(The Center Square) – A proposed federal rule that would expand Medicare coverage for certain colorectal cancer screening tests could benefit a company whose board includes former U.S. Health and Human Services Secretary Alex Azar.
The Centers for Medicare & Medicaid Services has proposed new national coverage standards for blood-based colorectal cancer screening tests. The agency says the change would expand screening options available to Medicare beneficiaries.
Doctors and former government health officials have raised concerns about the proposal, arguing it focuses too heavily on detecting cancer after it develops rather than identifying and removing precancerous growths before they become cancerous.
Guardant Health, a precision oncology company, manufactures the Shield blood test for colorectal cancer screening. The company’s test could qualify for Medicare coverage under the proposed framework.
Azar joined Guardant Health’s board of directors in September 2025. Medicare coverage for blood-based cancer screening has been in place since 2021 for any product that has FDA approval and meets performance requirements. Guardant Health’s Shield blood test is the first to meet both qualifications and was approved by the FDA in July 2024, Guardant Health told The Center Square.
Company filings with the U.S. Securities and Exchange Commission show Azar was set to receive compensation valued at roughly $725,000 per year, including stock options and restricted stock awards.
Guardant Health is a publicly traded company with a market value of roughly $15 billion.
Guardant co-CEO AmirAli Talasaz submitted comments to CMS in support of the proposal.
Medical experts have raised concerns about blood-based screening tests that do not detect precancerous lesions as effectively as other screening methods.
Last month, former U.S. Surgeon General Dr. Richard Carmona said the proposal does not reflect how colorectal cancer screening reduces deaths.
“The evidence is compelling and consistent: the majority of the long-term mortality benefit from colorectal cancer screening comes from detecting and removing precancerous lesions before they develop into cancer,” Carmona wrote in a public comment. “A coverage framework built primarily around cancer detection thresholds, without meaningful requirements for precancerous lesion sensitivity, is a framework that is not fully aligned with that evidence.”
Former U.S. Surgeon General Dr. Jerome Adams also criticized the proposal.
“The proposed framework emphasizes performance thresholds focused primarily on cancer detection,” Adams wrote in his proposal. “While that is important, it risks underweighting the need for strong sensitivity to precancerous lesions.”
The Guardant Shield test costs about $1,500, compared to roughly $500 for stool-based screening tests, according to comments submitted to CMS by critics of the proposal.
Critics argue taxpayers could end up paying more for tests that are less effective at detecting precancerous growths.
Azar served as HHS secretary during President Donald Trump’s first term.
After the Jan. 6, 2021, riot at the U.S. Capitol, Azar submitted a resignation letter in which he criticized Trump’s conduct surrounding the events.
In the letter, Azar wrote that Trump’s “actions and rhetoric” had damaged the administration’s legacy.
Azar has also publicly praised his role in developing mRNA COVID-19 vaccines during the Trump administration, calling it his biggest achievement at HHS.
CMS is accepting public comments on the proposed changes to colorectal cancer screening coverage.
