Thrombopoietic Growth factor - Oprelvekin (L30151)

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation
Contractor Number
00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402
Contractor Type
Carrier - FI - MAC

LCD Information

Document Information
LCD ID Number
L30151

LCD Title
Thrombopoietic Growth factor - Oprelvekin

Contractor's Determination Number
INJ-034

AMA CPT/ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2011 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


Oversight Region



Original Determination Effective Date
For services performed on or after 11/15/2009

Original Determination Ending Date


Revision Effective Date
For services performed on or after 10/01/2011

Revision Ending Date


CMS National Coverage Policy
Title XVIII of the Social Security Act section 1862 (a)(1)(A). This section allows coverage and payment of those services that are considered to be medically reasonable and necessary.

Title XVIII of the Social Security Act section 1862 (a)(7). This section excludes routine physical examinations and services

Title XVIII of the Social Security Act section 1833 (e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Manual System Medicare Benefit Policy 100-2 Chapter 15 Chapter 50
Indications and Limitations of Coverage and/or Medical Necessity
Interleukin eleven (IL-11) is a thrombopoietic growth factor that directly stimulates the proliferation of hematopoietic stem cells and megakaryocyte progenitor cells and induces megakaryocyte maturation resulting in increased platelet production. Thrombocytopenia may compromise cancer treatment, causing a reduction in chemotherapy dosing, alteration in schedule or the need for platelet transfusions. Thrombopoietic growth factors may decrease the need for platelet transfusions for patients undergoing dose-intensive chemotherapy.

A. Oprelvekin is indicated to prevent severe thrombocytopenia (platelet counts of less than or equal to 20,000 cells/uL) and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy for patients with non-myeloid malignancies, who are at high risk of severe thrombocytopenia. Oprelvekin will be covered for patients with non-myeloid malignancies who have a platelet count of less than or equal to 50,000 cells/uL, or for patients with non-myeloid malignancies who had required a platelet transfusion after a previous myelosuppressive chemotherapy regimen.

B. Medicare will not consider coverage of Oprelvekin medically reasonable and necessary when it is administered simply because the patient has received a chemotherapeutic agent that has a high propensity to cause thrombocytopenia.

C. Oprelvekin is not indicated following myeloablative chemotherapy

D. Dosing should begin 6 to 24 hours following the completion of chemotherapy dosing. The safety and efficacy of Oprelvekin given immediately prior to or concurrently with cytotoxic chemotherapy has not been established.

E. Platelet counts should be monitored periodically to assess the optimal duration of therapy.
Dosing should be continued until the post-nadir platelet count is greater than 50,000 cells/UL.

1. Dosing beyond 21 days per treatment course is not recommended.

2. Treatment with Oprelvekin should be discontinued at least 2 days before starting the next planned cycle of chemotherapy.


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.

013x Hospital Outpatient
023x Skilled Nursing - 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.

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

96372THERAPEUTIC, PROPHYLACTIC, OR DIAGNOSTIC INJECTION (SPECIFY SUBSTANCE OR DRUG); SUBCUTANEOUS OR INTRAMUSCULAR
J2355INJECTION, OPRELVEKIN, 5 MG

ICD-9 Codes that Support Medical Necessity

Note: ICD-9 codes must be coded to the highest level of specificity.

The billing of Oprelvekin requires two diagnoses. Providers must use a non-myeloid malignancy ICD-9 code (140.0-204.92, 230.0-237.72, 237.9, 238.0-238.6, 238.8-239.9) and thrombocytopenia due to drugs ICD-9 code (287.49).

140.0 - 204.92MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER - UNSPECIFIED LYMPHOID LEUKEMIA, IN RELAPSE
230.0 - 237.72CARCINOMA IN SITU OF LIP ORAL CAVITY AND PHARYNX - NEUROFIBROMATOSIS TYPE 2 ACOUSTIC NEUROFIBROMATOSIS
237.9NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPECIFIED PARTS OF NERVOUS SYSTEM
238.0 - 238.6NEOPLASM OF UNCERTAIN BEHAVIOR OF BONE AND ARTICULAR CARTILAGE - NEOPLASM OF UNCERTAIN BEHAVIOR OF PLASMA CELLS
238.8 - 239.9NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER SPECIFIED SITES - NEOPLASM OF UNSPECIFIED NATURE SITE UNSPECIFIED
287.49OTHER SECONDARY THROMBOCYTOPENIA

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

General Information

Documentations Requirements
The medical record should include a platelet count of 50,000 or less. Documentation of a prior platelet transfusions for those patients with non-myeloid malignancies who had required a platelet transfusion after a previous myelosuppressive chemotherapy regimen. These records should be available to the Carrier upon request.
Appendices
Utilization Guidelines
Safety and efficacy of Interleukin-11 beyond six courses of chemotherapy has not been established to date.
Sources of Information and Basis for Decision
Isaacs, Claudine, MD Randomized Placebo-Controlled Study of Recombinant Human Interleukin-11 to Prevent Chemotherapy-Induced Thrombocytopenia in Patients with Breast Cancer Receiving Dose-Intensive Cyclophosphamide and Doxorubicin, Journal of Clinical Oncology, Vol 15, No 11 (November), 1977
Neumega Package Insert
Immuno facts Vaccines and Immunologic Drugs
Drug Facts and Comparisons
Other Medicare Carrier's policy

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.
Advisory Committee Meeting Notes
Meeting Date:
Wisconsin 05/15/2009
Illinois 05/13/2009
Michigan 05/06/2009
Minnesota 05/21/2009
J5 MAC 06/04/2009
Jurisdictional Open meeting 04/15/2009
Start Date of Comment Period
06/04/2009
End Date of Comment Period
07/20/2009
Start Date of Notice Period
10/01/2010
Revision History Number
X
Revision History Explanation
09/01/2010- Diagnosis code update-Added 287.49; Code range 230.0-238.6 separated out to 230.0-237.72, 237.9, 238.0-238.6

02/01/2010-Typo corrected in coding range statement above ICD-9 code listing- changed range to 204.92.

7/25/09 Removed contractor number 05392. Effective 8/01/09 this number will no longer be effective for E MO as MO is combining under one contractor number.

04/03/2009 Approved
04/03/2009 Entered as draft

08/08/2009 - This policy was updated by the ICD-9 2009-2010 Annual Update.

09/08/2009 Sent to approved due to ICD-9 2008-2009 Annual Update.

09/23/2009 Added 96372 to CPT/HCPCS.

11/19/2009 Released draft to final

04/19/2010-In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of American Somoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands were removed from this LCD because claims processing for those states are transitioning from FI Contractor Wisconsin Physician Services (WPS - 52280) to MAC Part A Contractor  Palmetto.

8/1/2010 - The description for Bill Type Code 13 was changed
8/1/2010 - The description for Bill Type Code 23 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

09/06/2010 - This policy was updated by the ICD-9 2010-2011 Annual Update.

10/18/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Colorado, New Mexico, Oklahoma and Texas were removed from this LCD because claims processing for those states are transitioning from FI Wisconsin Physicians Service (52280) to MAC Part A Trailblazer (04901).

11/21/2010 - 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:
96372 descriptor was changed in Group 1

02/21/2011 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901).

06/01/2011- Annual Review no change to coverage

08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update.

10/01/2011- 2012 ICD-9 code update Article published-added 173.00-173.99 to J2355
Reason for Change
Related Documents
This LCD has no Related Documents.

LCD Attachments
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Page Last Updated: Thursday, 20-Oct-2011 15:36:05 CDT