The Inflation Reduction Act of 2022 (IRA), just signed into law (as discussed in this CMA Alert will provide important new prescription drug savings for beneficiaries. In addition, the Administration has taken other steps to fill some other coverage gaps.
Over-the-Counter Hearing Aids
Although Medicare coverage was not expanded to include coverage of hearing aids, there has been positive movement on hearing coverage, many years in the making. Following legislation passed in 2017, and an Executive Order issued last year instructing the Food and Drug Administration (FDA) to issue long-delayed regulations, on August 16, 2022, the FDA announced a final a rule that will soon lead to the availability of over the counter hearing aids.
The rule will, as described by the Washington Post (8/16/22), “create a new category of hearing aids that supersede state-level regulations requiring patients to visit physicians or audiologists to get prescriptions and fittings. The devices will be available for individuals 18 and older with mild to moderate hearing loss at pharmacies, stores and online.” As noted by Inside Health Policy (8/16/22), “[h]earing aids that do not meet the requirements for the OTC category, for example because they are intended for severe hearing impairment or users younger than 18, are still considered prescription devices.”
Further, notes the Post, “[t]he change is expected to significantly benefit older adults — individuals who are most likely to experience hearing loss and to be on a fixed income — as well as those in poor and rural communities that have fewer audiologists.” According to a statement released by the White House, this action “deliver[s] nearly $3,000 in savings to American families for a pair of hearing aids and giv[es] people more choices to improve their health and wellbeing.”
The final rule was published in the Federal Register on August 17, 2022 “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Guidance for Industry and Food and Drug Administration Staff; Availability” 87 Fed Reg 50568 (Aug. 17, 2022).
Oral Health Services
While broad coverage for dental services has not been expanded to all Medicare beneficiaries, the Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule, currently open for comment (until Sept. 6, 2022), that includes a proposal to broaden reimbursement for medically necessary dental services.
August 18, 2022 – D. Lipschutz