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Local Coverage Determination (LCD) for CEREDASE/CEREZYME (L28795)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28795

LCD Title CEREDASE/CEREZYME

Contractor's Determination Number AJ0205

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/16/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/01/2011

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, Sections 50.1-50.4.3

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Sections 10 and 40

Indications and Limitations of Coverage and/or Medical Necessity

Ceredase (alglucerase) and Cerezyme (imiglucerase) are analogues of the human enzyme B-glucocerebrosidase, produced by recombinant DNA technology. Ceredase and Cerezyme each catalyze the hydrolysis of glucocerebroside to glucose and ceramide.

Medicare will consider Ceredase and Cerezyme to be medically reasonable and necessary for use as long-term enzyme replacement therapy for patients with a confirmed diagnosis of Type I Gaucher’s disease who, upon initiation of treatment, exhibit signs and symptoms that are severe enough to result in one or more of the following conditions:

• Moderate to severe anemia (Hgb < 10 g/dL for females; Hgb < 10 g/dL for males)

• Thrombocytopenia with bleeding tendency (platelets < 100,000/uL)

• Any evidence of bone disease other than Erlenmeyer flask deformity or mild osteopenia

• Significant hepotamegaly or splenomegaly which verifies that spleen is 5 times normal size or the liver is 1.25 times normal size according to a MRI or CT scan

Dosage and Administration

Ceredase/Cerezyme are administered by intravenous infusion over 1-2 hours. Dosage should be individualized to each patient. Initial dosage may be as little as 2.5 units/kg of body weight 3 times a week, up to as much as 60 U/kg administered as frequently as once a week or as infrequently as every 4 weeks. Disease severity may dictate that treatment be initiated at a relatively high dose or relatively frequent administration.

After patient response is well established, a reduction in dosage may be attempted for maintenance therapy. Maintenance therapy should be directed at achieving sustained benefit with the lowest possible dose. Progressive reductions can be made at intervals of 3-6 months while carefully monitoring response parameters.

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

022x Skilled Nursing - Inpatient (Medicare Part B only) 023x Skilled Nursing - Outpatient

071x Clinic - Rural Health

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

J0205 INJECTION, ALGLUCERASE, PER 10 UNITS J1786 INJECTION, IMIGLUCERASE, 10 UNITS

ICD-9 Codes that Support Medical Necessity

272.7 LIPIDOSES

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

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

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical necessity for the services must be clearly documented in the patient’s medical record and made available to the Carrier upon request. Documentation should be maintained by the ordering/referring physician. The following should be included in the documentation:

• Evidence of a confirmed diagnosis of Gaucher’s disease exhibited by an enzyme assay or DNA-typing.

• The documentation must include a copy of the DNA-typing or enzyme assay with interpretation. Statement(s) by the physician stating the results without a copy of the test would not be considered adequate.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Dosage is not expected to exceed 60 u/kg every two weeks.

Sources of Information and Basis for Decision

Fauci, A., Braunwald, E., Isselbacher, K., et. al. (1998). Harrison’s Principles of Internal Medicine (14th ed.). New

York: McGraw-Hill. Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 01/01/2011

Revision History Number 1

Revision History Explanation Revision Number1 Start Date of Comment Period:N/A

Start Date of Notice Period:01/01/2011 Revision Effective Date 01/01/2011

LCR A2011-014

December 2010 Bulletin

Explanation of Revision: Annual 2011 HCPCS Update. HCPCS code J1785 was deleted and replaced with HCPCS code J1786. The effective date of this revision is based on date of service.

Revision Number: Original

Start Date of Comment Period: N/A Start Date of Notice Period: 12/04/2008 Original Effective Date: 02/16/2009

LCR A2008-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28795) replaces LCD L1289 as the policy in notice. This document (L28795) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 22 was changed 8/1/2010 - The description for Bill Type Code 23 was changed 8/1/2010 - The description for Bill Type Code 71 was changed

8/1/2010 - The description for Revenue code 0636 was changed 11/21/2010 - The following CPT/HCPCS codes were deleted:

J1785 was deleted from Group 1

Reason for Change