1. Aetna considers transrectal ultrasound (TRUS) medically necessary for any of the specific conditions involving the prostate, rectum and surrounding tissues listed below:

   1. A suspicion of prostatic disease documented by any of the following:

      1. Member's history; or
      2. Abnormal digital rectal examination; or

      3. Elevation of prostate-specific antigen (PSA greater than 10 ng/ml); or
         

   2. Clinical staging of a member with prostate cancer; or
   3. Metastatic lesions of unknown source, with a high PSA level (PSA greater than 10 ng/ml), which could have their origin in the prostate; or
   4. Determining volume of the prostate prior to brachytherapy; or
   5. Clinical staging of a member with rectal carcinoma; or
   6. Evaluation of members who have had definitive treatment for carcinoma of the rectum where recurrent disease is noted; or
   7. Evaluation of malignant or benign perirectal tumors; or
   8. Evaluation of anal and/or rectal perirectal abscesses; or
   9. Evaluation of an anal or rectal fistula; or
   10. Assessment of anal sphincter dysfunction; or
   11. Infertility and azoospermia where an ejaculatory duct cyst is suspected. (Note: Some benefit plans exclude coverage of infertility services. Please check benefit plan descriptions for details); or

   12. Evaluation of hematospermia (hemospermia), to distinguish idiopathic from secondary causes.
       

2. Aetna considers transrectal ultrasound experimental and investigational as a screening test for prostate disease and for all other indications because peer-reviewed medical literature does not support its use for these indications.

See also CPB 327 - Infertility, CPB 521 - Prostate Cancer Screening.

Prostate cancer is the most common cause of cancer and the second most common cause of cancer deaths in men in the United States. Prostatic carcinoma generally is slowly progressive and may cause no symptoms. Approximately 50 percent of patients with carcinoma of the prostate have either advanced local disease or metastases at the time of diagnosis. This emphasizes the need to detect those patients with potentially curable carcinoma of the prostate at a localized pathologic state. With the development of prostatic ultrasonographic technology, urologists have gained a tool that allows better visualization, more accurate biopsy and earlier detection of carcinoma of the prostate.

Carcinoma of the prostate should be suspected on the basis of abnormal digital rectal findings, hypoechoic lesions on TRUS, or elevated levels of PSA. However, diagnosis requires histologic confirmation, most commonly by TRUS-guided transrectal needle biopsy, which can be done without anesthesia. The advent of TRUS-guided biopsies of the prostate, as opposed to blind finger-guided biopsies, has increased the detection rate of prostate cancer when performed in the presence of an abnormal digital rectal examination (DRE) or with an elevation of the prostatic serum antigen (PSA) above 10 ng/ml.

Among several treatment options available, transperineal prostate brachytherapy has evolved as a medically successful, cost-effective outpatient procedure for treating localized prostate cancer. Transperineal prostate brachytherapy utilizes TRUS as the primary imaging procedure to accurately plan and execute the placement of radioactive seeds into the prostate.

There is insufficient information in the published medical literature to support the use of TRUS alone as a screening tool for prostate cancer; however, TRUS can reduce the number of missed cancers in patients with signs or symptoms that may be related to prostate cancer.

In the preoperative staging of rectal cancer, TRUS is the most accurate imaging modality. It is possible to evaluate the layers of the rectal wall, the depth of tumor penetration and the perirectal lymph nodes. TRUS is 85-95 percent accurate in determining bowel wall penetration and 70-80 percent accurate in identifying lymph node involvement. The accuracy of the findings, as with all ultrasound examinations, depends on the operator.

Obstructive azoospermia represents approximately 10 percent of male hypofertility cases. Cystic lesions of the prostate involving the ejaculatory duct are uncommon in healthy, fertile men; their prevalence increases in infertile men whose examination and semen analyses make them “at risk” for having ductal obstruction. TRUS accurately visualizes abnormalities of the caudal junction of the vas deferens and seminal vesicles, providing a definitive diagnosis without scrototomy.

Transrectal ultrasound is a useful clinical tool for specific conditions involving the prostate, rectum and surrounding tissues. TRUS is less expensive than CT or MRI; the equipment is more mobile, and the procedure can be performed more quickly. Finally, TRUS is well tolerated by patients, and involves no radiation exposure.

Transrectal ultrasound is the imaging procedure of choice for patients with hematospermia.  Polito et al (2006) stated that the presence of blood in ejaculate represents 1 % of all andrological and urological symptoms.  In most cases it has a benign character and tends to regress spontaneously after the first episode.  But in the same case it can be caused by bladder-prostate or systemic malignant pathology, so it is necessary to subject the patient to laboratory and instrumental tests in order to find the best treatment that, as for hematospermia, is an etiological one.  Most important for correct diagnosis are patient history, physical examination, laboratory tests, TRUS examination of the prostate, MRI, CT, cystoscopy.  Hematospermia is rarely associated with significant pathology, especially in younger men.  The three factors that dictate the extent of the evaluation and treatment are age of patient, the duration and recurrence of the hematospermia, and the presence of any associated hematuria.  Thus, it is possible to distinguish idiopathic from secondary hematospermia, because secondary hematospermia, namely. the one in which the bleeding cause is known or suspected, requires an etiologic treatment.  Understanding the pathophysiology and prevalence in populations of different ages helps minimize the likelihood of problems.  When in doubt, performing a TRUS, cystoscopy, and basic laboratory analyses limits exposure.  Also, Zhang et al (2003) reported that TRUS-guided transperineal aspiration of seminal vesicle fluid was helpful to the etiologic diagnosis of persistent hematospermia.  Furthermore, Yagci et al (2004) noted that TRUS is a safe, non-invasive method for examining causes of hematospermia.  These researchers believed that it should be the first radiological investigationimaging procedure to be performed in patients presenting with hematospermia.