Site of Care Medical Pharmacy
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Defines site-of-care prior authorization requirements for select outpatient-administered medical pharmacy drugs when they can be safely administered in the home, in-network infusion center, or in-network office; affects providers seeking reimbursement for outpatient hospital administration. Applies to Medicaid members per policy language.
Added language to clarify that a site-of-care (SOC) authorization is distinct from a clinical authorization.
Added anaphylaxis as a site-of-care exemption criteria.
Added FDA-approved biosimilars for drugs already in the policy and automatic inclusion of newly approved biosimilars/generics/505(b)(2) products.
Added Code list and Code Description; updated related HCPCS/J-codes list including new products and removals.
Coverage Criteria and Exemptions
Site-of-Care (SOC) Exemption / Hospital Administration Criteria
Authorization for outpatient hospital administration will be provided when ANY of the following site-of-care exemption conditions are met:
Added explicitly in 5/2026 update
All three conditions required for this pathway
Specific medications used in the pediatric population (<21 years) are excluded from the site-of-care prior authorization requirement. These pediatric medications are not subject to the SOC authorization rules described in this policy.
Per Louisiana Department of Health (LDH) requirements, certain medications noted with a caret (^) in the drug list are not included for AmeriHealth Caritas Louisiana under this SOC policy. The policy also states that newly approved generics, biosimilars, or 505(b)(2) products for drugs already listed will automatically be included in the policy.
When a drug can be safely administered in the home, an in‑network infusion center, or an in‑network office and no SOC exemption criteria are met or documented, outpatient hospital administration is not considered the most appropriate setting for reimbursement. Site‑of‑Care prior authorization is required for listed drugs administered in an outpatient hospital setting when they can safely be given at those alternative sites; SOC authorization is a distinct requirement in addition to any clinical prior authorization criteria that may apply.
Related HCPCS / J / Q Codes
Provider Requirements and Prior Authorization
Site-of-Care prior authorization required for outpatient hospital administration
Site-of-care prior authorization is required for listed drugs when administered in an outpatient hospital setting if they can be safely given in the home, an in‑network infusion center, or an in‑network office; SOC authorization is distinct from any clinical prior authorization.
No step therapy requirements specified
No step therapy requirements or step sequence are specified in this document.
Required supporting documentation for site‑of‑care exemption
Documented evidence supporting a site‑of‑care exemption is required. Acceptable documentation includes a history of anaphylaxis or severe infusion reaction, documentation of medical instability or complex condition, evidence of difficulty establishing/maintaining vascular access, IgA deficiency with anti‑IgA antibodies for IVIG/SCIG, or documentation that the home environment is unsuitable plus prescriber inability to give the drug in office and no ambulatory infusion suite options.
- Documented history of anaphylaxis or severe adverse reaction during or immediately following an infusion, unresponsive to conventional interventions
- Documentation that member is medically unstable (complex condition/status/therapy, significant comorbidity, fluid status concerns, or physical/cognitive impairment)
- Evidence of difficulty establishing/maintaining reliable vascular access
- For IVIG/SCIG: IgA deficiency with anti‑IgA antibodies
- For home unsuitability: homecare/home infusion provider statement + prescriber unable to administer in office + no ambulatory infusion suite options
Reimbursement contingent on SOC medical necessity and documented exemption
Authorization for reimbursement of outpatient hospital administration will only be provided when the hospital site meets medical necessity for that level of care; if the drug can be safely administered in the home, in‑network infusion center, or in‑network office and no SOC exemption is documented, claims may be denied or require SOC prior authorization.
Policy Background
This policy promotes administration of outpatient medical pharmacy drugs in the most appropriate and cost‑effective non‑hospital setting (home, in‑network infusion center, or in‑network office) when clinically safe. Hospital outpatient administration will be authorized only when one or more SOC exemption criteria are met (for example: documented anaphylaxis or severe infusion reaction, medically unstable status, difficulty maintaining vascular access, IVIG/SCIG with IgA deficiency and anti‑IgA antibodies, or when a home environment is deemed unsuitable and the other home‑alternative conditions are not met).
Key Definitions
Allowed Sites of Care
Prefer non‑hospital settings when drugs can be safely given outside hospital outpatient
When listed drugs are able to be safely administered in the home, an in‑network infusion center, or an in‑network office, in‑network infusion/home/office administration is the preferred setting; in‑network infusion or home administration should be pursued before outpatient hospital administration and authorization is required if hospital outpatient setting is requested without an approved SOC exemption.
- Hospital outpatient administration will only be authorized when one of the specified SOC exemption criteria is met.
Biosimilars and Automatic Inclusion
Policy includes listed drugs and automatically includes approved biosimilars/generics
Drugs and their FDA‑approved biosimilars referenced throughout the policy are automatically included when approved; the policy has been updated to add FDA‑approved biosimilars and newly approved generics/505(b)(2) products for listed drugs.
- All FDA‑approved biosimilars and newly approved generics/505(b)(2) products for drugs already listed are included automatically.
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