The American College of Radiology is voicing concerns about the Centers for Medicare & Medicaid Services’ proposed approach to expediting payment for emerging technologies.
Federal officials first released the proposal in June, hoping to grant seniors “more timely and predictable” access to innovative new treatment and diagnosis methods. This new “Transitional Coverage for Emerging Technologies,” or TCET, pathway for breakthrough devices 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 at the time.
ACR this week detailed its apprehension about the scope and utility of the program as proposed while agreeing that a fresh approach is needed.
“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,” CEO William T. Thorwarth Jr., MD, wrote in a Aug. 28 letter to the CMS administrator. “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.”
CMS has said that its goal is to finalize a Transitional Coverage for Emerging Technologies determination within six months after FDA market authorization, the college noted. And it intends to have that coverage continue as long as it is needed to facilitate the timely generation of evidence to inform patient and provider decision-making around new devices.
Thorwarth listed several potential remedies to address the college’s concerns. Those include evaluating CMS’ current national coverage determination pathway to ensure it is granting efficient market access for advanced imaging solutions, radiopharmaceuticals, contrast agents and focused ultrasound therapies. ACR also encouraged the agency to issue earlier guidance on how to coordinate coding and payment applications to secure Medicare reimbursement for such technologies. In coordination with the Food and Drug Administration, ACR is asking officials to maintain an up-to-date list of all breakthrough devices CMS is considering for the TCET program. And the college is advocating that CMS add more staff while assessing other resource constraints to help streamline this new process.
“ACR appreciates CMS’ recognition that medical specialty societies ‘have valuable expertise and first-hand experience’ in the field that will help CMS develop Medicare coverage policies,'” Thorwarth wrote. “We will continue to monitor the opening of a TCET [national coverage determination] analysis and offer guidance where possible. We urge CMS to communicate with specialty societies regarding relevant opportunities to provide feedback and encourage CMS to be flexible regarding the time it takes specialty societies to collect evidence and determine consensus perspectives as they pertain to coverage decisions.”
The Medical Imaging and Technology Alliance, which represents device manufacturers, issued its own comments on the proposal on Aug. 28. In a news update issued Wednesday, ACR said it looks forward to seeing the final procedural notice and CMS’ implementation plans.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.