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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsMedStar Family Choice Drug Coverage | OpenPayer
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    ModifiedMedStar Family Choice, Inc.Policy 2001

    Medical Drug Benefit Policy

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    Establishes medical necessity, prior authorization, utilization management, formulary, biosimilar, continuation-of-therapy, and site-of-care requirements for provider-administered drugs covered under the medical benefit.

    Policy Summary
    PayerMedStar Family Choice, Inc.
    PolicyMedical Drug Benefit Policy
    Policy CodePolicy 2001
    Change TypeNew policy
    Effective DateJuly 16, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization requests with required clinical documentation supporting medical necessity.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    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.

    5Approved administration settings
    4Primary clinical review domains
    18Denial triggers or conditions
    30+High-cost drugs listed
    HCPCS/J-code mappingsBilling information

    Medical Benefit Coverage Criteria

    Medical Necessity Review

    Coverage requires assessment of all applicable clinical and benefit requirements.

    ALL of the following

    • Applicable coverage requirements

      • Medical necessity is established.
      • The requested use is consistent with FDA-approved indications.
      • The requested therapy is consistent with accepted standards of medical practice.
      • The requested therapy is supported by nationally recognized clinical guidelines.
      • Drug-specific clinical criteria are satisfied.
      • Applicable health plan coverage requirements are met.

    • Clinical assessment

      • The therapy is appropriate for the member's clinical condition.
      • The clinical indication is documented.
      • The requested dose and frequency are appropriate.
      • The requested duration of treatment is appropriate.
      • Safety considerations have been evaluated.
      • Required monitoring is identified and feasible.

    Formulary and Biosimilar Exception

    Coverage of a non-formulary medication or non-preferred biosimilar requires sufficient clinical justification and satisfaction of applicable formulary and biosimilar requirements.

    ALL of the following

    • The requested medication's status as preferred, nonpreferred, formulary, or non-formulary under the medical benefit has been determined.

    • ONE or more qualifying circumstances

      • The member has experienced failure of the preferred product or biosimilar.
      • The preferred product or biosimilar is contraindicated.
      • The member has demonstrated intolerance or an adverse reaction to the preferred product or biosimilar.

    Point of Service and Site of Care

    The requested point of service or site of care must be clinically appropriate, safe, and cost-effective.

    ALL of the following

    • The requested point of service is appropriate based on the member's condition, the medication requested, monitoring requirements, and benefit rules.
    • The setting is safe and suitable for the drug-specific administration requirements and the member's patient-safety and monitoring needs.
    • Provider capability and setting suitability are established.
    • Applicable benefit design and utilization management requirements are satisfied.

    • Approved point of service or site of care

    Continuation of Therapy

    Continuation of therapy and reauthorization require evidence of ongoing clinical benefit and satisfaction of applicable coverage and utilization management requirements.

    ALL of the following

    • Clinical response to treatment is documented.
    • Ongoing medical necessity is established.
    • Treatment adherence has been assessed.
    • Adverse effects have been assessed.
    • Continued appropriateness of the therapy is established.
    • Continued appropriateness of the point of service or site of care is established.

    This policy does not apply to medications covered exclusively under the pharmacy benefit. It applies to medications administered under the medical benefit, including infused, injected, and physician-administered drugs billed through Buy & Bill arrangements in outpatient hospital, physician office, ambulatory infusion, home infusion, and inpatient settings.

    A request for a point of service or site of care that is not medically necessary or is not supported by clinical documentation may be denied or redirected to an alternative approved setting.

    Requests may be denied when medical necessity is not established, coverage criteria are not met, insufficient documentation is provided, the requested use is not supported by applicable guidelines, a required preferred alternative has not been utilized, or the requested point of service is not medically necessary or is not supported by documentation. Medical benefit criteria can be found at www.medstarfamilychoice.com.

    Initial Authorization Requirements

    Initial Authorization

    Initial authorization requires all applicable eligibility, benefit, documentation, and clinical requirements to be satisfied.

    Initial medical benefit drug authorization: The member must be eligible and enrolled, the requested service must be a covered medical benefit, and the servicing provider must be participating or authorized as applicable.
    Clinical documentation: The request must include sufficient documentation to support the diagnosis and ICD-10 code, clinical progress notes, treatment plan, previous treatment history and outcomes when applicable, laboratory findings, pathology reports, imaging studies, medication dose and frequency, requested duration of therapy, point of service or site of administration, and member weight or body surface area when applicable.
    Medical necessity review: The request must satisfy requirements for medical necessity, FDA-approved indication, accepted standards of medical practice, nationally recognized clinical guidelines, drug-specific clinical criteria, health plan coverage, therapy appropriateness, clinical indication, dose, frequency, duration, safety, and monitoring.

    Continuation and Reauthorization

    Continuation of Medical Benefit Drug Therapy

    For reauthorization requests, continued coverage requires ongoing clinical benefit and appropriateness.

    Continuation of medical benefit drug therapy: The request must document clinical response to treatment, ongoing medical necessity, treatment adherence, adverse effects, continued appropriateness of therapy, continued appropriateness of the point of service, and continued benefit.
    Authorization requirements: Coverage criteria must continue to be met, required documentation must have been received, applicable utilization management requirements must be satisfied, and the requested or approved point of service must remain clinically appropriate.

    The authorization may include the drug name, dose, frequency, duration, authorized units, and authorized point of service or site of care.

    Preferred Product and Biosimilar Sequencing

    StepRequirementException documentation
    1Use the designated preferred product or biosimilar when an FDA-approved preferred product or biosimilar has been designated by MedStar Family Choice.A non-preferred product or biosimilar may be considered when documentation demonstrates failure, contraindication, intolerance or adverse reaction to the preferred product or biosimilar, or other clinical circumstances supporting the requested product over the preferred alternative.

    Approved Administration Settings

    Prior Authorization

    Approved Administration Settings

    The reviewer evaluates the requested administration setting for clinical medical necessity, safety, monitoring needs, benefit rules, and cost-effectiveness. Enhanced review applies to high-cost drugs and requests for higher-acuity or higher-cost settings; unsupported requests may be denied or redirected to an approved alternative.

    • Approved points of service may include the physician office, ambulatory infusion center, home infusion, and outpatient hospital department.
    • The initial request must include clinical documentation supporting the medication, requested setting, drug-specific administration and safety requirements, monitoring needs, patient history, provider capability, and benefit or utilization-management requirements.
    • A site-of-care justification is required for a higher-acuity or higher-cost setting, such as intensive monitoring, a history of severe infusion reaction, drug-specific safety requirements, lack of access to a lower-acuity setting, or other documented clinical circumstances.
    • When multiple clinically appropriate settings are available, administration may be required at the most appropriate and cost-effective point of service.
    • Use the preferred product or an appropriate biosimilar when required by the plan; requests for nonpreferred products must include supporting clinical justification.
    • The reviewer considers lower-cost clinically appropriate alternatives, including the preferred product or biosimilar, before approving the requested drug and setting.

    Reference Biologic and Preferred Biosimilar Requirements

    Billing Rule

    Use the applicable preferred biologic

    Coverage may be limited to an FDA-approved preferred product or biosimilar designated by MedStar Family Choice. The plan may require use of preferred biosimilars when clinically appropriate and consistent with applicable coverage requirements.

    High-Cost Medication and Medical Drug Formulary Codes

    High-Cost Medication List: Abecma through CinryzeHCPCS
    J9999Abecma (idecabtagene vicleucel)
    J9216Actimmune (interferon gamma-1B)
    J9042Aetris (brentuximab vedotin)
    J3590Alhemo (concizumab)
    J7214Altuviiio (antihemophilic factor-recombinant)
    J1426Amondys 45 (casimersen)
    J3590Andembry (garadacimab)
    J9028Anktiva (inbakicept-pmln)
    J8499Aqneursa (levacetylleucine)
    J3590Avlayah (tividenofusp alfa-eknm)
    1–10 of 18
    1/2
    High-Cost Medication List: Ctexli through DanyelzaHCPCS
    J8499Ctexli (chenodiol)
    J9348Danyelza (naxitamab)
    High-Cost Medication List: Daybue through JoenjaHCPCS
    J8499Daybue (trofinetide); document also lists J3490
    J8499Duvyzat (givinostat); document also lists J3490
    J1413Elevidys (delandistrogene moxeparvovec-rokl); document also lists J3490
    J7205Eloctate (antihemophilic factor VIII FC fusion protein recombinant); document also lists J3490
    J7799Empaveli (pegcetacoplan); document also lists J3490
    J3403Encelto (revakinagene tarorectcel-lwey); document also lists J3490
    J1305Evkeeza (evinacumab); document also lists J3490
    J8499Fabhalta (iptacopan); document also lists J3490
    J3490Filsuvez (birch triterpenes)
    J3490Forzinity (elamipretide)
    1–10 of 21
    1/3
    High-Cost Medication List: Juxtapid through LamzedeHCPCS
    J8499Juxtapid (lomitapide mesylate); document lists J3490 = J8499 and also J8499
    J2840Kanuma (sebelipase alfa); document also lists J3490
    Kimmtrak (tebentafusp-tebn); no HCPCS code shown
    J9274Krystexxa (pegloticase); document also lists J3490
    J0217Lamzede (velmanase alfa-tycv); document also lists J3490
    Appendix drug-to-J-code mappingsHCPCS
    J8499Daybue (trofinetide)
    J8499Duvyzat (givinostat)
    J1413Elevidys (delandistrogene moxeparvovec-rokl)
    J7205Eloctate (antihemophilic factor VIII FC fusion protein recombinant)
    J7799Empaveli (pegcetacoplan)
    J3403Encelto (revakinagene tarorectcel-lwey)
    J1305Evkeeza (evinacumab)
    J8499Fabhalta (iptacopan)
    J3490Filsuvez (birch triterpenes)
    J3490Forzinity (elamipretide)
    1–10 of 21
    1/3
    Appendix drug-to-J-code mappingsHCPCS
    J8499Juxtapid (lomitapide/lomitapide mesylate)
    J2840Kanuma (sebelipase alfa)
    J9274Krystexxa (pegloticase)
    J2507Lamzede (velmanase alfa-tycv)
    Appendix drug-to-J-code mappingsHCPCS
    J8499Miplyffa (arimoclomol)
    J8999Modeyso (dordaviprone)
    J3490Myalept (metreleptin)
    J0219Nexviazyme (avalglucosidase alfa-ngpt)
    J7189Novoseven (coagulation factor VIIa, recombinant)
    J3490Nulibry (fesdenopterin)
    J8499Olpruva (sodium phenylbutyrate)
    J3590Omisirge (omidubicel)
    J3590Orladeyo (berotralstat)
    J0224Oxlumo (lumasiran)
    1–10 of 21
    1/3
    Appendix drug-to-J-code mappingsHCPCS
    J8499Sephience (sepiapterin)
    J8499Sohonos (palovarotene)
    J1299Soliris (eculizumab)
    J2326Spinraza (nusinersen)
    J3490Strensiq (asfotase alfa)
    J0593Takhzyro (lanadelumab-flyo)
    J3490Tryngolza (olezarsen sodium)
    J9376Veopoz (pozelimab)
    J1427Viltepso (viltolarsen)
    J1322Vimizim (elosulfase alfa)
    1–10 of 21
    1/3
    Appendix drug-to-J-code mappingsHCPCS
    J1428Exondys 51 (eteplirsen)
    J9248Hepzato (melphalan)
    J8999Ogsiveo (nirogacestat)
    J1823Uplizna (inebilizumab-cdo)
    J9029Adstiladrin (darbepoetin alfa)
    J7171Adzynma (ADAMTS13)
    J3590Amtagvi (lifileucel)
    J0225Amvuttra (vutrisiran)
    J9039Blincyto (blinatumomab)
    J0567Brineura (cerliponase alfa)
    1–10 of 25
    1/3
    Appendix drug-to-J-code mappingsHCPCS
    J8499Mifepristone (Korlym)
    J3590Lenmeldy (atidarsagene autotemcel)
    C9399Lenmeldy (atidarsagene autotemcel)
    J0220Lumizyme (alglucosidase alfa)
    J9350Lunsumio (mosunetuzumab)
    J3398Luxturna (voretigene neparvovec)
    J3394Lyfgenia (lovotibeglogene autoemcel)
    J3397Mepsevii (vestronidase alpha)
    J3490Ojemda (tovorafenib)
    C9399Onpattro (patisiran)
    1–10 of 30
    1/3
    Medical Drug Formulary List: Neurology / MS / Migraine; Autoimmune / Inflammatory / GI Biologics; IVIG/SCIG; Ophthalmology; Other Specialty Injectables; Oncology / Hematology / Supportive CareHCPCS
    J2350Ocrelizumab (Ocrevus)
    J2323Natalizumab (Tysabri)
    J3032Eptinezumab (Vyepti)
    J3380Vedolizumab (Entyvio)
    J1745Infliximab (Remicade and biosimilars)
    J2327Ustekinumab (Stelara)
    J0490Belimumab (Benlysta)
    J3262Tocilizumab (Actemra)
    J1561Immune globulin (IVIG), e.g., Gamunex-C, Gammaked
    J1459Immune globulin (IVIG), e.g., Privigen
    1–10 of 26
    1/3
    Medical Drug Formulary List: Oncology / Hematology / Supportive CareHCPCS
    J9177Enfortumab vedotin (Padcev)
    J9202Goserelin (Zoladex)
    J9223Leuprolide acetate (Lupron Depot)
    J9228Ipilimumab (Yervoy)
    J9261Gemcitabine (Gemzar)
    J9264Paclitaxel protein-bound (Abraxane)
    J9271Pembrolizumab (Keytruda)
    J9272Nivolumab + relatlimab (Opdualag)
    J9298Nivolumab (Opdivo)
    J9299Nivolumab (Opdivo, alternative billing unit)
    1–10 of 20
    1/2
    Medical Drug Formulary List: Other High-Cost / Supportive AgentsHCPCS
    J0881Darbepoetin alfa (Aranesp)
    J0896Luspatercept (Reblozyl)
    J2506Pegfilgrastim (Neulasta and biosimilars)
    J2802Sutimlimab (Enjaymo)
    J2353Octreotide (Sandostatin LAR)

    Authorization, Documentation, and Review Actions

    Prior Authorization

    Submit the prior authorization request

    Submit prior authorization requests for Medical Benefit drugs through the applicable process. Requests may be submitted by the prescribing provider, servicing provider, facility, or authorized representative and must include all required clinical documentation supporting medical necessity.

    • Requests are logged and assigned for review in accordance with applicable regulatory and organizational turnaround time requirements.
    Prior Authorization

    Verify eligibility and provider status

    Before review, verify member eligibility and enrollment, confirm that the requested service is a covered Medical Benefit, confirm enrollment in the applicable MedStar Family Choice plan, and verify that the servicing provider is participating or authorized, as applicable.

    Prior Authorization

    Support the clinical medical necessity review

    The request must satisfy medical necessity and applicable coverage requirements, including an FDA-approved indication, accepted standards of medical practice, nationally recognized clinical guidelines, drug-specific clinical criteria, and health plan requirements.

    Policy Scope and Medical Benefit Context

    This policy establishes requirements for the review, authorization, and management of provider-administered medical benefit drugs, including infused, injected, and physician-administered medications billed through Buy & Bill arrangements. It applies to administration in outpatient hospitals, physician offices, ambulatory infusion centers, home infusion settings, and inpatient settings. Coverage decisions consider FDA-approved labeling, nationally recognized clinical guidelines, peer-reviewed medical literature, medical necessity, and applicable health plan requirements.

    Key Policy Terms

    Medical Reviewer
    RoleMedical Director
    Qualified reviewerHealth Plan Pharmacist
    DefinitionMedical Director or Health Plan Pharmacist
    Medical Benefit Drug
    TypeMedication administered under the medical benefit
    AdministrationInfused or injected
    Provider administrationPhysician-administered drugs
    Policy Summary
    PayerMedStar Family Choice, Inc.
    PolicyMedical Drug Benefit Policy
    Policy CodePolicy 2001
    Change TypeNew policy
    Effective DateJuly 16, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization requests with required clinical documentation supporting medical necessity.
    SourceLink
    On This Page
    Medical Benefit Coverage CriteriaInitial Authorization RequirementsContinuation and ReauthorizationPreferred Product and Biosimilar SequencingApproved Administration SettingsReference Biologic and Preferred Biosimilar RequirementsHigh-Cost Medication and Medical Drug Formulary CodesAuthorization, Documentation, and Review ActionsPolicy Scope and Medical Benefit ContextKey Policy Terms
    Documented clinical circumstances support use of the requested product over the preferred alternative.
  1. Previous treatment history, clinical outcomes, and supporting documentation have been reviewed.
  2. Sufficient documentation supporting medical necessity for the requested non-preferred product or biosimilar has been submitted.

    3. Preferred-product requirement

    • The requested medication is the designated preferred product or biosimilar.
    • The request meets the qualifying exception requirements for a non-formulary medication or non-preferred biosimilar.
    Physician office.
  3. Ambulatory infusion center.
  4. Home infusion.
  5. Outpatient hospital department.

  6. When a higher-acuity or higher-cost setting is requested, ONE or more documented justifications

    • Need for intensive monitoring.
    • History of severe infusion reaction.
    • Drug-specific safety requirements.
    • Lack of access to a lower-acuity setting.
    • Other documented clinical circumstances supporting the requested setting.
  7. Documentation supporting continued benefit has been submitted for review.
  8. Coverage criteria continue to be met.
  9. Required documentation has been received.
  10. Applicable utilization management requirements are satisfied.
  11. The requested or approved point of service is clinically appropriate.

    12. Authorization details, as applicable

    • Medical necessity is established for the reauthorization period.
    • The drug name is specified.
    • The dose is specified.
    • The frequency is specified.
    • The duration is specified.
    • Authorized units are specified.
    • The authorized point of service or site of care is specified.

    Requests without sufficient clinical documentation to support medical necessity and coverage requirements may be denied for insufficient information.

    • Review therapy appropriateness, clinical indication, dose and frequency, treatment duration, safety considerations, and monitoring requirements.
    Prior Authorization

    Prepare for enhanced high-cost drug review

    Requests involving significant financial impact, non-formulary products, exceptions to established criteria, or complex clinical circumstances are subject to enhanced clinical and financial review. Such requests are escalated to the Chief Medical Officer or designee for review.

    Step Therapy

    Use the preferred product or biosimilar

    When MedStar Family Choice designates an FDA-approved preferred product or biosimilar, coverage may be limited to that product. Use the designated preferred product or biosimilar unless documentation supports an exception.

    • A non-preferred product generally requires documentation of failure, contraindication, intolerance, adverse reaction, or other clinical circumstances supporting its use.
    Documentation Required

    Document the initial request

    Submit all clinical documentation necessary to support medical necessity, including the diagnosis and ICD-10 code, clinical progress notes, treatment plan, prior treatment history and outcomes when applicable, laboratory findings, pathology reports, imaging studies, dose and frequency, requested duration, point of service or site of administration, and member weight or body surface area when applicable.

    Documentation Required

    Justify a non-preferred product

    For a non-preferred product or biosimilar, document medical necessity for using the requested product over the preferred alternative. Supporting circumstances may include failure, contraindication, intolerance, adverse reaction, or other documented clinical circumstances.

    Documentation Required

    Justify the requested site of care

    A request for a higher-acuity or higher-cost point of service must include clinical justification for the requested setting. Examples include intensive monitoring, a history of severe infusion reaction, drug-specific safety requirements, lack of access to a lower-acuity setting, or other documented clinical circumstances.

    Documentation Required

    Document continuation of therapy

    For continuation or reauthorization, submit documentation supporting continued benefit and address clinical response, ongoing medical necessity, adherence, adverse effects, continued appropriateness of therapy, and continued appropriateness of the point of service.

    • The request must also satisfy coverage criteria, required documentation, and applicable utilization management requirements.
    Denial Risk

    Avoid insufficient documentation

    Requests may be denied when submitted clinical documentation is insufficient to establish medical necessity and coverage requirements. Include the clinical information needed to support the diagnosis, treatment plan, prior treatment history when applicable, dosing, duration, administration setting, and medical necessity.

    Denial Risk

    Justify non-preferred products

    Requests for non-preferred products or biosimilars may be denied when formulary or biosimilar requirements are not met and sufficient clinical justification is absent. Document failure, contraindication, intolerance, adverse reaction, or other clinical circumstances supporting the requested product.

    Denial Risk

    Support the requested site of care

    A requested point of service may be denied or redirected when it is not medically necessary or is not supported by clinical documentation. Higher-acuity or higher-cost settings require documented clinical justification.

    Denial Risk

    Avoid common denial conditions

    Denial may result when medical necessity is not established, coverage criteria are not met, documentation is insufficient, applicable guidelines do not support the requested use, a required preferred alternative has not been utilized, or the requested point of service is not medically necessary or supported by documentation.

    Point of Service
    DefinitionApproved location or setting
    PurposeLocation or setting in which the medication is administered
    Coverage basisAdministration under the medical benefit
    Site of Care
    Clinical standardClinically appropriate setting
    Cost standardCost-effective setting
    PurposeSetting for administration of a medical benefit drug