructive sleep apnea, I understand the value of matching the right diagnostic test with a particular patient. A big part of my job is training patients how to use home sleep testing devices, thus I have first-hand experience with the importance of choosing a diagnostic device that a patient will be able to apply without difficulty and that will provide the patient with the greatest degree of comfort. After all, the goal is to try to ensure the patient has as "normal" a night sleep as possible. Thus, it is important for our patients to have access to the various home sleep testing devices available, including the Watch-PAT devices.

A particular patient comes to mind when using the Watch-PAT device for the chosen sleep study testing device. This patient was under a lot of stress and very 'scatter-brained' as the patient described herself. She specifically mentioned that she was extremely glad there were only a couple of probes to put on, as she has a very difficult time remembering things, and the Watch-PAT seemed extremely easy and fool-proof to use. Upon returning the device, the patient had a positive testing experience and said that due to the simplicity of the device, she didn't have any difficulties in putting it on and using it. Had this particular patient had to use a device with more attachments to connect, she may have had problems completing the test successfully. In this case, the Watch-PAT made this patient's home sleep testing experience a success.

I urge CMS to finalize, as soon as possible, the proposed coverage policy ensuring that the Watch-PAT devices are covered. Our patients universally find the Watch-PAT easy to use, and I'm happy that I don't have to train them to wear a nasal cannula or thoracic band. It has been difficult to know whether Medicare beneficiaries could be offered the Watch-PAT. This new policy is important to clear up the great deal of confusion and misinformation that has been circulating among the sleep community. I applaud CMS's efforts to take action to eliminate this confusion.

Sincerely,

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January 5,2008

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore Maryland 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this con1ment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (GSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23,2009. As a respiratory therapist, who has worked for the past 5 years with patients suffering with obstructive sleep apnea, I understand the value of n1atching the right diagnostic test with a particular patient. Part of my job is to train patients how to use home sleep testing devices and to answers telephone questions, thus I have fIrst-hand experience with the iluportance of choosing a diagnostic device that a patient will be able to apply without difficulty and that will provide the patient with the greatest degree of comfort. After all, the goal is to try to ensure the patient has as "normal" a night sleep as possible. Thus, it is important for our patients to have access to the various home sleep testing devices available, including the Watch-PAT devices.

I urge CMS to finalize, as soon as possible, the proposed coverage policy ensuring that the Watch-PAT devices are covered. Our patients find the Watch-PAT easy to use and they generally are relieved to learn that the Watch-PAT does not require them to wear an uncomfortable nasal canula or thoracic band. It has been difficult to know whether Medicare beneficiaries could be offered the Watch-PAT. This new policy is important to clear up the great deal of confusion and misinformation that has been circulating among the sleep community. I applaud CMS's efforts to take action to eliminate this confusion

Respectfully submitted,

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January 5, 2009

Dear Drs. Phurrough, Jacques, and Brechner and Ms. Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issues by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As a physician who cares for patients with obstructive sleep apnea, I know the importance of choosing the right diagnostic testing modality for my patients. It is critical that I have the ability to choose among polysomnography and home sleep testing, including studies using peripheral arterial tonometry. Providing physicians managing patients with suspected sleep apnea the various diagnostic options listed in the proposed NCD allows them to best match the diagnostic test with the particular clinical and physical needs of patients. Thus, I urge CMS to finalize, as soon as possible, to clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment.

I am double Board Certified in Otolaryngology and Sleep Medicine and a Fellow of the American Academy of Otolaryngology and Head and Neck Surgery and the American Academy of Sleep Medicine. I have treated patients with obstructive sleep apnea for 27 years. As a sleep expert, I follow the peer-reviewed literature regarding home or portable sleep testing (HST) and have had the opportunity to use a number of different HST devices, including the Watch-PAT devices. I agree with CMS's findings that the evidence is sufficient to conclude that all HST devices listed in the NCD are reasonable and necessary and when properly used, lead to improved health outcomes by assisting physicians, like myself, diagnose patients accurately and in a timely manner.

Coverage for HST devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level II devices. There are a number of patients in whom obtaining total sleep time, as opposed to total time in bed, is critically important to making an accurate diagnosis of sleep apnea. Therefore, I believe it is important for CMS to add the "sleep" element to the description of the Watch-PAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by description. This change would fully capture the data provided by the device and I use in my clinical assessment.

In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV using three or more channels, and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is clear distinction among the groups and devices using PAT not to be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD.

Thus the descriptor could read:

A sleep-testing device measuring three or more channels that include actigraphy, oximetry, sleep time, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

In conclusion, I support CMS's Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) and urge CAG to finalize the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.

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Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As one who must train and educate patients in the use of home sleep testing, I have found the Watch PAT to be easy to use and it causes our patients limited challenges to having a successful diagnostic. Thus, I urge CMS to finalize, as soon as possible, to clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment.

Coverage for HST devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level II devices. There are a number of patients in whom obtaining total sleep time, as opposed to total time in bed, is critically important to making an accurate diagnosis of sleep apnea. Therefore, I believe it is important for CMS to add the "sleep" element to the description of the Watch-PAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by descriptor. This change would fully capture the data provided by the device and I use in my clinical assessment.

In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV using three or more channels, and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is clear distinction among the groups and devices using PAT not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD.

Thus, the descriptor could read:

A sleep testing device measuring three or more channels that include actigraphy, oximetry, sleep time, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

In conclusion, I support CMS's Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) and urge CAG to finalizes the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.

Respectfully submitted,

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Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore Maryland 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As a physician who cares for patients with obstructive sleep apnea, I know the importance of choosing the right diagnostic testing modality for my patients. It is critical that I have the ability to choose among polysomnography and home sleep testing, including studies using peripheral arterial tonometry. Providing physicians managing patients with suspected sleep apnea the various diagnostic options listed in the proposed NCD allows them to best match the diagnostic test with the particular clinical and physical needs of patients. Thus, I urge CMS to finalize, as soon as possible, to clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment. Over the last two years I have had the privilege of seeing all of you at various meetings on the topic of home sleep studies. My position and reasoning have been stated already and I won’t repeat them. But I would like you to know that home studies are a routine part of my sleep medicine practice that I cannot imagine doing without. About a fifth of our sleep studies, more than 4,000 in total, were Watch-PATs last year. This has allowed us to reach patients who cannot come to the sleep lab, making the difference between therapy and no therapy in many cases.

Respectfully submitted,

Mark G. Goetting, MD

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January 2, 2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore Maryland 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As one who must train and educate patients in the use of home sleep testing, I have found the Watch PAT to be easy to use and it causes our patients limited challenges to having a successful diagnostic. Thus, I urge CMS to finalize, as soon as possible, to clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment.

In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV using three or more channels, and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is clear distinction among the groups and devices using PAT not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD.

I have found in using the Watch PAT device with patients that it is extremely user friendly and our patients have been able to have the initial study performed in the comfort of their own home. This has been especially useful in getting sleep data on patients who may be reluctant to go in for initial overnight studies at a sleep lab or for whom distance is an issue. Many of the patients we see in our office live in outlying rural areas and travel can be a major issue. This device has given us valuable information in providing optimal care to our patient population.

In conclusion, I support CMS's Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) and urge CAG to finalize the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.

Respectfully submitted,

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January 2, 2009

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As a physician who cares for patients with obstructive sleep apnea, I know the importance of choosing the right diagnostic testing modality for my patients. It is critical that I have the ability to choose among polysomnography and home sleep testing, including studies using peripheral arterial tonometry. Providing physicians managing patients with suspected sleep apnea the various diagnostic options listed in the proposed NCD allows them to best match the diagnostic test with the particular clinical and physical needs of patients. Thus, I urge CMS to finalize, as soon as possible, to clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment.

I am a Board Certified in Internal Medicine and Pulmonary Diseases and a member of the American Academy of Sleep Medicine. I have treated patients with obstructive sleep apnea for 12 years. As a sleep expert, I follow the peer reviewed literature regarding home or portable sleep testing (HST) and have had the opportunity to use a number of different HST devices, including the Watch-PAT devices. I agree with CMS's findings that the evidence is sufficient to conclude that all HST devices listed in the NCD are reasonable and necessary and when properly used, lead to improved health outcomes by assisting physicians, like myself, diagnose patients accurately and in a timely manner.

Coverage for HST devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level II devices. There are a number of patients in whom obtaining total sleep time, as opposed to total time in bed, is critically important to making an accurate diagnosis of sleep apnea. Therefore, I believe it is important for CMS to add the "sleep" element to the description of the Watch-PAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by descriptor. This change would fully capture the data provided by the device and I use in my clinical assessment.

In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV using three or more channels, and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is clear distinction among the groups and devices using PAT not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD.

Thus, the descriptor could read:

A sleep testing device measuring three or more channels that include actigraphy, oximetry, sleep time, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

THE USE OF HOME SLEEP TESTING (HST) WILL ALLOW FOR EARLY DETECTION OF CONTRIBUTORY RISK FACTORS FOR CARDIOVASCULAR, CEREBROVASCULAR, AND ENDOCRINE DISEASES. EARLY TREATMENT WILL RESULT IN LESS COSTLY MEANS OF TREATMENT. I HAVE SEVERAL PATIENTS WITH DIABETES, AND CARDIAC DISEASES, WITHOUT ANY RESPONSE TO MEDICATIONS THAT IMPROVE ONCE OBSTRUCTIVE SLEEP APNEA IS DETECTED WITH THE USE OF THE WATCH-PAT. PATIENTS ALSO SLEEP BETTER AT HOME WHEN USING SUCH PORTABLE DEVICES. TREATMENT WITH CPAP IS INITIATED PROMPTLY, THUS PREVENTING EMERGENCY VISITS TO THE HOSPITAL FOR CONGESTIVE HEART FAILURE, STROKES, AND EXACERBATION OF DIABETES.

In conclusion, I support CMS's Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) and urge CAG to finalizes the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.

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January 2, 2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Drs. Phurrough, Jacques, and Brechner, and Ms. Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services on December 23 2008. As a Registered Nurse and Manager of a large Multi-specialty Medical Group I must advocate for high quality patient care and diagnostics. It is very important to many of my practitioners and Physicians to choose a mode of diagnosis for patients suffering from sleep disturbances that will provide the patient with the greatest degree of comfort while providing a high quality means of testing. It is extremely necessary to provide the patient with as "normal" a night sleep as possible to determine their level of sleep apnea/sleep disturbances. Thus, it is important for our patients to have access to the various home sleep-testing devices available, including the Watch-PAT devices.

I urge CMS to finalize, as soon as possible, the proposed coverage policy ensuring that the home sleep study devices are covered. Our patients find the Watch-PAT easy to use and they generally are relieved to learn that the Watch-PAT does not require them to wear an uncomfortable nasal canula or thoracic band. In addition, it has been a wonderful technological advance in Medicine to keep patients in their homes during testing. It has been difficult to know whether Medicare beneficiaries could be offered the Watch-PAT. This new policy is important to clear up the great deal of confusion our offices experience when trying to determine if our patients can have this type of testing ordered. I applaud CMS's efforts to take action to eliminate this confusion and allow our medical professionals to determine what steps to take when diagnosing/treating sleep apnea or other sleep disturbances.

Respectfully Submitted,

Christine Larson, BSN RN

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January 2, 2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore Maryland 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms.Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2009. As a sleep technologist who has worked for the past 15 years with patients suffering with obstructive sleep apnea, I understand the value of matching the right diagnostic test with a particular patient. We utilize these devices within our AASM accredited sleep disorders centers. We have evaluated many devices for ambulatory usage and this device has been most consistent with the fewest number of failures. Patients are highly receptive to it's use and training sessions tend to go very smoothly. Patients who have undergone full PSG as well as Watch-PAT always comment about the much higher degree of comfort the find when utilizing the device. Being an accredited sleep center we do realize that this device is not appropriate in every case or for every patient. We view this as another "tool in the toolkit" to help better diagnose and treat sleep disordered breathing. We have utilized this for patients who need quick access to testing and where unable to wait, for patients who are homebound, for remote testing of patients who hold safety sensitive positions. Our view of Watch-PAT is that it is the next best thing to inlab PSG for GSA patients and in some cases a superior choice. Thus, it is important for our patients to have access to the various home sleep testing devices available, including the Watch-PAT devices.

I urge CMS to finalize, as soon as possible, the proposed coverage policy ensuring that the Watch-PAT devices are covered. Our patients find the Watch-PAT easy to use and they generally are relieved to learn that the Watch-PAT does not require them to wear an uncomfortable nasal canula or thoracic band. It has been difficult to know whether Medicare beneficiaries could be offered the Watch-PAT. This new policy is important to clear up the great deal of confusion and misinformation that has been circulating among the sleep community. I applaud CMS's efforts to take action to eliminate this confusion.

Respectfully submitted,

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January 2, 2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore Maryland 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As one who must train and educate patients in the use of home sleep testing, I have found the Watch PAT to be easy to use and it causes our patients limited challenges to having a successful diagnostic. Thus, I urge CMS to finalize, as soon as possible, to clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment.

Coverage for HST devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level II devices. There are a number of patients in whom obtaining total sleep time, as opposed to total time in bed, is critically important to making an accurate diagnosis of sleep apnea. Therefore, I believe it is important for CMS to add the “sleep” element to the description of the Watch-PAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by descriptor. This change would fully capture the data provided by the device and I use in my clinical assessment.

In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV using three or more channels, and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is clear distinction among the groups and devices using PAT not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD.

Thus, the descriptor could read:

A sleep testing device measuring three or more channels that include actigraphy, oximetry, sleep time, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

In conclusion, I support CMS’s Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) and urge CAG to finalizes the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.

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January 2, 2009

Coverage and Analysis Group
Office of Coverage, Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore Maryland 21244-1850

Dear Drs. Phurrough, Jacques and Brechner and Ms. Stiller:

I submit this comment letter in strong support of the proposed National Coverage Determination for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) issued by the Center for Medicare and Medicaid Services (CMS) on December 23, 2008. As a physician who cares for patients with obstructive sleep apnea, I know the importance of choosing the right diagnostic testing modality for my patients. It is critical that I have the ability to choose between polysomnography and home sleep testing (including studies using peripheral arterial tonometry). Providing physicians who manage patients with suspected sleep apnea the various diagnostic options listed in the proposed NCD allows them to best match the diagnostic test with the particular clinical, physical, and social needs of their patients. Thus, I urge CMS to finalize, clarify and ensure coverage for home sleep testing and the corresponding coverage for Continuous Positive Airway Pressure treatment.

I am a Board Certified Cardiologist and recognize the relationship between sleep disordered breathing and cardiovascular disease. Furthermore, I am keenly aware of the difficulty in achieving patient compliance with overnight polysomnography in an accredited sleep lab. As such I have used the Watch PAT to diagnose patients in the home setting with obstructive sleep apnea. I follow the peer reviewed literature regarding home or portable sleep testing (HST) and I agree with CMS’s findings that the evidence is sufficient to conclude that all HST devices listed in the NCD are reasonable and necessary and when properly used, lead to improved health outcomes by assisting physicians, like myself, diagnose patients accurately and in a timely manner.

Coverage for HST devices utilizing actigraphy, oximetry and peripheral arterial tone (as well as additional optional channels) is of particular importance because these devices also record actual sleep time and provide extensive information about sleep architecture and sleep quality, information otherwise available only in PSG and in Level II devices. There are a number of patients in whom obtaining total sleep time, as opposed to total time in bed, is critically important to making an accurate diagnosis of sleep apnea. Therefore, I believe it is important for CMS to add the “sleep” element to the description of the Watch-PAT devices to be covered to ensure that the capabilities of this separate category of devices is captured by descriptor. This change would fully capture the data provided by the device and I use in my clinical assessment.

In addition, the proposed coverage policy makes the important distinction between Level II, Level III (the difference between these levels is the ability of Level II devices to record sleep information), Level IV using three or more channels, and HST devices including peripheral arterial tone, which do not fit any of the above categories. It is important that there is clear distinction among the groups and devices using PAT not be lumped with Level IV devices, which provide less clinical data than the other HST device categories included in the current draft NCD.

Thus, the descriptor could read:

A sleep testing device measuring three or more channels that include actigraphy, oximetry, sleep time, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

In conclusion, I support CMS’s Proposed Decision Memo for Sleep Testing for Obstructive Sleep Apnea (OSA) (CAG-00405N) and urge CAG to finalize the proposal. I appreciate CMS clarifying its coverage policy for sleep testing for OSA.

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I understand the problem with so many people having symptoms of obstructive sleep and and the high cost of test. Nevertheless, as a Sleep Specialist, my experience with Type III or IV devices in unattended studies has demonstrated several problems. Especially in patients with mild sleep apnea or snoring alone, these devices OVER diagnosis the problem. Patients then end up with CPAP machines prescribed for them who do not need this therapy. These patients may end up being retested in a sleep lab, thus increasing costs.

I do feel the Type III or IV devices have a place in screening. If the study is negative for Sleep Apnea, do further testing needs to be done in most cases. I do not feel the technology has advanced enough, however, to go directly from this type of diagnostic study to prescribing CPAP. This is especially true when the physician has little experience in treating this type of disorder.

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1. This draft NCD does not follow the American Academy of Sleep Medicine recommendations regarding sleep testing. The draft NCD is more liberal in allowing any physician (not just a Board certified Sleep specialist) to interpret sleep tests. There may be other differences as well. With Type II-IV testing, there may be spurius results and overtreatment by up to 15% (a serious cost-benefit concern, if not a concern for those patients mis-diagnosed) as well as undertreatment. (These statistics are from the NCD draft.)

2. The NCD states that there is no "gold standard" for diagnosing obstructive sleep apnea. However, Type I polysomnography (overnight testing monitored by a registered sleep technician in a sleep lab with EEG, EKG, EMG, EOG, video, snore microphone, body plethsymography, etc.) has been used as the clinical gold standard for over 25 years and was the test that allowed the condition to be identified. Any testing system that is approved by Medicare for reimburstment for this condition and/or by the FDA for use in the USA for diagnosiing sleep apnea should be required to show equivalent sensitivity and specifity to Type I testing.

3. Several HMOs have published studies showing the home/unattended sleep testing does not reduce the cost of diagnosing obstructive sleep apnea. In fact, it may increase costs, as patients frequently have to go to a lab to clarify whether they may have associated conditions, such as periodic limb movements and/or narcolepsy contributing to their daytime sleepiness. This is a concern for Medicare, as the Medicare budget is not increasing in size with the addition of these tests and paying for tests that are not definitive will reduce monies available to Medicare beneficiaries for other services.

4. While the draft NCD is correct that "most" patients are treated with CPAP, it does not look critically at other treatments which are favored by ENT surgeons and dentists. In fact CPAP compliance in the US is only approximately 40%. (It is higher in Europe where I have been told the insurance programs do not pay for surgery for obstructive sleep apnea.) As a result, the NCD should address the fact that a substantial number of patients "diagnosed" with sleep apnea may undergo surgery which has a 50-85% success rate. These surgeries often must be repeated and can involve nasal septal repair, turbinate reduction, insertion of Teflon strips in the soft palate, removal of the uvula, mandibular advancement, etc. As you can see the dollars going for this type of surgery are quite substantial. It has been my experience that patients who want cosmetic surgery or surgery to cure their snoring will obtain a sleep test to provide a diagnosis that will require the insurance to pay for their surgery, e.g. obstructive sleep apnea. Type II-IV sleep testing only encourages this patient behavior, as the study can be done in the comfort of their home. The NCD should address this aspect of the problem and how to keep type II-IV testing from such fraud. For instance, there is no way of knowing if an unattended study was performed on the individual who is claiming it. At the sleep labs I work with, we require photo ID of the patient coming to the lab. It appears to me that the ENT surgical society (in addition to the manufacturers of Type II-IV testing equipment and individual physicians who work with/own these manufacturers) has been the main specialty society recommending approval of allowing Type II-IV sleep tests to be covered by insurers.

5. While the underdiagnosis of sleep apnea is a public health concern (and seems to be the rational the NCD uses to expand testing coverage), my experience is that sleep apnea is underdiagnosed because the patient does not seek medical attention or the physician does not screen for the condition during a routine visit rather than a lack of availability of testing. (Patients with sleep apnea rarely have symptoms they attribute to a significant health problem and therefore do not seek medical attention themselves until their daytime sleepiness is impacting their lives.) Therefore, an NCD which expands coverage of tests may not have a significant favorable impact on the rate of diagnosis/effective treatment. Public/physician education about the condition (similar to what has occurred with hypertension) might be a more effective approach. While sleep labs may have a 4-8 week waiting period and there may be some areas of the country with a shortage of sleep labs, these problems could be addressed more effectively by increased funding for sleep labs in underserved areas, rather that expanding reimbursement for tests that in my opinion are not as accurate as Type I tests.

6. While I am not a statistician, I am concerned that the statistics quoted in the NCD may be spurius. I would be interested in an independent statistician''s evaluation of the statistics.

My conflict of interest in this matter is that I am a board certified sleep disorders specialist who reads sleep studies for my patients at several labs. I do not have a financial stake in any sleep lab or own sleep testing equipment. I do not perform surgery related to obstructive sleep apnea. Most of my income is derived from direct patient care and I have seen my reimbursements for direct patient care decrease significantly over the past 10 years.

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