Medicare Part B Reimbursement
Obtaining reimbursement for Cerezyme varies by payer and setting.
- The Medicare allowable amount for Cerezyme is Average Sales Price (ASP) plus 6%. Rates are updated quarterly.
- Medicare covers 80% of the allowable amount, and the beneficiary or their supplemental policy is responsible for the remaining 20%.
- Reimbursement for physician services is based upon the Medicare Physician Fee Schedule (MPFS).
- The Medicare allowable amount for Cerezyme® (imiglucerase for injection) is Average Sales Price (ASP) plus 5%. Rates are updated quarterly.
- Medicare covers 80% of the allowable amount, and the beneficiary or their supplemental policy is responsible for the remaining 20% balance; however, in this site of service, the patient’s 20% coinsurance liability is limited to the current year’s Part A deductible dollar amount [Section 1833(t)(8)(C) of the Social Security Act].
- Medicare pays 80% of the allowable amount plus any additional amount remaining on the beneficiary’s 20% coinsurance when the limitation on the coinsurance applies [Section 1833(t)(4)(C)].
- Reimbursement for services is based upon the Ambulatory Payment Classification (APC).
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, 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).