ModifiedPremera BluecrossPolicy N/A

Formulary prior authorization, step therapy, and site-of-service criteria for specialty/infusion drugs

Defines authorization, step therapy, and site-of-service medical necessity criteria for select IV, SC, and oral specialty drugs on two custom Premera formularies (Open formulary ID 6062; Preferred formulary ID 6064) and specifies which drugs and clinical indications are subject to review.

Policy Summary

PayerPremera Bluecross

PolicyFormulary prior authorization, step therapy, and site-of-service criteria for specialty/infusion drugs

Policy CodePolicy N/A

Change TypeCoverage expansionHCPCS updatesre-authorization revision

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of specialist prescribing and required prior trials/failures per the policy; submit claims using the listed HCPCS/Q-codes under the correct benefit.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for multiple adalimumab biosimilars and branded products (e.g., Abrilada, Amjevita, Cyltezo, Hyrimoz, Humira, Idacio, Simlandi, Yuflyma, Yusimry) and clarified they are subject to FDA dosing and administration information.

Added HCPCS codes J0135, J3590, Q5119, Q5115, J3262, Q5133, Q5135, J3247, JO129, J0717, J3245, Q5140-Q5145, Q5123, J9311, and J9312 and removed Q5131 and Q5132 per criteria updates.

Updated re-authorization duration of approval from 3 years to 12 months.

Added coverage criteria for multiple additional biologics (rituximab products, tocilizumab products, vedolizumab SC, anakinra, sarilumab, bimekizumab, tildrakizumab, baricitinib, ozanimod, abatacept, certolizumab, golimumab, etc.) for specified indications.

Removed Idacio (adalimumab-aacf) from the policy as it has been removed from the market.

2custom formularies governed (IDs 6062, 6064)

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Coverage Criteria and Medical Necessity

inv-09: Cosentyx, Siliq, Ilumya and other psoriasis/psoriatic agents — indication-specific criteria

Cosentyx (secukinumab), Siliq (brodalumab), Ilumya (tildrakizumab), and other indicated agents for psoriasis, psoriatic arthritis, and ankylosing spondylitis are covered when the specific indication criteria below are met. All therapies must be prescribed by or in consultation with the specialty indicated (dermatologist for psoriasis; rheumatologist for ankylosing spondylitis and most psoriatic arthritis cases) unless otherwise noted.

ALL of the following

Cosentyx (secukinumab) IV/SC may be considered medically necessary for ankylosing spondylitis when: The individual is aged 18 years or older.
For ankylosing spondylitis with Cosentyx: Has had an inadequate response or intolerance to 2 of the following agents: Enbrel (etanercept); any preferred adalimumab product (Cyltezo, Humira, Simlandi, adalimumab-adaz/adbm/ryvk); Rinvoq (upadacitinib); Taltz (ixekizumab); or Xeljanz (tofacitinib or XR).
Cosentyx (secukinumab) SC may be considered medically necessary for moderate to severe plaque psoriasis when: The individual is aged 6 years or older; has chronic plaque psoriasis involving ≥ 10% body surface area (BSA) (exceptions: extensive recalcitrant facial, pustular hands/feet, or genital involvement interfering with sexual function); has had an adequate trial and treatment failure with at least 1 approved systemic therapy (eg, methotrexate, cyclosporine, acitretin, PUVA) unless contraindicated or not tolerated; and has had an inadequate response or intolerance to 2 of the following agents: Enbrel (etanercept); preferred adalimumab products; Otezla (apremilast); Skyrizi (risankizumab); Sotyktu (deucravacitinib); Stelara (ustekinumab) products; Taltz (ixekizumab); Tremfya (guselkumab).
Cosentyx (secukinumab) IV/SC may be considered medically necessary for active psoriatic arthritis when: The individual is aged 2 years or older; has had an inadequate response or intolerance to 2 of the following agents: Enbrel (etanercept); preferred adalimumab products; Otezla (apremilast); Rinvoq (upadacitinib) or Rinvoq LQ; Skyrizi (risankizumab); Stelara (ustekinumab) products; Taltz (ixekizumab); Tremfya (guselkumab); Xeljanz (tofacitinib or XR). Medication must be prescribed by or in consultation with a rheumatologist or dermatologist.
Siliq (brodalumab) SC may be considered medically necessary for moderate to severe plaque psoriasis when: The individual is aged 18 years or older; has chronic plaque psoriasis involving ≥ 10% BSA (exceptions as above); has had an adequate trial and treatment failure with at least 1 approved systemic therapy unless contraindicated or not tolerated; and has had an inadequate response or intolerance to 2 of the following agents: Enbrel (etanercept); preferred adalimumab products; Otezla (apremilast); Skyrizi (risankizumab); Sotyktu (deucravacitinib); Stelara (ustekinumab) products; Taltz (ixekizumab); Tremfya (guselkumab).
Ilumya (tildrakizumab) SC may be considered medically necessary for moderate to severe plaque psoriasis when: The individual is aged 18 years or older; has chronic plaque psoriasis involving ≥ 10% BSA (exceptions as above); has had an adequate trial and treatment failure with at least 1 approved systemic therapy unless contraindicated or not tolerated; and has had an inadequate response or intolerance to 2 of the following agents: Enbrel (etanercept); preferred adalimumab products; Otezla (apremilast); Skyrizi (risankizumab); Sotyktu (deucravacitinib); Stelara (ustekinumab) products; Taltz (ixekizumab); Tremfya (guselkumab).
For all above IL-17/IL-12/23/IL-23 class or other biologic agents used for psoriasis, psoriatic arthritis, or ankylosing spondylitis: Medication must be prescribed by or in consultation with a dermatologist or rheumatologist as appropriate; prior authorization may be required; and documented trials and failures of required prior agents must be provided.

inv-11: Orencia (abatacept) IV/SC — JIA, PsA, RA (second-line) criteria

Orencia (abatacept) IV/SC is covered for juvenile idiopathic arthritis (polyarticular), psoriatic arthritis, and rheumatoid arthritis when the following criteria are met.

ALL of the following

Juvenile idiopathic arthritis (polyarticular)
- Orencia (abatacept) IV/SC may be considered medically necessary when: The individual is aged 2 years or older and has aggressive disease.
- Has had an inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine.
- Has had an inadequate response or intolerance to 2 of the following agents: Actemra (tocilizumab) SC or Tyenne (tocilizumab-aazg) SC; Enbrel (etanercept); any preferred adalimumab product (Cyltezo, Humira, Simlandi, adalimumab-adaz/adbm/ryvk); Rinvoq (upadacitinib or LQ); Xeljanz (tofacitinib or oral solution).
Psoriatic arthritis (adults)

inv-12: Second-line TNF-α inhibitors (adalimumab biosimilars and branded products) — Ankylosing spondylitis and Crohn's disease criteria

Second-line TNF-α inhibitors including adalimumab branded products and biosimilars (multiple listed agents) may be considered medically necessary for ankylosing spondylitis and Crohn's disease when the criteria below are met.

ALL of the following

Ankylosing spondylitis
- Preferred and non-preferred adalimumab products (including Abrilada, Abrilada/adbz? variants, Amjevita, Hadlima, Hulio, Hyrimoz, Cyltezo, Humira, Simlandi, Yuflyma, Yusimry, and others listed) may be considered medically necessary when: The individual is aged 18 years or older; medication is prescribed by or in consultation with a rheumatologist; and the individual has had an inadequate response or intolerance to ALL the following: Adalimumab-adaz (Hyrimoz unbranded), Cyltezo (adalimumab-adbm) or its unbranded equivalent, Humira (adalimumab) (AbbVie) [NDCs starting with 00074], and Simlandi (adalimumab-ryvk) or its unbranded equivalent.
- For ankylosing spondylitis some agents (per policy) require that the member has tried and failed the listed first-line adalimumab products prior to coverage of other branded/biosimilar adalimumab formulations.
Crohn's disease

Billing Codes, NDCs, and HCPCS/J-Codes

Formulary NDC clusters referencedNDC

NDCs starting with 00074	Humira (AbbVie) NDC subset
NDCs starting with 83457	Unclear NDC group referenced (context listing multiple SC products)

Drugs listed (no CPT/HCPCS in chunk)mixed

Actemra (tocilizumab) IV/SC; Orencia (abatacept) IV; Riabni (rituximab-arrx) IV; Rituxan (rituximab) IV; Ruxience (rituximab-pvvr) IV; Truxima (rituximab-abbs) IV; Tofidence (tocilizumab-bavi); Tyenne (tocilizumab-aazg); Entyvio (vedolizumab) IV/SC; multiple adalimumab biosimilars/brands (Cyltezo, Humira, Simlandi, Hyrimoz, Abrilada, Amjevita, Hadlima, Hulio, Yuflyma, Yusimry); Cimzia (certolizumab pegol); Omvoh (mirikizumab); Rinvoq (upadacitinib); ustekinumab products; Skyrizi; Tremfya; Zeposia; Kineret (anakinra); others as listed in policy.

Referenced NDC prefixesNDC

NDCs starting with 00074

Humira (adalimumab) (AbbVie) reference NDC prefix listed in policy

Referenced NDC prefixes (additional)NDC

NDCs starting with 83457

Humira (adalimumab) (Cordavis) reference NDC prefix listed in policy

HCPCS / Biologic injection codes (selected)HCPCS

J0129	Injection, abatacept (Orencia), 10 mg.
J0135	Injection, adalimumab (Humira) 20 mg (code terminated effective 01/01/25).
J0139	Injection, adalimumab (Humira) mg (new code effective 01/01/25).
J0717	Injection, certolizumab pegol (Cimzia) , mg.
J3245	Injection, tildrakizumab (Ilumya) , mg.
J3247	Injection, secukinumab (Cosentyx), IV, mg.
J3262	Injection, tocilizumab (Actemra), 1 mg.
J3590	Unclassified biologics (use to report: Amjevita, Bimzelx; Cyltezo, Hadlima, Hulio, Hyrimoz, Kevzara, Kineret; Siliq, Simlandi, Yuflyma and Yusimry).
J9311	Injection, rituximab 10 mg and hyaluronidase (Rituxan Hycela).
J9312	Injection, rituximab (Rituxan); 10 mg.

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Additional adalimumab biosimilar HCPCS codesHCPCS

Q5142	Injection, adalimumab-ryvk biosimilar (Simlandi), mg.
Q5143	Injection, adalimumab-adbm; biosimilar (Cyltezo), mg.
Q5144	Injection, adalimumab-aacf (Idacio), biosimilar, mg.
Q5145	Injection, adalimumab-afzb (Abrilada), biosimilar; mg

HCPCS biosimilar codesHCPCS

Q5144	Injection, adalimumab-adbm; biosimilar, mg.
Q5145	Injection, adalimumab-aacf (Idacio), biosimilar, mg.

Updated HCPCS/J-codes added in policy updateHCPCS

J0135	Injection, adalimumab, biosimilar/brand (added)
J3590	Unclassified biologic (added)
Q5119	Ruxience IV (added)
Q5115	Truxima IV (added)
J3262	Actemra (tocilizumab) (added)
Q5133	Tofidence IV (added)
Q5135	Tyenne (tocilizumab-aazg) (added)
J3247	Cosentyx (added)
JO129	Orencia (added)
J0717	Cimzia (added)

1–10 of 20

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inv-38: Hospital outpatient medically necessary initial period

Hospital outpatient medically necessary initial periodInitial course of infusion or re-initiation after ≥6 months is considered medically necessary for up to 90 days

When allowed due to accessWhen there is no outpatient infusion center within 50 miles and no contracted home infusion agency will travel to the home

When allowed due to clinical riskWhen the patient has increased infusion risk (significant cardiac or pulmonary disease, unstable renal function, difficult vascular access, acute mental status changes, or history of severe infusion reactions/anaphylaxis)

Exclusion for standard long-interval dosingDoes not apply when standard dosing interval between infusions is 6 months or longer

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for listed IV and injectable drugs on the custom Open and Preferred formularies. Requests must document consultation with or prescribing by the appropriate specialist (e.g., gastroenterologist for Entyvio, rheumatologist for many biologics, dermatologist for psoriasis agents) and must include documentation of prior therapies and trials/failures per the drug-specific criteria.

Applies to drugs on Formulary ID 6062 (Rx Plan F1) and Formulary ID 6064 (Rx Plan G3).
Site-of-service medical necessity review applies to medical benefit administration (IV/infusion); Alaska fully-insured members excluded from SOS criteria per policy.
Entyvio (vedolizumab) SC/IV: requires gastroenterologist prescribing/consult and prior trials (including induction IV for some SC uses).
Rituximab products, tocilizumab products, abatacept IV/SC, and other listed biologics require prior auth and specialist documentation.

Documentation Required

Initial Therapy Requirements and First-line Preferences

First-line therapy preferences and initial therapy choices

First-line therapy preferences and initial therapy expectations — overview:

First-line agents: Preferred first‑line agents listed by drug class (eg, preferred adalimumab products such as Cyltezo, Humira, Simlandi; Enbrel; preferred infliximab products) are generally required to be tried prior to second‑line agents

Initial therapy requirements (examples vary by agent and indication)

Initial therapy requirements (examples) — per agent and indication:

Crohn's prerequisites: Many biologic approvals for Crohn's require trial of one corticosteroid or one conventional Crohn's agent prior to biologic therapy

Entyvio IV induction for SC transition:

Re-authorization and Maintenance Therapy

Re-authorization criteria

Re-authorization criteria — conditions for ongoing approval:

Re-authorization: Drugs may be approved up to 12 months at re‑authorization if drug‑specific coverage criteria are met and chart notes demonstrate continued positive clinical response to therapy.

Continuation / Maintenance therapy

Continuation / Maintenance therapy — evidence and expectations from trials:

Crohn's maintenance evidence: In randomized maintenance arms (eg, CHARM), adalimumab 40 mg every other week or weekly maintained remission through Weeks 26 and 56 for responders; nonresponders after induction were unlikely to respond by 12 weeksWeeks 26 and 56 endpoints

Continuation/maintenance therapy — re-authorization operational note (12 months)

Step Therapy Tables and Required Prior Agents

Requirement	Notes
At least one on-formulary preferred product must be tried before approving second-line biologics
Preferred first-line agents include listed adalimumab products and other preferred agents per class (eg, Enbrel, preferred infliximab)

Required prior agents	Typical requirement
Specified preferred adalimumab products (examples: Cyltezo, Humira [NDCs starting with 00074], Simlandi, Hyrimoz, Yuflyma, Amjevita, Abrilada)
Trials and documented inadequate response/intolerance to one or more preferred adalimumab products or other class comparators (TNF inhibitors, IL inhibitors, JAKs) are required prior to second-line agents; number of required trials varies by indication (often 1–2)

Documentation required	Implication for approval
Chart notes showing trial and inadequate response or intolerance to the required prior systemic agents/biologics as listed for the indication
Approval contingent on documented failures/intolerance per the indication-specific step therapy rules (often failure of 1–2 agents) and specialist prescribing/consultation as required

Benefit routing note	Action
Multiple adalimumab biosimilars and branded products are managed through both the pharmacy and medical benefit
Verify and follow the payer's step therapy and benefit routing rules for the specific product and benefit channel when submitting prior authorization and claims

Policy update	Where to find details
Policy expanded to add multiple adalimumab biosimilars/brands and numerous other biologic agents; these additions may carry step therapy or sequencing requirements
Specific step requirements and sequencing for the newly added agents are detailed in the full indication-level criteria sections of the policy

Site-of-Service Policy and Administration Settings

Note

IV infusion therapy covered in the most appropriate, safe, cost-effective site (home, office, infusion center, hospital outpatient)

IV infusion therapy will be covered in the most appropriate, safe, and cost‑effective site (physician office, infusion center, home infusion); hospital-based outpatient is limited to initial course or re-initiation after >=6 months or when access/clinical risk criteria are met.

Preferred medically necessary sites: physician's office, infusion center, home infusion.
Hospital outpatient setting considered medically necessary for the first 90 days for initial course or when specified access/clinical criteria apply.

Note

Infusion center review — many IV-administered agents subject to site-of-service review

Many IV-administered agents listed in the policy (for example, rituximab products, Orencia IV, Cosentyx IV) are subject to site-of-service review and may require justification for infusion center or hospital outpatient administration.

Site-of-service review applies to specific IV products enumerated in the policy.
Documentation justifying the selected administration site may be required at authorization.

Biosimilar and Reference Product Guidance

Billing Rule

Humira (adalimumab) listed as preferred adalimumab product and often required first-line

Humira (adalimumab) is listed among the preferred adalimumab products and is frequently referenced as a required first-line agent in many step-therapy sequences across indications.

Humira NDCs starting with 00074 (AbbVie) and other Humira product references appear in first-line and comparator lists.
Humira and preferred adalimumab biosimilars are commonly required prior agents for second-line biologic approvals.

Billing Rule

Humira listed among preferred adalimumab products for first-line use

Humira is repeatedly listed among preferred adalimumab products used for first-line therapy and as a required prior agent in multiple indication criteria.

Preferred adalimumab products include Cyltezo, Humira, Simlandi, Hyrimoz and others referenced across indications.

Definitions and Clinical Terms

inv-61: Site of service — definition

DefinitionSite of service = location where the drug is administered (physician's office, infusion center, home infusion, or hospital outpatient)

Preferred medically necessary sitesPhysician's office, infusion center, or home infusion when appropriate and safe

Hospital outpatient roleHospital-based outpatient infusion (outpatient hospital IV infusion department) is reserved for initial courses/re-initiation or when access or clinical risk necessitates

inv-62: Hospital-based outpatient clinical level of care — medically necessary initial course definition

DefinitionHospital-based outpatient clinical level of care is medically necessary for the initial course of infusion or re-initiation after ≥6 months when no outpatient infusion center within 50 miles or no contracted home infusion agency will travel

Clinical-risk indications

Policy Background and Scope

Background: This policy defines medical necessity and site‑of‑service determinations for select IV and injectable biologic agents and certain oral specialty therapies used to treat autoimmune, inflammatory, and other complex conditions. It links coverage to indication‑specific criteria (age, specialist prescribing/consultation, and required prior therapy trials) and includes site‑of‑service review rules that designate physician office, infusion center, or home infusion as preferred sites and limit hospital‑based outpatient infusion to initial courses, re‑initiation after ≥6 months, lack of local outpatient/home infusion access, or elevated clinical risk. The policy also establishes benefit routing (medical vs pharmacy) and requires adherence to FDA dosing and required documentation for authorization and re‑authorization.

Policy Summary

PayerPremera Bluecross

PolicyFormulary prior authorization, step therapy, and site-of-service criteria for specialty/infusion drugs

Policy CodePolicy N/A

Change TypeCoverage expansionHCPCS updatesre-authorization revision

Effective DateOct 1, 2025

Next Review DateN/A

SourceLink

On This Page

Rheumatoid arthritis (adults)

Orencia (abatacept) IV/SC may be considered medically necessary for moderate to severe rheumatoid arthritis when: The individual is aged 18 years or older and medication is prescribed by or in consultation with a rheumatologist.
Has not responded to or does not tolerate methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine.
Has had an inadequate response or intolerance to 2 of the following agents: Actemra (tocilizumab) SC or Tyenne (tocilizumab-aazg) SC; Enbrel (etanercept); preferred adalimumab products; Rinvoq (upadacitinib); Xeljanz (tofacitinib).
Orencia is not covered when used in patients with heart failure, previously treated lymphoproliferative disorder, previous serious infection, or demyelinating disorder unless clearly justified and documented.

Adalimumab branded and biosimilar products (including but not limited to Abrilada, Amjevita, Cyltezo, Humira, Hyrimoz, Simlandi, Yusimry, Hulio, Hadlima, Yuflyma) may be considered medically necessary for Crohn's disease when: The individual is aged 6 years or older; has tried one corticosteroid or is currently taking corticosteroids OR has tried one other conventional agent for Crohn's (eg, azathioprine, 6-mercaptopurine, methotrexate, mesalamine [Pentasa]) or has enterocutaneous/rectovaginal fistulas or has had ileocolonic resection; and has had a trial and treatment failure with ONE preferred adalimumab product (eg, Cyltezo, Humira, Simlandi, adalimumab-adaz/adbm/ryvk) prior to use of alternative adalimumab formulations.

Step Therapy

Step Therapy and Benefit Routing

Step therapy — verify per benefit and product routing. Step therapy requirements and sequencing depend on the product and the member's benefit (pharmacy vs medical). Confirm whether the agent is managed under the pharmacy benefit, medical benefit, or both before applying step therapy rules.

Some agents are managed through the medical benefit (e.g., IV formulations such as Actemra IV, Orencia IV, rituximab products).
Many agents are managed through the pharmacy benefit or both (see Medical Pharmacy Benefit list); step/sequence requirements must be applied according to the applicable benefit.
Verify required first-line and subsequent agent trials (preferred adalimumab products, TNF inhibitors, DMARDs, or other class-specific agents) per the drug-specific criteria before approval.

Denial Risk

Site-of-Service Review / Denial Risk

Site-of-service and denial risk. Infusion site-of-service may be reviewed and denied when SOS criteria are not met. Outpatient infusion services may be denied if medically necessary site-of-service criteria are not satisfied.

Preferred medically necessary sites: physician office, infusion center, home infusion (when available and appropriate).
Hospital-based outpatient setting may be necessary for initial courses or when no infusion center/home infusion is available, or when patient risk factors (e.g., unstable cardiac/respiratory status, severe prior infusion reactions, CRS grade 3–4) are present.
Site-of-service medical necessity review applies to medical benefit claims and does not apply to Alaska fully-insured members per policy.

Billing Rule

Billing/Coding and Benefit Routing

Benefit routing and coding. Ensure accurate benefit routing and HCPCS/Q-code submission for biosimilars and specified agents to avoid misrouting or claim denials; include required codes and documentation with prior authorization requests.

Submit adalimumab biosimilars and specified biologics with the correct Q-codes/HCPCS listed in the policy (e.g., Q5144–Q5145, Q5119, Q5115, J3262, J9311, J9312, etc.) per the Coding section and History updates.
Confirm whether the drug is billed under the medical benefit (HCPCS/J-codes) or pharmacy benefit (NDC) and route the request accordingly.
Nonstandard uses, combinations not in policy, or uses without required documentation may be investigated or denied as investigational or not medically necessary.

Note

Authorization Length and Re-authorization Requirements

Authorization duration and re-authorization. Initial and continuation approvals are for up to 12 months when drug-specific criteria are met; re-authorization must document ongoing clinical benefit and continued fulfillment of criteria.

All drugs listed may be approved for up to 12 months; re-authorization requires chart notes demonstrating positive clinical response.
Policy expansions or updates may implement sequencing requirements; refer to the full drug-specific criteria for current step/sequence rules.
Adherence to FDA dosing and administration is expected; deviations may require additional justification and could affect coverage.

Initial therapy / induction dosing examples from trials

Initial therapy / induction dosing examples referenced in evidence and trials:

HS induction dosing example: Humira induction dosing used in HS trials: 160 mg Week 0, 80 mg Week 2, then 40 mg weekly starting Week 4 with HiSCR assessment at Week 12

Crohn's induction dosing example: Adalimumab induction regimens in trials included higher loading doses at Weeks 0 and 2 with assessment at Week 4 for CDAI remission and maintenance dosing QOW or QW as per trial arms

Note

Office/home administration considerations for SC agents — specialist prescribing and benefit route may apply

Some subcutaneous agents may be administered in-office or at home via specialty pharmacy, but these uses still often require specialist prescribing/consultation and correct benefit routing per the policy.

Examples include SC formulations managed through pharmacy or medical pharmacy benefits; specialist involvement is required for many SC agents.
Confirm benefit routing and authorization pathway prior to administration.

Note

Site-of-service review applies to listed drugs and links to medical necessity and specialty prescriber requirements

Site-of-service review applies to the listed drugs and ties medical necessity to both the specialty prescriber requirement and indication-specific criteria; the allowed setting is implied by the drug formulation and HCPCS/J‑code assignment.

Policy links site-of-service determinations to prescriber specialty and indication-specific medical necessity criteria.
HCPCS/J-code assignment helps indicate expected administration setting (IV vs SC).

Billing Rule

IV formulations managed under medical benefit (infusion center or hospital outpatient)

IV formulations referenced in the policy (e.g., Actemra IV, rituximab products, tocilizumab IV) are managed under the medical benefit and require medical‑benefit authorization and appropriate site‑of‑service justification.

Examples of medical benefit agents: Actemra IV, Rituxan, Ruxience, Truxima, Rituxan Hycela, Tofidence, Tyenne.
Authorization and billing should follow medical benefit procedures for IV products.

Billing Rule

Administration codes updated to include IV and SC formulations; site-specific settings implied by HCPCS (J/Q codes)

Administration and billing codes were updated to include both IV and SC formulations; site-specific settings are implied by HCPCS (IV products billed as J/Q codes) and should be used when submitting claims.

Updated HCPCS/J-codes were added to align coding with coverage criteria.
Use the appropriate J/Q HCPCS code corresponding to the product and formulation for billing and SOS determinations.

Billing Rule

Rituximab preferred products — inadequate response/intolerance required before other rituximab products

Rituximab products (Ruxience, Truxima, Riabni, Rituxan) are preferred for certain RA indications; inadequate response or intolerance to listed first-line therapies is required before other rituximab products are considered.

Ruxience and Truxima are listed as examples of rituximab products subject to site-of-service review.
Rituximab use for RA requires combination with methotrexate and second-line status after first-line therapy failure.

Billing Rule

Humira and listed biosimilars may be medically necessary when criteria met

Humira and listed biosimilars (multiple adalimumab brands) may be considered medically necessary for specified indications when the policy's criteria—including age, prescriber specialty, and required prior therapy trials—are met.

Multiple adalimumab biosimilars and brands are included in coverage criteria and used as prior agents across indications.
Coverage requires meeting indication-specific clinical and prior‑therapy rules.

Billing Rule

Humira included in coverage criteria (additional reference)

Humira and referenced adalimumab biosimilars are incorporated into the policy's coverage criteria across multiple indications; ensure criteria and documentation requirements are met when requesting authorization.

Multiple biosimilars and branded adalimumab products were added to the policy and are listed as prior agents or preferred options per indication.
Providers must follow the policy's indication‑specific requirements for authorization.

inv-65: Medical Necessity definition per policy

DefinitionMedical Necessity = use of a listed agent for an indicated condition when the patient meets age requirements, specialty prescriber/consultation requirements, and required prior trials/failures as specified in the policy

DocumentationRequires provider documentation of age, indication-specific criteria (eg BSA for psoriasis), prior trials and treatment failures, and specialty prescribing/consultation

Approval durationWhen criteria are met, approvals may be granted up to 12 months; re-authorization requires documentation of continued clinical benefit

inv-67: HS / HiSCR definition

HiSCR definitionHidradenitis Suppurativa Clinical Response (HiSCR) = ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to baseline

Clinical useHiSCR assessed at Week 12 in HS trials (Humira induction regimen) and used as an efficacy endpoint to support treatment response

Disease descriptionHS = inflammatory skin disease with recurrent abscesses, nodules, sinus tracts, scarring, and recurrent discharge often affecting axillae, groin, buttocks, and inframammary areas