U.S. Representative Richard Hudson (R-NC) along with Reps. Terri Sewell (AL-07), Jodey Arrington (TX-19), and Raul Ruiz (CA-36), led 116 House colleagues in a bipartisan letter this week urging House leadership to bring H.R. 1946 to the Floor for a vote during the remainder of the 117th Congress. The Medicare Multi-Cancer Early Detection Screening Coverage Act would create a pathway for Medicare to cover emerging blood-based cancer screenings which hold the potential to detect cancer earlier than ever before. Rep. Hudson introduced H.R. 1946 in March 2021. With 257 House co-sponsors and 54 Senate co-sponsors, it enjoys the support of a bipartisan majority of the House and Senate and over 400 organizations across the nation.
"No family in America has been spared the scourge of cancer," the Members write. "Indeed, for our nation's seniors, the burden of cancer is highest, with more than 70% of all cancer deaths happening in the Medicare population. We must bring urgency and action to our fight against this terrible disease because the consequences of waiting are too great. We respectfully urge you to bring this bill to the floor this year and pave the way for a future where we win our war on cancer."
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. 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.