LCD/NCD MedicationsL30878 -LCD

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Local Coverage Determination (LCD) for Romiplostim (Nplate ®) (L30878)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L30878

LCD Title Romiplostim (Nplate ®)

Contractor's Determination Number J2796

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 06/07/2010

Original Determination Ending Date

Revision Effective Date

For services performed on or after 12/06/2011

Revision Ending Date

CMS National Coverage Policy N/A

Indications and Limitations of Coverage and/or Medical Necessity

Romiplostim (Nplate ®) is an injectable thrombopoietin (TPO) receptor agonist that stimulates bone marrow megakaryocytes to produce platelets. It is used in patients with chronic immune thrombocytopenia whose degree of thrombocytopenia (i.e., bleeding condition in which the blood doesn't clot as it should due to low platelet counts) and clinical condition increase the risk for bleeding.

Indications

Medicare considers romiplostim (Nplate ®) medically reasonable and necessary for the following indication approved by the Food and Drug Administration (FDA):

• Patients with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

Limitations

Romiplostim (Nplate ®) should not be used in an attempt to normalize platelet counts nor exceed the maximum weekly dose of 10 mcg/kg.

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.

CPT/HCPCS Codes

J2796 INJECTION, ROMIPLOSTIM, 10 MICROGRAMS

ICD-9 Codes that Support Medical Necessity

287.31 IMMUNE THROMBOCYTOPENIC PURPURA

Diagnoses that Support Medical Necessity

See ICD-9 code that supports medical necessity

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

Medical record documentation maintained by the performing provider must clearly indicate the medical necessity of the services being billed which includes the patient’s response to corticosteroids, immunoglobulins or splenectomy and made available to FCSO Medicare upon request. In addition, documentation that the service was performed must be included in the patient’s medical record. This information is normally found in the history and physical, office/progress notes, and/or procedure report. The medical record should also include the patient’s weight and laboratory test results (i.e., complete blood counts [CBCs], including platelet counts utilized for

monitoring treatment with romiplostim (Nplate ®).

Appendices

Utilization Guidelines Romiplostim (Nplate®) is supplied in single-use vials containing 250 mcg or 500 mcg of deliverable romiplostim. The initial dose is 1 mcg/kg (based on actual body weight) once weekly as a subcutaneous injection, then the weekly dose of romiplostim (Nplate®) is adjusted by increments of 1 mcg/kg to achieve and maintain a platelet count ≥ 50 x 10(9)/L as necessary to reduce the risk of bleeding. A dose of romiplostim (Nplate®) should not be given if the platelet count is > 400 x 10(9)/L.

It is expected that these services would be performed by current FDA indications. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Sources of Information and Basis for Decision

Bethan, P., & Bussel, J. B. (2007). Immune thrombocytopenic purpura. Hematology/Oncology Clinics of North America. 21(4), 743-759. Retrieved on October 10, 2009 from www.mdconsult.com.

Nplate Prescribing Information. Amgen Inc. (2008).

U.S. Food and Drug Administration (FDA). (2008).

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.

Florida Contractor Advisory Committee meeting February 13, 2010

Puerto Rico/U.S. Virgin Islands Contractor Advisory Committee meeting February 25, 2010

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 04/23/2010

Revision History Number 1

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

Start Date of Notice Period:04/01/2012 Revised Effective Date: 12/06/2011

LCR B2012-032

March 2012 Connection

Explanation of revision: LCD revised under the ‘Indications and Limitations of Coverage and/or Medical Necessity’ section to update the FDA indication to read chronic immune thrombocytopenia instead of chronic immune (idiopathic) thrombocytopenic purpura (ITP). The language was also updated under the following sections of the LCD to remove statements about the Nplate NEXUS Program: ‘Indications and Limitations of Coverage and/or Medical Necessity’ and ‘Documentation Requirements.’ The effective date of this revision is for claims processed on or after 02/23/2012 for dates of service on or after 12/06/2011.

Revision Number:Original

Start Date of Comment Period:02/04/2010 Start Date of Notice Period:04/23/2010 Original Effective Date:06/07/2010

LCR B2010 - 038

April 2010 Update

Reason for Change Typographical Correction