Nov 29, 2021 - Health

The push to revive an industry-backed medical device rule

Surgeons and technicians in blue protective gear stand around a patient on an operating room table.

Doctors and technicians perform a surgery. Photo: Melina Mara/The Washington Post via Getty Images

A bipartisan group of U.S. House members chided the Biden administration for repealing a rule that would have required Medicare to pay for any medical device deemed a "breakthrough" by the FDA.

The big picture: Medical device manufacturers really wanted the rule enacted, in part, because it would have led to higher sales. Now many members of Congress who receive sizable campaign donations from the industry want the federal government to revive the rule.

The state of play: The Centers for Medicare & Medicaid Services officially repealed the rule this month.

  • The agency said that although the FDA reviews breakthrough devices for safety and effectiveness, "there is often limited evidence regarding whether the device is clinically beneficial to Medicare patients."
  • "Although we continue to be in favor of increasing access to new technologies, we are also mindful that sometimes those devices have unknown or unexpected risks," the repeal notice said.

Driving the news: 61 House Democrats and Republicans said in a letter that CMS' decision to ax the rule "may delay future innovative medical devices and diagnostic tools," and the agency should "retain the crucial components" in a future rule.

Between the lines: The medical device industry's trade group, AdvaMed, gave at least $1,000 since 2018 to nearly half of the lawmakers who signed the letter, according to data within OpenSecrets, which tracks lobbying spending.

  • House Democrats Angie Craig of Minnesota, Suzan DelBene of Washington and Scott Peters of California signed the letter and are among the biggest recipients of campaign cash from AdvaMed, as well as other medical device companies.
  • Republicans who signed the letter and who have accepted funds from AdvaMed and other device firms include Reps. Michael Burgess of Texas, Brett Guthrie of Kentucky and Jackie Walorski of Indiana.

What they're saying: "A bipartisan letter signed by 61 members of Congress who support immediate coverage under Medicare for suffering seniors in need of FDA-approved breakthrough medical technologies practically writes itself," AdvaMed CEO Scott Whitaker said in a statement.

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