Biden Team Proposes to Nix Medicare Rule for Life-Saving Devices

Sept. 13, 2021, 9:23 PM

The Biden administration is proposing to repeal a Trump-era rule that gives medical device companies faster Medicare payments for life-saving products.

The rule (RIN 0938-AT88), which was finalized in January, allows Medicare to start paying for certain devices right after they get a green light from the Food and Drug Administration—cutting back the typical nine- to 12-month turnaround time companies wait to get paid. The rule was slated to take effect Dec. 15.

But the final rule “is not in the best interest of Medicare beneficiaries because the rule may provide coverage without adequate evidence that the Breakthrough Device would be a reasonable and necessary treatment” for the patient, the Centers for Medicare & Medicaid Services said in its Monday proposal to rescind the rule.

The Medicare agency developed the rule in part due to concerns that delays in Medicare coverage slowed access to devices the FDA deems “breakthrough,” such as implants or gene-based tests to diagnose diseases or conditions like cancer or heart disease.

CMS, in a blog post, said it intends to explore a new rule that would provide an expedited coverage pathway for innovative beneficial technologies.

The Biden administration is providing a public comment period for the proposed repeal. Comments are due by Oct. 15.

To contact the reporter on this story: Alexis Kramer in Washington at akramer@bloomberglaw.com

To contact the editors responsible for this story: Jo-el J. Meyer at jmeyer@bloomberglaw.com; Melissa B. Robinson at mrobinson@bloomberglaw.com

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