Site-of-Care Drug List
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Lists specialty drugs that, when covered under the medical benefit, require a site-of-care clinical review under Clinical Utilization Management Guideline CG-MED-83; applicable to Blue Cross and Blue Shield of North Carolina members and associated Medicaid plans.
No material clinical or coverage changes in this revision.
Coverage Criteria
Site-of-Care Review Applicability
Site-of-care clinical review requirement
If Clinical Criteria are not required for a listed drug, site-of-care requirements do not apply.
The site-of-care requirements apply only when a specialty drug on the list requires Clinical Criteria. If a listed drug does not require Clinical Criteria, the site-of-care clinical review and associated site-of-care requirements do not apply.
HCPCS / J-code and Q-code List
Provider Actions and Requirements
Site-of-care clinical review required for listed HCPCS/J/Q codes
Site-of-care clinical review is required for the specialty drugs billed under the medical benefit that are listed by HCPCS/J/Q code on this policy; these drugs remain subject to existing Clinical Criteria when applicable.
- Applies only when the drug is covered under the medical benefit.
- Requirement references Clinical Utilization Management Guideline CG-MED-83.
Step therapy governed by existing Clinical Criteria
This site-of-care policy does not itself impose step therapy; any step therapy requirements remain governed by existing Clinical Criteria that apply to the drug.
- If Clinical Criteria include step therapy, those requirements continue to apply.
- Site-of-care review and step therapy are separate components of authorization.
Follow existing Clinical Criteria and documentation requirements
Drugs on this list continue to be subject to existing Clinical Criteria and associated documentation requirements; site-of-care requirements do not apply when Clinical Criteria are not required for the drug.
- Provide documentation required by the applicable Clinical Criteria when requesting site-of-care review.
- If no Clinical Criteria exist for a listed drug, site-of-care review requirement is not applied.
Obtain required site-of-care clinical review or risk denial
When a specialty drug on this list requires Clinical Criteria, a site-of-care clinical review must be obtained; failure to obtain a required review may result in denial of site-of-care related requests.
- Obtain prior site-of-care clinical review per CG-MED-83 before billing/administering in the requested setting.
- Requests without required site-of-care review are at risk for denial.
Background
This document identifies specialty drugs that, when billed under the medical benefit, require a site-of-care clinical review per Clinical Utilization Management Guideline CG-MED-83. The list is intended to be used alongside existing Clinical Criteria to determine the appropriate administration setting; site-of-care review obligations are only triggered when Clinical Criteria are required for the drug.
Definitions
Site-of-Care Specifics
Infusion center: site-of-care clinical review required
A site-of-care clinical review is required for the listed drugs when they are covered under the medical benefit and when applicable Clinical Criteria require review for infusion center administration.
- This requirement applies to infusion center settings referenced under the policy.
- Ensure authorization and documentation align with CG-MED-83 for infusion center administration.
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