Imaging advocates blast CMS repeal of rule granting faster Medicare coverage for breakthrough devices
Imaging industry advocates on Thursday blasted plans to repeal a Trump-era policy granting faster Medicare coverage for breakthrough medical devices.
The Biden administration revealed the proposal on Sept. 13, quashing the Medicare Coverage of Innovative Technology, or MCIT, rule set to take effect in December. Consumer groups, physicians and health insurers had expressed concerns that speedier coverage might place seniors in danger. Device makers, however, believe the decision will stifle innovation.
“For all interested parties, patient safety is the foremost concern, but the repeal of MCIT is misguided,” said Patrick Hope, executive director of the Medical Imaging & Technology Alliance, which represents manufacturers of imaging equipment, radiopharmaceuticals and contrast media. “This is a major setback for efforts to eliminate the lengthy and costly lag between FDA approval and Medicare coverage determination. As a result, innovative technologies will not be available to Medicare beneficiaries sooner.”
Under the rule, the Centers for Medicare & Medicaid Services would have granted simultaneous national coverage with Food and Drug Administration approval, up to a period of four years. After that, the feds would have reevaluated the device based on clinical data to determine whether payment should persist.
Without the policy, new treatments have faced a “Catch-22 scenario,” Hope said, garnering approval but awaiting real-world data before gaining federal payment. But providers faced challenges collecting such proof without the necessary payment.
“Limiting access to only those who can afford to pay out-of-pocket for an FDA-approved diagnostic or therapy ultimately disadvantages millions of Medicare beneficiaries,” Hope said, adding that a solution is still “very much needed.” “Delays in coverage have held back medical innovation long enough.”
CMS finalized the rule in January ahead of the White House changeover, and the new administration delayed the launch from May until December prior to this month’s announcement.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.