CMS agrees to cover 'breakthrough' medical devices

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning.

Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date of a breakthrough device’s FDA market authorization would begin and continue for 4 years.

The proposed rule, scheduled to be published September 1 in the Federal Register, has been under discussion for years and would remedy a nationwide patchwork of Medicare coverage for such devices. Currently, a breakthrough device may be covered in one state or area of a state and not another, depending upon a local coverage determination made by a Medicare administrative contractor.

The MCIT pathway would be voluntary and device manufacturers would notify the Centers for Medicare and Medicaid Services if they want to use this coverage option.

“This coverage pathway delivers on the Administration’s commitment to give Medicare beneficiaries access to the newest innovations on the market, consistent with the statutory definitions of Medicare benefits,” U.S. Department of Health and Human Services administrator Alex Azar said in the proposed rule.

Medtech trade group AdvaMed hailed the publication of the proposed rule as a big step in a long struggle by the industry.

“In order to incentivize innovative medical breakthroughs, the federal government must ensure those breakthrough technologies are covered by Medicare,” said AdvaMed President and CEO Scott Whitaker in an email to MassDevice. “We are pleased that this proposed rule gets us closer to this goal, as it would help ensure the patients who need these innovative technologies have access to them.”


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