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Medicare Reconsiders Coverage for PET Beta Amyloid Imaging in Alzheimer's Disease: A Shift Towards Personalized Care

 Introduction:

As long time readers know, Medicare periodically reviews its national coverage policies for medical services. This includes the consideration of National Coverage Determinations (NCDs) regarding whether specific items or services should be covered nationally. One such NCD pertains to PET beta amyloid imaging for dementia and neurodegenerative disease.



Background:

In 2013, Medicare established the NCD for PET beta amyloid scans as a part of Coverage with Evidence Development (CED) studies. The current NCD allows for coverage of a single PET beta amyloid scan when provided through a clinical trial that has been reviewed and approved by CMS. All other use cases are non-covered.

There has been considerable stakeholder criticism that the NCD was overly restrictive and impacted Medicare beneficiary's ability to access care. However, with advances in medical care, standards of practice, and the development of promising anti-amyloid treatments, the application of amyloid PET scans has evolved.

Shift in Focus:

In response to stakeholder feedback and the availability of new evidence, Medicare is now considering two key questions:

  1. Should the requirement for CED in PET beta amyloid imaging be removed?
  2. Should Medicare remove the current NCD for beta amyloid PET in dementia and neurodegenerative disease?

Advancements in Alzheimer's Care:

The landscape of Alzheimer's disease (AD) care has significantly changed since Medicare finalized its CED coverage for PET Beta Amyloid Imaging in 2013. Treatment approaches now emphasize addressing health risk factors and comorbidities. With the rise in development of anti-amyloid drug treatments showing promise in modifying AD pathophysiology, many have questioned whether the current national policy restricting PET scans would serve as a barrier to these treatments.

Importance of Brain Amyloid Confirmation:

With the introduction of new pharmacological treatments such as Leqembi, confirming the presence of brain amyloid through PET scans has become crucial for appropriate patient selection. This ensures that patients receive treatments tailored to their individual characteristics, reducing the risk of unnecessary treatment harms.

The Role of Local Coverage Determinations:

With its proposed policy, CMS would rescind the national coverage policy and empower local Medicare Administrative Contractors (MACs) with the discretion to make coverage determinations regarding PET beta amyloid imaging. This flexibility allows prompt responses to new evidence on proven treatments for individual patients.

While the Local Coverage Determination process is, in fact, more nimble than the national process it still requires the MACs to review clinical evidence and allow for public notice and comment before they establish any new policy.

Addressing Health Disparities:

AD prevalence varies across racial and ethnic groups, with Blacks and Hispanics having a higher likelihood of AD compared to Whites. However, they are less likely to have a diagnosis due to various factors, including differing beliefs about AD and higher rates of discrimination in dementia healthcare.

Conclusion:

In light of advancements in medical care and the development of new anti-amyloid treatments, Medicare is proposing to remove the NCD for PET beta amyloid imaging. This decision aims to provide more personalized care for AD patients and reduce the burden on providers and patients. By empowering MACs to make coverage determinations, Medicare seeks to adapt to the evolving landscape of Alzheimer's care and address health disparities in dementia research and treatment.

The proposal to remove the NCD and end the provisional CED coverage for PET beta amyloid imaging is open for public comments until August 16, 2023.

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