USA – TCET pathway may broaden access to breakthrough devices, but reforms still needed

While the Transitional Coverage for Emerging Technologies (TCET) pathway proposed by the Centers for Medicare and Medicaid Services (CMS) offers the potential to speed access to breakthrough medical devices, it also highlights the pitfalls of implementing coverage reform through rulemaking, according to a recent perspective published in The New England Journal of Medicine.

“[M]ost novel devices lack any form of Medicare coverage 5 years after authorization, with local determinations relying on inconsistent standards and national determinations being significantly delayed,” Kushal T. Kadakia, of Harvard Medical School in Boston, and colleagues wrote. “Although rigorous assessment of health technologies is necessary to ensure appropriate use, the current system does not meet the goals of patients or policymakers, and many stakeholders have therefore called for reforms.”…