breakthrough

CMS rescinds final rule for ‘breakthrough’ medical devices

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The Centers for Medicare and Medicare Services is rescinding a final rule that would have granted expedited Medicare coverage for certain “breakthrough” devices.

The decision to rescind the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule is due to concerns that its provisions are insufficient to protect Medicare patients. 

The MCIT/R&N final rule gave expedited Medicare coverage for up to four years for certain Food and Drug Administration-designated “breakthrough” devices once they received or cleared market authorization.

CMS said that the kinds of clinical studies needed for FDA market authorization might not consider the differences in clinical profiles, complexities of medical conditions or associated treatments of the diverse population of Medicare patients.

WHY THIS MATTERS

By rescinding this rule, CMS can take action to better address safety concerns in the future, the agency said. 

CMS said it intends to explore coverage

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