October 19, 2022
Officials from the Centers for Medicare and Medicaid Services detailed the agency’s plans to improve Medicare beneficiaries’ access to new and emerging technologies last week in JAMA Internal Medicine.
In the article, Lee A. Fleisher, MD, chief medical officer and director of the Center for Clinical Standards and Quality; and Jonathan D. Blum, MPP, principal deputy administrator and chief operating officer, briefly described how the Food and Drug Administration determines that the item or is safe and effective for the intended population and how that process differs from CMS’s process when making coverage decisions. Differences in these processes have contributed to concerns around patient protections and a lack of evidence of clinical benefit for the newly approved medical devices among Medicare beneficiaries.
In keeping with the agency’s commitment to ensure effective treatments are made available to Medicare beneficiaries, Fleisher and Blum announced plans to initiate a notice and comment rulemaking to explore policy options that would create an accelerated CMS approval pathway. They also outlined the principles that will inform development of the proposed rule.
According to Fleisher and Blum, CMS believes that the proposed rule will strike a balance between promoting access to emerging medical technologies and maintaining the protections and evidence standards that are essential to the welfare of Medicare beneficiaries.
The agency plans to work closely with patient groups, medical professionals and societies, medical device manufacturers, other federal agencies and others involved in developing medical devices to develop the rule. AABB will monitor CMS communications for opportunities to share feedback from the blood and biotherapies community and expand Medicare beneficiaries’ access to novel blood products and biotherapies.