Representatives Gus Bilirakis, R-FL, and Suzan DelBene, D-WA, have introduced the Ensuring Patient Access to Critical Breakthrough Products Act, 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’s (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 2021, CMS finalized the Medicare Coverage for Innovative Technology (MCIT) rule, which like the bill proposed by Bilirakis and DelBene 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 legislation will help millions of seniors on Medicare by ensuring more timely access to the treatments they need,” said Congressman 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.”
“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.”
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