Immune globulins (IVIG, SCIG) pharmacy coverage criteria
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Describes Kentucky Medicaid pharmacy coverage and POS/prior authorization (PA) requirements for intravenous and subcutaneous immune globulin products, and what documentation is required for PA. Affects providers dispensing/administering IVIG or SCIG for Kentucky Medicaid members.
Intravenous immune globulin products will no longer reject at POS as 'medical only' and will now require a prior authorization.
Clinical criteria effective January 19, 2023 define POS billing, PA triggers, home administration requirement, and required documentation.
For claims to process at POS, recipients must have a billed diagnosis from the applicable table in the last 1 year; otherwise a PA is required.
Pharmacy Coverage Criteria for Immune Globulins
Initial IVIG pharmacy coverage
Covered when ALL of the following are met:
Approval for pharmacy coverage requires both meeting clinical criteria and administration by a home infusion provider.
Initial SCIG pharmacy coverage
Covered when ALL of the following are met:
Approval for pharmacy coverage requires meeting clinical criteria and self- or home-administration for SCIG.
Pharmacy coverage approval for intravenous immune globulin (IVIG) requires that the medication be administered in the home by a home infusion provider. If the IVIG is not administered in the home setting, pharmacy prior authorization (PA) approval for coverage will not be granted under this policy. For subcutaneous immune globulin (SCIG), pharmacy coverage requires that the medication be self‑administered or administered in the home by a home infusion provider as specified in the SCIG criteria. (If the member does not meet the home/self‑administration requirement or the POS billed‑diagnosis criteria, a PA request with required documentation must be submitted.)
Initial Therapy Requirements
Initial Therapy
Covered when ALL of the following are met:
Provider must supply chart notes, diagnosis, and rationale when submitting PA; pharmacy coverage approval requires home or self/home administration as specified.
Affected Billing Codes
| affected codes | Not specified in notice; indicates IVIG/SCIG products will require PA at POS |
Actions Required by Providers
Prior authorization required when POS criteria not met
IVIG and SCIG products require prior authorization for pharmacy coverage when POS criteria are not met; approval requires meeting clinical criteria and administration in the home setting (IVIG) or self/home administration (SCIG).
POS will deny without 1-year billed diagnosis
Claims will not process at POS unless the recipient has a billed diagnosis from the applicable table within the last 1 year; if that billed diagnosis is not present, providers should expect that a prior authorization will be required.
Submit chart notes, diagnosis, and clinical rationale with PA
The prior authorization request must include current chart notes, the diagnosis requiring immune globulin, and the clinical rationale or support for use; requests for diagnoses not listed must meet off-label criteria.
- Current chart notes
- Diagnosis requiring immune globulin
- Rationale or clinical support for use
- Off‑label justification if diagnosis is not listed in the applicable table
Use preferred drugs when appropriate
Providers are encouraged to select drugs on the preferred drug list when possible to help maintain access to cost‑effective medications.
Administration Setting Requirements
Home administration required for pharmacy coverage
Pharmacy coverage approval requires that the product be administered in the home setting: IVIG must be administered by a home infusion provider; SCIG may be self‑administered or administered by a home infusion provider as specified.
Key Terms and Definitions
Background and Scope
Immune globulins (intravenous IVIG and subcutaneous SCIG) are used to treat primary and secondary immunoglobulin deficiencies and certain autoimmune or inflammatory conditions. This policy notice updates POS and prior authorization handling for Kentucky Medicaid: effective January 19, 2023, IVIG products will no longer reject as “medical only” at the POS and instead will require a prior authorization for pharmacy coverage, and both IVIG and SCIG pharmacy approvals require meeting the clinical criteria plus administration in the home or self‑administered setting.
Under the update, POS processing is permitted only when the recipient has a billed diagnosis from the applicable indication table within the last 1 year. If that one‑year lookback is not met, providers must submit a PA with the required documentation (current chart notes, diagnosis, and clinical rationale); requests for diagnoses not listed in the tables must meet off‑label criteria. Providers are encouraged to select preferred products when appropriate, and the notice maps product–indication relationships to guide POS acceptance and PA decisions.
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