ARTICLE SUMMARY:
In August, CMS issued the final notice launching the Transitional Coverage for Emerging Technologies pathway, marking the start of this long-awaited new reimbursement program. This launch carries with it as many questions as answers. At MDIC’s Annual Public Forum, Steven Farmer, a key official at CMS in getting TCET off the ground, addressed at least some of industry’s concerns.
Few regulatory or reimbursement programs have traveled the winding path that the Transitional Coverage for Emerging Technologies (TCET) has followed in various incarnations before CMS launched the program with the final notice issued in August. The process for developing a streamlined path to Medicare coverage for innovative devices has been a long one. Declared dead on more than one occasion, TCET originated back in the Obama administration before languishing on the back burner until being revived in the Trump administration under the MCIT (Medicare Coverage of Innovative Technology) label, only to be repealed not long into the Biden administration to reemerge in its current form.
The long-anticipated final version largely resembles the draft that CMS released in June 2023, which while appreciated by industry as a good first step, prompted a flurry of concerns, many of which were spelled out in the numerous public comments the agency received. At the recent Medical Device Innovation Consortium (MDIC) Annual Public Forum (APF) in Washington, DC, Steven Farmer, MD, PhD, chief strategy officer of CMS’ Coverage and Analysis Group (CAG) and a driving force behind TCET, was interviewed by Lindsay Bockstedt, PhD, Medtronic’s VP of health economics, policy, and reimbursement, and a member of MDIC’s health economics/patient value working group, to address some of industry’s concerns about TCET and explain how the pathway is being rolled out.
