February 17, 2022
When the Centers for Medicare and Medicaid Services (CMS) issued a national coverage determination (NCD) analysis for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease, SNMMI took action. Since the CMS announcement in July 2021, SNMMI has been involved in various stakeholder and individual calls with CMS along with responding to a request for comment and the proposed decision. On January 11, 2022, CMS stated the therapy was to be covered under coverage with evidence development (CED).
In our latest letter to CMS, the Society advocated for the following:
CMS should cover an amyloid PET scan before a patient is considered eligible for a CMS-approved studyAmyloid PET can identify patients who will not benefit from monoclonal antibodies ahead of time and can simplify the enrollment process for patients and trial sponsors. It will also improve care for patients without beta amyloid, allowing treating professionals and caregivers to focus on treatment modalities that are appropriate for those patients. CMS should not limit coverage to trial participants but should provide coverage of amyloid PET to determine whether a patient should be enrolled in the trial.
CMS should not finalize a limit of one beta amyloid PET scan per lifetimeThere is no evidence to suggest that a single amyloid PET scan per patient is appropriate or that an outdated scan can provide the diagnostic information needed to determine whether a patient is currently a candidate for therapy. Not only can CNS beta-amyloid status change over time, as discussed below; ongoing clinical trials for monoclonal antibody therapies for AD have used the results of post-treatment beta amyloid PET to inform a decision to discontinue monoclonal antibody therapy.
CMS should require post-treatment beta amyloid PET to be performed as needed to document the removal of beta amyloid PET from the brainCMS should allow as many PET scans as are needed to ensure that the trial design is optimal and reliable and provides physicians with the information needed to make informed decisions about initiating and continuing therapy. Notably, one or more scans during therapy to verify removal of amyloid must be covered.
CMS should retire the current PET CED in conjunction with finalizing the monoclonal antibody NCD
Continuation of limitations on amyloid PET while other uses of PET for AD, such as tau PET, are covered at the discretion of the Medicare Administrative Contractors (MAC) creates an illogical and confusing situation for physicians, patients, and clinical trial designers.
CMS should not limit sites of service for approved clinical trials to hospitals
Limiting the trials to only hospitals would greatly impede patient access due to geographical and payment considerations and contribute to health care disparities.
Additionally, SNMMI reiterated that appropriate reimbursement of amyloid PET agents is necessary. Since 2008, CMS has been packaging diagnostic radiopharmaceuticals—including the three amyloid agents—with the related PET scan in hospital outpatient settings. The packaging begins after the expiration of a pass-through period—about 3 years—during which drugs are paid separately. The result is a reimbursement rate of about 9% of the pass-through rate. Though CMS has the authority to fix this problem, it has resisted. Therefore, SNMMI, the Medical Imaging & Technology Alliance, the Council on Radionuclides and Radiopharmaceuticals, and more than 70 supporting organizations are pursuing legislative action. The Facilitating Nuclear Diagnostics (FIND) Act, a bipartisan and bicameral bill, seeks to unpackage these life-saving diagnostics. More information on the FIND Act can be found here.