CMS Transrectal Ultrasound Form

Summary Of Evidence

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Analysis of Evidence

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Abstract:

Transrectal ultrasound (or echography) is a useful clinical tool for visualizing pathology for specific conditions involving the rectum and surrounding tissues. It is also used for needle guidance during prostatic biopsy and for assistance in the accurate placement of radiation therapy fields and interstitial radioelements. Despite technological improvements with ultrasonic imaging, limitations remain, including those related to the high level of operator dependence on the over-all outcome of the image. Consistent and accurate results can only be expected when the examiner and the interpreter have adequate training and maintain these skills through frequent use.

By itself, echography or ultrasonography has no validity as a screening test. There will be no reimbursement without Medicare-covered clinical indications.

Indications:

Prostate:

1. Clinical staging of a patient with prostate cancer in whom radical prostatectomy or radiation therapy is considered.
2. Evaluation of a patient following radical prostatectomy or radiation therapy for prostate cancer who has rising prostate specific antigen (PSA) levels.
3. A suspicion of prostatic disease documented from the patient’s history, rectal examination, or a clinically significant PSA increase, and/or bone scan evidence of metastasis without a diagnosis of prostate cancer.
4. Transrectal ultrasound is allowed for metastatic lesions of unknown source, with a high PSA level, which could have their origin in the prostate.
5. Infertility and azoospermia where an ejaculatory duct cyst is suspected.
6. Fever of unknown origin where a prostatic focus is suspected.
7. Evaluation of suspected prostatitis or prostatic abscess.
8. Congenital and acquired cystic conditions of prostate, seminal vesicles, and related tissues.
9. Measuring size/volume of prostate tissue prior to radiation therapy, transurethral needle ablation of the prostate (TUNA), or transurethral microwave thermotherapy (TUMT), Transurethral Resection of the Prostate (TURP) and Laser Ablation of Prostate (“green-light” laser).
10. Transrectal ultrasound is also used to guide correct interstitial radioelement application and placement of radiation therapy fields.
11. Monitoring of response to therapy in patients with prostate cancer
12. Evaluation of seminal vesicles in the presence of hematospermia.

Rectum:

1. Clinical staging of a patient with rectal carcinoma.
2. Evaluation of a patient who has had definitive treatment for carcinoma of the rectum at risk for recurrent disease.
3. Evaluation of a patient with anal or rectal fistula when documentation indicates the diagnostic result is necessary to determine the appropriate treatment.
4. Diagnostic evaluation of malignant or benign perirectal tumors such as, but not limited to, villous adenomas, chordomas, leiomyoscarcomas, and dermoid cysts.
5. Evaluation of anal and/or rectal or perirectal abscesses when the documentation indicates the diagnostic result is likely to contribute to the development of a treatment plan.
6. Evaluation of anal incontinence symptoms that are likely due to anatomic sphincter defects for which surgical reconstruction is most likely to be done. Typically, the patient has fecal incontinence with a history of traumatic risk (e.g., childbirth, rectal surgery or irradiation).

Limitations:

Measurement of prostate volume via a transrectal echography prior to brachytherapy
should be performed only for planned brachytherapy procedures.

Medicare will not cover transrectal ultrasound unless applicable criteria under the “Indications and Limitations of Coverage and/or Medical Necessity” section are met.

Examples of noncovered indications for the use of transrectal ultrasound include, but are not limited to, the following:

• Screening of asymptomatic patients;
• Confirmation of a known diagnosis when no significant additional information is expected;
• Evaluation of benign lesions except as noted in the “Indications” subsection above; and/or
• Family history of colorectal/prostate carcinoma.