Local Coverage Determination (LCD)

Transrectal Ultrasound


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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
Original ICD-9 LCD ID
Not Applicable
LCD Title
Transrectal Ultrasound
Proposed LCD in Comment Period
Source Proposed LCD
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 10/10/2019
Revision Ending Date
Retirement Date
Notice Period Start Date
Notice Period End Date

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Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Publications:

CMS Publication 100-03, Medicare National Coverage Determinations Manual (NCD) Manual, Chapter 1:
    220.5 Ultrasound Diagnostic Procedures
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 9:
    100 General Billing Requirements
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 12:
    70 Payment Conditions for Radiology Services

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity


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.



  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.


  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).


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.
Summary of Evidence


Analysis of Evidence (Rationale for Determination)


Proposed Process Information

Synopsis of Changes
Changes Fields Changed
Associated Information
Sources of Information
Open Meetings
Meeting Date Meeting States Meeting Information
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
MAC Meeting Information URLs
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

Revenue Codes

Code Description


Group 1

Group 1 Paragraph


Group 1 Codes



ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:


Group 1 Codes:



ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:


Group 1 Codes:



Additional ICD-10 Information

General Information

Associated Information
Sources of Information
This bibliography presents those sources that were obtained during the development of this policy. National Government Services is not responsible for the continuing viability of Web site addresses listed below.

Abir F, Alva S, Longo WE, Audiso R, Virgo KS, Johnson FE. The postoperative surveillance of patients with colon cancer and rectal cancer. The American Journal of Surgery. 2005;192:100-108.

Al-Azab R, Toi A, Lockwood G, Kulkarni GS, Fleshner N. Prostate volume is strongest predeictor of cancer diagnosis at tranrectal ultrasound-guided prostate biopsy with prostate-specific antigen values between 2.0 and 9.0 ng/ml. Urology. 2007;69(1).

Bahn D. Active surveillance with high resolution color-doppler transrectal ultrasound monitoring: Is it fool-proof? Prostate Institute of America, Ventura, California.

Ballentine HC, Allaf ME, Partin AW. Diagnosis and Staging of Prostate Cancer. In: Wein - Campbell-Walsh Urology, Ch 94, 9th ed. Saunders, an Imprint of Elseveier. Copyright 2007.

McAchran SE, Resnick MI. Prostate ultrasound: past present, and future. Department of Urology, University Hospitals of Cleveland. Ultrasound Clinics. Elsevier Sanders.

Wein: Campbell-Walsh Urology. Preoperative Evaluation. 9th ed. Saunders, an Imprint of Elseveier. Copyright 2007.


Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/10/2019 R5

Consistent with Change Request 10901, all coding information, National coverage provisions, and Associated Information (Documentation Requirements, Utilization Guidelines) have been removed from the LCD and placed in the related Billing and Coding Article, A57427. There has been no change in coverage with this LCD revision.

  • Revisions Due To Code Removal
10/01/2018 R4

Due to the annual ICD-10-CM code update, ICD-10 code K61.3 was deleted from "ICD-10 Codes that Support Medical Necessity" section - Group 1 and ICD-10 codes K61.31 and K61.39 were added as replacement codes.

DATE 10/01/2018: At this time, the 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which require comment and notice. This revision is not a restriction to the coverage determination; and therefore, not all the fields included are applicable as noted in this policy.

  • Revisions Due To ICD-10-CM Code Changes
10/01/2016 R3 Due to the annual ICD-10-CM code update for 2017, ICD-10-CM codes N42.3 and R97.2 were deleted from Group 1 of the "ICD-10-CM Codes that Support Medical Necessity" section of the LCD. ICD-10-CM codes N42.30, N42.31, N42.32, N42.39, R97.20 and R97.21 were added as the replacement codes.

The descriptors were changed for ICD-10-CM codes N40.0 and N40.1.
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R2 Additional minor template language change.
  • Other
10/01/2015 R1 Minor template language change.
  • Other

Associated Documents

Related Local Coverage Documents
A57427 - Billing and Coding: Transrectal Ultrasound
Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
10/04/2019 10/10/2019 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.


  • Prostate

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