College of American Pathologists
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Free PSA Proving Worthy, But Payers Wary Of Worth

April 2001
Karen Southwick

While support is growing for use of free PSA in instances where the total PSA result for prostate cancer is inconclusive, reimbursement by Medicare and other insurers remains spotty for the newer test.

According to the American Cancer Society, 198,100 men will be diagnosed with prostate cancer this year, and 31,500 will die. In its January/February issue of CA: A Cancer Journal for Clinicians, the ACS notes that prostate cancer mortality rates began to decline in 1994, a few years after prostate-specific antigen testing became widespread.

However, assuming their digital rectal exam is normal, men whose total PSA test result falls into the "gray zone," between 4 and 10 ng/mL, still have a one in four chance of having prostate cancer. Free PSA, or fPSA, can help to distinguish between cancer and benign prostatic hyperplasia. Men with BPH will have a higher percentage of fPSA, while those with cancer will have a lower percentage.

Some experts recommend use of fPSA to weed out men with BPH, thus avoiding the more costly and invasive transrectal ultrasound-guided biopsy. The American Cancer Society’s updated prostate cancer detection guidelines issued in February indicate that adding fPSA to the testing can improve specificity.

"For men with PSA results between 4.0 and 10.0 ng/mL, restricting ... biopsy to men with less than 20 percent free-PSA improves testing accuracy," states the explanation accompanying the guidelines. "Applying this strategy to men with PSA levels between 2.5 and 10.0 ng/mL may lead to detection of early disease in a larger number of men and may result in a lower biopsy rate compared with older strategies."

The guidelines do not indicate that fPSA should be used routinely in screening for prostate cancer, points out Andrew von Eschenbach, MD, an ACS vice president who chaired the committee that drafted the guidelines. Rather, the narrative "says that getting free and total PSA may help in the decision as to whether a patient should be biopsied," he says. "The gold standard still rests on what the pathologist sees [in the biopsy] under the microscope."

Dr. von Eschenbach, a urologist who is director of the Center for Genitourinary Cancer at the M.D. Anderson Cancer Center, Houston, says use of fPSA depends on the context and the patient being evaluated. For instance, a 50-year-old man with a normal size prostate and a PSA of 7.5 ng/mL should undergo an immediate biopsy. On the other hand, a 67-year-old man with an enlarged prostate and the same PSA reading might decide to have a fPSA test rather than a biopsy. "If the fPSA is above 20 percent, it’s probably due to benign growth, and we continue to watch and wait," he says.

William Catalona, MD, professor of urology at Washington University School of Medicine, St. Louis, and a world-renowned expert in prostate diseases, says he uses fPSA for men with PSA values down to 2.6, because there’s a significant chance of cancer even with the lower values. "About 10 percent of the population has a PSA between 4 and 10," he says. "That doubles when you go down to 2.6."

If the fPSA result is above 25 percent, the chance of a positive biopsy for cancer is extremely low. At that point, patients, especially if they’re older, might elect not to have a biopsy because any cancer present is slow-growing, he says. If fPSA is under 10 percent, "the chance of cancer is high, and it’s very likely that cancer would be aggressive," Dr. Catalona says. Then a biopsy is warranted.

The Food and Drug Administration has cleared two fPSA tests. Beckman Coulter has had a test on the market (the Hybritech free PSA assay) since 1998, while Roche Diagnostics just received FDA approval in February for its Elecsys free PSA immunoassay. Jim Rigo, Beckman Coulter’s market manager for immunochemistry, says the Hybritech assay’s clearance is for men with PSA readings down to 4 ng/mL. Published studies have shown the test to be effective in determining probability and risk assessment down to 2.5 ng/mL, Rigo adds, and this expanded range is used in Europe.

Spotty insurance coverage

Drs. Catalona and von Eschenbach agree that though it’s difficult to draw an exact standard for when fPSA should be used instead of biopsy, they want fPSA to be available when a physician feels it’s needed. Avoiding unnecessary biopsies saves patients from an often-painful procedure and reduces costs. While calculating fPSA/total PSA runs between $65-$100 to a patient or insurer, a biopsy can cost $1,000 or more.

One clinical study that Dr. Catalona directed, published in the May 20, 1998 issue of the Journal of the American Medical Association, showed that a free PSA blood test could be used to eliminate 20 percent of biopsies that would otherwise have been performed among men with moderately elevated PSA results and nonsuspicious digital rectal exams.

In addition, Dr. Catalona notes, fPSA can help in assessing risk and monitoring the progress of disease. "The patient can use the information to assess what chance he has of having a positive biopsy." With a negative biopsy, repeating the fPSA test at six-month intervals "helps discriminate among men who should be urged to have a repeat biopsy." If the fPSA level drops, another biopsy is indicated.

Although the Health Care Financing Administration, which administers Medicare, now pays for PSA screening, it has no national coverage policy for fPSA, and there are no plans now to consider adding the test, according to a HCFA spokesperson. That means each local Medicare carrier-usually designated on a state-by-state basis-decides whether to cover fPSA, under what conditions, and for how much.

"Coverage [by Medicare carriers] is spotty," says Dr. Catalona. "In our region most of the fPSA tests are covered, but sometimes they’ll debate it." HMOs and private insurers are similar, he adds. In most instances where a carrier or insurer doesn’t want to pay for the test, "I just write a letter and point out there’s a 25 percent chance this man may have prostate cancer. They usually will pay for it, because they don’t want to go on record as having refused it."

Beckman Coulter’s Rigo confirms that different local Medicare carriers have made "significantly different" decisions about whether to cover fPSA. "Local carriers have certain circumstances for which they may pay," he says. For example, Pennsylvania covers it for patients who have had a previous negative biopsy. "Generally, if they will cover it, they’ll pay around $24 for fPSA. That’s pretty low considering the sophisticated nature of immunoassays," Rigo says.

Due to the lack of clarity, Beckman Coulter supports a national coverage policy for fPSA. "We want HCFA to establish a standard," Rigo says. "Right now there’s confusion" because of the local carriers’ differing decisions.

A workgroup formed under the government’s Negotiated Rulemaking Committee on Clinical Diagnostic Laboratory Tests recommended in 1998 that HCFA adopt a national coverage policy for fPSA. But the recommendation was never implemented. "There’s no doubt about it: Adopting that recommendation would have eliminated any ambiguity about reimbursement for fPSA and benefited thousands of patients," Rigo says.

"I agree it should be covered," says Dr. von Eschenbach. "The challenge for HCFA is to determine when. It’s not a matter of blanket coverage. It should not be the routine first-line test. But in someone whose PSA is out of line and you’re trying to further discriminate as to whether that patient should be biopsied, free PSA is a very legitimate next step."

Dr. Catalona predicts HCFA will eventually approve the fPSA test nationally because "it’s going to get harder and harder for them to deny it." And if HCFA were to adopt a national coverage policy on fPSA, private insurers would be likely to follow the government agency’s recommendations.

But any quick action by HCFA is unlikely. The agency is notorious for prolonged debate over coverage of new technologies. In fact, it did not decide to reimburse for PSA until 1998, four years after the FDA cleared it for detection of prostate cancer, "and even then they said they wouldn’t start paying for it until January 2000," Dr. Catalona notes.

Streamlining approvals

The Advanced Medical Technology Association, or AdvaMed, which represents medical technology manufacturers, has been pushing HCFA to streamline its approval procedures for years. HCFA’s technology assessment "is a second hurdle after FDA approval," says Randy Burkholder, associate vice president of AdvaMed, formerly known as HIMA. "It typically takes 15 months to several years for HCFA to act."

One reason for the delay, Burkholder says, is Medicare’s committee process. HCFA has a series of expert advisory panels that, when asked, make recommendations on new technology coverage to an executive committee, which in turn makes recommendations to the administrator. That three-tier process is cumbersome and prone to delay, Burkholder says.

The massive Benefits Improvement and Protection Act (BIPA) of 2000 included technology access provisions encouraging HCFA to look at how it could speed up approvals, he says. For instance, HCFA is directed to issue annual reports on technology approvals, consider eliminating the executive committee approval step, and recommend what additional steps should be taken to streamline coding and payment decisions for new in vitro diagnostics. Another provision outlines the types of evidence HCFA should consider in making coverage decisions, including expert opinion and medical consensus.

Another reason HCFA’s coverage decisions are slow, Burkholder says, is that it accepts applications only once a year and requires six months of marketing data to designate a new coverage code. Depending on when a product got FDA clearance, the six months of marketing data might not be available the first time around at HCFA, "so then you might have to wait another year," he says. "It could take as long as 18 months before you can even submit an application." Although AdvaMed lobbied for BIPA language requiring quarterly instead of annual updates on new technology payment codes, "that provision didn’t get adopted."

The lobbying group will continue to press for "better methods to set proper reimbursement rates for new diagnostic tests and therapies," he adds. By building on the BIPA requirements, "HCFA could take small provisions and pump them up into a sound national method for recognizing the cost of a new test when setting payment levels." AdvaMed will closely monitor HCFA’s implementation this year of the BIPA provisions. "We hope they improve," Burkholder says. "We’re working with HCFA in every way possible."

fPSA’s value questioned

HCFA’s coverage decisions are often delayed until a clear medical consensus emerges. For many tests, including fPSA, that’s an enormous hurdle. Richard J. Hausner, MD, medical director of anatomic and clinical pathology at Cypress Fairbanks Medical Center, Houston, believes the fPSA test is of limited use, especially for younger men. "We hardly ever see anybody order it around here," he says.

According to information supplied by Beckman Coulter, Dr. Hausner notes, "eight of 100 patients in the gray zone for total PSA with elevated fPSA levels will have prostate cancer. Would you get in an airplane if you were told it had ’only’ an eight percent risk of crashing?" The fPSA test "falsely reassures a significant number of patients who actually have cancer," he says.

The test may have value for older men who might have a slow-growing cancer, he notes. "For these patients, a delayed diagnosis due to a misleading fPSA may not be harmful, because the approach to treatment is usually less aggressive than in younger patients," Dr. Hausner says. For younger men with unclear PSA results, most would probably accept the need for biopsy. "That’s not perfect either," he admits, "but if it’s positive, the diagnosis has been made with certainty. If the biopsy is negative, a reassuringly high fPSA still leaves that patient with a finite chance of harboring a malignancy."

Karen Southwick is a freelance writer in San Francisco.