The Centers for Medicare & Medicaid Services is proposing to kill a regulation the agency finalized earlier this year under the Trump administration that would have required Medicare to pay for any medical device deemed as a “breakthrough” by the FDA.
Driving the news: After receiving public feedback, CMS determined the rule was “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.”
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Between the lines: The rule would have been a gift to the medical device industry, which supported the rule.
It would have guaranteed four years of Medicare coverage for all devices designated as “breakthroughs” — i.e., new technologies that attempt to improve care for people with life-threatening conditions.
However, these kinds of devices often do not prove any clinical benefit and have safety risks.
The rule also did not require device manufacturers to conduct follow-up studies to show their devices specifically helped Medicare patients — that was completely voluntary.
CMS ultimately said the rule could be a disaster since the agency would automatically pay for devices, “even in the absence of data demonstrating 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 in full force.
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