HCPCS
J1602
1 mg = 1 unit
Phase 1
Identify what you're billing
Confirm you're billing the IV form, not the SC autoinjector.
Simponi Aria (IV) vs. Simponi (SC) FDA verified 2025
Same molecule (golimumab), entirely different billing pathway. The most common Simponi Aria coding error is treating the SC and IV forms as interchangeable.
Janssen markets golimumab in two formulations: the original subcutaneous Simponi (autoinjector or prefilled syringe, FDA-approved April 2009) and the intravenous Simponi Aria (FDA-approved July 2013). They share an active ingredient but diverge on every billing dimension — benefit type, J-code, dose, site of care, and patient assistance program.
| Simponi Aria (IV) | Simponi (SC) | |
|---|---|---|
| HCPCS | J1602 | None — pharmacy benefit, NDC-level billing |
| Generic | golimumab | golimumab |
| Benefit | Medical (provider buy-and-bill) | Pharmacy (specialty pharmacy) |
| FDA approval | July 2013 (BLA 125433) | April 2009 (BLA 125289) |
| Adult dose | 2 mg/kg IV at wks 0, 4, then q8wk | 50 mg SC monthly (100 mg for UC) |
| Administration | 30-min IV infusion in office/AIC/HOPD | SC autoinjector or prefilled syringe (patient self-admin) |
| Admin CPT | 96365 + 96366 if needed (non-chemo) | None — self-administered |
| Indications | RA (+MTX), PsA, AS, polyarticular JIA | RA, PsA, AS, ulcerative colitis |
| Manufacturer | Janssen Biotech (J&J) | Janssen Biotech (J&J) |
| Patient program | Janssen CarePath (Simponi Aria Savings Program) | Janssen CarePath (Simponi Savings Program) |
Cannot substitute SC for IV (or vice versa) without a separate prescription and payer authorization.
Different BLAs, different NDCs, different doses, different benefit. The pharmacy benefit will reject IV
Simponi Aria; the medical benefit will reject SC Simponi.
Why the IV form exists: Simponi Aria offers an in-office, monitored alternative to
self-injection for patients who prefer chair-time admin or have adherence concerns with SC. The 8-week
maintenance interval (vs Remicade's q8wk after loading at q2/q6) is competitive with infliximab in the
TNFi market without infliximab's higher infusion-reaction rate.
Dosing & unit math FDA label 2025
From the FDA prescribing information for Simponi Aria (BLA 125433).
Adult dosing — RA, PsA, AS
- 2 mg/kg IV at weeks 0 and 4 (loading)
- Then 2 mg/kg IV every 8 weeks (maintenance)
- RA requires concurrent methotrexate per FDA label and most payer PA criteria
- 1 mg = 1 unit — bill the actual mg administered
- Year 1: 9 doses (2 loading + 7 maintenance); Year 2+: ~6.5 doses/year
Pediatric dosing — polyarticular JIA (≥2 years)
- 80 mg/m² IV (maximum 240 mg) at weeks 0 and 4, then every 8 weeks
- Body surface area (BSA) calculation required — commonly Mosteller formula: BSA = sqrt(height_cm × weight_kg / 3600)
- Bill the actual mg administered (rounded to nearest mg)
Worked example — 70 kg adult RA patient, year 1
# Per-dose calculation
Weight: 70 kg · Dose: 2 mg/kg = 140 mg
Vials needed: 3 × 50 mg vials (150 mg drawn)
Administered: 140 mg · Discarded: 10 mg
# Billing lines
J1602 with JZ: N/A this dose (waste exists, use JW)
J1602 (administered): 140 units
J1602 with JW (discarded): 10 units
Admin: 96365 (30-min IV infusion, non-chemo)
# Year-1 totals (9 doses: weeks 0, 4, 12, 20, 28, 36, 44, 52 + 60-ish)
Total drug units billed: ~1,260 administered + ~90 waste = 1,350
Total drug cost (Q2 2026 ASP+6%): ~$15,237 before sequestration
Weight: 70 kg · Dose: 2 mg/kg = 140 mg
Vials needed: 3 × 50 mg vials (150 mg drawn)
Administered: 140 mg · Discarded: 10 mg
# Billing lines
J1602 with JZ: N/A this dose (waste exists, use JW)
J1602 (administered): 140 units
J1602 with JW (discarded): 10 units
Admin: 96365 (30-min IV infusion, non-chemo)
# Year-1 totals (9 doses: weeks 0, 4, 12, 20, 28, 36, 44, 52 + 60-ish)
Total drug units billed: ~1,260 administered + ~90 waste = 1,350
Total drug cost (Q2 2026 ASP+6%): ~$15,237 before sequestration
Worked example — 75 kg adult, no waste
# Per-dose calculation
Weight: 75 kg · Dose: 2 mg/kg = 150 mg
Vials needed: 3 × 50 mg vials (150 mg drawn)
Administered: 150 mg · Discarded: 0 mg
# Billing lines
J1602 with JZ: 150 units
Admin: 96365 (30-min IV infusion, non-chemo)
Per-dose Medicare reimbursement: ~$1,693 (ASP+6%)
Weight: 75 kg · Dose: 2 mg/kg = 150 mg
Vials needed: 3 × 50 mg vials (150 mg drawn)
Administered: 150 mg · Discarded: 0 mg
# Billing lines
J1602 with JZ: 150 units
Admin: 96365 (30-min IV infusion, non-chemo)
Per-dose Medicare reimbursement: ~$1,693 (ASP+6%)
No premedication routinely required
Unlike infliximab (Remicade) and certain anti-CD20 antibodies, Simponi Aria does not require routine premedication. Manage infusion reactions per FDA label if they occur. Some institutions still give prophylactic acetaminophen and diphenhydramine for high-risk patients — this is institutional protocol, not FDA-mandated.
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Package | Use |
|---|---|---|
57894-070-02 / 57894-0070-02 |
50 mg / 4 mL (12.5 mg/mL) single-dose vial — 1 vial per carton | All Simponi Aria adult and pediatric dosing |
Use carton-level NDC, not vial-level. Payers expect the carton NDC on the claim form.
Multi-vial doses use multiple cartons of the same NDC. Simponi Aria has only one strength (50 mg / 4 mL)
— there is no 100 mg or 200 mg presentation.
Simponi (SC) NDCs — for reference only, do NOT bill under J1602:
57894-070-01 (50 mg autoinjector), 57894-071-01 (100 mg autoinjector),
57894-070-03 (50 mg prefilled syringe), 57894-071-03 (100 mg prefilled syringe).
These are pharmacy-benefit products dispensed through specialty pharmacy.
Phase 2
Code the claim
Therapeutic IV admin codes apply — golimumab is a non-cytotoxic biologic.
Administration codes CPT verified May 2026
Simponi Aria is billed with non-chemotherapy IV infusion codes. Do NOT use chemo admin codes.
| Code | Description | When to use |
|---|---|---|
96365 |
Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour | Primary code for Simponi Aria. 30-minute standard infusion fits within the 1-hour window. |
96366 |
Intravenous infusion; each additional hour | Use only if infusion is extended beyond 60 minutes (rare for Simponi Aria monotherapy). |
96413 / 96415 |
Chemotherapy administration, IV infusion technique | NOT appropriate. Golimumab is a non-cytotoxic biologic TNF inhibitor and does not qualify for chemo admin codes per AMA CPT classification. |
Do not bill 96413 for Simponi Aria. Chemotherapy administration codes (96409–96425)
are reserved for cytotoxic agents and complex monoclonal antibodies classified as antineoplastic. Golimumab
is an anti-TNF biologic and bills under therapeutic IV codes 96365/96366. Submitting 96413 will be denied
as inappropriate code selection and may trigger a payer audit.
Modifiers CMS verified May 2026
JZ — required when no waste
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. For Simponi Aria, JZ applies when the patient's weight produces a dose evenly divisible by 50 mg (e.g., 50 kg → 100 mg / 2 vials; 75 kg → 150 mg / 3 vials). Bill JZ on the single drug line.
JW — weight-based waste is common
With a 50 mg single-dose vial and weight-based dosing, partial-vial waste is the rule rather than the exception. Example: a 70 kg patient receiving 140 mg uses three 50 mg vials, draws 150 mg, administers 140 mg, discards 10 mg. Bill the administered units (140) on one line and the discarded units (10) on a separate JW line. One of JZ or JW must be on every J1602 claim per CMS's July 2023 single-dose container policy.
Common error: Forgetting to report the waste line. CMS audits commonly catch this —
the wasted drug is reimbursable but must be reported with JW. Underbilling waste is also revenue left on
the table.
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 infusion. Routine pre-infusion clinical assessment (vitals, adverse-event check) is bundled into the admin code.
340B modifiers (JG, TB)
For 340B-acquired Simponi Aria, follow your MAC's current 340B modifier policy. Janssen's billing guide does not provide 340B-specific instructions.
ICD-10-CM by indication FY2026 verified May 2026
Use the most specific code supported by encounter documentation.
| Indication | ICD-10 family | Notes |
|---|---|---|
| Rheumatoid arthritis (seropositive) | M05.x | Site-specific 4th/5th characters; concurrent MTX required |
| Rheumatoid arthritis (other / seronegative) | M06.x | Includes M06.0 (seronegative), M06.4 (inflammatory polyarthropathy), M06.9 (RA unspecified); concurrent MTX required |
| Psoriatic arthritis (PsA) | L40.5x / M07.x | L40.50 (arthropathic psoriasis unspec); M07.0–M07.6 for specific joint involvement |
| Ankylosing spondylitis (AS) | M45.x | Site-specific 4th character (cervical, thoracic, lumbar, sacral) |
| Polyarticular JIA (≥2 yr) | M08.x | M08.0 (RA-like JIA), M08.2 (systemic onset), M08.3 (polyarticular RF-neg), M08.4 (pauciarticular) |
| Crohn's disease | K50.x | NOT approved — do not bill J1602 for Crohn's; use Stelara, Entyvio, or Remicade instead |
| Ulcerative colitis | K51.x | NOT approved for Simponi Aria. Simponi (SC) is approved for UC; Simponi Aria is not. |
| Plaque psoriasis | L40.0 | NOT approved. Use Stelara, Cosentyx, or other IL-17/IL-23 inhibitors. |
Indication discipline matters. Simponi Aria has only four FDA-approved indications:
RA, PsA, AS, and pJIA. Off-label uses (UC, Crohn's, plaque psoriasis) will be denied by payer PA. The SC
Simponi has UC; Simponi Aria does not.
Site of care & place of service Verified May 2026
Most commercial payers run site-of-care UM for IV biologics including Simponi Aria. UnitedHealthcare, Aetna, and major BCBS plans steer non-oncology biologics out of HOPD into office or AIC settings after initial dose tolerability is established.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Rheumatology office | 11 | CMS-1500 / 837P | Preferred by commercial UM |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored after initial dose |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored after initial dose |
| Patient home | 12 | CMS-1500 (home infusion) | Acceptable with home infusion vendor; verify per-payer |
Home infusion is feasible for Simponi Aria given the 30-min infusion time, low
infusion-reaction rate, and absence of routine premedication. Home infusion vendors (Option Care,
CVS Specialty, Coram) can administer with payer authorization. Use S9329 + 99601/99602 for home admin
codes (verify per-payer).
Claim form field mapping Janssen 2025
From Janssen CarePath HCP coding & coverage materials.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 57894-0070-02 + ML + total volume drawn (e.g., 12 mL for 150 mg) |
| HCPCS J1602 + JZ (or administered units) | 24D (drug line) | Bill actual mg administered as units |
| HCPCS J1602 + JW (waste line, if any) | 24D (separate line) | Discarded mg as units; required when partial vial waste |
| Drug units | 24G | Actual mg administered (e.g., 140 for 70 kg patient) |
| CPT 96365 (admin line) | 24D (admin line) | 30-min infusion fits within 1-hour window |
| ICD-10 | 21 | Indication-specific (M05.x, M06.x, L40.5x/M07.x, M45.x, M08.x) |
| PA number | 23 | Required by all major commercial payers |
Phase 3
Get paid
Step therapy and concurrent MTX documentation are the two most common PA gates.
Payer policy snapshot + step therapy Reviewed May 2026
Most commercial payers require a TNFi step before Simponi Aria for RA, PsA, and AS. Medicare LCDs cover all four FDA indications without step therapy.
| Payer | PA? | Step therapy | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Medical Drug Policy |
Yes | Trial & failure of at least one preferred TNFi (typically Humira or Remicade) for RA/PsA/AS; concurrent MTX required for RA | Yes — non-oncology biologics steered out of HOPD via Optum-managed program |
| Aetna CPB + Medical Drug policies |
Yes | Step from Humira or Remicade typical for RA/PsA/AS; some plans accept Cimzia or Enbrel | Yes — separate Site-of-Care policy |
| BCBS plans Vary by plan |
Yes | Most require TNFi step for RA/PsA/AS; criteria align with ACR rheumatology guidelines | Plan-specific; most have biologic site-of-care steering |
| Medicare (Part B) MAC LCDs |
No (typically) | None — covers all FDA-approved indications | No — Medicare does not impose site-of-care UM on Part B drugs |
Concurrent methotrexate for RA
FDA labeling requires Simponi Aria to be used in combination with methotrexate for RA. UnitedHealthcare, Aetna, and most BCBS plans enforce this in their PA criteria — PA submissions should document the current MTX dose, route, and duration. MTX intolerance or contraindication must be documented if MTX cannot be continued.
TB screening pre-therapy
Required: Document baseline TB screening (PPD or IGRA + chest X-ray) in the chart and PA
submission. Patients with latent TB must complete or be on appropriate TB therapy before initiating
Simponi Aria. Many payer denials cite missing or expired TB screening — rescreen annually.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J1602
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$11.287
per mg / per unit
140 mg dose (70 kg)
$1,580.18
140 units × ASP+6%
200 mg dose (100 kg)
$2,257.40
200 units × ASP+6%
Annualized cost (Year 1): 9 doses (2 loading + 7 maintenance) × weight-based mg.
For a 70 kg patient at 140 mg/dose: ~$14,222/year (Medicare ASP+6%, drug only, before sequestration).
For a 100 kg patient at 200 mg/dose: ~$20,317/year.
After ~2% sequestration: actual paid is roughly ASP + 4.3%.
Year 2+: ~6.5 doses/year — cost drops by roughly 30% vs Year 1.
Coverage
No NCD specific to golimumab. Coverage falls under MAC LCDs for biologics. All MACs cover J1602 for the four FDA-approved indications (RA, PsA, AS, pJIA) with appropriate ICD-10 documentation. Off-label use for UC, Crohn's, or plaque psoriasis is not covered.
Code history
- J1602 — permanent code, descriptor "Golimumab, for intravenous use, 1 mg" (also seen as "Golimumab for iv use 1mg")
- Initial FDA approval July 2013; permanent J-code assigned shortly thereafter (pre-J1602 period used unclassified J3490)
Patient assistance — Janssen CarePath Janssen verified May 2026
- Janssen CarePath: 1-877-CarePath (1-877-227-3728) / janssencarepath.com — benefits investigation, prior authorization assistance, appeal support, infusion-site coordination
- Simponi Aria Savings Program: commercial copay support — eligible commercially-insured patients pay as little as $5 per dose, up to $20,000 per year (excludes Medicare, Medicaid, federal program patients)
- Johnson & Johnson Patient Assistance Foundation: free product for uninsured / underinsured patients meeting income requirements (jjpaf.org)
- Independent foundations (for Medicare patients): refer to PAN, HealthWell, Good Days, CancerCare — verify open rheumatology funds quarterly. Funds open and close frequently.
- Web: simponiariahcp.com
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J1602 pre-loaded.
Phase 4
Fix problems
Wrong admin code, missing TB screening, and SC/IV confusion are the top three.
Boxed warning & key safety information FDA label 2025
BOXED WARNING — SERIOUS INFECTIONS AND MALIGNANCIES.
- Serious infections: increased risk leading to hospitalization or death — including active tuberculosis (often disseminated or extrapulmonary), invasive fungal infections (histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis), bacterial sepsis, viral infections, and other opportunistic infections.
- Tuberculosis: patients with latent TB may develop active disease while on therapy. Test for latent TB before and during therapy. Initiate treatment for latent TB before starting Simponi Aria.
- Malignancies: lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers. Hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma with very aggressive disease course and usually fatal, has been reported primarily in adolescent and young adult males with Crohn's disease or ulcerative colitis being treated with TNF blockers, including azathioprine or 6-mercaptopurine.
Other significant warnings & precautions
- Hepatitis B reactivation: screen all patients for HBV before initiation. HBV carriers can experience reactivation, sometimes fatal. Monitor for clinical and laboratory signs throughout therapy and for several months after discontinuation.
- Demyelinating disorders: new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and Guillain-Barré syndrome, has been reported. Caution in patients with pre-existing or recent-onset CNS demyelinating disorders.
- Heart failure: new or worsening congestive heart failure has been reported with TNF blockers. Caution in patients with heart failure (NYHA Class III/IV); discontinue if new or worsening symptoms develop.
- Lupus-like syndrome: autoantibody formation and rare cases of lupus-like syndrome reported. Discontinue if symptoms suggestive of lupus develop.
- Hypersensitivity reactions: serious systemic hypersensitivity reactions, including anaphylaxis, have been reported. Discontinue immediately if anaphylaxis or other serious hypersensitivity reactions occur.
- Live vaccines: avoid use of live vaccines concurrent with Simponi Aria.
Pre-therapy workup checklist: TB screening (PPD or IGRA + CXR), HBV serology (HBsAg,
anti-HBc), CBC, LFTs, baseline cardiac assessment in patients with HF risk, immunization update before
initiation. Document all in the PA submission to avoid back-and-forth with the payer.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong admin code (96413) | Chemotherapy admin billed for non-chemo biologic | Resubmit with 96365 (+96366 if >1 hr). Golimumab is not a chemo per AMA CPT classification. |
| Step therapy not met | No documented prior TNFi trial & failure | Submit clinical history of Humira/Remicade trial with reason for failure (efficacy or AE). Some plans accept inability to self-inject as justification. |
| RA without concurrent MTX | MTX dose not documented in PA submission | Submit current MTX dose, route, duration. If MTX cannot be continued, document intolerance or contraindication explicitly. |
| TB screening not documented | PPD/IGRA + CXR results missing or expired | Submit current TB screening results (within 12 months). Rescreen annually. |
| JZ/JW missing | Single-dose vial claim without modifier | Add JZ if no waste; JW with discarded units if partial vial. Required since 7/1/2023 on every claim. |
| SC Simponi billed as J1602 | Confusion between SC and IV formulations | SC Simponi bills through specialty pharmacy on the pharmacy benefit, NOT under J1602. Submit a separate Rx to specialty pharmacy. |
| Off-label indication | UC, Crohn's, or plaque psoriasis billed | Simponi Aria has only four indications: RA, PsA, AS, pJIA. UC patients need SC Simponi or different agent. |
| Site of care (HOPD) | HOPD administration after initial dose on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required. |
Frequently asked questions
What is the HCPCS code for Simponi Aria?
Simponi Aria (golimumab for IV use) is billed under HCPCS J1602 — "Golimumab, for
intravenous use, 1 mg." Each milligram equals one billable unit. The subcutaneous Simponi (autoinjector
or prefilled syringe) is a different formulation, dispensed through specialty pharmacy under a pharmacy
benefit, and is NOT billed under J1602.
How many units do I bill for a Simponi Aria dose?
Adult dosing is 2 mg/kg IV at weeks 0 and 4, then every 8 weeks. Bill the actual mg administered: a 70 kg patient receives 140 mg = 140 units; a 100 kg patient receives 200 mg = 200 units. Pediatric pJIA dosing is 80 mg/m² (max 240 mg) at weeks 0 and 4, then q8wk.
What administration CPT do I use for Simponi Aria?
CPT 96365 — "Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial,
up to 1 hour" — for the first hour. Add 96366 for each additional hour beyond the
first. Standard 30-minute infusion fits cleanly within 96365 alone. Do NOT bill 96413/96415 (chemotherapy
administration) — golimumab is a non-cytotoxic biologic.
Do I bill JZ or JW for Simponi Aria?
Both are common because the 50 mg single-dose vial frequently produces waste with weight-based dosing.
A 75 kg patient (150 mg dose) uses three vials with no waste → bill JZ. A 70 kg patient
(140 mg dose) draws 150 mg, administers 140 mg, discards 10 mg → bill 140 administered units +
JW on a 10-unit waste line. One of JZ or JW must be on every J1602 claim per CMS's July 2023
single-dose container policy.
What is the Medicare reimbursement for J1602?
For Q2 2026, the Medicare Part B payment limit for J1602 is $11.287 per mg (ASP + 6%). A 140 mg dose (70 kg patient) reimburses at approximately $1,580.18; a 200 mg dose (100 kg patient) at approximately $2,257.40. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
What indications does Simponi Aria cover?
Four FDA-approved indications: (1) moderate-to-severe active rheumatoid arthritis — combined with methotrexate; (2) active psoriatic arthritis; (3) active ankylosing spondylitis; (4) active polyarticular juvenile idiopathic arthritis in patients 2 years and older. RA combination with methotrexate is FDA-required and most payers enforce concurrent MTX documentation in the prior auth.
Does Simponi Aria require step therapy?
Yes for many commercial plans. UnitedHealthcare and Aetna typically require trial and failure of at least one other TNF inhibitor (commonly Humira or Remicade) before approving Simponi Aria for RA, PsA, or AS. Some plans also require failure of conventional DMARDs. Medicare LCDs cover all four indications without step therapy. Verify per-payer.
How does Simponi Aria differ from Simponi (SC autoinjector)?
Simponi Aria and Simponi share golimumab but are different formulations with different billing pathways.
Simponi Aria is the IV form, billed buy-and-bill under J1602 on the medical benefit. Simponi
(SC autoinjector or prefilled syringe) is dispensed through specialty pharmacy under the pharmacy benefit
with NDC-level billing — there is no J-code for the SC form. Doses also differ: Simponi Aria is
weight-based 2 mg/kg IV; Simponi SC is a flat 50 mg or 100 mg SC monthly. The two cannot be substituted
without a separate prescription and PA.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- Janssen Biotech — Simponi Aria HCP page (coding & coverage)
- DailyMed — SIMPONI ARIA (golimumab) Prescribing Information
- CMS — Medicare Part B Drug ASP Pricing File
- UnitedHealthcare — Simponi Aria Medical Drug Policy
- Aetna CPB — Tumor Necrosis Factor Inhibitors (covers Simponi Aria)
- American College of Rheumatology — RA, PsA, and AS treatment guidelines
- Janssen CarePath — Simponi Aria HCP support resources
- FDA National Drug Code Directory
- CMS — Medicare Coverage Database (MAC LCDs for biologics)
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
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, indication list, boxed warning | Event-driven | Tied to manufacturer document version + FDA label revision date. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS,
manufacturer, payer documents — 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. Manufacturer source: Janssen Biotech / Janssen CarePath (2025). FDA label: 2025 revision (BLA 125433). Four FDA-approved indications: RA (+MTX), PsA, AS, pJIA. Sister formulation Simponi (SC autoinjector/prefilled syringe) referenced for disambiguation but bills through specialty pharmacy, not J1602.
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.