Site-of-care requirements for specialty drugs (site-of-care drug list)
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Defines which specialty drugs (medical benefit) require a site-of-care clinical review and notes interaction with existing clinical criteria, step therapy, and quantity limits; applies to Amerigroup members in the Georgia markets listed.
No material clinical or coverage changes in this revision.
Site-of-Care Coverage Criteria
Site-of-care review applies when drug is medical-benefit covered and listed
Covered when ALL of the following are met:
When both conditions are true, a site-of-care clinical review per Clinical Utilization Management Guideline CG-MED-83 is required
The site-of-care requirements described in this policy do not apply to drugs that are carved out in a given market. When a specialty drug is carved out for a specific plan or market, site-of-care review provisions in Clinical Utilization Management Guideline CG-MED-83 are not enforced for that drug in that market.
Listed HCPCS / J / Q Codes
Provider Requirements and Impacts
Site-of-care clinical review required for listed J/Q codes
A site-of-care clinical review per Clinical Utilization Management Guideline CG-MED-83 is required for the listed HCPCS/J/Q codes when those specialty drugs are covered under the medical benefit.
- Applies only when the drug is covered under the medical benefit
- Referenced guideline: CG-MED-83
Existing clinical and step therapy rules remain applicable
All drugs on the site-of-care list remain subject to existing clinical criteria, step therapy criteria, and/or quantity limits; the site-of-care review is an additional requirement and does not replace those rules.
- Existing clinical criteria, step therapy, and quantity limits continue to apply
Documentation required for site-of-care review
Providers must submit the documentation necessary to support the site-of-care clinical review as required under Clinical Utilization Management Guideline CG-MED-83.
- Submit clinical assessment and any supporting records requested for CG-MED-83 review
Site-of-care review required — denial risk if not obtained
Failure to obtain a required site-of-care clinical review when a listed specialty drug is covered under the medical benefit may result in denial per Clinical Utilization Management Guideline CG-MED-83.
- Denial risk applies when site-of-care review is not completed for listed drugs covered under the medical benefit
Background and Rationale
Specialty drugs covered under the medical benefit may be administered in different care settings. Payer site-of-care review aims to direct the appropriate setting for administration by requiring a clinical assessment—referred to as a site-of-care clinical review—per Clinical Utilization Management Guideline CG-MED-83 when the drug is on the listed specialty drug site-of-care list and is billed under the medical benefit. All drugs on the list remain subject to existing clinical criteria, step therapy criteria, and/or quantity limits.
Key Definitions
Step Therapy Interaction
| Step therapy requirement | Notes |
|---|---|
| These drugs remain subject to existing step therapy criteria | Site-of-care clinical review is an additional requirement and does not replace step therapy; all drugs on the list remain subject to existing clinical criteria, step therapy criteria, and/or quantity limits |
Site-of-Care Review Details
Infusion center — site-of-care clinical review required
For specialty drugs on the listed site-of-care drug list that are administered in an infusion center, a site-of-care clinical review is required per Clinical Utilization Management Guideline CG-MED-83.
- Site-of-care review applies specifically to infusion center setting when drug is medical-benefit covered
- Site-of-care requirements do not apply to drugs carved out in a market
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