Biomarkers in urology: Policy and legislative advances

Lanton is government affairs director for the American Association of Clinical Urology.

As precision medicine continues to evolve, biomarkers have emerged as pivotal tools in the diagnosis and treatment of various diseases, notably within the field of urology.

Ron Lanton, Esq

Biomarkers are measurable indicators of biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. In urology, they play a critical role in detecting and managing conditions such as prostate cancer, bladder cancer, and kidney diseases.

According to the National Cancer Institute, “Biomarker testing is a way to look for genes, proteins, and other substances (called biomarkers or tumor markers) that can provide information about cancer. Each person’s cancer has a unique pattern of biomarkers. Some biomarkers affect how certain cancer treatments work. Biomarker testing may help you and your doctor choose a cancer treatment for you.”¹

Prostate cancer, one of the most common cancers among men, has seen significant advancements in early detection through the use of prostate-specific antigen (PSA) testing. PSA is a biomarker that, when elevated, may indicate the presence of prostate cancer, prompting further diagnostic evaluation.

According to Zero Prostate Cancer, “The Prostate-Specific Antigen (PSA)test is the most effective tool we have right now to detect prostate cancer, and most instances of prostate cancer are initially detected with this test. PSA is a substance made by the prostate, and the levels of PSA in the blood can be higher in men who have prostate cancer. By testing the PSA levels, we are able to detect possible signs of prostate cancer.The earlier the disease is caught, the higher the survival rates: Prostate cancer caught in Stage 1 is almost 100% survivable. However, if caught at a later stage, survival rates plummet to below 30%.”²

The AACU has been discussing the evolution of state policy to ensure that biomarker testing, including PSA screening, is covered by payers. This approach would reduce any monetary barriers for patients in need.

Here are a few states that have enacted recent legislation on this important issue:

• Pennsylvania: Act 39 of 2024, seen here, requires an insurer that offers, issues, or renews a health insurance policy to include biomarker testing as a covered benefit.
• Delaware: HB 302, seen here; requires all group, blanket, and individual health insurance policies to cover prostate screening for men at high risk for prostate cancer who are over the age of 40 years. Men at high risk for prostate cancer means African American men or those with a family history of prostate cancer.
• Kentucky: HB 52, seen here, mandates coverage of cancer screenings, including PSA tests, without out-of-pocket costs for high-risk individuals.
• Tennessee: HB 2954, seen here, provides coverage for prostate cancer screenings without out-of-pocket expenses for high-risk patients.
• Virginia: In March 2025, SB 1314, seen here and HB 2097, seen here, expands insurance coverage and eliminates out-of-pocket costs for prostate cancer screenings.
• District of Columbia: In October 2024, DC voted to remove out-of-pocket costs for prostate cancer screenings, addressing the highest per-capita fatality rate for prostate cancer in the US.³

These legislative efforts reflect a growing recognition of the value of biomarker testing in improving patient care and outcomes. By reducing financial barriers, states aim to promote early detection and personalized treatment strategies, particularly in urology, where timely intervention can be life-saving.

As the policy landscape continues to evolve, health care providers and patients alike should stay informed about state-specific legislation regarding biomarker testing.

The AACU stands with our urology partners and allies in the house of medicine in lending our continued support for this vital issue.

REFERENCES

1. National Cancer Institute, Biomarker Testing for Cancer Treatment. Accessed April 21, 2025. https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment

2. Zero Prostate Cancer; Overview: PSA Screening for HIM Act (H.R. 1826/S2821). Accessed April 21, 2025. https://zerocancer.org/educational-materials/overview-psa-screening-him-act

3. D.C. mayor signs landmark prostate cancer prevention bill into law. News release. Zero Prostate Cancer. October 29, 2024. Accessed April 21, 2025. https://zerocancer.org/stay-informed/press-releases/dc-mayor-signs-landmark-prostate-cancer-prevention-bill-law