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Medical-benefit coverage and prior authorization for intravenous ustekinumab products for Medicare Advantage members, including covered adult Crohn disease, ulcerative colitis, and selected immune-checkpoint-inhibitor toxicities; Part D pharmacy-benefit coverage is excluded.
Policy Summary
PayerAmeriHealth Caritas VIP Care
PolicyUstekinumab for intravenous use
Policy CodePolicy MA08.042l
Change TypeModified
Effective DateSeptember 18, 2026
Next Review DateN/A
Key ActionSubmit intravenous ustekinumab dose, frequency, or regimen changes for a new precertification approval.
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POLICY UPDATE CHANGES
The unclassified drug and biologic codes C9399 and J3590 were removed for Starjemza (ustekinumab-hmny).
HCPCS Q5164 was added to represent ustekinumab-hmny (Starjemza), biosimilar, 1 mg.
The continuation-therapy criterion was removed because members transition from intravenous initial infusion to subcutaneous maintenance, which is not covered under the medical benefit.
Multiple ustekinumab biosimilar HCPCS codes were added as medically necessary codes.
HCPCS code Q9999 for ustekinumab-aauz (Otulfi), biosimilar, 1 mg was added to the policy.
HCPCS codes C9399 and J3590 were identified to represent Starjemza (ustekinumab-hmny).
HCPCS code J3357 for subcutaneous ustekinumab injection was deleted from the policy.
ICD-10-CM code K52.1 for toxic gastroenteritis and colitis was added under intravenous ustekinumab infusion.
Diagnosis-code groupings for subcutaneous ustekinumab indications, including Crohn disease, psoriasis, psoriatic arthritis, and ulcerative colitis, were deleted from the policy.
2Covered indications
260/390/520 mgInitial IV dose options
18+Minimum covered age
2Unclassified codes removed
Q9999New Otulfi code
IV onlyFormulation scope
Coverage Criteria
Initial Therapy: Crohn Disease and Ulcerative Colitis
Covered when ALL of the following criteria and the Dosing and Frequency Requirements are met:
Covered when other etiologies have been ruled out, ANY of the following toxicity criteria is met, and the Dosing and Frequency Requirements are met:
ANY of the following
Infliximab- and/or vedolizumab-refractory mild (Grade 1) diarrhea or colitis with persistent or progressive symptoms and positive lactoferrin/calprotectin.
Infliximab- and/or vedolizumab-refractory moderate (Grade 2) or severe (Grade 3-4) diarrhea or colitis.
Dosing and Frequency
The following dosing requirements apply to Crohn disease, ulcerative colitis, and immune-checkpoint-inhibitor-related toxicity management (diarrhea or colitis):
ALL of the following
For the initial intravenous infusion, adults weighing up to 55 kg receive 260 mg (two vials).
For the initial intravenous infusion, adults weighing more than 55 kg to 85 kg receive 390 mg (three vials).
For the initial intravenous infusion, adults weighing more than 85 kg receive 520 mg (four vials).
Maintenance treatment is administered by subcutaneous formulation.
Qualifying Diagnosis
Ustekinumab and related biosimilars for intravenous use are medically necessary when reported with ANY of the following diagnosis codes:
ANY of the following ICD-10-CM diagnosis codes
K50.00 — Crohn's disease of small intestine without complications; K50.011 — Crohn's disease of small intestine with rectal bleeding; K50.012 — Crohn's disease of small intestine with intestinal obstruction; K50.013 — Crohn's disease of small intestine with fistula; K50.014 — Crohn's disease of small intestine with abscess; K50.018 — Crohn's disease of small intestine with other complication; K50.019 — Crohn's disease of small intestine with unspecified complications.
K50.10 — Crohn's disease of large intestine without complications; K50.111 — Crohn's disease of large intestine with rectal bleeding; K50.112 — Crohn's disease of large intestine with intestinal obstruction; K50.113 — Crohn's disease of large intestine with fistula; K50.114 — Crohn's disease of large intestine with abscess; K50.118 — Crohn's disease of large intestine with other complication; K50.119 — Crohn's disease of large intestine with unspecified complications.
K50.80 — Crohn's disease of both small and large intestine without complications; K50.811 — Crohn's disease of both small and large intestine with rectal bleeding; K50.812 — Crohn's disease of both small and large intestine with intestinal obstruction; K50.813 — Crohn's disease of both small and large intestine with fistula; K50.814 — Crohn's disease of both small and large intestine with abscess; K50.818 — Crohn's disease of both small and large intestine with other complication; K50.819 — Crohn's disease of both small and large intestine with unspecified complications.
Use of ustekinumab products in the pediatric population for the treatment of Crohn disease, ulcerative colitis, or immune-checkpoint-inhibitor-related toxicities is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this biologic cannot be established by review of the available published peer-reviewed literature.
All other uses of ustekinumab products for intravenous use are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the medical policy on off-label coverage for prescription drugs and biologics.
Coding and Billing
Intravenous administration modifierModifier
JA
Administered Intravenously
CPT Procedure Code Number(s)CPT
N/A
N/A
ICD-10 Procedure Code Number(s)ICD-10
N/A
N/A
ICD-10 Diagnosis Code Number(s)ICD-10Covered
K50.00
Crohn's disease of small intestine without complications
K50.011
Crohn's disease of small intestine with rectal bleeding
K50.012
Crohn's disease of small intestine with intestinal obstruction
K50.013
Crohn's disease of small intestine with fistula
K50.014
Crohn's disease of small intestine with abscess
K50.018
Crohn's disease of small intestine with other complication
K50.019
Crohn's disease of small intestine with unspecified complications
K50.10
Crohn's disease of large intestine without complications
K50.111
Crohn's disease of large intestine with rectal bleeding
K50.112
Crohn's disease of large intestine with intestinal obstruction
Submit the requested dose and frequency through the precertification process. If the member's dose, frequency, or regimen changes—for example, because of a change in weight or incomplete therapeutic response—submit the change to the Company for a new approval.
Accurate member information is required for approval.
The Company may conduct postpayment review and audit procedures.
Billing Rule
Use a Qualifying Diagnosis Code
Report a qualifying ICD-10-CM diagnosis code for ustekinumab products for intravenous use. Coverage is medically necessary when the drug is reported with one of the listed Crohn disease diagnosis codes.
Clinical Background
Crohn disease and ulcerative colitis are chronic inflammatory bowel diseases with overlapping symptoms but different anatomic patterns. Treatment is directed at controlling inflammation and preventing flares, using corticosteroids, immunomodulators, and biologic therapies according to disease severity. Ustekinumab is a human monoclonal antibody that targets the shared p40 subunit of interleukin-12 and interleukin-23. The policy also addresses selected immune-checkpoint-inhibitor-related autoimmune-like diarrhea and colitis.
Definitions
Ustekinumab
Drug classHuman IgG1 monoclonal antibody
TargetInterleukin-12 and interleukin-23 antagonist
Binding siteBinds with high affinity and specificity to the shared p40 protein subunit of IL-12 and IL-23
Biologic effectDisrupts IL-12- and IL-23-mediated signaling and cytokine cascades in in vitro models
Immune-related adverse events
DefinitionAutoimmune-like toxicities associated with immune-checkpoint-inhibitor treatment
Covered manifestations
Initial Therapy
Initial Therapy for Inflammatory Bowel Disease
Initial intravenous therapy is covered when all criteria are met:
Crohn disease or ulcerative colitis criteria: The individual is at least 18 years old, has moderately to severely active Crohn disease or ulcerative colitis, and has documented failure, contraindication, or intolerance to a trial of an immunomodulator, corticosteroid, or biologic therapy.>=18 years; at least one prior-treatment category
Initial Therapy for Immune-Related Toxicity
Initial intravenous therapy is covered when all lead-in conditions and one toxicity pathway are met:
Lead-in conditions and qualifying toxicity pathway
Lead-in conditions: Other etiologies of the autoimmune-like immune-checkpoint-inhibitor-related toxicity have been ruled out.
Continuation and Maintenance Therapy
Maintenance Therapy
After the initial intravenous infusion:
Maintenance formulation: Maintenance treatment is administered by subcutaneous formulation.
This policy addresses intravenous administration; subsequent maintenance dosing is subcutaneous.
Step Therapy Requirements
Step
Covered indication
Required prior treatment
1
Adult moderately to severely active Crohn disease or ulcerative colitis
Documented failure, contraindication, or intolerance to a trial of at least one of the following: an immunomodulator (for example, azathioprine, 6-mercaptopurine, or methotrexate); a corticosteroid (for example, budesonide, prednisone, hydrocortisone, or methylprednisolone); or biologic therapy (for example, certolizumab, adalimumab, infliximab, or vedolizumab).
Step
Covered toxicity
Required prior treatment failure
1
Immune-checkpoint-inhibitor-related diarrhea or colitis
Refractory to infliximab and/or vedolizumab. For Grade 1 disease, symptoms must be persistent or progressive and lactoferrin/calprotectin must be positive; Grade 2–4 disease must be refractory to infliximab and/or vedolizumab.
Quantity and Dose Limits
Ustekinumab: weight-based intravenous dose limits
Weight up to 55 kg260 mg for the initial intravenous infusion
Weight over 55 kg to 85 kg390 mg for the initial intravenous infusion
Weight over 85 kg520 mg for the initial intravenous infusion
Site of Care
Billing Rule
Use the appropriate infusion site of care
When services can be administered in various settings, reimbursement may be limited to services furnished in the most appropriate and cost-effective setting appropriate to the member’s medical needs and condition.
Consider the member’s current medical condition, required monitoring, and additional services associated with infusion delivery.
Biosimilar Coding
Billing Rule
Report Otulfi with Q9999
Use HCPCS Q9999 to represent ustekinumab-aauz (Otulfi), biosimilar, 1 mg, when reporting the product.
K50.90 — Crohn's disease, unspecified, without complications; K50.911 — Crohn's disease, unspecified, with rectal bleeding; K50.912 — Crohn's disease, unspecified, with intestinal obstruction; K50.913 — Crohn's disease, unspecified, with fistula; K50.914 — Crohn's disease, unspecified, with abscess; K50.918 — Crohn's disease, unspecified, with other complication; K50.919 — Crohn's disease, unspecified, with unspecified complications.
K51.00 — Ulcerative (chronic) pancolitis without complications; K51.011 — Ulcerative (chronic) pancolitis with rectal bleeding; K51.012 — Ulcerative (chronic) pancolitis with intestinal obstruction; K51.013 — Ulcerative (chronic) pancolitis with fistula; K51.014 — Ulcerative (chronic) pancolitis with abscess; K51.018 — Ulcerative (chronic) pancolitis with other complication; K51.019 — Ulcerative (chronic) pancolitis with unspecified complications.
K51.20 — Ulcerative (chronic) proctitis without complications; K51.211 — Ulcerative (chronic) proctitis with rectal bleeding; K51.212 — Ulcerative (chronic) proctitis with intestinal obstruction; K51.213 — Ulcerative (chronic) proctitis with fistula; K51.214 — Ulcerative (chronic) proctitis with abscess; K51.218 — Ulcerative (chronic) proctitis with other complication; K51.219 — Ulcerative (chronic) proctitis with unspecified complications.
K51.30 — Ulcerative (chronic) rectosigmoiditis without complications; K51.311 — Ulcerative (chronic) rectosigmoiditis with rectal bleeding; K51.312 — Ulcerative (chronic) rectosigmoiditis with intestinal obstruction; K51.313 — Ulcerative (chronic) rectosigmoiditis with fistula; K51.314 — Ulcerative (chronic) rectosigmoiditis with abscess; K51.318 — Ulcerative (chronic) rectosigmoiditis with other complication; K51.319 — Ulcerative (chronic) rectosigmoiditis with unspecified complications.
K51.40 — Inflammatory polyps of colon without complications; K51.411 — Inflammatory polyps of colon with rectal bleeding; K51.412 — Inflammatory polyps of colon with intestinal obstruction; K51.413 — Inflammatory polyps of colon with fistula; K51.414 — Inflammatory polyps of colon with abscess; K51.418 — Inflammatory polyps of colon with other complication; K51.419 — Inflammatory polyps of colon with unspecified complications.
K51.50 — Left sided colitis without complications; K51.511 — Left sided colitis with rectal bleeding; K51.512 — Left sided colitis with intestinal obstruction; K51.513 — Left sided colitis with fistula; K51.514 — Left sided colitis with abscess; K51.518 — Left sided colitis with other complication; K51.519 — Left sided colitis with unspecified complications.
K51.80 — Other ulcerative colitis without complications; K51.811 — Other ulcerative colitis with rectal bleeding; K51.812 — Other ulcerative colitis with intestinal obstruction; K51.813 — Other ulcerative colitis with fistula; K51.814 — Other ulcerative colitis with abscess; K51.818 — Other ulcerative colitis with other complication; K51.819 — Other ulcerative colitis with unspecified complications.
K51.90 — Ulcerative colitis, unspecified, without complications; K51.911 — Ulcerative colitis, unspecified with rectal bleeding; K51.912 — Ulcerative colitis, unspecified with intestinal obstruction; K51.913 — Ulcerative colitis, unspecified with fistula; K51.914 — Ulcerative colitis, unspecified with abscess; K51.918 — Ulcerative colitis, unspecified with other complication; K51.919 — Ulcerative colitis, unspecified with unspecified complications.
K52.1 — Toxic gastroenteritis and colitis.
CDAI baseline range
220 to 450
PopulationAdults with moderately to severely active Crohn disease
Assessment contextBaseline disease activity in the adult Crohn disease approval studies
Crohn disease clinical response
Primary response definitionReduction in CDAI score of at least 100 points
Alternative response definitionCDAI score below 150
Evaluation timingClinical response was evaluated at Week 6 in the adult induction studies
Crohn disease clinical remission
Remission thresholdCDAI score below 150
Induction-study assessmentClinical remission was evaluated at Week 8
Maintenance-study contextThe maintenance study evaluated individuals who achieved clinical response after induction
Ulcerative colitis clinical remission
Total Mayo score2 or less
Component subscoresNo component subscore greater than 1
Mayo scaleTotal score range 0 to 12; component subscores range 0 to 3
K50.00 — Crohn's disease of small intestine without complications
K50.011 — Crohn's disease of small intestine with rectal bleeding
K50.012 — Crohn's disease of small intestine with intestinal obstruction
K50.013 — Crohn's disease of small intestine with fistula
K50.014 — Crohn's disease of small intestine with abscess
K50.018 — Crohn's disease of small intestine with other complication
K50.019 — Crohn's disease of small intestine with unspecified complications
K50.10 — Crohn's disease of large intestine without complications
K50.111 — Crohn's disease of large intestine with rectal bleeding
K50.112 — Crohn's disease of large intestine with intestinal obstruction
K50.113 — Crohn's disease of large intestine with fistula
K50.114 — Crohn's disease of large intestine with abscess
K50.118 — Crohn's disease of large intestine with other complication
K50.119 — Crohn's disease of large intestine with unspecified complications
K50.80 — Crohn's disease of both small and large intestine without complications
K50.811 — Crohn's disease of both small and large intestine with rectal bleeding
K50.812 — Crohn's disease of both small and large intestine with intestinal obstruction
K50.813 — Crohn's disease of both small and large intestine with fistula
K50.814 — Crohn's disease of both small and large intestine with abscess
K50.818 — Crohn's disease of both small and large intestine with other complication
K50.819 — Crohn's disease of both small and large intestine with unspecified complications
K50.90 — Crohn's disease, unspecified, without complications
K50.911 — Crohn's disease, unspecified, with rectal bleeding
K50.912 — Crohn's disease, unspecified
Step Therapy
Required Prior Therapy
For moderately to severely active Crohn disease or ulcerative colitis, document that the individual is at least 18 years old and has failed, is contraindicated for, or is intolerant to a trial of at least one required prior-therapy category.
Immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate
Corticosteroids, such as budesonide, prednisone, hydrocortisone, or methylprednisolone
Biologic therapy, such as certolizumab, adalimumab, infliximab, or vedolizumab
Step Therapy
Document Refractory Toxicity Therapy
For immune-checkpoint inhibitor-related diarrhea or colitis, document that the condition is refractory to infliximab and/or vedolizumab before requesting ustekinumab for intravenous use.
Persistent or progressive mild (Grade 1) diarrhea or colitis must also have positive lactoferrin/calprotectin.
Moderate (Grade 2) or severe (Grade 3-4) diarrhea or colitis must be infliximab- and/or vedolizumab-refractory.
Documentation Required
Medical Necessity Records
Ensure the medical record reflects the medical necessity for the care provided and identify records supporting the request. Documentation must be available to the Company upon request.
Professional provider office records
Hospital, nursing home, or home health agency records
Therapy records and test reports
Failure to produce requested information may result in denial for the drug.
Documentation Required
Prior-Treatment History
Document the individual's age and complete prior-treatment history for the requested indication. The record must show relevant treatment failure, contraindication, or intolerance, including the therapy category and clinical rationale supporting the request.
For Crohn disease or ulcerative colitis, verify the individual is at least 18 years of age.
Record the prior immunomodulator, corticosteroid, or biologic therapy trial and the documented failure, contraindication, or intolerance.
Documentation Required
Immune-Related Toxicity Evidence
For immune-checkpoint inhibitor-related diarrhea or colitis, document that other etiologies have been ruled out and establish the applicable toxicity severity and clinical criteria.
Mild (Grade 1): symptoms are persistent or progressive and lactoferrin/calprotectin is positive.
Moderate (Grade 2) or severe (Grade 3-4): document the applicable grade and infliximab- and/or vedolizumab-refractory status.
Documentation Required
Support Nonstandard Dose or Regimen Requests
Requests for an amount, dose, frequency, or regimen outside the stated Dosing and Frequency Requirements must include supporting published peer-reviewed literature. The prescribing professional provider must submit the literature to the Company.
The Company may modify dosing and frequency requirements based on FDA recommendations, recognized pharmacology compendia, or published peer-reviewed clinical research.
Use the Company's off-label coverage policy for prescription drugs and biologics for the list of recognized pharmacology compendia.
Denial Risk
Pediatric and Other Noncovered Uses
Do not submit pediatric treatment of Crohn disease, ulcerative colitis, or immune-checkpoint inhibitor-related toxicities as covered use under this policy. These uses are experimental/investigational and not covered.
All other uses are experimental/investigational and not covered unless supported as an accepted off-label use under the Company's policy on off-label coverage for prescription drugs and biologics.
The pediatric exclusions apply because safety and/or effectiveness cannot be established from the available published peer-reviewed literature.
Denial Risk
Criteria or Dosing Not Met
Coverage may be denied when medical-necessity or dosing requirements are not met. Verify the applicable indication, age, prior-therapy requirement, toxicity criteria, and stated dose and frequency before submitting the request.
Crohn disease or ulcerative colitis requests must meet all applicable medical-necessity criteria and Dosing and Frequency Requirements.
Immune-checkpoint inhibitor-related toxicity requests must meet the applicable ruled-out-etiology, severity, and refractory-therapy criteria.
Requests outside the stated dosing requirements require supporting published peer-reviewed literature.
Denial Risk
Missing Documentation
Provide all requested medical records and supporting documentation to the Company. Failure to produce requested information, including documentation needed for an out-of-requirements dosing request, may result in denial for the drug.
Records may include professional provider, hospital, nursing home, home health, therapy, and test reports.
The Company may review and audit services regardless of the provider's participation status.
Published peer-reviewed literature is required for coverage requests outside the Dosing and Frequency Requirements.
Diarrhea or colitis related to immune-checkpoint-inhibitor treatment
Clinical qualificationOther etiologies must be ruled out before applying the toxicity criteria
Abbreviated Paediatric Crohn's Disease Activity Index (aPCDAI)
History itemsAbdominal pain; number and consistency of stools; patient functioning
Physical examination itemsWeight change; abdominal mass or tenderness; perirectal disease
Scoring range0 to 70
Suggested cutoffsLess than 10: remission; 10–15: mild disease; 16–25: moderate disease; greater than 25: severe disease
Partial Mayo Score (PMS)
Stool frequencyOne of the three noninvasive components
Rectal bleedingOne of the three noninvasive components
Physician's Global AssessmentOne of the three noninvasive components
ScoringEach component is scored from 0 to 3; maximum total score is 9
Harvey-Bradshaw Index (HBI)
General well-being and abdominal painTwo HBI variables recorded on one occasion
Stool frequencyNumber of liquid stools daily
Additional findingsAbdominal mass and extraintestinal complications
Clinical interpretationRemission: less than 5; mild disease: 5–7; moderate disease: 8–16; severe disease: greater than 16
Clinical response and remission in Crohn disease
Clinical responseReduction in CDAI score of at least 100 points or CDAI score below 150
Clinical remissionCDAI score below 150
Study populationAdults with moderately to severely active Crohn disease in the approval studies
Clinical remission in ulcerative colitis
Remission thresholdTotal Mayo score of 2 or less
Component requirementNo component subscore greater than 1 on any of the four Mayo scale components
Study assessment pointsClinical remission was assessed at Week 8 and Week 44
ONE of the following toxicity pathways
Refractory Grade 1 diarrhea or colitis: Infliximab- and/or vedolizumab-refractory mild (Grade 1) diarrhea or colitis with persistent or progressive symptoms and positive lactoferrin or calprotectin.Grade 1; positive lactoferrin or calprotectin
Refractory Grade 2–4 diarrhea or colitis: Infliximab- and/or vedolizumab-refractory moderate (Grade 2) or severe (Grade 3–4) diarrhea or colitis.Grade 2, 3, or 4