Insurers are backing the Centers for Medicare & Medicaid Services plan to repeal a Trump-era rule allowing Medicare to cover medical devices designated as "breakthrough" technology by the U.S. Food and Drug Administration, according to public comments on the proposed rule.
Payers, patient safety advocates and independent experts had recommended that President Joe Biden's administration walk back the rule, citing concerns over patient safety and questions about the value of automatically providing Medicare coverage for unproven technologies. If the original rule had taken effect, CMS would have lost its ability to withdraw coverage for devices later found to be harmful to people on Medicare, unless the FDA reversed its approval for a medical device under its Breakthrough Devices Program.
"In addition, our comments on the final rule noted a number of unaddressed operational issues, including how and when CMS would communicate to health insurance providers information on benefit category and appropriate billing codes," AHIP, an insurance lobbying group, wrote in a letter.
Medical device companies lauded the Trump-era rule when CMS announced it last year, and they're sad to see it go.
"We are disappointed that CMS does not intend to move forward with implementation at this time, as this means that measures to speed access for Medicare beneficiaries to breakthrough innovations that promise improvement in their care will be delayed," the Medical Device Manufacturers Association, a lobbying group, wrote in a letter.
Former President Donald Trump's administration had said the original rule was necessary because the existing Medicare coverage determination process is too slow, could delay beneficiaries' access to the latest medical technology and slow innovation. Under the current system, Medicare Administrative Contractors—16 in total—decide whether to cover a device within their region. Device makers must apply separately to each contractor to get coverage approval.
The Biden administration has hinted it could propose its own rule to cover breakthrough technologies in the future. If it does, insurers want CMS to require medical devicemakers to provide evidence that such products would benefit people on Medicare, according to AHIP.
Devicemakers also want to work with CMS on a new rule to speed Medicare coverage for breakthrough technology approved by the FDA.
"Creating an expedited coverage pathway for important and innovative new medical technologies will expand treatment choices for beneficiaries and physicians, support the collection of additional clinical evidence that can further improve care, and foster investment in the next generation of life-saving and life-improving innovations," MDMA wrote. "CMS should set a goal of completing the new rulemaking and implementing the coverage pathway no later than June 30, 2022."
