Press Releases

ICYMI: Medical Experts, Lawmakers, and Innovation Funders Urge Administration to Grant Medicare Beneficiaries Expanded Coverage of FDA-Designated “Breakthrough” Technologies Through MCIT Rule

Thought leaders across the country are urging the Administration to enact the Medicare Coverage of Innovative Technology (MCIT) rule that was set to go into effect March 15 before it was put on hold. The MCIT rule would allow Medicare beneficiaries suffering from chronic conditions access to “breakthrough” medical technologies that have been approved by FDA as safe and effective. The following leaders have expressed support for MCIT in recent editorials, commentary, and interviews:

Dr. Anand Shah, an oncologist and former deputy commissioner of the FDA and Chief Medical Officer of the Center for Medicare & Medicaid Innovation and coauthor of the MCIT rule, explains how it would improve the lives of Medicare beneficiaries suffering from chronic conditions in CNBC:

“The proposed policy would be a crucial step forward for Medicare beneficiaries to make informed choices about their care. … There is no downside to approving this policy change. Seniors will have more treatment options available to them, and medical technology innovators can work with CMS to carefully study these patients over four years, generate meaningful real-world evidence to prove a new device is ‘reasonable and necessary’ and potentially secure a more permanent Medicare coverage decision.”

Minnesota State Senators Karin Housley (R-Stillwater) and Karla Bingham (DFL-Cottage Grove) underscore the importance of not rescinding MCIT in MinnPost:

“There’s a reason MCIT has earned support from both sides of the aisle in Congress, and here in Minnesota. It’s good government, good policy, and good common sense. Minnesota is the backbone of America’s medical device industry. Our innovations save lives. We should put them in the hands of the people who need them by advancing, strengthening and finalizing the MCIT – as quickly as possible.”

Erik Paulsen, former U.S. Congressman from Minnesota and former member of the House Committee on Ways and Means Subcommittee on Health, highlights how MCIT would not only help improve the lives of seniors suffering from chronic conditions, but would also help ensure the medical technology industry can continue to innovate and develop breakthrough solutions in the Duluth News Tribune:

“Approving and adopting the MCIT would make a life-changing difference for millions of seniors whose symptoms and conditions could be better managed if Medicare covers important new treatments and diagnostics right away. … The MCIT isn’t just essential for seniors, it’s an important tool that allows Minnesota’s medical industry to continue its role as the catalyst of medical innovation.”

The National Venture Capital Association (NVCA) interviewed Justin Klein and Kirk Nelson from Vensana Capital, a firm dedicated to transforming healthcare through medtech innovation. In the interview, Klein and Nelson explained how MCIT would help boost investment in medtech innovation and expand patient access in NVCA’s blog:

“As a society, we need those breakthrough products that have the potential to dramatically improve our healthcare system, like percutaneous heart valves that turn an open-heart surgery into a minimally invasive procedure, platforms that can diagnose multiple cancer types through a single blood-draw, or therapies that change the way that major chronic diseases are treated. MCIT would be a major step toward making those transformative projects more readily fundable again, particularly at the seed and early stages.”

Brent Vaughan, CEO of Cognito Therapeutics, a clinical-stage company that develops disease-modifying therapeutics for neurodegenerative diseases, urges CMS to implement MCIT to improve disparities in medical treatment in the Medical Device and Diagnostic Industry’s online Regulatory & Quality page:

“MCIT addresses this challenge and increases access to care for Medicare patients by enabling reimbursement on day one of FDA authorization, which removes policy-based barriers between physicians and patients, allowing for improved access, uptake and utilization to be determined by clinical appropriateness and clinical need.”

Glenn G. Lammi, Vice President of Legal Studies at the Washington Legal Foundation explained how implementing MCIT would give Medicare beneficiaries the opportunity to improve their chronic conditions and would remove barriers to receiving medical care in Forbes

“Medicare patients with debilitating conditions, such as heart failure, diabetes, and kidney disease who may not have viable alternative treatment options, should be given the opportunity to choose a breakthrough device in consultation with their doctor.”

Mike Guerra, President and CEO of the California Life Sciences Association (CLSA), the largest advocacy organization representing California biotechnology, pharmaceutical, medical device and diagnostics companies, research universities and institutes, investors and service providers, highlights how MCIT will improve access to treatment options while promoting biotechnological innovation in RealClear Health:

“It is now up to the Biden Administration to implement the rule, ensuring beneficiary coverage and access to groundbreaking medical treatment while also sending a clear signal to our innovation ecosystem that risky and expensive investments in breakthrough medical technologies will be rewarded if FDA approves them.”

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