The Centers for Medicare and Medicaid Services issued a final rule Tuesday aimed to support innovative technology so that Medicare beneficiaries have access to newer and advanced devices, called Medicare Coverage of Innovative Technology (MCIT).
The hope is that this will help ease Medicare’s coverage path for innovative products, resulting in faster access to new devices for the elderly. The action is part of CMS’s Freeing Innovation and Patients Against Paperwork initiative.
Under current rules, approval of a device by the FDA is followed by an often lengthy and expensive process for Medicare coverage. The mismatch between the two causes innovators to spend time and resources first on FDA approval, and then on the Medicare coverage process. This, CMS said, places an undue burden on innovators and could delay access to potentially life-saving technologies during the process of determining existing Medicare coverage.
The MCIT rule is designed to eliminate this delay for the elderly and innovators, by creating a new path to accelerated Medicare coverage for innovative products that the FDA considers a “breakthrough,” which the FDA approves on a fast-track basis. This could include devices exploiting new technologies, such as implants or genetic tests to diagnose or treat life-threatening or irreversibly debilitating diseases or conditions such as cancer and heart disease.
WHAT IS THE IMPACT ?
Under the MCIT rule, Medicare can provide national coverage concurrently with FDA approval, for up to four years. Once the coverage period ends, CMS will reassess the device based on clinical and actual evidence of improved health outcomes among Medicare beneficiaries to determine more permanent coverage.
This four-year timeline may prompt the manufacturers of these devices to develop additional evidence regarding the applicability of their products to the Medicare population, so that they can continue Medicare coverage beyond the first four years.
Since the MCIT rule will provide national Medicare coverage for four years, it will align with the Local Coverage Determination (LCD) process, in the hope that it will promote equal access for people. the elderly, regardless of their place of residence.
Currently, as part of the local coverage process, 16 Medicare Administrative Contractors (MACs) make Medicare coverage decisions at the local level – 12 for Medicare parts A and B and four for durable medical equipment. MACs may cover items or services on a case-by-case basis or via an LCD screen, which only applies to the jurisdiction of that MAC. In the absence of a national Medicare coverage decision for an innovative technology, the technology could be covered in one region of the country but not in another.
To secure an LCD screen, innovators are required to request separate decisions from each of the MACs. MCIT makes this step unnecessary for innovators. Under MCIT, breakthrough devices enjoy nationwide coverage for four years from the date of FDA approval, meaning innovators no longer have to search for LCDs at every MAC. Innovators will have the flexibility to choose when they want coverage to begin, with the intention that this will give them the flexibility to align the coverage process with their manufacturing and distribution cycles.
After the final rule comes into effect, at the request of the manufacturer, Medicare may cover, through the MCIT, eligible breakthrough devices approved by the FDA, including breakthrough devices that have received marketing authorization. the FDA market within two calendar years of the final rule’s effective date, providing Medicare beneficiaries with better access to devices.
The rule will also clarify standard uses of the CMS in determining whether Medicare should cover items and services, such as appliances and surgeries. Under Medicare, with few exceptions, the program can only cover items or services “reasonable and necessary” for the diagnosis or treatment of illness or injury or to improve functioning. of a malformed body member. The final rule will codify CMS’s definition of reasonable and necessary in regulation to give innovators a clearer understanding of CMS standards.
Based on public feedback, the final rule included a more flexible start date for MCIT coverage. Manufacturers can choose the start date of coverage to better align with market availability. In addition, as requested by stakeholders, CMS will collect more information on the use of commercial insurers’ coverage policies and use them in specific circumstances.
THE BIGGEST TREND
The MCIT pathway is only available for revolutionary devices designated by the FDA (which include certain diagnostic tests) which have subsequently been released into the market. Device manufacturers must apply to the FDA for breakthrough status, and then the FDA reviews the application to determine if the device meets the breakthrough criteria. Not all devices receive the breakthrough designation.
Revolutionary devices must match a statutory Medicare benefit category to be covered. There are revolutionary devices that do not have a Medicare benefit category (for example, some portable health devices that are directly purchased by consumers), so not all revolutionary devices may be covered by Medicare due to this legal requirement. And if CMS has issued an NCD on a particular revolutionary device, that revolutionary device is not eligible for MCIT.
ON THE RECORD
“Government processes have slowed down beneficiaries’ access to innovative treatments,” said Seema Verma, CMS administrator. “Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable and immediate access to breakthrough innovative devices. In an ever-changing healthcare market, CMS remains committed to transforming the healthcare delivery system through initiatives like MCIT that focus on results, removing government barriers to advancing innovations, promoting competition and ensuring faster access to the most advanced therapies for Medicare beneficiaries while providing them with better value and better outcomes. “