ARTICLE SUMMARY:
Dr. Oz signals support for more automatic Medicare coverage of medtech; FDA staffers face space and other challenges in their return to in-person work; China NMPA advances policies for domestic manufacturing and clinical trial oversight; MedTech Europe’s regulatory advocacy; and more.
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Dr. Oz on medtech coverage, return-to-office challenges, and more:
Dr. Oz on FDA-CMS gap. Mehmet Oz, MD, signaled support for streamlining the path to Medicare coverage of new devices, more in line with the first Trump administration’s Medicare Coverage of Innovative Technology (MCIT), during his March 14 confirmation hearing. “We should make it easier for industry to create lifesaving tools by aligning when the FDA approves a product with when CMS begins to fund it for beneficiaries,” Dr. Oz said in response to a question from Sen. Steve Daines (R-MT) about whether the CMS administrator-nominee would return to a policy closer to the envisioned MCIT path, which would have featured an automatic four years of national coverage for most FDA Breakthrough Devices if it wasn’t repealed by the Biden administration. The Biden-era CMS changed course to the Transitional Coverage for Emerging Technologies (TCET) program that features more controls and limitations. Oz cited the MitraClip transcatheter mitral valve repair device (Abbott Laboratories) that he, as a cardiac surgeon, had a hand in inventing. Following FDA approval of MitraClip, “It took another seven or eight years for CMS to fund patients getting this device, who are dying in heart failure with a leaky valve,” Oz lamented. Industry groups have shifted most of their attention on this issue to lobbying Congress to legislate an MCIT-like program, but CMS can also address the matter on its own.
