CMS backs down; will preserve Medicare coverage of bone-anchored hearing systems

By David H. Kirkwood

WASHINGTON, DC—Responding to a broad-based national campaign by manufacturers, hearing care providers, and consumer advocates, the Centers for Medicare and Medicaid Services (CMS) announced on October 31 that it had reversed its position and would not end Medicare coverage of auditory osseointegrated implants (AOIs).

The Baha 4 System
The Baha 4 System

As previously reported on this blog, CMS issued a proposed rule in July that would for the first time put osseointegrated hearing devices such as the Cochlear Baha system and Oticon Medical’s Ponto bone-anchored hearing system into the same category as traditional air-conduction hearing aids, which have always been excluded from Medicare coverage. Since 2005, AOIs have been classified as prosthetics, not hearing aids, which made them a covered benefit.

 

PROPOSAL PROTESTED
CMS’s proposed change ignited a firestorm of opposition from people and organizations warning that the high cost of the systems would put them out of reach for many older Americans who need them if they were no longer paid for by Medicare.

Among those who urged CMS to reconsider were the American Speech-Language-Hearing Association (ASHA), the American Academy of Audiology, the Hearing Industries Association, and the Hearing Loss Association of America, which collected more than 11,000 signatures on a petition to the agency.

Tom Latham
Tom Latham
Carolyn McCarthy
Carolyn McCarthy

Many members of Congress, from both parties, wrote to CMS opposing the change. These included Representatives Tom Latham (R-IA) and Carolyn McCarthy (D-NY), the chairs of the Congressional Hearing Health Caucus, and 18 other House members. U.S. Senators Michael Bennet (D, CO), Dean Heller (R-NV), and Barbara Mikulski (D-MD) also added their voices to the cause.

Companies, such as Cochlear Americas, Oticon Medical, and Sonitus, that manufacture devices that would have been excluded from Medicare coverage helped lead the campaign.

 

MESSAGE RECEIVED
CMS’s October 31 announcement and its final rule make it clear that it heard the opposition to its proposal loud and clear.

The final rule (which also addresses a number of other Medicare-related topics) states that the agency had received approximately 2635 public comments on this provision. It adds, “After consideration of the comments received we have decided not to finalize our proposal to further interpret the hearing aid statutory exclusion.”

In a “Clarification of the statutory Medicare hearing aid coverage exclusion,” the agency states, “This rule codifies the Medicare policy guidance when a device is not subject to the hearing aid exclusion. The rule finalizes that certain auditory implants, including cochlear implants, brain stem implants, and osseointegrated implants, do not meet the definition of hearing aids that are excluded from coverage.”

The final rule is scheduled for publication in the Federal Register on November 6.

 

DECISION HAILED
Among those celebrating CMS’s ruling was Oticon Medical, which issued a statement November 5 saying that it “reflects the success of a concerted effort by professional organizations, bone-anchored hearing device providers, industry and advocacy groups to educate policy makers to the value of bone-anchored implants.”