The Centers for Medicare & Medicaid Services (CMS)—through its proposed rule for durable medical equipment, prosthetics, orthotics, and supplies for 2015—has proposed the reclassification of osseointegrated implants from prosthetic devices to hearing aids. Currently, Medicare does not cover hearing aids under the regular Medicare benefit. The proposal effectively eliminates Medicare coverage of osseointegrated implants. The CMS decision is based on the receipt of requests for the consideration of non-implanted, bone conduction hearing aid devices for single-sided deafness. CMS subsequently determined that all air or bone conduction hearing devices—whether external, internal, or implanted—do not replace all or parts of internal body organs and, therefore, are not prosthetics.
ASHA will be submitting comments on the rule, arguing that the osseointegrated implant does replace the components of the middle ear in cases of aural atresia, middle ear malformations, and/or ossicular malformations; chronic otitis media not amenable to successful treatment; chronic tympanic membrane perforation not amenable to treatment; or combinations of these disorders.
Arbitrarily classifying osseointegrated implants as hearing aids would remove functional hearing as a benefit for individuals with these impairments in the same manner that removing cochlear implants from prosthetic device classification would remove functional hearing as a benefit for individuals with severe or profound sensorineural hearing loss.
ASHA will work closely with consumer advocates and other health care providers to oppose this proposed change in coverage.
Comments can be made on or before September 2, 2014, at regulations.gov. Please refer to file code CMS-1614-P when commenting.
The Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) rule is proposed annually to update fee schedules and special payment rules. Cochlear implants, auditory brainstem implants, and osseointegrated implants have been classified as prosthetics since their inclusion as a Medicare benefit. Osseointegrated implants were defined by Medicare as "...devices implanted in the skull that replace the function of the middle ear and provide mechanical energy to the cochlea via a mechanical transducer."
Final rules are anticipated in November, to take effect January 1, 2015.
Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
For more information, or to share your thoughts on the DME proposed rules, please contact Lisa Satterfield, ASHA's director of health care regulatory advocacy, at firstname.lastname@example.org.