A bill has been proposed that will reduce the delay in Medicare approval of products and procedures that have not gone through the full FDA approval process.  Many seniors who could benefit and are willing to take the additional risks on not-fully-vetted products and procedures can hope that they can benefit without having to wait for full approval.  These are devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

While the bill has not yet been passed, it has bi-partisan support and has a good chance.

The bill would require Medicare to temporarily cover breakthrough devices for up to four years, while the Centers for Medicare & Medicaid Services (CMS) has time to make a permanent coverage determination.  This would eliminate the gap between FDA approval and Medicare coverage, which can sometimes take years and prevent seniors from accessing innovative and potentially lifesaving treatments.

The bill would also provide for temporary and, where appropriate, permanent Medicare coverage of breakthrough devices for which there is no existing benefit category. This would ensure that seniors are not denied access to breakthrough devices that do not fit into the current Medicare categories.

A Medicare diagnosis category refers to the Major Diagnostic Categories (MDC) that are used to group all possible principal diagnoses into 25 mutually exclusive diagnosis areas. MDC codes are used to assign cases for payment. The proposed legislation will require that Medicare expand its MDC’s to allow for earlier adoption of developing treatments even outside of the existing diagnosis areas.

The bill was introduced in the House of Representatives on March 22, 2023 by Rep. Brad Wenstrup (R-OH) and has seven co-sponsors (four Democrats and three Republicans).  “Our seniors deserve access to the best quality of care available,” U.S. Rep. Blake Moore (R-UT) says. “This bill will cut regulatory red tape and allow Medicare enrollees the ability to use breakthrough medical devices.”

With passage, the FDA can give “breakthrough designation” to new medical devices if they look to be more effective than alternatives or offer advantages over other options.  Approval can also be granted in cases where there are no approved alternatives, or the device provides care for a diagnosis of life-threatening or debilitating diseases or conditions.