Infusion and Injection Services Administered in Unregulated Space (Site-of-Service - Outpatient)
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Defines Maryland Physicians Care requirements for where outpatient provider-administered drugs (infusions/injections) should be administered, and when regulated (hospital outpatient) settings are required; applies to MPC Medicaid members and participating and non-participating providers.
Addition of Ocrevus Zunovo
Revised applicable code list to include multiple immune globulin and biologic J-codes and biosimilars
Clarified that medications are subject to separate medical necessity review using drug-specific clinical criteria regardless of site of care
Coverage Criteria — Regulated Infusion & Injection Services
Regulated Infusion and Injection Service Settings (Initial)
Regulated outpatient hospital infusion/injection is COVERED when ANY of the following are met (submission of medical records required).
submission of medical records required
examples provided in policy; supporting records required
provider assessment and documentation required
follow FDA label; documentation required
Reauthorization Criteria
Reauthorization for regulated service settings is reviewed annually and covered when ALL of the following are true:
all medications remain subject to medication-specific clinical criteria; submit supporting records
MPC requires members to use alternative sites of care for outpatient infusions and injections when appropriate. Alternative sites include non-hospital outpatient infusion centers, physician offices, ambulatory infusion suites, and home infusion services. These locations are considered acceptable places of service for administration of provider‑administered medications and are the preferred setting unless the member meets documented criteria for a regulated (hospital outpatient) infusion setting. Clinical rationale and supporting documentation must be submitted to justify exceptions to receive services in a regulated setting.
Use of a hospital outpatient (regulated) infusion setting is reserved for members who meet the policy’s specified regulated‑setting criteria (for example: need for enhanced monitoring, prior severe infusion‑related adverse events, unsuitable homecare/caregiver or environment, or an FDA label site restriction). Site‑of‑care prior authorization is required for regulated settings for all providers. Documentation supporting the medical necessity of a regulated setting (including relevant medical records) should be submitted with the request.
Initial Authorization Criteria
Initial Authorization Criteria
Initial authorization for regulated infusion setting
submission of medical records required to support the selected criterion
Reauthorization / Continuation Therapy
Reauthorization / Continuation Therapy
Reauthorization/continuation rules
initial authorizations are granted up to 6 months; reauthorizations up to 1 year; supporting documentation required
Applicable Codes & Network Standards
| J1745 | Injection, infliximab, excludes biosimilar (Remicade), 10 mg |
| Q5103 | Injection, infliximab-dyyb, biosimilar (Inflectra), 10 mg |
| Q5104 | Injection, infliximab-abda, biosimilar (Renflexis), 10 mg |
| Q5121 | Injection, infliximab-axxq, biosimilar (Avsola), 10 mg |
| J3380 | Injection, vedolizumab (Entyvio), 1 mg |
| J2350 | Injection, ocrelizumab (Ocrevus), 1 mg |
| J2351 | Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq |
| J3032 | Injection, eptinezumab-jjmr (Vyepti), 1 mg |
| J2507 | Injection, pegloticase (Krystexxa), 1 mg |
| J1300 | Injection, eculizumab (Soliris), 10 mg |
Provider Requirements & Prior Authorization
Site-of-care prior authorization rules for unregulated settings
Site-of-care prior authorization is not required when infusion services are administered in unregulated space by participating health professionals, home infusion service providers, or infusion centers contracted to perform infusion services. Non-participating providers, home infusion service providers, and infusion centers must obtain a site-of-care prior authorization from the PA review team before rendering services.
- PA not required for participating providers, contracted home infusion providers, and contracted infusion centers in unregulated spaces.
- Non-participating providers and non-contracted infusion centers must obtain site-of-care PA prior to rendering services.
Medication-specific prior authorization applies regardless of site
Medications administered in any setting are subject to a separate medication prior authorization and medical necessity review using drug-specific clinical criteria; this requirement applies regardless of the site of care.
- Medication prior authorization and medical necessity review use clinical criteria specific to the medication requested.
- Requirement applies whether the drug is given in regulated (hospital outpatient) or unregulated settings.
Provide medical records to support regulated-setting medical necessity
Submission of medical records is required to support that an outpatient hospital (regulated) setting is medically necessary. Records should document the clinical reason(s) the member meets regulated-setting criteria (for example, evidence of complex medical status, prior severe infusion-related adverse events, or unsuitability of home/caregiver/environment).
- Include infusion records or medical records documenting severe or life‑threatening infusion-related adverse events not responsive to standard rescue measures.
- Provide documentation that the individual remains inappropriate for alternative sites of care when requesting reauthorization.
Obtain site-of-care prior authorization for regulated settings and non‑contracted providers
Site-of-care prior authorization is required for infusion services administered in regulated space for all participating and non‑participating health professionals and infusion centers; services provided in regulated infusion settings without prior authorization may be denied. Non-participating or non-contracted providers must obtain site-of-care PA prior to rendering services in unregulated spaces.
- PA required for regulated (hospital outpatient) infusion services for all providers.
- Services in regulated settings without prior authorization may be denied.
- Non-participating/non-contracted providers must obtain site-of-care PA before providing services in unregulated settings.
Allowed Sites of Care
Use alternative (unregulated) sites of care when appropriate
Members must use alternative (unregulated) sites of care (e.g., physician office, ambulatory infusion center, home infusion) when appropriate; site-of-care prior authorization is not required for participating/contracted providers in unregulated settings but is required for regulated settings and for non-participating/non-contracted providers prior to rendering services.
- Encourage use of unregulated sites of care when member meets no regulated-setting criteria
- Home infusion is available statewide and is not subject to network travel distance requirements
- Network travel distance standards for infusion center access (when applicable): Rural 30 miles / Suburban 10 miles / Urban 5 miles
Step Therapy / Drug-Specific Criteria
| Step | Requirement |
|---|---|
| 1 | Medications are subject to separate medication prior authorization and medical necessity review using drug-specific clinical criteria regardless of site of care; step therapy specifics are not detailed in this policy. |
Definitions
Background
Many infusion and injection therapies routinely can be administered safely outside the hospital setting. MPC’s rationale is to reserve the hospital outpatient (regulated) infusion setting for patients who need enhanced monitoring or interventions beyond what can be provided in office, ambulatory infusion, or home environments. Accordingly, the policy frames hospital outpatient infusion as an exception—approved only when specific clinical criteria are met and documented—while encouraging use of unregulated sites when clinically appropriate.
Biosimilars & Specific Products
Revision History & Policy Changes
Addition of Ocrevus Zunovo to the policy (listed in revision log).
Revised applicable code list effective 04/2026 to update immune globulin and biologic J-/Q-codes (revision noted on Applicable Codes page).
Added eculizumab biosimilar products and Vyvgart Hytrulo (noted in revision log 06/2025).
Removed acute therapy medications including antibiotics and IV iron products (revision log entry 02/2025).
Annual review performed (revision log entry 02/2024).
Removal of Botox products from restriction (revision log entry 05/22/2023).
Policy originally issued (New Policy effective 04/01/2023).
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