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Contractor's Policy Number

96-04-R2

Contractor's Name

CareFirst of Maryland Inc., Medicare Part A

Contractor Number

00190

Contractor Type

Fiscal Intermediary

LMRP Title

Cerezyme and Ceredase

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 supercedes 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

NA

Revision Effective Date

07/12/2002

Revision Ending Date

07/11/2002

LMRP Description

Cerezyme (imiglucerase) and Ceredase (alglucerase) are enzyme replacement therapies used in the treatment of Type I Gaucher Disease, a rare hereditary disorder caused by a deficiency in the enzyme beta-glucocerebrocidase and characterized by anemia, leukopenia, thrombocytopenia, enlargment of the liver and spleen, bone abnormalities, and often a shortened life expectancy. Cerezyme is produced by recombinant technology and has largely replaced Ceredase, which is developed from pooled human placental tissue.

Indications and Limitations of Coverage and/or Medical Necessity

Cerezyme and Ceredase are indicated for the long-term enzyme replacement therapy for patients with a confirmed diagnosis of Type I Gaucher Disease that results in one or more of the following conditions:

Anemia

Thrombocytopenia

Bone Disease

Hepatomegaly or Splenomegaly.

CPT/HCPCS Section & Benefit Category

HCPCS Level II Code

Type of Bill Code

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

Revenue Codes

636

CPT/HCPCS Codes

Not Otherwise Classified (NOC)

NA

ICD-9 Codes that Support Medical Necessity

Diagnoses that Support Medical Necessity

Gaucher's Disease, Type I

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.
• The number of units given should be included on the claim.

Utilization Guidelines

The dosage is individualized by patient. The drug is given by IV infusion over 1-2 hours, and the dosage may range from 2.5 Units/kg of bodyweight 3 times per week, to 60 Units/kg of bodyweight every 2 weeks (up to every 4 weeks for Ceredase).

Other Comments

NA

Sources of Information and Basis for Decision

TrailBlazer Health Enterprises, Inc.

Medial Policy Committee, CareFirst BlueCross BlueShield, Inc.

Prescribing Information, Cerezyme and Ceredase.

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.

Advisor committee meeeting date: NA

Start Date of Comment Period

NA

End Date of Comment Period

NA

Start Date of Notice Period

September 12, 1996

Revision History

THIS BULLETIN SHOULD BE SHARED WITH ALL HEALTH CARE PRACTITIONERS AND MANAGERIAL MEMEBERS 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.