L29053-LCD

Automated World Health

Local Coverage Determination (LCD) for Aldesleukin (Proleukin®,

Interleukin-2, Recombinant, and RIL-2) (L29053)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number: 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29053

LCD Title Aldesleukin (Proleukin®, Interleukin-2, Recombinant, and RIL-2)

Contractor's Determination Number J9015

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. 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. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009 Original Determination Ending Date

Revision Effective Date

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the 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:

CMS Manual System, Pub. 100-02, Medicare Benefit Policy, Chapter 15, Section 50

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40

CMS Manual System, Pub. 100-08, Medicare Program Integrity, Chapter 13, Section 13.1.3

Indications and Limitations of Coverage and/or Medical Necessity

ALDESLEUKIN (PROLEUKIN, INTERLEUKIN-2, RECOMBINANT, AND RIL-2) - J9015

Aldesleukin is classified as a biological response modifier. It increases cellular immunity and inhibits tumor growth. Because of its potential life-threatening toxicities, it is recommended that this medication be given only after careful consideration of the risks and benefits.

Aldesleukin is FDA approved for the following indications:

• Treatment of adults with metastatic renal cell carcinoma, and

• Treatment of adults with metastatic melanoma

Medicare will consider the use of aldesleukin as medically reasonable and necessary for the FDA approved uses, as well as for the following off-labeled indications:

• Acute and chronic myeloid leukemia

Dosage:

Aldesleukin comes in a single-use vial containing 22 million IU (1.3 mg) of Proleukin. When reconstituted as directed, each ml contains 18 million IU (1.1 mg) of Proleukin. Any unused portion should be discarded.

The usual adult dose for aldesleukin for injection for metastatic renal cell carcinoma or metastatic melanoma carcinoma is:

High dose therapy: Intravenous infusion (over fifteen minutes), 600,000 International Units (IU) per kg of body weight (0.037 mg per kg of body weight) every eight hours for a total of fourteen doses. Following nine days of rest, the schedule is repeated for another fourteen doses, for a maximum of twenty-eight doses per course.

If a provider departs from the recommended high dose label recommendations for the hospital setting and gives

a reduced dosage (off-label) and/or different route of administration in an alternate setting, the rationale for such administration should be documented in the medical record.

Warnings on the FDA drug label for Aldesleukin (Proleukin®) for Injection include:

• Proleukin should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

• Proleukin administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space. CLS results in hypotension and reduced organ perfusion which may be severe and can result in death. CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory

insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.

• Proleukin administration should be withheld in patients developing moderate to severe lethargy or somnolence, continued administration may result in coma.

FDA label contraindications for aldesleukin (Proleukin®) include:

• Proleukin is contraindicated in patients with a known history of hypersensitivity to interkeukin-2 or any component of the Proleukin formulation.

• Proleukin is contraindicated in patients with an abnormal thalium stress test or abnormal pulmonary function tests and those with organ allografts.

(See product label for additional information).

Coding Information

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 policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

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 policy 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 policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

J9015 INJECTION, ALDESLEUKIN, PER SINGLE USE VIAL

ICD-9 Codes that Support Medical Necessity

172.0 - 172.9

MALIGNANT MELANOMA OF SKIN OF LIP - MELANOMA OF SKIN SITE UNSPECIFIED

189.1 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS

189.2 MALIGNANT NEOPLASM OF RENAL PELVIS

190.6 MALIGNANT NEOPLASM OF CHOROID

205.00 - 205.02 - ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

- ACUTE MYELOID LEUKEMIA, IN RELAPSE

205.10 - 205.12

CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - CHRONIC MYELOID LEUKEMIA, IN RELAPSE

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

All other diagnosis codes not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD.

XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

All other diagnoses not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD.

General Information

Documentations Requirements

Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the condition for which these drugs are being used. This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy. This documentation is usually found in the history and physical or in the office/progress notes.

If the provider of the service is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug. The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

The FDA label recognizes the higher dosages of Aldesleukin for an inpatient facility. Input from the provider community shows this drug is being given at lower dosages in the office or other outpatient setting with appropriate precautions. If a provider departs from the recommended high dose label recommendations and gives a reduced dosage (off-label) and/or different route of administration in an alternate setting, the rationale for such administration should be documented in the medical record.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Sources of Information and Basis for Decision

Compendia-Based Drug Bulletin. (November 2006). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

Hamilton, S. (2005). Chemotherapy Drugs, Aldesleukin [Electronic version]. Cleveland Clinic Cancer Center. Retrieved January 18, 2006, from http://www.Chemocare.com.

Proleukin® (Aldesleukin) for Injection package insert (2000). Chiron Corporation, Emeryville, CA.

Thomson Micromedex (2007). USP DI Drug Information for the Health Care Professional. [On-Line]. Available: http://www.thomsonhc.com/home/dispatch

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, February 2007.

Based on Change Request 6191, all new evaluations for this LCD will be performed utilizing one of the CMS

approved compendia. Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with the advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number Original

Revision History Explanation Revision Number:Original

Start Date of Comment Period:N/A

Start Date of Notice Period:12/04/2008

Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29053) replaces LCD L25063 as the policy in notice. This document (L29053) is effective on 02/02/2009.

Updated "Sources of Information and Basis for Decision" section to include statement regarding CR6191.

Reason for Change