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New bipartisan legislation is looking to improve the availability of breakthrough devices for Medicare beneficiaries. The Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333) was reintroduced by U.S. Rep. Suzan DelBene (D-Wash). She previously introduced the bill in 2018.
The bipartisan legislation is being co-led by Rep. Jackie Walorski (R-IN), Rep. Tony Cárdenas (D-CA), Rep. Gus Bilirakis (R-FL), Rep. Terri Sewell (D-AL), and Rep. Roger Marshall (R-KS).
Right now, Medicare does not automatically cover the latest advances in medical technology, even when the products are approved through FDA’s breakthrough pathway process.
Medicare’s coverage determination for FDA approved products can take up to three years, 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 FDA’s breakthrough pathway for three-years, during which the Centers for Medicare and Medicaid Services (CMS) must make a permanent coverage determination.
H.R. 5333 also provides temporary coverage for certain breakthrough devices that did not exist or were not contemplated when Medicare was first created and do not have a Medicare benefit category.
Since last Congress, FDA has granted breakthrough status to products that do not have a benefit category in Medicare, and therefore no pathway or coverage for Medicare patients. For example, software or digital products, such as Prescription Digital Therapeutics are not eligible for Medicare coverage because today there is no appropriate benefit category.
The bill would allow the Health and Human Services (HHS) Secretary the flexibility to make coverage determinations for products that have FDA breakthrough status but no benefit category.
“This hurry-up-and-wait situation makes no sense,” DelBene said in a release. “Seniors shouldn’t have to wait unnecessarily to access medical products that can change or even save their lives. Guaranteeing coverage of breakthrough technologies and opening the door to coverage of new digital-based products encourages investment in the industry, facilitating innovation, and future advancements.”
In a release, AdvaMed, medtech's advocacy group, applauded the proposed bill.
“CMS has made great strides in recent months to ensure Medicare beneficiaries have access to the most innovative medical care, and this important legislation would build on these critical reforms,” said AdvaMed president and CEO Scott Whitaker. “We thank Reps. DelBene, Walorski, Cardenas, Bilirakis, Marshall, and Sewell for their leadership and their commitment to ensuring patients and physicians benefit from breakthrough medical technologies in a timely manner. We look forward to working with Congress, CMS, and other key stakeholders to move the bill forward.”
The Breakthrough Device Designation pathway was initiated by FDA in late 2016. Since then, there have been many companies (too numerous to count here) that have had technologies receive the designation.
One of the most recent device designations MD+DI reported on was Vicarious Surgical’s robotically-assisted surgical platform that employs virtual reality. The Boston-based company said it was the first to receive this designation for a robotically-assisted surgical device.
Impulse Dynamics went through the device designation pathway and was one of the first companies in the program to secure a PMA for its heart failure treatment technology. The Mount Laurel, NJ-based company recently raised $80.3 million in a series D round.