Billing and Reimbursement

To bill for Cerezyme therapy, you must use the appropriate codes. The billing procedures may vary according to the site of service or third-party payer guidelines. Please reference this site or call a Genzyme Case Manager for updated billing codes.

In addition to the reimbursement expertise provided by our Case Managers, Genzyme also offers the following downloadable resources to help guide you through the process:

The Centers for Medicare and Medicaid Services (CMS) issued a unique HCPCS billing code for Cerezyme®.

2011 billing instructions for Cerezyme:

HCPCS code: J1786
Units: 10
Administration: Cerezyme® - injection, imiglucerase
The unique J-code assigned to Cerezyme, significantly streamlines the reimbursement process. Cerezyme is eligible for reimbursement by commercial payers and Medicare. However, specific policies vary across insurers and from plan to plan. Use the links below to find reimbursement information for the following payer types:
  • Private Payers – Understand the reimbursement guidelines for commercial payers, including specialty pharmacy.
  • Managed Care – Find out about Managed Care reimbursement across different settings of care
  • Medicaid Managed Care – Understand general reimbursement requirements across state Medicaid agencies

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 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).