Press Releases

Today, Representatives Suzan DelBene (WA-01), Jackie Walorski (IN-02), Tony Cárdenas (CA-29), Gus Bilirakis (FL-12), Terri Sewell (AL-07), and Fred Upton (MI-06) introduced the Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 4043), legislation that would guarantee Medicare beneficiaries access to cutting-edge medical innovation by expediting the coverage determination process and improving the availability of breakthrough devices for patients.

Currently, Medicare does not automatically cover the latest advances in medical technology, even when the products are approved or cleared by the Food and Drug Administration (FDA) and designated a breakthrough product. FDA-approved products can take up to three years to go through the Medicare coverage determination process, delaying vital treatments to millions of seniors.

The Ensuring Patient Access to Critical Breakthrough Products Act would require Medicare to temporarily cover all breakthrough products approved through the FDA for four years. During this period, the Centers for Medicare and Medicaid Services (CMS) would be required to make a permanent coverage determination. This allows patients and their providers access to the most cutting-edge, innovative care as soon as it comes to market.  

For a medical product to earn the FDA’s “breakthrough” designation, it must meet the following criteria: 

• Provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions;  
• Has no approved alternatives;  
• Offers significant advantages over existing approved alternatives; or 
• Its availability is in the best interest of patients. 

The bill also provides temporary coverage for certain breakthrough devices that did not exist or were not considered when Medicare was first created, like digital therapeutics.

In January, CMS finalized the Medicare Coverage for Innovative Technology (MCIT) rule, which like H.R. 4043 would provide temporary Medicare coverage for products that have received breakthrough designation by the FDA and help Medicare beneficiaries access these new technologies. However, the CMS has since delayed implementing this rule.

This proposal was included in the recent bipartisan 21^st Century Cures 2.0 discussion draft released by Representatives Diana DeGette (CO-01) and Upton.

“Seniors should not be waiting on new cures and therapies that could change or even save their lives,” said DelBene. “Guaranteeing the coverage of breakthrough therapies and treatments would encourage future innovation and investment in cutting-edge medical technologies while improving quality of life for millions of seniors. We can’t let the coverage approval process be a barrier to life-saving treatments or care.” 

“One of the best ways to encourage health care innovation is to remove unnecessary barriers patients face in getting the cutting-edge medical products they need,” said Walorski. “I’m grateful to reintroduce the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act, which will help break down these obstacles and delays. By streamlining the Medicare coverage process for new technologies, this commonsense legislation will boost American innovation and give Medicare patients faster access to life-saving medical devices.”

“No one should be forced to wait years to access critical treatments, especially our seniors,” said Cárdenas. “This bill ends the unnecessary delay of cutting-edge medical technologies that have the potential to save lives. By improving the determination process for patients, millions of seniors will have access to revolutionary care as soon as it comes to market and, as a result, an improved quality of life.”

“This legislation will help millions of seniors on Medicare by ensuring more timely access to the treatments they need,” said Bilirakis. “Additionally, there are more than 600 medical device companies in our state working to develop innovative and effective products.  I’ve heard from many of these businesses about how these lengthy and unnecessary Medicare coverage delays create a significant barrier in bringing new products to market. This bill is about connecting patients with important devices and technologies quicker. Additionally, it is about encouraging innovation rather than stifling it. Government has to get out of the way and streamline the payment process for effective new devices that can ultimately help improve and save lives.”

“When breakthrough medical technologies become available, our seniors should not have to wait to utilize them,” said Sewell. “I’m so proud to support this bill which would guarantee Medicare coverage for new, cutting-edge technologies and ensure that seniors in Alabama’s 7^th District receive the most advanced care our country has to offer.”

“Medicare has long served as a real lifeline for millions of Americans who rely on its quality care to stay healthy, and the COVID-19 pandemic only underscored its importance for our nation’s seniors who faced particularly high risks from contracting this vicious virus,” said Upton. “During my tenure, I have worked to expand access to cutting-edge treatments and medical technologies that can enhance quality of life and, in some cases, save lives. The Ensuring Patient Access to Critical Breakthrough Products Act sends a clear message that both Republicans and Democrats can work hand in hand to help folks lead healthier, longer lives. I am proud to support it.”

“Uncertainty about reimbursement is a huge barrier for young companies looking to invest in groundbreaking medical technologies,” said Leslie Alexandre, President & CEO of Life Science Washington. “The Ensuring Patient Access to Critical Breakthrough Products Act is a win-win because it provides the certainty that companies need to invest in new technologies to diagnose and treat diseases that don’t have effective therapies today, while also ensuring that doctors and patients are able to utilize game-changing medical technologies as soon as they are approved.”

The text of the legislation can be read here.