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Contractor's Policy Number

96-07-R1

Contractor's Name

CareFirst of Maryland Inc.

Contractor Number

00190

Contractor Type

Fiscal Intermediary

LMRP Title

Interleukin-2 - Proleukin™

AMA CPT 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.

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.

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

CMS Region

Region III

CMS Consortium

Northeast

Original Policy Effective Date

October 12, 1996

Original Policy Ending Date

NA

Revision Effective Date

07/22/2002

Revision Ending Date

NA

LMRP Description

Aldesleukin (tradename Proleukin™) is a form of human Interleukin-2 produced by recombinant DNA technology. Interleukin-2 activates T-cell lymphocytes and natural killer cells which are antagonistic to tumor cells.

Indications and Limitations of Coverage and/or Medical Necessity

Interleukin-2 is only indicated for the treatment of metastatic renal cell carcinoma and metastatic melanoma.

CPT/HCPCS Section & Benefit Category

HCPCS Level II Code

Type of Bill Code

13X, 21X, 22X, 23X, 83X

Revenue Codes

636

CPT/HCPCS Codes

Not Otherwise Classified (NOC)

NA

ICD-9 Codes that Support Medical Necessity

Covered for:

Diagnoses that Support Medical Necessity

Metastatic melanoma and metastatic renal cell carcinoma, as listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy

ICD-9 Codes that DO NOT Support Medical Necessity

Any diagnosis codes not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy

Diagnoses that DO NOT Support Medical Necessity

Conditions not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy.

Reasons for Denial

• All other indications not listed in the "Indications and Limitations of Coverage" section of this policy,
• The service is for screening purposes,
• The service is not medically necessary,
• The medical record does not verify that the service described by the HCPCS code was provided, and;
• The service does not follow the guidelines of this policy.

Non-covered ICD-9 Codes

Any diagnosis codes not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy

Non-covered Diagnoses

Conditions not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy.

Coding Guidelines

• To report this service, use the appropriate HCPCS code,
• All of the coverage criteria must be met before this service can be reimbursed by Medicare,
• Diagnosis (es) must be present on any claim submitted, and be coded to the highest level of specificity, and;
• The diagnosis code(s) must be representative of the patient's condition.

Documentation Requirements

• Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and available to Medicare upon request.
• The dosage of medication given should be included on the claim.

Utilization Guidelines

Interleukin-2 is generally given as 60,000 I.U./Kg every 8 hours for 5 days with a maximum of 14 doses per course. After a 9 day rest period, a second course of 14 doses is administered.

Other Comments

Interleukin-2 administration is associated with frequent and often serious adverse reactions and should be restricted to patients who have been shown to have normal stress thallium and pulmonary function tests.

Sources of Information and Basis for Decision

TrailBlazer Health Enterprises, Inc.

Medical Policy Committee, CareFirst BlueCross BlueShield, Inc.

Package insert - Proleukin™

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: NA

Start Date of Comment Period

NA

End Date of Comment Period

NA

Start Date of Notice Period

NA

Revision History

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.