Insurers Get Their Wish With Repeal of Medical Device Rule

  • Nov 19, 2021

    CMS repealed a proposed Trump-era regulation that would have required Medicare to cover experimental “breakthrough” medical devices that have been approved by the FDA but not cleared for Medicare use through a national coverage determination. Insurer groups opposed the rule and urged the Biden administration to revoke it, while the medical device industry’s largest trade group championed it as a breakthrough for patients.

    “Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries. The Medicare program needs to implement policies that balance access and appropriate safeguards,” said CMS Administrator Chiquita Brooks-LaSure in a Nov. 12 press release on the decision. CMS said it will begin to develop an alternative policy to ensure speedy access to breakthrough technologies.

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  • Peter Johnson

    Peter has worked as a journalist since 2011 and has covered health care since 2020. At AIS Health, Peter covers trends in finance, business and policy that affect the health insurance and pharma sectors. For Health Plan Weekly, he covers all aspects of the U.S. health insurance sector, including employer-sponsored insurance, Medicaid managed care, Medicare Advantage and the Affordable Care Act individual marketplaces. In Radar on Drug Benefits, Peter covers the operations of (and conflicts between) pharmacy benefit managers and pharmaceutical manufacturers, with a particular focus on pricing dynamics and market access. Before joining AIS Health, Peter covered transportation, public safety and local government for various outlets in Seattle, his hometown and current place of residence. He graduated with a B.A. from Colby College.

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