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 – applauds the Centers for Medicare & Medicaid Services (CMS) for retiring the national non-coverage language for positron emission tomography (PET) imaging using radiopharmaceuticals for non-oncologic indications. The provision updates section 220.6 of the Medicare National Coverage Determinations (NCD) Manual to allow Medicare to cover non-oncologic agents at the discretion of Medicare Administrative Contractors (MACs). This new policy, effective as of January 1, 2022, will align coverage of non-oncologic imaging agents with oncologic agents, which have been covered by Medicare contractors since 2013.
“MITA believes this jurisdictional change by CMS will improve beneficiary access to PET imaging for cardiac, neurologic, and other conditions while reducing CMS administrative burdens and allowing for innovative diagnostic tools still in development to get to patients more quickly,” said Sue Bunning, MITA Industry Director of Molecular Imaging & PET. “We applaud CMS on this step forward after working with the agency for nearly a decade to address this issue.”
In August, MITA submitted comments to CMS outlining proposed language changes to the NCD Manual to allow for this broader PET coverage. The letter noted that retiring the national non-coverage policy for non-oncologic indications of PET will eliminate the need for beneficiaries to wait for CMS to individually evaluate each agent for coverage through a separate and cumbersome NCD reconsideration, as is current policy. This change will enable faster patient access to FDA-approved diagnostics by reducing the regulatory “bottleneck” leading to delayed Medicare beneficiary access to critical imaging services. It will also allow CMS to focus its resources on other categories of cutting-edge technologies that have not been subject to extensive review by the agency.
Note that this policy will not apply to beta amyloid imaging agents, which remain under a separate NCD (220.6.20 Beta Amyloid Positron Tomography in Dementia and Neurodegenerative Disease). In September 2020, a formal reconsideration of the NCD Manual to allow for beta amyloid PET coverage was filed. MITA supported this reconsideration request and continues to believe that CMS should provide coverage for this critical diagnostic tool for patients suffering from cognitive decline.
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MITA is the collective voice of manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging innovations. These products include: magnetic resonance imaging (MRI), medical X-Ray equipment, computed tomography (CT) scanners, ultrasound, nuclear imaging, radiopharmaceuticals, and imaging information systems. MITA Member company technologies are an important part of our nation’s healthcare infrastructure and are essential for the screening, diagnosis, staging, managing, and effectively treating patients with cancer, heart disease, neurological degeneration, and numerous other medical conditions.