Republican leaders of the House and Senate Committees with oversight of the Centers for Medicare and Medicaid Services (CMS) are raising concerns with a recent decision to severely restrict coverage of a U.S. Food and Drug Administration (FDA)-approved Alzheimer’s treatment and any similar future treatments, in a disturbing break with precedent.   

In a letter to CMS, House Ways and Means Republican Leader Rep. Kevin Brady (R-TX), Senate Finance Committee Ranking Member Sen. Mike Crapo (R-ID), Senate Health, Education, Labor and Pensions Ranking Member Sen. Richard Burr (R-NC), and House Energy and Commerce Republican Leader Rep. Cathy McMorris Rodgers (R-WA) outline how the decision departs from precedent and creates dire new concerns, and ask for information on how CMS arrived at its decision.  

From the letter: 

“On various fronts, the national coverage determination issued by the agency strays from precedent, subordinates the clinical judgment and expertise of the Food and Drug Administration, and suggests a problematic new standard that risks chilling innovation and jeopardizing access to the cutting-edge treatments of the future.  We urge CMS to reconsider this approach and to operate within the bounds of its statutory authorities and directives, which this latest decision oversteps.”

The members outline a number of concerns with the final decision, including that:  

• CMS has never before restricted Medicare access (through CED) to an FDA-approved indication (use) of a drug or biologic.

• The decision restricts access to an entire class of FDA-approved drugs based on a single drug’s clinical trial results. 

• CMS’s decision inappropriately supplants FDA’s authority and exceeds its own. 

• Under the decision, many beneficiaries will receive a placebo, and some may even need to pay cost-sharing for it. 

• CMS has never before disadvantaged drugs approved via FDA’s accelerated approval pathway, which has led to hundreds of approvals for drugs treating cancer, HIV/AIDS, and other life-threatening conditions. The decision risks deterring and eroding the pathway, meaning delayed access to treatments. 

• Full-benefit dually eligible (Medicaid and Medicare) beneficiaries will have no access to these drugs outside of the stringent CED standards, even though other Medicaid enrollees will have access to these products (potentially subject to utilization management). 

• This decision could chill investment in high-risk R&D, particularly for Alzheimer’s treatments.

Full text of the letter is available here.  

Additional Background:

• In a hearing with Health and Human Services Secretary Xavier Becerra in April, Rep. Brady raised his concerns with the Administration’s decision to ignore the FDA’s “gold standard of approval.” See more highlights from the hearing here.
• House Republican Leaders on Health issued a joint statement in April blasting the Biden Administration’s decision to severely restrict coverage of an FDA-approved Alzheimer’s drug.
• Ways and Means Republicans held a meeting in March with experts to examine the devastating decision by Democrats to deny coverage for cures and treatments, and how to promote innovation to bring more cures to Americans at lower costs.
  • There, experts testified that the Democrats’ decision could “affect the exploration for new treatments for Alzheimer’s for years.”
• House Republican Leaders on Health wrote to Secretary Becerra in February urging the Administration not to deny Alzheimer’s patients the treatments they deserve.