LCD/NCD Portal

L30878

 

ROMIPLOSTIM (NPLATE ®)

 

 

12/06/2011

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Indications

 

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

o Patients with chronic immune thrombocytopenia who have had an insufficient response to

 Corticosteroids.

 Immunoglobulins.

 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.

 

 

CPT/HCPCS Codes

 

J2796 INJECTION, ROMIPLOSTIM, 10 MICROGRAMS

 

 

ICD-9 Codes that Support Medical Necessity

 

287.31 IMMUNE THROMBOCYTOPENIC PURPURA

 

 

Documentation 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 ®).

 

 

Utilization Guidelines

 

• Romiplostim (Nplate®) is supplied in single-use vials containing 250 mcg or 500 mcg of deliverable romiplostim.

o 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.

o 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.

 

 

Treatment Logic

 

• 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.

 

 

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.

 

FCSO LCD 30878, Romiplostim (Nplate ®), 12/06/2011. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Nplate Prescribing Information. Amgen Inc. (2008).

 

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

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 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.

 

 

CMS LCD L30878 ROMIPLOSTIM (NPLATE ®)