October 19, 2023

CMS Responds to Public Comments Received on Beta Amyloid PET Scan Proposed Coverage

The Centers for Medicare and Medicaid Services (CMS) recently released its final National Coverage Determination Reconsideration for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease. The American College of Radiology® (ACR®) supports these final changes in coverage and hopes it will allow patients greater access to amyloid PET scans for Alzheimer’s disease diagnosis, management and evaluation of newly approved therapies.

CMS in July posted the proposed decision memorandum for public comment. The second public comment period ended Aug. 16, resulting in 90 submissions.

Most commenters supported CMS’ proposal to remove the current coverage with evidence development requirement and the limitation of one Beta Amyloid PET scan per patient. They either supported CMS’ proposal to remove the current National Coverage Decision (NCD), permitting Medicare coverage determinations for Beta Amyloid PET scan imaging to be made by Medicare Administrative Contractors (MACs), or expressed their desire for CMS to revise the current NCD — or at least work with the MACs to ensure that there would be consistent coverage of Beta Amyloid PET scan imaging if the NCD is removed.

CMS provides a detailed explanation of comments received and their rationale for finalizing the coverage determination. ACR members are encouraged to read the full coverage determination, including the public comment section of the final coverage decision.

Notable changes in Medicare coverage of Beta Amyloid PET scan in Dementia and Neurodegenerative Disease include:

  • CMS is finalizing the policies to remove the NCD, end the CED requirement and eliminate the current limit of one Beta Amyloid PET scan per patient.
  • Amyloid PET scans can be used to confirm evidence of brain amyloid pathology to select appropriate patients for proven anti-amyloid treatments depending on individual patient characteristics.
  • MACs are able to promptly respond to the evidence on proven treatments for individual patients; they can make coverage determinations regarding the use of Beta Amyloid PET scan imaging, which may include covering more than one scan per patient’s lifetime.
  • MACs can use an evidence-based process for making coverage determinations. CMS believes there will be consistent coverage across regions for appropriate Medicare patients, based on the evidence.
  • Recognition of the value of access to Beta Amyloid PET scans. Appropriate patient selection is key to ensuring benefits outweigh the harms of newly developed drugs targeting amyloid. Diagnostic tests capable of measuring brain beta amyloid could help avoid harm from unnecessary anti-amyloid treatment by preventing drug use in patients who do not have brain amyloid pathology.
  • Payment for Beta Amyloid PET scan should be consistent with the payment usually received for such a procedure under the applicable Medicare payment system, e.g., Medicare Physician Fee Schedule, Hospital Outpatient Prospective Payment System (HOPPS). Payment for diagnostic radiopharmaceuticals used will also depend on the setting of care and applicable payment system in which they are used. Payment for diagnostic radiopharmaceuticals used in the physician office setting are determined by the MACs. Typically, diagnostic radiopharmaceuticals receive packaged payment in HOPPS if not on its pass-through status.
  • Original Medicare is required to assume the costs covered by the NCD for Medicare Advantage (MA) enrollees until the plan year for which the expected costs are appropriately reflected in MA benchmarks if CMS determines that an NCD would result in a significant change in costs.
  • The effective date for an NCD begins with the date the final decision memorandum is published. NCDs are prospective and reflect the public comments.

CMS will instruct all MACs to reimburse claims retroactively to the date the final decision memoranda was released. A Change Request (CR) transmittal and an MLN Matters article will be released by CMS that provide instructions to providers and MACs about the implementation of the final NCD policy and updates the Medicare Claims Processing Manual. ACR will alert members as new information is released by CMS to implement this policy.

If you have questions about the final coverage decision or the NCD process, contact Alicia Blakey, ACR Principal Economic Policy Analyst.