MCIT: Not a better way to pay for breakthrough devices
The Medicare Coverage of Innovative Technology (MCIT) pathway should be rescinded because it does not require thorough evidence of the safety and efficacy of the medical device for which it aims to provide coverage, Vinay K. Rathi, MD, of Harvard Medical School and colleagues wrote in a perspective published in the New England Journal of Medicine.MCIT would provide up to four years of Medicare coverage for medical devices authorized under the US Food and Drug Administration (FDA) Breakthrough Devices Program. The rule authorizing MCIT was finalized in the last fortnight of the Trump administration. The pathway was set to become effective on 15 March but has been held up by the regulatory freeze instituted at the start of the Biden administration.
While most Medicare coverage decisions are made at the local level by Medicare administrative contractors, MCIT would create National Coverage Decisions (NCD) for qualifying devices authorized under the Breakthrough Devices Program.
MCIT is one of several pathways Medicare uses to expedite coverage of innovative technologies. The difference, according to the authors, is that MCIT would undermine Medicare’s ability to take into consideration the clinical data supporting a new device.
Under the pathway, the Centers for Medicare and Medicaid Services (CMS) can use the FDA’s breakthrough designation to ensure “rapid adoption of breakthrough devices, which by definition provide more effective treatment or diagnosis for life threatening or debilitating conditions.” But the authors note that breakthrough designation – in its very short tenure – does not always work like that.
“In our review of the program’s first 3 years, we found that high-risk breakthrough devices were approved primarily on the basis of studies that used short-term, surrogate end points for effectiveness, which may not translate into clinical benefits,” Vinay and associates wrote. “Furthermore, the FDA authorized some breakthrough devices without supporting effectiveness data (i.e., they were approved on the basis of safety data alone) and authorized other devices that carried important known safety risks.”
FDA’s voluntary Breakthrough Devices program replaced the Expedited Access Pathway and the Priority Review programs for medical devices. In order to be eligible for breakthrough designation, devices must provide for “more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.” Also, a device must meet at least one of four criteria to be eligible: it must represent breakthrough technology, have no approved or cleared alternatives, offer significant advantages over existing approved or cleared alternatives, or be in the best interest of patients to have the device be available.
In establishing the MCIT pathway, CMS chose not to require companies to complete postmarket safety studies as a condition of coverage – including those studies mandated as part of FDA authorization. Further, use of the pathway could prove expensive for Medicare, the authors pointed out, especially given the rapid growth in authorizations under the Breakthrough Devices Program.
While CMS implementation of the MCIT pathway is frozen, the authors recommended that FDA refine its process for giving Breakthrough Device designation and that CMS ensure that such devices demonstrate substantial improvements over treatments already on the market as well as financially incentivize completion of FDA-mandated postmarket studies.
“These measures could free up resources that the agencies could use for joint endeavors, such as expanding the underused Parallel Review program to reward rigorous premarketing research and coordinating the FDA postmarketing-study requirements with the CMS Coverage with Evidence Development program to provide incentives for postmarketing evidence generation,” the authors concluded. “Such a collaboration would be ambitious, but we believe it is necessary to ensure that Medicare beneficiaries have access to truly innovative medical devices.”