Cerezyme (imiglucerase) (Intravenous) — Coverage Criteria
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Policy governing prior authorization, dosing limits, indications, and renewal criteria for intravenous Cerezyme (imiglucerase) for members covered by Moda Health.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Initial authorization provided for 12 months
Verify billing using J1786 where 1 billable unit = 10 units
Continuation/Renewal — Renewal requires ALL of the following
Renewal (continued coverage) requires ALL of the following:
Renewal prior authorization may be provided for 12 months
If a severe hypersensitivity or severe IAR occurs, discontinue CEREZYME and initiate appropriate medical treatment; for mild/moderate reactions consider infusion rate adjustment or supportive medications.
If a member experiences a severe hypersensitivity reaction (e.g., anaphylaxis) or a severe infusion-associated reaction (IAR) during CEREZYME (imiglucerase) administration, the drug must be discontinued immediately and appropriate medical treatment initiated. For mild to moderate hypersensitivity or IARs, consider slowing or temporarily stopping the infusion and administering supportive therapies such as antihistamines, antipyretics, and/or corticosteroids as clinically indicated.
Coding and Billing
| J1786 | Injection, imiglucerase, 10 units; 1 billable unit = 10 units |
| 58468-4663-xx | Cerezyme 400 unit powder for injection, single-dose vial |
| E75.22 | Gaucher disease |
| E75.22 | Gaucher disease |
| No codes listed |
Provider Actions and Requirements
Obtain prior authorization for 12 months
Prior authorization is required for Cerezyme (imiglucerase). Initial authorizations are provided for 12 months (365 days) and renewals may be issued every 12 months (365 days).
Verify Medicare coverage determinations before billing
For Medicare Part B claims, verify and comply with any applicable CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs) and follow jurisdictional guidance when submitting outpatient drug claims.
- Search for applicable NCD/LCD/LCA at the CMS Coverage Database: https://www.cms.gov/medicare-coveragedatabase/search.aspx
Use as single‑agent therapy (no step prerequisites)
Use Cerezyme as a single agent; no prerequisite step‑therapy agents are specified in this policy.
Verify site‑of‑care specialty infusion program requirements
Confirm site‑of‑care meets Moda’s specialty infusion program requirements when requesting authorization and delivering therapy.
- Refer to the Moda Site of Care Policy for program requirements.
Submit required clinical and billing documentation
Include documentation confirming Type 1 or Type 3 Gaucher disease and supporting clinical/laboratory evidence when requesting authorization or submitting claims.
- Confirmation by significantly reduced or absent glucocerebrosidase activity (beta‑glucosidase leukocyte [BGL] test) or detection of GBA gene mutations
- Documentation of non‑CNS manifestations (e.g., anemia-related symptoms, thrombocytopenia ≤120,000/mm3, hepatomegaly/splenomegaly, skeletal disease, symptomatic disease)
- Dosing information consistent with policy limits and HCPCS/NDC billing details
Bill with diagnosis code E75.22
Use ICD‑10 code E75.22 (Gaucher disease) on claims for Cerezyme.
Renewal may be denied for toxicity or lack of response
Renewal requests may be denied if the member has unacceptable toxicity (for example, severe hypersensitivity or severe infusion‑associated reactions) or if renewal criteria (ongoing meeting of initial criteria and evidence of disease response) are not met.
- Examples of unacceptable toxicity include anaphylaxis and severe infusion‑associated reactions (angioedema, urticaria, chest discomfort, chills, pyrexia, etc.)
- Renewal requires absence of unacceptable toxicity and objective or clinical evidence of response compared to pretreatment baseline
Ensure Medicare policy compliance to avoid denials
Medicare claims must comply with applicable NCDs, LCDs, or LCAs and any related jurisdictional guidance; failure to follow applicable Medicare policy may result in claim denial.
- This document governs non‑Medicare determinations; for Medicare Part B follow the Medicare Benefit Policy Manual Chapter 15 §50 and applicable NCD/LCD/LCA guidance
Background
Gaucher disease (Type 1 or Type 3) is an inherited lysosomal storage disorder caused by deficient glucocerebrosidase activity. Enzyme replacement therapy with imiglucerase (Cerezyme) replaces the deficient enzyme to reduce non‑CNS manifestations such as anemia, thrombocytopenia, hepatosplenomegaly, skeletal disease, and related symptoms. Diagnosis should be confirmed by markedly reduced or absent glucocerebrosidase activity or by identification of pathogenic GBA gene mutations; treatment decisions and dosing are guided by disease severity and therapeutic goals, with dosing ranges from low‑dose regimens up to higher intermittent dosing and a policy maximum quantity limit of 720 billable HCPCS units every 14 days (HCPCS code J1786, where 1 billable unit = 10 units). Prior authorization is required and initial and renewal approvals are typically valid for 12 months.
Definitions
Initial Therapy Dosing and Criteria
Initial Dosing
Initial dosages and policy limits:
1 billable HCPCS unit = 10 units (HCPCS J1786)
Continuation and Renewal Criteria
Renewal Criteria
Renewal (prior authorization renewal) requires continued documentation of all of the following:
Renewal authorization may be valid for 12 months
Step Therapy
| Step | Requirement |
|---|---|
| 1 | No prerequisite therapy required; medication must be used as a single agent. |
Quantity Limits
Site of Care
Use approved specialty infusion program site of care
Administer Cerezyme in a site-of-care that meets Moda’s specialty infusion program requirements as referenced in the Moda Site of Care Policy.
- Confirm infusion center participation in Moda’s specialty infusion program before authorizing treatment
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