House bill would speed CMS reimbursement for breakthrough devices

A new bill proposed by the U.S. House of Representatives looks to speed up the timeframes for Medicare reimbursement coverage for breakthrough medical devices that have won FDA approval .

The bill, titled “To amend titles XVIII and XIX of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare and Medicaid programs, and for other purposes,” would give newly FDA-cleared devices automatic 3-year Medicare coverage under the New Technologies Add-on Payment program, according to bill co-sponsor Gus Bilirakis (R-FL).

The bill was introduced by Congressman Dr. Charles Boustany, Jr. (R-LA) and co-sponsored by Bilirakis, Richard Neal (D-MA) and Tony Cardenas (D-CA).

“This legislation will help the 600 medical device companies in our state working to develop innovative and effective medical devices, as well as the millions of seniors on Medicare. During a roundtable discussion in my district, I heard from these businesses and organizations on the barriers they face when developing new innovative technologies only to face non-coverage by the Centers for Medicare and Medicaid Services (CMS). This bill works to address these issues to help them bring important devices and technologies to the many patients who need them. We must continue to encourage innovation, not stifle it. This legislation will streamline the payment process for effective new devices and ultimately help improve and save lives,” Bilirakis said in prepared remarks.

After the guaranteed 3-years of automatic coverage, technologies would have to be re-evaulated by the Centers for Medicare and Medicaid Services for permanent approval, and would gain coverage by private insurers, according to a press release from Bilirakis.

“As a surgeon, I know all too well how vital it is for patients and their doctors to have the most current and effective technology available. From diagnosing a simple cold to the early detection of a potentially fatal disease, we rely on the continued advancements in medicine to keep us at our best health. Delays in Medicare coverage of FDA-approved technologies present unnecessary financial uncertainty that can cripple medical research and development companies who are not only ensuring medical advancement continues, but are also creating high-paying American jobs. We must cut the red tape of Washington to ensure our physicians have access to the best technology available for our American families,” co-sponsor Boustany said in a prepared statement.

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