Cochlear Implant Eligibility Gap for Medicare Clients
February 2, 2004
The Honorable Tommy Thompson
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Dear Secretary Thompson:
I am writing to express my concern regarding the Center for Medicare and Medicaid Services’ (CMS) failure to align Medicare coverage criteria with current Food and Drug Administration (FDA) approved indications for the cochlear implant. I am concerned that Medicare beneficiaries who fall in the eligibility gap created by this misalignment are not being given the same opportunity to benefit from cochlear implant technology currently enjoyed by non-Medicare candidates.
In 1985, CMS first established coverage for cochlear implantation based upon FDA approved indications; at that time, the level of required speech understanding was 0%. Since then the FDA has approved expanded indications because, based upon clinical trials and outcomes, more pre-implant residual hearing is associated with better outcomes for cochlear implant patients. The latest FDA approved indications for cochlear implantation include speech-understanding scores higher than current Medicare coverage language. Since June 2001, a coalition of the cochlear implant community have worked with CMS to revise coverage language at Coverage Issues Manual 65-14 in an effort to address this disparity in access. CMS however, has yet to act to ensure access for the Medicare population that fall into the eligibility gap.
We believe the impasse is a result of timing. Unfortunately, the FDA approved expanded indications right at the time that CMS revised its national coverage policy and process. It is our contention that CMS reviewing staff are seeking additional information that does not exist and was not required prior to the change in CMS policy.
Despite extensive efforts to satisfy CMS questions, and provide data requested by that agency’s reviewing staff, the decision to align eligibility standards remains in a holding pattern. Since Medicare’s national coverage language for cochlear implants has not been updated since April 1998 and does not reflect current medical standards, we respectfully request that CMS immediately revise current Medicare coverage language to match FDA approved indications.
