MITA Encourages CMS to Consider Diagnostic Endpoints in Coverage Decision for Beta Amyloid PET Imaging


MITA Encourages CMS to Consider Diagnostic Endpoints in
Coverage Decision for Beta Amyloid PET Imaging

Washington, D.C. – The Medical Imaging & Technology Alliance (MITA) today encouraged the Centers for Medicare & Medicaid Services (CMS) to consider diagnostic endpoints as the basis for its coverage of beta amyloid positron emission tomography (PET) imaging despite Medicare Evidence Development and Coverage Advisory Committee (MEDCAC)'s determination that there is not adequate evidence that the technology improves health outcomes. Yesterday, MITA and other witnesses presented evidence of beta amyloid PET imaging's clinical performance in patients with signs of cognitive dysfunction to a MEDCAC advisory panel in support of a positive coverage decision.

"Thanks to PET imaging procedures, diseases that once eluded the medical community can now be better understood and detected earlier than ever before, which gives us hope of eventually finding an effective treatment," said Gail Rodriguez, Executive Director of MITA. "The data and evidence presented to MEDCAC clearly demonstrate the clinical benefits of beta amyloid PET imaging for patients with signs of cognitive dysfunction. MITA urges CMS to consider diagnostic endpoints – not therapeutic ones – when reviewing the evidence and making its coverage decision."

Yesterday's MEDCAC advisory panel convened physicians, medical societies, patient groups and industry representatives. On behalf of MITA, Richard A. Frank, MD, PhD, testified that the evidence used to gain FDA approval of the PET agent Amyvid™ (18-F Florbetapir) showed incremental patient benefit and clinical utility resulting from the highly accurate detection of amyloid in the brain, using the diagnostic endpoints of changes in diagnosis and patient management, as well as increased physician confidence. MITA also expressed support of the evidence-based Appropriate Use Criteria (AUC) for beta amyloid PET imaging published earlier this week by the Society of Nuclear Medicine and Molecular Imaging and the Alzheimer's Association.

"The AUC and the FDA-approved label for Amyvid are sufficiently evidence-based to warrant Medicare coverage of this innovative technology," said Rodriguez.


The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment, radiation therapy and radiopharmaceutical manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology. For more information, visit