Cimzia (certolizumab pegol) — HCPCS J0717

UCB Inc. · 200 mg/mL prefilled syringe, lyophilized vial, AutoClicks e-Device · Subcutaneous injection (NOT IV) · 6 FDA-approved adult indications across rheumatology, dermatology, and gastroenterology

Cimzia is the only PEGylated, Fc-free anti-TNF biologic, billed under HCPCS J0717 at 1 mg per unit. Common doses: 400 mg loading (weeks 0, 2, 4) then 200 mg q2wk or 400 mg q4wk maintenance. Subcutaneous injection — CPT 96372 when office-administered, NOT 96365/96413. Q2 2026 Medicare reimbursement: $3.790/mg ($1,516.00 per 400 mg dose, ASP + 6%). Medical benefit (J0717, office-admin) vs pharmacy benefit (home self-inject) is the most common billing decision.

ASP data:Q2 2026 (live)
Payer policies:verified May 2026
Manufacturer guide:UCB CIMplicity 2026
FDA label:revised 2025
Page reviewed:

Instant Answer — the 5 things you need to bill J0717

HCPCS
J0717
1 mg = 1 unit
Loading dose
400 units
400 mg SC at wks 0, 2, 4
Modifier
JZ
Single-dose syringe, no waste
Admin CPT
96372
Therapeutic SC (NOT IV)
Medicare ASP+6%
$3.790
per mg, Q2 2026 · $1,516.00/400 mg
HCPCS descriptor
J0717 — "Injection, certolizumab pegol, 1 mg" (excludes biosimilars) Permanent
Loading regimen
400 mg SC (administered as 2 × 200 mg injections at separate sites) at weeks 0, 2, and 4 — for RA, PsA, AS, nr-axSpA, plaque psoriasis, and Crohn's
Maintenance — rheum / spondylo
RA, PsA, AS, nr-axSpA: 400 mg q4wk OR 200 mg q2wk SC
Maintenance — psoriasis
Plaque PsO: 400 mg q2wk SC; if body weight ≤90 kg, may use 200 mg q2wk after the first 3 doses
Maintenance — Crohn's
Crohn's disease: 400 mg q4wk SC
NDC
50474-700-79 (2 × 200 mg/mL prefilled syringe Starter Kit options vary; verify on UCB CIMplicity)
Presentations
200 mg/mL single-dose prefilled syringe; 200 mg lyophilized powder single-dose vial (requires reconstitution); 200 mg/mL prefilled e-Device (UCB AutoClicks / SmartJect)
Route
Subcutaneous injection only. NOT for IV use. Self-administered or HCP-administered into abdomen or thigh.
Premedication
Not routinely required. No infusion-reaction premed protocol.
Boxed warning
YES — Serious infections (incl. TB, invasive fungal, opportunistic) AND malignancies (lymphoma, HSTCL). Class-wide TNF blocker boxed warning.
FDA approval
April 2008 (Crohn's); subsequent approvals through 2019 covering RA, PsA, AS, nr-axSpA, plaque PsO; label routinely revised
⚠️
BOXED WARNING — serious infections AND malignancies. Cimzia carries the class-wide TNF blocker boxed warning: increased risk of serious infections (active TB — often disseminated or extrapulmonary, including reactivation of latent TB; invasive fungal infections; bacterial, viral, and opportunistic pathogens) and malignancies (lymphoma; postmarketing hepatosplenic T-cell lymphoma in adolescents/young adults receiving TNFi + thiopurines for IBD). Mandatory pre-treatment TB screening (PPD or IGRA) and hepatitis B screening required. Discontinue if patient develops serious infection or sepsis.
ℹ️
Medical benefit (J0717) vs pharmacy benefit decision. When administered in office / infusion suite / clinic by HCP and the provider buys-and-bills, Cimzia is billed under the MEDICAL benefit using J0717 + 96372. When the patient self-injects at home from a specialty pharmacy fill (UCB-aligned SP network), it is billed under the PHARMACY benefit using NDC, and J0717 does NOT apply. Many commercial plans steer Cimzia to pharmacy benefit. Verify benefit pathway BEFORE submitting the claim — this is the most common Cimzia billing error. See Phase 1 benefit pathway.
Pregnancy use — clinical advantage over other TNFi. Cimzia is a PEGylated humanized Fab′ fragment that lacks an Fc region. Because placental IgG transfer is FcRn-mediated, certolizumab pegol shows minimal active placental transfer (CRIB study: median infant cord blood <0.41 µg/mL vs maternal 24 µg/mL at delivery). When TNFi therapy is required during pregnancy, ACR, EULAR, and the AGA pregnancy in IBD guideline often prefer Cimzia over Humira, Enbrel, Remicade, and Simponi (all full IgG with active third-trimester transfer). Document the indication and rationale in the PA narrative when this drives the choice.
Phase 1 Identify what you're billing Decide medical vs pharmacy benefit before doing anything else — the rest of the workflow depends on it.

Medical benefit (J0717) vs pharmacy benefit (NDC) UCB CIMplicity verified May 2026

The single most important Cimzia billing decision. Get it wrong and the claim denies before any coding question matters.

Cimzia is a subcutaneous biologic with two legitimate dispensing and billing pathways. Which one applies is determined by where the dose is administered and who buys the drug, not by the indication.

Side-by-side comparison of Cimzia medical and pharmacy benefit billing.
Medical benefit (office-administered)Pharmacy benefit (home self-inject)
SettingPhysician office, infusion suite, clinic, ASCPatient home (self-injection)
Who buys the drugProvider (buy-and-bill) or specialty pharmacy white-bag/brown-bagSpecialty pharmacy ships to patient
Drug code on claimJ0717 + units (1 mg = 1 unit)NDC only — no J0717
Admin code96372 (therapeutic SC) by HCPNone — patient self-administers
Claim formCMS-1500 / 837P (provider) or UB-04 / 837I (HOPD)Pharmacy NCPDP
Insurance benefitCommercial medical, Medicare Part B (incident-to physician), Medicaid medicalCommercial pharmacy, Medicare Part D, Medicaid pharmacy
Patient cost shareMedical deductible + coinsurance (often 20% Part B)Pharmacy tier copay (often Tier 5 specialty)
Copay assistance applies?UCB Cimzia Cost Coverage Support (commercial only)Same UCB program (commercial only)
Most common Cimzia billing error: billing J0717 under the medical benefit when the specialty pharmacy already filled the drug under pharmacy benefit. This produces duplicate-billing denials and recoupment risk. Confirm the dispensing pathway with the SP and the patient's plan BEFORE the encounter.
Medicare specifics: Part B covers J0717 only when the drug is furnished and administered incident to a physician's professional service in the office. Self-injected Cimzia at home is a Part D drug. If the patient has Part B + Part D and the dose is given in office, bill Part B; if the patient self-injects at home, bill Part D via specialty pharmacy.

Dosing & unit math FDA label revised 2025

From the FDA prescribing information; six adult indications across rheumatology, dermatology, and gastroenterology.

Rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA)

  • Loading: 400 mg SC (given as 2 × 200 mg injections at separate sites) at weeks 0, 2, and 4
  • Maintenance: 400 mg q4wk SC OR 200 mg q2wk SC
  • 1 mg = 1 unit → 400 units per loading dose; 200 or 400 units per maintenance dose
  • For RA: may be given as monotherapy or in combination with methotrexate

Plaque psoriasis (PsO)

  • Standard: 400 mg SC every 2 weeks (no separate loading; the q2wk schedule applies from week 0)
  • Body weight ≤90 kg: consider 400 mg SC at weeks 0, 2, and 4 then 200 mg q2wk SC
  • 1 mg = 1 unit → 200 or 400 units per dose

Crohn's disease (adult, after inadequate response to conventional therapy)

  • Loading: 400 mg SC at weeks 0, 2, and 4
  • Maintenance: 400 mg q4wk SC if clinical response is achieved
  • 1 mg = 1 unit → 400 units per dose
  • Pediatric Crohn's is NOT an approved indication for Cimzia in the US

Worked example — first-year billing for an RA patient on 200 mg q2wk maintenance

# Loading: 400 mg at weeks 0, 2, 4 (3 doses)
Units per loading dose: 400 (J0717)
Loading total units (3 × 400): 1,200

# Maintenance: 200 mg q2wk starting week 6 (~24 doses in remaining weeks of year 1)
Units per maintenance dose: 200
Maintenance total units (24 × 200): 4,800

# Year-1 totals
Total doses: 27 · Total units: 6,000
Total drug cost (Q2 2026 ASP+6%): ~$22,740 before sequestration
Admin code: 96372 per encounter when office-administered · Modifier: JZ

No premedication routinely required

Unlike infused biologics (Remicade, Tysabri, Ocrevus), Cimzia does not require pre-administration steroid or antihistamine premedication. Manage injection-site reactions or the rare hypersensitivity reaction per FDA label.

Presentations & NDC FDA NDC Directory verified May 2026

PresentationNDC (10-digit)Notes
200 mg/mL single-dose prefilled syringe (Starter Kit, 2 × 200 mg) 50474-700-79 Standard for self-injection and office administration; ready-to-use, no reconstitution
200 mg lyophilized powder single-dose vial (kit with diluent) 50474-710-62 Requires reconstitution with sterile water for injection; primarily HCP-administered
200 mg/mL prefilled e-Device (UCB AutoClicks / SmartJect) Verify on UCB CIMplicity Patient-friendly device for self-injection; ergonomic alternative to syringe
Use carton-level NDC, not vial- or syringe-level when payer expects 11-digit format. Convert 10-digit to 11-digit by inserting the leading zero in the segment with 4 digits (e.g., 50474-700-7950474-0700-79). Use N4 qualifier on CMS-1500 24A shaded area.
HCPCS J0717 excludes biosimilars. As of May 2026, no biosimilar to certolizumab pegol has been FDA-approved in the US. Any future biosimilar would receive its own permanent Q-code, not bill under J0717.
Phase 2 Code the claim SC injection means CPT 96372 — not 96365 or 96413. Get this right or claim denies.

Administration codes CPT verified May 2026

Cimzia is a SUBCUTANEOUS injection — the admin code reflects that. Do NOT bill IV admin codes.

CodeDescriptionWhen to use
96372 Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular Primary code for office-administered Cimzia. Standard non-chemo SC therapeutic admin code for anti-TNF biologics.
96401 Chemotherapy administration, SC/IM; non-hormonal anti-neoplastic Some payers accept 96401 for biologic SC administration. Cimzia is non-oncologic; check payer policy. 96372 is the safer default.
96365 / 96366 Therapeutic IV infusion (non-chemo) NOT appropriate. Cimzia is NEVER given IV. Billing 96365 will trigger denial and audit risk.
96413 / 96415 Chemotherapy IV infusion NOT appropriate. Cimzia is SC, not IV, and is not classified as chemotherapy admin.
Two injections, one encounter: the 400 mg dose is administered as 2 × 200 mg injections at separate anatomic sites. Most payers reimburse 96372 once per encounter regardless of the number of injections given of the same drug. Check payer policy before billing 96372 × 2 — some payers explicitly disallow it for the same drug at the same encounter.
Why SC therapeutic admin (96372), not chemo admin (96401): Cimzia is a non-oncologic biologic. CPT chemo admin codes 96401–96425 apply to anti-neoplastic and certain immunotherapy agents. For anti-TNF biologics like Cimzia, Humira, Enbrel, and Simponi, 96372 is the standard SC therapeutic admin code. Some commercial payers historically accepted 96401 for biologic SC; verify per payer.
Patient self-injection at home: no admin code is billed. The drug is dispensed via specialty pharmacy under pharmacy benefit. Do not submit J0717 or 96372 if the patient self-injects.

Modifiers CMS verified May 2026

JZ — required on virtually every medical-benefit claim

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Cimzia 200 mg/mL prefilled syringes and 200 mg lyophilized vials are both single-dose containers. The 200 mg dose uses one syringe with zero waste; the 400 mg dose uses two syringes with zero waste. JZ applies to virtually every J0717 medical-benefit claim.

JW — rarely applies with prefilled syringes

JW reports the discarded portion of a single-dose container. Because Cimzia syringes are pre-measured at 200 mg and the labeled doses (200 or 400 mg) are exact multiples, partial-vial waste is uncommon. JW may apply only if a clinician draws a partial dose from the lyophilized-vial preparation and discards the remainder. One of JZ or JW must be on every J0717 claim under medical benefit.

Modifier 25 — same-day E/M

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. Routine pre-injection clinical assessment is bundled into 96372.

340B modifiers (JG, TB)

For 340B-acquired Cimzia administered under medical benefit, follow your MAC's current 340B modifier policy. Self-injected pharmacy-benefit dispensing is not subject to 340B medical claim modifiers.

ICD-10-CM by indication FY2026 verified May 2026

Six FDA-approved adult indications. Use the most specific code supported by encounter documentation.

IndicationICD-10 familyNotes
Rheumatoid arthritis (seropositive / seronegative)M05.x (seropositive) / M06.x (other)Most common Cimzia indication; payer step therapy from MTX/csDMARD typical
Psoriatic arthritisL40.5x (arthropathic psoriasis) / M07.x (psoriatic and enteropathic arthropathies)Combined dermatologic + joint disease
Ankylosing spondylitisM45.xSpecify region (cervical, thoracic, lumbar, etc.)
Non-radiographic axial spondyloarthritis (nr-axSpA)M46.8 (other specified inflammatory spondylopathies) or per payer policyRequires objective signs of inflammation (elevated CRP or MRI findings); document carefully
Plaque psoriasis (moderate-to-severe)L40.0 (psoriasis vulgaris) / L40.x per subtypeBSA ≥10% or PASI/DLQI thresholds typical for PA
Crohn's disease (adult, after conventional therapy)K50.x (specify location: small intestine K50.0x, large intestine K50.1x, both K50.8x, unspecified K50.9x; with/without complications)Pediatric Crohn's NOT an approved indication; do not use K50.x for pediatric patients on Cimzia PA
Indication-specific PA criteria are universal. All major payers require ICD-10 code, prior conventional therapy documentation (e.g., MTX failure for RA, 5-ASA/steroid for Crohn's, topicals and phototherapy for PsO), and often step therapy through preferred TNFi (Humira/Enbrel) before approving Cimzia. The ICD-10 code alone is not sufficient.

Site of care & place of service Verified May 2026

Most commercial Cimzia volume is patient self-injection at home under pharmacy benefit. Office administration accounts for the medical-benefit J0717 claim volume and is subject to standard site-of-care UM for biologics.

SettingPOSClaim formBenefit / payer steering
Patient home (self-injection)n/aPharmacy NCPDPMost common pathway. Pharmacy benefit; SP-dispensed
Physician office (rheumatology, derm, GI)11CMS-1500 / 837PMedical benefit; preferred by commercial UM when office-administered
Ambulatory infusion suite49CMS-1500 / 837PAcceptable; less common for SC-only drugs
Hospital outpatient (on-campus)22UB-04 / 837IDisfavored; commercial site-of-care UM steers SC biologics out of HOPD
Hospital outpatient (off-campus PBD)19UB-04 / 837IDisfavored
Why office or home wins for Cimzia: SC injection takes seconds and requires no infusion chair, no nursing supervision beyond the injection itself, and no observation period. Commercial payers will not authorize HOPD administration of an SC biologic in nearly all cases.

Claim form field mapping (medical benefit) UCB CIMplicity 2026

For office-administered Cimzia under the medical benefit. Pharmacy-benefit self-injection uses NCPDP, not CMS-1500.

InformationCMS-1500 boxNotes
NPI17bRendering provider
NDC qualifier + 11-digit NDC + UoM + qty24A shaded areaN4 + carton NDC + ML + total volume (1 mL for 200 mg, 2 mL for 400 mg)
HCPCS J0717 + JZ (or JW if waste)24D (drug line)JZ on virtually every claim — single-dose syringe, no waste
Drug units24G200 (200 mg dose) or 400 (400 mg dose)
CPT 96372 (admin line)24D (admin line)Therapeutic SC, non-chemo
ICD-1021Indication-specific (see ICD-10 table)
PA number23Required by all major commercial payers
TB screening documentationchartMaintain in chart for audit; payers may request copy as part of PA
Phase 3 Get paid PA is universal. Step therapy from preferred TNFi is the most common approval barrier.

Payer policy snapshot + step therapy Reviewed May 2026

All major commercial payers require PA. Step therapy through Humira or Enbrel is common; the pregnancy use case can drive an exception.

PayerPA?Step therapyNotes
UnitedHealthcare
Pharmacy & medical drug policies
Yes Step from preferred TNFi (Humira / Enbrel) typical for RA, PsA, PsO, AS Pregnancy / planning pregnancy is recognized exception; Crohn's typically step from infliximab or adalimumab
Aetna
CPB + Medical Drug policies
Yes Step therapy varies by plan; many plans require failure of one preferred TNFi Aetna recognizes pregnancy exception; nr-axSpA requires objective inflammation documentation
BCBS plans
Vary by plan
Yes Step therapy in most commercial plans; Federal Employee Program follows tiered formulary Some BCBS plans now require biosimilar adalimumab trial first
Cigna / Express Scripts
Accredo SP-aligned
Yes Step therapy through Humira biosimilar typical SP-dispensed under pharmacy benefit
Medicare Part B
when office-administered
No (FFS); MA plans may require None at FFS Medicare Advantage plans frequently apply commercial-style PA + step
Medicare Part D
when self-injected
Yes (formulary tier) Tier 5 specialty typical; PA per plan Patient OOP is often substantial; refer to copay assistance pathways below

Pre-treatment screening required by all payers (and the FDA label)

  • TB screening (PPD or IGRA) — baseline before initiation, with treatment of latent TB infection (LTBI) prior to or concurrent with Cimzia start
  • Hepatitis B serology — risk of HBV reactivation in chronic carriers
  • Vaccination status review — live vaccines should be brought up to date BEFORE starting Cimzia (no live vaccines while on therapy)
  • Heart failure screening — TNFi caution in NYHA III/IV CHF
  • Demyelinating disease history — TNFi caution in MS or optic neuritis history
TB screening is non-negotiable. Document PPD or IGRA result, date, and any LTBI treatment in the chart and PA submission. Payers commonly request this documentation; missing TB screening is a frequent cause of PA denials and downstream audit findings.

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter. Applies only when J0717 is billed (office-administered, Part B).

Q2 2026 payment snapshot — J0717

Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions

ASP + 6%
$3.790
per mg / per unit
200 mg dose (q2wk)
$758.00
200 units × ASP+6%
400 mg dose (loading or q4wk)
$1,516.00
400 units × ASP+6%
Annualized cost (medical benefit, ASP+6%): 200 mg q2wk × 26 doses + 3 loading doses (400 mg) = ~$5,548 (loading) + ~$19,708 (maintenance) = ~$25,256 year-1; steady-state ~$19,708/year. 400 mg q4wk × 13 doses + 3 loading = same total drug volume. After ~2% sequestration, actual paid is roughly ASP + 4.3%.

Coverage

No NCD specific to certolizumab pegol. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J0717 for FDA-approved on-label indications when administered incident-to a physician's service with appropriate ICD-10 documentation.

Code history

  • J0717 — permanent code, "Injection, certolizumab pegol, 1 mg (code may be used for Medicare when drug administered under direct supervision of a physician, not for use when drug is self-administered)" — reflects the medical-benefit-only nature of J0717
  • Prior to permanent code: billed under unclassified J3490 / J3590

Patient assistance — UCB CIMplicity UCB verified May 2026

  • UCB CIMplicity: 1-844-246-9425 (1-844-2-CIMZIA) / cimzia.com — benefits investigation, PA support, appeal assistance, nurse support
  • Cimzia Cost Coverage Support (commercial copay program): eligible commercially-insured patients may pay as little as $0 per dose, up to $20,000/year; excludes Medicare, Medicaid, TRICARE, VA, and other federal program patients
  • Cimzia Patient Assistance Program: free drug for uninsured / underinsured patients meeting income requirements; administered through UCB's PAP
  • Bridge program: short-term free drug while PA is in process for commercially-insured patients with documented coverage
  • Foundations (for Medicare patients): refer to PAN Foundation, HealthWell Foundation — verify open RA / PsA / Crohn's / PsO funds quarterly
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and OOP max? Run a CareCost Estimate — J0717 pre-loaded.
Phase 4 Fix problems Wrong admin code (96365 instead of 96372), missing TB documentation, and benefit-pathway mix-ups are the top three.

Common denials & how to fix them

Denial reasonCommon causeFix
Wrong admin code (96365 / 96413)IV admin code billed for SC injectionResubmit with 96372. Cimzia is SC, never IV. Update biller education.
Duplicate billing (medical + pharmacy)J0717 billed under medical benefit when SP already filled it under pharmacy benefitVerify dispensing pathway with SP and patient's plan BEFORE encounter. Reverse the duplicate claim and bill only the appropriate pathway.
Missing TB screening documentationPA submitted without PPD/IGRA resultSubmit PPD or IGRA result + LTBI treatment plan if positive. Required by FDA label and every payer policy.
Step therapy not metCimzia requested before trial of preferred TNFi (Humira / Enbrel / biosimilar)Document failure / intolerance / contraindication to preferred TNFi. Pregnancy or planning pregnancy is a recognized exception — cite the Fc-free clinical advantage.
JZ missing on adult claimSingle-dose syringe claim without JZResubmit with JZ. Required since 7/1/2023 on every J0717 medical-benefit claim with no waste.
Wrong NDC format10-digit NDC submitted when payer requires 11-digitConvert to 11-digit (e.g., 50474-700-7950474-0700-79). Use N4 qualifier.
Site of care (HOPD)HOPD administration of an SC biologicMove to office (POS 11) or to home self-injection via pharmacy benefit. Commercial payers will not authorize HOPD for SC biologics in most cases.
nr-axSpA without objective inflammationPA submitted without elevated CRP or MRI findingsDocument either elevated CRP or MRI evidence of active inflammation; required by FDA label and PA criteria.
Pediatric Crohn's PACimzia requested for pediatric Crohn's patientPediatric Crohn's is NOT an FDA-approved Cimzia indication. Use alternative TNFi with pediatric Crohn's labeling (e.g., infliximab, adalimumab).
Self-injection billed as medical benefitJ0717 + 96372 submitted when patient self-injected at homeReverse claim. Self-injection is pharmacy benefit only; no medical-benefit claim is appropriate.

Frequently asked questions

What is the HCPCS code for Cimzia?

Cimzia (certolizumab pegol) is billed under HCPCS J0717 — "Injection, certolizumab pegol, 1 mg." Each milligram equals one billable unit. The standard 400 mg loading dose (weeks 0, 2, 4) is billed as 400 units; 200 mg q2wk maintenance is billed as 200 units; 400 mg q4wk maintenance is billed as 400 units.

Is Cimzia billed under medical or pharmacy benefit?

It depends on where it is administered. When administered in a physician office, infusion suite, or clinic and the provider buys-and-bills, Cimzia is billed under the MEDICAL benefit using HCPCS J0717. When the patient self-injects at home from a specialty pharmacy fill, it is billed under the PHARMACY benefit using NDC, not J0717. Many commercial payers and Medicare Part D plans push Cimzia to pharmacy benefit; Medicare Part B covers J0717 only when furnished and administered incident-to a physician's service. Always verify benefit pathway before submitting the claim.

What administration CPT do I use for Cimzia?

When administered in office, use CPT 96372 — "Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular." Cimzia is a SUBCUTANEOUS injection — NOT IV — so do NOT bill 96365 (therapeutic IV) or 96413 (chemo IV). Some payers accept 96401 (chemo SC) for biologic SC, but 96372 is the standard non-chemo SC code for anti-TNF biologics.

Do I bill JZ or JW for Cimzia?

Bill JZ on Cimzia claims when administered from a single-dose prefilled syringe or single-dose vial with no waste — the standard scenario. The 400 mg dose uses two 200 mg syringes with zero waste. JW only applies if a partial dose is drawn and the remainder discarded (uncommon with prefilled syringes). One of JZ or JW must be on every J0717 claim under medical benefit per CMS's July 2023 single-dose container policy.

What is the Medicare reimbursement for J0717?

For Q2 2026, the Medicare Part B payment limit for J0717 is $3.790 per mg (ASP + 6%). The 400 mg loading dose reimburses at approximately $1,516.00; the 200 mg q2wk maintenance dose at approximately $758.00; the 400 mg q4wk maintenance dose at approximately $1,516.00. Annualized cost (Medicare ASP+6%) maintenance ~$19,708. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.

What indications is Cimzia approved for?

Cimzia is FDA-approved for six adult indications: (1) moderately to severely active rheumatoid arthritis (RA), (2) active psoriatic arthritis (PsA), (3) active ankylosing spondylitis (AS), (4) active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, (5) moderate-to-severe plaque psoriasis (PsO), and (6) moderate-to-severe Crohn's disease in adults with inadequate response to conventional therapy. Pediatric Crohn's and pediatric uveitis are NOT approved indications.

Why is Cimzia often preferred over other TNFi in pregnancy?

Cimzia is a PEGylated humanized antibody Fab′ fragment — it lacks an Fc region. Placental transfer of antibodies is mediated by the FcRn receptor binding to the Fc portion of IgG. Without an Fc, certolizumab pegol shows minimal active placental transfer (CRIB study: median infant cord blood concentration <0.41 µg/mL vs maternal 24 µg/mL at delivery). For patients requiring TNFi during pregnancy, Cimzia is often preferred over Humira, Enbrel, Remicade, and Simponi — all of which are full IgG with active placental transfer in the third trimester. ACR, EULAR, and the AGA pregnancy in IBD guideline all reflect this.

What is the boxed warning for Cimzia?

Cimzia carries a class-wide TNF blocker boxed warning with two components: (1) SERIOUS INFECTIONS — increased risk including active TB (often disseminated or extrapulmonary, including reactivation of latent TB), invasive fungal infections (histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis), and bacterial, viral, and other opportunistic pathogens; mandatory pre-treatment TB screening (PPD or IGRA) and hepatitis B screening required. (2) MALIGNANCIES — lymphoma and other malignancies, some fatal, in children and adolescents treated with TNF blockers; postmarketing reports of hepatosplenic T-cell lymphoma (HSTCL) primarily in adolescent and young adult males with IBD treated with TNFi plus thiopurines (azathioprine, 6-MP). Discontinue Cimzia if the patient develops a serious infection or sepsis.

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

Source documents

  1. UCB Cimzia HCP and patient site
    UCB Inc. official product website (Smyrna, GA / Brussels, Belgium)
  2. DailyMed — CIMZIA (certolizumab pegol) Prescribing Information
    FDA-approved label, most recent revision 2025
  3. FDA Cimzia label PDF (Drugs@FDA)
  4. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file, effective April 1 – June 30, 2026; J0717 = $3.790/mg
  5. CMS HCPCS Level II quarterly file — J0717 descriptor
  6. UCB CIMplicity patient & HCP support program
    1-844-246-9425; benefits investigation, PA, copay assistance, PAP
  7. UnitedHealthcare medical and pharmacy drug policies (TNFi class)
  8. Aetna CPB — TNF-alpha inhibitors (Cimzia covered)
  9. ACR clinical practice guidelines — RA, PsA, AS
    Including ACR reproductive health guideline (Cimzia in pregnancy)
  10. AGA — pregnancy in IBD guidance
  11. CRIB study — Mariette et al., Ann Rheum Dis 2018 (placental transfer of certolizumab pegol)
  12. FDA National Drug Code Directory

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. Coding and policy 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 ASP pricingQuarterlyAuto-bound to CareCost ASP layer; updates on CMS file release.
Payer policies (UHC, Aetna, BCBS, Cigna)Semi-annualManual review against published payer policy documents.
HCPCS / CPT / modifier rulesAnnualReviewed against CMS HCPCS quarterly files and AMA CPT releases.
NDC, dosing, FDA label, indication listEvent-drivenTied to UCB document version + FDA label revision date.
UCB CIMplicity benefits + copay program detailsAnnualVerified against UCB's published HCP and patient resources.

Reviewer

Pending SME review. This page is staff-authored from primary sources (FDA, CMS, UCB, payer documents, ACR/EULAR/AGA guidelines — all linked above). Editorial review in progress. Until that review is complete, treat this as a draft reference and verify each cited source for high-stakes claims.

Change log

  • — Initial publication. ASP data: Q2 2026 ($3.790/mg). Manufacturer source: UCB CIMplicity 2026. FDA label: 2025 revision. Six FDA-approved adult indications (RA, PsA, AS, nr-axSpA, plaque PsO, Crohn's). Medical vs pharmacy benefit pathway disambiguation called out as primary billing decision.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list is verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.

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