Health Subcommittee Chair Guthrie Opening Statement on Innovation in Medicare

Washington, D.C. — Subcommittee on Health Chair Brett Guthrie (R-KY) delivered the following opening statement at today’s Health Subcommittee hearing titled “Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology.”

Excerpts and highlights below:


“Our goal today is to identify possible solutions to help address the financial sustainability of the Medicare program that also can help promote a greater quality of life and give way to a longer life-expectancy for today’s seniors and for future seniors.

“Over the past 50 years, we have developed therapies to help treat and manage chronic conditions, such as diabetes and transformative diagnostic imaging technology, such as MRI, CT scans, and ultrasound technology to help diagnose other complex conditions that were once death sentences.

“Researchers are now racing against the clock to help diagnose and treat other diseases that reduce patient’s overall quality of life and serve as a cost burden on our health care system.

“This includes the FDA’s accelerated approval of an Alzheimer’s Disease drug two years ago and the agency’s recent traditional approval of another drug used to the same symptoms only two weeks ago.

“Despite the historic advancements in treatments for Alzheimer’s Disease, the Biden administration has decided to limit access to these therapies through onerous coverage policies that require patients and their providers to take great lengths in order to administer and gain access to these drugs.

“I remain extremely frustrated by the Biden administration’s restrictive approach to addressing this vicious disease.”


“The costs associated with treating patients earlier in the disease may not only potentially save Medicare money, but, more importantly, it will also give these patients more time with their families until more effective treatments are developed.

“The Biden administration is also undermining our innovative ecosystem through actions taken to limit Medicare access to FDA approved breakthrough medical devices and technologies.

“Instead of rewarding this innovation by providing a streamlined path to Medicare coverage for these novel products, like the Trump-era Medicare Coverage of Innovative Technologies rule would have done, the Biden administration is reducing access to cures for patient policies through its proposed Transitional Coverage of Innovative Technologies rule.

“This significantly narrows the number and type of products that can use the Breakthrough Devices program for streamlined Medicare coverage.

“While I am pleased to see any action on this important issue from CMS, I believe this proposal misses the mark for patients and undermines the bipartisan work this committee did by creating the Breakthrough Devices program in the 21st Century Cures Act.

“I look forward to working with my colleagues on the subcommittee to address many of the proposal’s shortcomings and to provide greater clarity for patients, their doctors, and innovators by passing H.R. 1691, the Ensuring Patient Access to Critical Breakthrough Products Act.

“This would more provide patients more predictable access to FDA approved breakthrough devices if certain conditions are met.

“Congress should also act to ensure patients are able to access these therapies by identifying reimbursement models that drive value.

“For example, the Medicare Advantage program could lead in the adoption of value-based contracting for certain drugs or therapies.

“In addition to novel therapies, we now have diagnostic tools that can help us detect diseases sooner, such as multicancer screening diagnostics, leading to improved patient outcomes and savings to the health care system.

“These tools represent another opportunity to ensure our Medicare policies strike the appropriate balance of increasing access while driving higher quality care.

“In closing, with a finite number of Medicare resources and an aging population, it is absolutely imperative for policy makers to ensure we are appropriately striking the balance of rewarding innovation while providing access to quality care in a way that doesn’t bankrupt the system.”