Medicare Proposal to Penalize PSA Testing Draws Criticism

The proposal defined non- recommended PSA testing according to the guidelines released by the United States Preventive Services Task Force (USPSTF) in 2012. These guidelines recommend against the use of routine PSA testing in otherwise healthy men of all ages, stating that the harms of PSA-based screening outweigh the benefits.

The USPSTF’s main concern is that PSA testing will diagnose prostate cancers that are nonlethal, and men will undergo unnecessary treatment. The USPSTF recommendations remain controversial, as they are based on incomplete, flawed data and inaccurate estimates of the benefits and harms of screening.

Under the Medicare proposal, lower use of PSA testing would be an indicator of better performance.

The proposal contains some categories of men who would be excluded from the penalty, such as those with a history of prostate cancer or enlarged prostate, prior elevated PSA levels or men taking certain medications for prostate problems. The measure does not exclude men at high risk for prostate cancer, such as African-American men or men with a family history of the disease. PSA testing for the purpose of diagnosing or surveillance is exempted from the proposal.

The Value of PSA testing

The prostate-specific antigen (PSA) test is a simple blood test that looks for the presence of an antigen in a patient’s blood. Dr. Catalona led the groundbreaking study that led to the adoption of the PSA test for prostate cancer screening in 1991.

Since the advent of PSA testing, there has been an 80% decrease in the percentage of men with metastatic cancer at diagnosis and a 50% decrease in the U.S. prostate cancer mortality rate.

As previously reported in QUEST, the prospective, randomized clinical trials used to evaluate PSA testing have generated mixed results. For example, a high-quality Swedish trial reported a 44% lower mortality rate in the group of men who underwent PSA testing. In contrast, the U.S. Prostate, Long, Colorectal, Ovarian Cancer (PLCO) trial reported no benefit, although the trial was flawed.

The USPSTF recommendation has appreciably affected global clinical practice. There has been less PSA testing, worrisome PSA results are being ignored, and more patients are presenting with advanced disease.

The next step for PSA screening— which is already underway—is to avoid its misuse in testing men who are too old or to ill too benefit from screening and to delay treatment in men whose disease may not have lethal potential. In this regard, active surveillance is on the upswing.

Public criticism

The official comment period for the Medicare proposal ended in November. Many critics of the proposal said that the measure would discourage doctors from practicing shared decision making with their patients, in which doctors and patients discuss the pros and cons of PSA screening and allow the patient to decide to pursue screening or not. Several major medical groups recommend the practice, including the American Urological Association (AUA) and the American Cancer Society.

On January 7, the New York Times published an editorial by H. Gilbert Welch and Peter C. Albertson entitled “Why Doctors Shouldn’t Be Punished for Giving Prostate Tests.” Drs. Welch and Albertson have both previously raised questions about prostate cancer screening. Yet, in their editorial, they made the case that screening is a choice and Medicare should not penalize doctors for ordering PSA tests.

Drs. Welch and Albertson expressed three main concerns regarding the proposed Medicare measure. First, they feel that doctors don’t need another performance measure. Second, they are “not comfortable rewarding doctors for withholding a test that could help some men.” Individual men should be able to weigh the pros and cons of screening and make their own decision. Finally, they do not want to reinforce a “misleading narrative” often put forth by screening proponents that concerns about early detection are actually about saving money.

Pendulum Begins to Shift Back on PSA Testing

In March, the Patient-Centered Prostate Cancer Collaboration Coalition (PCPC3) reported that a key advisory group to Medicare recommended that the Centers for Medicare & Medicaid Services (CMS) step back from the proposal.

The PCPC3 wrote, “…there is no doubt whatsoever that, at this time, [the PSA test] remains a low-cost and simple blood test that offers concerned men and their families valuable information about their possible risk for diagnosis with the commonest form of cancer found among men in America.”

In addition, the USPSTF is reconsidering their grade D recommendation on PSA screening.

Drs. Welch and Albertson offer an alternate plan. Instead of penalizing doctors for ordering PSA tests, Medicare should not give PSA tests for free. “Requiring men to bear the small cost of the test is not a punishment, it’s a motivation for them to consider the screening decision more carefully,” they wrote.

Dr. Catalona’s Response

Under the Affordable Care Act, if an intervention like PSA testing gets a grade D recommendation from the USPSTF, Medicare and Medicaid and the VA hospitals do not have to pay for it, and the private insurance companies often follow suit. This means that all men would have to pay for a PSA test ordered for early detection of prostate cancer. This creates another health care disparity for people who can’t afford to pay for a PSA test. There is ample evidence that PSA testing saves thousands of lives. In my opinion, it is unconscionable for Medicare to withhold a simple blood test that could save a man from suffering and death from prostate cancer, and it is “over the top” to penalize doctors from offering a possibly life-saving blood test to their patients who have decided they want it.