New bill aims to make Medicare cover breakthrough medical devices for 4 years

A new bill aims to require Medicare cover new breakthrough medical devices for four years as the agency prepares for its own regulation on the issue. 

A bipartisan group of House lawmakers introduced Wednesday (PDF) the Ensuring Patient Access to Critical Breakthrough Products Act. The legislation aims to close a gap between Food and Drug Administration (FDA) clearance of a breakthrough medical device and when the Centers for Medicare & Medicaid Services (CMS) covers it for Medicare. 

“Seniors should not be forced to wait years for cutting-edge, safe and effective treatments that could change or even save their lives,” said Rep. Suzan DelBene, D-Washington, one of the co-sponsors of the bill. 

The legislation comes as CMS is expected to issue a regulation later this year that addresses coverage for breakthrough devices, which get a faster FDA review if they offer a better treatment of a life-threatening or debilitating disease. However, it can at times take several years for such treatments to get Medicare coverage. 

The legislation would require CMS to cover all breakthrough products in Medicare for four years. 

“During this period, CMS would be required to make a permanent coverage determination,” according to a release on the bill. “This will ensure that seniors have access to the most innovative care as soon as it is deemed safe and effective.”

It would also extend this temporary coverage for devices that were already approved as breakthrough products such as digital therapeutics. 

DelBene introduced the legislation alongside Reps. Brad Wenstrup, R-Ohio; Terri Sewell, D-Alabama; Anna Eshoo, D-California; Blake Moore, R-Utah; Gus Bilirakis, R-Florida; Brett Guthrie, R-Kentucky; and Tony Cardenas, D-California.

Despite the bipartisan support, it remains unclear if the legislation can make it through a divided Congress. But the bill can also show CMS where Congress stands on the issue, DelBene told Fierce Healthcare in a statement. 

"With potential administration rulemaking on 'breakthrough' products any day now, Congress must make clear where we stand," she said. "With healthcare inflation outpacing the price increase of many other products, this legislation is an opportunity to make new treatments and diagnostics affordable and available to our seniors."

Last fall, CMS officials said they are considering a new pathway for Medicare’s device review process. The voluntary program would only be limited to devices relevant to Medicare’s population. 

If a devicemaker agrees, CMS would start the coverage review process before the FDA clears the product. 

So far, no rule has been released, although the regulatory agenda for CMS projects it will be released next month. 

In 2021, the agency pulled a rule passed in the waning days of the Trump administration that also required Medicare coverage of all breakthrough devices for four years. 

That rule has drawn criticism from insurers and patient advocates that it could lead to unsafe devices harming Medicare beneficiaries. 

CMS told Fierce Healthcare that it does not comment on pending legislation and did not say when its own rule will be released.