The Centers for Medicare & Medicaid Services has suspended the effective date for the proposed Medicare coverage program for FDA-designated breakthrough devices, temporarily reversing a program that won widespread support from device makers. The program was not universally well received, however, and CMS justified the move by arguing that the process used to vet the rule was deficient.
The agency said the suspension offers a new 30-day window for additional feedback on the rule and a second 30-day window for considering the comments. At the end of those 60 days, the agency will exercise the option of revising or rescinding the rule. The Medicare Coverage of Innovative Technology (MCIT) rule was subject to the Biden administration’s Jan. 20 regulatory freeze order, which directed federal government agencies to review any rules put into effect in the final days of the Trump administration.
There were several considerations to be examined by agencies in carrying out the regulatory freeze, including whether the rulemaking process was procedurally adequate and whether the issuing agency had properly considered all the relevant facts. The CMS suspension order stated that the MCIT rule had not addressed operational issues, such as the processes needed to establish coding and payment levels. The related questions revolve in part around whether the device and related services would fall into a benefit category for the Part A hospital benefits category or the Part B physician services category.
CMS said some observers had pointed to a need to delay payment for a breakthrough device pending completion of administrative tasks, such as assignment of a CPT code, but added that the agency had previously underestimated the operational challenges referenced in those comments to the docket. Another procedural problem cited by CMS was that the agency had proposed a rule related to durable medical equipment that chronologically overlapped with the MCIT rule, and consequently stakeholders might have had difficulty responding to both proposals.
The draft MCIT rue carried the assumption that five or fewer devices would qualify for the coverage policy each year, based on the relatively small number of breakthrough devices that had been cleared or approved by the FDA. CMS cast doubt on this projection, given that the FDA’s numbers suggest that more than 400 devices have entered the breakthrough devices program. CMS acknowledged, however, that not all of these will win market access.
MCIT said to threaten ‘decades of progress’
One of the sources of negative commentary regarding the MCIT program was two medical researchers whose editorial in the Dec. 2, 2020, issue of Health Affairs included the charge that the program “threatens to erode decades of progress” in requiring adequate evidence for Medicare coverage. One of the issues cited by the authors was that the program stopped short of requiring industry to conduct the studies that would ordinarily be needed for coverage, but merely recommended that those studies be conducted.
Another point raised by the authors is that a device could easily become obsolete by the end of the MCIT coverage period of four years, thanks to the rapid pace of device iteration. They suggested that the MCIT program’s approach constitutes an unfettered path to coverage that “is a recipe for future problems.” Perhaps the most pressing long-term concern cited by the authors is the prospect that the MCIT program would amplify inflation in Medicare spending. The better solution would be to make improvements to the coverage with evidence development program, they stated, although they reiterated a previous editorial that urged CMS to incorporate cost effectiveness analyses into its coverage decisions.