Lawmakers Want Speedy Medicare Reimbursement for Breakthrough Devices

Congress has focused in recent years on easing the regulatory burden for medical device makers. But since reimbursement hurdles often outweigh regulatory or funding challenges as the top concern for the medtech industry, it's fitting that legislators are also trying to tackle delays in Medicare coverage.

A 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," was recently proposed before the House of Representatives. Its sponsors want to shorten the time period between FDA approval and Medicare reimbursement coverage.

This legislation would give new medical technologies that had received FDA approval automatic three-year Medicare coverage under the New Technologies Add-on Payment (NTAP) mechanism, according to a press release. At the end of those three years, CMS would re-examine the technology for permanent coverage. The bill, H.R. 5009, was introduced by Charles Boustany, Jr., MD (R-LA) and cosponsored by Gus Bilirakis (R-FL), Richard Neal (D-MA), and Tony Cardenas (D-CA). 

The legislation would apply to new medical devices and technologies that are approved by FDA. "During a roundtable discussion in my district, I heard from these businesses and organizations on the barriers they face when developing new innovative technology only to face non-coverage by [CMS]. This bill works to address these issues to help them bring important devices and technology to the many patient who need them," Congressman Bilirakis said in a press release. 

Medical device companies already have the Parallel Review option to try to align FDA approval and CMS coverage timelines. Under that program, FDA and CMS work together to shorten the lag between a regulatory approval and a CMS reimbursement national coverage determination (NCD). The first device through the program, the Cologuard colon cancer screening test from Exact Sciences, received FDA approval and a proposed CMS NCD on the same day in August 2014. Still, the program's impact has been limited and no other device approval-NCDs have been announced. CDRH has since expanded the program as part of its Payer Communication Task Force, offering medtech companies the chance to work with private payers as well as CMS to better understand data needed for reimbursement coverage and possibly shorten time to a coverage determination.

Congressman Boustany, who is also a surgeon, said in the press release, "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."

Neal and Cardenas, representatives from major medtech states Massachusetts and California, emphasized the importance of such legislation to the medtech industry. Neal said that this bill "ensure that [Massachusetts] remain[s] at the forefront" of medical research. Cardenas said that H.R. 5009 would "also promote a more efficient regulatory ecosystem so that the roughly 1700 medical device companies in California could continue to develop and innovate and spend more time taking care of customers in need."

Medtech industry group AdvaMed applauded the bill's introduction. Scott Whitaker, AdvaMed president and CEO, said in a statement, "Once FDA determines a breakthrough technology is safe and effective, coverage and reimbursement delays at CMS frequently deny Medicare patients the opportunity to receive them--often for years after FDA approval . . . Taken together, the breakthrough policy proposal and NTAP reforms would both stimulate development of important new devices and diagnostics and assure more rapid availability of those treatment options to patients."

[Image courtesy of DAVID CASTILLO DOMINICI/FREEDIGITALPHOTOS.NET]