Cerezyme Billing Codes

ICD-9-CM 272.7 Lipidosis (Gaucher Disease)
NDC 58468-1983-1
58468-4663-1		 200 unit vial
400 unit vial
HCPCS J1786 Cerezyme® - injection, imiglucerase, 10 units
CPT-4 96365



96366

Intravenous infusion therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour

Each additional hour (List separately in addition to primary procedure code, 96365)
Revenue 260
261
258
636		 General IV therapy service
Infusion pump
IV solutions
Drugs and biologicals requiring a HCPCS code

Providers are responsible for the selection of appropriate codes. Information in the table below provides a general framework for understanding possible coding alternatives. It should not be used as a substitute for a healthcare professional’s own judgment. Any specific guidance or direction regarding claims submission offered by the payer supersedes the information below.

Note:

Since third party payers evaluate treatment based on medical necessity, expected outcome, and cost, they generally require documentation of diagnosis and clinical symptoms of type I Gaucher disease. Refer to the Statement of Medical Necessity sample in the back of this guide (Appendix B). This information may need to be submitted with the claim; for specific requirements check with the payer or contact your Genzyme Case Manager.

To help avoid potential problems obtaining reimbursement, the treating physician should request written confirmation of coverage from the third party payer prior to initiation of enzyme replacement therapy. Genzyme Case Managers can assist in obtaining written authorization for Cerezyme treatment.

Indication & Usage

Cerezyme® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions:

  1. anemia
  2. thrombocytopenia
  3. bone disease
  4. hepatomegaly or splenomegaly

Important Safety Information

Approximately 15% of patients have developed IgG antibodies, and these patients have a higher risk of hypersensitivity reaction. Therefore periodic monitoring is suggested; caution should be exercised in patients with antibodies or prior symptoms of hypersensitivity. Symptoms suggestive of hypersensitivity occurred in 6.6% of patients, and include anaphylactoid reaction, pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis and hypotension.

Reactions related to Cerezyme administration have been reported in less than 15% of patients. Each of the following events occurred in less than 2% of the total patient population. Reported adverse events include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Adverse events associated with the route of administration include discomfort, pruritus, burning, swelling or sterile abscess at the site at the site of injection.

To report suspected adverse reactions, contact Genzyme at 800-745-4447, option 2 or FDA at 800-FDA-1088 or http://www.fda.gov/Safety/MedWatch

Please see Full Prescribing Information (PDF).