Cochlear Implantation

The Ohio Academy of Audiology (OAA) is an organization representing approximately 1100 audiologists in the state of Ohio. On behalf of OAA I would like to commend and thank you for considering the proposed expansion of coverage for cochlear implantation (CI) for adults with aided open-set sentence recognition scores of less than or equal to 60% (up from 40%) on recorded tests. The OAA is an organization committed to improving quality of life for individuals with balance and communication disorders; audiologists are the primary health-care professionals who evaluate, diagnose, treat, and manage hearing loss and balance disorders in individuals of all ages.

As stated in our initial letter of support regarding this proposed expansion, by approving this expansion of coverage, Medicare Part B beneficiaries will be afforded the same opportunities for improvement in communication, tinnitus, depression, cognition and social isolation as individuals with commercial insurance. It has been reported by the members of OAA that they must often inform their Medicare Part B patients that they meet FDA labeling criteria for cochlear implantation; however, Medicare Part B will not cover the cost of cochlear implantation which has great potential to improve their ability to hear and communicate, in turn improving their quality of life. This leaves their patients and their family members frustrated, depressed and seeking other opportunities for hearing improvement that are not as effective. By approving this expansion, you are providing our patients with hope for enhanced ability to communicate and improved quality of life. If you have questions about these comments, or OAA’s support of the larger American Academy of Audiology/American Academy of Otolaryngology document submitted, please feel free to contact me.

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National Center for Health Research’s Comments On Broadening the National Coverage for Cochlear Implantation

We are writing to express our views on the Centers for Medicare and Medicaid Services (CMS) proposed decision memo reconsidering the national coverage determination for cochlear implantation.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We agree that cochlear implants have been shown to improve sentence recognition, thus helping affected adults communicate better and reducing feelings of isolation [1,2]. However, there are several issues that we strongly urge CMS to consider before deciding whether to broaden the national coverage.

We are especially concerned about the high percentage (13%) of adverse events for cochlear implantation, which can include minor infections and vertigo, to more serious infections like Meningitis [1, 3]. Even relatively minor adverse events such as taste disturbances and tinnitus can affect a person’s quality of life. Moreover, 2.7% of the reported adverse events can have life-altering consequences, such as permanent facial paralysis or loss of pre-operative functional acoustic hearing [1, 3]. We are concerned that the CMS decision memo did not include information from the FDA’s website regarding the numerous risks of cochlear implants, or about the previous recalls of cochlear implants that were found to cause permanent damage. In fact, when we analyzed the number of adverse events reported to the FDA’s MAUDE adverse event reporting system we saw thousands of adverse event reports, including more than 4,000 adverse events reported to the FDA in 2021 alone; approximately 2,000 from device malfunctions and more than 2,000 reported patient injuries. Tragically, more than 50 deaths have been reported to the FDA by health professionals and others that were attributed to cochlear implants. Although the adverse event reports to the FDA are not always confirmed by medical records, it is a voluntary reporting system that is considered to be “the tip of the iceberg” for any medical device, since many surgeons and other medical professionals are reluctant to take the time to report any but the more serious adverse events where the medical device seems clearly to blame.

All the statistics we cited above could be acceptable if there were adequate data on whether specific demographic or medical traits put Medicare beneficiaries at higher or lower risk. Unfortunately, as CMS points out, there is not enough research on which traits or pre-existing risk factors cause a greater chance of failure of the cochlear implantation and who is most at-risk for having severe complications. Moreover, even though these are life-long devices, there was insufficient long-term data on cochlear implants that are implanted for more than 2 years. Filling in these research gaps is vital to enable providers and patients to make educated decisions about whether the benefits outweigh the risks for them, which is essential information for adults whose hearing disability is less harmful to their quality of life.

We strongly urge CMS to require the makers of cochlear implants to gather this information prior to CMS making a decision of whether and under what conditions to broaden coverage to those who’s sentence recognition score is below 60%, and to those who do not meet clinical criteria but are involved in Category B IDE Studies or Routine Cost Trials. The companies need to have the incentive to conduct this research, and they will not have that incentive if the national coverage determination is expanded without that data. We are concerned that broadening coverage without more precise information about which patients are likely to be at greatest risk of serious adverse events would make it very difficult for patients with less severe hearing loss to make informed decisions about whether the benefits outweigh the risks for them. We do not oppose broadening the coverage when it is possible to provide more meaningful information to patients and providers about the short-term and long-term risks for patient subpopulations. If data become available that would reduce the chances of serious adverse events, broadening coverage could help to reduce hospitalization, death, falls, dementia and depression reported for older persons with severe hearing loss that cannot be corrected by hearing aids [1,4].

In addition, we urge CMS to clarify whether any broadening of coverage would also include broadening access to all necessary aspects of proper usage of cochlear implants, including follow-up appointments and specialists needed in the recovery process. CMS should also clarify the required qualifications for implantation. For example, CMS states that patients need to demonstrate “a willingness to undergo an extended program of rehabilitation”. However, patients may not be perceived as willing if they cannot take time off for all the recommended appointments, cannot drive due to other impairments, or live in rural areas that are far from the services needed. Additional resources should be made available to reduce discrimination against patients who may be perceived as unwilling or ineligible through no fault of their own.

The National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.

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Dear Director Syrek Jensen:

On behalf of Cochlear Americas (Cochlear), we appreciate the opportunity to provide comments on the Centers for Medicare & Medicaid Services’ (CMS’s) Proposed Decision Memo that would revise National Coverage Determination (NCD) 50.3 for Cochlear Implantation (CAG-00107R). For over 40 years, Cochlear has been a global leader in implantable hearing solutions. Our goal is to deliver value by helping more people to hear, which contributes to building a healthier and more productive society.

We appreciate the time and effort CMS has put in to analyzing the clinical literature and data and engaging with stakeholders to address the outdated coverage criteria in NCD 50.3, which, as CMS is aware, was last updated nearly two decades ago. As we previously commented, cochlear implant technology has improved considerably in the intervening 17 years. Advances in implant technology and sound processing strategies have resulted in progressively improved outcomes and enhanced quality of life for cochlear implant recipients, and these improvements are well documented in the clinical and empirical literature.

As acknowledged by CMS in its Proposed Decision Memo, the current evidence overwhelmingly supports that the benefits of cochlear implantation extend to patients whose conditions fall well outside the criteria established for coverage under the current version of NCD 50.3. Most notably, the literature clearly supports full national coverage for beneficiaries with bilateral pre- or-post-linguistic, sensorineural, moderate-to-profound hearing loss and hearing test scores of greater than 40% and less than or equal to 60%. Currently, these beneficiaries only have coverage in the context of clinical trials.

To that end, we agree and support CMS’s proposed decision to expand coverage of cochlear implantation for Medicare beneficiaries by:

• Removing the Coverage with Evidence Development (CED) component of the NCD that covered cochlear implantation for individuals with hearing test scores of greater than 40% and less than or equal to 60% only when the provider was participating in, and patients were enrolled in, either a Food and Drug Administration (FDA)-approved category B investigational device exemption (IDE) trial, a trial under CMS’s Clinical Trial Policy, or a prospective, controlled comparative trial approved by CMS as consistent with the evidentiary requirements for National Coverage Analyses and meeting specific quality standards;
• Covering cochlear implantation for treatment of bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss in individuals who demonstrate limited benefit from amplification, which is defined by test scores of less than or equal to 60% correct in the best-aided listening condition on recorded tests of open-set sentence cognition;
• Removing the outdated media requirement of tape-recorded tests in favor of simple recorded open-set sentences; and
• Specifying that CMS may provide coverage of cochlear implants for beneficiaries not meeting the coverage criteria listed in Section B when performed in the context of FDA-approved category B IDE clinical trials as defined at 42 CFR 405.201 or as a routine cost in clinical trials under section 310.1 of the NCD Manual titled Routine Costs in Clinical Trials.

However, we urge CMS to make a few more changes that are imperative to prevent disruptions in patient access and to be consistent with the language used in FDA-approved labeling of cochlear implants. Specifically, we recommend that CMS incorporate the following into the Final Decision Memo and revised NCD:

We discuss these in more detail below.

I. Coverage of Cochlear Implants for Beneficiaries Not Meeting the Coverage Criteria Specified in the NCD Should Be Left to MAC Discretion

Section C of the proposed NCD language provides that Medicare beneficiaries not meeting all of the coverage criteria for cochlear implantation listed in Section B are deemed not eligible for Medicare coverage except as described in Section D. Section D of the proposed NCD language states that “CMS may provide coverage of cochlear implants for beneficiaries not meeting the coverage criteria listed in Section B when performed in the context of FDA-approved category B investigational device exemption clinical trials as defined at 42 CFR 405.201 or as a routine cost in clinical trials under section 310.1 of the National Coverage Determinations Manual titled Routine Costs in Clinical Trials.“ Although we appreciate and support this clarification in the NCD, we are concerned that there is the potential for a significant, and we believe unintended, coverage gap for Medicare beneficiaries.

That is, as proposed, a Medicare beneficiary who does not otherwise meet the coverage criteria in the NCD could have their cochlear implant covered as part of a Category B IDE study or as a routine cost in a clinical trial. However, when the cochlear implant ultimately is cleared or approved by the FDA (and thus the IDE study ends), Medicare beneficiaries no longer would have access to the same device that they did prior to FDA marketing authorization. This would have the anomalous result of beneficiaries having coverage for an investigational device but not for a FDA-cleared or approved device.

Thus, in order to avoid these coverage gaps, we urge CMS to revise the NCD to clarify that cochlear implantation performed with a FDA-approved device, for a patient who otherwise does not meet the coverage criteria in the NCD, may be covered if, in the judgment of the local MAC, such use is medically necessary. The MACs are well positioned to make coverage determinations for beneficiaries who do not otherwise meet the NCD coverage criteria, and doing so would avoid the coverage gaps noted above.

Medicare coverage pursuant to a Category B IDE or other clinical study is beneficial, but in those cases where a Category B IDE study ends and the device becomes FDA-cleared or approved, and/or when there is no clinical study in which the beneficiary can enroll, it is appropriate for the MAC to be able to make a coverage determination. This approach also mitigates the need for CMS to reconsider the Cochlear Implantation NCD frequently, and avoids beneficiary access issues in between NCD reconsiderations. Given the pace of innovation for cochlear implantation and significant investment in further understanding clinical benefit for patients, it behooves the agency to facilitate appropriate coverage in ways that are complementary to the NCD, most specifically via MAC discretion.

We urge CMS to consider revising the criteria that patients be free from lesions in the auditory nerve and acoustic area of the central nervous system to instead include language that aligns with current FDA labeling which recognizes efficacy of treatment for those patients with a functional auditory nerve regardless of whether there are lesions. As demonstrated below, there is now sufficient clinical evidence for a medical professional to make an informed decision to provide a cochlear implant to a patient with compromised hearing due to a lesion of the acoustic nerve or central auditory pathway. This is reflected in recent FDA labeling of cochlear implants that simply require the patient to have a functional auditory nerve, and do not limit use of the devices to individuals without lesions.

There have been several papers published over the past few years regarding the safety and effectiveness of cochlear implantation after both radiation therapy and surgery (with preservation of the cochlear nerve) for acoustic neuromas, as well as implantation of observed vestibular schwannomas. In a review of the recent literature, 23 studies were found to be relevant involving a total of 123 patients with some form of schwannoma who received a cochlear implant. Sixty-nine subjects had a vestibular schwannoma and the other 59 were neurofibromatosis Type 2 (NF2). When the tumor was removed, the cochlear implant procedure was done simultaneously (at the same time as tumor removal in one procedure) in 38 cases; 18 cases had the cochlear implant implanted sequentially during a second procedure after the tumor removal at a later date. Of the 72 tumors left in situ, 38 cases received some form of radiation therapy, while 34 patients were observed with no therapy other than the cochlear implant. All these studies had most subjects showing favorable performance outcomes, demonstrating the effectiveness of cochlear implantation with a schwannoma left in situ or after the tumor removal.

Having a preserved cochlear nerve and cochlear patency is required for cochlear implantation after a lesion resection. When this type of lesion is removed partially or in whole, cochlear fibrosis can occur and studies have cited that the safest time window for potential cochlear implantation in cases with a preserved nerve is within six months. It has been found that the onset of cochlear obliteration occurred within two to seven months in most translabyrinthine patients, and these findings may support the need for simultaneous cochlear electrode or dummy implantation in translabyrinthine surgery. Second stage implantation could be feasible in cases where a retrosigmoid approach is used; however, the implantation should be considered within the initial months to avoid cochlear obliteration. (Carswell et al., (2019); Hill et al., (2018); Rodgers et al., (2017); van Waegeningh et al., (2020)). , , ,

Carswell et al., (2019) found that after a vestibular schwannoma resection of 39 patients, the cochlea showed no evidence of obliteration in 75% of the study group at six months, 38.5% by one year and 27% beyond one year. The progress of cochlear obliteration that occurred between 6 and 12 months following vestibular schwannoma resection indicates that the first six months provides the safest time window for cochlear patency. This recommendation is supported by Hill et. al. 2018, who stated that cochlear implantation would ideally need to be performed either simultaneous to translabyrinthine surgery or as an early second stage procedure to maximize the chance of a successful electrode insertion, or one can consider a placeholder. Hill et al. (2018) found that of 49 patients who underwent translabyrinthine removal of a vestibular schwannoma, the majority of cochlea signal changes identified at six months were minor and of the patients with a normal cochlea at six months, 78% maintained a normal cochlea to the 48-month scan.

B. Clinical evidence of effectiveness of cochlear implantation in patients with current or prior lesions in the auditory nerve and acoustic area of the central nervous system

Several recent studies report on the effectiveness of a cochlear implant following a resection of a vestibular schwannoma or when the tumor is left in situ. Generally, these studies reported that most patients can achieve some level of open set word recognition, that patients are full time users of their device and that patients subjectively report that the cochlear implant is beneficial.

• Sanna et al., (2017) reported the hearing results of cochlear implantation simultaneous to vestibular schwannoma resection in 13 subjects. Full electrode insertion into the scala tympani was achieved through the round window in all cases and x-ray confirmed the correct positioning of the intracochlear electrodes. All patients had auditory sensation; however, two patients did not have improvement in sentence recognition, disyllabic word recognition or recognition of common phrases.
• In a population of 10 ears (nine patients), Carlson et al., (2016) reported all subjects having inner ear schwannomas where the intracochlear tumor was left in situ to preserve cochlear anatomy and a full electrode insertion was achieved. Eight of the 10 ears achieved good open-set word recognition, consonant-nucleus-consonant (CNC) 50% median (28-88%) and AzBio 73% (60-91%) with a median audiological follow up of six months and median duration of postoperative clinical follow-up of 21 months.
• Aschendorff et al., (2017) reported on six subjects who underwent cochlear implantation treatment following the removal of intralabryinthine tumors. In four cases the procedure was done simultaneously, and two were done sequentially. In all cases the tumor was removed without compromising the cochlear nerve. Five of the six patients receive some open set word recognition with improvement on the Freiburg monosyllabic test ranging from 10 to 50 percentage point improvement. It was noted that performance was best for the patients who had early simultaneous treatment (i.e. removal of tumor and placement of CI at the same surgery). All patients use their cochlear implant daily and reported subjective benefit.
• Klenzner et al., (2019) reported on 13 patients who received a cochlear implant. In all cases a complete removal of the tumor was achieved, and the cochlear nerve was preserved. One subject was implanted with a cochlear implant simultaneous to the tumor removal and the remaining 12 were implanted sequentially. During the first postoperative 12 months, six of 13 patients achieved a level of monosyllabic speech recognition of 60-80% and one patient that of 50-60%, two patients that of <50% and three patients that of 0%. Seven of the 13 subjects also showed an improvement in their speech understanding in noise. It was reported that all patients wear the speech processor daily and report that it significantly improves orientation and makes everyday living easier.
• Plontke et al., (2018) reported on eight patients who had simultaneous removal of an intralabyrinthine schwannoma and implantation of a cochlear implant. At three months post-surgery, average monosyllabic word recognition was 64% (standard deviation (SD) +/- 14%). Only one of the eight patients did not demonstrate improvement in word recognition.
• Borsetto et al., (2020) completed a systematic review of hearing outcomes in cochlear implant recipients with vestibular schwannoma whose tumors had been managed prior to cochlear implantation with either observation or radiotherapy. The review included 12 studies involving 50 patients. Cochlear implantation outcomes were similar between the groups with 64% and 60% of patients in the radiotherapy and observation groups achieving open-set speech perception, respectively.
• Urban et al., (2020) highlighted that hearing out comes with cochlear implantation for vestibular schwannoma patients are superior to those achieved with auditory brainstem implant (ABI). Seven patients underwent ipsilateral cochlear implantation in the presence of observed (n=2) or irradiated (n=5) vestibular schwannomas. Full electrode insertion was achieved in all cases and mean post-operative sentence score was 63.9% (range 48-91) (4 AzBio / 1 hearing in noise test (HINT)) at an average of 28 months follow up. Average post-implant CNC word scores were available for five patients and averaged 59%. All patients initially reported daily use of their implants and achieved open set discrimination. However, one patient became a nonuser 18 months post-op as benefit was no longer achieved.
• Plontke et al., (2021) reported on six patients with cochleovestibular schwannoma (all tumors removed, and cochlear implant implanted at the same time as the removal). All patients had some open set word recognition with four scoring between 65–85% on a monosyllabic word test. On average, word recognition was 94% (SD+/-9%) for numbers and 52% (SD+/- 31%) for monosyllables at 65 decibel (dB) sound pressure level (SPL) (after six months, n= 5). Two patients had only poor word recognition after six months (25%, 15%), with further worsening of results thereafter. The follow-up magnetic resonance imaging (MRI) in these two patients showed only minimal tumor growth of 0.5mm (two years after implantation) and 3.6mm (two years and five months after implantation) for each of the two patients respectively.

Thus, as demonstrated here, there is substantial and growing evidence that cochlear implantation is reasonable and necessary for patients with current or previous lesions on the auditory nerve or acoustic area of the central nervous system so long as the cochlear implant is implanted concurrently with tumor removal or shortly thereafter, and there is a working cochlear nerve. Thus, the requirement in the Proposed Decision Memo that the patient be free from lesions is outdated and will unreasonably restrict beneficiary access to cochlear implants contrary to the clinical evidence.

In light of the above, we recommend that CMS revise the proposed NCD language and finalize it as follows:

Cochlear thanks CMS for this opportunity to comment on the Proposed Decision Memo and address the need to modernize Medicare coverage standards related to cochlear implants to address the current empirical literature, which strongly supports expanded Medicare coverage. We enthusiastically support the changes to the NCD proposed by CMS. However, we also recommend that CMS: (1) leave coverage determinations to MAC discretion for beneficiaries who do not meet the criteria of the NCD and who are not enrolled in a Category B IDE study or a different clinical study where the cochlear implant is a routine cost; and (2) revise the requirement that patients be free from lesions in the auditory nerve and acoustic area of the central nervous system to instead include language that aligns with current FDA labelling, which recognizes the efficacy of treatment for patients with a functional auditory nerve, regardless of whether there are lesions.

We appreciate the significant time and effort that CMS has devoted to reconsidering the Cochlear Implantation NCD. If CMS has any questions about this comment letter or if Cochlear can assist CMS in any way as it reconsiders NCD 50.3, please do not hesitate to contact me at jbyrd@cochlear.com.

Sincerely,

Jim Byrd
Sr. Director, Reimbursement Strategy
Cochlear Americas

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Comments of American Cochlear Implant Alliance (ACI Alliance) regarding the Proposed Coverage Expansion for Cochlear Implants Under Medicare
August 3, 2022

American Cochlear Implant Alliance, a membership organization comprised of cochlear implant (CI) clinicians and scientists as well as members of the CI patient community, supports this important proposal by CMS to expand candidacy criteria as presented in the July 6 Decision Summary. The reconsideration process began with an October 27, 2020 complete and formal request to CMS to reconsider NCD 50.3 submitted by Drs. Teresa Zwolan and Craig Buchman.

In addition to reviewing the October 27, 2020 complete and formal request with related research documentation, CMS conducted its own internal technology assessment. The Decision Summary includes reviews of published studies, a consensus statement, and a professional society guideline. Public comments provided further support for the expansion.

We are grateful to CMS for the thorough and open manner in which the National Coverage Analysis was conducted. American Cochlear Implant Alliance supports the CMS proposal for Medicare coverage of cochlear implantation when patients derive limited benefit from amplification as defined by test scores of less than or equal to 60% correct in the best-aided listening condition on recorded tests of open-set sentence cognition.

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The Cleveland Clinic Hearing Implant Program commends CMS for the proposed expansion of the National Coverage Determination policy for cochlear implantation (CI) for adults. Increasing the required aided sentence recognition scores up to 60% (instead of 40%) provides coverage for Medicare beneficiaries that more closely aligns with FDA labeling and clinical best practices.

Our program implanted its first cochlear implant in 1983 and currently supports well over 2,000 recipients across the lifespan. Our team is comprised of nine doctoral-level audiologists, three neurotologists, one pediatric otolaryngologist, and an auditory-verbal therapist. We pride ourselves on optimizing access for cochlear implant candidates, increasing utilization of this life-changing technology, maximizing outcomes and benefit for our recipients, and basing our practice on evidence that leads to a high-quality, patient-centered implant experience.

Without reservation, we acknowledge that the revision of the National Coverage Determination policy as outlined will facilitate the delivery of more optimal and appropriate care for our patients and is the right thing to do.

Sincerely,

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The American Academy of Audiology is pleased to write in support of the July 6 proposed decision by the Centers for Medicare and Medicaid Services (CMS) to expand the National Coverage Determination policy for cochlear implantation (CI). We wholeheartedly agree with the decision to broaden the CI patient criteria to include individuals with aided sentence recognition scores up to 60%, instead of 40%. As the largest organization in the nation of, by, and for audiologists, the Academy regards this policy decision as a needed change in hearing health care in the best interest of Medicare beneficiaries.

The Academy and the American Academy of Otolaryngology-Head and Neck Surgery previously submitted joint comments to endorse the expanded coverage determination (March 29, 2022), As demonstrated through the evidence we cited in our earlier comments, CI is a well-established, non-experimental intervention that is appropriate for Medicare beneficiaries (and other adults) who receive limited benefit from hearing aids. CIs have been approved by the FDA since the mid-1980s and have continued to evolve to support more individuals with a greater diversity of hearing loss. Post-operative outcomes are impacted by cochlear health, hence CI intervention before prolonged duration of severe-to-profound hearing loss will yield greater benefit to the Medicare beneficiary. The expanded CI coverage policy will support best clinical practices.

The Academy applauds CMS for its decision to modernize the CI coverage policy and expand access to Medicare beneficiaries. We strongly believe that this coverage decision will significantly enhance clinical outcomes.

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I have worked with cochlear implants since graduate school in the mid 1990's. I have seen first hand the hugely positive impact that they have on hearing health and quality of life. My patients use words like "miracle" and thank me for "giving them their life back". We know that hearing loss can lead to anxiety, isolation, depression, cognitive decline and memory loss. Expanding CMS cochlear implant criteria to match that of private insurance is critical in caring for our aging population. Cochlear implants have been proven to be safe and effective for those in this expanded criteria range. This expansion is long overdue. I implore you to adopt this change.

Sincerely,
Sheryl Erenberg, AuD
Doctor of Audiology

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I support the Centers for Medicare & Medicaid Services (CMS) expanding coverage for cochlear implants from "less than or equal to 40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition" to "less than or equal to 60% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition." It is important that people with hearing loss have access to cochlear implant technology. Under the previous coverage criteria, many patients who would benefit from cochlear implant use did not have coverage. A lack of coverage limits access to cochlear implant technology and restricts the ability to effectively address significant hearing loss that cannot be addressed with hearing aids.

Professionally, I have worked with patients who have other insurance coverage and who met the less than or equal to 60% sentence recognition criteria and who do very well with cochlear implants. It is sad when the 40% criteria prevents an adult struggling with everyday listening from receiving and benefitting from a cochlear implant.

Thank you for your work to expand coverage for cochlear implants, as it increases effective communication options for people with hearing loss.

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Dear CMS:
Dr. Craig Buchman and I would like to applaud CMS' decision to reconsider the national coverage determination and your proposed expansion of coverage for cochlear implants. If this change is approved, CMS indications for a cochlear implant will be better aligned with indications of both the FDA and many private insurers. Importantly, such a change will enable individuals with significant hearing loss to receive treatment prior to the loss of all functional auditory skills, which will likely result in improved outcomes with the CI.

We appreciate working with you to update the NCD for Cochlear Implants.

Sincerely,
Terry Zwolan, Ph.D., CCC-A Director of Audiology, Hearing First Clinical Professor Emerita, Department of Otolaryngology Head & Neck Surgery, Michigan Medicine

Craig A. Buchman, MD, FACS (he/him/his)
Lindburg Professor and Chair
Department of Otolaryngology-Head & Neck Surgery
Washington University School of Medicine
Campus Box 8115 | 660 South Euclid Avenue | St. Louis, MO 63110-1093
Tel: 314-362-7667 | Fax: 314-362-2914
Visit us at: https://oto.wustl.edu

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The American Speech-Language-Hearing Association (ASHA) commends Centers for Medicare & Medicaid Services (CMS) for considering expansion of coverage for cochlear implants under the National Coverage Determination (NCD). ASHA is the national professional, scientific, and credentialing association for 218,000 members and affiliates who are audiologists; speech-language pathologists; speech, language, and hearing scientists; audiology and speech-language pathology support personnel; and students.

ASHA was pleased to see feedback CMS received in March 2022 reinforced the appropriateness of a change in the NCD and that ASHA’s comments were acknowledged. As the NCD change is finalized associated with this comment period, ASHA is committed to ensuring that Medicare coverage decisions are based on research and evidence that ensure appropriate access to cochlear implants for Medicare beneficiaries.

Audiologists play a critical role in identifying cochlear implant candidates, counseling patients on cochlear implant use/expectations, programming the device, assessing patient benefit/performance, and providing maintenance services for the processor and accompanying technologies. We strongly support updating the coverage guidance to expand the coverage from “less than or equal to 40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition” to “less than or equal to 60% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition.” The principal study upon which this reconsideration request is founded, authored by Dr. Terry Zwolan, Dr. Craig Buchman, and Dr. John Niparko, demonstrates the importance of this coverage expansion based on the improved quality of life of patients receiving the implants.

Untreated hearing loss is associated with a variety of negative health outcomes including depression, anxiety, and emotional instability (Oxford Academic. (May 2012). Hearing-impaired adults are at increased risk of experiencing emotional distress and social engagement restrictions five years later. https://academic.oup.com/ageing/article/41/5/618/47025/Hearing-impaired-adults-are-at-increased-risk-of..).

Research illustrates that older cochlear implant recipients that are implanted outside of current, CMS candidacy, benefit greatly from cochlear implant use (Zhang and Coelho, 2018; Zwolan, Kallogjeri, Firszt, Buchman, 2020), supporting the need to make this technology available to more Americans. A broader speech perception score range ensures that appropriate cochlear implant candidates have access to this important technology in a timely fashion. Patients who must wait for a more profound level of hearing loss risk losing the benefit of timely implantation including (but not limited to) improved communication, maintaining independence, mental health benefits, and participation in interactions with colleagues, friends, and family. Under the previous coverage criteria patients who would benefit from cochlear implant use likely did not receive coverage, thus limiting their access to cochlear implants and restricting their ability to communicate with other and participate in their lives in a meaningful way. It appears this research reinforced CMS’ decision to expand coverage as outlined in the revised draft NCD.

For these reasons, ASHA recommends CMS adopt the updates to the NCD.

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Dear committee:

As a cochlear implant surgeon, I strongly support the expansion of cochlear implant coverage by CMS. I have seen the benefit of implantation to patients who fall outside the current CMS guidelines. Because so many of our elders are insured through CMS, they are currently more restricted in their access to this life altering and improving technology. At a time in life when people are becoming more medically fragile and dependent, they really need access to all ways to maintain as much of their autonomy as possible. Cataract surgery allows so many seniors to keep seeing. Likewise, expanded CI coverage will help them to maintain functional hearing more easily and smoothly.

Sincerely,
Laura Brainard, MD

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The word recognition criteria for medicare beneficiaries should be changed form 40% to 60 %, in line with current CI guidelines.

We have seen patients who scored just above 60% in the best aided condition, and then undergo re-evaluation a year or 2 later after aging into medicare eligibility see their scores drop below 60%- but then have to wait until performance further decreases to below 40%. During the time the patient could benefit from improved access to conversation and possibly decrease the impact of social isolation from hearing loss, they have to wait several year and suffer the consequences of declining hearing ability on cognition and overall health.

Removing the "doughnut hole" in word recognition will allow medicare beneficiaries the best opportunity for healthy aging and maintaining independence. There is evidence the use of well fit amplification can slow the rate of cognitive decline- there should be a similar benefit to providing earlier, rather than later, access to implantation. Denying this access feels like a form of age discrimination. Waiting until performance decreases from 60% to 40% increases the likelihood that "Cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation..." will not be possible or practical. This population especially is defined less by laps around the sun and more by health and functional ability. Changing the criteria form 40% to 60% ( or what ever the current research based criteria is) will allow maintenance of independence and functional ability in the medicare population. Any increased costs of additional surgery should be offset by reduced healthcare costs.

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support the Centers for Medicare & Medicaid Services expanding coverage for cochlear implants from "less than or equal to 40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition" to "less than or equal to 60% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition." It is important that people with hearing loss have access to cochlear implant technology. Under the previous coverage criteria, many patients who would benefit from cochlear implant use did not have coverage. A lack of coverage limits access to cochlear implant technology and restricts the ability to effectively address significant hearing loss that cannot be addressed with hearing aids. Thank you for your work to expand coverage for cochlear implants, as it increases effective communication options for people with hearing loss.

Thank you!

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As a hearing health care provider, I fully support these changes to the CMS guidelines for cochlear implant candidacy.

This will provide access to CMS beneficiaries who previously did not meet criteria because their hearing was “too good” for a cochlear implant even though they were missing up to 60% of what is being said. This lack of access can lead to disparities in healthcare but also prolongs the time the CMS beneficiary are deprived of optimized hearing. Based on published research, this auditory deprivation can also negatively impact outcome once individuals do qualify for a CI.

Changing the CMS guidelines to better align with FDA indications will likely decrease health disparities and will likely improve the outcomes being received by patients with CMS coverage who receive a cochlear implant.

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I support the Centers for Medicare & Medicaid Services (CMS) expanding coverage for cochlear implants from "less than or equal to 40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition" to "less than or equal to 60% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition." It is important that people with hearing loss have access to cochlear implant technology. Under the previous coverage criteria, many patients who would benefit from cochlear implant use did not have coverage. A lack of coverage limits access to cochlear implant technology and restricts the ability to effectively address significant hearing loss that cannot be addressed with hearing aids. Professionally, I have witnessed (enter experience you'd like to share here.) Thank you for your work to expand coverage for cochlear implants, as it increases effective communication options for people with hearing loss

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I support the Centers for Medicare & Medicaid Services (CMS) expanding coverage for cochlear implants from "less than or equal to 40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition" to "less than or equal to 60% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition." It is important that people with hearing loss have access to cochlear implant technology. Under the previous coverage criteria, many patients who would benefit from cochlear implant use did not have coverage. A lack of coverage limits access to cochlear implant technology and restricts the ability to effectively address significant hearing loss that cannot be addressed with hearing aids. Thank you for your work to expand coverage for cochlear implants, as it increases effective communication options for people with hearing loss."

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I support the Centers for Medicare & Medicaid Services (CMS) expanding coverage for cochlear implants from "less than or equal to 40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition" to "less than or equal to 60% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition." It is important that people with hearing loss have access to cochlear implant technology. Under the previous coverage criteria, many patients who would benefit from cochlear implant use did not have coverage. A lack of coverage limits access to cochlear implant technology and restricts the ability to effectively address significant hearing loss that cannot be addressed with hearing aids.
Thank you for your work to expand coverage for cochlear implants, as it increases effective communication options for people with hearing loss.

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I support the Centers for Medicare & Medicaid Services (CMS) expanding coverage for cochlear implants from "less than or equal to 40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition" to "less than or equal to 60% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition." It is important that people with hearing loss have access to cochlear implant technology. Under the previous coverage criteria, many patients who would benefit from cochlear implant use did not have coverage. A lack of coverage limits access to cochlear implant technology and restricts the ability to effectively address significant hearing loss that cannot be addressed with hearing aids.

Professionally as an audiologist, I have witnessed countless patients with private insurance who fall within this wider range (>40% and < or =60%) benefit from cochlear implants. I have also witnessed many patients with Medicare who fall within this range who were previously not able to obtain a cochlear implant. They were told to wait until their hearing was poorer; however, in the process, they also became older and more likely to struggle with communication, withdraw from relationships and society, experience the challenges of cognitive decline. As a result, they would have poorer outcomes. Expanding coverage for cochlear implants will allow for more patients to benefit from cochlear implants sooner. Thank you for your work to expand coverage for cochlear implants, as it increases effective communication options for people with hearing loss."

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I support the Centers for Medicare & Medicaid Services (CMS) expanding coverage for cochlear implants from "less than or equal to 40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition" to "less than or equal to 60% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition." It is important that people with hearing loss have access to cochlear implant technology. Under the previous coverage criteria, many patients who would benefit from cochlear implant use did not have coverage. A lack of coverage limits access to cochlear implant technology and restricts the ability to effectively address significant hearing loss that cannot be addressed with hearing aids. Professionally, I have witnessed (enter experience you'd like to share here.)
Thank you for your work to expand coverage for cochlear implants, as it increases effective communication options for people with hearing loss.

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I support the Centers for Medicare & Medicaid Services (CMS) expanding coverage for cochlear implants from “less than or equal to 40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition” to “less than or equal to 60% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition.”

As an audiologist, I feel that it is important that people with hearing loss have access to cochlear implant technology. Under the previous coverage criteria, many patients who would benefit from cochlear implant use did not have coverage. A lack of coverage limits access to cochlear implant technology and restricts the ability to effectively address significant hearing loss that cannot be addressed with hearing aids. Professionally, I have witnessed the economic impact of access to cochlear implant technology, as I have seen cochlear implant users avoid early retirement. I have also seen cochlear implant users come out of social isolation as this technology gives them the ability to communicate with others again.

Thank you for your work to expand coverage for cochlear implants, as it increases effective communication options for people with hearing loss.

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As a hearing health care provider, I fully support these changes to the CMS guidelines for cochlear implant candidacy.

This will provide access to CMS beneficiaries who previously did not meet criteria because their hearing was “too good” for a cochlear implant even though they were missing up to 60% of what is being said. This lack of access can lead to disparities in healthcare but also prolongs the time the CMS beneficiary are deprived of optimized hearing. Based on published research, this auditory deprivation can also negatively impact outcome once individuals do qualify for a CI.

Changing the CMS guidelines to better align with FDA indications will likely decrease health disparities and will likely improve the outcomes being received by patients with CMS coverage who receive a cochlear implant.

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Thank you for considering broadening cochlear implant candidacy criteria to allow individuals with hearing test scores of >40% and =60%. As an audiologist who works daily with patients with hearing loss, I can speak from experience that my patients who receive a cochlear implant with 50-60% scores have significantly better outcomes with their cochlear implants than those who are made to wait until their scores drop below 40%. By the time a patient has gotten to 40%, they progress more slowly with their cochlear implant, require more follow up appointments with their cochlear implant, and do not have as good long term outcomes with their cochlear implants.

Thank you again for this consideration.

Dr. Link

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I support this expansion of hearing health coverage. This important expansion will provide access to hearing for many individuals who would otherwise be unable to communicate socially and professionally. In addition, hearing loss is the most common treatable contributing factor for the development of cognitive decline and dementia. Allowing improved access to hearing care and cochlear implantation may help delay or prevent the onset of cognitive decline and the costs associated with dementia. This also corrects the inequitable application of FDA approved hearing care to patients with CMS related coverage vs commercial insurance. This is an important update to CMS policy and one that I fully support.

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As a hearing health care provider, I fully support these changes to the CMS guidelines for cochlear implant candidacy.

This will provide access to CMS beneficiaries who previously did not meet criteria because their hearing was “too good” for a cochlear implant even though they were missing up to 60% of what is being said. This lack of access can lead to disparities in healthcare but also prolongs the time the CMS beneficiary are deprived of optimized hearing. Based on published research, this auditory deprivation can also negatively impact outcome once individuals do qualify for a CI.

Changing the CMS guidelines to better align with FDA indications will likely decrease health disparities and will likely improve the outcomes being received by patients with CMS coverage who receive a cochlear implant.

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We agree with the CMS proposed cochlear benefit expansion, as follows:

The Centers for Medicare & Medicaid Services (CMS) is reconsidering the national coverage determination established at section 50.3 of the Medicare National Coverage Determinations manual. We are proposing to expand coverage by broadening the patient criteria and removing the requirement that for individuals with hearing test scores of > 40 % and = 60 %, cochlear implantation may be covered only when the provider is participating in and patients are enrolled in either an FDA-approved category B IDE clinical trial, a trial under the CMS Clinical Trial Policy, or a prospective, controlled comparative trial approved by CMS. We are proposing that the evidence is sufficient to determine that cochlear implantation may be covered for treatment of bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss in individuals who demonstrate limited benefit from amplification. Limited benefit from amplification is defined by test scores of less than or equal to 60% correct in the best-aided listening condition on recorded tests of open-set sentence cognition. Patients must meet all of the following criteria.

Diagnosis of bilateral moderate-to-profound sensorineural hearing impairment with limited benefit from appropriate hearing (or vibrotactile) aids;
Cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation;
Freedom from middle ear infection, an accessible cochlear lumen that is structurally suited to implantation, and freedom from lesions in the auditory nerve and acoustic areas of the central nervous system;
No contraindications to surgery; and
The device must be used in accordance with Food and Drug Administration (FDA)-approved labeling.

CMS is also proposing that we may provide coverage of cochlear implants for beneficiaries not meeting the coverage criteria listed above when performed in the context of FDA-approved category B investigational device exemption clinical trials as defined at 42 CFR 405.201 or as a routine cost in clinical trials under section 310.1 of the National Coverage Determinations Manual titled Routine Costs in Clinical Trials.

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Hello,

I have been working with cochlear implant patients for over 10 years. I understand this was a very large undertaking to review patient candidacy and outcomes. As with all areas of medicine, we want to ensure we are doing right by the patients we see. I fully support the expansion of candidacy criteria. I have seen a large number of patients gain a substantial improvement in quality of life by pursuing cochlear implantation outside the existing metrics used by Medicare (these were non-Medicare patients). I am grateful to this organization for taking the time to do this work and offer those struggling with hearing loss increased access to a cochlear implant when appropriate.

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“As a hearing health care provider, I fully support these changes to the CMS guidelines for cochlear implant candidacy.

This will provide access to CMS beneficiaries who previously did not meet criteria because their hearing was “too good” for a cochlear implant even though they were missing up to 60% of what is being said. This lack of access can lead to disparities in healthcare but also prolongs the time the CMS beneficiary are deprived of optimized hearing. Based on published research, this auditory deprivation can also negatively impact outcome once individuals qualify for a CI.

Changing the CMS guidelines to better align with FDA indications will likely decrease health disparities and will likely improve the outcomes being received by patients with CMS coverage who receive a cochlear implant

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I wanted to send a letter of support in the proposed coverage expansion for cochlear implants. I encourage CMS to adopt the broader candidacy criteria to allow individuals with hearing test scores of >40% and =60%. This expansion is appropriate for treating hearing loss and allows for critical access of communication for bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss in individuals who demonstrate limited benefit from amplification. Thank you for the hard work of the teams that have reviewed the documentation in support of this expansion and CMS' consideration for their recipients hearing health.

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I am a 30-year clinical audiologist who has worked directly with cochlear implants for over 15 years and have managed several CI programs including at the Veterans Administration. In that time, the only universal truth I have have found in the arena of cochlear implantation in the US is that there are no firm or enforced standard protocols across clinics. If Medicare is to expand coverage to this technology, those of us providing this treatment option need to be held to a higher standard.

I am in favor of expanding coverage with the following requests:

1. Criteria has long been described with the assumption that "best aided condition" is a known entity. In my experience, this is not true. I propose that this condition be specifically defined and that documentation be required to ensure that candidacy is evaluated under this standard.

In patients using Behind The Ear (BTE) hearing aids, a Continuous Flow Adapter (CFA) earmold should be used to ensure that the sound bore remains as it was during audibility confirmation. Standard glued or "tube lock" tubing is made of tygon which shrinks over time reducing hearing aid output, thus taking patient out of "best aided condition."

In patients using RICs or custom In The Ear (ITE) hearing aids with replaceable wax guards, attempts should be made to ensure these critical "plumbing" components are changes regularly. Recent advances in tele-audiology should allow this to be done quite easily using support or para-professional staff.

Above measures should be evaluated in both "automatic" and dedicated noise reduction programs as well as with a compatible remote microphone connected and placed 3" from the center of the speaker presenting the stimulus sentences.

If patient wear only one hearing aid or a BiCROS system, this should be documented.

I expect this level of detail will be opposed by some, but feel that this not only benefits the patient, but can serve to create a standard metric for the collection of big data across clinics. I would encourage CMS to develop a HIPAA and HL7 compliant web-based data entry interface and require that all requests for cochlear implant coverage be entered into this form. Additionally, post-operative aided speech perception data as detailed above should be entered into this national system at a minimum of 3, 6 and 12 months post initial stimulation and then annually thereafter to bolster the outcome database which, to this point, is isolated to individual clinics. Failure to comply with this should result in a warning followed by fines.

2. A taskforce consisting of stakeholders should be formed and should meet at least semi-annually to review the outcome data and track the need for modifications of this protocol. Stakeholders should include representatives from CMS. university faculty actively involved in NIH-funded clinical research, the Hearing Loss Association of America, the American Cochlear Implant Alliance, the National Association of the Deaf, the Association of Late Deafened Adults, the Association of Medical Professionals with Hearing Loss and the Association of Adult Musicians with Hearing Loss. Hearing aid and cochlear implant manufactures should make data available to this group, but should not have a seat.

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