The Centers for Medicare & Medicare Services (CMS) is hosting two public meetings to help inform its development of an alternative coverage pathway to provide transitional coverage for emerging technologies. The sessions will be held February 17 and March 31, at 3 p.m. ET.
Following the repeal of the Medicare Coverage of Innovative Technologies and Reasonable and Necessary (MCIT/R&N) final rule, CMS says it remains committed to establishing an alternative expedited coverage pathway and other coverage process improvements. The rule was rescinded due to concerns that its provisions may not have been sufficient to protect Medicare patients.
The MCIT/R&N final rule would have granted expedited Medicare coverage for up to four years for certain Food and Drug Administration (FDA)-designated “breakthrough” devices once they received or cleared market authorization. However, the kinds of clinical studies needed for FDA market authorization might not have considered the differences in clinical profiles, complexities of medical conditions, or associated treatments of the diverse population of Medicare patients.
CMS Administrator Chiquita Brooks-LaSure said CMS is working “with the FDA, Agency for Healthcare Research and Quality (AHRQ), medical device manufacturers, and other stakeholders to develop an expeditious process to cover innovative devices that benefit Medicare patients and intends to hold at least two stakeholder public meetings in [calendar year] 2022 to inform our future policymaking in this space.”
The meetings are part of several steps CMS said it is taking “to help better achieve the goals of timely and predictable Medicare coverage of devices while ensuring that Medicare covers items and services on the basis of scientifically sound clinical evidence and with appropriate safeguards.”
CMS said it is particularly interested in having stakeholders communicate any new and innovative approaches and ideas for it to consider as it moves forward, and encouraged stakeholders to attend both meetings as the second session will build on information gathered in the first session.
Visit the CMS webinar registration by February 16 at 5 p.m. ET and indicate on the registration form if you wish to speak at the meeting.
