Washington, DC – The Medical Imaging & Technology Alliance (MITA) – the leading trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices  – expressed concern that the Centers for Medicare & Medicaid Services (CMS) announcement on how the agency plans to ensure Medicare beneficiary access to FDA-approved Alzheimer’s drugs failed to address coverage for beta-amyloid PET imaging.

MITA and its members have a long history in the development of evidence on the clinical utility of beta-amyloid PET imaging agents – to aid diagnosis and management and help identify patients for treatment with monoclonal antibodies for AD. Beta-amyloid PET has become a key tool in the diagnostic workup of dementia patients. There is a considerable amount of published evidence that the use of beta-amyloid imaging positively impacts patient management and leads to changes in diagnosis, even in the absence of a disease-modifying therapy.

However, beta-amyloid PET remains under CMS’ restricted coverage with evidence development (CED) policy, severely limiting access for patients. The announcement fails to address beta-amyloid PET. As it stands today, CMS’ plan for beneficiary access to FDA-approved Alzheimer’s drugs does not make clear how physicians will have access to this critical diagnostic tool to determine appropriate patient selection.

CMS must ensure beneficiaries have access to the appropriate diagnostic imaging test that confirms or rules out the presence of amyloid beta pathology: an important element for diagnosis and critical to qualify patients for FDA-approved therapies. In a letter sent last month, MITA requested that CMS expeditiously finalize the pending national coverage reconsideration of beta-amyloid PET, as supported by the clinical evidence, to ensure that providers can identify and manage appropriate candidates for treatment with anti-amyloid therapies.

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