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August 28, 2023
According to the U.S. Centers for Disease Control and Prevention (CDC),1 after heart disease, cancer is the second leading cause of death in the US. Early detection of cancer significantly saves lives and cuts treatment costs. Because elderly people are at heightened risk of cancer, Medicare could play a key role in cancer prevention by covering blood-based tests designed to detect cancer early. With that role in mind, a bipartisan group of federal lawmakers has renewed efforts to pass legislation ensuring Medicare coverage of multi-cancer early detection (MCED) tests, a test type also known as liquid biopsy.
Current Medicare Cancer Screening Coverage Rules
According to the Prevent Cancer Foundation, despite the demonstrated value of screening and early detection, Medicare only reimburses for cancer screening tests that the U.S. Preventive Services Task Force (USPSTF) recommends with a grade of A or B. Currently, there are only five types of cancer that have screening tests that meet those criteria—breast, cervical, colorectal, prostate, and lung cancers (only in high-risk people for lung). The Centers for Medicare & Medicaid Services (CMS) has tight coverage requirements that exclude many other cancers. These uncovered cancers account for nearly three of every four cancer deaths in the US each year.2
Though not yet cleared or approved by the FDA, and with many questions left to be answered about their accuracy and efficacy, MCED tests could help fill this large gap in coverage. Such tests can also detect circulating tumor DNA (ctDNA) and protein biomarkers shed into the blood and other bodily fluids from many different types of tumors.3 Being able to screen asymptomatic individuals for several different cancers at once could potentially be more efficient and cost-effective than screening people for one cancer at a time the way current covered cancer screening tests do.4 However, securing government and private payer coverage for MCED tests remains a major hurdle.
The Newly Proposed Legislation
On June 22, Democratic and Republican senators reintroduced the Medicare Multi-Cancer Early Detection Screening Coverage Act as S.2085, which would authorize CMS to cover certain MCED tests after approval from the FDA.5 With this new legislation, patients wouldn’t need to wait years to get recommendations for grade A and B tests from their clinicians. Based on the text of the original bill, the new legislation would provide/include coverage for:
Providing coverage for MCED tests is meant to supplement, rather than replace, colonoscopy, mammography, prostate, and other traditional cancer screening tests covered by Medicare. Accordingly, the bill states that receiving an MCED test will not affect an individual's Medicare coverage for traditional cancer screening tests, but MCED tests will not be covered if an individual has already had MCED tests in the previous 11 months.
The Senate bill is equivalent to the House version, titled the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, named for the late mother of lead Democrat co-sponsor U.S. Representative Terri Sewell (AL-07). Representative Sewell’s mother, Nancy Gardner Sewell, died from pancreatic cancer in 2021.7,8
“Innovative multi-cancer early detection screenings are emerging which hold the potential to detect cancer earlier than ever before,” said Sewell in a press release accompanying the reintroduction of the bill on March 30, 2023. “Not only will this bill save lives, but it will also help reduce the glaring racial disparities in cancer diagnosis and death.”8
Addressing Health Disparities
As Sewell notes, the MCED testing bill is designed not simply to expand cancer screening coverage but also to begin to address racial and socio-economic disparities in cancer diagnosis, treatment, and outcomes by making testing more widely available.
According to the National Cancer Institute, in the US, certain groups experience cancer disparities due to social, environmental, and economic barriers to accessing care, as well as a lack of diversity in clinical research and clinical trials, such that the results may not apply to certain populations.9
For example, NCI’s Surveillance, Epidemiology, and End Results Program reports the following:
To address these disparities, the new bill requires the Comptroller General to conduct a study on Medicare beneficiaries’ utilization of MCED tests that analyzes aggregate data on:
Once MCED coverage begins, the Comptroller General would have three years to submit a report to Congress listing the results of the study, along with recommendations for increasing access and utilization in underserved areas.
Prospects for Passage
The new bills are reintroduced versions of legislation that was proposed but was not passed in the last Congress. As before, the new legislation to ensure Medicare coverage of MCED screening has support from both political parties, as well as more than 500 advocacy organizations located in all 50 states, including the American Cancer Society Cancer Action Network, National Minority Quality Forum, Cancer Support Community, Association of Community Cancer Centers, Community Oncology Alliance, and Oncology Nursing Society.10
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Congressional Support for MCED Screening Coverage Bill Congressional support for the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act and its Senate counterpart, S. 2085, includes:
Source: December 2022 letter from members of the House of Representatives to former and current Speaker of the House, respectively, Nancy Pelosi and Kevin McCarthy11 |
On June 22, the Prevent Cancer Foundation issued a public letter calling on congressional leaders to pass the House and Senate bills. “As science moves forward, so must health care policy,” the letter states. The newly proposed legislation “responds to the misalignment between advances in science and outdated policy by allowing for Medicare coverage of multi-cancer screening.”2
Takeaway
According to the letter, Congress has a history of passing bipartisan legislation to ensure Medicare coverage of cancer screening, including mammograms, Pap tests, and prostate and colorectal cancer screenings. Sponsors and supporters of the new legislation seek to position MCED screening as the next logical step in this evolution.
“Multi-cancer early detection testing technologies have the potential to provide a vital new tool in the fight against cancer, transforming the screening landscape to detect as many as dozens of cancer types, often long before symptoms even emerge,” said co-sponsor of the Senate bill Mike Crapo (R-ID) in a statement.12
However, according to a 2022 study published in Health Affairs, what makes MCED screening tests so innovative may also complicate payers’ decision making, as there is no evidence-based framework for payers to apply to MCED tests where the test sensitivity varies by cancer and stage such that the benefits and harms of screening vary by tumor type. “It is unclear whether payers will continue to review the clinical utility of the new test for each cancer type individually rather than for the test as a whole,” noted the researchers.4 “Although the cost of the MCED screening test may be fully covered, patients may face high out-of-pocket expenses for follow-up diagnostic procedures.”
If the bills do pass, one of the biggest winners may be GRAIL, producer of the Galleri lab-developed test, one of the leading MCED tests on the market. Medicare coverage of MCED testing would also potentially be great news for other lab companies developing their own versions of such products, including Exact Sciences and Freenome.
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This article originally appeared in G2 Intelligence, National Lab Reporter, August 2023.
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