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Medicare to repeal medical device rule pushed by Trump administration


The Centers for Medicare & Medicaid Services are proposing to remove a regulation the agency finalized earlier this year under the Trump administration that would have required Medicare to pay for any medical device deemed a “breakthrough” by the FDA.

Driving the news: After receiving public comments, CMS determined that the rule was “not in the best interests of Medicare beneficiaries because the rule can provide coverage without adequate proof that the revolutionary device would be reasonable and necessary treatment.”

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Between the lines: The rule would have been a giveaway for the medical device industry, which supported the rule.

  • It would have guaranteed four years of Medicare coverage for all devices designated as “breakthroughs” – new technologies that attempt to improve care for people with life-threatening illnesses.

  • However, these types of devices often have no clinical benefit and present safety risks.

  • The rule also didn’t require device makers to conduct follow-up studies to show that their devices were specifically helping Medicare patients – it was completely voluntary.

CMS finally declared the rule could be a disaster since the agency would automatically pay for the devices, “even without data showing that the device is reasonable and necessary for Medicare patients.”

What to watch: This is still a proposal with another 30 days of public comment. Medical device lobbyists will be out in force.

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