How the new CMS pathway might change things for breakthrough devices

Sometimes the waiting game isn’t just a bureaucratic hurdle—it’s a matter of life and death.

Patients and device manufacturers are tired of counting down the days for Medicare to cover treatments designated as breakthrough devices, a label given to inventions the FDA thinks could significantly improve serious or life-threatening conditions. Breakthrough devices receive speedier development, review, and FDA approval—but sometimes they get stuck in CMS limbo.

After years of pressure, however, the Centers for Medicare and Medicaid Services (CMS) unveiled a final notice on August 7 to reduce wait times for Medicare coverage of these inventions.

Still, not everyone thinks these changes are for the better. Some researchers have raised safety concerns, and some manufacturers and lobbyists want CMS to do even more to eliminate hurdles to patient access.

The basics. After giving a device the breakthrough label, the FDA evaluates its safety and effectiveness and approves it for market. From the program’s creation in 2015 to 2023, 95 of all 933 breakthrough devices received FDA market approval.

After market approval, CMS then makes coverage decisions locally or it can go through a national coverage determination (NCD), which takes an average of nearly five years, according to a 2021 industry professional survey—a timeline that feels too long for manufacturers and patients alike.

“It affects a lot of people who may not have the time to wait,” Sandra Waugh Ruggles, director of policy research at the Stanford Byers Center for Biodesign, said in a press release about the survey’s results.

Through the new Transitional Coverage for Emerging Technologies (TCET) pathway, CMS aims to make NCD decisions within six months of FDA market approval and accept up to five breakthrough device candidates per year, the agency wrote in its notice.

In comparison, a CMS report found there were six NCDs implemented in 2023, including for things that weren’t medical devices, like drugs and therapies.

Evidence collection would continue while the devices are provisionally covered under the TCET, with a permanent coverage decision expected within about five years, the final notice said.

Talk safety to me. “Now Healthcare Brew,” you might say. “I hate waiting as much as the next person, but isn’t there a reason that NCD reviews take so long?”

The answer is yes, according to Rita Redberg, a cardiologist and professor of medicine at the University of California, San Francisco. Redberg previously chaired the Medicare Evidence Development and Coverage Advisory Committee for CMS.

She worries that rushing the process could give patients access to new technologies that eventually prove to be unsafe or ineffective.

“It could be very good for device manufacturers because they will be able to see profits much sooner,” Redberg said. “For patients, it’s a little scary.”

Federal guidance notes that the FDA “may accept a greater extent of uncertainty of the benefit-risk profile” when approving breakthrough devices for market.

Medicare makes allowances, too. Devices in the TCET pathway don’t have to pass the normal “reasonable and necessary” evidence threshold for Medicare coverage. Instead, the evidence needs to be “promising” and “potentially important for the Medicare population,” per an August 12 CMS notice.

Too much, or not enough? On the other side, device manufacturers don’t think this new pathway goes far enough.

A coalition including the American Telemedicine Association and the American Academy of Neurology signed a letter supporting the TCET pathway, but also pushed for CMS to consider accepting more annual candidates and diagnostic tools.

CMS spokesperson Stephanie Rossy, however, told Healthcare Brew that just isn’t possible right now.

“We limit to five because that is the largest number that we feel we can address within our available resources,” she said.

Looking forward. Not only do some see the five-device limit as not enough, it’s also a downgrade from a previous Trump-era proposal that would have automatically given up to four years of Medicare coverage to any breakthrough device with market authorization. CMS later rescinded the rule, arguing FDA market authorization is based on clinical studies that don’t always account for Medicare patients’ “differences in clinical profiles, complexities of medical conditions, or associated treatments.”

A 2023 bipartisan bill, HR 1691, would enact a structure similar to that proposal, with additional funding for CMS of $10 million a year for five years, Fierce Healthcare reported.

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough,” an August 8 statement from the Advanced Medical Technology Association said.