Nursing home residents would have more access to new and breakthrough technology as treatment options under a new Medicare coverage pathway proposed by the federal health officials.
The Medicare Coverage of Innovative Technology (MCIT) proposed rule was unveiled Monday by the Centers for Medicare & Medicaid Services, and is aimed at giving beneficiaries access to the latest medical technology sooner.
Under the new rule, Medicare will cover breakthrough devices immediately after it receives market authorization from the Food and Drug Administration — eliminating the current lag time between FDA approval and the existing Medicare coverage determination process. That coverage would last for four years.
CMS Administration Seema Verma described the current coverage process as a “chicken and egg issue.”
“Innovators had to prove their technologies were appropriate for seniors, but that was almost impossible since the technology was not yet covered by Medicare and thus widely used enough to demonstrate their suitability for Medicare beneficiaries,” Verma said in a prepared statement.
“These efforts will ensure seniors get access to the latest technologies while lowering costs for innovators. Arcane bureaucratic requirements have no business preventing seniors’ access to a technology that might save their lives,” she added.
The agency explained the proposal would also cover eligible breakthrough devices approved for use by the FDA in 2019 or 2020. Coverage won’t exceed four years from the date of market authorizations, and claims would not be retroactively payable prior to the effective date of the proposed rule.
CMS added that the proposal would clarify the standard it uses to determine whether Medicare should cover a product.
“Under the Medicare law, the program can only pay for items or services that are “reasonable and necessary” for the Medicare population. If finalized, the MCIT proposal would clarify CMS’ definition of reasonable and necessary in regulation to give innovators a clearer understanding of CMS standards,” the agency wrote.
The public comment period for the proposed rule will be open until Nov. 2, 2020.
