The push to revive an industry-backed medical device rule

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A bipartisan group of US House members slammed the Biden administration for repealing a rule that would require Medicare to pay for any medical device deemed a “breakthrough” by the FDA.

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big picture: medical equipment manufacturer must be sure Rules enacted, partly because it would have made sales higher. Now many members of Congress who receive massive campaign donations from industry want the federal government to revive the rule.

state of play: Centers for Medicare and Medicaid Services officially canceled Rules this month.

  • The agency said that although the FDA reviews successful devices for safety and effectiveness, “there is often limited evidence about whether the device is clinically beneficial for Medicare patients.”
  • “While we remain in favor of increasing access to new technologies, we also note that those tools sometimes have unknown or unexpected risks,” the repeal notice states.

Running news: 61 House Democrats and Republicans said in a letter CMS’ decision to end the rule “could delay future innovative medical devices and diagnostic devices,” and the agency should “retain critical components” of the future rule.

Between the lines: The medical device industry’s trade group, AdvaMed, has given at least $1,000 since 2018 to nearly half of lawmakers who signed the letter, according to data. open secret, which tracks lobbying spending.

  • Democrats Angie Craig of Minnesota, Suzanne 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 have signed the letter and who have accepted funding from AdvaMed and other device firms include Michael Burgess of Texas, Brett Guthrie of Kentucky and Jackie Walorsky of Indiana.
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What are they saying: Scott Whitaker, CEO of AdvaMed, said in a statement, “A bipartisan letter signed by 61 members of Congress that supports immediate coverage under Medicare for seniors suffering in need of FDA-approved breakthrough medical technologies, practically itself.” writes.”


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