The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) was established to provide independent guidance and expert advice to the Centers for Medicare and Medicaid Services (CMS) on specific clinical topics. MEDCAC input supplements CMS's internal expertise. MEDCAC provides unbiased reviews and evaluations of medical literature, technology assessments (TAs) and data on the effectiveness and appropriateness of medical items and services that are covered (or may be eligible for coverage) under Medicare. The MEDCAC judges and uses the strength of the available evidence to make recommendations on coverage to CMS.
CMS selects up to 100 MEDCAC members who are experts in clinical and administrative medicine, biologic and physical sciences, public health administration, patient advocacy, health care data and information management and analysis, health care economics, and medical ethics. The panel meets about 6 times a year to review medical evidence for various topics, listens to public testimony, and provides advice about the quality of the evidence. For these meetings, CMS chooses 15 members who are knowledgeable on the topic to be discussed. CMS may also recruit non-MEDCAC members who have relevant expertise to provide additional input to panel members. The agency also invites independent experts to make formal presentations.
On May 11, 2011, there was a MEDCAC meeting at the CMS head quarters in Baltimore, Maryland. The topic for discussion was, “Cochlear Implants (CI) for Sensorineural Hearing Loss.” Through this meeting, MEDCAC considered and evaluated recent research (derived after the last revision (in April 2005) of the National Coverage Determination (NCD) on CIs) on the health outcomes and quality of life (QOL) of unilateral and bilateral cochlear implanted Medicare patients. To provide more context, we provide a summary of Medicare’s historical coverage for CI, a summary of the May 2011 MEDCAC meeting and future implications for Medicare coverage for CI.
Medicare Coverage for Cochlear Implants
CMS first created the NCD for cochlear implants in 1986. Then, the agency covered post-lingual deaf patients. In 1992, the NCD was expanded to cover children with bilateral profound sensorineural hearing impairment with minimal or negligible benefit from hearing aids. In 1998, CMS further revised the NCD so it would reflect changes in technology and product labeling for CIs from the Food and Drug Administration (FDA). CMS last revised the CI NCD in April 2005. Currently, CMS covers cochlear implantation for the treatment of bilateral pre- or post-linguistic, moderate to profound sensorineural hearing loss in patients who demonstrate limited benefit from hearing aids (this is defined by test scores of ≤ 40% correct in the best aided listening condition on tape-recorded tests of open-set sentence cognition). In addition, the patient must also meet certain selection guidelines such as:
CMS also covers CIs in patients who fulfill the selection guidelines above andhave hearing test scores ≥40% and ≤60%, and are enrolled with their providers in an FDA-approved clinical trial. It is important to note that, according to CMS staff, there have not been any clinical trial submissions. Also, the CI NCD does not address coverage for bilateral CI, which means that local Medicare contractors may use their discretion to determine coverage for bilateral CIs. This may potentially lead to inconsistent coverage patterns for CIs in various regions. According to data from Cochlear Americas, the average cost for each cochlear implantation is approximately $30,000. Given these high costs and that hearing loss is a top chronic condition in the U.S (about 30% of Medicare beneficiaries suffer from some type of hearing loss), it was important for CMS to re-visit its coverage for CIs to determine if there was enough compelling evidence to support an expansion of coverage for these devices. This trend of CMS conducting reviews of data on health outcomes may become a general trajectory in CMS’ coverage policy development processes. Medical device and drug manufacturers will certainly need to take heed to these requirements and prepare in advance by conducting or sponsoring studies, randomized clinical trials, and creating registries to provide more robust health outcomes data on their new products.
Summary of the MEDCAC Meeting
As mentioned above, the MEDCAC panel that presided over the meeting consisted of primary care providers (nurse practitioners, family practitioners, geriatricians, and internists) and John K. Niparko MD, a leading expert in cochlear implantation. Due to its relevance to members, Academy staff, Jack J. Wazen MD (implantable hearing devices subcommittee member) attended the meeting as well as delegates from American Otological Society (Debara L. Tucci MD – also invited as one of two speakers to give the panel background information on cochlear implantation), American Neurotology Society (Craig A. Buchman MD), American Academy of Audiology, American Speech-Language-Hearing Association, and the manufacturers of CI (Advanced Bionics, Cochlear Americas, and MEL-EL). These subject matter experts also facilitated presentations supplying health outcomes data associated with bilateral and unilateral CIs.
Prior to the meeting, CMS had commissioned the Agency for Healthcare Research and Quality (AHRQ) to conduct a TA (performed by the Tufts Evidence-Based Practice Center), which was completed in April 2011. (Dennis S. Poe MD served as a consultant for the study) In this TA, AHRQ concluded that the data it reviewed demonstrated efficacy of unilateral implants. AHRQ also determined that the current literature was of moderate quality with low to moderate level of evidence with regard to outcomes for bilateral cochlear implants. The study suggested further larger studies using validated measures including specific health-related QOL measures are needed before determining long-term efficacy and the risks of bilateral implants compared to unilateral implants.
After listening to the various presentations from the subject matter experts, the MEDCAC panel answered (on a scale of confidence from 1 to 5) 11 voting questions which addressed the use of CIs in adults with bilateral sensorineural moderate to profound hearing loss (HL) who show limited benefit from amplification. For example, the first voting question asked the panel’s confidence on if there was enough evidence to determine whether a unilateral CI improved health outcomes for adults with HL having tests scores of a. >40% and ≤50% b. >50% and ≤60%. Overall, the panel (as expected) closely mirrored the conclusion of the AHRQ assessment by agreeing there was inadequate data demonstrating the long-term benefits and improvements to QOL in Medicare patients with unilateral and bilateral CIs. View a compilation of the voting results
Through its discussions, the panel recommended an immediate need for future research using larger sample sizes, and which would cover the health-related QOL outcomes. The committee also recommended the development of registries, more studies to determine the impact of HL on caregivers (by finding out caregivers’ QOL post-implantation) and addressing the issue of dementia (HL may exacerbate dementia)in CI candidate’s functional status to develop coverage. Finally, the committee recommended future studies that show the impact of HL on the community.
If MEDCAC had concluded and recommended to CMS that there was sufficient strong data demonstrating positive health outcomes and QOL for Medicare patients with CIs, then CMS would have begun a process to modify its CI NCD. (This process is as follows – data gathering via National Coverage Analysis (NCA) then expanding coverage via revised NCD). As this was not the case, the next step is for interested parties such as specialty and national societies and device manufacturers to compile and submit more health outcomes and QOL data to CMS. Then CMS staff could notify MEDCAC to reconvene on the issue. At this point, CMS could also subsequently request another TA, and follow the process outlined above. As one would expect, this process may be lengthy, but the Academy will continue to address and facilitate it by working closely with interested parties to proceed with the agenda.
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Uploaded on May 24, 2011
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