CMS Plans to Scrap Innovative mHealth Technology Program
CMS has proposed eliminating the Medicare Coverage of Innovative Technology (MCIT) program, which would have sped up Medicare coverage for mHealth technology classified by the FDA as 'breakthrough medical devices.'
Federal officials are ditching a plan to speed up Medicare coverage for innovative mHealth technology, saying the Trump-era plan would have put patients at risk.
The Centers for Medicare & Medicaid Services is publishing a proposal in this week’s Federal Register to end the proposed Medicare Coverage of Innovative Technology (MCIT) program, which would have allowed Medicare coverage for US Food and Drug Administration-designated breakthrough devices on the same day that the FDA provides market authorization - which occurs after 510(k) premarket notification, De Novo request or premarket approval application - for those devices. The coverage would last for four years, after which the FDA would review the technology.
CMS unveiled the program in August 2020, saying the time lag between FDA review and Medicare coverage was stifling connected health innovation and depriving beneficiaries of potentially life-saving treatment.
“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.”
The rule would also have clarified how CMS covers new telemedicine and mHealth technology, by codifying the definition of “reasonable and necessary” for the Medicare population. Under the proposed definition the device must be (1) safe and effective, (2) not experimental or investigational, and (3) appropriate for use by Medicare patients.
CMS issued a final rule earlier this year, but the Biden Administration delayed implementation until this December. Now the agency is planning to scrap the program altogether.
“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.
The agency added that “significant concerns persist about the availability of clinical evidence on Breakthrough Devices when used in the Medicare population as well as the benefit or risks of these devices with respect to use in the Medicare population upon receipt of coverage.”
"We believe that it is important to require manufacturers participating in an innovative coverage pathway, such as MCIT, to produce evidence that demonstrates the health benefit of the device and the related services for patients with demographics similar to that of the Medicare population," the agency concluded.
This week’s announcement was met with criticism from the Advanced Medical Technology Association (AdvaMed), a Washington DC-based trade association that had supported MCIT.
“It’s unfortunate for patients across the country that the Administration has decided to reject a rule to allow Medicare patients immediate access to breakthrough medical innovations,” president and CEO Scott Whitaker said in a press release. “Any Medicare patient and their doctor who has exhausted all existing medical options should have immediate access to FDA-approved breakthrough medical technologies. That’s what this is all about. Doctors and patients should be trusted to make the right medical decision to treat a life-threatening condition.”
“The federal government should incentivize access to these new breakthrough technologies,” he added. “Repealing MCIT is the wrong decision for countless Medicare patients, and it’s the wrong decision for American medical innovation. Our goal in this country should be to spur and not inhibit innovation that will change patients’ lives. We will continue to make this important case with the Administration and Congress, and we are hopeful they will make the right decision.”