Act Now to Create a Coverage Pathway for Future Blood-Based Detection

Act now to create a coverage pathway for future blood-based detection

By Eric Hargis

Act Now to Create a Coverage Pathway for Future Blood-Based Detection

Screening methods to detect colorectal cancer have been in use since fecal immunochemical tests were introduced in the 1970s. Colonoscopies gained wide acceptance after a life-saving colonoscopy was performed on President Reagan in 1985. However, for most forms of cancer, there is no test to screen for the cancer, and far too often treatment is not initiated until symptoms are present and the cancer is advanced. 

Fortunately, on the horizon are blood tests that have shown the ability to detect a variety of cancers including colorectal and rare cancers. Though these tests are still in development and are not yet approved by the FDA, clinical trials have shown impressive results. 

For example, results of a trial of GRAIL’s multi-cancer early detection (MCED) blood test were published in The Lancet. Study results showed that the multi-cancer test doubled the number of cancers found when used alongside recommended screening. Patients who received a cancer signal positive result had resolution of their cancer diagnosis in less than three months. 

However, it is important to note that, if approved by the FDA, these tests may be supplemental to colonoscopy, mammography, prostate, and other tests with an A or B rating by the U.S. Preventive Services Task Force (USPSTF). 

If the Food and Drug Administration (FDA) approves one or more of these tests, when will they be available for Medicare patients? There are two paths to have these technologies covered by Medicare. The first was created by Congress in 2008, which says that Medicare can cover USPSTF-recommended screenings. Unfortunately, past USPSTF reviews significantly delayed Medicare access to new screenings. 

For this reason, there is strong support for an alternative pathway to Medicare coverage. The second path MCEDs can take for Medicare coverage, which is the same path colorectal screenings follow, allows Congress to pass legislation to create a coverage pathway. Legislation has been introduced that would do just that.

This legislation would give Medicare the authority to cover MCED tests upon approval by the FDA. Bipartisan majorities in the House and Senate, and over 500 stakeholders from across the country, support this approach because it will ensure seniors don’t face unnecessary access delays to new multi-cancer screening technologies once the FDA approves them. 

In the House, the bill is the Nancy Gardner Sewell Medicare Multi-Cancer Early Cancer Detection Screening Coverage Act (HR 2407), named after Representative Sewell’s late mother who died in 2021 from pancreatic cancer. The Senate has introduced the bill, too, S2085, the Medicare Multi-Cancer Early Detection Screening Act. Both bills have strong, bipartisan support. 

The Colorectal Cancer Alliance strongly supports the passage of this legislation. According to the Alliance’s CEO, Michael Sapienza, “Today only 14% of cancers are found with existing screening methods. Early detection is vital to reducing late-stage diagnosis. In addition, blood tests can be readily included in routine clinical care.” 

Please help our advocacy efforts to get this legislation into law. Just send a quick email to your Representative asking to co-sponsor HR 2407/S2085. Click here to find the email address. Then send a similar email to your Senators, asking them to sign on to The Medicare Multi Cancer Early Detection Screening Act. You can find their contact information here.




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