Insurers want CMS to waive disruptive technology coverage rules

Insurers support the Centers for Medicare & Medicaid’s plan to end the Trump-era rule allowing Medicare to cover medical devices designated by the US Food and Drug Administration as “breakthrough,” according to public comments on the proposed rule.

Payers, patient safety advocates and independent experts have recommended that President Joe Biden’s administration waive the rule, citing concerns about patient safety and questions about the value of automated Medicare coverage for untested technologies. If the original rule were to take effect, CMS would lose the ability to revoke approval for devices that were later found to be harmful to people on Medicare.

“In addition, our comments on the final rule highlighted a number of unresolved operational issues, including how and when the CMS will communicate the benefit category and associated billing codes to health providers,” the AHIP insurance lobbying team wrote in the letter. …

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Medical device companies have praised the Trump-era rule when CMS announced it last year and are sad to see it go away.

“We are disappointed that CMS does not intend to move forward with implementation at this time, as it means that measures to accelerate Medicare recipients’ access to groundbreaking innovations that promise to improve their care will be delayed,” the Medical Device Manufacturers Association said. lobby group written in the letter.

Former President Donald Trump’s administration said the original rule was necessary because the current process for determining Medicare coverage 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 manufacturers must contact each contractor separately to obtain approval for coverage.

The Biden administration has hinted that it may propose its own rule regarding disruptive technologies in the future. If so, insurers want CMS to require medical device manufacturers to provide evidence that such products will benefit people in Medicare, according to the AHIP.

Device manufacturers also want to work with CMS on a new rule to expedite Medicare coverage of FDA-approved advanced technology.

“Creating a fast track to reach important and innovative health technologies will expand treatment choices for beneficiaries and clinicians, support the collection of additional clinical data that can further improve treatment, and foster investment in the next generation of saving and improving lives. Innovation,” wrote MDMA “The CMS should aim to complete the development of the new rules and implement the coverage scheme no later than June 30, 2022.”

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