Medicare coverage for novel drugs to treat Alzheimer’s disease will continue to be restricted by the Biden Administration’s Center for Medicare and Medicaid Services (CMS), the agency announced this week, despite numerous bipartisan requests to reconsider. Ways and Means Chairman Jason Smith (R-MO) and Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) issued the following statement condemning the announcement:

“President Biden and Washington Democrats have waged a sustained assault on Medicare, and this week’s decision by CMS is the latest example. Their reckless spending agenda threatens hundreds of billions of dollars in cuts to the program, and now the Biden Administration is doubling down by restricting Medicare coverage of FDA-approved Alzheimer’s treatments. This is an unprecedented overreach by the administration to override its own FDA.  It is setting a troubling precedent for a massive health care bureaucracy to restrict coverage to an entire class of drugs, regardless of the potential for life-saving benefits to patients.

“The Biden Administration’s move to restrict coverage for novel Alzheimer’s drugs will chill innovation in developing new medicines and treatments for patients facing life-threatening illnesses. President Biden owes an explanation to the millions of patients, caregivers, and families praying for breakthrough cures who will now be denied access, and whose Medicare coverage will become less guaranteed.”

BACKGROUND:

• June 2021: FDA approves Biogen’s Aduhelm, the first treatment for Alzheimer’s in nearly 20 years, through its industry gold-standard process.
• April 2022: CMS proposes an unprecedented National Coverage Determination (NCD) for Aduhelm – and all future drugs of the same class – limiting drug access only to Medicare patients enrolled in qualifying clinical trials.
• This limited coverage has a chilling effect on new medicines and treatments – indicating that FDA-approved drugs may not receive insurance coverage under Medicare. In fact, one medical company has already slowed its timeline of its experimental Alzheimer’s drug, which is terrible news for the Alzheimer’s patients and those with other neurological or medical conditions such as Down Syndrome.
• In testimony before a meeting of Ways and Means Republicans following the decision, Duane Schulthess, CEO of Vital Transformation warned that CMS guidance will result in less research in cures for Alzheimer’s: “Alzheimer’s is a very risky investment. So risky, in fact, that its clinical developments have declined by over fifty percent over the last decade. There is half as much Alzheimer’s R&D today than there was a decade ago. […] If the CMS guidance is implemented, the risk reward for investing in new treatments for Alzheimer’s is seriously impaired, and likely no longer viable.”
• February 6, 2023: Representative Darin LaHood (R-IL-16) led a bipartisan letter to Secretary of Health and Human Services Xavier Becerra and the Administrator of the Centers for Medicare and Medicaid Services (CMS) Chiquita Brooks-LaSure urging CMS to expand treatment access for Alzheimer’s patients.