September 02, 2020
The Centers for Medicare & Medicaid Services (CMS) recently released a newly proposed rule that aims to improve access to care and the latest treatments for older adults.
CMS explained that the announcement of “the Medicare Coverage of Innovative Technology (MCIT) (CMS-3372-P) proposed rule, would provide Medicare beneficiaries access to the latest medical technology faster than ever.”
According to US Department of Health and Human Services (HHS) Secretary Alex Azar, “This new proposal would give Medicare beneficiaries faster access to the latest lifesaving technologies and provide more support for breakthrough innovations by finally delivering Medicare reimbursement at the same time as FDA approval.”
Under the current rule, there is often a lengthy and costly process for Medicare coverage following the FDA approval of a medical device. Because of this, innovators often face a waste of resources, and older adults face prevented access to potentially lifesaving technologies during the existing Medicare coverage determination process.
“The lag time between the two has been called the ‘valley of death’ for innovative products, with innovators spending time and resources on FDA approval, only to be forced to spend additional time and money on the Medicare coverage process.
If approved, the MCIT proposed rule would eliminate the long wait time that both older adults and innovators face. Further, Medicare would provide national coverage simultaneously with FDA approval, for a period of four years.
“This four-year timeline would incentivize the manufacturers of these breakthrough devices to develop additional evidence regarding the applicability of their products to the Medicare population, so they might continue Medicare coverage beyond the initial four years,” CMS explained.
Of important note, CMS said that based on the four-year timeline, it would streamline identical local coverage decisions (LCDs), which promotes equal access for older adults and helping innovators focus on getting their devices to patients and clinicians. CMS also noted that this proposed rule would allow Medicare to cover eligible breakthrough devices that the FDA has approved for use in both 2019 and 2020. This would give Medicare beneficiaries immediate access to these devices.
Finally, under the MCIT proposed rule, clarity would be better defined in order to determine whether a drug, device or biologic should be covered by Medicare.
“For new technologies, CMS coverage approval has been 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 not widely used enough to demonstrate their suitability for Medicare beneficiaries,” said CMS Administrator Seema Verma, MPH.
“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.”
Centers for Medicare & Medicaid Serivces (CMS). CMS Acts to Spur Innovtion for America’s Seniors [press release]. CMS Website. https://www.cms.gov/newsroom/press-releases/cms-acts-spur-innovation-americas-seniors. Published online August 31, 2020. Accessed September 2, 2020.