Prior Authorization Requirements for Immune Globulins
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Governs prior authorization (PA) requirements and medical necessity review criteria for all prescriptions of immune globulins for Pennsylvania Medical Assistance recipients.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
inv-01: Initial Therapy — Prior authorization will be approved when the requested prescription meets one of the following or by physician reviewer judgment:
Prior authorization will be approved when the requested prescription meets one of the following or by physician reviewer judgment:
If none are met, the request may still be approved based on the professional judgment of a physician reviewer.
inv-02: Continuation/Renewal Therapy — Renewal requests for previously approved immune globulin prescriptions will be approved when ALL of the following are provided:
Renewal requests for previously approved immune globulin prescriptions will be approved when ALL of the following are provided:
Failure to provide these items will result in referral to a physician reviewer and may lead to denial if ongoing medical necessity is not demonstrated.
Prior authorization is required for all prescriptions of immune globulin. Initial authorization will be approved when one of the following is met: the recipient’s diagnosis and prescribed dose align with the product package insert; the indication is supported in nationally recognized compendia for medically accepted off‑label uses; or the prescriber provides peer‑reviewed medical literature supporting the requested use. If none of these conditions are met, the request may still be approved at the discretion of the physician reviewer based on professional judgment.
Requests that do not meet the renewal or clinical guidelines in Section B will be referred to a physician reviewer. If the physician reviewer does not determine the services to be medically necessary, the prior authorization request will not be approved.
Initial Authorization Criteria
inv-13: Initial Authorization — Initial prior authorization is approved when clinical criteria are met or when physician reviewer judges medically necessary:
Initial prior authorization is approved when clinical criteria are met or when physician reviewer judges medically necessary:
All prescriptions for immune globulins require prior authorization.
Renewal and Continuation Requirements
inv-14: Renewal Evidence Requirements — For renewals of previously approved immune globulin therapy:
For renewals of previously approved immune globulin therapy:
These items support ongoing medical necessity determinations; absence of adequate evidence may prompt physician review or denial.
Coding
| No codes listed |
Provider Actions and Documentation Requirements
Prior authorization required for all immune globulin prescriptions
All prescriptions for Immune Globulins require prior authorization. Initial requests are evaluated against the clinical review guidelines in Section B, including whether the recipient's diagnosis and prescribed dosage are indicated in the package insert, listed in nationally recognized compendia for medically-accepted off‑label uses, or supported by peer‑reviewed medical literature; physician reviewer judgment may also be used.
- PA must be obtained before dispensing any IVIG/SCIG/IMIG prescription.
- Initial evaluation follows the Section B clinical review guidelines (package insert, compendia, or peer‑reviewed literature).
Refer to physician reviewer when guidelines not met
When a prior authorization request does not meet the Section B clinical guidelines, the request will be referred to a physician reviewer for a medical necessity determination; the physician reviewer may approve based on professional judgment or determine the request is not medically necessary.
- Referral to a physician reviewer occurs when Section B guidelines are not met.
- Physician reviewer may approve on professional judgment or deny if not deemed medically necessary.
Renewal: document clinical response and supporting references
For renewals of previously approved immune globulin prescriptions, the prescriber must provide documentation that the recipient experienced a positive clinical response and supply supporting references (package insert, nationally recognized compendia, peer‑reviewed medical literature, or nationally recognized treatment guidelines) that justify the frequency and duration of treatment.
- Documented positive clinical response is required.
- Provide supporting sources that support the continued frequency/duration (package insert, compendia, peer‑reviewed literature, or treatment guidelines).
Referral for physician review may result in denial
If a prior authorization request does not meet the clinical guidelines in Section B, prior authorization staff will refer the request to a physician reviewer and the request may be denied if the physician reviewer does not judge the services medically necessary.
- Requests failing Section B criteria are escalated for physician review.
- Escalated requests may be denied if not considered medically necessary by the physician reviewer.
Definitions
Background
Immune globulins are preparations of pooled immunoglobulin G (IgG) administered intravenously, subcutaneously, or intramuscularly for primary immunodeficiencies and certain immune‑mediated conditions. Approval decisions consider whether the diagnosis and dose are consistent with labeled indications, recognized compendia, or supporting peer‑reviewed evidence; when criteria are not strictly met, a physician reviewer may use professional judgment to determine medical necessity.
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