Federal authorities are abandoning a plan to hasten Medicare coverage for new mHealth technology, claiming that the Trump administration’s plan will endanger patients. The Medicare Coverage of Innovative Technology (MCIT) program, which would have accelerated Medicare coverage for mHealth technology certified as “breakthrough medical devices” by the FDA, has been recommended to be eliminated by CMS.
- A new proposal: In this week’s Federal Register, the Centers for Medicare & Medicaid Services proposes to cancel the proposed Medicare Coverage of Innovative Technology (MCIT) program, which would have permitted Medicare coverage for FDA-designated breakthrough devices on the same day.
- Reviewal: The coverage would be in place for four years, following which the technology would be reviewed by the FDA. The scheme was announced by CMS in August 2020, with the agency claiming that the period between FDA approval and Medicare coverage was impeding connected health innovation and denying beneficiaries of potentially life-saving therapy.
- Approval: “For new technologies, CMS coverage approval has been a chicken and egg issue,” then-CMS Administrator Seema Verma said at the time. “Innovators had to prove their technologies were appropriate for seniors, but that was almost impossible since the technology was not yet covered by Medicare and thus widely used enough to demonstrate their suitability for Medicare beneficiaries. These efforts will ensure seniors get access to the latest technologies while lowering costs for innovators.”
- Regulations: By codifying the meaning of “reasonable and necessary” for the Medicare population, the regulation would have defined how CMS supports new telemedicine and mHealth technology. The device must be (1) safe and effective, (2) not experimental or investigational, and (3) appropriate for use by Medicare patients, according to the proposed criteria.
- Commitments: “We believe that the finalized MCIT/R&N rule is not in the best interest of Medicare beneficiaries because the rule may provide coverage without adequate evidence that the Breakthrough Device would be a reasonable and necessary treatment for the Medicare patients that have the particular disease or condition that the device is intended to treat or diagnose,” the agency said in its announcement.