CurrentAetnaPolicy N/A

Lumizyme (alglucosidase alfa) Precertification Request Form Coverage Criteria

Precertification form and requirements for Aetna coverage review of Lumizyme (alglucosidase alfa) infusion therapy for members, including initiation and continuation requests and clinical questions confirming Pompe disease diagnosis and treatment response.

Policy Summary

PayerAetna

PolicyLumizyme (alglucosidase alfa) Precertification Request Form Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification form including diagnostic confirmation for initiation or documentation of response for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2page form length

1-866-752-7021Aetna precertification phone

1-888-267-3277Aetna precertification fax

MA Part Bseparate phone/fax provided

Coverage Criteria

Policy Summary

PayerAetna

PolicyLumizyme (alglucosidase alfa) Precertification Request Form Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification form including diagnostic confirmation for initiation or documentation of response for continuation.

SourceLink

On This Page

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Initiation criteria: Diagnosis of Pompe disease confirmed by enzyme assay demonstrating a deficiency of acid alpha-glucosidase (GAA) enzyme activity OR by genetic testing

checkbox on initiation section

Continuation criteria: Documentation that the patient is responding to therapy (e.g., improvement, stabilization, or slowing of disease progression for motor function, walking capacity, cardiorespiratory function, decrease in left ventricular mass index [LVMI], or delay in death)

checkbox on continuation section

inv-02: Site of care safety criteria

Use an outpatient hospital setting when ANY of the following safety concerns apply:

Outpatient hospital setting considerations: Severe adverse events or adverse events not responsive to conventional interventions (e.g., anaphylaxis, anaphylactoid reactions, myocardial infarction, thromboembolism, seizures, or reactions not controlled by acetaminophen, steroids, antihistamines, fluids, pre-medications, or slowing infusion rate)

checkboxes on form to justify outpatient hospital setting

Venous access or caregiver/behavioral considerations: Severe venous access issues requiring special interventions only available in outpatient hospital setting OR significant behavioral/physical/cognitive impairment that impacts infusion safety and no caregiver is available

checkboxes on form

Medical instability (respiratory, cardiovascular, renal, or other) that may limit tolerance of infusion volume/load or predispose to severe adverse events that cannot be managed outside a hospital setting

checkbox on form to describe condition

The form requires completion of specific diagnostic and response documentation and indicates that requests lacking these items will not meet the stated requirements. For initiation requests the form asks whether the diagnosis of Pompe disease was confirmed by enzyme assay demonstrating GAA deficiency or by genetic testing. For continuation requests the form requires documentation that the patient is responding to therapy (for example, improvement, stabilization, or slowing of disease progression in motor function, walking capacity, cardiorespiratory function, reduction in left ventricular mass index (LVMI), or delay in death). Absence of these required confirmations or response documentation would prevent approval.

Initial Therapy Criteria

inv-14: Initiation requires diagnostic confirmation

Initiation is approved when ANY of the following diagnostic confirmation criteria are met:

Diagnostic confirmation: Diagnosis of Pompe disease confirmed by enzyme assay demonstrating a deficiency of acid alpha-glucosidase (GAA) enzyme activity OR by genetic testing

checkbox on initiation section

Continuation Therapy Criteria

inv-15: Continuation requests must document therapeutic response

Continuation requests are approved when ALL of the following are documented:

Response documentation: Is the patient responding to therapy (e.g., improvement, stabilization, or slowing of disease progression for motor function, walking capacity, cardiorespiratory function, decrease in left ventricular mass index [LVMI], or delay in death)?

checkbox on continuation section

Place of Administration

Prior Authorization

Prior Authorization — Place of Administration and Codes

Provider action: Place of administration and administration codes — Indicate the intended site of administration on the form. Select one of: Self-administered; Physician's Office; Outpatient Infusion Center; Home Infusion Center. If an outpatient hospital setting is selected, document why the outpatient hospital is required (see safety criteria below). Include administration CPT code(s) when applicable.

Place of Administration: Self-administered | Physician's Office | Outpatient Infusion Center | Home Infusion Center
If outpatient hospital setting selected, specify reason (severe reactions, refractory adverse events, need for advanced monitoring/equipment, severe venous access issues, medical instability, significant behavioral or cognitive impairment without caregiver)
List administration code(s) (CPT) on the form

Documentation Required

Documentation Required — Complete Clinical Information

Provider action: Incomplete clinical documentation — Precertification requests will be delayed or denied if required clinical fields are not completed. Ensure responses are provided for ALL required safety and diagnostic questions, including whether the infusion is requested in an outpatient hospital setting, history of adverse events and response to interventions, antibody status, venous access issues, behavioral or cognitive impairments affecting safety, medical instability, and diagnosis of Pompe disease.

Is this infusion request in an outpatient hospital setting? (Yes/No)
Has the patient experienced an adverse event not responsive to conventional interventions or a severe adverse event? (Yes/No) — if Yes, describe interventions tried and the event
Does the patient have laboratory confirmed alglucosidase alfa antibodies? (Yes/No)
Does the patient have severe venous access issues requiring outpatient hospital-only interventions? (Yes/No) — if Yes, describe
Does the patient have significant behavioral issues and/or physical or cognitive impairment impacting infusion safety and no caregiver available? (Yes/No) — if Yes, describe
Is the patient medically unstable (respiratory, cardiovascular, renal conditions) that may limit tolerance or predispose to severe adverse events? (Yes/No) — if Yes, describe and specify system involvement: Cardiopulmonary, Respiratory, Renal, Other
Is the patient diagnosed with Pompe disease (acid alpha‑glucosidase [GAA] deficiency)? (Yes/No)

Prior Authorization

Precertification — Required Supporting Documentation

Provider action: Required documentation for precertification — Attach supporting clinical records that substantiate answers on the form. This includes prior infusion records describing adverse events and management, lab results showing antibody status, documentation of venous access problems and prior access attempts/interventions, clinical notes describing behavioral/cognitive limitations and caregiver availability, hospital records or specialist notes supporting medical instability, and diagnostic confirmation of Pompe disease.

Attach prior infusion records and notes detailing any adverse events and treatments attempted (e.g., acetaminophen, steroids, antihistamines, fluids, slowed infusion)
Attach laboratory results for alglucosidase alfa antibodies
Provide operative or procedure notes documenting venous access difficulties or specialized interventions
Provide clinical/social work notes describing behavioral/cognitive impairments and caregiver availability
Provide pertinent hospital or specialist records demonstrating medical instability (respiratory, cardiovascular, renal)
Provide diagnostic documentation confirming Pompe disease (GAA deficiency)

Note

Form omissions — Items to add if not captured

Provider action: Not specified in form — If a choice of dispensing provider/pharmacy or other site is selected as "Other," specify the site name and contact information. If the form does not capture necessary details (e.g., specific administration CPT modifiers, expected infusion duration, or anticipated need for advanced monitoring/equipment), include these in the accompanying documentation to avoid processing delays.

If 'Other' selected for Dispensing Provider/Pharmacy, specify name, address, phone, fax, TIN/PIN as applicable
If administration CPT modifiers, infusion duration, or advanced monitoring/equipment needs are not captured on the form, include them in the submitted documentation

Provider Actions & Documentation Requirements

Prior Authorization

Obtain precertification prior to Lumizyme infusion

Precertification (prior authorization) is required for Lumizyme (alglucosidase alfa); the request must indicate whether this is a start of treatment or continuation and include product dose and directions.

Select Start of treatment (with start date) or Continuation of therapy (with date of last treatment) on page 1 (chunk 0).
Include the requested product (Lumizyme), dose, and directions for use in the product information section (chunk 5).

Billing Rule

Provide place of administration and CPT administration codes

When completing the form, specify the place of administration and list any applicable CPT administration code(s) in the Administration code(s) field.

Place of Administration checkboxes include Self-administered, Physician's Office, Outpatient Infusion Center, Home Infusion Center (chunk 4).
Enter Administration code(s) (CPT) in the designated field when applicable (chunk 4).

Documentation Required

Complete all required administrative fields on the form

Complete all required form fields for the request; ensure patient, insurance, prescriber, dispensing provider, product, and diagnosis information are filled in before submission.

Patient demographics and indication (chunks 0 and 9).
Dispensing provider/administration information including dispensing provider type, name, address, and contact (chunk 4).
Product information: Lumizyme, dose, and directions for use (chunk 5).

Documentation Required

Include completed precertification form and required clinical documentation

Submit a completed precertification form that includes patient, insurance, prescriber, dispensing provider, requested product and dose, primary ICD diagnosis code, and the required clinical information (diagnostic confirmation for initiation or response documentation for continuation).

Include primary ICD code in the Diagnosis Information section (chunk 6 preview reflected in brief and chunk 4 shows administration section; diagnostic field referenced in chunk 9).
For initiation: confirm Pompe diagnosis by enzyme assay demonstrating GAA deficiency or by genetic testing (chunk 9).
For continuation: document response to therapy (improvement, stabilization, or slowing of disease progression) as indicated on the form (chunk 9).

Step Therapy

Provide requested clinical detail (no step-therapy specified)

Use the provided free-text or checklist fields on the form to supply any additional clinical details requested by the form; the form does not specify other separate step-therapy actions.

Provide descriptions for behavioral issues, medical instability, cardiopulmonary/respiratory/renal conditions when requested (chunk 7).
No step-therapy requirements are specified on the form.

Definitions

Confirmed Pompe disease

DefinitionDiagnosis of Pompe disease confirmed by enzyme assay demonstrating a deficiency of acid alpha-glucosidase (GAA) enzyme activity OR by genetic testing.

Source evidence (initiation)Initiation requests must indicate that diagnosis was confirmed by enzyme assay demonstrating GAA deficiency or by genetic testing (checkbox on form).

Clinical sectionForm asks whether the patient is diagnosed with Pompe disease (acid alpha-glucosidase [GAA] deficiency) as part of required clinical information.

Background

Pompe disease is caused by deficiency of the enzyme acid alpha‑glucosidase (GAA). Enzyme replacement therapy with alglucosidase alfa (Lumizyme) is administered by infusion. The precertification form collects the clinical information needed to confirm diagnosis (enzyme assay or genetic testing) for initiation and to document therapeutic response for continuation, as well as safety and site‑of‑care considerations for infusion administration.

OpenPayer

Lumizyme (alglucosidase alfa) Precertification Request Form Coverage Criteria

Coverage Criteria

Initial Therapy Criteria

Continuation Therapy Criteria

Coding

Place of Administration

Provider Actions & Documentation Requirements

Definitions

Background