CMS Weighs Medicare Coverage at the Time of FDA Approval for Breakthrough Devices

The US Centers for Medicare & Medicaid Services is considering a proposed rule change that would see “breakthrough” medical devices receive national Medicare coverage for reimbursement at the time they are approved by the Food and Drug Administration.

The new rule is called Medicare Coverage of Innovative Technology (MCIT), and as currently drafted, would see breakthrough medical devices receive 4 years of Medicare coverage the same day they are approved by the FDA. The rule change is intended to provide “broad immediate access” to breakthrough medical devices and foster innovation, according to CMS.

Once the 4 years are up and MCIT coverage sunsets, the devices would require the standard national coverage determination (NCD), local coverage determination (LCD), or a claim-by-claim decision for reimbursement. The 4-year window is intended for device manufacturers to generate clinical and real-world evidence on health outcomes among the Medicare population.

Currently, Medicare coverage is limited to drugs, devices, or services deemed “reasonable and necessary for the diagnosis or treatment of an illness or injury.” Traditionally, the NCD lags behind the FDA approval, putting physicians in a quandary if they believe a patient could urgently benefit, but can’t afford to pay for it. In one study of pharmaceuticals, biologics, and moderate-to-high-risk medical devices, the median time from FDA approval to the initiation of an NCD was 9 months. The median time from FDA approval to the publication of an NCD memorandum was 17 months. During that time, even though the device is approved by the agency, Medicare beneficiaries are not allowed access to the technology.

“We are aware that there are promising technologies being designated by the FDA for expedited development and priority review through the FDA Breakthrough Devices Program,” according to a fact sheet issue by CMS. “However, with the current Medicare coverage options, we have had challenges keeping national Medicare coverage on pace with these innovations because of the availability of clinical evidence required to approve technologies through the NCD process.”

To respond to the challenge, and in support of President Donald Trump’s executive order issued in 2019 that called for “protecting and improving Medicare,” the MCIT rule change is intended to “create a more efficient coverage pathway for breakthrough devices,” according to CMS.  

MCIT would only apply to breakthrough medical devices, or device-led combination products that “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” As part of the breakthrough devices program, the manufacturer would also have to show that the device either represented a breakthrough technology, that no approved or cleared alternatives exist, that it offered significant advantages over existing or cleared alternatives, or that its availability is in the best interest of patients.

Public Comments Still Open

CMS is currently encouraging comments from the public until November 2, 2020. Many of the comments published to date favor the MCIT rule change, with one physician observing that “waiting for code approval of an already FDA approved device is a logistical bureaucratic roadblock in providing the newest scientific technology to the patient.” Another stated that the “rule will accelerate the delivery to market of innovative medical devices, which will make them available to patients sooner and hence deliver the health benefits earlier than today's system.” 

However, Daniel Silverman, MD, PhD (University of California, Los Angeles), who also posted through the public comment process, says some refinements to the current rule may be necessary. Silverman points to the FDA approval of three amyloid imaging radiotracers back in 2012, 2013, and 2014 intended for use with positron emission tomography (PET). At the time, CMS declined national coverage for PET imaging with the tracers based on inadequate data that their use would be beneficial to the Medicare population. CMS did support “Coverage with Evidence Development” for investigating the value of amyloid imaging to improve patient outcomes, but a $100 million trial found no meaningful benefit relative to the study’s primary endpoint. Had the amyloid tracers received an NCD, considerable taxpayer money would have been spent on a technology with no proven benefit to Medicare patients, according to Silverman.

For that reason, Silverman suggests incorporating a streamlined Coverage with Evidence Development-type process as a phase-in “prior to all-out expenditure of our resources on technologies that may be deemed by the FDA to be safe and effective in accomplishing a goal within the limited scope of a labeled indication, yet of no proven value in actually benefiting the patients whose health and welfare has been entrusted to our care.” 

Presenting data to Congress early in 2019, former FDA Commissioner Scott Gottlieb, MD, reported that at the close of 2018 they’d granted breakthrough designation to 97 devices while turning down 41 products. The most common clinical specialties for devices granted breakthrough device designation were neurology and cardiovascular medicine.