Local Coverage Determination (LCD)

Transrectal Ultrasound

L33578

Expand All | Collapse All

Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
National Government Services, Inc.	MAC - Part A	06101 - MAC A	J - 06	Illinois
National Government Services, Inc.	MAC - Part B	06102 - MAC B	J - 06	Illinois
National Government Services, Inc.	MAC - Part A	06201 - MAC A	J - 06	Minnesota
National Government Services, Inc.	MAC - Part B	06202 - MAC B	J - 06	Minnesota
National Government Services, Inc.	MAC - Part A	06301 - MAC A	J - 06	Wisconsin
National Government Services, Inc.	MAC - Part B	06302 - MAC B	J - 06	Wisconsin
National Government Services, Inc.	A and B and HHH MAC	13101 - MAC A	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13102 - MAC B	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13201 - MAC A	J - K	New York - Entire State
National Government Services, Inc.	A and B and HHH MAC	13202 - MAC B	J - K	New York - Downstate
National Government Services, Inc.	A and B and HHH MAC	13282 - MAC B	J - K	New York - Upstate
National Government Services, Inc.	A and B and HHH MAC	13292 - MAC B	J - K	New York - Queens
National Government Services, Inc.	A and B and HHH MAC	14111 - MAC A	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14112 - MAC B	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14211 - MAC A	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14212 - MAC B	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14311 - MAC A	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14312 - MAC B	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14411 - MAC A	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14412 - MAC B	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14511 - MAC A	J - K	Vermont
National Government Services, Inc.	A and B and HHH MAC	14512 - MAC B	J - K	Vermont

LCD Information

Document Information

LCD ID
L33578

LCD Title
Transrectal Ultrasound

Proposed LCD in Comment Period
N/A

Source Proposed LCD
N/A

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
N/A

Retirement Date
N/A

Notice Period Start Date
N/A

Notice Period End Date
N/A

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

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 ProceduresCMS Publication 100-04, Medicare Claims Processing Manual, Chapter 9:

100 General Billing RequirementsCMS Publication 100-04, Medicare Claims Processing Manual, Chapter 12:

70 Payment Conditions for Radiology Services

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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:

Clinical staging of a patient with prostate cancer in whom radical prostatectomy or radiation therapy is considered.
Evaluation of a patient following radical prostatectomy or radiation therapy for prostate cancer who has rising prostate specific antigen (PSA) levels.
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.
Transrectal ultrasound is allowed for metastatic lesions of unknown source, with a high PSA level, which could have their origin in the prostate.
Infertility and azoospermia where an ejaculatory duct cyst is suspected.
Fever of unknown origin where a prostatic focus is suspected.
Evaluation of suspected prostatitis or prostatic abscess.
Congenital and acquired cystic conditions of prostate, seminal vesicles, and related tissues.
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).
Transrectal ultrasound is also used to guide correct interstitial radioelement application and placement of radiation therapy fields.
Monitoring of response to therapy in patients with prostate cancer
Evaluation of seminal vesicles in the presence of hematospermia.

Rectum:

Clinical staging of a patient with rectal carcinoma.
Evaluation of a patient who has had definitive treatment for carcinoma of the rectum at risk for recurrent disease.
Evaluation of a patient with anal or rectal fistula when documentation indicates the diagnostic result is necessary to determine the appropriate treatment.
Diagnostic evaluation of malignant or benign perirectal tumors such as, but not limited to, villous adenomas, chordomas, leiomyoscarcomas, and dermoid cysts.
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.
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.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes

Changes	Fields Changed
	N/A

Associated Information

Sources of Information

Bibliography

Open Meetings

Contractor Advisory Committee (CAC) Meetings

MAC Meeting Information URLs

Proposed LCD Posting Date

Comment Period Start Date

Comment Period End Date

Reason for Proposed LCD

Requestor Name	Requestor Letter
	View Letter

Requestor Information

Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code	Description
Please accept the License to see the codes.

Revenue Codes

Code	Description
Please accept the License to see the codes.

ICD-10-CM Codes that Support Medical Necessity

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

Additional ICD-10 Information

General Information

Associated Information
N/A

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.

Bibliography

N/A

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

Attachments
N/A

Related Local Coverage Documents
Articles
A57427 - Billing and Coding: Transrectal Ultrasound

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.

Keywords

Prostate

Read the LCD Disclaimer

License Agreements
American Medical Association Current Procedural Terminology
American Dental Association Current Dental Terminology
American Hospital Association NUBC UB-04

Please review the licensing information below and indicate your agreement and acceptance.

License for Use of Current Procedural Terminology (CPT)

End User Point and Click Agreement: CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved (or such other date of publication of CPT). CPT is a trademark of the American Medical Association (AMA).

You, your employees, and agents are authorized to use CPT only as agreed upon with the AMA internally within your organization within the United States for the sole use by yourself, employees, and agents. Use is limited to use in Medicare, Medicaid or other programs administered by the Centers for Medicare and Medicaid Services (CMS). You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement.

Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CPT for resale and/or license, transferring copies of CPT to any party not bound by this agreement, creating any modified or derivative work of CPT, or making any commercial use of CPT. License to use CPT for any use not authorized herein must be obtained through the AMA, CPT Intellectual Property Services, AMA Plaza, 330 Wabash Ave., Suite 39300, Chicago, IL 60611-5885. Applications are available at the AMA Web site, http://www.ama-assn.org/go/cpt http://www.ama-assn.org/go/cpt.

Applicable FARS\DFARS Restrictions Apply to Government Use.

This product includes CPT which is commercial technical data and/or computer data bases and/or commercial computer software and/or commercial computer software documentation, as applicable which were developed exclusively at private expense by the American Medical Association, AMA Plaza, 330 N. Wabash Ave., Suite 39300, Chicago, IL 60611-5885. U.S. Government rights to use, modify, reproduce, release, perform, display, or disclose these technical data and/or computer data bases and/or computer software and/or computer software documentation are subject to the limited rights restrictions of FAR 52.227-14 (December 2007) and/or subject to the restricted rights provisions of FAR 52.227-14 (December 2007) and FAR 52.227-19 (December 2007), as applicable, and any applicable agency FAR Supplements, for non-Department of Defense Federal procurements.

The scope of this license is determined by the AMA, the copyright holder. Any questions pertaining to the license or use of the CPT should be addressed to the AMA. End Users do not act for or on behalf of the CMS. CMS disclaims responsibility for any liability attributable to end user use of the CPT. CMS will not be liable for any claims attributable to any errors, omissions, or other inaccuracies in the information or material contained on this page. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

License For Use of Current Dental Terminology (CDT^TM)

The license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. By clicking below on the button labeled "I accept", you hereby acknowledge that you have read, understood, and agreed to all terms and conditions set forth in this agreement.

If you do not agree with all terms and conditions set forth herein, click below on the button labeled "I do not accept" and exit from this computer screen.

If you are acting on behalf of an organization, you represent that you are authorized to act on behalf of such organization and that your acceptance of the terms of this agreement creates a legally enforceable obligation of the organization. As used herein, "you" and "your" refer to you and any organization on behalf of which you are acting.

Subject to the terms and conditions contained in this Agreement, you, your employees and agents are authorized to use CDT only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. Use of CDT is limited to use in programs administered by Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to ensure that your employees and agents abide by the terms of this agreement. You acknowledge that the ADA holds all copyright, trademark and other rights in CDT. You shall not remove, alter, or obscure any ADA copyright notices or other proprietary rights notices included in the materials.

Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CDT for resale and/or license, transferring copies of CDT to any party not bound by this agreement, creating any modified or derivative work of CDT, or making any commercial use of CDT. License to use CDT for any use not authorized herein must be obtained through the American Dental Association, 211 East Chicago Avenue, Chicago, IL 60611. Applications are available at the American Dental Association web site, http://www.ADA.org/ http://www.ADA.org/.

Applicable Federal Acquisition Regulation Clauses (FARS)/Department of Defense Federal Acquisition Regulation supplement (DFARS) Restrictions Apply to Government Use.

Organizations who contract with CMS acknowledge that they may have a commercial CDT license with the ADA, and that use of CDT codes as permitted herein for the administration of CMS programs does not extend to any other programs or services the organization may administer and royalties dues for the use of the CDT codes are governed by their commercial license.

ADA DISCLAIMER OF WARRANTIES AND LIABILITIES

CDT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. No fee schedules, basic unit, relative values, or related listings are included in CDT. The ADA does not directly or indirectly practice medicine or dispense dental services. The sole responsibility for software, including any CDT and other content contained therein, is with (insert name of applicable entity) or the CMS; and no endorsement by the ADA is intended or implied. The ADA expressly disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice to you if you violate the terms of this Agreement. The ADA is a third-party beneficiary to this Agreement.

CMS DISCLAIMER

The scope of this license is determined by the ADA, the copyright holder. Any questions pertaining to the license or use of the CDT should be addressed to the ADA. End Users do not act for or on behalf of the CMS. CMS disclaims responsibility for any liability attributable to end user use of the CDT. CMS will not be liable for any claims attributable to any errors, omissions, or other inaccuracies in the information or material covered by this license. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

The license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. If the foregoing terms and conditions are acceptable to you, please indicate your agreement by clicking below on the button labeled "I Accept". If you do not agree to the terms and conditions, you may not access or use software. Instead, you must click below on the button labeled "I Do Not Accept" and exit from this computer screen.

License For Use of National Uniform Billing Committee (NUBC) UB-04

These materials contain NUBC Official UB-04 Specifications (UB-04 Data), which is copyrighted by the American Hospital Association (AHA).

THE LICENSE GRANTED HEREIN IS EXPRESSLY CONDITIONED UPON YOUR ACCEPTANCE OF ALL TERMS AND CONDITIONS CONTAINED IN THIS AGREEMENT. BY CLICKING BELOW ON THE BUTTON LABELED "I ACCEPT", YOU HEREBY ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD AND AGREED TO ALL TERMS AND CONDITIONS SET FORTH IN THIS AGREEMENT.

IF YOU DO NOT AGREE WITH ALL TERMS AND CONDITIONS SET FORTH HEREIN, CLICK BELOW ON THE BUTTON LABELED "I DO NOT ACCEPT" AND EXIT FROM THIS COMPUTER SCREEN. IF YOU ARE ACTING ON BEHALF OF AN ORGANIZATION, YOU REPRESENT THAT YOU ARE AUTHORIZED TO ACT ON BEHALF OF SUCH ORGANIZATION AND THAT YOUR ACCEPTANCE OF THE TERMS OF THIS AGREEMENT CREATES A LEGALLY ENFORCEABLE OBLIGATION OF THE ORGANIZATION. AS USED HEREIN, "YOU" AND "YOUR" REFER TO YOU AND ANY ORGANIZATION ON BEHALF OF WHICH YOU ARE ACTING.

Subject to the terms and conditions contained in this Agreement, you, your employees, and agents are authorized to use UB-04 Data only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. Use of UB-04 Data is limited to use in programs administered by Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to ensure that your employees and agents abide by the terms of this Agreement. You acknowledge that the AHA holds all copyright, trademark, and other rights in UB-04 Data. You shall not remove, alter, or obscure any AHA copyright notices or other proprietary rights notices included in the materials.
Any use not authorized herein is prohibited, including, by way of illustration and not by way of limitation, making copies of UB-04 Data for resale and/or license, transferring copies of UB-04 Data to any party not bound by this agreement, creating any modified or derivative work of UB-04 Data, or making any commercial use of UB-04 Data. License to use UB-04 Data for any use not authorized herein must be obtained through the American Hospital Association, 155 N. Wacker Drive, Suite 400, Chicago, Illinois, 60606. Applications are available at the NUBC website, http://www.nubc.org/ http://www.nubc.org/.
The UB-04 Data included in this product is commercial technical data and/or computer databases and/or commercial computer software and/or commercial computer software documentation, as applicable, which was developed exclusively at private expense by the American Hospital Association, 155 N. Wacker Drive, Suite 400, Chicago, Illinois 60606. U.S. Government rights to use, modify, reproduce, release, perform, display, or disclose these technical data and/or computer data bases and/or computer software and/or computer software documentation are subject to the limited rights restrictions of DFARS 252.227-7015(b)(2) (November 1995) and/or subject to the restrictions of DFARS 227.7202-1(a) (June 1995) and DFARS 227.7202-3(a) (June 1995), as applicable for U.S. Department of Defense procurements and the limited rights restrictions of FAR 52.227-14 (December 2007) and FAR 52.227-19 (December 2007), as applicable, and any applicable agency FAR Supplements, for non-Department of Defense Federal procurements.
AHA DISCLAIMER OF WARRANTIES AND LIABILITIES. UB-04 Data is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. The sole responsibility for the software, including any UB-04 Data and other content contained therein, is with the Medicare/Medicaid Contractor or the CMS; and no endorsement by the AHA is intended or implied. The AHA expressly disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice to you if you violate the terms of this Agreement. The AHA is a third-party beneficiary to this Agreement.
CMS DISCLAIMER. The scope of this license is determined by the AHA, the copyright holder. Any questions pertaining to the license or use of the UB-04 Data should be addressed to the AHA. End users do not act for or on behalf of the CMS. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE UB-04 DATA. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL COVERED BY THIS LICENSE. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

Submit Feedback/Ask a Question

Transrectal Ultrasound

Document Note

Note History

Contractor Information

LCD Information

Document Information

Issue

CMS National Coverage Policy

Coverage Guidance

Proposed Process Information

Coding Information

Bill Type Codes

Please accept the License to see the codes.

Revenue Codes

Please accept the License to see the codes.

CPT/HCPCS Codes

Please accept the License to see the codes.

ICD-10-CM Codes that Support Medical Necessity

Group 1

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

Group 1

Additional ICD-10 Information

General Information

Revision History Information

Associated Documents

Keywords

Page Help for LCD - Transrectal Ultrasound (L33578)

Introduction

More information

Tracking Sheet

Printing a Document to PDF

Get email updates

CMS & HHS WEBSITES

HELPFUL LINKS

RSS FEEDS