In November 2021, the Centers for Medicare and Medicaid announced that it was rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule, which would have gone into effect on December 5, 2021.
The rule would have granted Medicare coverage for up to four years for devices granted both FDA “breakthrough” designation and market authorization.
The CMS, by rescinding the rule, says it is addressing safety concerns that FDA market authorization standards may not adequately protect Medicare patients.
What the MCIT/R&N Would Have Provided
The rule emerged towards the end of the Trump administration, and its implementation had already been delayed by the CMS once by the time it was rescinded.
If enacted, the rule would have established a Medicare coverage pathway for FDA breakthrough devices that would be available to manufacturers for up to four years after the device received its breakthrough designation.
Other innovative healthcare technologies that did not have or could not receive breakthrough designation, like second-to-market devices and other devices ineligible for FDA breakthrough designation, would have been precluded from Medicare coverage by the MCIT/R&N rule.
The Repeal of the MCIT/R&N Rule
The proposal to rescind the rule was published on September 15, 2021, triggering a 30-day comment period during which the public was invited to offer feedback on the proposed rule repeal.
The CMS received more than 100 comments. While a number of commenters argued that repealing the rule could reduce the quality of care provided to Medicare patients, many commenters agreed with the CMS that FDA standards on breakthrough devices may not adequately address safety concerns.
Notable commenters included America’s Health Insurance Plans (AHIP) and the Medical Images Technology Alliance (MITA).
After considering public comments, the CMS determined “that the FDA safety and effectiveness standards alone are [not] sufficient to support open-ended Medicare coverage.”
The rule’s repeal may help defend the CMS against accusations that the Centers are providing an unfair advantage to certain categories of devices or failing to protect Medicare patients. The repeal could also help prevent legal challenges — like the 2017 lawsuit that challenged the Pennsylvania Department of Human Services’ handling of a $12 billion Medicaid procurement.
Future Rules May Provide Medicare Patients With Access to Innovative Healthcare Devices
The CMS’s press release on the rule’s repeal, published in the Federal Register, suggests that the Centers will revisit rulemaking on innovative healthcare technology in the near future, in a way that better protects Medicare patients while possibly expanding coverage of new devices.
The CMS plans to open a dialogue with the FDA, medical device manufacturers and Medicare stakeholders to determine the best path of action.
The Centers will also review the current Coverage with Evidence Development (CED) study criteria to determine if it can be modified to perform a similar, and more effective, role as the proposed MCIT/R&N rule — providing selective coverage to innovative devices that may otherwise be difficult to access for Medicare patients.
This process could help the Centers identify a new pathway for innovative device coverage that also considers health and safety concerns that are unique to the Medicare population.
Updates on this process will likely come in 2022, in one of the planned stakeholder meetings set to take place during the year.
Despite the rule’s repeal, pathways still exist right now for breakthrough devices — along with other innovative medical technology — to receive Medicare coverage.
Individual claim determinations, local coverage determinations and national coverage determination can all provide coverage for innovative devices that are not already covered by Medicare.
However, manufacturers and individuals will have to pursue these determinations on a per-device basis. The determination process can also be particularly involved — and not nearly as streamlined as the coverage process for breakthrough devices that the MCIT/R&N rule would have provided.
What Manufacturers and Patients Should Expect After the MCIT/R&N Rule Repeal
On December 15, 2021, the MCIT/R&N rule will not go into effect. Medicare patients and manufacturers of breakthrough devices will have to wait a little longer for a pathway to coverage for innovative medical devices.
CMS communications suggest that the Centers are already beginning discussions with relevant stakeholders about a new pathway for innovative device coverage. An update on these discussions may come at any point next year.
By Shannon Flynn, ReHack
