A committee of the U.S. House of Representatives wrapped up business in a late-running June 14 markup of spending bills that would give the U.S. FDA roughly $6.6 billion to work with in fiscal 2024. However, the final bill omits language in the manager’s mark that had called on the FDA to engage in rulemaking or guidance development for lab-developed tests, but the FDA made up for that by adding a proposal to engage in rulemaking for LDTs in its regulatory agenda.
The Medical Device Manufacturers Association (MDMA) has led the policy charge for smaller medical device manufacturers for decades, but each year brings its own unique set of hazards and opportunities. In an interview with BioWorld, MDMA President and CEO Mark Leahey said that while the Medicare policy for coverage of breakthrough devices has gone through some unanticipated twists and turns, that policy is not yet fixed and thus there is still some prospect that such a policy will not devolve into a stew of leftovers drawn from existing coverage mechanisms.
Medicare coverage of breakthrough medical devices is in its fourth iteration under the rubric of Transitional Coverage of Emerging Technologies (TCET) and two managers at the Centers for Medicare & Medicaid Services recently penned an op-ed in a leading medical journal about the TCET program, which generated at least as many questions as answers.
The question of Medicare coverage for breakthrough devices is still in play at CMS, but managers there penned an Oct. 12 editorial that suggests that existing coverage mechanisms may have to suffice. CMS’s Lee Fleisher and Jonathan Blum said in the JAMA Internal Medicine (JAMA: IM) editorial that the agency might respond to the breakthrough device coverage question by applying the coverage with evidence development (CED) mechanism for breakthrough devices, suggesting that the policy might ultimately resemble the coverage mechanisms already available to industry.
