The CMS repeals rule allowing coverage of breakthrough technologies for Medicare patients



CMS is exploring a new rule due to concerns raised and operational challenges.

The rule that would have allowed access to Food and Drug Administration-designated and -approved technologies for Medicare patients suffering from illnesses and conditions that existing treatments and technologies are unable to address.

CMS is exploring a new rule due to concerns raised and operational challenges, according to Dr. Lee A. Fleisher, chief medical officer and director of the Center for Clinical Standards and Quality.


The final rule, called “The Medicare Coverage of Innovative Technology and Definition of ‘Reasonable and Necessary'” would have granted expedited Medicare coverage for up to four years for any FDA-designated breakthrough device once the device received or cleared market authorization. This was assuming the device was not excluded from coverage by the Medicare statute.

While CMS is committed to ensuring people on Medicare have quicker access to innovative medical technologies, through the public comment process, concerns were raised about the lack of information on whether the device would be beneficial or harmful to Medicare beneficiaries, Fleisher said by CMS blog.

“This is important because Medicare patients have different clinical profiles and considerations due to the complexity of their medical conditions and concomitant treatments, compared to other groups,” he said.

The rule also presented operational challenges to CMS as to implementation.

“It would have guaranteed coverage of any device that received FDA breakthrough designation and market authorization without consideration as to whether the device is appropriate and provides benefits for the Medicare population,” Fleisher said. “In other words, the rule did not require that the device demonstrate clinical benefits for people with Medicare – as well as concerns that the device might later be shown to pose greater risk of harm for those patients.”

CMS is taking comments starting September 15 through October 15.

It will evaluate the decision-making process for how a device works for Medicare patients. This could include requiring clinical trials or having outcome registries before broadly covering the device in the Medicare program.

CMS will conduct future rulemaking to explore an expedited coverage pathway that provides access to innovative beneficial technologies, Fleisher said.


CMS developed the rule in part due to concerns that delays and uncertainty in Medicare coverage impaired beneficiary access to new and innovative technologies, specifically those designated as breakthrough devices by FDA.

Medicare’s local contractors are empowered to offer coverage for items and services on a claim-by-claim basis – as long as such items and services meet the statutory requirements for coverage. Contractors use the best available evidence, and take an individual patient’s clinical condition under consideration when making these determinations.

“We recognize the claim-by-claim process can create a risk of noncoverage for providers and patients, as well as time lags and potential regional variation in local determinations,” Fleisher said. “This is why we will continue to pursue additional policymaking avenues beyond local claim-by-claim determinations.”


AdvaMed president and CEO Scott Whitaker said, “It’s unfortunate for patients across the country that the Administration has decided to reject a rule to allow Medicare patients immediate access to breakthrough medical innovations. Any Medicare patient and their doctor who [have] exhausted all existing medical options should have immediate access to FDA-approved breakthrough medical technologies.”

For More Information:



Request a Free Quote