Humira (adalimumab) — HCPCS J0135 / J0139

AbbVie Inc. · 40 mg/0.4 mL high-concentration pen or 40 mg/0.8 mL syringe · Subcutaneous (self-injection) · Reference product (FDA-approved Dec 2002)

Humira is AbbVie's anti-TNFα monoclonal antibody covering ten autoimmune indications across rheumatology, gastroenterology, dermatology, and ophthalmology. Pharmacy benefit primary; medical-benefit billing rare. >95% of utilization is patient self-injection at home dispensed via specialty pharmacy — no medical claim is generated. The HCPCS codes J0135 ("Injection, adalimumab, 20 mg") and J0139 ("Injection, adalimumab, 1 mg") apply only when adalimumab is administered in a physician office. Six biosimilars carry permanent Q-codes (Q5140–Q5145); four are FDA-designated interchangeable. In 2026, branded Humira is non-preferred or excluded at most national PBMs.

ASP data:Q2 2026 (live binding; pharmacy-benefit dominant)
Payer policies:verified May 2026
Manufacturer guide:AbbVie 2025 Pro coding
FDA label:current revision
Page reviewed:

Instant Answer — the 5 things you need to bill adalimumab

HCPCS
J0135
20 mg = 1 unit (or J0139, 1 mg = 1 unit)
Dose
40 mg q2wk
Most adult indications (HS = weekly)
Modifier
JZ
Whole-syringe use; verify CMS list
Admin CPT
96372
SC injection (office) — not chemo
Benefit channel
Pharmacy
>95% pharmacy benefit; medical rare
HCPCS descriptor
J0135 — "Injection, adalimumab, 20 mg" Permanent · J0139 — "Injection, adalimumab, 1 mg" (alternate; Aetna policy uses J0139)
Dose (RA/PsA/AS)
40 mg SC every other week (q2wk) — indication-specific loading doses for Crohn's, UC, plaque psoriasis, HS
Form / strength
Prefilled pen or syringe; 40 mg/0.4 mL (citrate-free, high-concentration) or 40 mg/0.8 mL (citrate-containing)
Route
Subcutaneous (patient self-injection at home; office administration rare)
Benefit channel
Pharmacy benefit primary — specialty pharmacy dispensing; medical-benefit billing only for in-office administration (uncommon)
Biosimilars (Q-coded)
Six: Hulio (Q5140), Yuflyma (Q5141), Simlandi (Q5142), Cyltezo (Q5143), Idacio (Q5144), Abrilada (Q5145). Four interchangeable: Q5141, Q5142, Q5143, Q5145.
Biosimilars (no Q-code)
Amjevita, Hadlima, Hyrimoz, Yusimry — bill medically under unclassified J3490/J3590/C9399
2026 PBM status
Branded Humira non-preferred or excluded at most national PBMs (CVS Caremark, Express Scripts, OptumRx)
Boxed warnings
SERIOUS INFECTIONS (TB, fungal, opportunistic) and MALIGNANCY (lymphoma, including HSTCL in IBD adolescents/young adults)
FDA approval
December 31, 2002 (BLA 125057) — Humira reference product
ℹ️
Pharmacy benefit dominates — this page covers BOTH scenarios. >95% of Humira use runs through the pharmacy benefit (self-injected SC at home, dispensed by specialty pharmacy — no medical claim generated). The J-codes (J0135, J0139) and Q-codes (Q5140–Q5145) apply only when adalimumab is administered in a physician office, which is uncommon. See the Pharmacy vs medical benefit section for routing guidance and the six-biosimilar comparison for substitution detail.
⚠️
10+ adalimumab products in market — payer-driven substitution is the norm. Humira reference now competes with six Q-coded biosimilars and four additional biosimilars billed under unclassified codes. Interchangeability status (Cyltezo, Yuflyma, Simlandi, Abrilada) allows pharmacy-level substitution where state law permits. CVS Caremark, Express Scripts, and OptumRx have all moved branded Humira off preferred tiers in 2026. Verify the actual product dispensed against the payer's preferred biosimilar at every fill — mismatches drive the most common rejection. See 2026 PBM policies.
Phase 1 Identify what you're billing Confirm benefit channel first — for adalimumab, pharmacy is the default, not medical.

Pharmacy benefit vs. medical benefit — routing the claim correctly Verified May 2026

For adalimumab, the benefit-channel decision happens before any J-code or Q-code is selected.

Adalimumab is a subcutaneous self-injectable. Across the entire adalimumab class — Humira reference and every biosimilar — the dominant utilization pattern is patient self-administration at home, dispensed through a specialty pharmacy and adjudicated under the pharmacy benefit. The medical-benefit J-codes and Q-codes only apply to the small minority of doses administered in a physician's office. Get the routing wrong and the claim either rejects (medical claim for a pharmacy-benefit drug) or duplicates (both channels paid for the same fill).

When to bill adalimumab under the pharmacy benefit vs. the medical benefit.
ScenarioBenefit channelCodingFrequency
Patient self-injects at home; specialty pharmacy ships pen/syringe to home Pharmacy benefit NDC-level pharmacy claim only; no HCPCS, no admin CPT >95% of all adalimumab use
First-dose teaching/training in clinic (rare; nurse demonstrates injection) Often pharmacy benefit; medical only if drug is buy-and-bill If medical: J0135 (or J0139) + 96372 admin Uncommon
Office administration (patient cannot self-inject; clinic stocks drug) Medical benefit (buy-and-bill) J0135 (20 mg = 1 unit) or J0139 (1 mg = 1 unit) + CPT 96372 Rare
Biosimilar administered in office Medical benefit Use the appropriate Q5140–Q5145; or J3490/J3590/C9399 if no Q-code (Amjevita, Hadlima, Hyrimoz, Yusimry) Rare
Inpatient administration Medical benefit (DRG-bundled) Drug bundled in DRG; document NDC for inpatient pharmacy reconciliation Very rare
Default workflow: Verify pharmacy-benefit coverage first via the patient's PBM (CVS Caremark, Express Scripts, OptumRx, Humana Pharmacy, etc.). Confirm preferred product (Humira reference vs. biosimilar) before sending the prescription to specialty pharmacy. Only escalate to medical-benefit billing if the patient cannot self-administer AND the office stocks adalimumab AND the payer authorizes office administration.
Why ASP is not the headline number on this page: for true pharmacy-benefit drugs like adalimumab, CMS Medicare Part B ASP files do not drive most reimbursement — pharmacy-benefit drugs price through plan-specific formulary tiers, manufacturer rebates, and PBM-negotiated net costs. CareCost's live ASP binding will gracefully no-op for J0135 in most cases. For accurate cost-share modeling, run a pharmacy benefit estimate, not a Part B estimate.

What this means for your coding workflow

  • Step 1: Confirm benefit channel. Pharmacy benefit → route to specialty pharmacy, no claim coding.
  • Step 2 (if medical): Identify the exact product (reference vs. specific biosimilar) by NDC.
  • Step 3 (if medical): Map to the correct HCPCS — J0135 or J0139 for Humira reference; Q5140–Q5145 for the six Q-coded biosimilars; J3490/J3590/C9399 for the four un-Q-coded biosimilars.
  • Step 4 (if medical): Add 96372 admin code, NDC in 24A shaded area, ICD-10 matching the indication.

Six Q-coded adalimumab biosimilars — side by side FDA Purple Book verified May 2026

Same molecule, same dose, same indications — different HCPCS, different NDC, different formulation, different payer preferences.

Ten adalimumab products are now FDA-approved: Humira reference plus nine biosimilars. Six biosimilars carry permanent CMS Q-codes (Q5140 through Q5145). The remaining four (Amjevita, Hadlima, Hyrimoz, Yusimry) bill medically under unclassified codes (J3490 / J3590 / C9399) until CMS issues product-specific Q-codes. Four biosimilars are FDA-designated interchangeable, allowing pharmacy-level substitution where state law permits without prescriber intervention.

Side-by-side comparison of six Q-coded adalimumab biosimilars vs. Humira reference.
HCPCSBrandProper nameManufacturerInterchangeable?Citrate-free / HC?
J0135 / J0139 Humira (reference) adalimumab AbbVie n/a (reference product) Yes (modern Humira is citrate-free, high-concentration)
Q5140 Hulio adalimumab-fkjp Biocon Biologics No Varies by SKU (citrate-containing common)
Q5141 Yuflyma adalimumab-aaty Celltrion Yes (April 2024) Yes (citrate-free, high-concentration)
Q5142 Simlandi adalimumab-ryvk Alvotech / Teva Yes Yes (citrate-free, high-concentration)
Q5143 Cyltezo adalimumab-adbm Boehringer Ingelheim Yes (1st FDA-designated interchangeable adalimumab) HC version available
Q5144 Idacio adalimumab-aacf Fresenius Kabi No Citrate-containing
Q5145 Abrilada adalimumab-afzb Pfizer Yes (October 2023) HC (citrate-free) version available

Biosimilars without dedicated Q-codes (bill unclassified when medical)

BrandProper nameManufacturerMedical billingCitrate status
Amjevitaadalimumab-attoAmgenJ3490 / J3590 / C9399Original citrate-containing; HC version available
Hadlimaadalimumab-bwwdSamsung Bioepis / OrganonJ3490 / J3590 / C9399HC (citrate-free) version available
Hyrimozadalimumab-adazSandozJ3490 / J3590 / C9399Original LC (citrate); HC (citrate-free) version available
Yusimryadalimumab-aqvhCoherus BioSciencesJ3490 / J3590 / C9399Citrate-containing
Citrate-free vs. citrate-containing matters to patients: citrate-free / high-concentration formulations (100 mg/mL) deliver a 40 mg dose in 0.4 mL with materially less injection-site burning vs. citrate-containing (50 mg/mL, 0.8 mL). Many 2026 payer formularies prefer citrate-free formulations. Confirm the exact SKU dispensed if patient tolerability is in question.
Interchangeability is a substitution rule, not a clinical-equivalence statement: all FDA-approved adalimumab biosimilars are biosimilar to Humira (highly similar; no clinically meaningful differences). "Interchangeable" status (Cyltezo, Yuflyma, Simlandi, Abrilada) additionally permits pharmacist-level substitution where state law allows — like a generic substitution. It does not change clinical efficacy expectations.

Dosing by indication FDA label current

From FDA prescribing information (BLA 125057) — Humira reference; biosimilar dosing identical.

Humira's label covers ten indications across four therapeutic areas. Dosing varies materially by indication — especially loading-dose strategies for IBD and the weekly schedule for hidradenitis suppurativa.

FDA-approved Humira dosing by indication.
IndicationLoading doseMaintenance
Rheumatoid arthritis (adult)None40 mg SC every other week
Psoriatic arthritis (adult)None40 mg SC every other week
Ankylosing spondylitis (adult)None40 mg SC every other week
Polyarticular JIA (≥2 yr, weight-based)None10 mg (10–<15 kg) / 20 mg (15–<30 kg) / 40 mg (≥30 kg) SC q2wk
Crohn's disease (adult)160 mg Day 1 (or 80 mg × 2 days), 80 mg Day 1540 mg SC q2wk starting Day 29
Crohn's disease (pediatric ≥6, weight-based)Weight-based loading per labelWeight-based 40 mg or 20 mg q2wk
Ulcerative colitis (adult)160 mg Day 1, 80 mg Day 1540 mg SC q2wk
Ulcerative colitis (pediatric ≥5, weight-based)Weight-based loading per labelWeight-based q2wk
Plaque psoriasis (adult)80 mg loading40 mg SC q2wk starting one week after loading
Plaque psoriasis (pediatric)Weight-based per labelWeight-based q2wk
Hidradenitis suppurativa (adult + adolescent ≥12)160 mg Day 1, 80 mg Day 1540 mg SC WEEKLY from Day 29 (not q2wk)
Non-infectious uveitis (adult + pediatric ≥2)80 mg loading (adult)40 mg SC q2wk from Day 8 (adult); pediatric weight-based

Worked example — adult RA, 40 mg q2wk, in-office administration (rare)

# Single dose — 40 mg SC, given in office
Drug units billed (J0135): 2 · (J0139 alternate: 40)
HCPCS: J0135 (20 mg) or J0139 (1 mg) per MAC preference
Modifier: JZ (whole-syringe use) · Syringes: 1 × 40 mg
Admin: 96372 (therapeutic SC injection) — NOT 96401 (chemo)

# Year-1 dose count (RA, q2wk): 26 doses
# Total year-1 J0135 units (in-office only): 52 (26 × 2)

# Reality check: >95% of patients self-inject at home
# —> pharmacy claim only; no medical-benefit billing

Hidradenitis suppurativa — the only weekly indication

HS dosing is unusual: after the standard 160 mg / 80 mg loading sequence, maintenance is 40 mg weekly, not every other week. This doubles the annualized dose count (52 vs. 26) and is the most common dosing-error pattern at PA submission. Confirm HS-specific dosing is requested when ICD-10 L73.2 is on the claim.

NDC reference — common Humira & biosimilar SKUs FDA NDC Directory verified May 2026

ProductNDC (representative)PackageManufacturer
Humira Pen 40 mg/0.4 mL (citrate-free) 00074-0554-02 2-pack pens, prefilled, single-dose, high-concentration AbbVie (labeler 00074)
Humira Syringe 40 mg/0.4 mL (citrate-free) 00074-0124-02 2-pack syringes, prefilled, single-dose AbbVie
Humira Pen 40 mg/0.8 mL (citrate-containing, legacy) 00074-3799-02 2-pack pens, prefilled, single-dose AbbVie
Cyltezo (adalimumab-adbm) 40 mg/0.8 mL pen 00597-0151-02 2-pack autoinjector pens Boehringer Ingelheim (labeler 00597)
Yuflyma (adalimumab-aaty) 40 mg/0.4 mL HC pen 72606-0440-02 2-pack autoinjector pens, high-concentration Celltrion USA (labeler 72606)
Simlandi (adalimumab-ryvk) 40 mg/0.4 mL HC pen 72069-0420-02 2-pack autoinjector pens, citrate-free HC Alvotech / Teva (labeler 72069)
NDC-level matching is critical for biosimilar substitution. Payer formularies preference biosimilars at the NDC level, not the brand level. A single brand (e.g., Hyrimoz) may have separate NDCs for citrate-free HC and citrate-containing LC; only one may be on the formulary. Confirm the NDC dispensed matches the NDC authorized by the PBM — not just the brand name. Use the N4 qualifier with the 11-digit NDC in CMS-1500 Box 24A and UB-04 Box 43 for any medical-benefit claim.
Phase 2 Code the claim For medical-benefit office administration only. Skip this phase if pharmacy-benefit dispensing.

Administration codes CPT verified May 2026

Adalimumab is non-chemotherapeutic and subcutaneous — use therapeutic SC injection codes, not chemo.

CodeDescriptionWhen to use
96372 Therapeutic, prophylactic, or diagnostic injection (specify substance/drug); subcutaneous or intramuscular Primary code for in-office adalimumab administration. SC injection.
96401 Chemotherapy administration; SC or IM, non-hormonal anti-neoplastic NOT appropriate. Adalimumab is non-chemotherapeutic. Do not bill 96401 for higher reimbursement — documentation will not support it.
(none) Patient self-injection at home No CPT admin code billed. Pharmacy-benefit dispensing only — specialty pharmacy NCPDP claim, not a CMS-1500.
Why not chemo: some practices have historically attempted to bill 96401 for SC biologics targeting higher chemotherapy admin reimbursement. CMS, all major MACs, and commercial payers will deny these claims for non-chemotherapeutic monoclonal antibodies. Adalimumab has always belonged under 96372.

Modifiers CMS verified May 2026 — verify JZ list

JZ — whole-syringe use, default expectation when in office

Effective July 1, 2023, CMS requires JZ on all claims for single-dose container drugs when no drug is discarded — but only for codes on the CMS single-dose container list. Adalimumab's 40 mg dose uses one full prefilled syringe or pen with no discard, so JZ is the expected modifier when J0135 or J0139 appears on that list. Verify against the current CMS single-dose container list at billing time; the list is updated periodically.

JW — rarely applies

The 40 mg dose uses one full single-dose syringe/pen; no drug is discarded in routine adult use. JW applies only when documented wastage occurs — which is rare except for weight-based pediatric dosing.

Modifier 25 — situational

Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the injection.

340B modifiers (JG, TB)

For 340B-acquired adalimumab, follow your MAC's current 340B modifier policy — rarely encountered for adalimumab given the pharmacy-benefit dominance.

ICD-10-CM diagnosis codes FY2026 verified May 2026

Adalimumab covers the broadest indication set of any biologic — map carefully.

ICD-10-CM diagnosis families for Humira's ten FDA-approved indications.
IndicationICD-10 familyCommon specific codes
Rheumatoid arthritis (adult)M05.x, M06.xM05.79, M06.09, M06.9
Polyarticular JIA (≥2 yr)M08.xM08.00, M08.20, M08.40
Psoriatic arthritisL40.5xL40.50, L40.51, L40.52, L40.59
Ankylosing spondylitisM45.xM45.0–M45.9
Crohn's disease (adult + pediatric ≥6)K50.xK50.00, K50.10, K50.80, K50.90 (and complication subcodes)
Ulcerative colitis (adult + pediatric ≥5)K51.xK51.00, K51.20, K51.30, K51.50, K51.80, K51.90
Plaque psoriasis (adult + pediatric)L40.0L40.0
Hidradenitis suppurativa (adult + adolescent ≥12)L73.2L73.2
Non-infectious uveitis (adult + pediatric ≥2)H20.x, H30.xH20.00–H20.9, H30.00–H30.9
Map ICD-10 to the indication-specific dosing. The most common PA-clarification request asks the prescriber to confirm dosing matches the indication on the claim — especially for HS (weekly, not q2wk) and the IBD loading-dose sequences. Sending K50.x or K51.x without documented loading-dose history is a frequent rejection trigger.

Site of care & place of service Verified May 2026

Adalimumab is overwhelmingly self-administered at home. Office and hospital outpatient administration occur but are uncommon. Site-of-care UM programs are not typically applied to adalimumab because the default site is already the patient's home.

SettingPOSClaim formElectronic
Patient home (self-injection)n/a (pharmacy)NCPDP D.0 (pharmacy claim)NCPDP
Physician office11CMS-1500837P
Hospital outpatient19 or 22UB-04 / CMS-1450837I
Inpatient21UB-04 / CMS-1450 (DRG-bundled)837I
The default "site of care" for adalimumab is the patient's couch. No medical-benefit POS is required for the >95% of doses self-administered at home — only the pharmacy benefit fills the prescription. POS coding only applies when a clinician administers the dose in a clinical setting.

Claim form field mapping Verified May 2026

CMS-1500 / 837P (physician office, POS 11) — for the rare in-office administration only.

InformationCMS-1500 boxNotes
NPI17bRendering provider
NDC qualifier + 11-digit NDC + UoM + qty24A shaded areaFormat: N400074055402ML0.4 (Humira HC 40 mg/0.4 mL pen)
HCPCS J0135 (20 mg) or J0139 (1 mg) + admin CPT 9637224DEach on its own line. For biosimilar, substitute Q5140–Q5145.
Drug units24G40 mg dose → 2 units (J0135) or 40 units (J0139)
ICD-1021Match indication: M06.9 (RA) / L40.5x (PsA) / M45.x (AS) / K50.x (Crohn's) / K51.x (UC) / L40.0 (plaque psoriasis) / L73.2 (HS) / H20.x or H30.x (uveitis) / M08.x (JIA)
PA number23Required by virtually all commercial payers

Form references: NUCC (CMS-1500).

Phase 3 Get paid 2026 PBM dynamics: branded Humira excluded or non-preferred at most major PBMs; biosimilar steering is the rule.

Payer / PBM policy snapshot Reviewed May 2026 — Drug Channels 2026

In 2026, the major national PBMs have largely removed Humira reference from preferred status.

2026 PBM formulary status for Humira reference and adalimumab biosimilars at major commercial PBMs.
PBMHumira referencePreferred biosimilarsNotable exclusions
CVS Caremark
2026 standard formulary
Non-preferred / largely excluded Sandoz biosimilars (Hyrimoz / Cordavis private-label) and Biocon Hulio (Q5140) Branded Humira removed from preferred tiers
Express Scripts
2026 National Preferred Formulary
Non-preferred / largely excluded Cyltezo (BI, Q5143), Simlandi (Alvotech/Teva, Q5142), Hyrimoz (Sandoz) Humira reference removed; multi-biosimilar preferred set
OptumRx
2026 Premium formulary
Non-preferred Multiple biosimilars on preferred tiers Cyltezo (Q5143) EXCLUDED in 2026 — opposite of Express Scripts
Aetna
CPB 0655 — Adalimumab
Step therapy required Per CPB 0655; uses J0139 in coding examples (1 mg = 1 unit basis) ~98.5% of biologic plans require step therapy through cheaper agents first
Drug Channels 2026 finding: the major PBMs have largely removed Humira reference and Stelara reference from preferred lists for the 2026 plan year. Biosimilar uptake for adalimumab is now meaningful across commercial books, accelerated by interchangeability designations on Cyltezo, Yuflyma, Simlandi, and Abrilada plus the proliferation of citrate-free high-concentration formulations.
Step therapy is near-universal: approximately 98.5% of commercial biologic plans require documented failure of at least one cheaper agent (typically methotrexate for RA/PsA; mesalamine + steroid for UC; budesonide/azathioprine for Crohn's; topical/phototherapy for psoriasis) before approving any TNF inhibitor — and additional step therapy through preferred biosimilars before approving branded Humira. Submit step-therapy documentation up front for every PA.

What to document for approval (medical or pharmacy benefit)

  • Confirmed FDA-approved indication with matching ICD-10
  • TB screening (PPD or IGRA) within 12 months prior to initiation
  • Hepatitis B screening
  • For RA/PsA: documented inadequate response to methotrexate (or contraindication)
  • For Crohn's / UC: documented step therapy through conventional agents and (for second-line scenarios) prior TNF-inhibitor history
  • For HS: confirmation of weekly maintenance dosing
  • Confirmation of preferred biosimilar product where Humira reference is non-preferred

Medicare reimbursement CMS Q2 2026 — pharmacy benefit primary

Adalimumab is overwhelmingly Part D (pharmacy) for Medicare beneficiaries. Part B reimbursement applies only when administered in office.

Q2 2026 payment snapshot — J0135 / J0139 (medical benefit only)

Effective April 1 – June 30, 2026 · Part B medical-benefit rates (rarely invoked)

ASP + 6% (J0135, per 20 mg unit)
Pharmacy primary
CMS Part B ASP not the dominant pricing channel for adalimumab
40 mg dose (J0135 × 2)
Variable
Pharmacy benefit primary; medical-benefit ASP variable per MAC
Pharmacy benefit (Part D)
Plan-specific
Adjudicated through Part D plan formulary tiers
Why no headline ASP figure: adalimumab is a self-administered subcutaneous biologic. Under Medicare, it falls under Part D (pharmacy), not Part B (medical). The Part B ASP file for J0135 and J0139 applies only to the rare scenario of in-office administration. CareCost's live binding will surface a Part B rate when CMS publishes one for that quarter, otherwise display "Pharmacy benefit primary; medical-benefit ASP variable per MAC."
Approximate WAC (for context only, not for billing): Humira reference WAC has historically been ~$3,000 per 40 mg pen. Biosimilars commonly price 30–85% below reference WAC depending on manufacturer rebates and PBM contract terms. Plan-specific net cost can differ materially from WAC.

Coverage

No NCD specific to adalimumab. Medicare Part B coverage for in-office administration falls under generic drug-coverage LCDs (e.g., LCD L33394). Medicare Part D coverage is plan-specific; nearly all Part D plans cover at least one preferred adalimumab product (typically a biosimilar in 2026).

Code history

  • 2002 — FDA approval of Humira reference (BLA 125057)
  • J0135 — "Injection, adalimumab, 20 mg" (1 unit = 20 mg) — legacy reference code, still active
  • J0139 — "Injection, adalimumab, 1 mg" (1 unit = 1 mg) — alternate per-mg basis used by Aetna policy and several MACs
  • Q5140–Q5145 — permanent biosimilar Q-codes (Hulio, Yuflyma, Simlandi, Cyltezo, Idacio, Abrilada)
  • Amjevita, Hadlima, Hyrimoz, Yusimry — bill J3490 / J3590 / C9399 until product-specific Q-codes issue

Patient assistance — Humira Complete + biosimilar programs Manufacturer verified May 2026

Humira reference (AbbVie)

  • Humira Complete: AbbVie copay savings card — eligible commercially-insured patients pay as little as $5/month. Excludes Medicare, Medicaid, federal program patients.
  • Phone: 1-800-4HUMIRA (1-800-448-6472)
  • Web: humira.com/humira-complete
  • Nurse Ambassador program: in-home injection training and ongoing support

Biosimilar copay programs

  • Cyltezo Connect (Boehringer Ingelheim) — copay assistance for commercially-insured patients
  • Simlandi Plus (Alvotech / Teva) — copay support program
  • Celltrion CARES — for Yuflyma; copay and access support
  • Pfizer enCompass — for Abrilada; commercial copay assistance
  • Sandoz One Source — for Hyrimoz; copay and PA support
  • Idacio Direct (Fresenius Kabi)
  • Yusimry connection (Coherus BioSciences)

Foundations (income-eligible, including Medicare)

Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and OOP max — across the pharmacy benefit and (rarely) medical benefit? Run a CareCost Estimate — J0135 / J0139 pre-loaded.
Phase 4 Fix problems Benefit-channel routing, biosimilar mismatch, and step-therapy documentation are the top three.

Common denials & how to fix them

Denial reasonCommon causeFix
Wrong benefit channel (medical claim for pharmacy-benefit drug) CMS-1500 submitted with J0135 when patient self-injects at home Cancel medical claim. Route prescription to specialty pharmacy under pharmacy benefit. No medical billing required.
Branded Humira not preferred — biosimilar required 2026 PBM formulary has Humira reference excluded or non-preferred Switch to PBM-preferred biosimilar. CVS → Hyrimoz/Hulio. Express Scripts → Cyltezo/Simlandi/Hyrimoz. OptumRx → preferred non-Cyltezo biosimilar.
NDC mismatch — biosimilar dispensed not on formulary Specialty pharmacy dispensed citrate-containing SKU when payer prefers HC, or wrong biosimilar brand Verify NDC against PBM-preferred list before fill. Re-dispense correct NDC. Submit override if continuity-of-care exception applies.
Step therapy not documented PA submitted without prior trial of MTX (RA/PsA) or conventional therapy (IBD/psoriasis) Submit prior treatment history with dates, doses, response/intolerance. Required by ~98.5% of biologic plans.
HS dosing rejected (q2wk approved, weekly requested) HS PA approved at standard q2wk; clinician orders correct weekly maintenance Resubmit with L73.2 explicitly and request weekly maintenance dosing per FDA label. Cite Humira PI for HS.
TB screening missing PA submitted without documented PPD/IGRA result within 12 months Submit TB screening result. If positive, submit treatment plan for latent TB before initiating adalimumab.
Wrong J-code basis (J0135 billed as 1 mg unit) Coder used J0135 with 40 units instead of 2 units (forgot J0135 = 20 mg) Correct: J0135 = 20 mg/unit (40 mg dose → 2 units). For 1 mg/unit basis, use J0139 (40 mg dose → 40 units). Verify MAC preference.
Wrong admin code (96401 chemo) Chemo admin code billed for non-chemo adalimumab Resubmit with 96372 (therapeutic SC injection). Adalimumab is non-chemotherapeutic.
Unclassified Q-code denied (J3490 / J3590 / C9399) Amjevita / Hadlima / Hyrimoz / Yusimry billed without product detail Add NDC, drug name, units, and per-unit cost in claim narrative (Box 19 / NTE). Some payers require manual review.
NDC format 10-digit NDC submitted; payer requires 11-digit Use 11-digit NDC with N4 qualifier in CMS-1500 Box 24A shaded area.

Frequently asked questions

What is the HCPCS code for Humira?

Humira (adalimumab) reference product is billed under HCPCS J0135 — "Injection, adalimumab, 20 mg" (1 unit = 20 mg) or J0139 — "Injection, adalimumab, 1 mg" (1 unit = 1 mg). Both codes are in active use depending on Medicare Administrative Contractor (MAC) and payer. A standard 40 mg dose bills as 2 units of J0135 OR 40 units of J0139. These codes apply only when adalimumab is administered in a physician office under the medical benefit — which is rare. >95% of Humira utilization runs through the pharmacy benefit (self-injected at home, dispensed by specialty pharmacy).

Is Humira a pharmacy benefit or medical benefit drug?

Pharmacy benefit, overwhelmingly. Humira and its biosimilars are subcutaneous injections designed for patient self-administration at home (prefilled syringe or autoinjector pen). They are dispensed through specialty pharmacy and adjudicated under the pharmacy benefit. The J-codes (J0135, J0139) and the biosimilar Q-codes (Q5140Q5145) only apply when adalimumab is administered in a physician office under the medical benefit — an uncommon scenario. For the vast majority of patients, no medical-benefit claim is generated for Humira.

What are the biosimilar Q-codes for Humira?

Six adalimumab biosimilars have permanent Q-codes: Q5140 (Hulio, adalimumab-fkjp, Biocon), Q5141 (Yuflyma, adalimumab-aaty, Celltrion — interchangeable), Q5142 (Simlandi, adalimumab-ryvk, Alvotech/Teva — interchangeable, citrate-free high-concentration), Q5143 (Cyltezo, adalimumab-adbm, Boehringer Ingelheim — first interchangeable adalimumab biosimilar), Q5144 (Idacio, adalimumab-aacf, Fresenius Kabi), and Q5145 (Abrilada, adalimumab-afzb, Pfizer — interchangeable). Four additional biosimilars (Amjevita, Hadlima, Hyrimoz, Yusimry) currently bill under unclassified codes J3490 / J3590 / C9399 when administered medically.

Which adalimumab biosimilars are FDA-designated interchangeable?

Four: Cyltezo (Q5143, Boehringer Ingelheim — first FDA-designated interchangeable adalimumab biosimilar), Abrilada (Q5145, Pfizer — October 2023), Yuflyma (Q5141, Celltrion — April 2024), and Simlandi (Q5142, Alvotech/Teva). Interchangeability allows pharmacy-level substitution where state law permits, without prescriber intervention.

What is the difference between citrate-free and citrate-containing adalimumab?

Citrate-free / high-concentration formulations (100 mg/mL) deliver a 40 mg dose in a smaller volume (0.4 mL) and are reported by patients to cause less injection-site pain. Citrate-containing formulations (50 mg/mL, 0.8 mL) have historically been associated with more injection burning. Modern Humira is citrate-free. Citrate-free biosimilars include Simlandi, Yuflyma, Cyltezo HC, Hyrimoz HC, Abrilada HC, and Hadlima HC. Citrate-containing options include the original Amjevita, original Hyrimoz LC, Yusimry, Idacio, and Hulio (varies by SKU). Many 2026 payer formularies prefer citrate-free formulations.

Are PBMs excluding branded Humira in 2026?

Yes — at most national PBMs, branded Humira is non-preferred or excluded in 2026. CVS Caremark prefers Sandoz biosimilars (Hyrimoz/Cordavis private-label) and Biocon Hulio. Express Scripts prefers Cyltezo (Boehringer Ingelheim), Simlandi (Alvotech/Teva), and Hyrimoz (Sandoz). OptumRx specifically excluded Cyltezo from 2026 formularies. Per Drug Channels, the major PBMs have largely removed Humira reference and Stelara reference from their preferred lists. Approximately 98.5% of biologic plans require step therapy through cheaper agents before approving branded Humira.

What are the boxed warnings for Humira?

Two boxed warnings apply to Humira and all adalimumab biosimilars: (1) SERIOUS INFECTIONS — including tuberculosis (latent and active), invasive fungal infections (histoplasmosis, coccidioidomycosis, candidiasis), and other opportunistic infections. TB screening required before initiation. (2) MALIGNANCY — including lymphoma and other malignancies, particularly hepatosplenic T-cell lymphoma (HSTCL) in adolescents and young adults treated for inflammatory bowel disease, often in combination with azathioprine or 6-mercaptopurine.

What is the administration code for Humira when given in office?

CPT 96372 — "Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular." Adalimumab is non-chemotherapeutic, so 96401 (chemotherapy SC/IM admin) is NOT appropriate. When the patient self-administers at home, NO administration CPT is billed — only the pharmacy claim is generated.

How is Humira dosed by indication?

Adult RA, PsA, and AS: 40 mg SC every other week. Crohn's disease (adult): 160 mg loading on Day 1 (or 80 mg on each of two consecutive days), 80 mg on Day 15, then 40 mg every other week starting Day 29. Ulcerative colitis (adult): 160 mg loading, 80 mg on Day 15, then 40 mg every other week. Plaque psoriasis (adult): 80 mg loading, then 40 mg every other week starting one week after the loading dose. Hidradenitis suppurativa: 160 mg Day 1, 80 mg Day 15, then 40 mg WEEKLY (not every other week). Pediatric polyarticular JIA: weight-based — 10 mg (10 to <15 kg), 20 mg (15 to <30 kg), 40 mg (≥30 kg) every other week.

What is the patient assistance program for Humira?

Humira Complete is AbbVie's copay savings program — eligible commercially-insured patients pay as little as $5 per month. Excludes Medicare, Medicaid, and other federal program patients. Contact 1-800-4HUMIRA (1-800-448-6472). Each biosimilar has its own copay assistance program: Cyltezo Connect (Boehringer Ingelheim), Simlandi Plus (Alvotech/Teva), Celltrion CARES for Yuflyma, Pfizer enCompass for Abrilada, Sandoz One Source for Hyrimoz, Idacio Direct (Fresenius Kabi), and Yusimry connection (Coherus). Income-eligible Medicare patients should be referred to independent foundations: HealthWell Foundation, PAN Foundation, and Good Days.

Reference Sources & methodology Every claim on this page is sourced. Methodology and review history below.

Source documents

  1. DailyMed — HUMIRA (adalimumab) Prescribing Information
    FDA-approved label (BLA 125057)
  2. HCPCSdata — J0135 ("Injection, adalimumab, 20 mg")
    Confirms 20 mg/unit basis — common reference error attributes 1 mg/unit to J0135
  3. HCPCSdata — J0139 ("Injection, adalimumab, 1 mg")
    Alternate per-mg basis used by Aetna policy and several MACs
  4. AAPC — HCPCS Q5140 (Hulio, adalimumab-fkjp)
  5. AAPC — HCPCS Q5141 (Yuflyma, adalimumab-aaty)
  6. AAPC — HCPCS Q5142 (Simlandi, adalimumab-ryvk)
  7. AAPC — HCPCS Q5143 (Cyltezo, adalimumab-adbm)
  8. AAPC — HCPCS Q5144 (Idacio, adalimumab-aacf)
  9. AAPC — HCPCS Q5145 (Abrilada, adalimumab-afzb)
  10. Aetna Clinical Policy Bulletin 0655 — Adalimumab
    PA criteria, step therapy, J0139 (1 mg) coding basis
  11. AbbVie — Humira Pro coding & reimbursement guide
    Manufacturer coding guidance, NDC reference, copay program detail
  12. FDA — Biosimilar Product Information / Purple Book
    Adalimumab biosimilars approval status, interchangeability designations
  13. Drug Channels Institute — 2026 PBM formulary exclusions analysis
    CVS Caremark, Express Scripts, OptumRx 2026 Humira / biosimilar positioning
  14. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file (medical-benefit reimbursement only; pharmacy benefit primary for adalimumab)
  15. CMS — HCPCS quarterly update file (canonical J-code / Q-code source)
  16. FDA National Drug Code Directory
  17. FDA Drugs@FDA — HUMIRA (BLA 125057) approval history
    Initial FDA approval December 31, 2002

About this page

We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files — though for adalimumab, Part B ASP applies only to the rare in-office administration scenario. Coding, payer policy, and biosimilar formulary content is reviewed at least quarterly and updated whenever a source document changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

ElementCadenceHow it's refreshed
Medicare Part B ASP (J0135 / J0139, when listed)QuarterlyAuto-bound to CareCost ASP layer; updates on CMS file release. Pharmacy benefit primary for adalimumab.
PBM formulary status (CVS, ESI, OptumRx)Annual + mid-yearManual review against published 2026 formulary documents and Drug Channels analysis.
Payer medical policies (Aetna CPB 0655, etc.)Semi-annualManual review against published payer policy documents.
Biosimilar product information / Purple BookEvent-drivenUpdates triggered by FDA approval, interchangeability designation, or new Q-code issuance.
HCPCS / CPT / modifier rules + CMS single-dose container listQuarterlyJZ/JW applicability for adalimumab specifically requires verification.
NDC, dosing, FDA labelEvent-drivenTied to manufacturer document version + FDA label revision date.
Citrate-free / HC formulation trackingEvent-drivenNew SKUs and HC versions tracked at launch.

Reviewer

Pending SME review. This page is staff-authored from primary sources (FDA, CMS, manufacturer, payer documents — all linked above). Final review by our SME, Catherine Rose (CPC), is in progress. Until that review is complete, treat this as a draft reference and verify each cited source for high-stakes claims, particularly the J0135 vs. J0139 unit basis (a frequent reference-document error).

Change log

  • — Initial publication. Pharmacy-benefit-primary framing throughout. Six Q-coded biosimilars catalogued (Q5140–Q5145) with interchangeability and citrate-free status. 2026 PBM formulary exclusions documented (CVS / ESI / OptumRx). Aetna CPB 0655 cited for J0139 (1 mg) coding basis. HCPCSdata cited for J0135 = 20 mg/unit (correcting common reference error).

Methodology

Every claim on this page is sourced inline. PBM formulary positioning is read from each PBM's published 2026 formulary documents and triangulated against Drug Channels Institute's 2026 exclusions analysis. HCPCS unit basis is verified against HCPCSdata (J0135 = 20 mg, J0139 = 1 mg) because many billing-software vendor references incorrectly attribute 1 mg/unit to J0135. Biosimilar interchangeability status is read from the FDA Purple Book. We do not paraphrase from billing-software vendor blogs. When MAC interpretation is ambiguous (J0135 vs. J0139 preference), we surface the ambiguity rather than asserting a definitive answer.

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