Washington, D.C – The Medical Imaging & Technology Alliance (MITA) – the leading trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices – today expressed disappointment about the final decision from the Centers for Medicare & Medicaid (CMS) on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. The decision will severely limit patient access to both amyloid PET diagnostics and anti-amyloid monoclonal antibodies (mABs) treatment.

“Limiting coverage to randomized controlled trials (RCTs) for the existing FDA-approved mAB will significantly restrict and delay access for patients and families,” said Patrick Hope, executive director of MITA. “Removing the hospital outpatient-only requirement is one of the only positive changes in the final decision. Limiting amyloid PET scans to the outpatient setting would have exacerbated already severely restricted patient access due to existing Medicare payment policy.”

While CMS acknowledges that the current beta-amyloid PET coverage policy at NCD 220.6.20 needs to be revised, CMS did nothing to change the current non-coverage policy for amyloid imaging outside of a CMS-approved coverage with evidence development (CED) study. MITA strongly urges CMS to grant full coverage for amyloid PET immediately. It is appropriate to cover amyloid PET for all Medicare beneficiaries given the body of evidence that has accumulated over a decade from CMS-approved and other clinical studies. While MITA recognizes CMS’ decision to cover an amyloid PET scan as part of a protocol in an approved CMS study or NIH-supported trial, MITA supports removal by CMS of the current limitation of one scan per lifetime. A single amyloid PET scan performed years ago may not provide the diagnostic information needed for a patient currently being evaluated for therapy. Information from amyloid PET scans informs decisions about whether to start or continue therapy.

MITA is also concerned that the decision would non-cover any future FDA-approved product that demonstrates efficacy from a direct measure of clinical benefit outside of CED. This is inappropriate for FDA-approved medicines, especially given the significant unmet clinical need for Alzheimer’s Disease and the barriers that CED imposes on the community.

“It is unjustifiable to predetermine that an entire class of therapies, including future FDA-approved products, is not reasonable and necessary. With more therapies becoming available, it is increasingly important to ensure the appropriate patients are identified and placed on these therapies,” said Hope. “CMS must immediately and fully cover, and appropriately pay for, FDA-approved diagnostic amyloid PET in the hospital outpatient setting.”