Centers for Medicare and Medicaid Services (CMS) Archives

CMS proposes new TCET pathway for Medicare coverage of breakthrough devices

The Centers for Medicare & Medicaid Services (CMS) is proposing the new Transitional Coverage for Emerging Technologies (TCET) pathway for breakthrough devices to secure Medicare coverage.

The voluntary program would expedite Medicare coverage for new medtech innovations, offering an estimated three to five years of transitional coverage. CMS repealed a similar program, Medicare Coverage of Innovative Technology (MCIT), in 2021, citing concerns that it may have covered devices without adequate evidence.

The new TCET proposal “supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population,” CMS said in a statement.

CMS will be taking public comment on the notice for 60 days after publication. The notice is scheduled for publication on June 27, 2023.

CMS is currently seeking public comment on new guidance on evidence…

CMS aborts launch of MCIT payment program for breakthrough devices

CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs.

CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar on Wednesday — three months before the rule was set to take effect on Dec. 15 — saying the rule “is not in the best interest of Medicare beneficiaries.”

CMS created the MCIT pathway in the last days of the Trump Administration, and it was among a host of regulations the Biden Administration immediately put on hold for further consideration.

“While the rule tried to address stakeholder concerns about accelerating coverage of new devices, significant concerns persist about the availability of clinical evidence on Breakthrough Devices when used in the Medicare population as well as the benefit or risks of these devices with respect to use in the Medicare population…

Senate confirms new CMS leader

The U.S. Senate today confirmed President Joe Biden’s selection to lead CMS, Chiquita Brooks-Lasure, with a 55-44 vote in favor.

Brooks-Lasure will be the first Black woman to hold the position, according to Senate Majority Leader Chuck Schumer (D-N.Y.) on Twitter. She previously served in the U.S. Dept. of Health and Human Services during the Obama administration, during which time she helped to implement the Affordable Care Act, which she will now oversee as the Biden administration seeks to expand it.

Get the full story at our sister site, MassDevice.