House lawmakers ask CMS to temporarily cover “breakthrough” devices


On Tuesday, a bipartisan group of lawmakers urged Chiquita Brooks-LaSure, the administrator of the Medicare and Medicaid Services Center, to “quickly” propose policies to replace Trump-era Medicare’s underwriting policies for “breakthrough” devices. The agency was abolished this month.

Lawmakers said that at the same time, CMS should provide “immediate or near-immediate” temporary coverage for breakthrough devices.

Brett Guthrie (R-Ky.), Anna Eshoo (D-Calif.), Devin Nunes (R-Calif.) and Suzan DelBene (D-Wash.) and signed by more than 60 representatives.

Lawmakers argued that the rule not only makes it easier for seniors to obtain new devices approved by the Food and Drug Administration, but it also makes it easier for small medical device manufacturers to navigate the patchwork of local coverage decisions and the time-consuming process of medical insurance. Manage contractors to cover their equipment.

“Permanent withdrawal of MCIT rules may delay future innovative medical equipment and diagnostic tools,” the letter reads. “The MCIT rules can further encourage early investors to intervene to meet our most critical healthcare challenges and successfully provide patients with life-changing treatments.”

The now repealed medical insurance rules were finalized at the end of the Trump administration, allowing medical insurance to cover devices designated as “breakthrough technology” by the FDA for up to four years. The FDA’s breakthrough device program is Established as part of the 21st Century Cures Act, Prioritize the development of innovative equipment for certain life-threatening or debilitating diseases.

Medicare beneficiaries can currently obtain coverage for such equipment through other methods, such as national coverage determination, but the MCIT rules will create an accelerated path.

The Biden administration’s CMS issued the final rule to abolish the MCIT rule on November 12 — after several delays in implementing the rule — on the grounds that the policy would lead to equipment coverage without sufficient evidence. CMS stated in its November 12 rule that before FDA market authorization, medical insurance beneficiaries do not need to be included in clinical research.

CMS said at the time that it plans to continue to consider improving access to breakthrough technologies, perhaps through existing approaches or future rulemaking.

“[W]I want to assure stakeholders that CMS does not intend to maintain the status quo,” CMS wrote in its November 12 rule. “We remain committed to the goal of establishing an alternative rapid coverage approach to better achieve timely and predictable The coverage of medical insurance target equipment, while ensuring that Medicare covers projects and services based on scientific and reasonable clinical evidence and appropriate protective measures. “



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