Provider Administered Drugs - Site of Care Policy (expanded oncology injectable list)
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Defines site-of-care medical necessity review and coverage rules for certain provider-administered oncology drugs and who this affects (providers, members, and participating UnitedHealthcare commercial plans). Applies to prior authorization requests for listed injectable oncology medications beginning Aug 1, 2026.
Several oncology drugs (e.g., Darzalex Faspro, Imfinzi, Jemperli, Keytruda and variants, Libtayo, Opdivo and variants, Phesgo, Tecentriq and variants, Yervoy) are added to the Provider Administered Drugs - Site of Care Policy effective Aug. 1, 2026.
Coverage Criteria
Outpatient hospital infusion coverage criteria
Covered in outpatient hospital setting when ALL of the following are met:
Member residence will be mapped by the Cancer Guidance Program team to confirm distance and local availability.
Determination made by the Optum Cancer Guidance Program during prior authorization.
The Provider Administered Drug Program for medical injectable medications does not apply to Indemnity/Options PPO plans. These plan types are explicitly excluded from the program and are therefore not subject to the site-of-care requirements described in this policy.
When the Optum Cancer Guidance Program determines that a member does not meet medical necessity criteria for continued administration in the outpatient hospital setting, coverage for the hospital outpatient site may not be approved and an alternate eligible site of care will be required (for example, home infusion, ambulatory infusion center, or community oncology office).
The ordering provider will be notified through the Cancer Guidance Program workflow and must select an alternate site (home infusion, community oncology office, or ambulatory infusion suite) in the prior authorization tool for a specified number of infusions. If continued outpatient hospital treatment is not justified, the Cancer Guidance Program Nurse will contact the provider and request that the provider add the alternate site to the prior authorization.
Coding and Distance Rules
Provider Actions and Requirements
Prior Authorization and Site-of-Care Review
Prior authorization is required for medications in scope and must include site-of-care selection. The Optum Cancer Guidance Program will evaluate medical necessity for the selected site of care as part of the prior authorization review.
- Prior authorization already required for in-scope medications
- Site-of-care selection must be included in the prior authorization submission
- Optum Cancer Guidance Program conducts the site-of-care medical necessity review
Alternate Site Update Requirement
If medical necessity for continued outpatient hospital infusion is not met, the Cancer Guidance Program Nurse will contact the treating provider and request that an alternate site of care be added to the prior authorization for a specified number of infusions (e.g., home infusion, ambulatory infusion suite, or community oncology office).
- Provider may be asked to add an alternate site during the prior authorization process
- Alternate sites include home infusion, ambulatory infusion centers, and community oncology offices
Required Documentation for Site-of-Care Review
Providers must submit clinical records and the member's treatment plan to support the site-of-care medical necessity review. Documentation should include relevant diagnoses or clinical conditions that justify administration of the in-scope medication in an outpatient hospital setting when claimed.
- Submit clinical records and the member's treatment plan with the prior authorization
- Include documentation of diagnoses or conditions supporting outpatient hospital administration
Denial Risk for Outpatient Hospital Site
If the member does not meet the Optum Cancer Guidance Program's medical necessity criteria for outpatient hospital infusion, authorization for the outpatient hospital site may be denied; coverage will be provided for administration at an eligible alternate site of care when appropriate.
- Denial of authorization for outpatient hospital site is possible when medical necessity criteria are not met
- Coverage may continue at an alternate eligible site of care if outpatient hospital is not medically necessary
Background
This policy expands the Provider Administered Drugs - Site of Care Program effective Aug. 1, 2026 by adding several oncology injectable drugs (for example, Darzalex Faspro, Imfinzi, Jemperli, Keytruda and variants, Libtayo, Opdivo and variants, Phesgo, Tecentriq and variants, Yervoy). For prior authorizations that include these drugs, the Optum Cancer Guidance Program will perform a separate site-of-care medical necessity review to determine whether outpatient hospital administration is appropriate or whether administration should occur at an alternate eligible site of care.
Definitions
Initial Therapy Site-of-Care Authorization
Initial therapy site-of-care authorization
Initial prior authorization must include site-of-care selection; the Cancer Guidance Program will evaluate medical necessity for outpatient hospital administration.
Optum Cancer Guidance Program will perform the site-of-care medical necessity review during the prior authorization process and may request alternate site selections if hospital outpatient site is not justified.
Documentation is reviewed by the Cancer Guidance Program as part of the PA review.
Continuation Therapy Site Rules
Continuation therapy site rules
Continuation at hospital outpatient setting allowed only if medical necessity for that site is met; otherwise continuation must occur at an eligible alternate site.
If site-of-care medical necessity for continued outpatient hospital treatment is not met, the Cancer Guidance Program Nurse will request the provider add an alternate site of care to the prior authorization for a specified number of infusions.
Step Therapy / Alternate Site Requirements
| Requirement | Action for provider |
|---|---|
| When the Cancer Guidance Program requests an alternate site-of-care selection for continued outpatient therapy | |
| Provider must add an alternate site of care to the prior authorization for the specific number of infusions requested in the Cancer Guidance Program tool |
Site of Care Determination
Cancer Guidance Program determines hospital outpatient medical necessity
Medical necessity for administration in the hospital outpatient setting will be determined by the Optum Cancer Guidance Program during the PA review; if criteria are not met, coverage for the outpatient hospital site may not be approved and an alternate eligible site will be required.
Alternate covered settings when hospital outpatient not required
When hospital outpatient administration is not medically necessary, covered alternate settings include home health infusion, ambulatory infusion agencies/suites, or community oncology offices if they meet eligibility and geographic access requirements.
- Providers may select home infusion, a community oncology office, or an ambulatory infusion suite as alternate sites during the prior authorization process.
- Member residence will be mapped to confirm alternate providers are within the required geographic distance (30 miles one-way, or 10 miles in urban areas; state-required mileage may apply).
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