CurrentAmeriHealth Caritas VIP CarePolicy MA08.179a

Guselkumab (Tremfya) Injection for Intravenous Use

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This policy governs medical-benefit coverage and medical necessity for intravenous guselkumab induction in adults with moderate-to-severe active ulcerative colitis or Crohn’s disease. It applies to Medicare Advantage members when Evidence of Coverage terms, clinical criteria, dosing requirements, and documentation requirements are met; subcutaneous and Part D coverage are generally outside this policy.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyGuselkumab (Tremfya) Injection for Intravenous Use

Policy CodePolicy MA08.179a

Change TypeAdministrative reissuance

Effective DateSeptember 16, 2025

Next Review DateN/A

Key ActionDocument the medical necessity of care and submit supporting medical records with coverage requests.

SourceLink

POLICY UPDATE CHANGES

The policy was reissued on September 18, 2026 as part of the Company's annual review process.

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.

CurrentAmeriHealth Caritas VIP CarePolicy MA08.179a

Guselkumab (Tremfya) Injection for Intravenous Use

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Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyGuselkumab (Tremfya) Injection for Intravenous Use

Policy CodePolicy MA08.179a

Change TypeAdministrative reissuance

Effective DateSeptember 16, 2025

Next Review DateN/A

Key ActionDocument the medical necessity of care and submit supporting medical records with coverage requests.

SourceLink

POLICY UPDATE CHANGES

The policy was reissued on September 18, 2026 as part of the Company's annual review process.

Covered inflammatory bowel disease indications

18+Minimum age for covered IV therapy

200 mg at weeks 0, 4, and 8IV induction dosing

3 dosesMaximum IV induction course

JARequired IV administration modifier

Covered Uses and Exclusions

Initial IV induction therapy

Covered when all of the following criteria are met for an adult with moderate-to-severe active ulcerative colitis or Crohn’s disease:

ALL of the following

Adult patient: The individual is at least 18 years of age.>=18 years
Prior conventional therapy: There is documentation of inadequate response, lost response, or intolerance to a trial of one or more conventional therapies, such as immunomodulators, corticosteroid dependence, or biologics.Trial of >=1 conventional therapy
No concurrent biologic therapy: Guselkumab is not used concurrently with any other biologic therapy, including tumor necrosis factor antagonists.No concurrent biologic therapy
Gastroenterologist involvement: The drug is prescribed by or used in consultation with a gastroenterologist.Gastroenterologist prescription or consultation
Induction followed by maintenance: IV infusion is used as an induction dose, followed by maintenance dosing with subcutaneous Tremfya.IV induction followed by SC maintenance
IV induction dosing: Guselkumab 200 mg is administered by IV infusion at weeks 0, 4, and 8.200 mg IV at weeks 0, 4, and 8
The IV infusion is limited to three doses.

Subcutaneous guselkumab (Tremfya) is not covered under the medical benefits for most Company products. When applicable, subcutaneous therapy may be covered under the member’s pharmacy benefit.

All other intravenous uses of guselkumab (Tremfya) are considered experimental/investigational and are not covered unless the indication qualifies as an accepted off-label use under the Company’s policy for off-label coverage of prescription drugs and biologics.

Billing and Coding Requirements

Billing ModifierModifier

JA	Administered Intravenously

CPT Procedure Code Number(s)CPT

N/A

ICD-10 Procedure Code Number(s)ICD-10

N/A

Revenue Code Number(s)Revenue

N/A

HCPCS Level II Code Number(s)HCPCS

J1628

Injection, guselkumab, 1 mg

Intravenous Administration ModifierModifier

JA	Administered Intravenously

Documentation and Denial Risks

Documentation Required

Medical Necessity Records

The individual’s medical record must reflect the medical necessity for the care provided. Supporting records may include documentation from the professional provider’s office, hospital, nursing home, home health agency, therapy providers, and test reports.

Documentation Required

Exception Dosing Support

Requests for IV guselkumab outside the dosing and frequency requirements must include documentation supplied by the prescribing professional provider that supports the requested regimen, including published peer-reviewed literature.

Standard induction dosing is IV guselkumab 200 mg at weeks 0, 4, and 8, followed by subcutaneous maintenance dosing.
IV infusion is limited to three doses.

Therapy Overview

Guselkumab (Tremfya) is a fully human, dual-acting monoclonal antibody that blocks IL-23 and binds CD64 on IL-23-producing cells, inhibiting proinflammatory cytokines and chemokines. This mechanism is relevant to inflammatory bowel disease, which includes ulcerative colitis—primarily affecting the colon and rectum—and Crohn’s disease, which may affect the gastrointestinal tract from the mouth to the anus. Under this policy, intravenous guselkumab is used for induction therapy followed by subcutaneous maintenance therapy.

Key Terms

Inflammatory bowel disease (IBD)

DefinitionInflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract of unknown etiology.

Major category 1Ulcerative colitis (UC).

Major category 2Crohn’s disease (CD).

Guselkumab (Tremfya)

MedicationGuselkumab (Tremfya) injection for intravenous use is a fully human, dual-acting monoclonal antibody.

Primary mechanismBlocks IL-23, a cytokine involved in inflammatory and immune responses.

CD64 activity

Covered IV Induction Criteria

Covered IV induction

IV guselkumab is covered for adult individuals with moderate-to-severe active ulcerative colitis or Crohn’s disease when all of the following medical-necessity criteria are met:

ALL of the following

Age: The individual is at least 18 years of age.>=18 years
Documented prior treatment response: There is documented inadequate response, lost response, or intolerance to a trial of one or more conventional therapies.>=1 prior conventional therapy
Examples include immunomodulators, corticosteroid dependence, and biologics.
Concurrent therapy restriction:

Required Prior Therapy

Step	Requirement	Failure criteria
1	Trial of one or more conventional therapies before IV guselkumab	Documented inadequate response, lost response, or intolerance

IV Induction Quantity

Quantity limits

MedicationGuselkumab (Tremfya) IV

Induction schedule200 mg by IV infusion at weeks 0, 4, and 8.

Quantity limitLimited to three IV induction doses per course.

Appropriate Treatment Setting

Billing Rule

Use the appropriate infusion setting

When services can be administered in various settings, the Company reserves the right to reimburse only services furnished in the most appropriate and cost-effective setting appropriate to the member’s medical needs and condition.

Site-of-care decisions may consider the member’s current medical condition.
Required monitoring or additional services that coincide with delivery may also be considered.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyGuselkumab (Tremfya) Injection for Intravenous Use

Policy CodePolicy MA08.179a

Change TypeAdministrative reissuance

Effective DateSeptember 16, 2025

Next Review DateN/A

Key ActionDocument the medical necessity of care and submit supporting medical records with coverage requests.

SourceLink

On This Page

Denial Risk

Noncovered IV Uses

All other uses of IV guselkumab are considered experimental/investigational and are not covered unless the indication is supported as an accepted off-label use under the Company medical policy for off-label coverage of prescription drugs and biologics.

Denial Risk

Failure to Meet Medical Necessity Criteria

Coverage may be denied when the request does not meet the medical necessity requirements for ulcerative colitis or Crohn’s disease.

Individual is younger than 18 years of age.
The covered diagnosis is not ulcerative colitis or Crohn’s disease.
There is no documented inadequate response, lost response, or intolerance to one or more conventional therapies, such as immunomodulators, corticosteroids, or biologics.
The individual is receiving another biologic therapy, including a tumor necrosis factor antagonist.
The medication is not prescribed by or in consultation with a gastroenterologist.
The requested regimen does not use IV guselkumab for induction followed by subcutaneous maintenance dosing.

Denial Risk

Missing Records

All documentation requested by the Company must be available for review, including records supporting medical necessity and the care provided. Failure to produce requested medical records or supporting information may result in denial of the drug.

The Company may review and audit services for members regardless of the provider’s participation status.

Denial Risk

Unsupported Dosing

Dosing requests outside the policy requirements are not supported for coverage unless the prescribing professional provider submits published peer-reviewed literature supporting the requested dosing or frequency.

Unsupported dosing or frequency may result in denial.
The standard IV induction regimen is 200 mg at weeks 0, 4, and 8, with IV treatment limited to three doses before subcutaneous maintenance dosing.

Also binds CD64, a receptor on cells that produce IL-23.

ResultInhibits the release of proinflammatory cytokines and chemokines.

Ulcerative colitis and Crohn’s disease

Ulcerative colitisPrimarily causes inflammation of the mucosal lining and is generally limited to the colon and rectum.

Crohn’s diseaseMay cause inflammation anywhere in the digestive tract, from the mouth to the anus.

Most common Crohn’s disease distributionThe small intestine and the beginning of the large intestine are most commonly affected.

There is no concurrent use with any other biologic therapy.

This includes tumor necrosis factor antagonists.

Prescriber specialty: Guselkumab is prescribed by or used in consultation with a gastroenterologist.Gastroenterologist involvement

Treatment sequence: IV infusion is used as an induction dose, followed by maintenance dosing with subcutaneous Tremfya.IV induction followed by SC maintenance

Induction dose and frequency: Guselkumab 200 mg is administered by IV infusion at weeks 0, 4, and 8.200 mg IV at weeks 0, 4, and 8

The duration of IV induction is limited to three doses.