The American College of Radiology is urging the federal government to operate with more transparency in its efforts to accelerate Medicare coverage for “breakthrough” devices in imaging and other fields.
It was in September that the Centers for Medicare and Medicaid Services first announced its proposal to close the so-called “valley of death” between FDA approval and payment authorization. The goal is to eliminate any “arcane, bureaucratic requirements” preventing America’s seniors from accessing new technologies that might save their lives, CMS Administrator Seema Verma said at the time.
In public comments submitted Nov. 2, ACR noted that there are currently upward of 300 products in the pipeline for approval. And yet, the Food and Drug Administration offers little information on these breakthrough devices, until they have navigated the program and received market authorization, wrote CEO William Thorwarth Jr., MD.
“The ACR believes greater transparency and an opportunity for public feedback on [Medicare Coverage of Innovative Technology] coverage decisions would help ensure programmatic integrity,” he wrote to Verma last week. “We therefore encourage CMS to provide public notice and an opportunity for public comment prior to accepting a device under the MCIT pathway.”
Thorwarth and the college additionally want CMS and the FDA to maintain an up-to-date list of all devices seeking approval under the breakthrough device and MCIT programs. And he’s advocating for requirements which stipulate that imaging manufacturers submit clinical data during the coverage cycle, according to the letter. Under the proposed rule, CMS would grant instant payment that would last through a four-year period, when the agency would than reevaluate situation based on clinical outcomes.
“A phased-in approach with data submission beginning in year 2 will help the agency identify adverse events, utilization among Medicare beneficiaries, and improvements in healthcare outcomes,” Thorwarth advised. “We implore CMS not to use the existing guidance on coverage with evidence development, and to allow manufacturers to determine the best approach to share outcomes data. A formal clinical study is not feasible in the limited time allotted,” he added.
You can read the rest of the letter here, and an ACR summary here. The Medical Imaging & Technology Alliance and Focused Ultrasound Foundation also submitted comments Nov. 2. In a summary, the groups expressed support for the MCIT proposed rule, while recommending changes, including expanding the inclusion criteria.