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Biden Team Rescinds Trump-Era Rule for Life-Saving Devices (1)

Nov. 12, 2021, 2:32 PMUpdated: Nov. 12, 2021, 6:09 PM

The Biden administration on Friday rescinded a Trump-era rule that would have given medical device companies faster Medicare payments for life-saving products.

The Centers for Medicare & Medicare Services said in a statement it was taking the action “because of concerns that the provisions in the final rule may not have been sufficient to protect Medicare 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,” CMS Administrator Chiquita Brooks-LaSure said. “The Medicare program needs to implement policies that balance access and appropriate safeguards.”

The Trump administration rule (RIN 0938-AT88), finalized in January, allowed Medicare to start paying for certain “breakthrough” devices right after they got a green light from the Food and Drug Administration—cutting back the typical nine- to 12-month turnaround time for reimbursement. The rule was slated to take effect Dec. 15.

The CMS had said in its proposal to rescind the rule that it “is not in the best interest of Medicare beneficiaries” because it may “provide coverage without adequate evidence that the Breakthrough Device would be a reasonable and necessary treatment” for the patient.

Devices that the FDA deems “breakthrough” include implants or gene-based tests to diagnose diseases or conditions like cancer or heart disease.

Dozens of industry groups had rallied behind the proposal to rescind the rule out of concern that it didn’t guarantee the needs of Medicare patients would be adequately accounted for as the devices went through clinical studies.

The Advanced Medical Technology Association, however, said in a statement that it was “disappointed” in the decision to repeal the rule.

The rule “was truly transformational for Medicare patients and doctors looking for life-saving and life-enhancing breakthrough medical technology to diagnose and treat diseases,” AdvaMed, a trade group for device makers, said. “We are committed to working with CMS and lawmakers on both sides of the aisle to find a way forward.”

The Biden administration accepted public comments until Oct. 15 on the proposed repeal. The repeal takes effect Dec. 15.

(Updated with additional reporting.)

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