Archive Article for Azacitidine (e.g., Vidaza ™) - Related to LCD L25820 (A46099)

Contractor Information

Contractor Name 

National Government Services, Inc.  

Contractor Number 

Number	Type	State(s)
00130	FI	IN
00131	FI	IL
00160	FI	KY
00180	FI	ME
00181	FI	MA
00270	FI	NH, VT
00308	FI	CT, DE, NY
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00630	Carrier	IN
00660	Carrier	KY
00805	Carrier	NJ
13101	MAC	CT – Part A
13102	MAC	CT – Part B
13201	MAC	NY – Part A
13202	MAC	NY – Part B
13282	MAC	NY- Part B
13292	MAC	NY – Part B

Contractor Type 

Carrier

Fiscal Intermediary

MAC – Part A

MAC – Part B

Article Information

Article ID Number 

A46099 

Article Type 

Article

Key Article 

Yes

Article Title 

Azacitidine (e.g., Vidaza ™) - Related to LCD L25820 

AMA CPT / ADA CDT Copyright Statement 

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association.© 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction 

Number	Type	State(s)
00130	FI	IN
00131	FI	IL
00160	FI	KY
00180	FI	ME
00181	FI	MA
00270	FI	NH, VT
00308	FI	CT, DE, NY
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00630	Carrier	IN
00660	Carrier	KY
00805	Carrier	NJ
13101	MAC	CT – Part A
13102	MAC	CT – Part B
13201	MAC	NY – Part A
13202	MAC	NY – Part B
13282	MAC	NY- Part B
13292	MAC	NY – Part B

Original Article Effective Date 

12/01/2007

Article Revision Effective Date 

08/18/2008

Article Text 

This article defines coding and coverage for azacitidine including off-label indications. National Government Services Local Coverage Determination (LCD) “Coverage of Drugs and Biologicals for Label and Off-Label Uses” allows coverage for off-label indications only if the United States Pharmacopeia Drug Information (USP-DI), the American Hospital Formulary Services (AHFS) and/or Thomson Healthcare DrugPoints® (as described in the LCD) define such indications or if National Government Services has published an article or LCD expanding such coverage. Providers may request approval for additional off-label indications by submitting this request in writing with supporting medical literature. The aforementioned National Government Services LCD, which describes the requirements for such a request, can be accessed on our contractor Web site at www.NGSMedicare.com or on the Medicare Coverage Database at www.cms.hhs.gov/mcd.

Abstract:
Azacitidine is approved for the treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia and requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.

Acute myeloid leukemia

Coding Guidelines:

General Guidelines for claims submitted to Carriers or Intermediaries:

Azacitidine should be reported with HCPCS code J9025 (injection, azacitidine, 1 mg).

For claims submitted to the carrier:

Azacitidine should be billed using chemotherapy administration codes and is payable in the following places of service: office (11), skilled nursing home for patients in a Part A stay (31) [if the drug is supplied by the facility, no claims for the drug should be submitted to the Part B carrier.], nursing facility for patients not in a Part A stay (32) and independent clinic (49) only when supplied as an “incident to” service by the physician.

Coverage Topic 

Chemotherapy (Inpatient)
Chemotherapy (Outpatient)
Prescription Drugs

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

11x	Hospital-inpatient (including Part A)
13x	Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)
85x	Special facility or ASC surgery-rural primary care hospital (eff 10/94)

CPT/HCPCS Codes 

J9025

INJECTION, AZACITIDINE, 1 MG

ICD-9 Codes that are Covered 

205.00	ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
205.01	MYELOID LEUKEMIA ACUTE IN REMISSION
205.10	CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
205.20	SUBACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
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

Other Information

Other Comments 

Sources of Information

AHFS Drug Information, American Society of Health-System Pharmacists, Inc. Bethesda, MD. 2007.

Thomson Healthcare DrugPoints® at http://www.thomsonhc.com/home/dispatch

U.S. Food and Drug Administration label approved 05/18/2004 accessed on line at
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ on 11/19/2007.

United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.

08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this LCD as the claims processing for American Samoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands was transitioned to Palmetto GBA, the Part A/Part B MAC contractor in these states.

08/10/2008 - This policy was updated by the ICD-9 2008-2009 Annual Update.

Revision History Explanation 

This revised article is effective for all National Government Services jurisdictions on July 18, 2008 with these exceptions: for Connecticut – Part B the article is effective on August 1, 2008; for Upstate New York – Part B, the article is effective on September 1, 2008; and for New York and Connecticut – Part A, the article is effective on November 14, 2008. For New York – Part A (contract 00308), the content of this article is currently in effect but the article will be transferred to the J-13 contract number 13201 on November 14, 2008.

This article was revised to add the Jurisdiction 13 (J-13) MAC contractor numbers and to retain the most clinically appropriate medical policy information within the jurisdiction, including off-label indications and approved indications from DrugPoints®.

The following indication has been added: acute myeloid leukemia. The following ICD-9-CM codes have been added: 205.00, 205.01, 238.71, 238.74 and 238.76. Thomson Healthcare DrugPoints® has been added to the “Article Text” paragraph and “Sources of Information”. Bill type codes have been added. Places of service for claims submitted to the carrier has been revised.

This article has an effective date of 12/01/2007.

The original version of the corresponding LCD became effective on 12/01/2007.

08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this article as the claims processing for American Samoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands was transitioned to Palmetto GBA, the Part A/Part B MAC contractor in these states.

08/10/2008 - This policy was updated by the ICD-9 2008-2009 Annual Update.

Related Documents 

Article(s)
A44930 - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses - Supplemental Instructions Article

LCD(s)
L25820 - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses