Clinical UM Guideline
|Guideline #:||CG-MED-45||Current Effective Date:||05/13/2013|
|Status:||New||Last Review Date:||05/09/2013|
This document addresses the use of transrectal ultrasonography in the diagnosis, staging, and management of conditions involving the prostate, rectum, and surrounding tissues.
Note: Please see the following related document for additional information:
Transrectal ultrasonography (TRUS) is considered medically necessary for any of the following indications:
Not Medically Necessary:
Transrectal ultrasonography is considered not medically necessary for the following:
The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|154.0-154.8||Malignant neoplasm of rectum, rectosigmoid junction, and anus|
|185||Malignant neoplasm of prostate|
|195.3||Malignant neoplasm of pelvis|
|197.5||Secondary malignant neoplasm of large intestine and rectum|
|198.82||Secondary malignant neoplasm of genital organs|
|209.17||Malignant carcinoid tumor of the rectum|
|209.57||Benign carcinoid tumor of the rectum|
|211.4||Benign neoplasm of rectum and anal canal|
|222.2||Benign neoplasm of prostate|
|230.4-230.6||Carcinoma in situ of rectum, anal canal, anus|
|233.4||Carcinoma in situ of prostate|
|235.2||Neoplasm of uncertain behavior of stomach, intestines, and rectum|
|235.5||Neoplasm of uncertain behavior of other and unspecified digestive organs|
|236.5||Neoplasm of uncertain behavior of prostate|
|239.0||Neoplasms of unspecified nature, digestive system|
|239.5||Neoplasms of unspecified nature, other genitourinary organs|
|565.0-565.2||Anal fissure and fistula|
|566||Abscess of anal and rectal regions|
|569.0-569.5||Other disorders of intestine|
|600.00-600.91||Hyperplasia of prostate|
|601.0-601.9||Inflammatory diseases of prostate|
|602.0-602.9||Other disorders of prostate|
|614.0-616.9||Inflammatory disease of female pelvic organs|
|617.4||Endometriosis of rectovaginal septum and vagina|
|619.1||Digestive-genital tract fistula, female|
|751.2||Congenital atresia and stenosis of large intestine, rectum, and anal canal|
|751.4||Anomalies of intestinal fixation|
|751.5||Other anomalies of intestine|
|752.49||Other anomalies of cervix, vagina, and external female genitalia|
|752.89||Other specified anomalies of genital organs|
|787.60-787.63||Incontinence of feces|
|789.30-789.39||Abdominal or pelvic swelling, mass, or lump|
|790.93||Elevated prostate specific antigen (PSA)|
|796.4||Other abnormal clinical findings|
|V10.06||Personal history of malignant neoplasm of rectum, rectosigmoid junction, and anus|
|V10.46||Personal history of malignant neoplasm of prostate|
|ICD-10 Diagnosis||ICD-10-CM draft codes; effective 10/01/2014:|
|C19||Malignant neoplasm of rectosigmoid junction|
|C20||Malignant neoplasm of rectum|
|C21.0-C21.8||Malignant neoplasm of anus and anal canal|
|C61||Malignant neoplasm of prostate|
|C7A.026||Malignant carcinoid tumor of the rectum|
|C76.3||Malignant neoplasm of pelvis|
|C78.5||Secondary malignant neoplasm of large intestine and rectum|
|C79.82||Secondary malignant neoplasm of genital organs|
|D01.1-D01.3||Carcinoma in situ of rectosigmoid junction, rectum, anus and anal canal|
|D07.5||Carcinoma in situ of prostate|
|D12.7-D12.9||Benign neoplasm of rectosigmoid junction, rectum, anus and anal canal|
|D29.1||Benign neoplasm of prostate|
|D3A.026||Benign carcinoid tumor of the rectum|
|D37.5||Neoplasm of uncertain behavior of rectum|
|D37.8||Neoplasm of uncertain behavior of other specified digestive organs|
|D40.0||Neoplasm of uncertain behavior of prostate|
|D49.0||Neoplasm of unspecified behavior of digestive system|
|D49.5||Neoplasm of unspecified behavior of other genitourinary organs|
|K60.0-K60.5||Fissure and fistula of anal and rectal regions|
|K61.0-K61.4||Abscess of anal and rectal regions|
|K62.0-K62.9||Other diseases of anus and rectum|
|N41.0-N41.9||Inflammatory diseases of prostate|
|N42.0-N42.9||Other and unspecified disorders of prostate|
|N70.01-N77.1||Inflammatory diseases of female pelvic organs|
|N80.4||Endometriosis of rectovaginal septum and vagina|
|N82.3||Fistula of vagina to large intestine|
|Q42.0-Q42.9||Congenital absence, atresia and stenosis of large intestine|
|Q43.0-Q43.9||Other congenital malformations of intestine|
|Q52.2||Congenital rectovaginal fistula|
|Q55.4||Other congenital malformations of vas deferens, epididymis, seminal vesicles and prostate|
|R19.00-R19.09||Intra-abdominal and pelvic swelling, mass and lump|
|R19.8||Other specified symptoms and signs involving the digestive system and abdomen|
|R97.2||Elevated prostate specific antigen (PSA)|
|Z85.040-Z85.048||Personal history of malignant neoplasm of rectum, rectosigmoid junction, and anus|
|Z85.46||Personal history of malignant neoplasm of prostate|
|Z87.430||Personal history of prostatic dysplasia|
Transrectal ultrasonography (TRUS), also called endorectal ultrasound (ERUS), is an imaging procedure used in the diagnosis, staging, and management of conditions involving the prostate, rectum, and surrounding tissues. TRUS has both diagnostic and therapeutic indications. The brief outpatient procedure involves the use of a small lubricated probe inserted into the rectum that sends out high-energy sound waves. These sound waves bounce off internal tissues or organs, making echoes that form a picture of body tissue called a sonogram. While the probe may be temporarily uncomfortable, TRUS is essentially a painless procedure.
Prostate cancer is the most common cancer found in North American men other than skin cancer and is the second leading cause of cancer death. Estimated new cases and disease-related deaths from prostate cancer in the United States in 2013 is 238,590 and 29,720, respectively (NCI, 2013). Imaging procedures suggested as possible screening modalities for prostate cancer include ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI). Each modality has relative merits and disadvantages for distinguishing different features of prostate cancer. Ultrasound has received the most attention, having been examined by several investigators in observational settings (Waterhouse, 1989). The sensitivity of TRUS in these settings ranged from 71% to 92% for prostate cancer and 60% to 85% for subclinical disease. Specificity values ranged from 49% to 79%, and positive predictive values in the 30% range have been reported. The sensitivity and positive predictive value for ultrasound as a single test may be better than for rectal examination. The rate of cancer is extremely low among ultrasound-positive men in whom rectal and PSA examinations are normal (Cooner, 1988). "TRUS is generally relegated to a role in the diagnostic work-up of an abnormal screening test rather than in the screening algorithm. The cost and poor performance of other imaging modalities have led to their elimination from all early detection algorithms" (NCI, 2013).
According to the National Cancer Institute (NCI, 2013), the gold standard to assist in the diagnosis of prostate cancer is a prostate biopsy. Contemporary prostate biopsy relies on spring-loaded biopsy devices that are either digitally guided or guided via ultrasound. TRUS guidance is the most frequently used method of directing prostate needle biopsy because there is some suggestion that the yield of biopsy is improved with such guidance (Renfer, 1995). With the virtually simultaneous clinical acceptance of TRUS, spring-loaded biopsy devices, and the proliferation of PSA screening in the late 1980s, the number of prostate cores obtained from individuals with either an abnormal DRE or PSA was most commonly six, using a sextant method of sampling the prostate (Hodge, 1989).
The American College of Radiology (ACR) Appropriateness Criteria® for pretreatment detection, staging, and surveillance of prostate cancer recommends a TRUS-guided needle biopsy of the prostate gland if either the DRE or PSA test suggests malignancy (Eberhardt, 2013).
The National Comprehensive Cancer Network® guidelines for early detection of prostate cancer (NCCN, 2012) state a TRUS-guided transrectal needle biopsy should be performed in the follow-up evaluation of an abnormal (positive) DRE regardless of PSA results. In the presence of a negative DRE but a PSA greater than 10 ng/mL, the NCCN recommends a TRUS-guided biopsy. Repeat TRUS-guided biopsy for management of negative or positive biopsy results is based on DRE and PSA findings and the risk factors of the individual.
A best practice statement of the American Urological Association (AUA, 2009) recommends a standard prostate biopsy be performed after an elevated PSA test utilizing a TRUS-guided approach in the outpatient setting with local anesthesia. The AUA, however, does not recommend a single threshold value that would prompt a prostate biopsy. The AUA states the decision to proceed to prostate biopsy should be based primarily on PSA and DRE results but should take into account multiple factors, including free and total PSA, age of the individual, PSA velocity, PSA density, family history, ethnicity, prior biopsy history and comorbidities.
Transperineal prostate brachytherapy is considered a treatment option for clinically localized prostate cancer. TRUS is used as an effective guide prior to brachytherapy to determine the number of needles and corresponding radioactive seeds, the isotope, and the isotope strength for the procedure and during the procedure to execute the placement of the radioactive seeds into the prostate (Davis, 2012). A best practice statement of the AUA (2008) recommends assessment of the anatomic region adherent to the prostate gland with TRUS be performed prior to cryoablation for the treatment of localized prostate cancer, and to determine the placement of posterior cryoprobes and the tip of the thermocouple as documented by TRUS with or without cystoscopy (Donnelly, 2005).
The peer-reviewed medical literature does not support the use of TRUS alone as a screening tool for prostate cancer because of its low sensitivity and positive predictive value. A best practice statement of the AUA (2009) states that TRUS adds no additional information to the combination of PSA testing and DRE as screening tests, but is useful in biopsy guidance and staging. "It is important to note that as the presence of prostate cancer cannot be excluded on the basis of ultrasonography alone, there is no role for transrectal ultrasound by itself in screening for cancer" (AUA, 2009).
In 2013, the NCI estimates 40,340 new cases and 50,830 deaths from colorectal (combined) cancer in the United States. Pretreatment local staging evaluation for rectal cancer is mainly accomplished through physical examination, endoscopy, CT scans, MRI, and TRUS.
According to ACR Appropriateness Criteria for pretreatment staging of colorectal cancer, imaging modalities including TRUS, CT, and MRI have all been extensively evaluated in the initial staging of colorectal cancer (Dewhurst, 2012). TRUS has become the standard imaging procedure for staging rectal cancer (Rifkin, 1986; Rifkin, 1989). TRUS is useful for locoregional tumor staging and is considered to be more accurate than axial CT scans for assessing the depth of tumor invasion, perirectal spread, and nodal staging. Several studies comparing the accuracy of TRUS to CT and MRI suggest that TRUS is superior to both for primary tumor (T) staging of rectal cancer (Kim, 1999). In one systematic review, the accuracy of TRUS was greatest (95%) in distinguishing whether a tumor was confined to the rectal wall or invaded through it (tumor grades T1-T2 versus T3 or greater). TRUS has also been associated with overstaging of rectal cancer and is not fully accurate in differentiating T2 from T3 lesions (Dewhurst, 2012).
Comparative studies report the accuracy of TRUS for defining the status of the regional lymph nodes (approximately 70% to 75%) is similar to CT (55% to 65%) and MRI (60% to 65%). TRUS, however, has not been shown to be predictive of the histology of the visualized lymph nodes. Many lymph nodes measuring less than five millimeters in diameter have associated micrometastases, and some early-stage T1 and T2 tumors are likely to have lymph node micrometastases missed by TRUS (Dewhurst, 2012).
Bipat and colleagues (2004) performed a meta-analysis of 90 articles published between 1985 and 2002 comparing the staging accuracy of TRUS, CT, and MRI to histopathologic findings as the reference standard. TRUS and MRI had similar sensitivity for muscularis propria invasion (T1 versus T2 disease), and specificity of TRUS was significantly higher (86% versus 69%). The sensitivity of TRUS for perirectal tissue invasion (T3 disease) was significantly higher than either MRI or CT (90% versus 82% and 79%, respectively). For invasion of adjacent organs (T4 disease) and lymph node involvement, estimates for TRUS, CT, and MRI were comparable. However, Dewhurst and colleagues (2012) state that although reports suggest that TRUS and MRI "may provide better methods than CT for staging rectal cancer, to date they have not been successful enough to be used routinely as the sole imaging modality."
The American Society of Colon and Rectal Surgeons (ASCRS) practice parameters for the treatment of rectal cancer (Tjandra, 2004) recommend that TRUS, CT, or MRI of the abdomen and pelvis should typically be performed in individuals who are potential surgical candidates. "Transrectal ultrasound has emerged as the diagnostic modality of choice for preoperative local staging of mid and distal rectal cancers. TRUS more accurately assesses bowel wall penetration and lymph node involvement." The practice parameter states that "Overall MRI has similar accuracy to TRUS in tumor staging," however, "MRI seems to be more accurate in assessing T4 and T4 lesions, whereas TRUS may be more accurate in defining earlier-stage lesions (T1, T2). Nodal staging seems to be comparable between TRUS and MRI."
TRUS is a clinically useful tool for evaluation of other conditions involving the prostate, rectum, and surrounding tissues and has been used in the evaluation of congenital anomalies. The procedure can be performed quickly and is well-tolerated by individuals with no exposure to radiation. TRUS can identify structural abnormalities of the prostate gland, seminal vesicles, and spermatic cord, and guide biopsies if suspicious abnormalities are identified in those organs. Additional uses of TRUS include assessment of the prostate gland and prostate volume before medical management or minimally invasive surgical procedures for BPH (for example, transurethral microwave thermotherapy [TUMT]) (Wasserman, 2006), and, to evaluate other conditions of the prostate including symptoms of prostatitis, suspected abscess, or prostatic calculi.
In evaluation of infertility, the male partner is involved in approximately one-third of the cases. TRUS, with or without seminal vesicle aspiration and seminal vesiculography, is considered as an initial minimally invasive diagnostic test to identify ejaculatory duct obstruction in azoospermic men with low ejaculate volumes and bilateral palpable vasa (ASRM, 2012; AUA, 2011; Gangel, 2002). In men with ejaculatory duct obstruction demonstrated by TRUS, the findings may direct testis biopsy if needed to confirm normal spermatogenesis. TRUS is also used to rule out seminal vesicular cysts, müllerian cysts, or utricular cysts.
Hematospermia (hemospermia), defined as blood in the semen, is a common condition that is rarely associated with significant pathology. Hematospermia may be the result of an infection (prostatitis), prostate cancer, conditions of the urethra (urethritis and other lesions), congenital and acquired seminal vesicle lesions, systemic disorders, or trauma. TRUS is considered the imaging procedure of choice for evaluation of men with persistent hematospermia (lasting more than one month) to distinguish idiopathic from secondary hematospermia when the bleeding cause is known or suspected (for example, bladder, prostate or systemic malignant pathology) and an accurate diagnosis dictates the extent of further evaluation and treatment of the condition (Manohar, 2008; Yagci, 2004).
Endometriosis is a condition in which tissue similar to that normally lining the uterus is found outside the uterus (usually on the ovaries, fallopian tubes, and other pelvic structures) and affects 10% to 15% of women of reproductive age. TRUS has been used for assessing the extent of endometriosis and is accurate in the diagnosis and management of endometriosis in the rectovaginal septum. The sensitivity and specificity of preoperative imaging with TRUS in defining the extent of endometrial lesions and predicting rectovaginal septum or rectosigmoid infiltration has been confirmed in prospective and retrospective case series (Abrão, 2004; Delpy, 2005; Fedele, 1998; Kruse, 2012; Ribeiro, 2008).
TRUS and TRUS-guided transrectal biopsy have been used with or without other imaging modalities including pelvic or transvaginal ultrasonography to evaluate the extension of gynecologic-related pelvic masses (including cervical, retroperitoneal, ovarian, or uterine masses) into surrounding tissues and to guide further treatment (such as drainage of deep pelvic and perirectal abscesses) (Giede, 2004; Lorentzen, 2011; Nielsen, 2004; Zaritzky, 1979). When transvaginal scanning is not feasible or contraindicated, TRUS has been used as an alternative to transvaginal ultrasonography to evaluate conditions of the female pelvis (Fleischer, 1995; Timor-Tritsch, 2003). For women with endometrial cancer in the presence of atrophic or post-radiation vaginal stenosis, TRUS has been used to define the extent of the cancer and guide fine-needle aspiration biopsy of recurrent tumors (Squaillaci, 1988).
Structural abnormalities of the anal sphincter, the rectal wall, and the puborectalis muscle can be identified in detail with TRUS. TRUS has been used as an alternative to MRI evaluation of anal, rectal, and perianal abscesses and fistulas, and benign tumors. The vast majority of TRUS studies have focused on individuals without Crohn's disease. The rigid nature of the TRUS probe, however, may prevent good acoustic coupling higher in the rectum, thus preventing the interpretation of higher fistula tracks in the evaluation of these conditions in individuals with or without Crohn's disease. For management of severe Crohn's disease, an American College of Gastroenterology (ACG) (Lichtenstein, 2009) practice guideline recommends evaluation of an abdominal mass/abscesses or perianal complications with serial imaging, including endoscopic ultrasonography, CT, or MRI, prior to consideration of surgical intervention.
TRUS is also useful for establishing a diagnosis in individuals in whom a medical history or manometric findings suggest sphincter dysfunction or occult sphincter injury, and is currently the simplest, most reliable, and least invasive test for defining anatomic defects in the external and internal anal sphincters. For persons with suspected fecal incontinence, an ACG practice guideline (Rao, 2004) recommends imaging with endosonography to assess and define structural defects of the external and internal anal sphincter muscle for the presence of scarring, loss of muscle tissue, and other local pathology.
An American Institute of Ultrasound in Medicine (AIUM, 2012) Practice Guideline for the Performance of an Ultrasound Examination in the Practice of Urology (developed in collaboration with the AUA) states the indications for the transrectal approach to ultrasound of the prostate include, but are not limited to: 1) guidance for biopsy in the presence of abnormal DRE examination findings or an elevated PSA level; 2) assessment of gland and prostate volume before medical, surgical, or radiation therapy; 3) symptoms of prostatitis with a suspected abscess; 4) assessment of congenital anomalies; 5) infertility; and 6) hematospermia.
Biopsy: The removal of a sample of tissue for examination under a microscope for diagnostic purposes.
Digital rectal examination (DRE): An examination of the lower rectum where the medical practitioner uses a gloved, lubricated finger to check for abnormalities of the prostate.
Prostate: A walnut-shaped gland in men that extends around the urethra at the neck of the urinary bladder and supplies fluid that goes into semen.
Prostate-specific antigen (PSA): A blood test that measures the amount of a specific prostate-related protein in blood, used to screen for prostate cancer and other conditions. A high PSA level in the blood has been linked to an increased chance of having prostate cancer.
Transrectal ultrasound (TRUS): A procedure in which sound waves produced by a probe inserted into the rectum bounce off internal tissues or organs and make echoes to form a picture of body tissue called a sonogram.
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|New||05/09/2013||Medical Policy & Technology Assessment Committee (MPTAC) review. Initial document development.|