Infusion and Injection Services Administered in Unregulated Space
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Defines Maryland Physicians Care requirements for site-of-care determination and prior authorization for outpatient infusion and injection services for Maryland Medicaid members, applying to participating and non-participating providers and infusion/home infusion service providers.
Addition of Eculizumab biosimilar products and Vyvgart Hytrulo.
Removal of acute therapy medications - antibiotics, IV iron products and Lemtrada.
Removal of Botox products from restriction.
Coverage Criteria — Regulated Setting and Site-of-Care Rules
Regulated setting medical necessity criteria
Regulated outpatient hospital setting is considered medically necessary when ANY of the following are met:
Regulated setting criteria
- Enhanced monitoring or intervention: The individual's complex medical status or therapy requires enhanced monitoring and potential intervention above and beyond the capabilities of the office or home infusion setting; submission of medical records is required.
- Prior severe infusion-related adverse events: Documentation (eg, infusion records, medical records) of episodes of severe or potentially life-threatening infusion-related adverse events (eg, anaphylaxis, seizure, thromboembolism, myocardial infarction) that have not been responsive to acetaminophen, steroids, diphenhydramine, fluids, infusion rate reductions, or other premedications, thereby increasing risk to the individual when administration is in the home or office setting; submission of medical records is required.
- Unsuitable home caregiver or environment: Homecare or infusion provider has deemed that the individual, home caregiver, or home environment is not suitable for home infusion therapy (if the prescriber cannot infuse in the office setting); submission of medical records is required.
- FDA label site-of-care restriction: The prescribed medication has a site-of-care restriction for administration per the FDA-approved label; submission of medical records is required.
Site-of-care general coverage
General coverage stance for site-of-care and medications:
Outpatient hospital facility-based infusions and injections are not considered medically necessary unless the member meets at least one of the regulated outpatient hospital setting criteria. These criteria require submission of supporting medical records and include: the member’s complex medical status or therapy requiring enhanced monitoring/intervention beyond office or home capabilities; documented episodes of severe or potentially life‑threatening infusion‑related adverse events (for example, anaphylaxis, seizure, thromboembolism, myocardial infarction) that were not responsive to standard measures such as acetaminophen, steroids, diphenhydramine, fluids, infusion rate reductions, or other premedications; a determination by the homecare or infusion provider that the member, caregiver, or home environment is unsuitable for home infusion when the prescriber cannot provide office administration; or an FDA‑approved label site‑of‑care restriction for the prescribed medication.
Use of a regulated (hospital outpatient) infusion setting is permitted only when at least one of the specified regulated‑setting medical necessity criteria is met and supporting medical records are provided. Site‑of‑care prior authorization rules apply: participating providers and contracted home infusion/infusion centers generally do not require a site‑of‑care PA for procedures performed in unregulated space, but site‑of‑care PA is required for services in regulated space and for non‑participating providers or non‑contracted infusion providers. Regardless of site of care, medications remain subject to separate medication‑specific medical necessity review and prior authorization.
Applicable Codes for Infused/Injected Medications
| 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 |
| J3032 | Injection, eptinezumab-jjmr (Vyepti), 1 mg |
| J2507 | Injection, pegloticase (Krystexxa), 1 mg |
| J1300 | Injection, eculizumab (Soliris), 10 mg |
| J1303 | Injection, ravulizumab-cwvz (Ultomiris), 10 mg |
Provider Actions, Prior Authorization, and Documentation Requirements
Site-of-care prior authorization rules
Site-of-care prior authorization is not required when infusion services are administered in unregulated space by participating health professionals, contracted home infusion service providers, or contracted infusion centers. However, 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; site-of-care PA is required for all providers when services are administered in regulated (hospital outpatient) space.
- No site-of-care PA required for participating providers and contracted home infusion/infusion centers when care is in unregulated space.
- Non‑participating providers and certain uncontracted providers must obtain site-of-care PA prior to service delivery.
- Site-of-care PA is required for all providers for infusions administered in regulated (hospital outpatient) settings.
Medication-specific prior authorization required
Medications administered via infusion or injection remain subject to separate medication-specific medical necessity review (medical prior authorization) regardless of whether the service is provided in an unregulated or regulated site of care.
- Submit medication-specific PA requests using the clinical criteria applicable to the requested medication.
- Site-of-care determination does not substitute for medication-level medical necessity review.
Medical records required for regulated setting PA
When requesting authorization for a regulated (outpatient hospital) infusion or injection setting, submit supporting medical records to document the member’s condition — for example, complex medical status requiring enhanced monitoring, prior severe or potentially life‑threatening infusion‑related adverse events not responsive to standard measures, or documentation that the home caregiver/environment is unsuitable for home infusion.
- Include infusion records and medical records documenting prior severe infusion‑related adverse events (e.g., anaphylaxis, seizure, thromboembolism, myocardial infarction) and failure of standard premedication/management.
- Provide documentation that the member remains medically inappropriate for administration at alternative (unregulated) sites when requesting renewal.
Prior authorization required — risk of denial if not obtained
Failure to obtain site-of-care prior authorization for infusion services administered in regulated (hospital outpatient) space will result in the services being subject to PA denial; non‑participating providers and certain unregulated providers that do not obtain required site-of-care PA prior to service may also be at risk for denial or payment reduction.
- Services delivered in regulated space without prior site-of-care authorization are subject to denial.
- Non‑participating and uncontracted providers must secure site-of-care PA before rendering services to avoid denial/payment risk.
Background and Rationale
Outpatient hospital (regulated) infusion settings are reserved for members whose clinical complexity or therapy requires enhanced monitoring/intervention beyond office or home capabilities, for members with documented episodes of severe or potentially life‑threatening infusion‑related adverse events not responsive to standard measures, when the home environment or caregiver is unsuitable for home infusion, or when the medication’s FDA label includes a site‑of‑care restriction.
Key Definitions
Initial Authorization for Regulated Infusion Setting
Initial Authorization
Initial authorization for regulated infusion setting
Medications requested remain subject to separate medication‑specific prior authorization and clinical review.
Reauthorization / Continuation Criteria
Reauthorization
Reauthorization requirements for regulated infusion settings
All medications remain subject to separate medication‑specific medical necessity review regardless of site of care.
Step Therapy and Medication Prior Authorization
| Requirement | Details |
|---|---|
| Medication-specific prior authorization status | Medications are subject to separate medical necessity review using clinical criteria specific to the medication requested, regardless of site of care. |
| Coverage implication | Medication medical necessity review (medical PA) is required whether the drug is administered in regulated (hospital outpatient) or unregulated settings. |
| Provider action | Providers must obtain medication-specific prior authorization when required by the drug’s clinical criteria; site-of-care PA rules are separate and do not replace medication PAs. |
Preferred and Allowed Sites of Care
Prefer and require unregulated sites unless regulated-setting criteria are met
Use alternative (unregulated) sites of care—physician office, ambulatory infusion center, or home infusion—by default; the regulated (outpatient hospital) setting is required only when the member meets the policy's regulated‑setting medical necessity criteria.
- Home infusion is available statewide and not subject to travel distance network access limits.
- Travel distance standards for infusion centers (urban 1:5 miles, suburban 1:10 miles, rural 1:30 miles) are used when assessing network access for infusion center services.
Biosimilar Policy Updates
Eculizumab biosimilars added to policy (06/2025)
Eculizumab biosimilar products have been added to the policy’s list (revision 06/2025) and are included among the applicable injectable therapies; treat these biosimilars like the reference product for coverage and medication-specific medical necessity review.
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