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.

References
1. Carlson ML. (2020). Cochlear Implantation in Adults. New England Journal of Medicine, 382(16),1531-1542. doi: 10.1056/NEJMra1904407.
2. Mahboubi H, Lin HW, Bhattacharyya N. (2018). Prevalence, Characteristics, and Treatment Patterns of Hearing Difficulty in the United States. JAMA Otolaryngol Head Neck Surg, 144(1),65-70. doi: 10.1001/jamaoto.2017.2223.
3. U.S. Food and Drug Administration. (2021). Benefits and Risks of Cochlear Implants. https://www.fda.gov/medical-devices/cochlear-implants/benefits-and-risks-cochlear-implants
4. Cunningham LL, Tucci DL. (2017). Hearing Loss in Adults. New England Journal of Medicine, 377(25), 2465-2473. doi: 10.1056/NEJMra1616601.

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I support the proposed expansion of cochlear implantation coverage to less than or equal to 60% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition. This change will better align CMS indications of cochlear implantation to those of the Food and Drug Administration and private insurers. The potential societal benefits are tremendous: the research literature is inundated with the realization of the negative impacts of hearing loss, including cognitive decline, social isolation, and mental unhealthiness, and these consequences can be curtailed with the appropriate intervention and patient-centered decision making. Increasing the criterion threshold to less than or equal to 60% correct will empower beneficiaries with significant hearing loss to regain control of their life and enjoy the life they envision, as well as increase the overall quality of life for themselves and their loved ones.

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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.

II. Revise the Requirement that Patients Be Free From Lesions in the Auditory Nerve and Acoustic Area of the Central Nervous System

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);