LCD/NCD MedicationsL29051-LCD

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Local Coverage Determination (LCD) for Abatacept (L29051)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number

09102

Contractor Type

MAC - Part B

LCD Information

Document Information

LCD ID Number L29051

LCD Title Abatacept

Contractor's Determination Number J0129

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. 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

For services performed on or after 01/01/2012

Revision Ending Date

CMS National Coverage Policy

CMS Manual System, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, § 50.3; 50.5

Indications and Limitations of Coverage and/or Medical Necessity

Abatacept is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderate to severe active rheumatoid arthritis. Abatacept may be used as monotherapy or concomitantly with DMARDS other than TNF antagonists.

Abatacept is indicated for reducing signs and symptoms in pediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. Abatacept may be used as monotherapy or concomitantly with methotrexate.

Abatacept should not be administered concomitantly with TNF antagonists. It is not recommended for use concomitantly with other biologic rheumatoid arthiritis (RA) therapy, such as anakinra.

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.

999x Not Applicable

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

J0129 INJECTION, ABATACEPT, 10 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED)

ICD-9 Codes that Support Medical Necessity

714.0 RHEUMATOID ARTHRITIS

714.2 OTHER RHEUMATOID ARTHRITIS WITH VISCERAL OR SYSTEMIC INVOLVEMENT

714.30 CHRONIC OR UNSPECIFIED POLYARTICULAR JUVENILE RHEUMATOID ARTHRITIS

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT 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

Documentation must be made available to Medicare upon request. The medical records should include the following:

• The order/prescription form of the referring/treating physician

• History of condition being treated. This should include onset, duration and other treatment

• Dosage administered and patient response

• Weight in kilograms

Appendices

Utilization Guidelines The patient’s weight determines the dosage of abatacept administration. It is expected that the following dosage guidelines will be followed.

Weight in kilograms(Dosage)

<60(500 mgm)

60-100(750 mgm)

>100(1000 mgm)

Following initial administration, abatacept should be given at 2 and 4 weeks after the first infusion, then every 4 weeks.

Sources of Information and Basis for Decision AHFS Drug Information® 2006

AHA Coding Clinic® for HCPCS Changes for the reporting of drug administration Volume 6 Number 4 Fourth Quarter 2006

American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines (2002). Guidelines for the Management of Rheumatoid Arthritis. Arthritis & Rheumatism 46,(2), 328-346.

Bristol Meyer website. Full prescribing information. http://www.orencia.com/Accessed April 17, 2008. FDA Website. Approval History: sBLA 125057/114. Available at:

http://www.fda.gov/cder/foi/appletter/2008/125057s114ltr.pdf. April 17, 2008.

FDA Website. Approval History: sBLA 103795/1001. Available at: http://www.fda.gov/cder/foi/appletter/1999/etanimm052799L.htm. Accessed April 17, 2008.

Genovese, M et al (2005). Abatacept for rheumatoid arthritis refractory to tumor necrosis factor ά inhibition. The New England Journal of Medicine 353: 1114-23.

Kremer, JM et al (2005). Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept. Arthritis & Rheumatism 52, 8:2263-2271.

Kremer, JM et al (2006). Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis. Annals of Internal Medicine 144:865-876.

U.S. Food and Drug Administration Center for Drug Evaluation and Research http://www.accessdata.fda.gov/scripts/cder/drugssadfda/index.cfm

Weinblatt, M et al (2006) Safety of the selective costimulation modulator abatacept in rheumatoid arthritis patients receiving background biologic and nonbiologic disease-modifying antirheumatic drugs. Arthritis and Rhematism 54,9:2807-2816.

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 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 1

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

Start Date of Notice Period:01/01/2012 Revised Effective Date:01/01/2012

LCR B2012-019

December 2011 Connection

Explanation of Revision: Annual 2012 HCPCS Update. Descriptor revised for HCPCS code J0129. 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 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 (L29051) replaces LCD L24540 as the policy in notice. This document (L29051) is effective on 02/02/2009.

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

J0129 descriptor was changed in Group 1

Reason for Change