Viva Health infliximab IV Coverage Update

Coverage and Medical Necessity Criteria

Initial / Universal Criteria

Covered when ALL of the following are met

Universal requirements: Patient must have a contraindication, intolerance, or failure to Avsola and Inflectra prior to consideration of another infliximab product; AND Patient has been evaluated and screened for hepatitis B infection (HBsAg and anti-HBc) prior to initiating treatment; AND Patient is up to date with vaccinations per current guidelines prior to initiating therapy; AND Patient is at least 18 years of age (unless otherwise specified); AND Patient has been evaluated and screened for latent tuberculosis prior to initiating treatment and will receive ongoing TB monitoring during treatment; AND Patient does not have an active infection (including clinically important localized infections); AND Therapy must not be administered concurrently with live vaccines or therapeutic infectious agents (e.g., BCG bladder instillation); AND Patient is not on concurrent biologic or targeted synthetic therapy; AND Therapy will not be used in patients with moderate or severe heart failure (NYHA Class III/IV) when doses >5 mg/kg are used.

Crohn's Disease

Covered when ALL of the following are met

Crohn's Disease (adult): Physician has assessed baseline disease severity using an objective measure/tool; AND Documented moderate to severe disease; AND one of the following: documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR evidence of high‑risk disease for which corticosteroids or immunomodulators are inadequate and biologic therapy is necessary; OR patient is already established on biologic or targeted synthetic therapy for treatment of Crohn's disease.3 months

Pediatric Crohn's Disease

Covered when ALL of the following are met

Pediatric Crohn's Disease: Physician has assessed baseline disease severity using an objective measure/tool; AND Patient is at least 6 years of age; AND Documented moderate to severe active disease; AND one of the following: documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of corticosteroids or immunomodulators (e.g., azathioprine, etc.); OR evidence of high‑risk disease for which corticosteroids or immunomodulators are inadequate and biologic therapy is necessary; OR patient is already established on biologic or targeted synthetic therapy for treatment of Crohn's disease.6 years, 3 months

Ulcerative Colitis

Covered when ALL of the following are met

Ulcerative Colitis (adult): Physician has assessed baseline disease severity using an objective measure/tool; AND Documented moderate to severe active disease; AND one of the following: documented failure or ineffective response to a minimum 3-month trial of conventional therapy (aminosalicylates, corticosteroids, or immunomodulators such as azathioprine, 6‑mercaptopurine, or methotrexate) at maximum tolerated doses unless contraindicated or intolerant; OR patient is already established on biologic or targeted synthetic therapy for treatment of ulcerative colitis.3 months

Pediatric Ulcerative Colitis

Covered when ALL of the following are met

Pediatric Ulcerative Colitis: Physician has assessed baseline disease severity using an objective measure/tool; AND Patient is at least 6 years of age; AND Documented moderate to severe active disease; AND one of the following: documented failure or ineffective response to a minimum 3-month trial of conventional therapy (aminosalicylates, corticosteroids, or immunomodulators such as azathioprine, 6‑mercaptopurine, or methotrexate) at maximum tolerated doses unless contraindicated or intolerant; OR patient is already established on biologic or targeted synthetic therapy for treatment of ulcerative colitis.6 years, 3 months

Fistulizing Crohn's Disease

Covered when ALL of the following are met

Fistulizing Crohn's Disease: Physician has assessed baseline disease severity using an objective measure/tool; AND Patient has at least one draining fistula (enterovesical, enterocutaneous, enteroenteric, or enterovaginal).

Rheumatoid Arthritis

Covered when ALL of the following are met

Rheumatoid Arthritis: Physician has assessed baseline disease severity using an objective measure/tool; AND Documented moderate to severe active disease; AND one of the following: at least a 3‑month trial and failure of one conventional synthetic DMARD (e.g., methotrexate, azathioprine, sulfasalazine, leflunomide, hydroxychloroquine, etc.); OR patient is already established on biologic or targeted synthetic therapy for treatment of RA; AND infliximab is used in combination with methotrexate unless contraindicated or intolerant.3 months

Psoriatic Arthritis

Covered when ALL of the following are met

Psoriatic Arthritis: Physician has assessed baseline disease severity using an objective measure/tool; AND Documented moderate to severe active disease; AND depending on phenotype: for predominantly axial disease or enthesitis, failure of at least a 4‑week trial of one NSAID unless contraindicated; OR for peripheral arthritis or dactylitis, failure of at least a 3‑month trial of one csDMARD (e.g., methotrexate, azathioprine, sulfasalazine, hydroxychloroquine, etc.); OR patient is already established on biologic or targeted synthetic therapy for treatment of PsA.4 weeks or 3 months

Ankylosing Spondylitis

Covered when ALL of the following are met

Ankylosing Spondylitis: Physician has assessed baseline disease severity using an objective measure/tool; AND Documented active disease; AND one of the following: adequate trial and failure of at least two NSAIDs over a total of 4 weeks unless contraindicated; OR patient is already established on biologic or targeted synthetic therapy for treatment of ankylosing spondylitis.2 NSAIDs over 4 weeks

Plaque Psoriasis

Covered when ALL of the following are met

Plaque Psoriasis: Physician has assessed baseline disease severity using an objective measure/tool; AND Documented moderate to severe chronic disease for at least 6 months with at least one of: ≥3% body surface area involvement; OR PASI ≥10; OR incapacitating location or intractable pruritus; AND patient meets all of the following unless already established on biologic/targeted therapy or >10% BSA: did not respond adequately (or is not a candidate) to a minimum 4‑week trial of topical agents; AND did not respond adequately (or is not a candidate) to a minimum 3‑month trial of at least one non‑biologic systemic agent (e.g., methotrexate); AND did not respond adequately (or is not a candidate) to a minimum 3‑month trial of phototherapy (PUVA or UVB).6 months, 4 weeks, 3 months

Uveitis Associated with Behçet's Syndrome

Covered when ALL of the following are met

Uveitis Associated with Behçet's Syndrome: Physician has assessed baseline disease severity using an objective measure/tool; AND Patient's disease is refractory to immunosuppressive therapy (e.g., corticosteroids, cyclosporine, azathioprine); AND patient had an inadequate response to a self‑administered biologic therapy (e.g., adalimumab).

Hidradenitis Suppurativa

Covered when ALL of the following are met

Hidradenitis Suppurativa: Physician has assessed baseline disease severity using an objective measure/tool; AND Patient has moderate to severe disease; AND one of the following: documented failure, contraindication, or intolerance to a minimum 3‑month trial of conventional therapies (e.g., antibiotics, retinoids, hormonal therapies); OR patient is already established on another biologic or targeted synthetic therapy for treatment of hidradenitis suppurativa.3 months

Acute GVHD

Covered when ALL of the following are met

Acute Graft Versus Host Disease (aGVHD): Patient has received an allogeneic hematopoietic stem cell transplant; AND Therapy is used for steroid‑refractory acute GVHD; AND Therapy is used in combination with systemic corticosteroids as additional therapy following no response to first‑line therapies.

Requests for continued therapy beyond four doses will be reviewed case‑by‑case; some aGVHD requests may not be renewed.

Immune Checkpoint Inhibitor-Related Toxicities

Covered when ALL of the following are met

Immune Checkpoint Inhibitor‑Related Toxicities: Patient is receiving an immune checkpoint inhibitor and has one of the specified severe or refractory toxicities (e.g., myocarditis not improving within 24‑48 hours of high‑dose methylprednisolone; specified GI, pulmonary, renal, hematologic, ocular, or musculoskeletal toxicities meeting listed failure/time criteria); AND dosing is induction only (no maintenance per policy).varies by toxicity

Therapy for these toxicities may not be renewed; examples and specific thresholds listed in the policy.

Renewal

Coverage can be renewed based upon the following criteria:

Renewal requirements: Patient continues to meet the universal and indication‑specific relevant criteria identified in Section III; AND Duration of authorization has not been exceeded; AND Absence of unacceptable toxicity from the drug (examples include severe hypersensitivity, malignancy, significant hematologic abnormalities, serious infections including TB or HBV reactivation, cardiovascular/cerebrovascular events, heart failure, neurotoxicity/demyelinating disorders, hepatotoxicity, lupus‑like syndrome, etc.).

Dose Escalation

Dose escalation allowed upon clinical review if ALL of the following are met:

Dose escalation conditions: Patient has shown an initial response to therapy; AND Received the three loading doses at the dose and interval specified in the dosing section; AND Received a minimum of one maintenance dose at the dose and interval specified; AND Responded to therapy by treatment week 16 with subsequent loss of response; AND Dose escalation does not exceed specified maximum dose or decreased interval limits (dose increase by no more than 2.5 mg/kg OR interval decrease by no more than 2 weeks and must not exceed indication‑specific maximums, e.g., up to 10 mg/kg every 4–8 weeks as specified).Dose increase ≤2.5 mg/kg OR interval decrease ≤2 weeks; do not exceed indication‑specific maximums

Assess neutralizing infliximab antibodies and consider adding a DMARD prior to escalation; patients with NYHA III/IV or LVEF ≤35% should not receive doses >5 mg/kg.

Disease-specific Response Criteria

Disease response for continuation/renewal is defined per indication by improvement in signs, symptoms, objective measures, or validated scoring tools:

Crohn's Disease: Improvement in signs/symptoms, endoscopic activity, stool frequency/consistency, abdominal pain, weight regain, hematocrit, extra‑intestinal complications, steroid tapering/discontinuation, reduced anti‑diarrheal use, biomarker improvement (fecal calprotectin or CRP), and/or improved Harvey‑Bradshaw Index.

Pediatric Crohn's Disease: Same disease response metrics as adult Crohn's disease (including fecal calprotectin or CRP and Harvey‑Bradshaw Index improvements).

Ulcerative Colitis: Improvement in stool frequency, rectal bleeding, endoscopic activity, steroid tapering/discontinuation, normalization of CRP or fecal calprotectin, and/or improved disease activity scoring tool.

Pediatric Ulcerative Colitis: Same response metrics as adult ulcerative colitis.

Covered Diagnoses (Appendix 1)

Covered diagnoses (Appendix 1) — entries listed are acceptable ICD-10 primary or secondary diagnoses for coverage where relevant clinical criteria are met elsewhere in the policy.

Appendix inclusion: The diagnosis code submitted on the claim or prior authorization must match one of the ICD‑10 codes listed in Appendix 1 of this document; inclusion in Appendix 1 is required for coverage consideration under the clinical criteria in this policy.

This appendix is a code list only; separate medical necessity criteria elsewhere in the policy determine clinical coverage eligibility.

Covered Diagnoses

Covered when ANY of the following diagnosis codes are present

Listed ICD-10 codes: Presence of any ICD‑10 code enumerated in Appendix 1 on the claim or prior authorization request constitutes an acceptable covered diagnosis for therapies referenced by this policy, provided the patient meets the applicable medical necessity criteria elsewhere in the policy.

All listed codes in Appendix 1 are accepted as covered diagnoses for the therapies referenced in this policy.

Infliximab must not be administered concurrently with live vaccines or therapeutic infectious agents (for example, BCG bladder instillation). This is part of the Universal Criteria that must be met prior to initiating therapy and during treatment monitoring for latent infections and active infection status.

Examples of contraindications to phototherapy (PUVA or UVB) are listed for relevant indications and include: xeroderma pigmentosum; other rare photosensitive genodermatoses (e.g., trichothiodystrophy, Cockayne syndrome, Bloom syndrome, Rothmund–Thomson syndrome for UVB only); genetic disorders with increased skin‑cancer risk (e.g., Gorlin syndrome, oculocutaneous albinism for UVB only); pregnancy or lactation (PUVA only); Lupus erythematosus; history of photosensitivity diseases, melanoma or non‑melanoma skin cancer, or extensive solar damage (PUVA only); immunosuppression in organ transplant patients (UVB only); use of photosensitizing medications (PUVA only); severe liver, renal, or cardiac disease (PUVA only); and young age <12 years (PUVA only). Anatomical locations deemed ineligible for phototherapy (face, genital, scalp, nail) are also noted; patients without access to phototherapy may be reviewed case‑by‑case.

Within the provided excerpt there are no additional explicit exclusions beyond the specified universal safety and clinical criteria; any indication‑specific exclusions would be determined by the clinical criteria sections elsewhere in the policy.

The Appendix 1 code list defines covered ICD‑10 diagnosis codes for use with prior authorization and claims. Diagnoses that are not included in Appendix 1 are not supported by this appendix for coverage determination; clinical eligibility must still meet the policy’s medical necessity criteria.

Medicare Part B coverage rules may differ from the non‑Medicare coverage described here. Medicare NCDs, LCDs, and LCAs may apply and supersede non‑Medicare policy; providers must follow applicable Medicare guidance and consult the CMS coverage database for relevant determinations when submitting Part B claims.

The policy notes a specific heart‑failure safety consideration: infliximab will not be used in patients with moderate or severe heart failure (NYHA Class III/IV) when doses greater than 5 mg/kg are used.

Prior to dose escalation and in dosing decisions, patients with NYHA Functional Class III/IV heart failure or left ventricular ejection fraction ≤35% should not receive infliximab doses in excess of 5 mg/kg.

In the provided excerpt there are no explicit statements labeling services as 'not medically necessary'; determinations about medical necessity or non‑coverage are applied using the clinical criteria and exclusions elsewhere in the policy.

The excerpt does not explicitly list determinations of 'not medically necessary' for specific indications; such NMN determinations are made based on the full clinical criteria sections that govern each indication and are not included in this window.

Billing, Codes, and Dosing Limits

Covered ICD-10 codes (rheumatologic: rheumatoid disease variants)ICD-10Covered

M05.622	Rheumatoid arthritis of left elbow with involvement of other organs and systems
M05.629	Rheumatoid arthritis of unspecified elbow with involvement of other organs and systems
M05.631	Rheumatoid arthritis of right wrist with involvement of other organs and systems
M05.632	Rheumatoid arthritis of left wrist with involvement of other organs and systems
M05.639	Rheumatoid arthritis of unspecified wrist with involvement of other organs and systems
M05.641	Rheumatoid arthritis of right hand with involvement of other organs and systems
M05.642	Rheumatoid arthritis of left hand with involvement of other organs and systems
M05.649	Rheumatoid arthritis of unspecified hand with involvement of other organs and systems
M05.651	Rheumatoid arthritis of right hip with involvement of other organs and systems
M05.652	Rheumatoid arthritis of left hip with involvement of other organs and systems

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NDCs — 5 codes (covered)NDCCovered

57894-0030-xx	Remicade 100 mg single-dose vial for injection
57894-0160-xx	Infliximab 100 mg single-dose vial for injection (Unbranded biologic)
00069-0809-xx	Inflectra 100 mg single-dose vial
78206-0162-xx	Renflexis 100 mg single-dose vial
55513-0670-xx	Avsola 100 mg single-dose vial for injection

Infliximab NDCs — 5 codes (neutral)NDC

57894-0030-xx	Remicade 100 mg single-dose vial for injection
57894-0160-xx	Infliximab 100 mg single-dose vial for injection (Unbranded biologic)
00069-0809-xx	Inflectra 100 mg single-dose vial
78206-0162-xx	Renflexis 100 mg single-dose vial
55513-0670-xx	Avsola 100 mg single-dose vial for injection

Covered ICD-10 codes (hematology / graft-vs-host)ICD-10Covered

D59.0	Drug-induced autoimmune hemolytic anemia
D59.2	Drug-induced nonautoimmune hemolytic anemia
D89.810	Acute graft-versus host disease
D89.812	Acute on chronic graft-versus-host-disease
D89.813	Graft-versus-host disease unspecified

Covered ICD-10 codes (ophthalmology)ICD-10Covered

H30.891	Other chorioretinal inflammations, right eye
H30.892	Other chorioretinal inflammations, left eye
H30.893	Other chorioretinal inflammations, bilateral
H30.899	Other chorioretinal inflammations, unspecified eye
H30.90	Unspecified chorioretinal inflammation, unspecified eye
H30.91	Unspecified chorioretinal inflammation, right eye
H30.92	Unspecified chorioretinal inflammation, left eye
H30.93	Unspecified chorioretinal inflammation, bilateral
H44.111	Panuveitis, right eye
H44.112	Panuveitis, left eye

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Covered ICD-10 codes (cardiac inflammatory conditions)ICD-10Covered

I30.8	Other forms of acute pericarditis
I30.9	Acute pericarditis, unspecified
I40.8	Other acute myocarditis
I40.9	Acute myocarditis, unspecified

Covered ICD-10 codes (pulmonary / GI inflammatory)ICD-10Covered

J70.2	Acute drug-induced interstitial lung disorders
J70.4	Drug-induced interstitial lung disorders, unspecified
K20.80	Other esophagitis without bleeding
K20.81	Other esophagitis with bleeding
K20.90	Esophagitis, unspecified without bleeding
K20.91	Esophagitis, unspecified with bleeding
K29.00	Acute gastritis without bleeding
K29.01	Acute gastritis with bleeding
K29.80	Duodenitis without bleeding
K29.81	Duodenitis with bleeding

Covered ICD-10 codes (IBD: Crohn's disease & ulcerative colitis)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

Covered ICD-10 codes (ulcerative colitis continued)ICD-10Covered

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

Covered ICD-10 codes (dermatology / hidradenitis / psoriasis)ICD-10Covered

K52.1	Toxic gastroenteritis and colitis
L73.2	Hidradenitis suppurativa
L40.0	Psoriasis vulgaris
L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis mutilans
L40.53	Psoriatic spondylitis
L40.59	Other psoriatic arthropathy

Covered ICD-10 Diagnosis Codes — 146 codes (covered)ICD-10Covered

M05.10	Rheumatoid lung disease with rheumatoid arthritis of unspecified site
M05.111	Rheumatoid lung disease with rheumatoid arthritis of right shoulder
M05.112	Rheumatoid lung disease with rheumatoid arthritis of left shoulder
M05.119	Rheumatoid lung disease with rheumatoid arthritis of unspecified shoulder
M05.121	Rheumatoid lung disease with rheumatoid arthritis of right elbow
M05.122	Rheumatoid lung disease with rheumatoid arthritis of left elbow
M05.129	Rheumatoid lung disease with rheumatoid arthritis of unspecified elbow
M05.131	Rheumatoid lung disease with rheumatoid arthritis of right wrist
M05.132	Rheumatoid lung disease with rheumatoid arthritis of left wrist
M05.139	Rheumatoid lung disease with rheumatoid arthritis of unspecified wrist

Max Units (per dose and over time) [HCPCS Unit]mixedCovered

Rheumatoid Arthritis	40 billing units at weeks 0, 2, 6, then 40 billing units every 56 days
Ankylosing Spondylitis	60 billing units at weeks 0, 2, 6, then 60 billing units every 42 days
Crohn's Disease & Ulcerative Colitis, Psoriatic Arthritis, Plaque Psoriasis, Behcet's Uveitis, Hidradenitis Suppurativa	60 billing units at weeks 0, 2, 6 then 60 billing units every 56 days
Management of Immune Checkpoint Inhibitor-Related Toxicities	60 billing units at weeks 0 & 2; no maintenance dosing
Acute GVHD	120 billing units at weeks 0, 1, 2, 3; no maintenance dosing

Plaque Psoriasis BSA / PASI thresholdsmixedCovered

Criteria

Involvement of ≥3% BSA or PASI ≥10 or incapacitating location; baseline objective assessment and prior trials of topical, systemic, and phototherapy unless exceptions apply

Maximum dosing limitsmixedCovered

Rheumatoid Arthritis	Loading: 3 mg/kg at weeks 0,2,6; Maintenance: 3 mg/kg every 8 weeks; Max: up to 10 mg/kg every 4 weeks
Ankylosing Spondylitis	Loading: 5 mg/kg at weeks 0,2,6; Maintenance: 5 mg/kg every 6 weeks; Max: 5 mg/kg every 6 weeks
Crohn's Disease & Ulcerative Colitis	Loading: 5 mg/kg at weeks 0,2,6; Maintenance: 5 mg/kg every 8 weeks; Max: up to 10 mg/kg every 8 weeks
Psoriatic Arthritis, Plaque Psoriasis, Behçet's Uveitis	Loading: 5 mg/kg at weeks 0,2,6; Maintenance: 5 mg/kg every 8 weeks; Max: 5 mg/kg every 8 weeks
Hidradenitis Suppurativa	Loading: 5 mg/kg at weeks 0,2,6; Maintenance: 5 mg/kg every 8 weeks; Max: up to 10 mg/kg every 4 weeks
Management of Immune Checkpoint Inhibitor-Related Toxicities	5 mg/kg at weeks 0 and 2; no maintenance
Acute GVHD	10 mg/kg at weeks 0,1,2,3; no maintenance

Medicare Part B applicability — Medicare NCD/LCD/LCA guidance may supersedemixed

Note	Medicare Part B NCDs/LCDs/LCAs may apply and supersede this policy for outpatient drugs; consult CMS coverage database and contractor guidance

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Summary

Prior authorization is required. Initial authorization length: 6 months (may be renewed annually unless otherwise specified). Certain indications have limited initial/repeat dosing (see dosing limits). Therapy for Management of Immune Checkpoint Inhibitor-Related Toxicities and Acute GVHD may not be renewed; requests for continued aGVHD therapy beyond four doses will be reviewed case-by-case.

Initial authorization: 6 months; renewals generally annual
Immune checkpoint inhibitor–related toxicities: no maintenance dosing; not routinely renewable
Acute GVHD: limited to induction (weekly dosing up to four doses); continuation reviewed individually

Documentation Required

Prior Authorization Requirements — Documentation

Providers must document that the patient meets indication-specific criteria and dosing rules. Include evidence of prior trials/ failures or contraindication to required biosimilars/originator when applicable; baseline screening and monitoring documentation (HBsAg and anti-HBc for HBV; latent TB screening) and vaccination status; objective measures of disease severity as noted per indication; and age eligibility.

Drug and Policy Background

Background: Infliximab is an intravenous anti–tumor necrosis factor (anti‑TNF) biologic available as the reference product (Remicade) and multiple biosimilars/unbranded infliximab products. It is used for multiple immune‑mediated inflammatory diseases, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, Behçet’s uveitis, steroid‑refractory acute graft‑versus‑host disease, and management of certain immune checkpoint inhibitor–related toxicities; screening for latent infections (HBV, TB) and vaccination status is required before initiation. The NDC list in the policy identifies Remicade and listed biosimilars/unbranded infliximab preparations used for administration.

Key Definitions and Dosing Terms

Moderate or severe heart failure definition (NYHA III/IV)

DefinitionNew York Heart Association (NYHA) Functional Class III/IV

Policy implicationInfliximab should not be used at doses >5 mg/kg in patients with moderate or severe heart failure (NYHA III/IV)

Related screeningAssess cardiac history and LVEF prior to dose escalation above 5 mg/kg

Loading and maintenance dosing — weight-based loading at weeks 0,2,6 and maintenance schedules

Typical loading scheduleWeight‑based loading doses at weeks 0, 2, and 6

Common maintenance intervalsMaintenance dosing at disease‑specific intervals (commonly every 6–8 weeks) per indication

OpenPayer

Infliximab (intravenous) coverage

Coverage and Medical Necessity Criteria

Billing, Codes, and Dosing Limits

Prior Authorization, Documentation, and Billing Guidance

Drug and Policy Background

Key Definitions and Dosing Terms