Chairman Griffith Delivers Opening Statement at Subcommittee on Health Legislative Hearing on Enhancing Seniors’ Access to Breakthrough Medical Technology

WASHINGTON, D.C. - Congressman Morgan Griffith (VA-09), Chairman of the Subcommittee on Health, delivered the following opening statement at today's legislative hearing on policies to enhance seniors' access to breakthrough medical technologies.

Subcommittee Chairman Griffith's opening statement as prepared for delivery:

"Today's legislative hearing will focus on several bills aimed at enhancing seniors' access to life-saving and life-sustaining breakthrough medical technologies.

"These policies are essential to reducing regulatory barriers to help patients get timely access to care while also bringing more transparency into the coverage process at CMS.

"I think we can all agree that federal agencies can be inefficient and very bureaucratic in instances.

"It is our job as Congress to ensure that patients are able to access treatments, screenings, or devices in a timely manner, especially if there are no other alternatives on the market.

"This hearing is the next step in the process.

"One of the bills we are considering is H.R. 842, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, led by Representatives Arrington and Sewell, would establish a new coverage pathway at CMS for multi-cancer early detection screening test-so that once these tests are approved by FDA, Medicare beneficiaries can access these tests in a timely manner.

"These multi-cancer screening tests allow for patients to take a blood test to screen for over 50 different types of cancers.

"This allows us to do additional testing to narrow the results down to one potential cancer and yields a low false positive rate.

"It is essential that Medicare beneficiaries can get screened for cancers early and get treated. This can save lives and reduce costs for patients and Federal taxpayers.

"I am proud to be one of this bill's 300 bipartisan cosponsors.

"Another bill being considered today is the Ensuring Patient Access to Critical Breakthrough Products Act, which will ensure seniors have timely access to innovative medical technologies.

"Many medical devices currently fall into what is known as the 'valley of death.'

"This refers to the period between FDA approval of a device and when Medicare covers this technology. During the first Trump Administration, this led to CMS issuing a proposed rule in 2020 titled Medicare Coverage of Innovative Technology (or MCIT).

"This pathway would have provided FDA-approved breakthrough medical devices four years of Medicare coverage while working on a longer term coverage determination.

"The goal was to accelerate the benefits of these innovative technologies to benefit patients quicker.

"This rule was repealed in 2021 by the Biden Administration and was replaced with the Transitional Coverage for Emerging Technologies (or TCET) pathway.

"They cited the repeal was due to it having 'unknown or unexpected risks' for Medicare beneficiaries, which compared to MCIT, had many more regulatory hurdles and barriers for devices to come to market and is limited to only five new breakthrough technologies each year.

"Getting this bill signed into law will bring us back closer to the original MCIT rule, spurring more innovation in the medical device and enhancing seniors timely access to medical innovations.

"I personally am frustrated with CMS acting more as a scientific regulatory agency than an agency focused on reimbursing for FDA approved products.

FDA is the scientific regulatory agency.

"I am sure everyone here has heard complaints about the opaque and slow-moving National Coverage Determination process at CMS or had frustrations with Local Coverage Determinations.

"One of the bills in front of us today will bring more transparency and accountability at CMS into both these coverage determination processes.

"The final bill being considered today is H.R. 3826, the Expanding Access to Diabetes Self-Management Training Act by Representatives Schrier and Bilirakis.

"This bill expands access to Diabetes Self-Management Training. This training is critical for individuals living with diabetes since it will help them cope, manage, and learn best practices when dealing with their diabetes.

This bill will help increase the amount of educational opportunities for diabetes wellness training, lower costs for patients, and provide more access to certain services.

"All of these bills before us today are important to bring more care to patients and achieve better health outcomes overall.

"I am excited to hear from our expert panelists today to learn more about these bills and the importance of them."