U.S. Rep. Jackie Walorski (R-IN) on June 5 introduced a bipartisan bill that would guarantee new and revolutionary medical products are made immediately accessible to Americans receiving federal health coverage.
The Ensuring Patient Access to Critical Breakthrough Products Act of 2018, H.R. 5997, would amend the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare and Medicaid programs, among other purposes, according to the draft text of the bill in the congressional record.
“The best way to encourage life-saving medical innovation is to remove unnecessary barriers to patients getting the cutting-edge medical products they need,” said Rep. Walorski, who was joined in introducing H.R. 5997 by U.S. Rep. Suzan DelBene (D-WA) and original cosponsors U.S. Reps. Terri Sewell (D-AL), Gus Bilirakis (R-FL), and Tony Cardenas (D-CA).
“By allowing Medicare patients to access breakthrough technologies faster, the Patient Access to Critical Breakthroughs Act will expand treatment options for patients and open new doors for future innovative therapies and cures,” Rep. Walorski added.
Currently, Medicare doesn’t automatically cover costs for the latest medical advances, including any medical devices that are Food and Drug Administration-approved (FDA) via an expedited review process, according to information provided by the congresswoman’s staff. The lag between FDA’s approval and Medicare’s coverage determination can take up to three years.
H.R. 5997 would require federal health coverage for three years for all breakthrough products approved through the FDA’s expedited review process, and to also make a permanent coverage determination within that time frame, according to a summary from Rep. Walorski’s staff.
For a medical device to be designated as “breakthrough,” according to the summary, a new product would be required to: provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions; have no approved alternatives; offer significant advantages over existing approved alternatives; or its availability would be in the best interest of patients.
“It makes no sense that Medicare drags its feet to cover cutting-edge technologies, especially when the FDA works to expedite their own review process for these same treatments,” Rep. DelBene said in a joint statement released by Rep. Walorski’s office.
“Seniors shouldn’t have to wait to access medical products that can change or even save their lives,” said Rep. DelBene. “The guaranteed coverage of these breakthrough technologies will also foster investment in the industry and which will yield greater advances in the future.”
Rep. Sewell added that H.R. 5997 marks “a step towards streamlining the regulatory process and ensuring that these devices reach the patients who need them in a timely manner.”
Rep. Bilirakis pointed out that more than 600 medical device companies in his home state are developing new medical products and during a recent roundtable, leaders from many of these businesses told him how lengthy and unnecessary federal health coverage delays prohibit new products from getting quickly to the commercial market.
“This bill is about connecting patients with important devices and technologies more quickly,” said Rep. Bilirakis. “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.”
Rep. Cardenas added that H.R. 5997 “would also promote a more efficient regulatory ecosystem so that the roughly 1,700 medical device companies in California could continue to develop and innovate and spend more time taking care of customers in need.”
The bill has been referred to the U.S. House Ways and Means Committee and the U.S. House Energy and Commerce Committee for consideration.