LCD/NCD Portal

L29096

 

CEREDASE/CEREZYME

 

 

01/01/2011

 

Indications and Limitations of Coverage and/or Medical Necessity

 

• 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:

o Moderate to severe anemia (Hgb < 10 g/dL for females; Hgb < 11 g/dL for males).

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

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

o Significant hepatomegaly 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.

o Dosage should be individualized to each patient.

o 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.

o 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.

o Maintenance therapy should be directed at achieving sustained benefit with the lowest possible dose.

o Progressive reductions can be made at intervals of 3-6 months while carefully monitoring response parameters.

 

 

CPT/HCPCS Codes

 

J0205 INJECTION, ALGLUCERASE, PER 10 UNITS

J1786 INJECTION, IMIGLUCERASE, 10 UNITS

 

 

ICD-9 Codes that Support Medical Necessity

 

272.7 LIPIDOSES

 

 

Documentation 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:

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

o 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.

Utilization Guidelines

• It is expected that these services would be performed as indicated by current medical literature and/or standards of practice.

o 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.

Treatment Logic:

• 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.

 

Sources of Information and Basis for Decision

 

Ceredase Prescribing Information. Retrieved April 22, 2005 from http://neuro-www2.mgh.harvard.edu/gaucher/ceredaseprescribe.html

 

Cerezyme Prescribing Information. Retrieved April 22, 2005 from http://gaucher.mgh.harvard.edu/cerezymeprescribe.html

 

Facts and Comparisons, Jan. 2000.

 

FCSO LCD 29096, Ceredase/Cerezyme, 01/01/2011. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Weinrab, N.J., Charrow, J., Anderson, H.C., et al. Effectiveness of enzyme replacement therapy in 1028 patients with type I Gaucher disease after 2 to 5 years of treatment: a report from the Gaucher registry. American Medical Journal 2002, 113:112-119.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 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.

 

 

CMS LCD L29096 CEREDASE/CEREZYME