America's Health Insurance Plans, a health insurance lobby, submitted comments on a CMS proposal that would bring faster Medicare coverage for medical devices, according to a Nov. 2 press release.
The proposed rule would establish a coverage pathway for FDA-approved breakthrough devices, the release said.
In its comments, AHIP expressed concern about safety, saying newly approved FDA devices should still go under further evaluation by a medical policy committee. The lobby also suggested CMS streamline reviews of breakthrough devices to ensure safety and effectiveness.
"Should CMS decide to proceed with the proposal, it is essential that the new pathway include a process for stakeholders to evaluate the medical device for safety, efficacy and value before a Medicare coverage determination is made, as well as a process to enable ongoing evaluations of data during the MCIT coverage period, to protect the Medicare population," the comments said. "We further recommend that CMS make clear that the significant cost policy would apply to devices covered under this pathway."
AHIP commented on another aspect of the rule that would modify Medicare's definition of "reasonable and necessary," the release said. The lobby raised concerns of potential unintended consequences.
Read the press release here and access comments here.