Local Coverage Article Billing and Coding

Billing and Coding: Lab: Bladder/Urothelial Tumor Markers

A53095

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Palmetto GBA	A and B MAC	10111 - MAC A	J - J	Alabama
Palmetto GBA	A and B MAC	10112 - MAC B	J - J	Alabama
Palmetto GBA	A and B MAC	10211 - MAC A	J - J	Georgia
Palmetto GBA	A and B MAC	10212 - MAC B	J - J	Georgia
Palmetto GBA	A and B MAC	10311 - MAC A	J - J	Tennessee
Palmetto GBA	A and B MAC	10312 - MAC B	J - J	Tennessee
Palmetto GBA	A and B and HHH MAC	11201 - MAC A	J - M	South Carolina
Palmetto GBA	A and B and HHH MAC	11202 - MAC B	J - M	South Carolina
Palmetto GBA	A and B and HHH MAC	11301 - MAC A	J - M	Virginia
Palmetto GBA	A and B and HHH MAC	11302 - MAC B	J - M	Virginia
Palmetto GBA	A and B and HHH MAC	11401 - MAC A	J - M	West Virginia
Palmetto GBA	A and B and HHH MAC	11402 - MAC B	J - M	West Virginia
Palmetto GBA	A and B and HHH MAC	11501 - MAC A	J - M	North Carolina
Palmetto GBA	A and B and HHH MAC	11502 - MAC B	J - M	North Carolina

Article Information

General Information

Article ID
A53095

Article Title
Billing and Coding: Lab: Bladder/Urothelial Tumor Markers

Article Type
Billing and Coding

Original Effective Date
10/01/2015

Revision Effective Date
09/22/2022

Revision Ending Date
N/A

Retirement Date
N/A

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CMS National Coverage Policy

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.

CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.2 Independent Laboratory Specimen Drawing, §60.2 Travel Allowance

CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting ICD Diagnosis and Procedure Codes

Article Guidance

Article Text

The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for Lab: Bladder/Urothelial Tumor Markers (L33420).

Palmetto GBA will only cover bladder tumor marker fluorescence in situ hybridization (FISH) testing services when performed using validated assays. To date, UroVysion™ Bladder Cancer Kit is the only Federal Drug Administration (FDA) approved assay that is designed to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via FISH. The assay is performed on urine specimens from persons with hematuria suspected of having bladder cancer as an aid for initial diagnosis of bladder carcinoma and subsequent monitoring for tumor recurrence in patient previously diagnosed with bladder cancer. UroVysion™ Bladder Kit services may only be billed by a CLIA certified lab.

To bill UroVysion™ Bladder Kit services, submit the following claim information:

Select CPT^® code 88120 or 88121 as appropriate

Laboratories reporting only the technical component for a UroVysion™ service should append the appropriate code 88120 or 88121 with the TC modifier.

All other services that meet the code 88120 or 88121 definition performed by any provider type MUST bill the following claim information.

Select CPT^® code 88120 or 88121 as appropriate

Note: Physicians may NOT submit claims for a code 88120 and 88121 professional component when the interpretive information is provided by a lab technician or scientist. Per Chapter 10 in the NCCI Policy Manual for Medicare Services, Version 16.3, the physician work component requires a physician to read, quantitate and interpret the tissues/cells stained with the probes(s). Physicians who knowingly report and interpretation based on the documented results of another professional may be subject to additional corrective action including Recovery Audit Contractor (RAC) or fraud referrals.

To report a Bladder/Urothelial Tumor Marker service, please submit the following claim information:

Select the appropriate CPT^® code
Enter 1 unit of service (UOS)
Select the appropriate ICD-10 code

Coding Information

CPT/HCPCS Codes

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Group 1

(5 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code	Description
86294	IMMUNOASSAY FOR TUMOR ANTIGEN, QUALITATIVE OR SEMIQUANTITATIVE (EG, BLADDER TUMOR ANTIGEN)
86316	IMMUNOASSAY FOR TUMOR ANTIGEN, OTHER ANTIGEN, QUANTITATIVE (EG, CA 50, 72-4, 549), EACH
86386	NUCLEAR MATRIX PROTEIN 22 (NMP22), QUALITATIVE
88120	CYTOPATHOLOGY, IN SITU HYBRIDIZATION (EG, FISH), URINARY TRACT SPECIMEN WITH MORPHOMETRIC ANALYSIS, 3-5 MOLECULAR PROBES, EACH SPECIMEN; MANUAL
88121	CYTOPATHOLOGY, IN SITU HYBRIDIZATION (EG, FISH), URINARY TRACT SPECIMEN WITH MORPHOMETRIC ANALYSIS, 3-5 MOLECULAR PROBES, EACH SPECIMEN; USING COMPUTER-ASSISTED TECHNOLOGY

CPT/HCPCS Modifiers

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Group 1

(1 Code)

Group 1 Paragraph

N/A

Group 1 Codes

Code	Description
TC	TECHNICAL COMPONENT; UNDER CERTAIN CIRCUMSTANCES, A CHARGE MAY BE MADE FOR THE TECHNICAL COMPONENT ALONE; UNDER THOSE CIRCUMSTANCES THE TECHNICAL COMPONENT CHARGE IS IDENTIFIED BY ADDING MODIFIER 'TC' TO THE USUAL PROCEDURE NUMBER; TECHNICAL COMPONENT CHARGES ARE INSTITUTIONAL CHARGES AND NOT BILLED SEPARATELY BY PHYSICIANS; HOWEVER, PORTABLE X-RAY SUPPLIERS ONLY BILL FOR TECHNICAL COMPONENT AND SHOULD UTILIZE MODIFIER TC; THE CHARGE DATA FROM PORTABLE X-RAY SUPPLIERS WILL THEN BE USED TO BUILD CUSTOMARY AND PREVAILING PROFILES

ICD-10-CM Codes that Support Medical Necessity

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Group 1

(42 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code	Description
C67.0	Malignant neoplasm of trigone of bladder
C67.1	Malignant neoplasm of dome of bladder
C67.2	Malignant neoplasm of lateral wall of bladder
C67.3	Malignant neoplasm of anterior wall of bladder
C67.4	Malignant neoplasm of posterior wall of bladder
C67.5	Malignant neoplasm of bladder neck
C67.6	Malignant neoplasm of ureteric orifice
C67.7	Malignant neoplasm of urachus
C67.8	Malignant neoplasm of overlapping sites of bladder
C67.9	Malignant neoplasm of bladder, unspecified
C7A.010	Malignant carcinoid tumor of the duodenum
C7A.011	Malignant carcinoid tumor of the jejunum
C7A.012	Malignant carcinoid tumor of the ileum
C7A.020	Malignant carcinoid tumor of the appendix
C7A.021	Malignant carcinoid tumor of the cecum
C7A.022	Malignant carcinoid tumor of the ascending colon
C7A.023	Malignant carcinoid tumor of the transverse colon
C7A.024	Malignant carcinoid tumor of the descending colon
C7A.025	Malignant carcinoid tumor of the sigmoid colon
C7A.026	Malignant carcinoid tumor of the rectum
C7A.090	Malignant carcinoid tumor of the bronchus and lung
C7A.091	Malignant carcinoid tumor of the thymus
C7A.092	Malignant carcinoid tumor of the stomach
C7A.093	Malignant carcinoid tumor of the kidney
C7A.098	Malignant carcinoid tumors of other sites
C7A.8	Other malignant neuroendocrine tumors
C7B.01	Secondary carcinoid tumors of distant lymph nodes
C7B.02	Secondary carcinoid tumors of liver
C7B.03	Secondary carcinoid tumors of bone
C7B.04	Secondary carcinoid tumors of peritoneum
C7B.09	Secondary carcinoid tumors of other sites
C7B.8	Other secondary neuroendocrine tumors
D09.0	Carcinoma in situ of bladder
D41.4	Neoplasm of uncertain behavior of bladder
D49.4	Neoplasm of unspecified behavior of bladder
E34.0	Carcinoid syndrome
R31.0	Gross hematuria
R31.1	Benign essential microscopic hematuria
R31.21*	Asymptomatic microscopic hematuria
R31.29*	Other microscopic hematuria
Z78.9*	Other specified health status
Z85.51	Personal history of malignant neoplasm of bladder

Group 1 Medical Necessity ICD-10-CM Codes Asterisk Explanation

R31.2 (before October 1, 2016) and R31.21 or R31.29 (effective October 1, 2016) are to be used only when repeat testing is believed to be medically reasonable and necessary, and must be listed as secondary with the primary neoplastic diagnosis.

Z78.9 To be used only when repeat testing is believed to be medically reasonable and necessary, and must be listed as secondary with the primary neoplastic diagnosis.

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

N/A

ICD-10-PCS Codes

N/A

Additional ICD-10 Information

N/A

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

N/A

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Code	Description
99999	Not Applicable

Other Coding Information

N/A

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation
09/22/2022	R12	Under *Article Text* removed verbiage regarding instructions on how to submit a DEX Z-code™ on claims and how to register a test for a DEX Z-code™ identifier.
02/11/2021	R11	Under *Article Text* inserted UroVysion™ where applicable. In paragraphs 3 and 5 revised 1^st bullet points to read “Select CPT^® code 88120 or 88121 as appropriate,” and 2^nd and 3^rd bullet points to read “Enter the appropriate DEX Z-CODE™ Identifier adjacent to the CPT^®code in the comment/narrative field for the following Part A claim field/types:”. Under *CPT/HCPCS Codes Group 1: Paragraph* deleted the verbiage “CPT Codes”. Under *ICD-10 Codes that Support Medical Necessity Group 1: Codes* deleted C7A.00, C7A.019, C7A.029, C7A.094. C7A.095, C7A.096, C7B.00, C78.00, and R31.9. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted and defined where appropriate throughout the article.
10/31/2019	R10	This article is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into related Billing and Coding Articles. Regulations regarding billing and coding were removed from the *CMS National Coverage Policy* section of the related Lab: Bladder/Urothelial Tumor Markers L33420 LCD and placed in this article. Moved all verbiage in the *ICD-10 Codes that Support Medical Necessity Group 1: Paragraph* section to the *Group 1: Medical Necessity ICD-10 Codes Asterisk Explanation* section. Under *ICD-10 Codes that Support Medical Necessity Group 1: Codes* placed an asterisk by ICD-10 Codes R31.21, R31.29 and Z78.9. Under *CPT/HCPCS Modifiers* added modifier TC. CPT^® was inserted throughout the article where applicable.
08/22/2019	R9	All coding located in the *Coding Information* section has been removed from the related Lab: Bladder/Urothelial Tumor Markers L33420 LCD and added to this article.
08/22/2019	R8	Under *Article Title* changed the name from “MolDX: Bladder Tumor Marker FISH Billing and Coding Guidelines Update” to “Billing and Coding: Lab: Bladder/Urothelial Tumor Markers”. Under *Article Text* added the verbiage “The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for Lab: Bladder/Urothelial Tumor Markers (L33420)." at the beginning of the section. The verbiage “To report a Bladder/Urothelial Tumor Marker service, please submit the following claim information: •Select the appropriate CPT code •Enter 1 unit of service (UOS) •Select the appropriate ICD-10-CM code” was added at the end of the section.
02/26/2018	R7	The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
01/29/2018	R6	The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
09/28/2017	R5	Added MolDX in title and specified "identifier" as DEX Z-Code™ identifier in the test registration paragraph.
09/28/2017	R4	Added Part A contract numbers and Dex Z-Code identifiers
10/01/2015	R3	Added the word "assigned" before Z-Code Identifier
10/01/2015	R2	Removed Jurisdiction references and Z-Code Identifier.
10/01/2015	R1	Updated Annual Review Date.

Associated Documents

Related Local Coverage Documents
LCDs
L33420 - Lab: Bladder/Urothelial Tumor Markers

Updated On	Effective Dates	Status
09/12/2022	09/22/2022 - N/A	Currently in Effect	You are here
02/02/2021	02/11/2021 - 09/21/2022	Superseded	View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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Billing and Coding: Lab: Bladder/Urothelial Tumor Markers

Contractor Information

Article Information

General Information

CMS National Coverage Policy

Article Guidance

Coding Information

CPT/HCPCS Codes

Group 1

CPT/HCPCS Modifiers

Group 1

ICD-10-CM Codes that Support Medical Necessity

Group 1

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

ICD-10-PCS Codes

Additional ICD-10 Information

Bill Type Codes

Revenue Codes

Other Coding Information

Revision History Information

Associated Documents

Keywords

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