Prostate Specific Antigen (PSA)
DESCRIPTION
The prostate specific antigen (PSA) test measures serum levels of the prostate cancer-associated antigen, PSA. The test is used to monitor for progression or regression of prostate cancer after therapy. Although increased serum prostate specific antigen (PSA) can be an early indicator of prostate cancer, other conditions such as benign prostatic hypertrophy (BPH) can also cause an elevation in the serum PSA level. Measurement of different molecular forms of PSA (free or protein-bound) can increase specificity of the PSA test.
The percent free PSA test measures the free-to-total PSA ration and is intended for use in conjunction with the total PSA test to aid in distinguishing between prostate cancer and benign prostate conditions. Percent free PSA is significantly lower in individuals who have prostate cancer; therefore, this test is intended to improve the clinical usefulness of the PSA test for detecting early prostate cancer, while decreasing the number of unnecessary prostate biopsies.
POLICY
Total prostate specific antigen (PSA) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
The percent free PSA is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
MEDICAL APPROPRIATENESS
Prostate specific antigen (PSA) is considered medically appropriate if ANY ONE of the following criteria is met:
Total PSA for ANY ONE of the following:
Men age 50 years or older
Men under age 50 when determined by a physician to be medically necessary
The percent free PSA test for ALL of the following:
When used in conjunction with the total PSA test to aid in distinguishing between malignant and benign prostate conditions
Men age 50 years or older
Have a total PSA level between 4 and 10 ng/mL
Digital rectal examination is not suspicious for malignancy
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
This medical policy does not apply to TennCare, please refer to the TennCare policy.
ADDITIONAL INFORMATION
The PSA is accepted in accordance with the 1997 TN State mandate.
SOURCES
American Cancer Society (2009, January) Detailed Guide: Prostate Cancer. Can prostate cancer be found early? Retrieved May 14, 2009 from http://www.cancer.org/docroot/CRI/content/CRI_2_4_3X_Can_prostate_cancer_be_found_early_36.asp?sitearea=.
American Urological Association, Inc. (2000). Prostate-specific antigen (PSA) best practice policy. Oncology, 14 (2), 267-286. (Level 4 Evidence)
American Urological Association, Inc. (2009, April) AUA Policy 2009 Early detection of prostate cancer. Retrieved May 14, 2009 from http://www.auanet.org/content/guidelines-and-quality-care/policy-statements/e/early-detection-of-prostate-cancer.cfm.
American Urological Association, Inc. (2009, April) AUA Prostate-specific antigen best practice statement 2009 update. Retrieved May 14, 2009 from http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines/main-reports/psa09.pdf.
Andriole, G., Crawford, E., Grubb, R., Buys, S., Chia., D.,Church, T., et al. (2009). Mortality results from a randomized prostate-cancer screening trial. New England Journal of Medicine, 360 (13), 1310 - 1319. (Level 2 Evidence)
Bergstralh, E., Roberts, R., Farmer,S., SLezak, J., Lieber, M., & Jacobsen, S. (2007). Population-based case-control study of PSA and DRE screening on prostate cancer mortality. Urology, 70 (5), 936 - 941. (Level 4 Evidence)
Calogne, N., Petitti, D., DeWitt, T., Dietrich, A., Gregory, K., Harris, R. et al. (2008). Screening for prostate cancer: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine, 149 (3), 185 - 191. (Level 4 Evidence)
Code of Federal Regulations. Title 17, Session 111. (2009, April). H.R. 2115 IH. Men and Families Health Care Act of 2009. Retrieved May 14, 2009 from http://thomas.loc.gov/.
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, April). Prostate Specific Antigen PSA (NCD 190.31, p. 2-146). The Ingenix Complete Guide to Medicare Coverage Issues.
Croswell, J., Kramer, B., Kreimer, A., Prorok, P., Xu, J., Baker, S., et al. (2009). Cumulative incidence of false-positive results in repeated, multimodal cancer screening. Annals of Family Medicine, 7 (3), 212 - 222. (Level 4 Evidence)
ECRI Institute. Health Technology Assessment Information Service. Comprehensive technology assessments. (1999, December). Screening for prostate cancer with the serum PSA assay: A Markov process cost-effectiveness decision analysis. Retrieved August 28, 2006 from ECRI HTAIS. (334 articles and/ or guidelines reviewed)
Hayes. Medical Technology Directory Update Search. (2007 April). Prostate-specific antigen testing for prognosis and monitoring of patients with prostate cancer. Retrieved May 14, 2009 from https://www.hayesinc.com/subscribers/subscriberHome.do. (10 articles and/ or guidelines reviewed)
Hayes. Medical Technology Directory Update Search. (2008 February). Prostate-specific antigen testing for screening and early detection of prostate cancer. Retrieved May 14, 2009 from https://www.hayesinc.com/subscribers/subscriberHome.do. (19 articles and/ or guidelines reviewed)
Hayes. Medical Technology Directory. ( 2003, September). Prostate-specific antigen testing for screening and early detection of prostate cancer. Retrieved May 14, 2009 from https://www.hayesinc.com/subscribers/subscriberHome.do. (101 articles and/ or guidelines reviewed)
Hayes. Medical Technology Directory. (2002 February). Prostate-specific antigen testing for prognosis and monitoring of patients with prostate cancer. Retrieved May 14, 2009 from https://www.hayesinc.com/subscribers/subscriberHome.do. (44 articles and/ or guidelines reviewed)
Lim, L. S., Sherin, K., ACPM Prevention Practice Committee. (2008). Screening for prostate cancer in U.S. men ACPM position statement on preventive practice. American Journal of Preventive Medicine, 34 (2), 164 - 170. (Level 4 Evidence)
Lin,K., Lipsitz, R., Miller, T., & Janakiraman, S. U.S. Preventive Services Task Force.(2008). Benefits and harms of prostate-specific antigen screening for prostate cancer: an evidence update for the U.S. Preventive Services Task Force. Annals of Internal Medicine, 149 (3), 192 - 199. (Level 4 Evidence)
Lu-Yao, G., Albertson, P., Stanford, J., Stukel, T., Walker-Corkery, E., & Barry, M. (2008). Screening, treatment, and prostate cancer mortality in the Seattle area and Connecticut: fifteen-year follow-up. Journal of General Internal Medicine, 23(11), 1809 - 1814. (Level 4 Evidence)
Pienta, K. (2009) Critical appraisal of prostate-specific antigen in prostate cancer screening: 20 years later. Urology, 73 (5 Supplement) S11 - 20. (Level 4 Evidence)
Schroder, F., & Roobol, M. (2009). Defining the optimal prostate-specific antigen threshold for the diagnosis of prostate cancer. Current Opinion in Urology, 19 (3), 227 - 231. (Level 5 evidence)
Schroder, F., Hugosson, J., Roobol, M., Tammela, T., Ciatto, S., & Nelen, V. (2009). Screening and prostate-cancer mortality in a randomized European study. New England Journal of Medicine, 360 (13), 1320 - 1328. (Level 2 Evidence)
Stangelberger, A., Margreiter, M., Seitz, C., & Djavan, B. (2007). Prostate cancer screening markers. The Journal of Men’s Health and Gender, 4 (3), 233 - 244. (Level 4 Evidence)
Tennessee Code. Title 56 Insurance. Chapter 7 Policies and Policyholders, Part 23 Mandated Insurer or Plan Coverage, 56-7-2354. 1997. Early detection of prostate cancer.
U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. National Coverage Analyses. (July, 2007). NCD for prostate cancer screening tests (210.1). Retrieved May 14, 2009 from http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=210.1&ncd_version=2&show=all.
U. S. Food and Drug Administration. (1994, August). Center for Devices and Radiological Health. Pre-market approval P000027. Retrieved May 14, 2009 from http://www.fda.gov/cdrh/pdf/p000027a.pdf.
Wang, Y., Sun, G., Pan, J., Guo, Z., & Li, T. Performance of tPSA and f/tPSA for prostate cancer in Chinese. A systematic review and meta-analysis. ( 2006). Prostate Cancer and Prostatic Diseases, 9(4), 374 - 378. (Level 4 Evidence)
Wein, A., Kavoussi, L., Novick, A., Partin, A., & Peters, C. (Eds.). (2007). Campbell-Walsh Urology (9th ed., pp. 2912 - 2948). Philadelphia, PA: Saunders Elsevier.
Wilbur, J. (2008). Prostate cancer screening: the continuing controversy. American Family Physician, 78 (12), 1377 - 1384. (Level 5 Evidence)
ORIGINAL EFFECTIVE DATE: 7/1995
MOST RECENT REVIEW DATE: 7/9/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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