Site of Care (hospital outpatient infusion) coverage criteria
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Defines when hospital outpatient facility infusion is medically necessary versus preferred alternate sites (home/office) for commercial GlobalHealth members; applies to outpatient injectable drugs/biologics requiring infusion.
Clarified language in 1.1.1 regarding physical or cognitive impairments as justification for hospital outpatient infusion.
Removed 'infed' from list of applicable drugs.
Coverage Criteria — Site of Care for Infusion
The policy was revised in January 2020 to remove the drug infed from the list of applicable medications. No other explicit drug exclusions are listed in the policy revision notes.
Hospital outpatient facility infusion is not supported when none of criteria 1.1–1.4 are met — i.e., when the member is medically stable for administration in a preferred alternate place of service, first-dose requirements can be met in that preferred place of service, the drug is available for administration outside the hospital (not limited distribution), and the member has access to home or office-based infusion providers.
Coding — Affected Drugs and Procedure Codes
| No codes listed |
| J7210 | Afstyla (antihemophilic factor (recombinant) single chain) |
| J7192 | Advate; Helixate; Kogenate FS (antihemophilic factor (recombinant) / human variants) |
| J7186 | Alphanate (antihemophilic factor/von Willebrand factor complex (human)) |
| J7194 | AlphaNine; Bebulin; Mononine (factor IX / factor IX complex codes) |
| J7201 | Alprolix (coagulation factor IX (recombinant), Fc fusion protein) |
| J7195 | Benefix; Ixinity (coagulation factor IX (recombinant)) |
| J7175 | Coagadex (coagulation factor X (human)) |
| J7180 | Corifact (factor XIII concentrate (human)) |
| J7205 | Eloctate (antihemophilic factor (recombinant), Fc fusion protein) |
| J7198 | Feiba NH (anti - inhibitor coagulant complex) |
| J1556 | Bivigam (immune globulin) |
| J1555 | Cuvitru (immune globulin) |
| J1572 | Flebogamma (immune globulin) |
| J1566 | Gamastan S/D (immune globulin) |
| J1569 | Gammagard S/D (immune globulin) |
| J1561 | Gammaked; Gamunex (immune globulin) |
| J1559 | Hizentra (immune globulin) |
| J1460 | HyQvia (immune globulin) |
| J1560 | HyQvia (immune globulin) |
| J1568 | Octagam (immune globulin) |
Provider Actions — Authorization, Documentation, and Denials
Prior authorization required for injectable drugs/biologics
Prior authorization is required for injectable drugs or biologics; requests are reviewed using pharmacologic criteria.
Additional provider-action note
No additional provider-action notes are specified in the source policy beyond the prior authorization, documentation, and denial language; follow the other listed provider actions for authorization, documentation, and site-of-care criteria as applicable.
Documentation must support one of criteria 1.1–1.4
Documentation submitted with the request must support at least one of the medical necessity criteria (1.1–1.4), e.g., evidence of medical instability (including 1.1.1 physical or cognitive impairments), prior severe or potentially life‑threatening infusion reaction, limited distribution of the drug, or lack of access to home/office infusion providers.
- Support for 1.1: evidence of medical instability, including physical or cognitive impairments (1.1.1) or prior severe infusion adverse event (1.1.2).
- Support for 1.2: documentation that first-dose requirements cannot be met in preferred place of service.
- Support for 1.3: evidence the drug is limited distribution and not available for non-hospital administration.
- Support for 1.4: documentation that member lacks access to home or office infusion in their geographic area.
Denial risk if no medical necessity criteria met
Requests for hospital outpatient infusion may be denied if none of the medical necessity criteria (1.1–1.4) are met.
- Denial risk applies when the member is stable for alternate sites, first-dose requirements can be met in preferred place of service, the drug is available for home/office administration, and the member has access to home/office infusion providers.
Site of Care — Hospital Outpatient vs Alternate Settings
Site‑of‑care requirement for hospital outpatient infusion
Hospital outpatient facility infusion is considered medically necessary only when one or more of criteria 1.1–1.4 are met; otherwise the preferred sites of administration are home or office.
- If criteria 1.1–1.4 are not documented, arrange infusion at home or office where appropriate.
Background
Many infused medications can be safely administered in the home or an office setting when the member is stable and appropriate supports exist. Hospital outpatient infusion is reserved for members who meet one or more specific criteria — for example, those who are medically unstable due to physical or cognitive impairments, have a history of severe infusion reactions that cannot be managed in non-hospital settings, require a first dose that cannot be administered in the preferred site, have a drug that is limited distribution, or lack geographic access to alternative infusion providers.
Definitions — Key Terms
Revision History
Clarified language in criterion 1.1.1 regarding physical or cognitive impairments and removed 'infed' from the list of applicable drugs.
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