“Breakthrough” medical technologies treat life-threatening or irreversibly debilitating conditions for which there are no treatments or for which existing treatments are lacking. In other words, breakthrough technologies are a beacon of hope for seniors suffering from terrible, often untreatable conditions.
The Biden Administration is considering rescinding a rule, entitled Medicare Coverage of Innovation Technology (MCIT) that has received bipartisan support in Congress. Under this rule, if the FDA approves a breakthrough technology, Medicare can quickly cover it, assuring immediate national coverage of devices for seniors in need of lifesaving treatments.
MCIT ensures the safety and efficacy of breakthrough technologies. After receiving breakthrough designation, these technologies must still undergo the rigorous FDA review process – the global gold standard for medical safety and effectiveness – to achieve approval. Medicare coverage of breakthrough technologies under MCIT is temporary, allowing for the ongoing collection of data to better understand the impact of these technologies.
“This crucial change to federal law will leave the decision about whether a breakthrough medical technology is right for your grandfather precisely where it belongs: between your grandfather and his doctor.”––Scott Whitaker, AdvaMed CEO, in Morning Consult
- Improves Access
Seniors are the most vulnerable group of patients in the country. These patients traditionally suffer from diminished access to advanced technologies to treat their conditions. MCIT would ensure these vulnerable patients have access to the breakthrough technologies they need.
- Provides Hope
When a device or diagnostic test that is designated as a breakthrough technology and approved by the FDA as safe and effective, Medicare patients can be the first in line to get it. Medicare beneficiaries deserve access to truly breakthrough technologies, as soon as possible. Once approved under MCIT, doctors will have the option to provide these technologies, or order these diagnostic tests, when necessary, for patients who can benefit from them.
- Ensures Safety
Once breakthrough medical technologies have received a breakthrough designation, they still must undergo the rigorous FDA review process – the global gold standard for medical device safety and effectiveness – to achieve approval or clearance. Medicare coverage of a breakthrough device under MCIT is temporary, allowing for the ongoing collection of real-world data and evidence to understand better the true impact of lifechanging medical technologies on Medicare patients.
The impact on Medicare spending would be minimal relative to CMS’s budget. The new technology may mitigate ongoing chronic health issues and reduce some costs for Medicare while increasing quality of life and health outcomes.
Did you know?
More than 400 medical devices have received the FDA “breakthrough” designation.
- Since the breakthrough designation was established through the 21st Century Cures Act in 2016, more than 400 devices have received the FDA’s breakthrough designation. Only 26 of those devices would qualify for Medicare coverage under MCIT. However, currently, only 23 of those devices have been approved by the FDA.
MCIT would not be cost prohibitive
- Some budget projections find that MCIT will result in no additional cost. Even the top end of CMS’s budget estimate places MCIT’s cost at just over $2 billion by 2024 – less than 0.3% of Medicare’s $722 billion budget in FY2021.
- CMS also notes that MCIT could even save money by lowering healthcare costs for Medicare beneficiaries who would have access to life-saving medical devices, sparing them from expensive ongoing treatments and further complications caused by their conditions.
- Medicare’s mission is to meet the needs of the population it represents; MCIT does that by providing life-changing medical innovations at a minimal cost.
FDA-designated breakthrough devices have been sufficiently tested
- All treatments eligible for MCIT must be first deemed safe and effective by the FDA. The FDA is considered the global gold standard for medical device safety.
- Breakthrough technologies treat life-threatening or irreversibly debilitating conditions for which there are no current treatments or for which existing treatments are lacking. Medicare coverage of these treatments represents the last hope for many seniors to live with and manage chronic medical conditions.
- Medicare coverage under MCIT is temporary, lasting four years. During that time, Medicare would be able to collect evidence and real-world data about the true impact of these life-changing technologies on Medicare patients.
MCIT will ensure that medical treatments covered by Medicare will treat conditions in a cost-effective manner
- All breakthrough treatments eligible for coverage under MCIT have already been approved and deemed safe and effective by the FDA, the global gold standard of safety and effectiveness.
- MCIT acknowledges that it’s time to let patients and their doctors decide what’s best for them and their health.
MCIT has received bipartisan support in Congress and has been a priority of AdvaMed’s and the medical device industry for years
- In February, Democrats called on CMS to allow MCIT to take effect as scheduled.
- The FDA’s breakthrough program was created by the 21st Century Cures Act, signed into law by President Barack Obama. This program allows manufacturers to collaborate closely with the FDA to efficiently move life-saving technologies through the approval process. Once those technologies are approved, they should be available to seniors.
- Better care for seniors and greater access to lifesaving medical technology should be a bipartisan goal.
What the Experts Say
- Alliance for Aging Research
The Alliance supports “the proposal to align Medicare coverage for breakthrough medical devices with FDA market approval for a period up to four years.” It believes this change would “improve access to innovative devices for which there are no equivalent therapies, or for which outcomes are superior in clinical trials.” Read more
- American Geriatrics Society (AGS)
The AGS applauds CMS’ engagement to expand “Medicare coverage for faster access to innovative medical devices designated as breakthrough by the FDA.” Read more
- Heart Valve Voice
Heart valve voice endorses MCIT because “patients deserve the certainty of having access to the most innovative medical technology without concerns over coverage and reimbursement. It believes that “MCIT could potentially accelerate access for patients to new technologies that could increase quality of life as well as overall health outcomes.” Read more
- Medicare Rights Center
Medicare Rights supports “increasing the access people with Medicare have to innovative health services and devices,” and urges CMS “to continue to monitor and oversee research into such devices and to remove such coverage if the devices are found to cause harm or have little to no utility.” Read more
- Morning Consult: CMS Policy Update Breathes New Life into Care Options for Medicare Beneficiaries
- VC Policy Pulse: Medical Device Coverage Reform with Vensana’s Justin Klein & Kirk Nielsen
- Duluth News Tribune: Statewide View: Policy would benefit Minnesota’s seniors, medical-device community