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Contractor Name

CareFirst of Maryland INC., Medicare Part A

Contractor Number

00190

Contractor Type

Fiscal Intermediary

LCD Database ID Number

L16598

LCD Title

Trastuzumab (Herceptin®)

Contractor's Determination Number

04-02

AMA/CPT and ADA/CPT Copyright Statement

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

CMS National Coverage Policy

  • Establishment of national policy supersedes all previous contractor policy statements, including Local Medical 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

Original Determination Effective Date

08/02/2004

Revision Effective Date

 

Indications and Limitations of Coverage and/or Medical Necessity

Description

Herceptin is a recombinant DNA-derived humanized monoclonal antibody that selectively binds with high affinity in a cell-based assay to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Overexpression of HER2 is observed in 25-30% of primary breast cancers. Herceptin has been shown in both in vitro and in animals to inhibit the proliferation of human tumor cells that overexpress HER2.

 

Indications

  • Herceptin is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.
  • Herceptin in combination with chemotherapy is indicated for treatment of patients with metastic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy for their metastatic disease.
  • Herceptin should only be used in patients whose tumors have HER2 protein overexpression.

·         Herceptin is administered by intravenous infusion.

·         The recommended initial loading is 4mg/kg and may be administered as a 90-minute infusion, followed by a weekly maintenance dose of 2mg/kg if the initial loading dose was well-tolerated.

·         The treatment may be administered in an outpatient setting.

 

Limitations

  • The administration of Herceptin can result in the development of ventricular dysfunction and congestive heart failure. Left ventricular function should be evaluated in patients prior to and during treatment with Herceptin.
  • Discontinuation of the drug should be strongly considered in patients who develop a clinically significant decrease in left ventricular function.
  • The incidence and severity of cardiac dysfunction has been found to be high in patients who received Herceptin in combination with anthracyclines and cyclophosphamide.

Coverage Topics

Chemotherapy (Outpatient)

Outpatient Hospital Services

Bill Type Codes

13X, 21X, 83X, 85X

Revenue Codes

636

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 codes:

J9355

 

Trastuzumab, 10mg

© CPT American Medical Association

Does the “CPT 30% Coding Rule” Apply?

N/A

ICD-9 Codes that Support Medical Necessity

ICD-9-CM code listings may cover a range and include truncated codes. It is the provider’s responsibility to avoid truncated codes by selecting a code(s) carried out to the highest level of specificity and selected from the ICD-9-CM book appropriate to the year in which the claim is submitted.

It is not enough to link the procedure code to a correct, payable ICD-9-CM code. The diagnosis or clinical suspicion must be present for the procedure to be paid.

Medicare is establishing the following limited coverage for J9355

Covered for:

174.0-174.9

 

Malignant neoplasm of female breast

175.0-175.9

 

Malignant neoplasm of male breast

 

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 procedure through the Medical Review process.

Sources of Information and Basis for Decision

  • TrailBlazer, Drugs and Biologicals LCD
  • BCBS of Alabama, LCD
  • Herceptin® (Trastuzumab) Product Label

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).

Advisory Committee Meeting Date:

Start Date of Comment Period

04/16/2004

End Date of Comment Period

06/01/2004

Start Date of Notice Period

06/18/2004

Revision History Number

 

Revision History Explanation

 

Does this LCD contain a “Least Costly Alternative” provision?

N/A

 

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