Granulocyte Colony Stimulating Factors-Neupogen

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Contractor's Policy Number

96-06-R4

Contractor Number

00190

Contractor Type

Fiscal Intermediary

LMRP Title

Granulocyte Colony Stimulating Factors - (Neupogen™ and Neulasta™)

AMA CPT Copyright Statement

CMS National Coverage Policy

Establishment of national policy supersedes all previous contractor policy statements, including Local Medical Policy coverage guidelines
Title XVIII of the Social Security Act, section 1862 (a) (7). This section excludes routine physical examinations.
Title XVIII of the Social Security Act, section 1862 (a) (1) (A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Primary Geographic Jurisdiction

Maryland

Washington, DC

Secondary Geographic Jurisdiction

Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington state, and Wyoming

CMS Region

Region III

CMS Consortium

Northeast

Original Policy Effective Date

October 12, 1996

Original Policy Ending Date

Revision Effective Date

01/01/2004

07/01/2003

01/01/2003

07/22/2002

Revision Ending Date

LMRP Description

Filgrastim (Neupogen™) is a human granulocyte colony stimulating factor (G-CSF) produced by recombinant DNA technology. G-CSF stimulates the production of neutrophils within the bone marrow. Pegfilgrastim (tradename Neulasta™) is the same molecule with a covalent bond to a polyethylene glycol molecule, and has the same effect on the bone marrow. Both are effective in accelerating the recovery of neutrophil counts following myelosuppressive chemotherapy.

Indications and Limitations of Coverage and/or Medical Necessity

Neupogen™ is indicated:

To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
For reducing the time to neutrophil recovery and duration of fever, following induction of consolidation chemotherapy treatment of adults with AML.
To reduce the duration of neutropenia in patients undergoing myeloablative chemotherapy followed by marrow transplantation for a nonmyeloid malignancy.
To mobilize hematopoietic progenitor cells for collection by leukapheresis for engraftment after myeloablative chemotherapy.
To reduce the incidence and duration of sequelae of neutropenia in symptomatic patients with severe chronic neutropenia.
To reduce the neutropenia of AIDs in children.
To reduce the neutropenia of AIDs patients treated with AZT.
To reduce the neutropenia of AIDs patients treated with ganciclovir for CMV chororetinitis.

Neulasta™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

CPT/HCPCS Section & Benefit Category

HCPCS Level II Codes

Type of Bill Code

13X, 21X, 22X, 23X, , 72X, 83X

Revenue Codes

636

CPT/HCPCS Codes

Providers should refer to a current version of the CPT book for the long descriptors. The AMA and CMS require the use of short descriptors in policies published on the Web.

J1440 Filgrastim 300 mcg

J1441 Filgrastim 480 mcg

J2505 Pegfilgrastim, 6 mg

Not Otherwise Classified (NOC)

ICD-9 Codes that Support Medical Necessity

042		Human immunodeficiency virus [HIV] disease
		Use this code (042) only for AIDS neutropenia in children
238.7		Neoplasm of uncertain behavior of other and unspecified sites and tissues, other lymphatic and
		hematopoietic tissues
		Note: Use this code (238.7) for myelodysplastic syndrome
284.0		Constitutional aplastic anemia
284.8		Other specified aplastic anemias
284.9		Aplastic anemia, unspecified
288.0		Agranulocytosis
288.9		Unspecified disease of white blood cells
V42.81		Organ or tissue replaced by transplant, other specified organ or tissue, bone marrow
V42.82		Organ or tissue replaced by transplant, other specified organ or tissue, peripheral stem cells
V42.9		Organ or tissue replaced by transplant, unspecified organ or tissue
V59.9		Donors, unspecified organ or tissue
		Use V59.8 when patient is being primed for autologous stem cells
V66.2		Convalescence and palliative care, following chemotherapy
V66.5		Convalescence and palliative care, following other treatment
		Use V66.5 when the patient has neutropenia secondary to the use of AZT or ganciclovir

Diagnoses that Support Medical Necessity

As listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy

ICD-9 Codes that DO NOT Support Medical Necessity

Any diagnosis codes not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy

Diagnoses that DO NOT Support Medical Necessity

Conditions not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy.

Reasons for Denial

The medical record does not document that the service described by the HCPCS code was provided.
The service was provided for an indication not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy.
The service does not follow the guidelines of this policy.
The documentation in the medical record does not support the medical necessity of providing this service.

Non-covered ICD-9 Codes

Any diagnosis codes not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy

Non-covered Diagnoses

Conditions not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy.

Coding Guidelines

Diagnosis (diagnoses) must be present on the submitted claim, and be coded to the highest level of specificity to accurately represent the patient's condition
The service(s) should be reported using the appropriate HCPCS code(s)
Refer to the Correct Coding Initiative for "bundling" information

Documentation Requirements

Documentation supporting the medical necessity for this procedure should be legible, maintained in the patient's medical record, and available to Medicare upon request.
Appropriate HCPCS codes should be used when reporting this service.
An appropriate diagnosis code should be submitted on the claim. The patient's medical record should indicate the signs/symptoms supporting the diagnosis, as well as functional impairments.
Documentation of dosage of drug administered should be included with the claim.

Utilization Guidelines

When used for cytotoxic therapy induced neutropenia, Neupogen™ should be discontinued when the absolute neutrophil count reaches 10,000, or after two weeks of daily therapy.

Neulasta™ should be given once per chemotherapy cycle.

Other Comments

"Least costly alternative" provisions apply when there is a significant disparity between the overall costs of using two medications which are clinically equivalent.

Sources of Information and Basis for Decision

TrailBlazer Health Enterprises, Inc.

CareFirst INC., Medical Policy Committee

Neupogen™ package insert

Neulasta™

package insert

Advisory Committee Notes

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups.

Advisory Committee Meeting Date: NA

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period

9/12/1996

Revision History

Number	Date	Change
96-06-R4	01/01/2004	Annual update of CPT/HCPCS codes. Added J2505, discontinued Q4053.
96-06-R3	07/01/2003	Deleted C9119 code and replaced with Q4053 Pegfilgrastim per 1 mg.
		(Updates in PM A-03-051, CR2771)
96-06-R2	01/01/2003	Annual CPT/HCPCS updates. Addition of C9119, removal of J3490 from
		policy due to addition of new code. CPT descriptors changed to short
		descriptor.
96-06-R1	07/22/2002	Changed title. Adapted policy to CMS format. Added information
		concerning Neulasta. Added indications. Updated HCPCS
		codes. Added ICD-9 codes.

THIS BULLETIN SHOULD BE SHARED WITH ALL HEALTH CARE PRACTITIONERS AND MANAGERIAL MEMBERS OF THE PROVIDER/SUPPLIER STAFF. BULLETINS ISSUED AFTER OCTOBER 1, 1999 ARE AVAILABLE FROM OUR WEBSITE AT www.marylandmedicare.com

Italicized and or quoted material is excerpted from the American Medical Association Current Procedural Terminology CPT codes, descriptions and other data only are copyrighted 1999 American Medical Association (or such other publication of CPT). All rights reserved. Applicable FARS/DFARS apply.