LCD/NCD MedicationsL28779-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for ATGAM (Lymphocyte Immune Globulin,

Antithymocyte Globulin (Equine) (L28779)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28779

LCD Title ATGAM (Lymphocyte Immune Globulin, Antithymocyte Globulin (Equine)

Contractor's Determination Number AJ7504

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 02/16/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 06/14/2011

Revision Ending Date

CMS National Coverage Policy

CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1, 50.4.2, 50.5.1 CMS Manual System, Pub. 100-03, Medicare National Coverage, Chapter 1, Section 110.8.1 and 260.7

CMS Manual System, Pub. 100-08, Program Integrity Manual, Chapter 13, Section 5.1

Indications and Limitations of Coverage and/or Medical Necessity

Indications

ATGAM is a nonpasteurized, purified, concentrated and sterile gamma globulin, primarily momomeric IgG, from hyperimmune serum of horses immunized with human thymus lymphocytes. ATGAM mainly exhibits immunosuppressive activity; inhibiting cell mediated immune responses, such as allograft rejection and delayed hypersensitivity reactions. ATGAM reduces the number of circulating T lymphocytes measured by the E-rosette inhibition assay.

The FDA has approved one lymphocyte immune globulin preparation for marketing, lymphocyte immune globulin, anti-thymocyte globulin (equine). This drug is indicated for the management of allograft rejection episodes in renal transplantation. It is covered under Medicare when used for this purpose. Other forms of lymphocyte globulin preparation, which the FDA approves for this indication in the future, may be covered under Medicare

Medicare will cover ATGAM for the following FDA approved indications:

Renal Transplantation

ATGAM is indicted for the management of allograft rejection in renal transplant patients. When administered with conventional therapy at the time of rejection, it increases the frequency of resolution of the acute rejection episode. The drug has also been administered as an adjunct to other immunosuppressive therapy to delay the onset of the first rejection episode.

Aplastic Anemia

ATGAM is indicated for the treatment of moderate to severe Aplastic anemia in patients who are unsuitable for bone marrow transplantation. When administered with a regimen of supportive care, ATGAM may induce partial or complete hematologic remission.

In addition to the covered indication for Aplastic Anemia, Medicare will cover ATGAM for the following off-label use:

When given as a preparatory regimen in patients with severe aplastic anemia who are suitable for stem cell transplantation.

Limitations

The CMS Manual System, Pub. 100-8, Program Integrity Manual, Chapter 13, Section 5.1 (http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf) outlines that "reasonable and necessary" services

are "ordered and/or furnished by qualified personnel." Services will be considered medically reasonable and

necessary only if performed by appropriately trained providers.

A qualified physician for this service/procedure is defined as follows: A) Physician is properly enrolled in Medicare.

B) Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States or must reflect equivalent education, training, and expertise endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States.

"Doses and frequencies that exceed the accepted standard of recommended dosage and/or frequency, as described in the package insert, are considered not medically reasonable and necessary and, therefore, not reimbursable."

Do not administer ATGAM sterile solution to a patient who has had a severe systemic reaction during prior administration of ATGAM or any other equine gamma globulin preparation. Caution should be taken in giving this drug to patients who are receiving additional immunosuppressive therapy (such as corticosteroids and azathiprine) because of increased potential for infection.

Doses and frequencies that exceed the accepted standard of recommended dosage and/or frequency are considered not medically reasonable and necessary and, therefore, not reimbursable

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.

012x Hospital Inpatient (Medicare Part B only) 013x Hospital 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

J7504 LYMPHOCYTE IMMUNE GLOBULIN, ANTITHYMOCYTE GLOBULIN, EQUINE, PARENTERAL, 250 MG

ICD-9 Codes that Support Medical Necessity

284.81 - 284.89 RED CELL APLASIA (ACQUIRED) (ADULT) (WITH THYMOMA) - OTHER SPECIFIED APLASTIC ANEMIAS

996.81 COMPLICATIONS OF TRANSPLANTED KIDNEY

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity

Any ICD-9 code not listed under the ICD-9 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 patient’s medical record must support the medical necessity for the use of ATGAM. For Aplastic Anemia, the medical record must also support that the patient is not a suitable candidate for bone marrow transplantation as outlined under the indications and limitations section of the LCD. This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. This information must be available to Medicare upon request.

For patient’s receiving ATGAM as a preparatory regimen for stem cell transplant, the medical record must reflect why the patient needs a preparatory regimen of ATGAM and the approximate date of the upcoming transplant. This information must be made available to Medicare upon request.

Any pertinent laboratory tests that were performed that support the diagnosis of aplastic anemia or renal allograft rejection should be included in the medical record.

Appendices

Utilization Guidelines The manufacturer strongly recommends that patients be tested with an intradermal injection of 0.1mL of a 1:1,000 dilution of ATGAM in sodium chloride injection, USP and a contralateral sodium chloride injection control, before the first infusion of ATGAM.

ATGAM can appropriately be administered into a vascular shunt, arterial venous fistula, or in a high flow central vein through an in-line filter with a pore size of 0.2 to 1.0 cm. Do not infuse ATGAM in less than 4 hours.

Only physicians experienced in immunosuppressive therapy treatment of renal transplant or Aplastic anemia patients should use ATGAM. Patients receiving ATGAM should be treated in facilities equipped and staffed with adequate laboratory and supportive medical resources.

Renal Allograft Recipients

Adult renal allograft patients have received ATGAM Sterile Solution at the dosage of 10 to 30 mg/kg of body weight daily. ATGAM has been used to delay the onset of the first rejection episode and at the time of the first rejection episode.

Delaying the Onset of Allograft Rejection: Give a fixed dose of 15mg/kgdaily for 14 days, then every other day for 14 days for a total of 21 doses in 28 days. Administer the first dose within 24 hours before or after the

transplant.

Treatment of Rejection: The first dose of ATGAM can be delayed until the diagnosis of the first rejection episode. The recommended dose is 10-15 mg/kg daily for 14 days. Additional alternate-day therapy up to a total of 21 doses can be given.

Aplastic Anemia

The recommended dosage regimen is 10-20mg/kg daily for 8-14 days. Additional alternate-day therapy up to a total of 21 doses can be administered. Because thrombocytopenia can be associated with the administration of ATGAM, patients receiving it for the treatment of Aplastic anemia may need prophylactic platelet transfusions to maintain platelets at clinically acceptable levels.

Sources of Information and Basis for Decision

ATGAM (2003). Pharmacia & Upjohn Company, manufacturers drug label.

Bacigalupo A, Locatelli F, Lanino E, Marsh J, Socie G, Maury S, Prete A, Locasciulli A, Cesaro S, Passweg J; Severe Aplastic Anemia Working Party of the European Group for Blood and Marrow Transplantation. Fludarabine, cyclophosphamide and anti-thymocyte globulin for alternative donor transplants in acquired severe aplastic anemia: a report from the EBMT-SAA Working Party. Bone Marrow Transplant. 2005 Dec; 36(11):947-50.

Campbell, P. (2004). Pathology of acute renal rejection in the renal allograft. ASHI Quarterly. Scientific Communications.

Gaber, A; First, M.; Tesi, R; et al ( 1998). Results of the double-blind, randomized, multicenter, Phase III clinical trial of thymoglobulin versus ATGAM in the treatment of acute graft rejection episodes after renal transplantation. Transplantation, 66 (1), 29-37. Williams & Wilkins.

Kahl C, Leisenring W, Deeg HJ, Chauncey TR, Flowers ME, Martin PJ, Sanders JE, Storb R. Cyclophosphamide and antithymocyte globulin as a conditioning regimen for allogeneic marrow transplantation in patients with aplastic anemia: a long-term follow-up. Br J Haematol. 2005 Sep: 130(5):747-51.

Kang HJ, Shin HY, Choi HS, Ahn HS. Fludarabine, cyclophosphamide plus thymoglobulin conditioning regimen for unrelated bone marrow transplantation in severe aplastic anemia. Bone Marrow Transplant. 2004 Dec; 34(11):939-43.

Kroger N, Zabelina T, Renges H, Kruger W, Kordes U, Rischewski J, Schrum J, Hortsmann M, Ayuk F, Erttmann R, Kabisch H, Zander AR. Long-term follow-up of allogeneic stem cell transplantation in patients with severe aplastic anemia after conditioning with cyclophosphamide plus antithymocyte globulin. Ann Hematol. 2002 Nov; 81(11): 627-31. Epub 2002 Nov. 9.

Kumar R, Prem S, Mahapatra M, Seth T, Chowdhary DR, Mishra P, Pillai L, Narendra AM, Mehra NK, Saxena R, Choudhry VP. Fludarabine, cyclophosphamide and horse antithymocyte globulin conditioning regimen for allogeneic peripheral blood stem cell transplantation performed in non-HEPA filter rooms for multiply transfused patients with severe aplastic anemia. Bone Marrow Transplant. 2006 Apr; 37(8):745-9.

Mao P, Wang S, Wang S, Zhu Z, Liv Q, Xuv Y, Mo W, Ying Y. Umbilical cord blood transplant for adult patients with severe aplastic anemia using anti-lymphocyte globulin and cyclophosphamide as conditioning therapy. Bone Marrow Transplant. 2004 Jan:33(1):33-8.

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 Hematology and Oncology.

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:07/01/2011 Revised Effective Date:06/14/2011

LCR A2011-065

June 2011 Connection

Explanation of Revision: Based on an outside request to clarify our current training statement outlined in this

LCD, language under the “Limitations” section of the LCD has been deleted and replaced with a revised statement regarding the qualification and training. Revisions will be effective based on process date.

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 (L28779) replaces LCD L23127 as the policy in notice. This document (L28779) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 12 was changed 8/1/2010 - The description for Bill Type Code 13 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