ModifiedPremera Blue Cross of WashingtonPolicy 5.01.645

Medical Necessity Criteria for Drugs Subject to Site of Service Review

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This policy establishes medical-necessity, step-therapy, site-of-service, authorization, and documentation requirements for intravenous, injectable, and selected oral drugs used to treat active psoriatic arthritis. Site-of-service review applies to members age 13 and older, except Alaska fully insured members.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyMedical Necessity Criteria for Drugs Subject to Site of Service Review

Policy CodePolicy 5.01.645

Change TypeModified

Effective DateJanuary 1, 2027

Next Review DateN/A

Key ActionSubmit clinical records documenting the diagnosis, relevant history, physical evaluation, medication history, and applicable medical-necessity criteria.

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.

ModifiedPremera Blue Cross of WashingtonPolicy 5.01.645

Medical Necessity Criteria for Drugs Subject to Site of Service Review

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Sign up for premerabluecrossofwashington Policy 5.01.645 alerts

Get alerted when Policy 5.01.645 changes without checking for updates manually.

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Policy Summary

PayerPremera Blue Cross of Washington

PolicyMedical Necessity Criteria for Drugs Subject to Site of Service Review

Policy CodePolicy 5.01.645

Change TypeModified

Effective DateJanuary 1, 2027

Next Review DateN/A

Key ActionSubmit clinical records documenting the diagnosis, relevant history, physical evaluation, medication history, and applicable medical-necessity criteria.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for multiple ustekinumab biosimilars and related products, including Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Steqeyma, Yesintek, and Wezlana.

Updated Otezla criteria to require a body weight of at least 20 kg, added Otezla XR criteria, changed Simponi Aria eligibility from age 18 or older to age 2 or older, and updated Tremfya criteria to require a body weight of at least 40 kg.

Added or updated preferred and non-preferred product positioning for several biologics, including Cyltezo, Yuflyma, Avsola, infliximab, and Remicade.

Added HCPCS codes for Wezlana, Steqeyma, Imuldosa, Otulfi, and Yesintek.

Removed Idacio because it was removed from the market.

Added coverage criteria for Starjemza and Sotyktu, including Sotyktu criteria for active psoriatic arthritis.

Updated Stelara coverage criteria to require a trial with Steqeyma and Yesintek for individuals who have not previously been treated.

Updated preferred and non-preferred product assignments for multiple adalimumab, infliximab, and ustekinumab products, including Cyltezo, Yuflyma, Avsola, Renflexis, and ustekinumab-aauz.

Updated age and weight requirements for Tremfya, Otezla, Xeljanz, Simponi Aria, and Skyrizi.

Added tofacitinib and tofacitinib extended-release with the same criteria as Xeljanz and Xeljanz XR.

Added adalimumab-bwwd with the same criteria as Hadlima and second-line adalimumab products.

Added Immgolis and Immgolis Intri with the same criteria as the corresponding subcutaneous and intravenous Simponi formulations.

Removed Stelara as a preferred alternative for all non-preferred agents.

12 monthsMaximum authorization period

13+Site-of-service review age

50 milesInfusion-center access threshold

90 daysInitial or reinitiated hospital outpatient period

Active psoriatic arthritisCovered condition

8HCPCS codes added

General Coverage Framework

General coverage framework

The following applies to medical-benefit reviews.

General review: Specific intravenous and injectable drugs are reviewed for medical necessity for all ages.

For members age 13 and older, site of service is also reviewed.

Site-of-service medical necessity

Preferred sites are covered when medically appropriate. Hospital-based outpatient administration requires an applicable exception.

Preferred sites: The drug is administered in a physician's office, infusion center, or home infusion setting for specified drugs.

These are the preferred medically necessary sites of service.

Hospital outpatient exceptions

Applicable exception: The administration is during the first 90 days of an initial infusion or injection course, or after therapy is reinitiated following discontinuation for 6 months or longer.
Standard dosing intervals of 6 months or longer do not by themselves qualify.
Applicable exception: There is no outpatient infusion center within 50 miles of the individual's home and no contracted home infusion agency will travel to the home, or the hospital is the only place that offers the drug.
Applicable exception: The individual has a qualifying condition that increases the risk of infusion or injection complications, including a known cardiac or pulmonary condition, unstable renal function that reduces the ability to respond to fluids, difficult or unstable vascular access, acute mental-status or cognitive conditions affecting safety, or a history of severe adverse drug reaction or anaphylaxis to a related or similar drug.

Severe cytokine release syndrome exception: The individual has cytokine release syndrome and will be admitted to an inpatient setting as soon as possible.Grade 3 or 4 CRS

Grade 3 or 4 CRS requires temperature at least 38 °C, hypotension requiring 1 or more vasopressors, and hypoxia requiring a high-flow nasal cannula, face mask, non-rebreather mask, or Venturi mask, or positive pressure, intubation, or mechanical ventilation.

Drug-specific medical necessity and step therapy

The requested drug may be considered medically necessary for active psoriatic arthritis when all drug-specific age, prescriber, indication, and step-therapy requirements are met.

Disease and specialist requirement: Active psoriatic arthritis is documented, and the medication is prescribed by or in consultation with a rheumatologist or dermatologist when required by the drug-specific criterion.

Age and formulation requirements vary by drug.

Infliximab sequencing: Infliximab Janssen-unbranded or Remicade is requested for an individual age 18 years or older who has documented treatment failure with Avsola, Inflectra, and Renflexis, and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.Failure of all three listed infliximab products

This failure requirement applies to individuals not previously treated with the requested therapy. The products are subject to site-of-service review.

JAK inhibitor sequencing: Rinvoq or Rinvoq LQ is requested for an individual age 2 years or older with inadequate response or intolerance to 1 or more TNF blockers, and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.

Use of the listed drugs in combination with each other, for conditions not outlined in this policy or a related medical policy, or outside the product’s FDA dosage and administration information is considered investigational.

For Alaska fully insured members, site-of-service medical-necessity criteria do not apply. These members are subject only to the infusion and injection drug medical-necessity criteria.

Individuals younger than 13 years are outside the population for site-of-service medical-necessity review. Drug medical-necessity review continues to apply according to the applicable drug-specific criteria.

This medical policy does not apply to Medicare Advantage members.

Infusion and injectable therapy provided at a site that does not satisfy the policy’s site-of-service medical-necessity criteria is considered not medically necessary.

All other uses of the listed drugs for approved conditions addressed in this policy are considered not medically necessary when the applicable coverage criteria are not met.

HCPCS and Operational Coding References

HCPCSHCPCS

J0129	Injection, abatacept (Orencia), 10 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered).
J0139	Injection, adalimumab (Humira), 1 mg.
J0717	Injection, certolizumab pegol (Cimzia), 1 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered).
J1438	Injection, etanercept (Enbrel), 25mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered).
J1602	Injection, golimumab (Simponi Aria), 1 mg, for intravenous use.
J1628	Injection, guselkumab (Tremfya), 1 mg.
J1745	Injection, infliximab, excludes biosimilar (Remicade or Janssen unbranded), 10mg.
J3247	Injection, secukinumab, intravenous, (Cosentyx) 1 mg.
J3357	Injection, ustekinumab, subcutaneous injection (Stelara), 1mg.
J3590	Unclassified biologics (use to report: Abrilada, Adalimumab-adaz HCF, Amjevita, Bimzelx, Cyltezo, Hadlima, Hulio, Hyrimoz LCF, Hyrimoz HCF, Immgolis, Imgolis Intri, Imuldosa, Kevzara, Kineret, Sandoz (unbranded), Simponi, Skyrizi, Starjemza, Taltz, Yuflyma, Yusimry).

1–10 of 11

1/2

HCPCSHCPCS

J0129	Injection, abatacept (Orencia), 10 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered)
J0139	Injection, adalimumab (Humira), 1 mg
J0717	Injection, certolizumab pegol (Cimzia), 1 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered)
J1438	Injection, etanercept (Enbrel), 25 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered)
J1602	Injection, golimumab (Simponi Aria), 1 mg, for intravenous use
J1628	Injection, guselkumab (Tremfya), 1 mg
J1745	Injection, infliximab, excludes biosimilar (Remicade or Janssen unbranded), 10 mg
J3247	Injection, secukinumab, intravenous (Cosentyx), 1 mg
J3357	Injection, ustekinumab, subcutaneous injection (Stelara), 1 mg
J3590	Unclassified biologics (use to report: Abrilada, Adalimumab-adaz HCF, Amjevita, Bimzelx, Cyltezo, Hadlima, Hulio, Hyrimoz LCF, Hyrimoz HCF, Immgolis, Imgolis Intri, Imuldosa, Kevzara, Kineret, Sandoz unbranded, Simponi, Skyrizi, Starjemza, Taltz, Yuflyma, Yusimry)

1–10 of 29

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Added HCPCS CodesHCPCS

Q9999	HCPCS code added
Q5137	HCPCS code for Wezlana
Q5138	HCPCS code for Wezlana
Q9996	HCPCS code for Steqeyma
Q9998	HCPCS code for Steqeyma
Q5098	HCPCS code for Imuldosa
Q5099	HCPCS code for Otulfi
Q5100	HCPCS code for Yesintek

Added HCPCS CodesHCPCS

Q5164

New HCPCS code

Outpatient infusion-center access

Distance thresholdNo outpatient infusion center within 50 miles of the individual’s home

Home infusion accessNo contracted home infusion agency will travel to the individual’s home

Hospital outpatient exceptionHospital-based outpatient administration may be medically necessary when both access conditions are met, or when the hospital is the only place offering the drug

Initial or reinitiated therapy in hospital outpatient setting

Initial courseHospital-based outpatient administration is medically necessary for the first 90 days of the initial infusion or injection course

Authorization, Documentation, and Review Requirements

Prior Authorization

Medical Necessity and Site-of-Service Review

Submit medical-necessity documentation for covered intravenous and injectable drugs under the medical benefit. Site-of-service medical-necessity review applies only to members age 13 and older; it does not apply to Alaska fully insured members, who are reviewed under infusion and injection drug medical-necessity criteria only.

Medical-necessity review applies to all ages for specified IV and injectable drugs.
For individuals age 13 and older, also document the medically necessary administration site.
Site of service includes a hospital-based outpatient setting, infusion center, physician’s office, or home.

Prior Authorization

Reauthorization Up to 12 Months

Reauthorization may be approved for up to 12 months when the applicable drug-specific coverage criteria continue to be met and chart notes demonstrate that the individual continues to show a positive clinical response to therapy.

Include current clinical documentation supporting continued response and ongoing medical necessity.

Condition Overview

Psoriatic arthritis is an inflammatory disease that affects the joints and the areas where tendons and ligaments attach to bone. Common symptoms include joint pain and stiffness, skin rashes, and changes to the fingernails or toenails. This policy addresses when biologic and other specialty drugs may be medically necessary to treat psoriatic arthritis.

Policy Terms

Site of service

Hospital outpatientHospital-based outpatient setting or outpatient hospital IV infusion department

Infusion centerAn outpatient infusion center

Physician’s officeThe physician’s office

HomeHome or home infusion

Reauthorization

TimingApproval after the initial authorization period

Continued criteriaDrug-specific coverage criteria must continue to be met

Initial Psoriatic Arthritis Therapy

Initial psoriatic arthritis therapy

Initial coverage is drug-specific and requires documented active psoriatic arthritis, applicable age criteria, specialist prescribing or consultation, and required step-therapy history.

Active disease and specialist management: The individual has active psoriatic arthritis, and the medication is prescribed by or in consultation with a rheumatologist or dermatologist when required by the drug-specific criterion.

Age requirements vary by drug and formulation.

Drug-specific age and product criteria: The requested product meets its applicable age, formulation, and product requirements, including age 18 years or older for specified adult products; age 2 years or older for Simponi Aria, Immgolis IV, Rinvoq, Rinvoq LQ, tofacitinib, Xeljanz, and pediatric Orencia SC; and age 6 years or older for Steqeyma, Yesintek, Tremfya, Skyrizi, and listed ustekinumab products.

Tremfya additionally requires body weight of at least 40 kg.

TNF blocker step therapy: Rinvoq, Rinvoq LQ, tofacitinib, and Xeljanz have inadequate response or intolerance to 1 or more TNF blockers.

Continuation and Reauthorization

Continuation and reauthorization

Continuation requires ongoing fulfillment of the drug-specific coverage criteria.

Reauthorization: The drug-specific coverage criteria continue to be met, and chart notes demonstrate that the individual continues to show a positive clinical response to therapy.Up to 12 months

Applies to all drugs listed in the policy.

Product Sequencing Requirements

First-line therapy category	Applicable examples	Requirement
TNF-alpha inhibitors
Avsola; adalimumab products; Enbrel; Simponi Aria
Use or demonstrate eligibility for the applicable first-line agent before higher-tier therapy.
IL-17, IL-12/23, IL-23, Janus kinase, or PDE-4 inhibitors
Taltz; Steqeyma; Yesintek; Tremfya; Skyrizi; Rinvoq; Rinvoq LQ; tofacitinib; Xeljanz; Xeljanz XR
The specific first-line agent depends on the requested higher-tier therapy and its drug-specific criteria.

Higher-tier therapy	Required prior therapy	Failure or intolerance requirement
Rinvoq, Rinvoq LQ, tofacitinib, or Xeljanz
One or more TNF blockers
Document inadequate response or intolerance to at least one TNF blocker.
Tofacitinib extended-release or Xeljanz XR
Adalimumab-aaty, adalimumab-adaz, and adalimumab-adbm with NDCs beginning 00597
Document inadequate response or intolerance to all specified adalimumab products.
Bimzelx
One listed agent, including specified TNF, Otezla/Otezla XR, Skyrizi, Sotyktu, Steqeyma/Yesintek, Taltz, or Tremfya options
Document inadequate response or intolerance to one listed agent.
Cimzia, Immgolis SC, Simponi SC, Cosentyx, or adult Orencia
Two listed agents, from the drug-specific qualifying-agent list
Document inadequate response or intolerance to two listed agents.
Infliximab Janssen-unbranded or Remicade
Avsola, Inflectra, and Renflexis
For individuals not previously treated with the requested therapy, document treatment failure with all three products.
Other ustekinumab products, including Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Stelara, and Wezlana
Steqeyma and Yesintek
Document inadequate response or intolerance to both Steqeyma and Yesintek.

Requested therapy	Population	Required trial	Coverage condition
Stelara (ustekinumab)
Individuals who have not previously been treated with Stelara
Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce)
Coverage requires a trial with both Steqeyma and Yesintek.

Administration Setting Requirements

Billing Rule

Select a preferred site of care

Use a physician’s office, infusion center, or home infusion as the preferred medically necessary site for specified drugs when medically appropriate.

Preferred sites: physician’s office, infusion center, and home infusion.

Billing Rule

Document the 90-day hospital outpatient exception

Hospital-based outpatient administration may be medically necessary for the first 90 days of an initial infusion or injection course or after reinitiation following discontinuation for 6 months or longer. Standard dosing intervals of 6 months or longer do not by themselves qualify.

Document whether the treatment is an initial course or reinitiation after at least 6 months off therapy.

Biosimilar and Preferred Product Positioning

Step Therapy

Document biosimilar failure before infliximab or Remicade

Infliximab Janssen-unbranded and Remicade are subject to site-of-service review. For individuals not previously treated with the requested therapy, document a trial and treatment failure with Avsola, Inflectra, and Renflexis.

Required failed products: Avsola (infliximab-axxq), Inflectra (infliximab-dyyb), and Renflexis (infliximab-abda).
The requested medication must be prescribed by or in consultation with a rheumatologist or dermatologist.

Step Therapy

Use first-line ustekinumab options appropriately

Steqeyma and Yesintek are first-line IL-12/23 inhibitor options. Other ustekinumab products require inadequate response or intolerance to both Steqeyma and Yesintek, along with the applicable age and specialist-prescribing requirements.

Steqeyma and Yesintek require active psoriatic arthritis and age 6 years or older.
Other listed ustekinumab products require failure or intolerance of both Steqeyma and Yesintek.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyMedical Necessity Criteria for Drugs Subject to Site of Service Review

Policy CodePolicy 5.01.645

Change TypeModified

Effective DateJanuary 1, 2027

Next Review DateN/A

Key ActionSubmit clinical records documenting the diagnosis, relevant history, physical evaluation, medication history, and applicable medical-necessity criteria.

SourceLink

On This Page

At least 1 TNF blocker

Tofacitinib sequencing: Tofacitinib or Xeljanz is requested for an individual age 2 years or older with inadequate response or intolerance to 1 or more TNF blockers, and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.At least 1 TNF blocker

Extended-release tofacitinib sequencing: Tofacitinib extended-release or Xeljanz XR is requested for an individual age 18 years or older with inadequate response or intolerance to the specified adalimumab products.All specified adalimumab-aaty, adalimumab-adaz, and adalimumab-adbm products with NDCs beginning 00597

Second-line biologic therapy: Bimzelx is requested after inadequate response or intolerance to 1 listed agent. Cimzia, Immgolis SC, Simponi SC, Cosentyx, and adult Orencia are requested after inadequate response or intolerance to 2 listed agents.1 listed agent for Bimzelx; 2 listed agents for Cimzia, Immgolis SC, Simponi SC, Cosentyx, and adult Orencia

The qualifying agents are drug-specific and are listed in the policy.

Ustekinumab sequencing: Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Stelara, other listed ustekinumab products, and Wezlana are requested for an individual age 6 years or older with inadequate response or intolerance to both Steqeyma and Yesintek, and the medication is prescribed by or in consultation with a dermatologist or rheumatologist.Failure or intolerance of both Steqeyma and Yesintek

Pediatric pathways: Simponi Aria or Immgolis IV is requested for an individual age 2 years or older with active psoriatic arthritis and specialist prescribing. Steqeyma or Yesintek is requested for an individual age 6 years or older. Orencia SC is requested for a pediatric individual age 2 years or older after inadequate response or intolerance to Enbrel, Rinvoq or Rinvoq LQ, or Steqeyma or Yesintek, or under the specified serious-comorbidity pathway.Age thresholds vary by drug

Specialist prescribing or consultation is required where specified by the drug-specific criterion.

The 90-day period also applies after re-initiation following discontinuation of therapy for 6 months or longer

Dosing interval limitationStandard dosing intervals of 6 months or longer do not by themselves qualify for this exception

Cytokine release syndrome severity

TemperatureAt least 38 °C

HypotensionRequires 1 or more vasopressors

HypoxiaRequires oxygen through a high-flow nasal cannula, face mask, non-rebreather mask, or Venturi mask, or requires positive pressure

Additional requirementThe individual will be admitted into an inpatient setting as soon as possible

Minimum age for site-of-service review

Minimum age13 years of age or older

Review applies toSite-of-service medical-necessity review

Below the thresholdIndividuals younger than 13 years are outside the site-of-service medical-necessity review population

Otezla minimum body weight

DrugOtezla (apremilast)

Minimum body weightAt least 20 kg

Covered conditionPsoriatic arthritis

Tremfya minimum body weight

DrugTremfya (guselkumab)

Minimum body weightAt least 40 kg

Criteria updateThe Tremfya coverage criteria were updated to include individuals who weigh at least 40 kg

Approval remains subject to the applicable drug-specific criteria.

Unsupported block type: billing_rule

Step Therapy

Trial Required Before Stelara

Before requesting Stelara for an individual who has not previously been treated, document trials with both Steqeyma and Yesintek as required by the policy’s updated Stelara coverage criteria.

Steqeyma: ustekinumab-stba.
Yesintek: ustekinumab-kfce.
Document inadequate response, intolerance, or other applicable trial history when submitting the request.

Step Therapy

Psoriatic Arthritis Step Therapy

For active psoriatic arthritis, submit documentation showing that the requested product’s applicable first-line or second-line step-therapy requirements have been satisfied. Requirements vary by product and may require an inadequate response or intolerance to specified alternatives, generally with prescribing by or consultation with a dermatologist or rheumatologist.

First-line options include specified TNF-α inhibitors, IL-17, IL-12/23, IL-23, Janus kinase, and PDE-4 inhibitors.
Second-line products may require inadequate response or intolerance to one or two specified agents, depending on the product.
Common required alternatives include Enbrel; specified adalimumab products; Otezla or Otezla XR; Rinvoq or Rinvoq LQ; Skyrizi; Sotyktu; Steqeyma or Yesintek; Taltz; Tremfya; tofacitinib or Xeljanz products; and other product-specific agents.
Verify age requirements: many adult criteria require age 18 or older, while pediatric Orencia criteria begin at age 2.
For IV products such as Avsola, Inflectra, Renflexis, Cosentyx, and Orencia, site-of-service administration is also subject to review.

Documentation Required

Required Clinical Records

Submit clinical records establishing that the applicable medical-necessity criteria are met. Records should support the diagnosis and show the individual’s relevant clinical history, physical evaluation, and medication history.

Document the condition being treated and its active status when required.
Include relevant prior treatment, response, intolerance, and contraindication history.
Include the prescriber’s specialty or consultation when required by the drug-specific criteria.

Documentation Required

Medical Records and Office Visit Notes

Office visit notes and other submitted medical records must demonstrate medical necessity for the requested drug and administration setting. Ensure the documentation is sufficiently current and directly supports the criteria being requested.

Office visit notes must contain the diagnosis, relevant history, physical evaluation, and medication history.
Connect the documented findings to the requested drug, indication, dose, and site of administration.
Incomplete records may delay review or result in nonapproval.

Denial Risk

Investigational Use

Uses outside the policy are investigational. Do not request coverage for the listed agents in combination with each other or for conditions not outlined in this policy or related medical policies unless supported by applicable policy criteria.

Follow the product’s U.S. Food and Drug Administration dosage and administration prescribing information.
Combination use involving the medications listed in this policy is considered investigational when not otherwise addressed by policy.
Uses for conditions not outlined in this policy or related medical policies are considered investigational.

Denial Risk

Unmet Policy Criteria

All other uses of the drugs for approved conditions listed in this policy are considered not medically necessary when the applicable policy criteria are not met.

Submit documentation for the specific indication, age, prior-therapy, prescriber, and other criteria applicable to the requested product.
Do not assume FDA approval alone establishes coverage under this policy.

Denial Risk

Nonqualifying Site of Service

Infusion or injectable therapy delivered at a site that does not meet the policy’s site-of-service medical-necessity criteria is not medically necessary. Document why the requested location is appropriate and satisfies the applicable review criteria.

Potential administration sites include hospital-based outpatient settings, infusion centers, physician’s offices, and the individual’s home.
Hospital-based outpatient administration may be medically necessary for unstable renal function, difficult or unstable vascular access, acute cognitive or mental-status conditions affecting safety, or a history of severe adverse reactions or anaphylaxis to related treatment.
For grade 3 or 4 cytokine release syndrome, document the required temperature, vasopressor, and hypoxia findings and the plan for prompt inpatient admission.

Note

Age Below Site-of-Service Review Threshold

Site-of-service medical-necessity review is limited to individuals age 13 and older. Individuals younger than 13 are outside the site-of-service review threshold because pediatric infusion and injection care requires age-appropriate dosing, equipment, infusion rates, venipuncture, and specialty training.

Apply the site-of-service age threshold at age 13 or older.
Do not apply site-of-service review to individuals younger than 13.
Medical-necessity review for the drug itself may still apply regardless of age.

Response documentationChart notes must demonstrate that the individual continues to show a positive clinical response to therapy

Maximum periodUp to 12 months

Site of service

DefinitionThe location where the drug is administered

Hospital outpatientHospital-based outpatient setting

Infusion center or officeInfusion center or physician’s office

HomeThe individual’s home

At least 1 TNF blocker

Extended-release adalimumab step therapy: Tofacitinib extended-release or Xeljanz XR has inadequate response or intolerance to all specified adalimumab products.All specified adalimumab-aaty, adalimumab-adaz, and adalimumab-adbm products with NDCs beginning 00597

Second-line therapy: Bimzelx has failure or intolerance of 1 listed agent. Cimzia, Immgolis SC, Simponi SC, Cosentyx, and adult Orencia have failure or intolerance of 2 listed agents.1 or 2 agents, depending on the requested drug

Qualifying agents are listed in the drug-specific policy criteria.

Ustekinumab product sequencing: The listed second-line ustekinumab products have inadequate response or intolerance to both Steqeyma and Yesintek.Both Steqeyma and Yesintek

This includes Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Stelara, other listed ustekinumab products, and Wezlana.

Infliximab product sequencing: Infliximab Janssen-unbranded or Remicade is requested by an individual age 18 years or older who has documented treatment failure with Avsola, Inflectra, and Renflexis, and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.Failure of all three listed infliximab products

This applies to individuals not previously treated with the requested therapy.

Billing Rule

Document access limitations for hospital outpatient care

Hospital-based outpatient administration may be medically necessary when there is no outpatient infusion center within 50 miles of the individual’s home and no contracted home infusion agency will travel to the home, or when the hospital is the only place offering the drug.

Document the absence of an outpatient infusion center within 50 miles.
Document the lack of a contracted home infusion agency that will travel to the home, when applicable.
Document when the hospital is the only location offering the drug.

Billing Rule

Document increased complication risk

Hospital-based outpatient administration may be medically necessary when the individual has a qualifying condition that increases the risk of infusion or injection complications.

Known cardiac or pulmonary condition.
Unstable renal function that decreases the ability to respond to fluids.
Difficult or unstable vascular access.
Acute mental-status or cognitive conditions affecting treatment safety.
Prior severe adverse drug reaction or anaphylaxis to a related or similar drug.

Billing Rule

Document the severe CRS exception

Hospital-based outpatient administration may be medically necessary for grade 3 or 4 cytokine release syndrome when all specified clinical findings are present and the individual will be admitted to an inpatient setting as soon as possible.

Temperature at least 38 °C.
Hypotension requiring one or more vasopressors.
Hypoxia requiring specified high-flow oxygen, positive pressure, intubation, or mechanical ventilation.
Planned admission to an inpatient setting as soon as possible.

Prior Authorization

Confirm the reviewed administration location

Apply site-of-service review to the location where the drug is administered, including a hospital-based outpatient setting, infusion center, physician’s office, or home. Site-of-service medical-necessity review is limited to individuals age 13 or older.

Covered administration locations include hospital outpatient, infusion center, physician’s office, and home.
The age threshold for site-of-service review is 13 years or older.

Prescribing must be by or in consultation with a rheumatologist or dermatologist where required.

Billing Rule

Check preferred Yuflyma positioning

Yuflyma (adalimumab-aaty) and adalimumab-aaty were updated from non-preferred to preferred product positioning. Confirm the member’s applicable formulary and product requirements before submission.

Preferred positioning applies to adalimumab-aaty/Yuflyma.
Formulary-specific criteria may differ.

Billing Rule

Check preferred Avsola positioning

Avsola (infliximab-axxq) was updated from a non-preferred product to a preferred product. Confirm the member’s applicable formulary and continue to apply site-of-service and clinical criteria.

Avsola remains subject to site-of-service review.
Clinical and medical-necessity criteria still apply.

Billing Rule

Check non-preferred Cyltezo positioning

Cyltezo (adalimumab-adbm) was updated from a preferred product to a non-preferred product. Confirm the member’s applicable formulary and product requirements before selecting or submitting Cyltezo.

Cyltezo is the affected adalimumab product.
Formulary-specific criteria may differ.