Cerezyme Billing Codes
||Lipidosis (Gaucher Disease)
|200 unit vial
400 unit vial
||Cerezyme® - injection, imiglucerase, 10 units
|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)
|General IV therapy service
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.
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:
- bone disease
- hepatomegaly or splenomegaly
Important Safety Information
Approximately 15% of patients have developed IgG antibodies to Cerezyme during the first year of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity, and these patients have a higher risk of hypersensitivity. It is suggested that patients be monitored periodically for IgG antibody formation during the first year of treatment.
Hypersensitivity has also been observed in patients without detectable IgG antibodies. Symptoms suggestive of hypersensitivity have been noted in approximately 6.6% of all patients, and anaphylactoid reactions in less than 1%. Treatment with Cerezyme should be approached with caution in patients who have exhibited hypersensitivity symptoms such as pruritus, flushing, urticarial, angioedema, chest discomfort, dyspnea, coughing, cyanosis, and hypotension. Pre-treatment with antihistamines and/or corticosteroids and a reduced rate of infusion may allow continued treatment in most patients.
In less than 1% of patients, pulmonary hypertension and pneumonia have been observed during treatment with Cerezyme. These are known complications of Gaucher disease regardless of treatment. Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension.
Approximately 13.8% of patients have experienced adverse events related to treatment with Cerezyme. Some of these are injection site reactions such as discomfort, pruritus, burning, swelling or sterile abscess at the site at the site of venipuncture. Additional adverse reactions that have been reported include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Transient peripheral edema has also been reported for this therapeutic class of drug.
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).