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Medicare is rescinding a major medical device rule. Photo: Matt McClain/The Washington Post via Getty Images

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."

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.

Go deeper

Sep 21, 2021 - Health

Democrats' case for prioritizing health care policies

Expand chart
Reproduced from Hart Research Associates; Chart: Axios Visuals

Health care advocates are making the case that the pieces of Democrats' legislative agenda that lower health care costs and expand coverage are the most popular with voters — and should thus be prioritized.

Why it matters: Democrats are trying to figure out what topline spending number they have to work with for their reconciliation package. The lower that number goes, the more the party will have to cut from the package.

Special Envoy for Haiti resigns over Biden deportations

Daniel Foote testifies during a Senate Foreign Relations Committee hearing on May 26, 2016. Photo: Drew Angerer/Getty Images

The Special Envoy for Haiti on Wednesday resigned from his position, writing in his resignation letter obtained by PBS that he "will not be associated with the United States inhumane, counterproductive decision to deport thousands of Haitian refugees."

Why it matters: Ambassador Daniel Foote's resignation comes amid heightened anger over the treatment of Haitian migrants and asylum-seekers living in a temporary encampment in Del Rio, Texas — especially after images surfaced of Border Patrol agents whipping at the migrants from horseback.

First-time homebuyers shrink as prices spike

Data: National Association of Realtors; Chart: Axios Visuals

Home sales cooled as prices continued to heat up in August.

Driving the news: The share of first-time existing homebuyers (29%) last month was the smallest in two years, according to new data from the National Association of Realtors.