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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAmbetter Nevada Infusion Site Coverage | OpenPayer
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    CurrentAmbetter NevadaPolicy FL.CP.PHAR.493

    Clinical Policy: Infusion Therapy Site of Care Optimization

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    This policy governs when intravenous or injectable specialty drug therapy may be administered in an outpatient hospital or office/facility versus a lower-cost alternative site such as home infusion, an ambulatory infusion center, or a pharmacy.

    Policy Summary
    PayerAmbetter Nevada
    PolicyInfusion Therapy Site of Care Optimization
    Policy CodePolicy FL.CP.PHAR.493
    Change TypeNo material change
    Effective DateJul 1, 2025
    Last ReviewApr 1, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization with clinical documentation for intravenous or injectable therapy requested at an outpatient hospital or non-hospital outpatient facility.
    SourceLink

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Up to 1 yearInitial approval duration
    Up to 1 yearContinued approval duration
    4Alternative site-of-care categories
    6 monthsRestart threshold
    Not authorizedNon-qualifying outpatient therapy

    Coverage Criteria

    Initial approval criteria

    Outpatient hospital or non-hospital outpatient office/facility IV or injectable therapy is medically necessary when all applicable criteria are met.

    Initial approval

    • Therapy and documentation

      • The requested therapy is intravenous or injectable specialty therapy listed in Appendix B and will be provided by an in-network outpatient hospital or non-hospital outpatient office or facility.
      • The provider submits documentation, such as office chart notes, laboratory results, or other clinical information, supporting that the member has met all applicable approval criteria.

    • ONE qualifying site-of-care circumstance

      • There is no home infusion provider, ambulatory infusion center, or lower-cost site of care able to provide administration, or the specialty pharmacy is unable to provide the drug.
      • An FDA-approved indication requires administration at an outpatient hospital, office, or clinic.
      • The request is for the initial treatment dose or a restart after a six-month treatment disruption for a short duration of therapy.6-month disruption

        For an initial dose or qualifying restart, the provider must request the initial visit and identify continued administration through home infusion or an ambulatory infusion suite when applicable.

      • Documentation shows that home-based therapy or an ambulatory surgical/infusion center would pose a health risk because of a physical or behavioral impairment.

        Examples include severe venous access issues when a vein finder is unavailable, lack of caregiver access, cardiopulmonary disorder, inability to tolerate intravenous fluid loads, or cognitive concerns affecting patient safety.

      • Medical or infusion records document severe or life-threatening adverse events that were non-responsive to pre-medications, analgesics, steroids, antihistamines such as diphenhydramine, fluids, or infusion-rate reductions.

        Examples include seizures, anaphylaxis with no other therapy options, myocardial infarction, or renal failure.

    Continuation therapy

    Continued services at the requested infusion location are medically necessary when all of the following are met.

    Continued approval

    • The provider submits medical or infusion records that allow reassessment of the member's site of care.
    • The documentation establishes the need to continue monitoring and advanced treatment capabilities beyond what is routinely needed for the infusion therapy.

    Outpatient IV or injectable therapy that does not meet the initial approval criteria is not authorized at the requested outpatient location. When the criteria are not met, the therapy should be provided at an alternate, less intensive site of care.

    The following do not establish medical necessity for the requested outpatient hospital site: trypanophobia (fear of needles), pediatric status, member preference or convenience, frequent laboratory monitoring, or continuation of services from a previous plan.

    Initial Site-of-Care Approval

    Initial site-of-care approval

    Initial outpatient hospital or non-hospital outpatient office/facility administration may be covered when all applicable documentation requirements are met and at least one qualifying site-of-care circumstance applies.

    • Required therapy and documentation

      • The requested drug is intravenous or injectable specialty therapy and will be administered by an in-network outpatient hospital or non-hospital outpatient office or facility.
      • The provider submits clinical documentation supporting every applicable approval criterion.

    • ONE qualifying medical-necessity circumstance

      • No home infusion provider, ambulatory infusion center, or lower-cost site of care can provide administration, or the specialty pharmacy cannot provide the drug.

    Continued Site-of-Care Approval

    Continued site-of-care approval

    Continuation at the requested infusion location is approved when all of the following are met.

    Continuation at requested site

    • Medical or infusion records reassess the member's site of care.
    • The records document the need for continued monitoring and advanced treatment capabilities beyond what is routinely needed for the infusion therapy.

    Appendix B and Operational Coding Details

    Appendix B specialty infusion therapiesHCPCS
    J0129Abatacept; Orencia
    J0172Aducanumab-Avwa; Aduhelm
    J0180Agalsidase beta; Fabrazyme
    J0202Alemtuzumab; Lemtrada
    J0218Olipudase Alfa; Xenopozyme
    J0219Avalglucosidase alfa-ngpt; Nexviazyme
    J0221Alglucosidase alfa; Lumizyme
    J0222Patisiran; Onpattro
    J0223Givosiran; Givlaari
    J0224Lumasiran; Oxlumo
    1–10 of 16
    1/2
    Appendix B specialty infusion therapiesHCPCS
    J0517Benralizumab; Fasenra
    J0565Bezlotoxumab; Zinplava
    J0584Burosumab-twza; Crysvita
    J0597C1 Esterase Inhibitor, human; BERINERT
    J0598C1 Esterase Inhibitor, human; Cinryze
    J0638Canakinumab; Ilaris
    J0695Ceftolozane/tazobactam; Zerbaxa
    J0717Certolizumab pegol; Cimzia
    J0739Cabotegravir; Apretude
    J0740Cidofovir; Vistide
    1–10 of 15
    1/2
    Appendix B specialty infusion therapiesHCPCS
    J0878Dalbavancin; Dalvance; daptomycin; Cubicin
    J0881Darbepoetin alfa (not-ESRD); Aranesp
    J0882Darbepoetin alfa (ESRD); Aranesp
    J0885Epoetin alfa (non-ESRD); Epogen; Procrit
    J0887Epoetin beta (ESRD); Mircera
    J0888Epoetin beta (non-ESRD); Mircera
    J0895Deferoxamine mesyl; Desferal
    J0896Luspatercept; Reblozyl
    J0897Denosumab; Prolia; Xgeva
    J1290Ecallantide; Kalbitor
    1–10 of 32
    1/4
    Appendix B specialty infusion therapiesHCPCS
    J1558Immune globulin; Gammaplex; Xembify
    J1559Immune globulin; Gammaplex; Hizentra
    J1560Immune globulin; Gammaplex; Gamastan
    J1561Immune globulin; Gammaplex; Gammaked; Gamunex-C
    J1566Immune globulin; Gammaplex; Carimune NF; Gammagard
    J1568Immune globulin; Gammaplex; Octagam
    J1569Immune globulin; Gammaplex; Gammagard Liquid
    J1570Ganciclovir; Gammaplex; Cytovene
    J1571Immune globulin; Gammaplex; Hepagam IV
    J1572Immune globulin; Gammaplex; Flebogamma
    1–10 of 13
    1/2
    Immune globulin / Gammaplex product mappingsHCPCS
    J1558immune globulin; Gammaplex = Xembify
    J1559immune globulin; Gammaplex = Hizentra
    J1560immune globulin; Gammaplex = Gamastan
    J1561immune globulin; Gammaplex = Gammaked; Gamunex-C
    J1566immune globulin; Gammaplex = Carimune NF; Gammagard
    J1568immune globulin; Gammaplex = Octagam
    J1569immune globulin; Gammaplex = Gammagard Liquid
    J1570ganciclovir; Gammaplex = Cytovene
    J1571immune globulin; Gammaplex = Hepagam IV
    J1572immune globulin; Gammaplex = Flebogamma
    1–10 of 31
    1/4
    Risankizumab-rzaa / Skyrizi product mappingsHCPCS
    J2329ublituximab-xiiy; Skyrizi = Briumvi
    J2350ocrelizumab; Skyrizi = Ocrevus
    J2351ocrelizumab and hyaluronidase-ocsq; Skyrizi = Ocrevus Zunovo
    J2356tezepelumab-ekko; Skyrizi = Tezspire
    J2357omalizumab; Skyrizi = Xolair
    J2406oritavancin; Skyrizi = Kimyrsa
    J2407oritavancin; Skyrizi = Orbactiv
    J2426paliperidone injection; Skyrizi = Invega Sustenna; all strengths
    J2430pamidronate; Skyrizi = Aredia
    J2469palonosetron; Skyrizi = Aloxi
    1–10 of 33
    1/4
    Vedolizumab / Entyvio product mappingsHCPCS
    J3385velaglucerase alfa; Entyvio = Vpriv
    J3485zidovudine; Entyvio = Retrovi
    J3489zoledronic acid; Entyvio = Reclast
    J7170emicizumab-kxwh; Entyvio = Hemlibra
    J7175coagulation factor X; Entyvio = Coagadex
    J7177human fibrinogen concentrate; Entyvio = Fibryga
    J7178human fibrinogen concentrate; Entyvio = Riastap
    J7179von willebrand factor; Entyvio = Vonvendi
    J7180factor XIII concentrate; Entyvio = Corifact
    J7181Factor XIII; Entyvio = Tretten
    1–10 of 28
    1/3
    Efmoroctocog alfa / Eloctate product mappingsHCPCS
    J7207factor VIII; Eloctate = Adynovate
    J7208damoctocog alfa pegol; Eloctate = Jivi
    J7209factor VIII; Eloctate = Nuwiq
    J7210factor VIII; Eloctate = Afstyla
    J7211factor VIII; Eloctate = Kovaltry
    J7212factor VIII; Eloctate = Sevenfact
    J3303Aristospan
    J9217leuprolide; Eloctate = Lupron
    J9218leuprolide; Eloctate = lupron
    J9312rituximab; Eloctate = Rituxan; first visit in AIS; includes biosimilars
    1–10 of 25
    1/3
    Treatment disruption
    Disruption period6 months
    Review impactA restart after a six-month treatment disruption is reviewed under the initial-dose criteria.
    Provider actionFor a restart, submit the request for the initial visit and identify continued administration through home infusion or an ambulatory infusion suite when applicable.
    Approval duration
    Maximum durationUp to one year

    Authorization and Documentation Requirements

    Prior Authorization

    Site-of-Care Prior Authorization

    Prior authorization is required for intravenous or injectable therapy administered in an outpatient hospital department or a non-hospital outpatient office or facility. The provider must establish that the requested outpatient setting meets the applicable approval criteria.

    • Applies to therapy provided in an outpatient hospital department or non-hospital outpatient office or facility.
    • If the criteria are not met, use an alternate, less intensive site of care.
    Prior Authorization

    Initial or Restart Dose Request

    For the initial dose or a restart after a six-month disruption, request authorization for the initial visit and identify the planned continuation setting and duration of therapy.

    • Submit the request for the initial visit.
    • Identify continued administration at home infusion or an ambulatory infusion suite (AIS), when applicable.

    Policy Background

    Specialty infusion therapy is the intravenous or injectable administration of medication used to manage complex and often chronic conditions. Depending on the member’s clinical needs, administration or dispensing may occur in the home, at an ambulatory surgical or infusion center, or through a pharmacy; a higher-acuity outpatient setting is used when treatment requirements or clinical risks make it necessary.

    Key Definitions

    Site of Care
    DefinitionRedirection of specialty drug administration and/or dispensing from outpatient facilities to a lower-cost setting when the higher-acuity setting is not medically necessary.
    Higher-cost settingsHospitals and community offices, including Place of Service codes 19, 22, and 11.
    Alternative settingsHome-based care, an ambulatory surgical/infusion center, or a pharmacy, including Place of Service codes 12, 24, 11, and 01.
    FDA
    AbbreviationFDA
    Full nameFood and Drug Administration.
    Policy application

    Site-of-Care Options

    Note

    Consider home-based care

    Home-based administration or dispensing may be used as an alternative site when the higher-acuity outpatient setting is not medically necessary.

    • Home-based setting: Place of Service code 12.
    Note

    Consider an ambulatory infusion center

    An ambulatory surgical or infusion center is an alternative site for specialty-drug administration when an outpatient hospital or office/facility is not required.

    • Ambulatory surgical/infusion center: Place of Service code 24 or 11.
    Prior Authorization

    Use hospital outpatient care only when criteria are met

    Outpatient hospital or non-hospital outpatient office/facility administration is covered only when the policy’s qualifying initial or continued medical-necessity criteria are met.

    Biosimilar Product Mappings

    Billing Rule

    Account for included infliximab and rituximab biosimilars

    The product mapping includes all biosimilars for J1745 infliximab and includes biosimilars for J9312 rituximab.

    • J1745: infliximab; includes all biosimilars.
    • J9312: rituximab; includes biosimilars.
    Policy Summary
    PayerAmbetter Nevada
    PolicyInfusion Therapy Site of Care Optimization
    Policy CodePolicy FL.CP.PHAR.493
    Change TypeNo material change
    Effective DateJul 1, 2025
    Last ReviewApr 1, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization with clinical documentation for intravenous or injectable therapy requested at an outpatient hospital or non-hospital outpatient facility.
    SourceLink
    On This Page
    Coverage CriteriaInitial Site-of-Care ApprovalContinued Site-of-Care ApprovalAppendix B and Operational Coding DetailsAuthorization and Documentation RequirementsPolicy BackgroundKey DefinitionsSite-of-Care OptionsBiosimilar Product Mappings
  1. An FDA-approved indication requires administration at an outpatient hospital, office, or clinic.
  2. The request is for an initial treatment dose or a restart after a six-month disruption for a short duration of therapy.6-month disruption

    The provider must request the initial visit and identify continued administration at home infusion or an ambulatory infusion suite when applicable.

  3. Documentation shows that home-based therapy or an ambulatory surgical/infusion center presents a health risk because of a physical or behavioral impairment.

    Examples include severe venous access issues when a vein finder is unavailable, no caregiver access, cardiopulmonary disorder, inability to tolerate intravenous fluid loads, or cognitive concerns affecting safety.

  4. Medical or infusion records document severe or life-threatening adverse events that did not respond to pre-medications, analgesics, steroids, antihistamines such as diphenhydramine, fluids, or infusion-rate reductions.

    Examples include seizures, anaphylaxis with no other therapy options, myocardial infarction, or renal failure.

    5. Shorter limitThe approval period is limited to the length of approval for the drug when that period is shorter than one year.
    Applies toInitial and continued approval at the requested outpatient location.
  5. Short-duration therapy may include approximately four weeks.

    6. Unsupported block type: documentation

    Documentation Required

    Alternative-Site Health Risk

    Document that home-based therapy or an ambulatory surgical or infusion center would pose a health risk because of the member’s physical or behavioral impairment.

    • Severe venous-access issues when a vein finder is unavailable
    • No access to a caregiver
    • Cardiopulmonary disorder
    • Inability to tolerate intravenous fluid loads
    • Cognitive concerns that affect patient safety
    Documentation Required

    Severe Adverse-Event Records

    Submit medical or infusion records documenting severe or life-threatening adverse events that were non-responsive to appropriate mitigation measures.

    • Document failure to respond to pre-medications, analgesics, steroids, antihistamines such as diphenhydramine, fluids, or infusion-rate reductions.
    • Examples include seizures, anaphylaxis with no other therapy options, myocardial infarction, and renal failure.
    Documentation Required

    Continuation Reassessment

    For continued services at the requested location, submit records that reassess the member’s site of care and support the need for continued monitoring or advanced treatment capabilities.

    • Submit medical records or infusion records for continuation.
    • Document why monitoring and advanced treatment capabilities beyond those routinely needed for infusion therapy remain necessary.
    • Approval may extend up to one year or the drug’s approval duration.
    Denial Risk

    Failure to Meet Outpatient Hospital Criteria

    Requests for outpatient hospital therapy should be denied when FDA-approved indications do not require administration in an outpatient hospital, office, or clinic and no other qualifying initial approval criterion is met.

    • The member has an available home infusion provider, ambulatory infusion center, or lower-cost site of care able to provide administration.
    • Specialty pharmacy is able to provide the drug.
    • The request lacks a qualifying FDA site-of-care requirement, initial dose or six-month restart, documented alternative-site health risk, or severe non-responsive adverse event.
    • Requests that do not meet the initial approval criteria must be provided at an alternate, less intensive site of care.
    Denial Risk

    Non-Qualifying Medical Necessity Reasons

    The following reasons, standing alone, do not establish medical necessity for outpatient hospital infusion or injectable therapy.

    • Trypanophobia or fear of needles
    • Pediatric status
    • Member or provider preference or convenience
    • Frequent laboratory monitoring
    • Continuation of services from a previous plan
    Denial Risk

    Alternate Site Required

    Therapy that does not meet the initial approval criteria must be provided at an alternate, less intensive site of care.

    • Use an appropriate home infusion, ambulatory infusion, or other lower-intensity setting when available and clinically suitable.
    Billing Rule

    Use of an Uncertified Facility

    The facility used for the service associated with HCPCS J2315 must be certified and approved for that service.

    • Verify facility certification before requesting or billing the service.
    • Uncertified or unapproved facilities do not satisfy the facility requirement for J2315.
    An FDA-approved indication may require administration at an outpatient hospital, office, or clinic.
    IV
    AbbreviationIV
    MeaningIntravenous.
    Policy contextSpecialty infusion therapy may involve intravenous or injectable administration of medication.
    • The requested therapy must be IV or injectable specialty therapy.
    • For continuation, records must support reassessment of the site of care and the need for advanced monitoring or treatment capabilities.
    Note

    Consider pharmacy dispensing

    A pharmacy may be used as a possible lower-cost site for dispensing specialty drugs when appropriate.

    • Pharmacy setting: Place of Service code 01.
    Billing Rule

    Confirm infusion-center certification

    Verify that the infusion facility is certified and approved for the listed service before submitting the request.