14. Department of Health and Human Services · Notable

Restore the Medicare Coverage of Innovative Technologies (MCIT) rule

Attempted

Printed page 463 14. Department of Health and Human Services

“The next Administration should reintroduce and restore regulations and demonstrations from the Trump Administration that were withdrawn, weakened, or never finalized by the Biden Administration, including: … The Medicare Coverage of Innovative Technologies (MCIT) rule;”

What has happened

Aug 11, 2026 Attempted
CMS published the RAPID coverage pathway as a notice with comment period, saying in terms that it "reflects feedback that CMS sought after the November 15, 2021 repeal of the January 2021 Medicare Coverage of Innovative Technology (MCIT) final rule" and the 2024 Transitional Coverage for Emerging Technologies pathway. The comment period was still open on 2026-08-28 and the pathway leverages existing coverage processes rather than restoring MCIT's automatic four-year national coverage, so nothing has changed yet.
- CMS notice with comment period: Medicare Program; Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway
  Primary Executive branch Aug 11, 2026
Apr 23, 2026 Attempted
CMS and FDA announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new route to expedited national Medicare coverage for FDA-designated Class II and Class III Breakthrough Devices. It is a replacement for, not a restoration of, the January 2021 MCIT rule, which was repealed on 2021-11-15 and has not been reinstated.
- CMS press release: CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices
  Primary Executive branch Apr 23, 2026

Research log

What was searched, and what didn’t count as evidence

Research notes

The notice’s operative text was read at https://www.govinfo.gov/content/pkg/FR-2026-08-11/html/2026-16368.htm.
The FY2027 IPPS final rule of 2026-08-04 discusses RAPID and moves against the Breakthrough Device alternative pathway for new technology add-on payments; that is payment, not coverage, so it is context rather than Evidence here.
If CMS finalizes RAPID this becomes partial: the ask names the MCIT rule, and a different pathway that delivers only part of what MCIT did is “the ask achieved by a different instrument”.

Action: reinstate
Object: Medicare Coverage of Innovative Technologies (MCIT) rule
ID: 1254