Because PSA is a prostate cancer marker, it is a valuable tool for detecting and monitoring the disease. PSA travels in the blood, and the total level is readily measured in a serum specimen. However, a large percentage of PSA is bound, or complexed to protein in the blood, with the remaining portion known as free PSA.
It is the level of cPSA that is most strongly associated with prostate cancer, but until recently, there was no way to measure that fraction directly. Only free and total PSA could be measured, and the ratio of free/total PSA was reported as an approximation of the cPSA. The level of total PSA has often been used as a screening indicator for prostate cancer. As a diagnostic tool, all three assays (total, complexed and free/total ratio) have about the same sensitivity, meaning that they detect the same percentage of cancer patients, explains Lawrence Ferreri, PhD, clinical chemist at Northwest Clinical Laboratory in Northwest Hospital, Seattle. The difference is in the specificity, or the number of false positives. Both complexed PSA and free/total PSA ratio have fewer false positives than the traditional total PSA assay, perhaps 20 to 30 percent fewer, Ferreri says.
This improved specificity is important, because all positive PSA tests must be confirmed by biopsy. The goal is to use a more specific test that will help us avoid a significant number of patients undergoing biopsies that turn out to be negative, Ferreri says.
The data are unclear if the cPSA affords greater specificity than the free/total ratio. However, it is clear that calculating the free/total PSA ratio requires two tests, reported as CPT 84153 (prostate specific antigen [PSA]; total) and 84154 (prostate specific antigen [PSA]; free). Because each test involves analytical variation, the free/total PSA ratio will be inherently less accurate than the direct measure of cPSA, Ferreri says.
Coding for Prostate Cancer Screening
The most common blood test we see ordered for prostate cancer screening is total PSA, says Jean Borgman, MT (ASCP), MBA, director of laboratory services at Northwest Clinical Laboratory in Northwest Hospital, Seattle. The CPT code for this test is 84153, but when reporting the screening test to Medicare, coders must use G0103 (prostate cancer screening; prostate specific antigen test [PSA], total).
Medicare began coverage for prostate cancer screening on Jan. 1, 2000. Subject to the HCFA restrictions, Medicare patients who do not have symptoms or a diagnosis that supports a PSA test can now benefit from its use as an early-detection tool, according to Ken Wolfgang MT (ASCP), CPC, CPC-H, director of coding and analysis for National Health Systems Inc., a coding consultation company in Camp Hill, Pa. Healthcare providers should check with other payers to determine their specific coverage policies for prostate cancer screening, Wolfgang says. An appropriate ICD-9 code to identify the reason for the screening procedures is V76.44 (special screening for malignant neoplasms, prostate).
Whether the patient comes in for a preventive medicine evaluation or presents with symptomatic complaints unrelated to prostate disease, G0103 can be reported on the same day for the same patient as the appropriate E/M code, Wolfgang says. G0103 represents a screening laboratory procedure that is ordered by the patients physician or other approved healthcare provider. HCFA has placed restrictions on reimbursement for PSA testing for prostate cancer screening. Three requirements must be met:
1. Patient is a male, aged 50 or older;
2. Test/procedure is ordered/performed by a doctor of medicine or osteopathy, or a qualified physician assistant, nurse practitioner or clinical nurse specialist; and
3. Test/procedure is performed at a frequency no greater than once every 12 months.
HCFA edits will result in reimbursement denial for patients who do not meet these age, sex and frequency guidelines.
What about the use of the direct cPSA test (84152) or the calculated free/total PSA ratio (84154, 84153) for prostate cancer screening? Compared to using total PSA, we can see an enhancement in the specificity of the screening using either cPSA or free/total PSA ratio, Ferreri says. The advantage of cPSA is that a single test provides at least the same avoidance of negative biopsy as the two tests required for the free/total PSA ratio. Medicare will only reimburse for one PSA blood test for prostate cancer screening, with obvious economic consequences for running the free and total tests to acquire the calculated ratio.
According to John Talley, marketing manager for Bayer Corp., Diagnostics Division in Tarrytown, N.Y., the use of the cPSA test on the Bayer Immuno1 Analyzer has been approved by the U.S. Food and Drug Administration (FDA) as an aid in detecting of prostate cancer and cleared by FDA for monitoring prostate cancer. The G0103 code means that the cPSA test on this instrument is coded for coverage by Medicare for prostate cancer screening the same as total PSA, he says. Talley clarifies that the cPSA test on two other Bayer analyzer platforms, the ACS:180 and ADVIA Centaur, is approved for prostate cancer monitoring, and is pending FDA approval for use as an aid in detecting of prostate cancer.
Coding for Diagnostic PSA Testing
According to Wolfgang, the CPT codes for PSA testing (complexed 84152, total 84153 and free 84154) are used when the tests serve a diagnostic, rather than a screening, purpose. The physician determines which test to administer, based on the medical needs of the patient, Wolfgang says. These tests may be carried out for patients who returned a positive PSA screen (ICD-9 code 790.93 elevated prostate specific antigen), or who are being treated for prostate cancer (185) or benign prostatic hypertrophy (600.0).
For example, the physician may order periodic total PSA (84153) to monitor a patient following surgery for prostate cancer. If the descending level of total PSA rebounds and begins to rise again, the physician may order free PSA (84154) to isolate the source of the increasing antigen levels.
Complexed PSA is a valuable tool not only as an aid in detection of prostate cancer but also for monitoring the progress of treatment in prostate cancer patients, Talley says. When physicians use this test for diagnostic purposes on non-Medicare patients and monitoring purposes on all patients, they should report the service as 84152. Prior to the addition of this code in CPT 2001, the cPSA test was reported using the nonspecific tumor marker code 86316 (immunoassay for tumor antigen each) Now that the new code is in place, 86316 should no longer be used to report the cPSA test, Talley says.