The Centers for Medicare & Medicaid Services (CMS) are currently working to develop a new rule that could provide Medicare patients faster access to innovative, lifesaving, and life-enhancing medical devices and diagnostics. This CMS initiative is called the Transitional Coverage for Emerging Technologies (TCET) rule. It would modernize Medicare for patients and create an alternative, expedited pathway to provide coverage and payment for emerging devices and diagnostics. Transitional coverage for these technologies would give Medicare patients more healthcare options and would support health innovators here in Colorado and across the U.S.

CBSA urges CMS to adopt this rule. It balances access to innovative technologies with patient protection, while also guaranteeing coverage is flexible, predictable, and evidence based.

Details on the Current Situation

Last year, Centers for Medicare & Medicaid Services (CMS) repealed the Medicare Coverage for Innovative Technology rule (MCIT). Since the repeal, CMS has expressed support for a flexible coverage pathway that improves access to innovative devices. The TCET rule achieves that goal, allowing Medicare patients access to medical devices or device-led combination products after they are approved or cleared by the Food and Drug Administration (FDA).

This is an important opportunity for our industry and CMS to modernize the coverage process, allowing swifter access to innovative, lifesaving technologies and therapies to Medicare beneficiaries. A recent survey led by the Stanford Byers Center for Biodesign identified the current lag time is anywhere from two-and-one-half years to nearly eight years before full patient access to new technologies, due to adoption of applicable coding, coverage, and payment changes. This rule would help speed up this timeline.

CBSA and Partner Engagement

CBSA will work with our national partners at Advanced Medical Technology Association (AdvaMed) and Medical Device Manufacturers Association (MDMA) and will express our support for CMS to issue a proposed rule.  

We encourage CMS to move quickly to help improve the lives of patients by issuing the TCET proposed rule by the end of the year.

CBSA’s outreach has included:

• Partnering with national partners AdvaMed and MDMA on outreach.
• Urging the Colorado Congressional Delegation to also engage with CMS on this important issue.

Learn More

Visit our national partner AdvaMed’s website with more information on TCET.