CMS Releases Medicare Coverage Proposal for Alzheimer’s Treatment

Updated 1/12/2022: This article has been updated to correct the drug price for Aduhelm. The article previously cited the drug price as the original price, which was $56,000. However, Biogen reduced that price to $28,200 in December 2021.

Medicare may start covering monoclonal antibodies directed against amyloid as an Alzheimer’s treatment, according to a proposed National Coverage Determination (NCD) decision memorandum which CMS released.

“CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders,” said CMS Administrator  Chiquita Brooks-LaSure. 

“Before finalizing this proposal, we will have more opportunities to hear from people with Medicare living with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia, their family members and caregivers, as well as many other stakeholders, including patient advocacy groups, medical experts, states, payers, and industry professionals.”

The treatment would fall under coverage with evidence development for approval. Routine costs and costs for services related to the therapy—including PET scans—would be covered under this approval.

If finalized, CMS would begin processing potential clinical trials and the approval would also cover trials at the National Institutes of Health (NIH). However, before CMS chooses whether to finalize this decision, the agency will conduct a 30-day public comment period through the CMS site.

CMS will finalize its decision by April 11, 2022.

Until CMS issues a decision, Medicare administrative contractors have the deciding voice on whether a Medicare claim for this treatment receives coverage.

“This proposed National Coverage Determination is the result of robust evidence analysis conducted through a thorough review process that found while there may be the potential for promise with this treatment, there is also the potential for harm to patients,” said Lee Fleisher, MD, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality.

The only Alzheimer’s drug using monoclonal antibodies that target amyloid to receive approval from the Food and Drug Administration (FDA) is the controversial drug aducanumab or Aduhelm.

Aduhelm received approval for use in early-stage Alzheimer’s back in July 2021, a move that reversed the FDA’s general approval for the drug. The reversal came in response to provider backlash. Providers pointed out the drug’s mixed results and uncertain long-term effects, in addition to the drug’s pricetag: $28,200.

CMS started the Medicare coverage determination Aduhelm in July 2021 when the drug received FDA approval.

The National Association of Medicaid Directors came out in favor of Medicare coverage for Aduhelm in August 2021.