CMS expands coverage pathway for emerging technologies, drawing imaging industry criticism

The Centers for Medicare & Medicaid Services on Aug. 7 issued a final notice, offering details on potential expedited payment for certain medical technologies.

Federal officials first detailed the policy last year, hoping to grant seniors “more timely and predictable” access to innovative new treatment and diagnosis methods. This “Transitional Coverage for Emerging Technologies,” or TCET, pathway would support patient care and innovation by providing a “clear, transparent and consistent coverage process while maintaining robust safeguards for the Medicare population,” CMS said previously.

AdvaMed, which represents imaging device manufacturers, expressed disappointment Aug. 8.

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering,” CEO Scott Whitaker said in a statement. “The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources at CMS. And the exclusion of diagnostics is disappointing, particularly considering the potential for a breakthrough diagnostic technology to save not only lives but costs to the healthcare system overall through earlier detection.”

The American College of Radiology issued a news update about TCET on Aug. 14. It noted that the pathway uses current national coverage determination and other processes to expedite Medicare reimbursement for certain breakthrough devices. ACR has been tracking the process, having previously submitted comments in August 2023. The college continues to review the notice and hopes to provide a detailed summary soon.

Last year, former ACR CEO William T. Thorwarth Jr., MD, criticized details about the program’s scope and utility.

 “We are concerned that TCET will not address certain fundamental coverage, coding and payment issues facing innovative technologies and will not adequately support the volume of new products coming to market,” Thorwarth told CMS in 2023. “Appropriate candidates for the TCET pathway include devices with a Medicare benefit category but do not address the need to reexamine the definition of existing benefit categories to include many innovative devices. Overreliance on this criterion will leave emerging technologies without appropriate Medicare reimbursement under the TCET pathway.”

In its fact sheet, CMS said the new payment pathway will increase the number of coverage determinations conducted each year. CMS will accept up to five TCET candidates annually, with the goal of finalizing national coverage determinations within six months of FDA market authorization.

Lawmakers last year introduced the Ensuring Patient Access to Critical Breakthrough Products Act to increase seniors’ opportunities to use these innovative treatments. The House Ways & Means Committee reported favorably on the bill in June but it has yet to advance further. The legislation would allow designated devices to be covered temporarily by Medicare for four years, ACR noted. CMS also would need to assign payment codes within three months of an FDA approval while also establishing a process for seeking continued coverage after this period.

“While we appreciate that CMS has released the rule, we call on Congress to finish the job by passing H.R. 1691, the Ensuring Access to Critical Breakthrough Products Act. Too many patients in need of breakthrough diagnoses and treatments are counting on it,” AdvaMed’s CEO said in the statement.

Consulting firm McDermott+ offered further analysis of the CMS announcement on Monday. For more, you can read the final procedural notice and a CMS blog on the program.