L28780-LCD

Automated World Health

Local Coverage Determination (LCD) for Azacitidine (Vidaza®) (L28780)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28780

LCD Title

Azacitidine (Vidaza®)

Contractor's Determination Number AJ9025

Primary Geographic Jurisdiction opens in new window 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 02/16/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 12/10/2009 Revision Ending Date

CMS National Coverage Policy

CMS Manual System, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50 CMS Manual System, Pub 100-04, Medicare Claims Processing, Chapter 17, Section 20

Indications and Limitations of Coverage and/or Medical Necessity

Azacitidine is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis.

Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. The cytotoxic effects of azacitidine cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanism. Non-proliferating cells are relatively insensitive to VIDAZA.

Indications

Medicare will cover VIDAZA for the following FDA-approved labeled indications:

VIDAZA is indicated for treatment of patients with the following myelodysplastic syndrome subtypes:

- Refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusion)

- Refractory anemia with excess blasts,

- Refractory anemia with excess blasts in transformation

- Chronic myelomonocytic leukemia (CMML)

Medicare will cover VIDAZA for the following off-label indication:

- Acute Myeloid Leukemia (AML)

Limitations

VIDAZA is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. VIDAZA is also contraindicated in patients with advanced malignant hepatic tumors.

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.

013x Hospital Outpatient

021x Skilled Nursing - Inpatient (Including Medicare Part A) 022x Skilled Nursing - Inpatient (Medicare Part B only) 023x Skilled Nursing - Outpatient

085x Critical Access Hospital

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.

0636 Pharmacy - Drugs Requiring Detailed Coding

CPT/HCPCS Codes

J9025 INJECTION, AZACITIDINE, 1 MG

ICD-9 Codes that Support Medical Necessity

205.00 - 205.02 opens in new window

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

238.71 ESSENTIAL THROMBOCYTHEMIA

238.72 LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS

238.73 HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS

238.74 MYELODYSPLASTIC SYNDROME WITH 5Q DELETION

238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED

238.76 MYELOFIBROSIS WITH MYELOID METAPLASIA

Diagnoses that Support Medical Necessity

See ICD-9 CM codes that support medical necessity

ICD-9 Codes that DO NOT Support Medical Necessity

Any ICD-9 CM code that is not listed under ICD-9 CM codes that support medical necessity XX000 Not Applicable

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

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

The medical record should contain a history and physical that substantiates the medical necessity of using this drug. The medical record should also contain laboratory studies indicated under the utilization guidelines and the medical record must support the ongoing treatment and that there is a continued benefit to the patient receiving additional treatment beyond 6 treatment cycles. The medical record must support that dosages are reduced for subsequent treatment cycles based on the FDA drug label. All laboratory tests preformed to determine the dose reductions must be reported in the medical record. The medical record must be made available to Medicare upon request.

Appendices

Utilization Guidelines Dosage and Administration

First Treatment Cycle

The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75mg/m2 subcutaneously or intravenously, daily for 7 days. Patients should be pre- medicated for nausea and vomiting.

Subsequent Treatment Cycles

Cycles should be repeated every 4 weeks. The dose may be increased to 100mg/m2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred. It is recommended that patients be treated for a minimum of 4 cycles. However, complete or partial response may require more than 4 treatment cycles. Treatment may continue as long as the patient continues to benefit.

Patients should be monitored for hematologic response and renal toxicities, and dosage delay or reduction may be necessary.

Complete blood counts should be preformed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle. Liver chemistries and serum creatinine should be obtained prior to initiation of therapy.

After administration of the recommended dosage for the first cycle, dosage for subsequent cycles should be reduced or delayed based on nadir counts and hematologic response as described in the FDA approved drug label for VIDAZA®. Liver chemistries and serum creatinine should be obtained prior to initiation of therapy.

Sources of Information and Basis for Decision

American Hospital Formulary Service’s Drug Information (2008) (Compendia). Clinical Pharmacology (2009) (Compendia).

DrugDex Evaluations (2009) (Compendia).

National Cancer Institute. Myelodysplastic Syndromes (PDQ®): Treatment. Accessed via www.cancer.gov

Sudan, N., Rossetti, J.M., Shadduck, R.K., Latsko, J., Lech, J.A., Kaplan, R.B., et al. (2006). Treatment of acute myelogenous leukemia with outpatient azacitidine. American Cancer Society.

Vidaza product information (2007). Pharmion Corp.

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 advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 01/01/2010

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A

Start Date of Notice Period:01/01/2010 Revised Effective Date: 12/10/2009

LCR A2009-094

December 2009 Bulletin

Explanation of Revision: Revision to add acute myeloid leukemia as an off-label indication under the “Indications and Limitations of Coverage and/or Medical Necessity” section; and under the “ICD-9 Codes that Support Medical Necessity” section, the diagnosis code range 205.00-205.02 was added to the LCD. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Original Effective Date: 02/16/2009

LCR A2009-

December 2008 Bulletin

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

For Florida (00090) this LCD (L28780) replaces LCD L26284 as the policy in notice. This document (L28780) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 21 was changed 8/1/2010 - The description for Bill Type Code 22 was changed 8/1/2010 - The description for Bill Type Code 23 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0636 was changed

Reason for Change Coverage Change (actual change in medical parameters) ICD9 Addition/Deletion