LCD/NCD Portal

L28795

 

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.

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.

 

13x Hospital Outpatient

22x Skilled Nursing - Inpatient (Medicare Part B only)

23x Skilled Nursing - Outpatient

71x 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

 

 

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 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.

 

 

CMS LCD L28795 CEREDASE/CEREZYME