Pathology/Lab Coding Alert

Four new and one revised code in CPT Codes 2001 have helped clarify coding for tumor markers, but getting paid for the tests can still be a problem. "The key to payment is understanding what diagnoses support medical necessity for the tests," says Kenneth Wolfgang, MT (ASCP), CPC, CPC-H, director of coding and analysis at National Health Systems Inc., a coding consultation company in Camp Hill, Pa. Laboratories should educate physicians about these coverage issues when they order the tests, and should ensure that an advance beneficiary notice (ABN) is on file for the service if it is ordered without a payable diagnosis.

"Prior to 2001, code 86316 described most immunoassays for tumor antigens, primarily in serum specimens," Wolfgang says. "However, some markers were covered by insurance based on their clinical usefulness for certain cancers, and others were not. Because 86316 did not provide a definitive account of which assay was carried out, it was difficult to establish medical necessity for the test."

With the addition of the four new codes, several specific tumor markers now have their own, and 86316 (immunoassay for tumor antigen; other antigen, quantitative [e.g., CA 50, 72-4, 549], each) was changed to represent any "other" antigen not specified in the new or existing codes. The new codes are 86294 (immunoassay for tumor antigen, qualitative or semiquantitative [e.g., bladder tumor antigen]), 86300 (immunoassay for tumor antigen, quantitative; CA 15-3 [27.29]), 86301 (immunoassay for tumor antigen, quantitative; CA 19-9) and 86304 (immunoassay for tumor antigen, quantitative; CA 125).

Medicare rules state that "Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered. Failure to provide documentation of the medical necessity of tests may result in denial of claims." For many tests, the local Medicare carrier establishes the specific criteria for medical necessity in a local medical review policy (LMRP). But some tests are subject to a national Medicare coverage policy. Although many of the tumor markers are now under local rules, a national coverage policy has been proposed for the majority of these tests. The proposed rule was published in the March 10, 2000, Federal Register (pages 13082-13167), which can be downloaded from www.nara.gov/fedreg/index.html.

Some local carriers follow the proposed national rule while others do not, and still others have no written policy for the tests. "HCFA has reviewed comments for the proposed rule, and the final version is expected to be published in September 2001," says Suzzette Feliciano, reimbursement specialist for Polymedco, maker of several tumor- marker tests. After the final rule is published, carriers are expected to have one to two years to comply with the national coverage policy.

Note: HCFA has changed its name to the Centers for Medicare & Medicaid Services (CMS). See story,  -News Brief, Article 4, of this publication.

"Laboratories need to find their carriers' coverage policies for these tests," Wolfgang says. "This may be an established LMRP or a written response to a query by the lab if no LMRP exists." Coverage may be limited to certain diagnoses and certain purposes, e.g., to monitor but not diagnose disease. Wolfgang says labs then need to communicate the coverage policies and limitations to physicians through their catalog, newsletter or requisition forms. If the physician requests a test without a supporting diagnosis based on the coverage criteria, an ABN must be on file so the lab can bill the patient if the service is not covered.

Although individual carriers and third-party payers may have different coverage rules for tumor markers that laboratories must abide by, the proposed national rule is instructive regarding indications for these tests based on current clinical research. The proposed rule lists coverage policies for the markers represented by new codes 86300-86304, which are discussed below. "One of the reasons that certain tumor markers were pulled out of the 86316 code and given their own code is that they have become more accepted for certain clinical applications and are no longer generally considered experimental," Wolfgang says. Some of the "other" markers that still fall under  86316 are considered investigational for certain purposes and may not be covered.

Use 86294 for Qualitative Markers

Code 86294 was added in CPT 2001 to distinguish methods that provide only a qualitative or semiquantitative test for tumor antigen, as opposed to a quantitative measurement. This type of test essentially indicates the presence or absence of an antigen rather than the amount of the antigen in the specimen. Certain tests for bladder-tumor antigen fit in this category.

For example, BTA stat is a qualitative bladder-tumor antigen test that indicates only the presence or absence of the marker in urine. Prior to the addition of 86294, this test was reported using 86316 if a laboratory with a moderately complex or higher clinical laboratories improvement act (CLIA) license carried it out. Coders should now bill 86294 when used by these labs. "But the BTA stat test has CLIA waived status and must be reported as 83518-QW (immunoassay for analyte other than infectious agent antibody or infectious agent antigen, qualitative or semiquantitative; single-step method [e.g., reagent strip], -CLIA waived test) when carried out by waived-status labs," Feliciano says. "This has created an inequity in reimbursement, because 86316 pays about $28 while 83518-QW pays between $4.42 and $11.72 for the exact same test." The inequity has not been rectified with the addition of 86294, which pays about $20, because CLIA waived labs cannot use this code but must continue to report the test with 83518-QW.

Other tests for bladder-tumor antigen are quantitative and are used to monitor the level of the marker in urine over time. "These tests are still reported as 86316," Feliciano says. "Payment for this test still remains problematic because many local carriers do not cover 86316 since it is the code used to report many tumor markers that are still considered investigational."

Tumor antigens CA 15-3 and CA 27.29 are often considered medically necessary to aid in the management of patients with breast cancer. Either of these markers may be ordered periodically to assess the patient's response to treatment such as chemotherapy.

For monitoring, either CA 15-3 or CA 27.29 would be used consistently, rather than alternating between the tests. These tumor markers might also be used for postsurgical evaluation for residual tumors or recurrence of disease. CA 15-3 and CA 27.29 are generally not covered for evaluation of patients with signs and symptoms of breast cancer. According to the proposed national rule, 86300 would be payable only for patients with a confirmed diagnosis of breast cancer (174.x-175.x, 198.2, 198.81 or V10.3)

Patients diagnosed with various cancers, including pancreatic, bile duct, colorectal, liver or gastric, may be tested for tumor antigen CA 19-9 to monitor the response to therapy. The physician may order the test at intervals with multiple treatment cycles, or to assess for recurrent disease.

Generally, using CA 19-9 to diagnosis these cancers is not covered. Under the proposed national rule, the test would be covered for patients with a confirmed diagnosis of pancreatic or biliary ductal carcinoma (primary neoplasms 155.1, 156.1, 156.8, 156.9 and 157.x), secondary and other neoplasms of digestive organs (197.8, 235.3 and 235.5) or other personal history of cancer (V10.09). "Currently, CA 19-9 does not have FDA approval and is therefore not reimbursed by Medicare," Feliciano says.

Tumor marker CA 125 is elevated in 80 percent of patients with epithelial ovarian carcinoma. Less often, it is present in patients with cancer of the fallopian tube, endometrium and endocervix. Although not indicated for strictly diagnostic purposes, CA 125 may be covered as part of preoperative testing for a woman with a suspicious pelvic mass. Follow-up levels of the marker may be ordered for postoperative monitoring. According to the proposed rule, three serum levels of the marker may be covered in the first month following treatment to calculate the CA 125 half-life, which is significant for the patient's prognosis. 

Following the completion of treatment, a CA 125 test may be covered as an indicator of residual disease. Periodic measurements of CA 125 might be taken for years to monitor for recurrence of disease.

Medicare's proposed national rule suggests coverage for CA 125 for patients with confirmed diagnoses of neoplasm of the endocervix (180.0), corpus uteri (182.0), ovary (183.0), fallopian tube (183.2) and other female genital organ sites (183.8, 184.8), and secondary or personal history of genital neoplasms (198.6, 198.82, 236.0-236.3 and V10.43-V10.44). 

This code was revised in CPT 2001 to exclude the tumor markers that were assigned to separate codes. The code now reads, "other antigen" to indicate that it is for tumor markers aside from those covered in different codes, e.g., 86304 for CA 125. The word "quantitative" was also added to the definition of 86316 to distinguish it from tests that are qualitative or semiquantitative, which are now reported with 86294. CPT lists three examples of tumor markers to be reported with this code: CA 50, CA 72-4 and CA 549. Most carriers consider these and a host of other tumor markers investigational and do not cover many of them.

Several tumor markers have established clinical uses and have been represented by different CPT codes prior to 2001. Without an awareness of these codes, coders could inadvertently report the services using 86316. Although 86316 is a "catchall" code for unlisted immunoassays for tumor antigen, it would be inappropriate to report a test that has a more specific code using 86316. A brief description of some of these tumor markers, their use and their CPT code is listed below.

Prostate Specific Antigen (PSA). Serum PSA levels are used for monitoring prostate cancer patients. There are three CPT codes for PSA: 84153 (PSA; total) for total PSA; 84154 (PSA: free) for free PSA; and a new code in CPT 2001, 84152 (PSA; complexed [direct measurement]) for a direct measure of complexed PSA. For a complete discussion of these tests, see "New Code Provides Accurate Billing for Prostate Cancer Screening and Monitoring" in the May 2001 issue of Pathology/Lab Coding Alert.

Medicare approves most tumor markers for monitoring, but not for diagnoses. But HCFA (now CMS) has approved PSA for annual prostate-cancer screening in men age 50 or older. When used for screening, the serum PSA test should be reported with G0103.

Alpha-Fetoprotein (AFP). Serum AFP levels are useful for the diagnosis of liver cancer in high-risk patients, such as those with cirrhosis and various forms of hepatitis. The test is reported with 82105 (alpha-fetoprotein; serum).

Carcinoembryonic Antigen (CEA). CEA is indicated for monitoring colorectal cancer and, in some cases, certain other cancers that do not express a more specific marker. It is generally not covered for diagnostic purposes. CEA is reported with 82378.

Human Chorionic Gonadotropin (HCG). Besides being used as a pregnancy test, serum hCG is also used as a tumor marker for the diagnosis and monitoring of germ- cell neoplasms of the ovary and testes. The service is reported with 84702 (gonadotropin, chorionic [hCG]; quantitative).