In a milestone moment for PET, CMS has ended its policy of only paying for PET scans of dementia patients if they are enrolled in a clinical trial. The move paves the way for broader use of PET for conditions like Alzheimer’s disease as new diagnostic and therapeutic agents become available.
CMS said it was rescinding its coverage with evidence development (CED) requirement for PET payments within Medicare and Medicaid.
- Advocates for PET have chafed at the policy since it was established in 2013, claiming that it restricted use of PET to detect buildup of amyloid and tau in the brain – widely considered to be precursors to Alzheimer’s disease. The policy limits PET payments to one scan per lifetime for patients enrolled in clinical trials.
But the landscape began changing with the arrival of new Alzheimer’s treatments like Leqembi, approved in January 2023. CMS telegraphed its changing position in July, when it announced a review of the CED policy, and followed through with the change on October 13. The new policy…
- Eliminates the requirement that patients be enrolled in clinical trials
- Ends the limit of one PET scan per Alzheimer’s patient per lifetime
- Allows Medicare Administrative Contractors (MACs) to make coverage decisions on Alzheimer’s PET
- Rejects requests to have the policy applied retroactively, such as to when Leqembi was approved
CMS specifically cited the introduction of new anti-amyloid treatments as one of the reasons behind its change in policy.
- The lifetime limit is “outdated” and “not clinically appropriate” given the need for PET for both patient selection and to potentially discontinue treatment if it’s ineffective or if it’s worked to clear amyloid from the brain – a key need for such expensive therapies.
The CMS decision is great news for the PET community as well as for patients facing a diagnosis of Alzheimer’s disease. The question remains as to what sort of reimbursement rates providers will see from the various MACs around the US, and whether commercial payers will follow suit.