CMS Expedites Breakthrough Device Access; Industry Applauds

On January 12, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that propels innovative technology so Medicare beneficiaries have access to the latest, most advanced devices.
 
This action represents a step forward that will help smooth the Medicare coverage pathway for innovative products, resulting in faster access to new devices for America’s seniors.
 
“Government processes have slowed beneficiaries’ access to innovative treatments. Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable, immediate access to innovative breakthrough devices,” said CMS Administrator Seema Verma. “In an ever-evolving health care marketplace, CMS remains committed to transforming the health care delivery system through initiatives like MCIT that focus on results, removing government barriers to advancing innovations, fostering competition, and ensuring quicker access to the most advanced therapies for Medicare beneficiaries while providing them with better value and outcomes.”
 
Eliminating Lag Time for Seniors and Innovators
The Medicare Coverage of Innovative Technology (MCIT) (CMS-3372-F) final rule will provide the nation’s more than 60 million Medicare beneficiaries access to the latest medical technology faster than ever. Under current rules, FDA approval of a device is followed by an often lengthy and costly process for Medicare coverage. This causes undue burden for innovators and could delay access to these potentially lifesaving technologies during the existing Medicare coverage determination process.
 
The MCIT rule will eliminate this lag time for both seniors and innovators. It will create a new, accelerated Medicare coverage pathway for innovative products that the FDA deems “breakthrough,” which FDA approves on an expedited basis and could include devices harnessing new technologies like implants or gene-based tests to diagnose or treat life-threatening or irreversibly debilitating diseases or conditions like cancer and heart disease.
 
Under the MCIT rule, Medicare can provide national coverage simultaneously with FDA approval, up to a period of four years. After the coverage period is over, CMS will reevaluate the device based on clinical and real-world evidence of improvement in health outcomes among Medicare beneficiaries to determine more permanent coverage. This four-year timeline may 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.
 
Importantly, because the MCIT rule will provide national Medicare coverage for four years, it will harmonize with the local coverage determination (LCD) process, thus promoting equal access for seniors regardless of where they live.
 
Simplifying the Process
Additionally, to secure an LCD, innovators are required to seek separate decisions from each of the MACs. MCIT makes this step for innovators unnecessary, which helps innovators and beneficiaries alike. Under MCIT, breakthrough devices are given national coverage for four years, as early as the date of FDA approval, meaning innovators no longer have to seek LCDs from each MAC. Innovators will have the option to choose when they would like coverage to begin. This will give innovators flexibility to align the coverage process with their manufacturing and distribution cycles.
 
After the final rule takes effect, upon manufacturer request, Medicare may cover through MCIT eligible breakthrough devices the FDA has approved, including breakthrough devices that received FDA marketing authorization approval within two calendar years prior to the final rule’s effective date, giving Medicare beneficiaries access to these innovative and potentially life-saving devices.
 
In addition, the MCIT final rule will clarify the standard CMS uses to determine whether Medicare should cover items and services, like devices and surgical procedures. Under the Medicare law, with relatively few exceptions, the program can only cover items or services that are “reasonable and necessary” for the diagnosis or treatment of illness or injury or improve the functioning of a malformed body member. This final rule will codify CMS’s definition of reasonable and necessary in regulation to give innovators a clearer understanding of CMS standards. 
 
Reactions from Industry
The Medical Device Manufacturers Association’s (MDMA) president and CEO Mark Leahey issued the following statement applauding CMS’ final rule:
 
“CMS’ final rule to accelerate coverage for breakthrough technologies will allow our nation’s seniors to benefit from innovative solutions to their health care needs. MDMA continues to advocate for updated coverage policies that would allow innovative therapies and technologies to get into the hands of patients and physicians in an expedited manner, and the MCIT final rule is a major step towards achieving this goal. We remain focused on working with all stakeholders to continue improving the reimbursement landscape so that patients throughout the United States get timely access to medical technology innovation.”
 
AdvaMed president and CEO Scott Whitaker also commended CMS on the rule:
 
“Today’s announcement by CMS Administrator Verma will help ensure Medicare beneficiaries will benefit from breakthrough technologies. On behalf of our industry and the potentially millions of seniors who stand to benefit from these lifechanging innovations, we applaud the Adminstrator’s leadership and thank her and her team for taking this important step forward.
 
“Under the new MCIT rule, as soon as the FDA approves a new breakthrough technology, Medicare can cover that breakthrough technology. It’s that simple—and it should be that simple. It means that when a device or diagnostic test that is designated as a breakthrough and determined by the FDA to be safe and effective, Medicare patients can be the first in line to get it when their doctors determine it is necessary.  
 
“It’s good government, and it’s good common sense to recognize that if doctors and scientists at the FDA—the global gold standard for medical technology regulation—determine a device is safe and effective, another federal agency can then move quickly to ensure patients can access that lifechanging and often lifesaving technology. We urge the incoming administration to keep this important step forward for our seniors in place, and we look forward to working closely with them on its implementation.”