At the 2023 Annual Urology Advocacy Summit, one of the 4 bills advocated for legislation by the AUA was the PSA Screening for High-risk Insured Men (HIM) Act.¹ The purpose of this advocacy acknowledges the impact of prostate cancer, particularly in high-risk populations, and contends that PSA-based screening presently is beneficial in reducing the mortality of this disease. This article summarizes the presentation of this topic by the authors at the Summit and establishes the grounds for this advocacy. It also features a testimonial of relevance.

The incidence and mortality of prostate cancer have increased for the first time in 20 years, according to a 2023 American Cancer Society report.² Arguably, these outcomes have resulted from the changing directions and ensuing confusion over prostate cancer screening guidelines over the past decade. In 2012, the United States Preventive Services Task Force (USPSTF) recommended against the PSA-based screening test for prostate cancer in all men, regardless of risk.³ This determination arose from the belief that during the era of PSA testing since the mid-1990s the detection of indolent tumors along with the administration of treatments for prostate cancer having adverse effects had surged. Citing “insufficient evidence” that PSA-based screening reduces prostate cancer mortality, the USPSTF issued a draft Grade D recommendation (to discourage use of this service) concluding with modest certainty that “the benefits for PSA-based screening for prostate cancer do not outweigh the harms.”³ During this time, prostate cancer screening dropped and rates of advanced stage at presentation rose⁴ in line with an eventual increase in mortality rate.

On the basis of follow-up information from screening trials, the USPSTF revised its recommendation in 2018 to a draft Grade C rating, which encourages shared decision-making regarding PSA-based screening for men ages 55-69 years while maintaining a Grade D recommendation for men aged 70 years or older.⁵ This revision does concede evaluations for men with high-risk factors such as those with a family history of prostate cancer and Black men, who are recognized to bear substantially adverse outcomes from this disease. In point of fact, Black men and men with family history both endure a 70% higher prostate cancer incidence rate, and Blacks have twice the mortality rate of their White male counterparts.^6,7

Despite this auspicious revision, the Grade C recommendation nonetheless has guided some insurance providers not to cover the cost of PSA screening for men of any age group. This practice reveals that insurance companies commonly use the USPSTF recommendations at a Grade A or B level rating to determine which preventive services are covered. Given this predicament, men of high-risk populations for prostate cancer are denied insurance coverage for PSA testing and potentially forgo the opportunity for appropriate life-saving screening and treatment.

The value of PSA testing is highlighted by the life story of one of the coauthors, a Black man, Dr Patrick Bingham: “At 46 years old, I was diagnosed with prostate cancer…at an earlier age than many. At the time of my diagnosis, I really had no idea what prostate cancer was or the impact of my diagnosis. Early diagnosis is the key to helping men survive prostate cancer, which is why I support PSA-based screening for men in high-risk populations and especially African American men. The importance of this bill (the HIM Act) in preventing the barriers to screening for vulnerable groups cannot be overemphasized.”

The HIM Act seeks to require insurance providers to cover annual PSA screening for insured African American men and men aged 40-54 years with a family history of prostate cancer. It further pushes for this service to acquire a Grade A or B level USPSTF rating, which carves out a Prevention Health Benefit by the Affordable Care Act.¹ Accordingly, this action would require all private insurers and Medicare plans to cover PSA-based screening as a preventive service without any cost sharing (ie, no out-of-pocket cost to patients), and in so doing overcome an access barrier to this health care. A similar expansion of insurance coverage was done for mammography under the Affordable Care Act through the Women’s Preventive Services Guidelines for women aged 40 to 49 years for biennial breast cancer screening mammography despite its USPSTF Grade C rating.⁷

PSA-based screening reduced prostate cancer mortality by 40%-50% in the aforementioned screening trials.^8,9 An update on the European Randomized Study of Screening for Prostate Cancer shows that the number needed to invite to screening is 570 and the number needed to diagnose prostate cancer is 18 to prevent 1 cancer death.¹⁰ This compares favorably to mammography for breast cancer. An analysis of the impact of the USPSTF Grade D rating on prostate cancer survival revealed that when insurance coverage waned for PSA screening, prostate cancer mortality increased among insured men to mirror the rates of uninsured men.

This bill engendered quite a bit of discussion at the Summit. Some argued that annual PSA screening should be offered between the ages 40 and 54 years to men of all races. An analysis of baseline PSA of men in their early 40s has shown that an above median PSA level captures 90% of those who eventually will die of prostate cancer.¹¹ This strategy also allows men with below-median PSAs to safely avoid annual PSA testing for years. However, the USPSTF had not pursued this strategy and had otherwise analyzed specifically Level I screening trial findings discounting apparent benefits of screening in men in the 40-54 years age group.^8,9 Since African American men and men with a family history of prostate cancer both face 70% higher risk of developing prostate cancer, and since early onset prostate cancer is 3 times more lethal than cancers detected from age 55-69, they would derive similar benefit from annual screening as average-risk men.¹² One lobbying urologist shared that although the USPSTF only considers Level I evidence for evaluating the mortality benefit of screening by age group, the HIM act offers a practical approach for study compared to conducting a large-scale screening trial in high-risk groups.

The original sponsor for this bill was Bobby L. Rush, who was the U.S. Representative for Illinois’s first Congressional District; Mr Rush is now retired. Clearly, new champions for this bill are needed to reduce the burden of prostate cancer in high-risk men. Future bills should aim to expand insurance coverage for annual PSA screening to other high-risk populations like men with BRCA2 mutations, high polygenic risk scores, and above-median baseline PSA levels. Ongoing studies that delineate the population-attributable risk and the balance of risks and benefits of PSA screening, particularly in the 40-54 years age group, will inform a nuanced risk-stratified screening strategy.