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MEDICAL POLICY POLICY TITLE ULTRASOUND PROCEDURES OF THE PROSTATE GLAND POLICY NUMBER MP-5.020 Original Issue Date (Created): July 9, 2002 Most Recent Review Date (Revised): September 9, 2008 Effective Date: July 31, 2009- RETIRED I. DESCRIPTION/BACKGROUND Ultrasound uses high frequency sound waves to produce images of structures inside the body. Transrectal ultrasound (TRUS) and prostatic ultrasound are frequently used in the diagnosis and treatment of disorders of the prostate. TRUS is an imaging procedure used to diagnose specific conditions involving the rectum, prostate, genitals, and surrounding tissues. The instruments used in the procedure consist of a transducer (probe), which is inserted into the rectum, a radial or linear scanner, and an imaging screen. Sound waves travel through the body and bounce off the internal organs. The echoes from these waves are translated into an image displayed on an imaging screen. TRUS is also used to guide transrectal needle biopsy, which can be performed without anesthesia. TRUS guided biopsies assist the clinician in taking tissue samples necessary for diagnosis. Prostatic ultrasound is also used for prostate volume study for brachytherapy treatment planning for prostate cancer. TRUS of the prostate, including the seminal vesicles of the testicles, is also used to evaluate male infertility. II. DEFINITIONS AZOOSPERMIA refers to the absence of spermatozoa in the semen. BRACHYTHERAPY refers to in radiation therapy, the use of implants of radiaoactive materials such as radium, cesium, iridium, or gold at the treatment site. OLIGOSPERMIA is a temporary or permanent deficiency of spermatazoa in seminal fluid. PROSTATE SPECIFIC ANTIGEN (PSA) is a marker for cancer of the prostate, found in the blood. It is secreted by both benign and malignant prostate tumors, but cancerous prostate cells secrete it at much higher levels. Page 1 [Note: Final page is signature page and is kept on file, but not issued with Policy.] MEDICAL POLICY POLICY TITLE ULTRASOUND PROCEDURES OF THE PROSTATE GLAND POLICY NUMBER MP-5.020 III. POLICY Prostatic ultrasound may be considered medically necessary for the following indications: Guidance for needle biopsy of the prostate for patients with palpable prostatic nodules; Prostate volume study for brachytherapy treatment planning; Guidance for placement of approved brachytherapy seeds; Evaluation and diagnosis of patients with abnormal digital rectal exams; Evaluation and diagnosis of patients with elevated serum prostate specific antigen (PSA) levels. Transrectal ultrasound of the prostate, including the seminal vesicles of the testicles, may be considered medically necessary for infertility evaluation in male patients when any of the following conditions are present: Unexplained retrograde ejaculation or loss of ejaculation; Palpable seminal vesicle abnormality on digital rectal exam; Low semen volume azoospermia with the absence of severe testicular atrophy; Low semen volume, severe oligospermia (concentration less than five million). Transrectal ultrasound to guide biopsy of the prostate may be considered medically necessary for patients with palpable prostatic nodules. Cross-references MP-2.043 Permanent Low Dose Brachytherapy for Prostate Cancer MP-2.047 Temporary High Dose Brachytherapy for Prostate Cancer IV. EXCLUSIONS The use of prostatic ultrasound for male infertility evaluation when significant sperm are present on ejaculation is considered not medically necessary as there is no conclusive evidence that it clearly improves long term outcomes compared with other techniques. Transrectal ultrasound (without biopsy) is considered investigational for the following applications, as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure: Diagnosis of prostate cancer; Staging of prostate cancer; Screening for prostate cancer; Page 2 [Note: Final page is signature page and is kept on file, but not issued with Policy.] MEDICAL POLICY POLICY TITLE ULTRASOUND PROCEDURES OF THE PROSTATE GLAND POLICY NUMBER MP-5.020 Monitoring the response of prostate cancer to treatment. V. BENEFIT VARIATIONS The existence of this medical policy does not mean that this service is a covered benefit under the member's contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member’s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member’s benefit information or contact Capital for benefit information. VI. DISCLAIMER Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition with their provider and consult their benefit information to determine if the service is covered. If there is a discrepancy between this medical policy and a member’s benefit information, the benefit information will govern. Capital considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law. VII. REFERENCES BCBSA TEC Assessment, 1994; Tab 9. Okihara K, Kamoi K, Lane RB, Evans RB, Troncoso P, Babaian RJ. Role of systematic ultrasound-guided staging biopsies in predicting extraprostatic extension and seminal vesicle invasion in men with prostate cancer. J Clin Ultrasound 2002; 30(3): 123-31. Park SJ, Miyake H, Hara I, Eto H. Predictors of prostate cancer on repeat transrectal ultrasound-guided systematic prostate biopsy. Int J Urol 2003; 10(2): 68-71. Scherr DS, Eastham J, Ohori M, Scardino PT. Prostate biopsy techniques and indications: when, where, and how? Semin Urol Oncol 2002; 20(1): 18-31. Smajlovic F. Role of transrectal ultrasonography in evaluating azoospermia causes. Med Arh 2007; 61(1): 37-9. Taber's Cyclopedic Medical Dictionary, 19th edition. Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company® and Keystone Health Plan® Central. Independent licensees of the Blue Cross and Blue Shield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies. Page 3 [Note: Final page is signature page and is kept on file, but not issued with Policy.] MEDICAL POLICY POLICY TITLE ULTRASOUND PROCEDURES OF THE PROSTATE GLAND POLICY NUMBER MP-5.020 VIII. PRODUCT VARIATIONS [N] = No product variation, policy applies as stated [Y] = Standard product coverage varies from application of this policy, see below [N] CHIP POS [N] Indemnity [N] PPO [N] Special Care [N] HMO [N] POS [N] CHIP HMO [N] FEP HMO [N] SeniorBlue [N] FEP PPO [N] SeniorBlue PPO IX. POLICY HISTORY MP 5.020 CAC 1/27/04 CAC 5/31/05 CAC 6/28/05 CAC 7/25/06 CAC 7/31/07 CAC 7/29/08 Policy approved for retirement effective 7/31/2009. Page 4 [Note: Final page is signature page and is kept on file, but not issued with Policy.]