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Contractor's Policy Number

03-04

Contractor's Name

CareFirst of Maryland Inc., Medicare Part A

Contractor Number

00190

Contractor Type

Fiscal Intermediary

LMRP Title

Rituximab (RituxanŽ)

AMA CPT Copyright Statement

CPT codes, descriptions, and other data only are copyright 1999 American Medical Association (or such publication of CPT). All rights reserved. Applicable FARS/DFARS clauses apply.

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.
  • Title XVIII of the Social Security Act, Section 1833(e). This section prohibits Medicare payment for any claim that lacks the necessary information to process the claim.
  • Title XVIII of the Social Security Act, Section 1861 (s) and (t). These sections relate to drugs and biologicals.
  • Medicare Hospital Manual, Section 442.7
  • Medicare Intermediary Manual, Sections 3101.3, 3112.4, 3627.9, and 3627.10

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

 09/29/2003

Original Policy Ending Date

 

Revision Effective Date

 

Revision Ending Date

 

LMRP Description

Rituximab belongs to a group of cancer drugs known as monoclonal antibodies. It is specific for the CD20 antigen found on the surface of normal and malignant B-lymphocytes, and is used to treat patients with low-grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma. In addition to this primary indication, it may be used to treat other types of hematogenous malignancies. Often it is given to patients who have either not responded to chemotherapy, or whose cancer has returned after chemotherapy. However, it may be used as a first-line therapy.

This policy does not address the use of Ibritumomab-Tixutan.

Indications and Limitations of Coverage and/or Medical Necessity

  • Rituximab is indicated for the treatment of patients with low-grade or follicular CD20 positive, B-cell non-Hodgkin's lymphoma confirmed by histology.
  • Rituximab is indicated in the treatment of chronic lymphocytic leukemia.
  • Rituximab is indicated in the treatment of Waldenstrom's macroglobulinemia.
  • Rituximab is indicated for the treatment of chronic immune, drug induced, or idiopathic thrombocytopenia purpura when the patient meets the following criteria:
    • The patient has an initial pretreatment platelet count of 30,000 or less; or
    • There is the presence of significant purpura or mucous membrane bleeding; and,
    • They have previously undergone a splenectomy.
  • Prior to treatment with Rituximab, the presence of the CD20 marker on the targeted cells should be established.
  • The recommended dosage of Rituximab is 375 mg/m2 given as an IV infusion once weekly for four to eight doses. Repeat treatment with 375 mg/m2 given as an IV infusion once weekly for four doses every 4 to 6 months is presumed reasonable and necessary based on the patient's response to the original treatment. Rituximab may be administered in an outpatient setting, but it cannot be given as an intravenous push or bolus.

CPT/HCPCS Section & Benefit Category

Drugs and Biologicals

Type of Bill Code

13X, 22X, 23X

Revenue Codes

0636

CPT/HCPCS Codes

The AMA and CMS require the use of short descriptors for policies published on the Web. Refer to the CPT book for the long description of the following codes:

J9310

 

Rituximab, 100 mg

Not Otherwise Classified (NOC)

 

ICD-9 Codes that Support Medical Necessity

ICD-9-CM code listings may cover a range and include truncated codes. It is the provider’s responsibility to avoid truncated codes by selecting a code(s) carried out to the highest level of specificity and selected from the ICD-9-CM book appropriate to the year in which the claim is submitted.

It is not enough to link the procedure code to a correct, payable ICD-9-CM code. The diagnosis or clinical suspicion must be present for the procedure to be paid.

200.00

 

Reticulosarcoma; unspecified site, extranodal and solid organ sites

200.01

 

Reticulosarcoma; lymph nodes of head, face, and neck

200.02

 

Reticulosarcoma; intrathoracic lymph nodes

200.03

 

Reticulosarcoma; intraabdominal lymph nodes

200.04

 

Reticulosarcoma; lymph nodes of axilla and upper limb

200.05

 

Reticulosarcoma; lymph nodes on inguinal region and lower limb

200.06

 

Reticulosarcoma; intrapelvic lymph nodes

200.07

 

Reticulosarcoma; spleen

200.08

 

Reticulosarcoma; lymph nodes of multiple sites

200.10

 

Lymphosarcoma; unspecified site, extranodal and solid organ sites

200.11

 

Lymphosarcoma; lymph nodes of head, face, and neck

200.12

 

Lymphosarcoma; intrathoracic lymph nodes

200.13

 

Lymphosarcoma; intraabdominal lymph nodes

200.14

 

Lymphosarcoma; lymph nodes of axilla and upper limb

200.15

 

Lymphosarcoma; lymph nodes on inguinal region and lower limb

200.16

 

Lymphosarcoma; intrapelvic lymph nodes

200.17

 

Lymphosarcoma; spleen

200.18

 

Lymphosarcoma; lymph nodes of multiple sites

200.20

 

Burkitt's tumor or lymphoma; unspecified site, extranodal and solid organ sites

200.21

 

Burkitt's tumor or lymphoma; lymph nodes of head, face, and neck

200.22

 

Burkitt's tumor or lymphoma; intrathoracic lymph nodes

200.23

 

Burkitt's tumor or lymphoma; intraabdominal lymph nodes

200.24

 

Burkitt's tumor or lymphoma; lymph nodes of axilla and upper limb

200.25

 

Burkitt's tumor or lymphoma; lymph nodes on inguinal region and lower limb

200.26

 

Burkitt's tumor or lymphoma; intrapelvic lymph nodes

200.27

 

Burkitt's tumor or lymphoma; spleen

200.28

 

Burkitt's tumor or lymphoma; lymph nodes of multiple sites

200.80

 

Mixed lymphosarcoma; unspecified site, extranodal and solid organ sites

200.81

 

Mixed lymphosarcoma; lymph nodes of head, face, and neck

200.82

 

Mixed lymphosarcoma; intrathoracic lymph nodes

200.83

 

Mixed lymphosarcoma; intraabdominal lymph nodes

200.84

 

Mixed lymphosarcoma; lymph nodes of axilla and upper limb

200.85

 

Mixed lymphosarcoma; lymph nodes on inguinal region and lower limb

200.86

 

Mixed lymphosarcoma; intrapelvic lymph nodes

200.87

 

Mixed lymphosarcoma; spleen

200.88

 

Mixed lymphosarcoma; lymph nodes of multiple sites

202.00

 

Nodular lymphoma; unspecified site, extranodal and solid organ sites

202.01

 

Nodular lymphoma; lymph nodes of head, face, and neck

202.02

 

Nodular lymphoma; intrathoracic lymph nodes

202.03

 

Nodular lymphoma; intraabdominal lymph nodes

202.04

 

Nodular lymphoma; lymph nodes of axilla and upper limb

202.05

 

Nodular lymphoma; lymph nodes on inguinal region and lower limb

202.06

 

Nodular lymphoma; intrapelvic lymph nodes

202.07

 

Nodular lymphoma; spleen

202.08

 

Nodular lymphoma; lymph nodes of multiple sites

202.40

 

Leukemic reticuloendotheliosis; unspecified site, extranodal and solid organ sites

202.41

 

Leukemic reticuloendotheliosis; lymph nodes of head, face, and neck

202.42

 

Leukemic reticuloendotheliosis; intrathoracic lymph nodes

202.43

 

Leukemic reticuloendotheliosis; intraabdominal lymph nodes

202.44

 

Leukemic reticuloendotheliosis; lymph nodes of axilla and upper limb

202.45

 

Leukemic reticuloendotheliosis; lymph nodes on inguinal region and lower limb

202.46

 

Leukemic reticuloendotheliosis; intrapelvic lymph nodes

202.47

 

Leukemic reticuloendotheliosis; spleen

202.48

 

Leukemic reticuloendotheliosis; lymph nodes of multiple sites

202.80

 

Other lymphomas; unspecified site, extranodal and solid organ sites

202.81

 

Other lymphomas; lymph nodes of head, face, and neck

202.82

 

Other lymphomas; intrathoracic lymph nodes

202.83

 

Other lymphomas; intraabdominal lymph nodes

202.84

 

Other lymphomas; lymph nodes of axilla and upper limb

202.85

 

Other lymphomas; lymph nodes on inguinal region and lower limb

202.86

 

Other lymphomas; intrapelvic lymph nodes

202.87

 

Other lymphomas; spleen

202.88

 

Other lymphomas; lymph nodes of multiple sites

204.10

 

Chronic lymphoid leukemia without mention of remission

204.11

 

Chronic lymphoid leukemia in remission

273.3

 

Macroglobulinemia

287.3

 

Primary thrombocytopenia

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

  • All other indications not listed in the "Indications and Limitations of Coverage" section of this policy,
  • The service is for screening purposes,
  • The service is not medically necessary,
  • The medical record does not verify that the service described by the HCPCS code was provided, or;
  • The service does not follow the guidelines of this policy.

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

  • To report this service, use the appropriate HCPCS code (J9310) and revenue code (636).
  • Use alpha-numeric code Q0084 with revenue code 335 for administration of this drug. Only one unit should be billed per visit.
  • While it is acceptable to bill V58.1, chemotherapy, it is insufficient when used alone. Refer to the "ICD-9 Codes that Support Medical Necessity" section for a listing of diagnoses.
  • All of the coverage criteria must be met before this service can be reimbursed by Medicare,
  • Diagnosis(es) must be present on any claim submitted, and be coded to the highest level of specificity.
  • The diagnosis code(s) must be representative of the patient's condition.

Documentation Requirements

  • Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and available to Medicare upon request.
  • Providers should retain documentation on file, which includes the presence of the CD20+ marker.

Utilization Guidelines

Medicare will monitor the utilization of this drug through the Medical Review process.

Other Comments

  • It is recommended that CD20 antigen testing be done, and the documentation of the test results be maintained by the provider.
  • An appropriate clinical evaluation of the patient should be done to assess for factors such as cardiac comorbidities, hydration status, and other medications in use to minimize potential risks and prevent adverse drug reactions related to the administration of Rituximab.

Financial Responsibility:

Provider Liable

The provider of the service or the ordering physician must have notified the patient in writing, prior to the service, and obtained a signature verifying Advance Beneficiary Notice. Without prior notice, services denied as not medically necessary cannot be billed to the beneficiary. The provider is liable.

Beneficiary Liable

If there is clear evidence that the beneficiary was issued and signed an Advanced Beneficiary Notice (ABN) prior to the service, the liability rests with the beneficiary. Claims for dates of service prior to January 1, 2003 should contain the condition code 20 and occurrence code 32, with date to signify that an ABN was issued to the beneficiary. Absence of these codes will result in a provider liable determination

Claims for dates of service beginning January 1, 2003 should contain the occurrence code 32 with date to signify that an ABN was issued to the beneficiary. Absence of this code will result in a provider liable determination.

Reference: PM AB-02-168, CR 2415

Sources of Information and Basis for Decision

Empire Medicare (NY), Georgia, Veritus Medicare (PA), TrailBlazer (MD) LMRPs.

FDA approval letter dated November 26, 1997.

Prescribing Information-RituxanŽ (Rituximab)

CAC representative for Medical Oncology

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 , which includes a representative from Medical Oncology.

Start Date of Comment Period

06/17/2003

End Date of Comment Period

08/01/2003

Start Date of Notice Period

 09/29/2003

Revision History

Number

 

Date

 

Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.