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Medical Policy: 02.04.25
Original Effective Date: October 2009
Reviewed: April 2012
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Prostate-specific antigen (PSA) is a serine protease secreted by normal prostate epithelium. Men with prostate cancer may have high PSA levels due to enhanced production of PSA, as well as architectural distortions in the gland that allow greater access to the circulation. Elevations of serum PSA may also be associated with other prostatic diseases including benign prostatic hypertrophy (BPH) and prostatitis.
Prostate cancer is the second leading cause of cancer death in men, although the vast majority of men diagnosed with the disease will not actually die from it. The results of two major clinical trials published in 2009 indicate the practice of routinely screening men with a PSA test has minimal impact on deaths from prostate cancer. Because most prostate tumors are slow-growing and would not lead to harm if untreated, screening has lead to unnecessary treatments with significant side effects. Subsequently, in many men more harm than good is accomplished by treating clinically insignificant tumors.
The American Cancer Society (ACS) does not support routine testing for prostate cancer at this time. ACS does believe the potential benefits and limitations of prostate cancer early detection should be discussed with average-risk men with a life expectancy of at least 10 years beginning at age 50 and men at high-risk starting at age 45. Such discussion should include an offer for testing with a PSA test and digital rectal exam. Men considered at high risk for developing prostate cancer include African-American men and those who have a first-degree relative (father, brother, or son) diagnosed with prostate cancer at an early age (younger than age 65).
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Prior Approval:
Not applicable
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Policy:
Annual total PSA testing for prostate cancer screening may be considered medically necessary for either of the following:
- Asymptomatic men at any age who are at high risk of prostate cancer due to any of the following factors:
- African-American race
- First degree relative(s) (father, brother, or son) diagnosed with prostate cancer at age 65 or younger
- Asymptomatic men age 50 and over with a life expectancy of at least 10 years.
All other screening indications are considered not medically necessary.
The percent free PSA test (%fPSA) when used in conjunction with the total PSA test to aid in distinguishing between malignant and benign prostate conditions, may be considered medically necessary if all of the following criteria are met:
- Men age 50 years or older
- Have a total PSA level between 4 and 10 ng/mL
- Digital rectal exam is not suspicious for malignancy
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- 84152 Prostate-specific antigen (PSA); complexed (direct measurement)
- 84153 Prostate specific antigen (PSA); total
- 84154 Prostate-specific antigen (PSA); free
- G0103 Prostate cancer screening; prostate specific antigen test (PSA)
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Selected References:
- Barry MJ. Clinical Practice. Prostate-specific-antigen testing for early diagnosis of prostate cancer. N Engl J Med. 2001 May 3; 344(18):1373-7.
- Wilson WG et al. Abelhoff’s Clinical Oncology, 4th ed. Churchill Livingstone Elsevier, Philadelphia, PA, 2008, Chap. 88, “Prostate Cancer”.
- Andriole GL, Crawford ED, Grubb 3rd RL et al. Mortality Results from a Randomized Prostate-Cancer Screening Trial. N Engl J Med 2009; 360(13): 1310-19.
- Brawley OW, Ankerst DP, Thompson IM. Screening for Prostate Cancer. CA Cancer J Clin 2009[Epub prior to print June 29, 2009].
- Schroder FH, Hugosson J, Roobol MJ et al. Screening and Prostate Cancer Mortality in a Randomized European Study. N Engl J Med 2009; 360(13): 1320-28.
- Miller MC, O’Dowd GJ, Partin AW et al. Contemporary use of complexed PSA and calculated percent free PSA for early detection of prostate cancer: Impact of changing disease demographics. Urology. 2001 Jun;57(6):1105-11.
- Catalona WJ, Partin AW, Slawin KM et al. Use of the percentage of free prostate-specific antigen to enhance differentiation of prostate cancer from benign prostatic disease: A prospective multicenter clinical trial. JAMA. 1998 May 20; 279(19):1542-7.
- Lin K, Lipsitz R, Miller T et al. Benefits and Harms of Prostate-specific Antigen Screening for Prostate Cancer: An Evidence Update for the U.S. Preventive Services Task Force. Ann Intern Med. 2008;149(3):192-99.
- Lim LS, Sherin K, and the American College of Preventive Medicine (ACPM) Prevention Practice Committee. Screening for Prostate Cancer in U.S. Men: ACPM Position Statement on Preventive Practice. Am J Prev Med 2008;34(2):164-70.
- Wolf AM, Wender RC, Etzioni RB et al. American Cancer Society Prostate Cancer Advisory Committee. American Cancer Society guideline for the early detection of prostate cancer: update 2010. CA Cancer J Clin 2010 Mar-Apr;60(2):70-98
- Sandblom G, Varenhorst E, Rosell J et al. Randomised prostate cancer screening trial: 20 year follow up. BMJ 2011;342:d1539. doi:10.1136/bmj.d1539.
- Shao Y-H, Albertsen PC, Roberts CB et al. Risk profiles and treatment patterns among men diagnosed as having prostate cancer and a prostate-specific antigen level below 4.0 ng/mL. Arch Intern Med. 2010;170(14):1256-61.
- Screening for Prostate Cancer, Topic Page. August 2008. U.S. Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/uspstf/uspsprca.htm.
- Djulbegovic M, Beyth RJ, Neuberger MM et al. Screening for prostate cancer: systematic review and meta-analysis of randomised controlled trials. BMJ 2010;341:c4543. doi:10.1136/bmj.c4543.
- Crawford ED, Grubb III R, Black A et al. Comorbidity and mortality results from a randomized prostate cancer screening trial. J Clin Oncol Feb 1,2011;29(4):355-61.
- Loeb S, Vonesh EF, Metter J et al. What is the true number needed to screen and treat to save a life with prostate-specific antigen testing? J Clin Oncol Feb1, 2011;29(4):464-67.
- Hugosson J, Carlsson S, Aus G et al. Morality results from the Göteborg randomised population-based prostate-cancer screening trial. Lancet Oncol 11:725-32, 2010.
- Chou R, Croswell JM, Dana T et al. Screening for prostate cancer: a review of the evidence for the US Preventive Services Task Force. Ann Intern Med. 2011; 155(11):762-71.
- Cooperberg MR, Broering JM, Carroll PR. Time trends and local variations in primary treatment of localized prostate cancer. J Clin Oncol. 2010; 28(7):1117-1123.
- US Preventive Services Task Force Screening for Prostate Cancer; US Preventive Services Task Force recommendation statement: draft summary of recommendation and evidence. http://www.uspreventiveservicestaskforce.org/uspstf12/prostate/draftrecprostate.htm Accessed April 2012.
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Policy History:
Date Reason Action
May 2011 Annual review Policy renewed
April 2012 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.
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