Renflexis (infliximab-abda) — HCPCS Q5104

Biosimilar vs. interchangeable — why it matters for Renflexis FDA / Purple Book verified Jul 2026

Renflexis is FDA-licensed as biosimilar to Remicade. It does not carry the interchangeable designation — a distinction that governs pharmacy-level substitution rights, not billing units.

Under the Biologics Price Competition and Innovation Act (BPCIA), the FDA grants two distinct tiers of biosimilar approval. A biosimilar license means the product has been shown to be highly similar to the reference product with no clinically meaningful differences in safety, purity, or potency — Renflexis cleared that bar on April 21, 2017 (BLA 761054). An interchangeable designation is a higher bar: it requires additional switching-study data showing that alternating or switching between the biosimilar and reference product produces no greater risk than staying on the reference product alone. An interchangeable biosimilar can be substituted for the reference product at the pharmacy level without contacting the prescriber, subject to state pharmacy law.

Renflexis has never received the interchangeable designation, and as of this review no infliximab biosimilar has — not Inflectra (Q5103), not Renflexis (Q5104), not Avsola (Q5121). For a buy-and-bill IV infusion drug this distinction is less operationally dramatic than it is for a retail pharmacy product (there is no pharmacist swapping vials on a prescriber's Remicade order without their knowledge), but it still matters: the ordering physician has to specifically prescribe Renflexis, and payer policy — not an automatic substitution right — is what actually drives which infliximab product a given patient receives.

Infliximab product map CMS HCPCS + FDA verified Jul 2026

Renflexis is one of four infliximab products currently commercially available in the US. All share the same 10 mg unit basis; only Renflexis, Inflectra, and Avsola are biosimilars (none interchangeable).

Dosing per indication FDA label + Organon billing PDFs verified Jul 2026

All indications: weight-based mg/kg dosing. Standard induction is 0, 2, and 6 weeks, then maintenance per indication — identical schedule to reference Remicade.

Premedications

Premedication varies by protocol and prior-reaction history. Common regimens include diphenhydramine, acetaminophen, and hydrocortisone for selected higher-risk patients. Premed administration is billed as separate admin codes (96372 IM/SC, or 96374 IV push) with the appropriate J-code for each agent.

NDC reference DailyMed / FDA NDC Directory verified Jul 2026

Pad to 11 digits with a leading zero in the labeler segment for CMS-1500 Box 24A. Verify the exact NDC on the vial before billing — a wrong NDC is a clean claim-accuracy error.

Administration codes CPT verified Jul 2026

Infliximab-abda is a non-cytotoxic biologic — therapeutic IV infusion codes (96365 + 96366), NOT chemotherapy admin codes (96413/96415).

Modifiers — JZ, JW, and TB (340B) CMS verified Jul 2026

JW applies to most Renflexis infusions because dosing is weight-based and 100 mg vials rarely match the calculated dose exactly. 340B claims use TB only — JG was retired January 1, 2025.

JZ — required when no drug discarded

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. For Renflexis, JZ applies when the calculated mg dose is an exact multiple of 100 mg (the vial size) — e.g., an 80 kg AS patient at 5 mg/kg = 400 mg = exactly 4 vials, no waste.

JW — required for documented waste of unused single-dose-vial drug

For most weight-and-dose combinations, the calculated mg dose is not an exact multiple of 100 mg, so partial-vial waste is the rule. Bill the administered units (no wastage modifier) on one line and the discarded units on a separate JW line, same date of service, same HCPCS code, with waste documented in the medical record.

Apply each MAC's rounding convention. Some MACs require billing the total drawn from the vial as administered units and reporting waste only above a threshold — refer to your local MAC billing article for the exact rule.

TB — the only current 340B modifier (JG retired Jan 1, 2025)

Effective January 1, 2025, CMS discontinued the JG modifier for all 340B-covered entities. Every 340B-covered entity — hospital-based or non-hospital-based, rural or not — now reports the TB modifier on claim lines for Renflexis acquired through the 340B Drug Pricing Program, so CMS can exclude those units from the Part B inflation-rebate calculation established by the Inflation Reduction Act. Do not use JG on any 2026 claim; pages or references still describing a JG/TB split by facility type are describing the pre-2025 rule.

Modifier 25 — same-day E/M

Append modifier 25 to the same-day E/M code if a significant, separately identifiable evaluation occurred (clinical reassessment for next-cycle decision, treatment-decision encounter, etc.). Routine pre-infusion check-in is bundled.

ICD-10-CM diagnosis codes FY2026 verified Jul 2026

Use the most specific code supported by chart documentation. Each indication has a distinct code family — identical to reference Remicade's indication panel.

Site of care & place of service Verified Jul 2026

First dose typically office, AIC, or hospital outpatient depending on payer site-of-care UM and reaction-risk profile. Subsequent doses often move to the lowest-cost site the plan allows.

Claim form field mapping Organon Coding & Billing reference

CMS-1500 / 837P (physician office, AIC; POS 11/49) example for a 5 mg/kg Crohn's dose of Q5104, 75 kg patient.

Source: Organon Renflexis Coding and Billing Guide (organonaccessprogram-renflexis.com); pattern verified against the analogous Amgen Avsola and Novartis Leqvio billing-and-coding guides.

Payer policy snapshot — biosimilar mandates 2026 Reviewed Jul 2026

National payers have moved decisively toward biosimilar-mandatory or strongly preferred infliximab policy. Renflexis is on the preferred list at every major payer surveyed.

What to document for a Remicade override (if reference product is desired instead)

• Documented intolerance, infusion-reaction, or inadequate response to Renflexis or another biosimilar (with objective measures: disease activity scores, endoscopy findings for IBD, imaging for inflammatory arthritis)
• Number of doses or duration of the biosimilar trial (most policies: at least one full induction cycle 0/2/6 plus one maintenance dose)
• Any clinical contraindication to the biosimilar pathway (rare; biosimilars share the same molecular structure as the reference product)

Medicare reimbursement CMS Q3 2026 (live)

Quarterly ASP from the CMS Part B Drug Pricing File.

Coverage

No NCD specific to infliximab as a class. Each MAC publishes a billing & coding article covering infliximab and its biosimilars with covered ICD-10 ranges per indication. Bill with the indication-specific ICD-10 (see ICD-10 by indication).

Canonical code source: CMS HCPCS quarterly update file.

Patient assistance — the Organon Access Program Organon flashcard verified Jul 2026

The Organon Access Program is the manufacturer support hub for Renflexis. Call 866-847-3539 (Monday–Friday, 8 AM–8 PM ET) or visit organonaccessprogram-renflexis.com to enroll. A dedicated representative can research a patient's insurance benefits, estimate out-of-pocket cost, help with billing codes and prior-authorization or appeal letters, and refer eligible patients to the Organon Patient Assistance Program (operated through Organon Patient Assistance Program Inc.) for free drug to qualifying uninsured or underinsured patients.

For eligible commercially insured patients, published third-party pricing summaries report a copay-card benefit as low as $5 per infusion with an annual program maximum around $20,000 — verify the current terms and conditions directly at the Organon Access Program site before quoting a figure to a patient, since manufacturer copay-card terms change without notice and are not valid for patients with government insurance (Medicare, Medicaid, TRICARE).

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Renflexis?

Renflexis (infliximab-abda) is billed under HCPCS Q5104 — "Injection, infliximab-abda, biosimilar, (Renflexis), 10 mg." Like reference Remicade (J1745) and the other infliximab biosimilars (Inflectra Q5103, Avsola Q5121), Q5104 uses a 10 mg unit basis. A 350 mg dose (5 mg/kg, 70 kg patient) is billed as 35 units.

Is Renflexis interchangeable with Remicade?

No. Renflexis is FDA-licensed as biosimilar to Remicade but does not carry the interchangeable designation — no infliximab biosimilar currently does. A prescriber must specifically order Renflexis; a pharmacy cannot automatically substitute it the way an interchangeable biosimilar could be substituted at a retail pharmacy.

How many units do I bill for a Renflexis dose?

Q5104 is billed at 1 unit = 10 mg. Convert mg to units by dividing by 10. Examples: a 70 kg RA patient at 3 mg/kg = 210 mg = 21 units; a 75 kg Crohn's patient at 5 mg/kg = 375 mg = 38 units administered (4 vials drawn = 40 units total, 2 units discarded — administered + discarded must equal the 40 units drawn); an 80 kg ankylosing spondylitis patient at 5 mg/kg = 400 mg = 40 units (4 vials, no waste).

Is the Renflexis admin code chemo or non-chemo?

NON-CHEMO. Infliximab-abda is a non-cytotoxic biologic (anti-TNF monoclonal antibody) — bill 96365 (therapeutic IV infusion, initial hour) plus 96366 (each additional hour). Do NOT use 96413 / 96415.

What is the 340B modifier for Renflexis in 2026?

TB only. Effective January 1, 2025, CMS discontinued the JG modifier for all 340B-covered entities and requires the TB modifier on every claim line for a drug acquired through the 340B Drug Pricing Program. Append TB to the Q5104 line for 340B-acquired drug; JG is retired.

What is the Q3 2026 Medicare reimbursement for Q5104?

Q3 2026 ASP + 6% for Q5104 Renflexis is approximately $26.615 per 10 mg unit — roughly 14% below reference Remicade (~$31.041/unit) in the same quarter. A 350 mg dose (5 mg/kg, 70 kg patient) is 35 units, which prices to roughly $938 before sequestration. ASP refreshes quarterly — see the live snapshot above.

Does Renflexis need prior authorization?

Yes for most payers, but in 2026 several national payers — notably UnitedHealthcare commercial — treat infliximab biosimilars including Renflexis as the preferred product, denying reference Remicade unless the prescriber documents medical necessity for the originator. Confirm each plan's current biosimilar policy before scheduling.

What FDA boxed warnings apply to Renflexis?

Renflexis carries the same boxed warnings as reference Remicade: (1) serious infections — TB reactivation (latent TB screening required pre-therapy with PPD or IGRA), invasive fungal infections, bacterial sepsis, opportunistic pathogens; (2) malignancies — lymphoma and other malignancies, including hepatosplenic T-cell lymphoma (HSTCL, mostly fatal) in adolescent and young adult patients receiving infliximab plus thiopurines (azathioprine, 6-MP) for IBD.

Source documents

1. DailyMed — RENFLEXIS (infliximab) prescribing information
   NDC 78206-162-01/-99; boxed warning; dosing per indication; biosimilar (not interchangeable) status
2. FDA — Renflexis original approval letter, BLA 761054 (April 21, 2017)
   Original biosimilar licensure; approval history
3. FDA Purple Book — Database of Licensed Biological Products
   Authoritative registry of biosimilar and interchangeable designations
4. AAPC — HCPCS Q5104 (Renflexis / infliximab-abda)
   Code descriptor and crosswalk reference
5. Organon — Renflexis full prescribing information
   Current label; indications; dosing; boxed warning
6. The Organon Access Program — HCP resources
   Coding & billing guide; Organon Patient Assistance Program; copay assistance (866-847-3539)
7. CMS — Medicare Part B inflation rebate guidance: use of the 340B modifier
   JG modifier discontinued for all 340B-covered entities effective January 1, 2025; TB is the sole 340B modifier
8. CMS — JW / JZ modifier FAQs
   Single-dose-container waste reporting (JZ effective 7/1/2023)
9. CMS — Medicare Part B Drug ASP Pricing File
   Q3 2026 quarterly file (Q5104)
10. UnitedHealthcare — Commercial Medical Drug policy database (infliximab)
    2026 biosimilar-preferred designation; medical-necessity criteria for Remicade override
11. CareCost Estimate — Remicade family reference (J1745/Q5103/Q5104/Q5121/Q5109)
    Full five-product infliximab comparison, worked JW math, Zymfentra distinction

About this page

Medicare ASP pricing for Q5104 is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever the manufacturer guide, FDA label, or a major payer policy changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

Reviewer

Change log

• Jul 25, 2026 — Initial publication. Renflexis-specific (Q5104) billing reference split out from the Remicade family page: biosimilar-not-interchangeable framing, DailyMed-verified NDC (78206-162-01), non-chemo admin codes (96365/96366), JZ/JW/TB modifier guidance (JG retired 1/1/2025 per CMS MLN4800856), weight-based dosing math, ICD-10 by indication, 2026 payer biosimilar-preferred policy snapshot, and the Organon Access Program.

Methodology

Every claim on this page is sourced inline. NDC and dosing are taken from the current DailyMed structured product label; the ASP figure is read live from the CMS Part B ASP file; the 340B modifier rule is taken directly from the CMS Part B inflation-rebate guidance document; and payer rules are read from each plan's published medical policy. We do not paraphrase from billing-software vendor blogs, and we flag anything not yet SME-verified rather than assert it.