Join Now

Utah Life Sciences News & Events

CMS Again Delays Program to Expedite Coverage of Innovative Technologies

May 20, 2021

The Centers for Medicare & Medicaid Services (CMS) has once again delayed the January 14, 2021 final rule to establish the Medicare Coverage of Innovative Technology (MCIT) program. In a rule published in the federal register May 18, CMS further delays the effective date of the program to December 15, 2021.

In issuing the rule, CMS highlighted certain areas of interest and concern based on public comment solicited March 15-April 15. At the time, BioUtah submitted comments urging that the MCIT program be implemented without additional delay. 

The MCIT program, finalized just prior to President Biden taking office, would provide immediate national Medicare coverage for up to four years for FDA-cleared or -approved “breakthrough” devices and diagnostics. 

“BioUtah is disappointed in this further delay,” said Kelvyn Cullimore, president and CEO of BIoUtah. “A number of Utah life sciences companies have received FDA breakthrough designation for their innovative medical technologies. Timely implementation of the MCIT pathway is important to ensuring that their novel products can benefit patients. We look forward to working with the agency and Congress to establish a meaningful streamlined coverage pathway.”

At the end of the MCIT coverage period, the breakthrough device or diagnostic would be subject to traditional Medicare coverage policy (national or local coverage determinations or claim-by-claim adjudication by the Medicare Administrative Contractors (MACs)). It also codified a change in the Medicare definition of “reasonable and necessary”.

Under the January final rule, the program was set to take effect March 15. However, before the program could take effect, the Biden Administration pulled the rule for further public comment and postponed implementation until May 15. Now, according to this most recent rule, the MCIT program will be delayed once again until December 15.

Although the new rule simply delays the MCIT program in the form it was issued in January, CMS expresses concerns about MCIT as currently constructed. This suggests that additional rule making, on or before December 15, may be forthcoming to revise how the MCIT program will work.

Certain aspects of the MCIT pathway are poised for closer examination, including new evidence requirements specific to the Medicare population; additional coverage criteria beyond the FDA; a process for appropriate coding and payment and; closer scrutiny on cost implications.