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Xenpozyme (olipudase alfa-rpcp) precertification request form and coverage criteria
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This document is Aetna's precertification/notification form and clinical criteria checklist for requesting coverage of Xenpozyme (olipudase alfa-rpcp) for members; it guides providers on required data for initiation and continuation requests and site-of-care considerations.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy — Initiation and continuation documentation requirements
Initiation and continuation documentation requirements
At least one diagnostic confirmation method (enzyme assay or SMPD1 genetic testing) must be provided.
Continuation Therapy — Continuation requirements
Continuation requirements
Provider must indicate clinical response to therapy for continuation review.
Site-of-Care Criteria — Site-of-care and safety considerations
Site-of-care and safety considerations
A positive response to any of these items may justify administration in an outpatient hospital setting; provide descriptions where requested on the form (e.g., behavioral issues, medical condition specifics).
The precertification form does not list specific therapeutic agents or clinical scenarios that are categorically excluded from coverage. Instead, the form captures clinical safety and site-of-care considerations — for example, whether the infusion is being requested in an outpatient hospital setting, prior severe or treatment-refractory infusion-related adverse events, presence of anti-olipudase alfa-rpcp IgE antibodies, severe venous access issues, significant behavioral/physical/cognitive impairments without caregiver support, or medical instability (cardiovascular, respiratory, renal) that would limit tolerance of infusion. These documented factors are used to justify hospital outpatient administration when needed rather than to enumerate explicit therapeutic exclusions.
The form does not present a list of conditions labeled as not medically necessary. Rather, approval depends on submission of the required clinical documentation and demonstration of indicated use. Failure to provide requested documentation (for example, details about infusion-related adverse events, IgE antibody status, site-of-care rationale, or confirmation of diagnosis) or lack of required information for continuation requests may lead to non-approval or requests for additional information.
Coding
| Administration code(s) (CPT): | Place on form for provider to supply applicable infusion CPT codes |
| Primary ICD Code: | Primary diagnosis code field for provider to enter (ASMD) |
| Secondary ICD Code: | Secondary diagnosis code field |
| Other ICD Code: | Additional diagnosis code field |
Provider Actions & Requirements
Precertification required — submit form and supporting documentation
Precertification/notification is required. Providers must submit the completed Aetna Precertification Notification form and supporting clinical documentation to the listed phone or fax numbers for precertification review.
- Aetna Precertification Notification phone: 1-866-752-7021 (TTY: 711)
- Fax: 1-888-267-3277
- All fields must be completed and legible for precertification review
Document prior infusion adverse events and response to interventions
The form specifically asks whether the patient experienced infusion-related adverse events not responsive to conventional interventions (e.g., acetaminophen, steroids, diphenhydramine, fluids, other pre-medications, or slowing of infusion rate) or severe events during or up to 3 hours after infusion; this information is used to inform site-of-care and safety decisions.
- Severe events listed include anaphylaxis, anaphylactoid reactions, myocardial infarction, thromboembolism, or seizures
- Question about laboratory-confirmed anti-olipudase alfa-rpcp IgE antibodies increasing infusion reaction risk
Complete required form fields and clinical sections
Complete all required form fields including patient demographics, insurance information, prescriber and dispensing provider details, product name/dose/frequency, and diagnosis information; include required clinical information for initiation or continuation requests.
- Patient information: name, DOB, weight/height, contact information, allergies
- Insurance: Aetna Member ID, group number, other coverage details
- Prescriber: name, specialty, phone/fax, NPI, license numbers
- Dispensing/provider administration: place of administration, CPT administration codes, provider/pharmacy details
- Product: Xenpozyme dose and frequency
- Diagnosis: primary and secondary ICD codes
- Clinical: confirmation of ASMD diagnosis for initiation and documentation of response for continuation
- Signature and date on acknowledgement section
Missing documentation may lead to denial or requests for more information
Failure to provide the required clinical documentation or a fully completed form may result in a denial of the precertification request or a request for additional information.
- The plan may request additional information or clarification if needed to evaluate requests
- All fields must be completed and legible for precertification review
Background
Acid sphingomyelinase deficiency (ASMD) is the condition targeted by Xenpozyme on this precertification form. The clinical section requires confirmation that the patient has a diagnosis of ASMD and documents non–central nervous system factors relevant to treatment and safety (for example, prior infusion-related adverse events, presence of anti-olipudase alfa-rpcp IgE antibodies, venous access issues, behavioral or cognitive impairments, and medical instability). This diagnostic confirmation is required as part of the clinical information for all precertification requests.
Definitions
Initial Therapy Criteria
Initial therapy — Initiation documentation
Initiation documentation
Complete the corresponding form fields indicating which diagnostic method is provided.
Continuation Therapy Criteria
Continuation therapy — Continuation requests must document clinical benefit
Continuation requests must document clinical benefit
Indicate 'Yes' to the form question confirming response to therapy and provide supporting data for continuation authorization.
Step Therapy / Safety Steps
| Question | Response |
|---|---|
| Has the patient experienced an adverse event with the requested product that has not responded to conventional interventions (e.g., acetaminophen, steroids, diphenhydramine, fluids, other pre-medications, or slowing of infusion rate) or a severe adverse event (anaphylaxis, anaphylactoid reactions, myocardial infarction, thromboembolism, or seizures) during or immediately after an infusion (up to 3 hours post infusion)? | |
| Yes / No (form documents this to determine need for outpatient hospital setting or additional safety measures) |
Site of Care
Specify place of administration and provide site details
The form captures the requested place of administration; providers must indicate the selected site and supply related administration details as applicable.
- Place of Administration options: Self-administered; Physician's Office; Outpatient Infusion Center; Home Infusion
- Provide phone and center/agency name for infusion sites and include administration CPT code(s) when applicable
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