Regulatory Advocacy

The AAO-HNS has a long history of working closely with regulatory agencies (e.g., Centers for Medicare & Medicaid Services, U.S. Food and Drug Administration) to maintain our visibility and credibility with national representatives regarding federal regulatory issues.

We believe that advocacy is the key to defining the future of otolaryngology. Federal regulatory advocacy is a top priority of the AAO-HNS.

Advocacy Update on CMS' Proposed Exclusion of Coverage of Osseointegrated Implants (11/3/14)

On October 31, the Centers for Medicare & Medicaid Services (CMS) released its final rule addressing the 2015 Durable Medical Equipment Prosthetics Orthotics and Supplies (DMEPOS) fee schedule. In the proposed version of this rule, CMS stated that the Medicare reimbursement exclusion for hearing aids would encompass all types of air conduction and bone conduction auditory prosthetics (external, internal, or implanted). After carefully reviewing comments and concerns from various groups including the AcademyCMS clarifies in its final rule that the statutory Medicare hearing aid coverage exclusion will not include certain auditory implants, including cochlear implants, brain stem implants, and osseointegrated implants. Therefore, CMS will be modifying § 411.15 in the final rule to reflect that Auditory Osseointegrated Implants (AOIs) will continue to be covered under Medicare and are outside the scope of the hearing aid coverage exclusion.

The Academy’s repeated advocacy was critical to helping CMS reach this conclusion. The Academy applauds this as a decision which will only yield a higher quality of care for the hearing health community! In addition, the Academy extends a warm thank you to all of the committee members and physician leaders involved in efforts to achieve this positive outcome!

While CMS will continue to exclude coverage non-osseointegrated devices (such as non-osseointegrated bone conduction hearing aids), CMS acknowledges the important technological advances that are occurring and leaves the door open for future consideration.

To view the Academy press release on the final rule, click here. To view the final rule, click here

Background
CMS published a proposed rule in July focusing on the 2015 Durable Medical Equipment Prosthetics Orthotics and Supplies (DMEPOS) fee schedule. Notably, part of the proposed rule specified that the Medicare reimbursement exclusion for hearing aids would encompass all types of air conduction and bone conduction auditory prosthetics (external, internal, or implanted). The rule essentially proposed to negate CMS' current coverage of osseointegrated implants. To view the proposed rule, click here

Advocacy Efforts
In response to the proposed rule, Academy leadership and health policy staff advocated on multiple levels and engaged Academy committees, otolaryngology specialty societies, and other leaders among our membership (within Otology/Neurotology as well as health policy and government affairs) to craft comments that best represented our members and patients. More specifically, Academy leadership and staff conferenced individually and collectively with members and chairs of the Hearing and Implantable Hearing Devices Committees to gather specific examples and feedback on how the proposed rule, if enacted, would negatively impact thousands of patients who have no other recourse to better hearing. Further, the Academy participated in three direct meetings with CMS, various audiology and public interest group conferences, and meetings with presidents of the American Neurotology Society (ANS) and American Otological Society (AOS).  All of these efforts were directed at raising awareness of the significant potential impact of this proposed rule and garnering support in defense of our position.

On September 2, 2014, the Academy, AOS, and ANS submitted a formal joint comment letter to CMS noting concerns about the proposal and providing a suggested alternative to the proposed rule that would allow for continued coverage of osseointegrated implants for Medicare patients. In addition, on September 3 the Academy met with Patrick Conway, MD, CMS Chief Medical Officer, Director, Center for Clinical Standards and Quality (CCSQ) and noted that our focus is on the patient and that as otolaryngologists, we are stewards of the patient’s health with the disagreement to the proposed change based on patient needs and outcomes, not personal or professional gain or concerns. We noted that while the comment letter is more focused on osseointegrated rather than non-osseintegrated bone conduction prostheses, there is a need for both. The focus on osseointegration does not mean that other types of prostheses should be excluded from coverage, just that they should be covered only when offered to patients with hearing loss due to medical/surgical conditions who cannot otherwise benefit from conventional hearing aids. The meeting went well with Dr. Conway asking Dr. Nielsen many specific questions related to our comments.

Subsequently, on October 31, CMS released its final rule and after careful consideration of comments received from various groups including the Academy, CMS clarified its definition of “hearing aid.” CMS will be revising its original proposal in the final rule to reflect that Auditory Osseointegrated Implants (AOIs) will continue to be covered by Medicare and are outside the scope of the hearing aid coverage exclusion.

Academy Comments on CY 2015 Medicare Physician Fee Schedule Proposed Rule (9/2/2014)

In July CMS released the proposed 2015 Medicare Physician Fee Schedule (MPFS) proposed rule. In its 2015 MPFS Proposed Rule, CMS proposed a new  more transparent process for establishing PFS payment rates that will allow for more public input prior to finalizing rates.  Under the new process, payment changes will go through notice and comment rulemaking before being adopted beginning for 2016.  In addition, CMS is proposing changes to several quality reporting initiatives, changes to the Physician Compare Website and to continue phasing in of the Value Based Payment Modifier.   Notably, CMS are also proposing to transform all 10- and 90-day global codes to 0-day global codes beginning in CY 2017, proposing to add roughly 80 codes to its list of potentially misvalued codes, and proposing adjustments to malpractice RVUs among other initiatives.

The Academy has reviewed and summarized the rule as a member benefit and has submitted formal comments on the rule by the September 2nd deadline. Click here to view the comment letter.