HCPCS
J9381
5 mcg = 1 unit
Phase 1
Identify what you're billing
The 5 mcg unit, 14-day course, and stage 2 T1D criteria are the three things to nail before submitting.
The 5 mcg unit basis — read this twice CMS HCPCS verified May 2026
J9381's unit descriptor is the most unusual in the J-code catalog. Unit math discipline prevents 200× over-billing.
The HCPCS descriptor for J9381 is "Injection, teplizumab-mzwv, 5 mcg." One billable unit equals five micrograms — not one milligram (the most common J-code basis) and not one microgram (occasionally seen for very-low-dose biologics). This basis is the single biggest source of clean-claim errors for Tzield.
| Quantity | = mcg | = mg | = units |
|---|---|---|---|
| 1 unit (J9381) | 5 mcg | 0.005 mg | 1 |
| 1 mcg | 1 mcg | 0.001 mg | 0.2 |
| 5 mcg | 5 mcg | 0.005 mg | 1 |
| 50 mcg | 50 mcg | 0.05 mg | 10 |
| 500 mcg | 500 mcg | 0.5 mg | 100 |
| 1,000 mcg | 1,000 mcg | 1 mg | 200 |
| 1 vial (2 mg / 2 mL) | 2,000 mcg | 2 mg | 400 |
| 1,751 mcg (~1.7 m² Day 14 dose) | 1,751 mcg | 1.751 mg | ~350 |
Top biller errors observed:
- Reading "5 mcg" as "5 mg" → bills 200× too few units (massive underpayment)
- Reading "5 mcg" as "1 mcg" → bills 5× too many units (overpayment, audit risk)
- Billing total mcg as units (forgetting the ×5 conversion) → 5× over-bill
- Mixing up vial mg (2 mg) with units (400 units per vial)
Sanity check formula:
units = ceil(mcg administered / 5). If a Day 14 dose for a 1.7 m² adult is
1.7 × 1,030 = 1,751 mcg, units billed = 1,751 / 5 = 350.2 → round per payer rule (typically 351
units administered + report waste from the vial(s) opened on the JW line).
14-day BSA-based IV course FDA label verified May 2026
From FDA prescribing information, BLA 761183, with pediatric ≥8 yr labeling added 2024.
Tzield is administered as a single 14-day IV course with escalating then maintenance dosing. The course is one-time — not repeated, not annual, not on relapse. All doses are BSA-based (mcg/m²), which means partial-vial waste on most or all 14 days.
| Day | Dose (mcg/m²) | Example 1.7 m² adult | Units billed (J9381) | Phase |
|---|---|---|---|---|
| Day 1 | 65 | ~111 mcg | ~22 | Ramp / loading |
| Day 2 | 125 | ~213 mcg | ~43 | Ramp |
| Day 3 | 250 | ~425 mcg | ~85 | Ramp |
| Day 4 | 500 | ~850 mcg | ~170 | Ramp (max ramp dose) |
| Days 5–14 (10 days) | 1,030 | ~1,751 mcg/day | ~351/day | Maintenance |
| Course total (1.7 m²) | — | ~19,108 mcg | ~3,822 units | One-time course |
14 separate daily admin claims. Each of the 14 daily infusions generates its own claim set:
drug + admin CPT + any same-day E/M with modifier 25. Schedule and billing systems must accommodate 14
consecutive daily visits with no gaps unless clinically required.
Worked example — full course for a 1.7 m² adult
# Day 14 (maintenance) — example
BSA dose: 1.7 m² × 1,030 mcg/m² = 1,751 mcg
Units billed: 1,751 / 5 = 351 units (J9381)
Vials opened: 1 vial (400 units / 2 mg / 2,000 mcg)
Waste: 2,000 - 1,751 = 249 mcg = 50 units on JW line
Admin: 96365 (initial therapeutic IV, up to 1 hr)
# Course total (Day 1 through Day 14)
Total drug: ~19,108 mcg = ~19.1 mg = ~3,822 units
Total daily admin claims: 14
Estimated drug cost (Q2 2026 ASP+6%): ~$146,700 before sequestration
BSA dose: 1.7 m² × 1,030 mcg/m² = 1,751 mcg
Units billed: 1,751 / 5 = 351 units (J9381)
Vials opened: 1 vial (400 units / 2 mg / 2,000 mcg)
Waste: 2,000 - 1,751 = 249 mcg = 50 units on JW line
Admin: 96365 (initial therapeutic IV, up to 1 hr)
# Course total (Day 1 through Day 14)
Total drug: ~19,108 mcg = ~19.1 mg = ~3,822 units
Total daily admin claims: 14
Estimated drug cost (Q2 2026 ASP+6%): ~$146,700 before sequestration
Pediatric patients (≥8 years)
- Same BSA schedule (mcg/m²) applies — pediatric labeling added 2024
- Smaller BSA → smaller daily doses → less drug per visit, but same 14-day cadence
- Pediatric endocrinology is the typical specialty; site-of-care often pediatric infusion suite
Reconstitution and administration
- Vial: 2 mg / 2 mL (1 mg/mL) single-dose
- Dilute to ≤25 mcg/mL in 0.9% sodium chloride
- Administer IV at room temperature over at least 30 minutes
- Do NOT administer undiluted; do NOT mix with other drugs
Stage 2 T1D criteria ADA/ISPAD verified May 2026
The eligibility gate that drives almost every Tzield prior auth.
The FDA-approved indication is "to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients aged 8 years and older with stage 2 type 1 diabetes." Stage 2 T1D is a research-staging concept that became clinically meaningful only when Tzield was approved — payers want documentary proof because there is no single ICD-10 code that captures it.
| Element | Requirement | How to document |
|---|---|---|
| T1D autoantibodies | ≥2 of 5 positive | Lab results: GAD65, IA-2, ZnT8, insulin autoantibody (IAA), islet cell antibody (ICA) |
| Dysglycemia | Abnormal OGTT or HbA1c showing impairment | Lab results + interpretation |
| No overt T1D | Not on insulin, no DKA history, no clinical T1D dx | Clinic note attestation |
| Specialist attestation | Endocrinology (or pediatric endocrinology) | Signed PA letter |
| Age | ≥8 years | DOB on claim |
The 5 T1D-related autoantibodies (memorize):
- GAD65 — glutamic acid decarboxylase
- IA-2 — insulinoma-associated antigen 2 (tyrosine phosphatase)
- ZnT8 — zinc transporter 8
- IAA — insulin autoantibody
- ICA — islet cell antibody
Required pre-treatment testing FDA label verified May 2026
Order this checklist before submitting the PA. Missing labs are a top denial driver.
| Test | Purpose | Timing |
|---|---|---|
| T1D autoantibody panel (GAD65, IA-2, ZnT8, IAA, ICA) | Confirm ≥2 positive for stage 2 eligibility | Before PA submission |
| Oral glucose tolerance test (OGTT) or HbA1c | Document dysglycemia | Before PA submission |
| Baseline CBC with differential | Lymphocyte count baseline; lymphopenia monitoring | Before Day 1 |
| Baseline liver function tests (LFTs) | Hepatotoxicity baseline | Before Day 1 |
| EBV / CMV serology (per clinical judgment) | Reactivation risk assessment | Before Day 1 (often) |
| Pregnancy test (if applicable) | Standard pre-mAb screening | Before Day 1 |
| Vaccination history review | Confirm no live vaccines in prior 6 weeks | Before Day 1 |
Monitor weekly during the 14-day course: CBC with differential to catch
treatment-emergent lymphopenia (which can be severe and prolonged). Adjust or pause per FDA label if
lymphopenia thresholds are crossed.
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Package | Use |
|---|---|---|
73070-201-01 / 73070-0201-01 |
2 mg / 2 mL (1 mg/mL) single-dose vial — 1 vial per carton | All Tzield doses; partial-vial waste expected on most days |
Use carton-level NDC (N4 qualifier) on the claim form. Vial-level NDC will trigger
denial. Document UoM as ML and the volume drawn (or full vial volume) per payer convention; report waste
with the JW modifier on a separate line.
Phase 2
Code the claim
Therapeutic IV admin (not chemo). 14 daily claim sets. JW common, JZ sometimes.
Administration codes CPT verified May 2026
Tzield is non-chemotherapy: bill therapeutic IV admin codes.
| Code | Description | When to use |
|---|---|---|
96365 |
Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour | Primary code for each Tzield infusion. 30-minute infusion fits within the 1-hour window. |
96366 |
IV infusion, therapy/prophylaxis/diagnosis; each additional hour | Rare for Tzield's 30-min schedule; use only if a specific infusion runs longer. |
96413 / 96415 |
Chemotherapy administration, IV infusion technique | NOT appropriate. Tzield is a non-chemotherapy mAb; bill 96365. |
99213 / 99214 + -25 |
E/M with modifier 25 | For separately identifiable same-day E/M (e.g., CRS-related assessment). Routine pre-infusion check is bundled. |
Why therapeutic, not chemo: CPT chemotherapy admin codes (96409–96425) apply to
anti-neoplastic and select complex biologics. Anti-CD3 mAbs for autoimmune indications are not on the
chemo admin list; therapeutic IV (96365) is correct for Tzield.
Modifiers CMS verified May 2026
JZ vs JW — one of them on every J9381 claim
Effective July 1, 2023, CMS requires JZ (no waste) or JW (with waste) on every single-dose container claim. Because Tzield doses are BSA-based and the vial holds 400 units (2 mg), partial-vial waste is the norm.
- JW — expected on most days. Report the discarded units on a separate line. Example: a 351-unit dose draws from one 400-unit vial → 49-unit waste on JW line.
- JZ — rare for Tzield. Only when the daily dose happens to use exactly the vial contents with zero waste (uncommon given BSA-based dosing).
Common error: billing only the administered portion and forgetting the JW waste line.
CMS audits catch this consistently. Record the vial volume actually opened, the volume administered, and
report the difference in units on the JW line for the same date of service.
Modifier 25 — same-day E/M
Use modifier 25 on the E/M code when a significant, separately identifiable evaluation (e.g., CRS workup, infection assessment) is performed on the same day as the infusion. Routine pre-infusion clinical check is bundled into the admin.
Modifier KX — payer-specific
Some commercial payers require KX to attest that medical-necessity criteria are met for high-cost therapies. Verify per-payer; not universal.
340B modifiers (JG, TB)
For 340B-acquired Tzield, follow your MAC's current 340B modifier policy. Sanofi's billing guide does not provide 340B-specific instructions.
ICD-10-CM documentation FY2026 verified May 2026
There is no perfect ICD-10 code for "stage 2 T1D." Most billers use R73.03 plus a clinical narrative.
| Code | Description | Use for Tzield |
|---|---|---|
R73.03 | Prediabetes | Most common — pair with clinical narrative attesting stage 2 T1D and autoantibody panel |
Z83.3 | Family history of diabetes mellitus | Supportive only; not primary |
R73.01 | Impaired fasting glucose | Use if FPG documents impairment; supports R73.03 |
R73.02 | Impaired glucose tolerance (oral) | Use if OGTT documents impairment; supports R73.03 |
R73.09 | Other abnormal glucose | If specific subcategory unclear |
E10.x | Type 1 diabetes mellitus (overt) | NOT appropriate — Tzield is for stage 2, not overt T1D |
Submit clinical narrative with the PA. Because no ICD-10 code uniquely identifies stage 2
T1D, payers expect a clinic-note attachment that documents: (1) the autoantibody panel results,
(2) the OGTT or HbA1c result, (3) absence of clinical T1D, (4) endocrinology specialist sign-off.
Site of care & place of service Verified May 2026
The 14-day daily-visit cadence is a major site-of-care driver. Most patients receive Tzield in an infusion center or hospital outpatient department. Home infusion is uncommon for Tzield given the CRS monitoring requirement during the first 5 doses.
| Setting | POS | Claim form | Notes |
|---|---|---|---|
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Common for endocrinology infusion programs |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Common |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Acceptable; CRS monitoring capacity required |
| Physician office | 11 | CMS-1500 / 837P | Acceptable for endocrinology with infusion capacity |
| Pediatric infusion center | 11 / 49 | CMS-1500 | Common for ≥8 yr peds patients |
| Patient home | 12 | CMS-1500 | Rare for Tzield; CRS monitoring concerns first 5 doses |
Logistics warning: 14 consecutive daily visits is a non-trivial scheduling burden.
Confirm site availability for the full course before initiating Day 1 to avoid a mid-course interruption
that could compromise efficacy and trigger re-PA.
Claim form field mapping Sanofi Apr 2026
Each of the 14 daily infusions is a separate claim set. Below is the per-day mapping.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 73070-0201-01 + ML + volume drawn |
| HCPCS J9381 + JZ or JW | 24D (drug line) | JW typical (BSA waste); JZ when no waste |
| Drug units | 24G | units = ceil(mcg / 5); see 5 mcg unit basis section |
| JW waste line (if applicable) | 24D | J9381 with JW + discarded units |
| CPT 96365 (admin line) | 24D (admin line) | 30-min infusion within 1-hr window |
| ICD-10 | 21 | R73.03 (most common) + clinical narrative attesting stage 2 T1D |
| PA number | 23 | Required by all major payers; one PA covers the full 14-day course |
| Date of service | 24A | Each of the 14 daily DOS billed separately |
Phase 3
Get paid
Stage 2 T1D documentation and the 5 mcg unit math are the two get-paid gates.
Payer policy snapshot Reviewed May 2026
All major payers require PA, stage 2 T1D documentation, and endocrinology specialist sign-off.
| Payer | PA? | Stage 2 T1D enforcement | Specialist requirement |
|---|---|---|---|
| UnitedHealthcare Medical Drug Policy |
Yes | Strict: autoantibody panel (≥2) + abnormal OGTT/HbA1c required in PA submission | Endocrinology or pediatric endocrinology (PA letter) |
| Aetna CPB / Medical Drug |
Yes | Stage 2 T1D documentation + age ≥8 + no clinical T1D | Endocrinology required |
| BCBS plans Vary by plan |
Yes | Generally aligned with FDA label + ADA stage 2 T1D criteria | Plan-specific; most require endocrinology |
| Medicare (LCD-driven) MAC LCDs evolving |
Variable | LCDs published 2024+; verify current LCD for your MAC at the time of each course | MAC-specific |
Step therapy: Generally NOT required. Tzield is the only FDA-approved
therapy for delaying stage 3 T1D — there is no class peer to step through. Some payers may require
ADA / ISPAD-aligned diagnostic workup as a prerequisite.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9381
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$38.394
per 5 mcg unit
Per mcg
$7.679
per microgram (unit / 5)
Per mg
$7,678.80
per milligram (unit × 200)
Day 14 (1.7 m², ~351 units)
$13,476.29
single maintenance day
Per vial (400 units)
$15,357.60
2 mg vial × ASP+6%
14-day course (1.7 m²)
$146,742
~3,822 units × ASP+6%
Course cost varies with BSA. For a 1.7 m² adult, the 14-day course runs roughly
$145,000–$200,000 (Medicare ASP+6%) before sequestration. Smaller pediatric BSA reduces total
course units proportionally. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
Coverage
No NCD specific to teplizumab-mzwv. Coverage falls under MAC LCDs for biologics. LCDs are evolving as of 2026; verify the current LCD for your MAC at the time of each course. Document stage 2 T1D criteria in the medical record to support post-payment review.
Code history
- J9381 — permanent code, effective July 1, 2024 (FDA approval was November 17, 2022; the pre-permanent-code period used unclassified J3490 with NDC and dose documentation)
- Pediatric ≥8 yr labeling added 2024
Patient assistance — Sanofi Patient Connection / Tzield Patient Support Sanofi verified May 2026
- Tzield Patient Support: 1-833-205-3220 — benefits investigation, prior authorization assistance, appeal support, scheduling logistics for 14-day course
- Sanofi Patient Connection: patient assistance program for uninsured / underinsured meeting income criteria
- Tzield Co-Pay Card: commercial copay support — eligible commercially-insured patients may pay as little as $0 per course (excludes Medicare, Medicaid, federal program patients)
- Foundations: for Medicare patients, refer to PAN, HealthWell, JDRF (T1D Fund) — verify open T1D / immunology funds quarterly
- Web: tzield.com · sanofipatientconnection.com
Need to model what a specific patient will actually pay across 14 daily visits after copay assistance,
deductible, coinsurance, and OOP max? Run a CareCost Estimate —
J9381 pre-loaded.
Phase 4
Safety, monitoring, and denial fixes
CRS in the first 5 doses, vaccinations contraindicated 6 wk before/during/after, and the most common denial causes.
Cytokine release syndrome (CRS) FDA label verified May 2026
CRS is the most common adverse event and peaks during the first 5 doses.
CRS warning — first 5 doses are highest risk. Cytokine release syndrome
(fever, chills, headache, nausea, fatigue, myalgia, rash) is the most common adverse event with Tzield
and concentrates in the early ramp doses. Premedication is required for each of the first 5 doses to
mitigate risk.
Required premedication for first 5 doses
- NSAID — ibuprofen (typical adult: 600 mg PO)
- Antihistamine — diphenhydramine (typical adult: 25–50 mg PO or IV)
- Antipyretic — acetaminophen (typical adult: 650–1,000 mg PO)
- Administer 30–60 minutes prior to each of Days 1–5 infusions
- Doses 6–14: premeds not required unless CRS develops
Monitoring during the 14-day course
- CBC weekly during the course (lymphopenia — can be severe and prolonged)
- Monitor for signs of serious infection (especially viral reactivation: EBV, CMV)
- Monitor for hypersensitivity reactions during and after each infusion
- Hold or discontinue per FDA label for severe CRS, severe lymphopenia, or serious infection
Vaccination contraindication FDA label verified May 2026
Vaccinations are contraindicated 6 weeks before, during, and 6 weeks after the 14-day Tzield course.
Live vaccines especially. The course schedule must be coordinated with the patient's vaccination
history and upcoming vaccination needs.
Practical implications
- Confirm no live vaccines in the prior 6 weeks before Day 1
- Defer non-urgent vaccinations until 6 weeks after Day 14
- Inactivated vaccines (e.g., flu shot) are typically deferred but may be permitted case-by-case
- For pediatric patients (≥8 yr), coordinate with pediatrician to review the immunization schedule before Day 1
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Stage 2 T1D not documented | PA submitted without autoantibody panel or abnormal OGTT/HbA1c | Submit complete stage 2 T1D documentation: ≥2 of 5 autoantibodies + dysglycemia + endocrinology attestation. Resubmit with complete labs. |
| Wrong unit count (5 mcg basis missed) | Total mcg billed as units (forgot ×5 conversion) | Recalculate: units = ceil(mcg / 5). Resubmit corrected claim. Verify HCPCS descriptor "5 mcg per unit" before keying. |
| JW missing on BSA-based dose | Wasted drug not reported on partial-vial day | Add JW line for discarded units alongside the JZ-style admin line for units administered. Required since 7/1/2023. |
| Wrong admin code (96413) | Chemo admin billed instead of therapeutic IV | Resubmit with 96365. Tzield is non-chemotherapy mAb. |
| Specialist not endocrinology | PA submitted by primary care without endo sign-off | Obtain endocrinology (or pediatric endocrinology) attestation in PA letter before resubmission. |
| ICD-10 inappropriate (E10.x) | Overt T1D code used instead of stage 2 / prediabetes | Use R73.03 + clinical narrative. E10.x is for overt T1D, not stage 2 (Tzield contraindicated for overt T1D). |
| Premedication not documented | First 5 doses without NSAID + antihistamine + antipyretic in record | Document premeds in the medical record for each of Days 1–5; some payers audit. |
| 14-day course interrupted | Mid-course gap or missed visit | Document clinical reason; some payers will require a re-PA if the course is split or extended. |
Frequently asked questions
What is the HCPCS code for Tzield?
Tzield (teplizumab-mzwv) is billed under HCPCS J9381 — "Injection, teplizumab-mzwv,
5 mcg." The unit basis is highly unusual: 1 unit = 5 mcg = 0.005 mg. That means
1 mg = 200 units, and a typical 1,030 mcg/m² maintenance dose for a 1.7 m² adult equals roughly
1,751 mcg = 350 units per daily infusion. J9381 is permanent and effective since July 1, 2024.
How is Tzield dosed?
Tzield is given as a one-time 14-day BSA-based IV course (not repeated). Day 1: 65 mcg/m². Day 2: 125 mcg/m². Day 3: 250 mcg/m². Day 4: 500 mcg/m². Days 5–14: 1,030 mcg/m² daily. Each infusion runs ~30 minutes. This produces 14 separate daily infusion claims. For a 1.7 m² adult, total course is approximately 19,108 mcg of drug across 14 visits.
What administration CPT do I use for Tzield?
CPT 96365 — "Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial,
up to 1 hour" for each ~30-minute Tzield infusion. Add 96366 only when a specific infusion runs longer
(rare). Tzield is non-chemotherapy: do NOT use 96413/96415.
What modifiers does Tzield require?
JZ (no waste) or JW (with waste) on every claim per CMS's July 2023 single-dose
container policy. Because Tzield doses are BSA-based and each 2 mg vial holds 400 units (2,000 mcg),
partial-vial waste is common — JW typically applies on most or all 14 daily claims.
What is the Medicare reimbursement for J9381?
For Q2 2026, the Medicare Part B payment limit for J9381 is $38.394 per 5 mcg unit (ASP + 6%) — equivalent to $7.679 per mcg or $7,678.80 per mg. A 1.7 m² adult on Day 14 (1,751 mcg, ~351 units) reimburses at roughly $13,476.29. The full 14-day course for that patient runs approximately $146,742.
What documentation is required for Tzield prior auth?
Stage 2 T1D documentation is mandatory: (1) at least 2 of 5 T1D-related autoantibodies positive (GAD65, IA-2, ZnT8, IAA, ICA); (2) abnormal OGTT or HbA1c; (3) absence of overt clinical T1D; (4) endocrinology specialist attestation; (5) baseline CBC and LFTs ordered; (6) ICD-10 codes (most billers use R73.03 plus a clinical narrative).
Why does Tzield require premedication?
Cytokine release syndrome (CRS) is the most common adverse event and peaks during the first 5 doses. The FDA label requires premedication before each of the first 5 daily infusions: an NSAID (ibuprofen), an antihistamine (diphenhydramine), and an antipyretic (acetaminophen). Premeds are not required for doses 6–14 unless CRS develops. Vaccinations are contraindicated 6 weeks before, during, and 6 weeks after treatment.
Why is Tzield's billing so complex?
Three things compound: (1) the 5 mcg unit basis is the most unusual in the J-code catalog and biller errors run 10–1,000× off if mcg is read as mg; (2) BSA-based dosing produces non-round mg amounts and partial-vial waste, requiring JW on most claims; (3) the 14-day course generates 14 separate daily infusion claim sets back-to-back over two weeks. As of 2026, Medicare LCDs are still evolving; verify the active LCD at the time of each course.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- Tzield HCP — Sanofi product site
- DailyMed — TZIELD (teplizumab-mzwv) Prescribing Information
- FDA Tzield label PDF (2024 pediatric supplement)
- FDA — Nov 17, 2022 approval announcement (first drug to delay clinical T1D)
- CMS — Medicare Part B Drug ASP Pricing File
- CMS HCPCS — J9381 permanent code (effective 7/1/2024)
- American Diabetes Association — Stages of Type 1 Diabetes
- ISPAD — International Society for Pediatric and Adolescent Diabetes (T1D prevention guidance)
- UnitedHealthcare — Medical Drug Policy (teplizumab)
- Aetna CPB — teplizumab medical drug policy
- Sanofi Patient Connection — PAP and copay assistance
- 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
| 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, Medicare LCDs) | Semi-annual | Manual review against published payer policy documents and active MAC LCDs. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label | Event-driven | Tied to manufacturer document version + FDA label revision date. Pediatric ≥8 yr labeling added 2024. |
| Stage 2 T1D criteria + autoantibody panel | Annual | Verified against ADA / ISPAD T1D prevention guidelines. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS, Sanofi,
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 — especially the 5 mcg unit conversion math.
Change log
- — Initial publication. ASP data: Q2 2026. Manufacturer source: Sanofi Apr 2026. FDA label: 2024 pediatric supplement (BLA 761183). First-in-class anti-CD3 mAb to delay clinical T1D. Permanent HCPCS J9381 effective 7/1/2024.
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. Stage 2 T1D criteria are verified against ADA / ISPAD T1D prevention guidelines. We do not paraphrase from billing-software vendor blogs.