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CurrentFidelis CarePolicy CP.PHAR.493

Infusion Therapy Site of Care Optimization

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Defines medical necessity criteria and authorization rules for the site of care for medically necessary specialty intravenous or injectable infusion services and lists affected HCPCS/J-codes. Applies to providers requesting outpatient hospital or non-hospital outpatient infusion site coverage for Fidelis Care members.

Policy Summary

PayerFidelis Care

PolicyInfusion Therapy Site of Care Optimization

Policy CodePolicy CP.PHAR.493

Change TypeNo material change

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) demonstrating that the member meets all approval criteria, including site-of-care justification and transition plan when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MultipleListed J-/Q-codes

Up to 1 yearInitial approval duration

Not permittedRe-authorization

Several codesAIS first-visit annotations

2 sourcesReferences

Coverage Criteria

inv-02: Home/Alternate Infusion Site medical necessity criteria

Covered at home/AIS when ALL of the following are met

Documented qualifying adverse effect(s): Documented history of a qualifying severe or life-threatening adverse effect including but not limited to: seizures, anaphylaxis with no alternatives, myocardial infarction, renal complications.

See Appendix C for examples; documentation must be present in medical records.

Patient safety risk documented: Chart notes document that home infusion or AIS is unsafe due to medical or behavioral impairment.

Examples include severe venous access issues without vein finder, absence of caregiver, cardiopulmonary disorder, inability to tolerate IV fluids, cognitive impairment affecting safety.

If a preferred (lower cost/less intensive) site of care—such as home infusion, ambulatory infusion center, physician office, or pharmacy—is available for the requested therapy, hospital outpatient or non-hospital outpatient administration is not covered. Providers should demonstrate that both a) a home infusion provider is unavailable and b) a lower-cost site cannot provide the administration before requesting coverage for a more intensive outpatient hospital or non-hospital outpatient infusion setting.

Policy Summary

PayerFidelis Care

PolicyInfusion Therapy Site of Care Optimization

Policy CodePolicy CP.PHAR.493

Change TypeNo material change

Effective DateMar 1, 2025

Next Review DateN/A

SourceLink

On This Page

Coding and Billable Codes

Alternative Site of Care List - HCPCS/J-codesHCPCSCovered

J0129	abatacept / Orencia
J0174	lecanemab-irmb / Leqembi
J0175	donanemab-azbt / Kisunla
J0180	agalsidase beta / Fabrazyme
J0202	alemtuzumab / Lemtrada
J0218	olipudase Alfa / Xenopozyme
J0219	avalglucosidase alfa-ngpt / Nexviazyme
J0221	algucosidase alfa / Lumizyme
J0222	patisiran / Onpattro
J0223	givosiran / Givlaari

1–10 of 128

1/13

Listed J-codes and product mappingsHCPCS

J3485	listed in Appendix — associated with Tysabri mapping
J3489	listed in Appendix — associated with natalizumab/Reclast mapping
J7170	listed in Appendix — associated with emicizumab/Hemlibra mapping
J7175	listed in Appendix — associated with coagulation factor X/Coagadex mapping
J7177	listed in Appendix — associated with human fibrinogen concentrate/Fibryga mapping
J7178	listed in Appendix — associated with human fibrinogen concentrate/Riastap mapping
J7180	von willebrand factor / factor XIII / Vonvendi = Corifact
J7181	von willebrand factor / Factor XIII / Vonvendi = Tretten
J7182	von willebrand factor / antihemophilic factor / Vonvendi = Novoeight
J7183	von willebrand factor / vwf and hemophilia A / Vonvendi = Wilate

1–10 of 39

1/4

Listed Q-/Q5* codes and product mappings (first-visit AIS notes)HCPCS

J9332	rituximab = Vyvgart mapping
J9334	rituximab = Vyvgart Hytrulo mapping
Q0138	Ferumoxytol / Feraheme (1st visit in AIS)
Q5100	Ustekinumab-kfce / Yesintek (1st visit in AIS)
Q5101	filgrastim-sndz / Zarxio (1st visit in AIS)
Q5103	infliximab / Inflectra (1st visit in AIS)
Q5104	infliximab / Renflexis (1st visit in AIS)
Q5106	epoetin alfa-epbx / Retacrit (1st visit in AIS)
Q5107	bevacizumab-awwb / Mvasi (1st visit in AIS)
Q5108	pegfilgrastim-jmdb / Fulphila (1st visit in AIS)

1–10 of 30

1/3

inv-10: Restart interval — >= 6 months

Restart interval>= 6 months

ContextApplies to first administration or restart after the specified interval (provider must document first administration or restart).

Use in criteriaRequired for requests that meet initial dosing/restart conditions for outpatient hospital/non-hospital outpatient infusion.

inv-11: Short duration example — e.g., 4 weeks

Short duration examplee.g., 4 weeks

Associated requirementProvider must submit a documented transition plan to home infusion or Ambulatory Infusion Suite (AIS) for short-duration administrations.

ContextUsed with initial administration or restart after >= 6 months per policy step expectations.

inv-12: Maintenance therapy restriction — Pembrolizumab (J9271) and Nivolumab (J9299) noted as 'Maintenance Therapy, only'

Pembrolizumab (J9271)Noted as 'Maintenance Therapy, only' in the policy's code mappings.

Nivolumab (J9299)Noted as 'Maintenance Therapy, only' in the policy's code mappings.

ImplicationRequests for initial/induction doses for these agents are restricted; policy limits coverage to maintenance therapy only as annotated.

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for outpatient hospital or non-hospital outpatient infusion when the requested drug is on the Alternative Site of Care List (Appendix B). Provider must submit a prior authorization request for listed infusion product codes and include supporting clinical documentation.

Affected codes: J- and Q-/Q5*-series codes listed in the AIS Appendix (see policy Appendix B).
Prior authorization applies to first administration, restarts, and ongoing outpatient infusion when the product is on the listed drug list.

Prior Authorization

Prior Authorization for Listed Infusion Product Codes

Some infusion products are identified for first-visit inclusion in an Alternative Infusion Site (AIS) or otherwise have site-of-care constraints; these products and biosimilars are listed by J- and Q-/Q5*-series codes in the policy. Requests for these codes may require PA specifically for first administration in AIS or to document maintenance-only use.

First-visit in AIS: selected J9332, J9334, Q0138, Q5100–Q5126, Q5109–Q5123, etc. (see Appendix B code list).
Maintenance therapy only: examples include J9271 and J9299 (maintenance therapy restrictions apply).

Step Therapy

Transition / Step Expectations

Requests for the initial dose or a restart after ≥ 6 months must be limited to the first administration or a short duration (e.g., ~4 weeks) and include a documented transition plan to home infusion or an AIS. If the request is for initial/restart dosing, include the plan and timeline for transition to a less intensive site of care.

Initial/restart criteria: first administration or restart after ≥ 6 months; short duration request (for example, 4 weeks).
Provider must submit a documented transition plan to home infusion or AIS.
Approval duration aligns with criteria — short-duration approval for transition requests.

Step Therapy

Step / Maintenance Restrictions

Some drugs are restricted to maintenance therapy only; requests for acute/initial administration may be denied unless criteria for initial dosing are met (see Transition/Step Expectations). Examples of codes with maintenance‑only restriction include J9271 and J9299.

If drug is designated maintenance-only, PA will only be approved for continuation/maintenance dosing per policy.
Initial or restart requests for maintenance‑only products must meet the explicit initial/restart criteria (first administration or ≥6-month restart plus transition plan).

Denial Risk

Denial Triggers and Required Documentation

Requests lacking sufficient clinical documentation will be denied. Providers must submit office chart notes, laboratory results, specialty pharmacy access information (if applicable), and other clinical records demonstrating medical necessity and that the requested setting is the least intensive appropriate option.

Denial triggers include availability of a preferred (lower‑cost/less intensive) site of care — if a preferred site is available, outpatient hospital or non-hospital outpatient administration is not covered.
Requests for home or AIS may be denied if medical necessity for that site is not documented (e.g., absence of documented severe adverse effect history, no evidence home/AIS is unsafe, or lack of required transition plan).
Non-qualifying reasons (examples) that do NOT establish medical necessity: trypanophobia (fear of needles), patient preference/convenience, pediatrics alone, continuation from a previous plan, or frequent lab monitoring without other criteria.

Initial Therapy and First-Visit Rules

inv-25: Initial therapy/site justification

Initial administration / restart conditions

Clinical justification for outpatient hospital administration: For initial dose or restart: the request is for the first administration or a restart after >= 6 months AND is for a short duration (e.g., 4 weeks) with a documented transition plan to home infusion or AIS; OR FDA-approved labeling explicitly requires outpatient hospital administration; OR documented history of qualifying severe or life-threatening adverse effects; OR documentation that home infusion/AIS is unsafe due to medical or behavioral impairment.

Provider must submit a transition plan when applicable; approval duration up to one year or per drug.

inv-26: Initial infusion visit site annotations

First visit in AIS annotations

First-visit AIS inclusion: Many Q-/Q5*-series codes and certain J-codes are annotated for first administration to occur in an Ambulatory Infusion Suite (AIS); these entries include originator products and biosimilars and should be adjudicated per the listed code annotations.

Applies to the specific codes listed in Appendix B and the Q-/Q5* listing; refer to coding appendix for exact code mappings.

Step Therapy and Transition Requirements

Step	Requirement	Provider documentation required
1	For initial administration or restart after ≥6 months, the request must be for the first administration or restart and be for a short duration (e.g., 4 weeks).	Documented transition plan to home infusion or Ambulatory Infusion Suite (AIS) submitted by provider (chart notes or infusion plan).
2	If initial/restart conditions are not met, other justifications may apply such as FDA labeling requiring outpatient hospital administration, documented qualifying severe or life‑threatening adverse effects, or documented that home/AIS is unsafe due to medical/behavioral impairment.	Relevant medical records demonstrating FDA labeling, history of qualifying adverse event (see Appendix C), or chart documentation of safety risk (e.g., severe venous access issues, absence of caregiver, cardiopulmonary disorder, inability to tolerate IV fluids, cognitive impairment).

Site of Care Guidance

Note

Deliver in least intensive appropriate site of care

Infusion services must be provided in the least intensive appropriate setting; available site options include hospital outpatient, ambulatory infusion center (AIS), physician office, home, or pharmacy — providers must justify why a less intensive setting is not appropriate.

Site options: hospital outpatient | ambulatory infusion center | physician office | home | pharmacy
Provider must show lack of a lower cost/preferred site of care when requesting hospital/non-hospital outpatient infusion

Note

First‑visit AIS annotations for specific codes

Certain drugs and biosimilars are annotated for inclusion of the first infusion visit in an Ambulatory Infusion Suite (AIS); site‑of‑care decisions for these codes should reference the listed annotations and include required documentation.

Q-/Q5* and select J-codes are marked '1st visit in AIS; includes biosimilars' in appendices

Definitions

inv-23: Site of Care definition — redirection of administration/dispensing to less intensive settings (home, ambulatory, etc.)

DefinitionSite of Care is the redirection of administration and/or dispensing of specialty drugs from hospital/community office settings to less intensive settings such as home, ambulatory surgical/infusion center (AIS), or pharmacy.

Examples of settingsHome-based setting (POS 12), ambulatory surgical/infusion center (POS 24 or 11), pharmacy (POS 01), hospital (POS 19 or 22) cited for context.

PurposeEmphasizes delivering specialty infusion therapy in the least intensive appropriate setting when medically appropriate.

inv-24: Patient safety risk — must be documented in chart notes when home/AIS unsafe due to medical or behavioral impairment (examples provided).

Documentation requirementPatient safety risk must be documented in chart notes that home/AIS is unsafe due to medical or behavioral impairment.

Examples of medical/behavioral impairmentsSevere venous access issues without vein finder; absence of caregiver; cardiopulmonary disorder; inability to tolerate IV fluids; cognitive impairment affecting safety.

Use in decision-makingSuch documentation is required to justify hospital or non-home administration when otherwise a less intensive site is available.