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Contractor Name

CareFirst of Maryland Inc., Medicare Part A

Contractor Number

00190

Contractor Type

Fiscal Intermediary

LCD Database ID Number

L13969

LCD Title

Bladder Tumor Assay

Contractor's Determination Number

03-08-R1

AMA/CPT and ADA/CDT Copyright Statement

CPT codes, descriptions, and other data only are copyright 1999 American Medical Association (or such publication of CPT). All rights reserved. Applicable FARS/DFARS clauses apply. CDT-4 codes and descriptions are ©2004 American Dental Association.  All rights reserved.

CMS National Coverage Policy

  • Establishment of national policy supersedes all previous contractor policy statements, including local policy coverage guidelines.
  • Title XVIII of the Social Security Act, section 1862 (a) (7). This section excludes routine physical examinations.
  • Title XVIII of the Social Security Act, section 1862 (a) (1) (A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
  • Title XVIII of the Social Security Act, Section 1833(e). This section prohibits Medicare payment for any claim that lacks the necessary information to process the claim.

Primary Geographic Jurisdiction

Maryland

Washington, DC

Secondary Geographic Jurisdiction

Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington state, and Wyoming

Oversight Region

Region III

CMS Consortium

Northeast

DMERC Region LCD Covers

N/A

Original Determination Effective Date

04/28/1997

Revision Effective Date

09/01/2004

04/21/2003

Indications and Limitations of Coverage and/or Medical Necessity

Description

Bladder tumor antigen (BTA) is a latex agglutination assay for the qualitative detection of bladder tumor antigen in the urine. The antigen is composed of basement membrane complexes that have been isolated and characterized from the urine of patients with bladder cancer. The test may be performed rapidly on a voided urine specimen and requires minimal technical expertise. Bladder tumor antigen may be used as a method of surveillance for patients with previously diagnosed bladder cancer. The predictive value of the test increases when the stage and grade of the tumor advances (i.e., it is more predictive for stage T1 grade 2 than for stage TA grade l.

Multiple non-invasive assays are available for both the supplemental diagnosis and monitoring of bladder cancer patients. The Nuclear Matrix Protein immunoassay for NMP22Ò is a qualitative assay that may be used either as a diagnostic or a monitoring tool for bladder cancer.  A urine collection for this protein is more sensitive than urine cytology and can be used either in the diagnosis of patients suspected to have bladder cancer, or in ongoing surveillance of those already diagnosed with that condition to monitor for recurrent disease.

Indications and Limitations

BTA testing, e.g., the Mentor Accu-Dx Recurrent Bladder Cancer Test is indicated for patients with biopsy proven bladder cancer. It is used as a surveillance technique to detect recurrent invasive bladder cancer. Active infections of the genitourinary tract, renal or bladder calculi and/or a positive leukocyte reading on a urinalysis test strip may cause false positive results. The BTA test should not be used for screening.

NMP22Ò (i.e. Bladderchek™) may be used a  surveillance in a patient previously diagnosed with bladder cancer, but may also be used in diagnosing a patient suspected of having this disease along with other techniques such as cystoscopy.  This test is unaffected by hematuria.

Medicare would not expect to see this test performed more than four times in a 12-month period.

Benefits of this test may include making a decision whether:

  • to perform a flexible versus a rigid cystoscopy; or,
  • to avoid local cystoscopy and move directly to the highly probable biopsy/resection/upper tract evaluation which would be performed when there was a negative cystoscopy, but positive voided urine cytology in the past.

The rapid determination of the BTA or NMP22Ò test results may allow this decision to be made while the patient is being prepared for cystoscopy. This may reduce the number of cystoscopies performed.

Coverage Topics

Diagnostic Tests and X-Rays

Lab services

Bill Type Codes

13X, 14X, 21X, 83X

Revenue Codes

30X, 31X

CPT/HCPCS Codes

The AMA and CMS require the use of short descriptors for policies published on the Web. Refer to the CPT book for the long description of the following code:

86294

©

Immunoassay, tumor qual

© CPT American Medical Association

Does the "CPT 30% Coding Rule" Apply?

N/A

ICD-9 Codes that Support Medical Necessity

Medicare is establishing the following limited coverage for HCPCS 86294:

Covered for:

188.0

 

Malignant neoplasm of bladder, trigone of urinary bladder

188.1

 

Malignant neoplasm of bladder, dome of urinary bladder

188.2

 

Malignant neoplasm of bladder, lateral wall of urinary bladder

188.3

 

Malignant neoplasm of bladder, anterior wall of urinary bladder

188.4

 

Malignant neoplasm of bladder, posterior wall of urinary bladder

188.5

 

Malignant neoplasm of bladder, bladder neck

188.6

 

Malignant neoplasm of bladder, ureteric orifice

188.7

 

Malignant neoplasm of bladder, urachus

188.8

 

Malignant neoplasm of bladder, other specified sites of bladder

188.9

 

Malignant neoplasm of bladder, bladder part unspecified

198.1

 

Secondary malignant neoplasm of other urinary organs

233.7

 

Carcinoma in situ of the bladder

239.4

 

Neoplasm of unspecified nature of the bladder

596.7

 

Hemorrhage into bladder wall

596.8

 

Other specified disorders of bladder

599.7

 

Hematuria

788.9

 

Other symptoms involving urinary system

V10.51

 

Personal history of malignant neoplasm of the bladder

V67.2

 

Follow-up examination following chemotherapy

 

Diagnoses that Support Medical Necessity

N/A

 

ICD-9 Codes that DO NOT Support Medical Necessity

N/A

 

Diagnoses that DO NOT Support Medical Necessity

N/A

Documentation Requirements

  • Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and available to Medicare upon request.

Utilization Guidelines

Medicare will monitor the utilization of this laboratory test through the Medical Review process.

Sources of Information and Basis for Decision

  • CareFirst, Inc., Medicare Part A, LMRP for Immunoassay for Tumor Antigen
  • TrailBlazer LMRP for Bladder Tumor Antigen

Advisory Committee Notes

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from the appropriate specialty (ies). N/A

Start Date of Comment Period

N/A

 

End Date of Comment Period

N/A

Start Date of Notice Period

N/A 

Revision History

Number

 

Date

 

Change

R-1

 

09/01/2004

 

Title updated from “Bladder Tumor Antigen” to “Bladder Tumor Assays”

 

 

 

 

Paragraphs added to “Description” and “Indications” for NMP22Ò.

 

 

 

 

Added bill types 14X and 21X. Addition of  ICD-9 codes 596.7, 596.8,

 

 

 

 

599.7, and 788.9. Converted format from LMRP to LCD.

03-08

 

04/21/2003

 

Information on bladder tumor antigen (86294) extracted from archived LMRP

 

 

 

 

for Immunoassay for Tumor and placed in policy of its own. No new

 

 

 

 

information included, just revised it into its own policy with policy number.

97-04-R4

 

11/24/2002

 

LMRP for Immunoassay for Tumor Antigen which contained this code was

 

 

 

 

archived due to implementation of Lab NCD.

 

THIS BULLETIN SHOULD BE SHARED WITH ALL HEALTH CARE PRACTITIONERS AND MANAGERIAL MEMBERS OF THE PROVIDER/SUPPLIER STAFF. BULLETINS ISSUED AFTER OCTOBER 1, 1999 ARE AVAILABLE FROM OUR WEBSITE AT www.marylandmedicare.com

Italicized and or quoted material is excerpted from the American Medical Association Current Procedural Terminology CPT codes, descriptions and other data only are copyrighted 1999 American Medical Association (or such other publication of CPT). All rights reserved. Applicable FARS/DFARS apply.