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

00332

FI

OH

00450

FI

WI

00452

FI

MI

00453

FI

VA, WV

00630

Carrier

IN

00660

Carrier

KY

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 2008 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

00332

FI

OH

00450

FI

WI

00452

FI

MI

00453

FI

VA, WV

00630

Carrier

IN

00660

Carrier

KY

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 

01/01/2009

 

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. Effective for dates of service on or after 11/25/2008, American Hospital Formulary Services (AHFS), Clinical Pharmacology, NCCN Drugs and Biologics Compendium and/or Thomson Micromedex DrugDex® compendium has replaced the USP-DI and Thomson Healthcare DrugsPoints®. 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 or Part A or Part B MAC:


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

For claims submitted to the carrier or Part B MAC:

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

205.02

ACUTE MYELOID LEUKEMIA, IN RELAPSE

205.10

CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

205.12

CHRONIC MYELOID LEUKEMIA, IN RELAPSE

205.20

SUBACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

205.22

SUBACUTE 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

 

Other Information

 

Other Comments 

Sources of Information

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

 

Clinical Pharmacology

 

NCCN Drugs and Biologics Compendium accessed at: http://www.nccn.org/

 

Thomson Micromedix DrugDex® accessed at: http://www.thomsonhc.com/home/dispatch

 

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.


Revision History Explanation 

 

Article published January 2009: Source of revision – Internal - The “Article Text” and “Sources of Information” have been revised to include compendia recognized by CMS based on Change Request 6191 (Compendia as Authoritative Sources for Use in the Determination of a Medically Accepted Indication of Drugs and Biologicals Used Off-Label in an Anti-Cancer Chemotherapeutic Regimen, effective 11/25/2008). This article has been reviewed using all listed compendia and is up to date. Minor changes were made to reflect current template language.

 

Article published October 2008: Source of revision – Internal (annual ICD-9-CM code updates for 2009). The “ICD-9-CM Codes That Support Medical Necessity” section of the article is modified as follows: the description for ICD-9-CM codes 205.00, 205.10 and 205.20 has been modified. ICD-9-CM codes 205.02, 205.12 and 205.22 have been added.

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.

Article published December 2007: Original version of article.


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.

 

11/14/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00308 is removed from this article. Effective on this date, claims processing for Delaware is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state, and the claims processing for New York and Connecticut is performed by National Government Services under the J-13 MAC contract; carrier number 00805 is removed, and claims processing for New Jersey is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state.

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