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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsBlue Cross Blue Shield Michigan prior auth updates…
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    Currentblue cross blue shield - michiganPolicy N/A

    Changes to medical necessity criteria for prior authorizations for medical benefit drugs

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    Updates to medical necessity criteria that affect prior authorization requirements for medical‑benefit drugs for Blue Cross commercial and BCN commercial members, including investigational determinations, step therapy, self‑administration rules, and condition‑specific thresholds.

    Policy Summary
    Payerblue cross blue shield - michigan
    PolicyChanges to medical necessity criteria for prior authorizations for medical benefit drugs
    Policy CodePolicy N/A
    Change TypeMultiple program and clinical updates (investigational determinations, step therapy, self‑administration, duration limits)
    Effective DateApr 10, 2025
    Last ReviewMar 31, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization documenting trial and failure, intolerance, or contraindication to specified preferred products before approval.
    SourceLink
    POLICY UPDATE CHANGES

    Hereditary Angioedema Products: genetic testing requirement for HAE diagnosis removed.

    Kebilidi (eladocagene exuparvovec-tneq) added as investigational/experimental for all indications due to insufficient evidence of clinical benefit.

    Lantidra (donislecel-jujn) added as investigational/experimental for all indications due to insufficient evidence of clinical benefit.

    Loqtorzi (toripalimab-tpzi): requires trial and failure, intolerance, or contraindication to preferred Oncology Value Management products.

    Skysona (elivaldogene autotemcel) listed as investigational/experimental for all indications.

    Entyvio (vedolizumab) prior auth requires trial and failure, contraindication, OR intolerance to preferred adalimumab AND preferred ustekinumab products.

    Immune globulin replacement therapy: defined preferred IV and subcutaneous products.

    Skyrizi and Tremfya IV Crohn's/UC edits: specify preferred products and require trial and failure, contraindication, or intolerance to preferred adalimumab AND preferred ustekinumab products.

    Multiple self-administration requirements: several biologics now require member self-administration unless clinically unable.

    Ultomiris (ravulizumab): requires trial and failure, contraindication, OR intolerance to preferred eculizumab product (Bkemv).

    Bkemv and Epysqli for myasthenia gravis require trial and failure, contraindication, OR intolerance to Rystiggo AND Vyvgart (or Vyvgart Hytrulo).

    Zevaskyn wound criteria: total wound area must be >200 cm2 and not used concurrently with other gene therapies for RDEB.

    Gamifant (emapalumab) criteria updated to specify primary HLH diagnostic criteria and detailed clinical thresholds.

    Oncology drug management: prior failure to a drug with same mechanism not required unless retrial recommended by guidelines or supported.

    Evenity (romosozumab) criteria clarified for osteoporosis including T-score, fracture/FRAX thresholds and required prior therapy sequencing.

    Keytruda and Opdivo: require trial and failure, intolerance or contraindication to preferred Oncology Value Management products; Opdivo NSCLC limited to treatment up to 24 months.

    Rebyota (fecal microbiota) cannot be used in combination with Zinplava or Vowst; Zinplava cannot be used with fecal microbiota products.

    Ryoncil (remestemcel-) requires prior try/fail or contraindication to Jakafi when age-appropriate and provider must attest to submitting clinical outcome information to Blue Cross or BCN.

    Multiple drugs updated with trial/failure or program-aligned prior authorization criteria and quantity/renewal rules aligned to FDA dosing and one-year authorization periods.

    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.

    ~40+drugs or drug groups with listed changes
    1 yearstandard authorization period
    24 monthsICI NSCLC max duration
    5/27/2025noted effective date for many oncology updates

    Coverage Criteria and Policy Changes

    Investigational/experimental determinations

    Coverage determinations for listed products:

    Investigational drugs: Coverage is considered investigational/experimental for all indications due to insufficient evidence of clinical benefit

    Applies to Kebilidi (eladocagene exuparvovec-tneq), Lantidra (donislecel-jujn)

    Required trial of preferred adalimumab and ustekinumab

    Step therapy requirement for specified GI and immunologic biologics:

    Primary step requirement: Trial and failure, contraindication, OR intolerance to preferred adalimumab AND preferred ustekinumab products is required for authorization for specified indications

    Applied to Entyvio (vedolizumab), Skyrizi (risankizumab), Tremfya IV (guselkumab), Omvoh (mirikizumab) and other listed products

    Gamifant HLH and MAS criteria — HLH diagnostic and laboratory thresholds

    Clinical and laboratory diagnostic thresholds for Gamifant (emapalumab):

    Diagnostic requirements: Must meet the FDA‑approved indication and age and diagnosis of primary (familial) HLH OR satisfy one of the alternate diagnostic categories (absent/low perforin or defective cytotoxic exocytosis with signs of HLH OR meet 5 of the listed clinical/laboratory criteria)

    Five-of-seven criteria include: fever >= 38.5°C; splenomegaly; cytopenias in >=2 lineages (Hgb <90 g/L [<100 g/L if <4 weeks old], platelets <100 x10^9/L, neutrophils <1.0 x10^9/L); hypertriglyceridemia (fasting TG >=3.0 mmol/L) and/or fibrinogen <=1.5 g/L; hemophagocytosis; ferritin >=500 μg/L; soluble CD25 >=2400 U/mL

    Refractory disease: Refractory, recurrent, or progressive disease or intolerance to conventional HLH therapy (dexamethasone and etoposide), defined as failure to achieve or maintain a satisfactory response or intolerance

    Also includes HLH/MAS in systemic JIA/Still's: ferritin >684 ng/mL plus any 2 of platelet <=181 x10^9/L, AST >48 U/L, triglycerides >156 mg/dL, fibrinogen <=360 mg/dL; and inadequate response to high‑dose IV glucocorticoids as specified

    Authorization and renewal — standard auth period and renewal expectations

    Authorization duration and renewal expectations:

    Authorization period: One year at a time for many drugs1 year

    Quantity limits align with FDA dosing; renewals require clinical documentation confirming continued benefit and that current criteria are still met

    Evenity coverage criteria — osteoporosis T-score and fracture/FRAX thresholds

    Coverage requirements for Evenity (romosozumab):

    General coverage: Diagnosis of osteoporosis with a T‑score <= -2.5, a history of fragility fracture, or high FRAX probability (10‑year major osteoporotic fracture risk >=20% or hip fracture risk >=3%) is requiredT-score <= -2.5 or FRAX major >=20% or hip >=3%

    For very high‑risk patients require trial and failure of zoledronate or a preferred denosumab product (if zoledronate contraindicated); for high‑risk patients require trial and failure of oral or IV bisphosphonates and preferred denosumab unless contraindicated

    Combination exclusions — immunotherapy and fecal microbiota combination rules

    Concurrent use exclusions for specified product pairs:

    Combination exclusions: Zinplava (bezlotoxumab) cannot be used with fecal microbiota products (e.g., Rebyota, Vowst); Rebyota cannot be used with Zinplava or Vowst

    Noncombinable product pairs listed; prescribing these combinations may trigger denial

    The following products are designated investigational/experimental and are excluded from coverage for all indications due to insufficient evidence of clinical benefit: Kebilidi (eladocagene exuparvovec-tneq), Lantidra (donislecel-jujn), and Skysona (elivaldogene autotemcel)

    Concurrent use of certain fecal microbiota products with other specified agents is prohibited. Specifically, Rebyota (fecal microbiota, livejslm) cannot be used in combination with Zinplava (bezlotoxumab) or Vowst. Likewise, Zinplava cannot be used in combination with fecal microbiota products such as Rebyota or Vowst. Prescribing these disallowed combinations may result in prior authorization denial.

    Gene and cell therapies listed as investigational are considered not medically necessary for all indications at this time. Coverage is specifically considered investigational/experimental for these products because current evidence is insufficient to demonstrate clinical benefit; Blue Cross and BCN are awaiting outcomes from ongoing clinical trials before reassessing coverage status. Examples called out in this policy include Kebilidi and Lantidra (both noted as investigational/experimental for all indications).

    Coding and Related Numeric Criteria

    Zevaskyn (prademagene zamikeracel) wound requirement
    Zevaskyn total wound area>200 cm2
    Combination restrictionNot to be used on the same wound concurrently with other gene therapies for RDEB, including prior treatment with Zevaskyn
    Policy published10/09/2025 (effective 11/24/2025)
    Ferritin thresholds for HLH / MAS
    HLH ferritin threshold>= 500 μg/L
    MAS alternate ferritin threshold>= 684 ng/mL (for HLH/macrophage activation syndrome in systemic JIA/Still's disease)
    Related diagnostic labs

    Provider Actions, Documentation, and Authorization Requirements

    Prior Authorization

    Document trial/failure (or intolerance/contraindication) to preferred products

    Prior authorization requires documentation that the member has tried and failed, or has a contraindication or intolerance to, the preferred products listed in the Oncology Value Management program (or other specified preferred lists) before approval; authorization periods are generally one year and quantity limits align with FDA dosing.

    Denial Risk

    Do not request coverage for listed gene/cell therapies — investigational

    Coverage is considered investigational/experimental for certain gene and cell therapies listed (Kebilidi, Lantidra, Skysona) due to insufficient evidence of clinical benefit; these products are excluded from coverage for all indications pending clinical trial results.

    Background and Policy Scope

    This document summarizes changes to medical-necessity criteria that were reviewed by the Pharmacy & Therapeutics (P&T) committee and align utilization management for medical-benefit drugs with current evidence and program preferred-product lists. Updates include investigational determinations, step-therapy requirements, self-administration expectations, and condition-specific diagnostic and response thresholds (for example, HLH, RDEB, and osteoporosis) intended to standardize prior authorization requirements and clinical review across Blue Cross and BCN medical-benefit drug policies.

    Definitions and Diagnostic Criteria

    HLH diagnostic criteria (summary)
    Core HLH diagnostic elementsFever >= 38.5°C; splenomegaly; cytopenias in ≥2 lineages (Hgb <90 g/L, platelets <100 x10^9/L, neutrophils <1.0 x10^9/L)
    Additional laboratory criteriaHypertriglyceridemia (fasting TG >=3.0 mmol/L) and/or hypofibrinogenemia (fibrinogen <=1.5 g/L); hemophagocytosis on biopsy
    Other supportive labsFerritin >=500 μg/L; soluble CD25 >=2,400 U/mL

    Initial Authorization and Therapy Requirements

    Initial authorization requirements — initial prior auth requirements for listed drugs

    Initial prior authorization requirements for many medical‑benefit drugs:

    Initial authorization requirement: Prior authorization requires trial and failure, intolerance, or contraindication to the preferred drugs as listed in BCBSM/BCN utilization management lists before approval

    Quantity limits align with FDA dosing; applies to the listed drugs managed under program prior authorization lists

    Continuation and Duration Limits

    ICI NSCLC duration — immune checkpoint inhibitor duration limits (e.g., Opdivo limited to 24 months in NSCLC)

    Continuation limits for immune checkpoint inhibitors in non‑small cell lung cancer (NSCLC):

    Duration: Treatment until unacceptable toxicity or disease progression for up to a total of 24 months of therapy for specified immune checkpoint inhibitors in NSCLC24 months

    Applies to Opdivo (nivolumab) and other listed agents; trial/failure to preferred Oncology Value Management products still required for authorization

    Step Therapy Requirements and Preferred Products

    Drug / IndicationRequired prior therapies before authorization
    Skyrizi (risankizumab) — Crohn's diseaseTrial and failure, contraindication, OR intolerance to preferred adalimumab biosimilar (pharmacy benefit), Rinvoq (pharmacy benefit), Tremfya (pharmacy benefit) AND preferred ustekinumab SC (pharmacy benefit).
    Skyrizi (risankizumab) — Ulcerative colitisTrial and failure, contraindication, OR intolerance to preferred adalimumab biosimilar (pharmacy benefit), Rinvoq (pharmacy benefit), Simponi (pharmacy benefit), preferred ustekinumab SC (pharmacy benefit), Tremfya (pharmacy benefit) AND Xeljanz/XR (pharmacy benefit).
    Tremfya IV (guselkumab) — specified indicationsTrial and failure, contraindication, OR intolerance to preferred adalimumab AND preferred ustekinumab products before authorization.
    Omvoh (mirikizumab) — Ulcerative colitisTrial and failure, contraindication, OR intolerance to preferred adalimumab biosimilar AND Simponi AND preferred ustekinumab SC AND Skyrizi AND Tremfya AND either Xeljanz/XR or Rinvoq (pharmacy benefit) prior to authorization. (Omvoh lists Entyvio SC and Zeposia as nonpreferred.)
    Omvoh (mirikizumab) — Crohn's diseaseTrial and failure, contraindication, OR intolerance to preferred adalimumab biosimilar, Rinvoq, Skyrizi, Tremfya AND preferred ustekinumab SC prior to authorization. (Cimzia and Entyvio SC listed as nonpreferred.)

    Quantity Limits and Dosing Alignment

    General quantity limits and dosing alignment
    Quantity limits standardQuantity limits align with FDA recommended dosing
    Authorization period linkageQuantity limits applied in context of one-year authorization periods for many drugs
    Requirement at renewalRenewals require clinical documentation confirming continued benefit and that criteria are met

    Site of Care and Self-Administration Requirements

    Note

    Expect member home/self-administration for SC products unless clinically unable

    Members will be expected to self-administer subcutaneous products at home unless clinical circumstances make self-administration inappropriate; apply this expectation across home and office settings where specified.

    • Applies to several biologics (e.g., Cimzia, Cosentyx, Entyvio, Omvoh, Orencia, Simponi Aria, Tremfya SC, Vyvgart Hytrulo, etc.)
    • Exception: clinically unable to self-administer
    Policy Summary
    Payerblue cross blue shield - michigan
    PolicyChanges to medical necessity criteria for prior authorizations for medical benefit drugs
    Policy CodePolicy N/A
    Change TypeMultiple program and clinical updates (investigational determinations, step therapy, self‑administration, duration limits)
    Effective DateApr 10, 2025
    Last ReviewMar 31, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization documenting trial and failure, intolerance, or contraindication to specified preferred products before approval.
    SourceLink
    On This Page
    Coverage Criteria and Policy ChangesCoding and Related Numeric CriteriaProvider Actions, Documentation, and Authorization RequirementsBackground and Policy ScopeDefinitions and Diagnostic CriteriaInitial Authorization and Therapy RequirementsContinuation and Duration LimitsStep Therapy Requirements and Preferred ProductsQuantity Limits and Dosing AlignmentSite of Care and Self-Administration Requirements
    Soluble CD25 >= 2,400 U/mL also included among diagnostic criteria
    Evenity (romosozumab) osteoporosis threshold
    Evenity T-score requirementT-score <= -2.5
    Alternate qualifying criteriaHistory of fragility fracture or high FRAX probability (10-year major >=20% or hip >=3%)
    Risk-based prior therapyVery high-risk patients: trial and failure of zoledronate or preferred denosumab if zoledronate contraindicated
    Step Therapy

    Step therapy: document trial/failure of preferred biologics

    For multiple specialty biologics, authorization requires documented trial and failure, contraindication, OR intolerance to specified preferred biologics — commonly preferred adalimumab products and preferred ustekinumab (SC) — before approval.

    • Applied to Entyvio, Skyrizi, Tremfya IV, Omvoh and others as listed
    • Preferred products commonly include preferred adalimumab biosimilars and preferred ustekinumab SC
    Documentation Required

    Provide clinical documentation at renewal to confirm ongoing benefit

    At renewal, submit clinical documentation demonstrating that the medication continues to meet criteria and is providing clinical benefit; prior authorizations are commonly issued one year at a time.

    • Quantity limits align with FDA dosing
    • Authorization period: one year
    Documentation Required

    Attest to submitting Ryoncil clinical outcomes

    For Ryoncil, attest in the appropriate provider portal that you have submitted requested clinical outcome information to Blue Cross/BCN as part of the authorization requirements.

    • Member must have tried and failed, or have a contraindication/intolerance to, Jakafi when age-appropriate per FDA labeling (related requirement)
    Denial Risk

    Risk of denial for missing trial/failure documentation

    Failure to document trial and failure, contraindication, or intolerance to the required preferred products (as listed in Oncology Value Management or other specified preferred lists) may result in prior authorization denial.

    Denial Risk

    Avoid prohibited combinations (fecal microbiota and Zinplava)

    Do not prescribe disallowed combinations: Rebyota cannot be used with Zinplava or Vowst, and Zinplava cannot be used with fecal microbiota products; use of these prohibited combinations may trigger denial.

    • Rebyota (fecal microbiota) cannot be used with Zinplava or Vowst
    • Zinplava (bezlotoxumab) cannot be used in combination with fecal microbiota products