Rep. Sewell’s Legislation to Ensure Access to Groundbreaking Cancer Detection Tools Gains Substantial Momentum in Congress
June 22, 2022
Washington, D.C. – Today, U.S. Rep. Terri Sewell (AL-07) announced that her legislation, the Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 1946), has achieved a significant milestone, earning the support of a bipartisan majority of members in the U.S. House of Representatives. This bipartisan and bicameral bill, which Sewell introduced with Reps. Jodey Arrington (TX-19), Raul Ruiz (CA-36), and Richard Hudson (NC-08), will allow for multi-cancer early detection (MCED) tests to be covered by Medicare in a timely manner upon approval by the Food and Drug Administration (FDA) and once a clinical benefit is shown. The legislation enjoys the support of nearly half of the U.S. Senate as well as more than 400 organizations across the country.
“Emerging multi-cancer early detection tests hold the potential to transform the way we detect and treat cancer by catching cancer earlier than ever before,” said Rep. Sewell, lead sponsor. “By creating a pathway for these screenings to be covered by Medicare, this bill will ensure that our nation's seniors can access these technologies when they become available. I’m thrilled that this legislation now enjoys the support of a bipartisan majority of my House colleagues! This critical milestone brings us one step closer to seeing this bill become law and saving lives. I am committed to harnessing this momentum to get this bill across the finish line."
“Multi-cancer early detection is an incredible example of the U.S. leading in medical innovation,” said Rep. Arrington. “This type of screening has the potential to drastically improve quality of life for American cancer patients and their families, and early detection will save taxpayer dollars by treating cancer before it spreads. I am proud of the bipartisan support H.R. 1946 has garnered and appreciate my colleagues’ recognition that this legislation will drastically improve our ability to treat and prevent cancer.”
“Today, we take a tremendous step forward in getting our legislation, the Multi-Cancer Early Detection Screening Coverage Act to the House floor for a vote,” said Dr. Ruiz.“With innovative medical technologies and multi-cancer screenings, we can catch more cancers earlier than ever before. However, these groundbreaking screenings remain out of reach for many Americans. Our much-needed legislation would improve health outcomes across the board by modernizing Medicare coverage so that older Americans can access them. I look forward to continuing to work with Rep. Sewell to push this legislation forward and improve access to crucial preventative care.”
“By increasing access to innovative multi-cancer early detection screening tests in Medicare, we can detect cancers sooner, lower health care costs, and save lives in North Carolina and around the country,” said Rep. Hudson. “I am proud our bipartisan legislation has now received support from a majority of our colleagues in Congress, and I look forward to seeing this bill become law.”
Cancer is the second leading cause of death in the United States. However, detecting cancer early can result in less invasive treatments, reduced costs, and most importantly, better outcomes for patients with cancer. Fortunately, scientists are developing and testing innovative blood-based multi-cancer early detection tests that can screen for many cancers at the same time, including rare cancers. The companies engaged in multi-cancer screening have both received breakthrough device designation for their tests and are pursuing FDA approval. Unfortunately, under current law, it could take several years after FDA approval before Medicare beneficiaries could receive coverage for such tests.
The Medicare Multi-Cancer Early Detection Screening Coverage Act responds to a misalignment between advances in science and Medicare coverage by allowing for Medicare coverage of multi-cancer screening. It would significantly reduce delays for Medicare beneficiaries, while allowing the Centers for Medicare and Medicaid Services (CMS) to use its evidence-based process to determine coverage. Accordingly, these new multi-cancer screening tools will complement existing screenings and dramatically improve our nation’s cancer early detection capabilities.
Specifically, the legislation would:
- Create the authority for CMS to cover blood-based multi-cancer early detection tests and future test methods (like urine or hair tests), once approved by the FDA. Congress has acted before to create coverage for other cancer screenings including mammography and colorectal screenings.
- Maintain CMS’ authority to use an evidence-based process to determine coverage parameters for these new tests.
- State that these new tools will complement, not replace, existing screenings and coverage and cost sharing will not be impacted.
“The positive momentum for this bill has been energizing for all of us dedicated to preventing deaths due to cancer,” said Jody Hoyos, President and COO of the Prevent Cancer Foundation. “We appreciate the leadership of Representatives Sewell, Arrington, Ruiz and Hudson and join them in celebrating this significant milestone: a bipartisan majority of cosponsors of the bill. We cannot move forward in decreasing health inequities and reducing cancer mortality without innovations that detect more cancers early and are accessible to all who need them.”
“ACS CAN is thrilled to see the strong bipartisan support for the MCED bill in the House,” said Lisa Lacasse, President of the American Cancer Society Cancer Action Network (ACS CAN). “We know early detection is critical to surviving cancer, so ensuring Medicare beneficiaries have access to the newest screening technology once approved by the FDA and shown to have clinical benefit will mean fewer lives lost to this disease.”
“The Association of Community Cancer Centers (ACCC) applauds Reps. Sewell, Arrington, Ruiz, and Hudson for their leadership in reaching this milestone and garnering an impressive amount of bipartisan support for this vital piece of legislation,” said Christian G. Downs, JD, MHA, ACCC Executive Director.“ACCC’s members are seeing and treating increasing numbers of Americans with late-stage cancer diagnoses, and this bill has great potential to help patients and providers access promising new technologies capable of detecting cancer earlier. In particular, creating a pathway to Medicare coverage for MCED tests will help to ensure equitable access to these technologies once they are approved by the FDA and start to address disparities in early detection and outcomes among racial and ethnic minorities."
"The National Minority Quality Forum applauds the bipartisan momentum towards passage of the Multi-Cancer Early Detection Screening Coverage Act,” said Gary A. Puckrein, PhD, President and CEO of the National Minority Quality Forum.“This bill will have a significant impact on the well-documented inequities in cancer detection and outcomes that communities of color experience in this country every day. Thanks to the leadership of Rep. Sewell, those at greatest risk for deadly cancers, older Americans, will have access to innovative tools that will reduce their risk for late detection and less than ideal outcomes of care.”
The text of the Medicare Multi-Cancer Early Detection Screening Coverage Act can be found here.