Federal legislation that would prevent the federal government from imposing wide-reaching coverage restrictions on Alzheimer’s treatments was reintroduced last week, providing “fair and accurate” coverage decisions, according to supporters.
The MERIT (Mandating Exclusive Review of Individual Treatments) Act, HR 133, sponsored by Reps. Vern Buchanan (R-MI) and Nanette Barragan (D-CA), was advanced by the House Energy & Commerce health subcommittee.
Buchanan said the bill is meant to prevent the Centers for Medicare & Medicaid Services from denying coverage for an entire class of drugs. If passed, the bill would require Medicare coverage determinations for drugs and biologics to be made individually, rather than being applied to a class of drugs or biologics.
“The federal government should make it easier for seniors to access breakthrough treatments, not unreasonably restrict potentially life-changing drugs for our nation’s most vulnerable patients,” Buchanan said in a statement.
The move comes after Medicare announced a national coverage determination in April 2022 that limited coverage of FDA-approved monoclonal antibody treatments — including aducanumab (Aduhelm) and lecanemab (Leqembi) — used to treat amyloid plaques in the brains of those living with Alzheimer’s. The federal government said it would cover only drugs approved under the FDA standard review process, not under the accelerated review program. CMS subsequently further limited coverage to treatments administered through clinical trials or other studies.
The approach applied not only to aducanumab but also to all future drugs in the same class, CMS said.
HR 133, if adopted, would only apply to future Medicare coverage determinations and would not affect the determination for anti-amyloid Alzhiemer’s treatments.
“Individual Alzheimer’s treatments act differently, even if they achieve similar end results,” Robert Egge, Alzheimer’s Association chief public policy officer and Alzheimer’s Impact Movement executive director, said in a statement. The MERIT Act, he added, would ensure that CMS evaluates treatments “individually and based on their own merits, rather than as a broad class of drugs.” “As new treatments are approved, the millions of Ameicans living with Alzheimer’s and other dementia cannot afford delays.”
In a letter of support earlier this year, Alzheimer’s Association Vice President of Federal Affairs Rachel Conant said that unless a treatment to slow, stop or prevent Alzheimer’s disease is approved and accessible, almost 13 million Americans will have received Alzheimer’s diagnoses by 2050, with care costing almost $1 trillion.
“The bipartisan MERIT Act would ensure that any NCD [national coverage determination] made by CMS only applies to that specific therapy and not an entire class of drugs,” Conant wrote. “As new treatments are in the pipeline and approved, early detection and diagnosis are even more critical to ensure individuals receive the most benefit at the earliest point possible.”
The MERIT Act is endorsed by the Alzheimer’s Association, UsAgainstAlzhimer’s, Association of Mature American Citizens, the Byrd Alzheimer’s Center and Research Institute, and the Global Alzheimer’s Platform Foundation.
The health subcommittee also passed three other bills aimed at reforming CMS’ coverage determination process:
- The National Coverage Determination Transparency Act, HR 5389, would require the Department of Health and Human Services to review all national coverage determination requests and allow HHS to work directly with submitters on updating and resubmitting applications. In addition, all completed determination applications would be made publicly available on the CMS website.
- The Coverage Determination Clarity Act, HR 5396, would prohibit Medicare’s local coverage determinations from restricting access to patient care, giving HHS the authority to review all local coverage determinations made by Medicare administrative contractors.
- The Supporting Innovations for Seniors Act, HR 5388, would expand flexibility for Medicare Advantage plans to cover products beyond what traditional Medicare covers.