HCPCS
J9173
10 mg = 1 unit
Phase 1
Identify what you're billing
Multi-indication regimens. Confirm the right dose, schedule, and combo partners before billing.
Dosing by indication — PACIFIC, ADRIATIC, HIMALAYA, AEGEAN FDA label most recent rev
Imfinzi has more regimen variation than any other PD-(L)1 inhibitor. Each indication has a distinct schedule. Verify the regimen against the encounter note before generating the claim.
Imfinzi is FDA-approved across Stage III NSCLC, limited- and extensive-stage SCLC, hepatocellular carcinoma, biliary tract cancer, endometrial cancer, urothelial carcinoma, and resectable NSCLC. Two flat-dose schedules (1,500 mg q3w with chemo / 1,500 mg q4w maintenance) cover most modern regimens; the original PACIFIC and urothelial indications still allow weight-based 10 mg/kg q2w. The 2024 ADRIATIC and AEGEAN approvals materially expanded billing volume.
| Indication | Trial / regimen | Dose & schedule | Units per dose | Combo partners |
|---|---|---|---|---|
| Stage III unresectable NSCLC, post-CRT | PACIFIC | 10 mg/kg q2w (orig) OR 1,500 mg q4w | kg-dependent / 150 | None (post-chemoradiation maintenance) |
| LS-SCLC, post-CRT (2024 approval) | ADRIATIC | 1,500 mg q4w | 150 | None (post-chemoradiation maintenance) |
| ES-SCLC, 1L | CASPIAN | 1,500 mg + chemo q3w × 4 → 1,500 mg q4w maintenance | 150 / 150 | Etoposide + carboplatin or cisplatin |
| HCC, 1L | HIMALAYA STRIDE | 1,500 mg + Imjudo 300 mg single dose → Imfinzi 1,500 mg q4w | 150 (J9173) + 30 (J9347) | Imjudo (tremelimumab-actl) priming |
| Biliary tract cancer, 1L | TOPAZ-1 | 1,500 mg + chemo q3w → 1,500 mg q4w maintenance | 150 / 150 | Gemcitabine + cisplatin |
| Endometrial, 1L | DUO-E | 1,500 mg + chemo q3w → 1,500 mg q4w ± olaparib maintenance | 150 / 150 | Carboplatin + paclitaxel; +/- olaparib |
| Resectable NSCLC, neoadjuvant + adjuvant (2024) | AEGEAN | 1,500 mg + chemo q3w × 4 (neoadj) → 1,500 mg q4w × 12 (adj) | 150 / 150 | Platinum doublet (neoadjuvant) |
| Locally advanced/metastatic urothelial, post-platinum (older) | Original 2017 indication | 10 mg/kg q2w | kg-dependent | None — less used in 2026 |
Two unit-math worlds. The 1,500 mg flat dose = 150 units, three 500 mg
single-dose vials, zero waste, JZ. Weight-based 10 mg/kg = bill the actual mg administered divided by 10;
partial-vial waste is the norm, JW required on a separate claim line. Confirm the encounter note specifies
which schedule was used — transcription errors here drive denials.
Worked example — Year-1 billing for Stage III NSCLC (PACIFIC, 1,500 mg q4w schedule)
# Standard PACIFIC q4w maintenance schedule
Drug units billed per dose: 150 (J9173)
HCPCS: J9173 · Modifier: JZ · Vials: 3 × 500 mg
Admin: 96413 (60-min first dose; ≥30 min subsequent)
# Year-1 totals (13 doses q4w × 52 weeks)
Total doses: 13
Total drug units billed: 1,950 (13 × 150)
Total drug cost (Q2 2026 ASP+6%): ~$167,985 before sequestration
Drug units billed per dose: 150 (J9173)
HCPCS: J9173 · Modifier: JZ · Vials: 3 × 500 mg
Admin: 96413 (60-min first dose; ≥30 min subsequent)
# Year-1 totals (13 doses q4w × 52 weeks)
Total doses: 13
Total drug units billed: 1,950 (13 × 150)
Total drug cost (Q2 2026 ASP+6%): ~$167,985 before sequestration
Worked example — Year-1 billing for ES-SCLC (CASPIAN: q3w combo + q4w maintenance)
# Cycles 1-4: 1,500 mg + chemo q3w · Cycles 5+: 1,500 mg q4w mono
Loading: 4 doses × 150 units = 600 J9173 units (12 weeks, q3w)
Maintenance (weeks 13-52): ~10 doses × 150 = 1,500 J9173 units
Year-1 total: ~14 doses, 2,100 units
Year-1 drug cost (Q2 2026 ASP+6%): ~$180,907 before sequestration
+ chemo + admin time
Loading: 4 doses × 150 units = 600 J9173 units (12 weeks, q3w)
Maintenance (weeks 13-52): ~10 doses × 150 = 1,500 J9173 units
Year-1 total: ~14 doses, 2,100 units
Year-1 drug cost (Q2 2026 ASP+6%): ~$180,907 before sequestration
+ chemo + admin time
Imjudo (tremelimumab-actl, J9347) combination billing AZ Access 360 verified May 2026
Imfinzi pairs with AstraZeneca's CTLA-4 inhibitor Imjudo in HIMALAYA (HCC) and POSEIDON (metastatic NSCLC). They are separate HCPCS codes on separate claim lines.
| Imfinzi | Imjudo | |
|---|---|---|
| Generic | durvalumab | tremelimumab-actl |
| HCPCS | J9173 (10 mg = 1 unit) | J9347 (1 mg = 1 unit) |
| Target | Anti-PD-L1 | Anti-CTLA-4 |
| FDA approval | May 2017 (BLA 761069) | October 2022 (BLA 761270) |
| HIMALAYA HCC dosing | 1,500 mg q4w (after Day 1 priming) | 300 mg single dose Day 1 only (priming) |
| POSEIDON 1L mNSCLC dosing | 1,500 mg + chemo q3w × 4 → q4w mono | 75 mg q3w × 5 doses (with platinum chemo cycles 1-4 + 1 priming after) |
| Vial | 120 mg / 2.4 mL or 500 mg / 10 mL (50 mg/mL) | 300 mg / 15 mL or 25 mg / 1.25 mL (20 mg/mL) |
| Admin CPT | 96413 | 96413 (or 96415 if subsequent same-day — sequence matters) |
Same-day infusion sequencing on Day 1 (HIMALAYA / POSEIDON): Both drugs typically infused on
the same day. Bill
96413 for the initial drug (the sequence depends on protocol — many sites
give Imjudo first, then Imfinzi 60 min later) and 96415 for each additional hour. Both drugs
carry their own JZ (or JW if any waste) on their own claim line. Each drug needs
its own NDC in the shaded 24A area.
Common Imjudo combo error: billing the Imjudo priming dose under
J9173. Imjudo
bills under J9347 only — mis-billing under J9173 will recover at the lower ASP and
trigger an audit when the claim is reconciled against the encounter NDC. Always confirm two distinct claim
lines on Day 1 of HIMALAYA.
Checkpoint inhibitor class comparison Reviewed May 2026
Imfinzi sits in the anti-PD-L1 cohort. Mechanism, dosing schedule, and indication overlap matter for payer step-therapy logic.
| Drug | HCPCS | Target | Manufacturer | Standard adult dose |
|---|---|---|---|---|
| Imfinzi (durvalumab) | J9173 (10 mg/unit) | PD-L1 | AstraZeneca | 1,500 mg q4w; 10 mg/kg q2w (PACIFIC alt) |
| Tecentriq (atezolizumab) | J9022 (10 mg/unit) | PD-L1 | Genentech | 1,200 mg q3w; 1,680 mg q4w |
| Keytruda (pembrolizumab) | J9271 (1 mg/unit) | PD-1 | Merck | 200 mg q3w; 400 mg q6w |
| Opdivo (nivolumab) | J9299 (1 mg/unit) | PD-1 | Bristol Myers Squibb | 240 mg q2w; 480 mg q4w |
| Libtayo (cemiplimab-rwlc) | J9119 (1 mg/unit) | PD-1 | Regeneron | 350 mg q3w |
| Jemperli (dostarlimab-gxly) | J9272 (10 mg/unit) | PD-1 | GSK | 500 mg q3w → 1,000 mg q6w |
| Yervoy (ipilimumab) | J9228 (1 mg/unit) | CTLA-4 | Bristol Myers Squibb | 3 mg/kg q3w (combo / mono) |
| Imjudo (tremelimumab-actl) | J9347 (1 mg/unit) | CTLA-4 | AstraZeneca | 300 mg single dose (HIMALAYA priming) |
PD-1 vs PD-L1 for billing: Same checkpoint axis, different molecular targets. Most payers
treat anti-PD-1 and anti-PD-L1 agents as therapeutically equivalent for step-therapy purposes within an
indication, but biomarker test thresholds and FDA-labeled patient subsets differ. Always match the agent
to the FDA label for the specific indication being billed — substituting Keytruda for Imfinzi in the
PACIFIC setting (post-CRT Stage III NSCLC) will be denied; that's a label-mandated PD-L1 indication.
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Package | Use |
|---|---|---|
0310-4500-12 / 00310-4500-12 |
120 mg / 2.4 mL single-dose vial — 1 vial per carton | Combination math for weight-based dosing; small total-dose flexibility |
0310-4611-50 / 00310-4611-50 |
500 mg / 10 mL single-dose vial — 1 vial per carton | Standard for 1,500 mg flat dose — three 500 mg vials per dose |
Use 11-digit NDC with N4 qualifier in 24A shaded area. For a 1,500 mg dose using three
500 mg vials, report
N4 00310-4611-50 ML 30 (3 vials × 10 mL = 30 mL total volume).
Vial-level errors (wrong NDC) are a common denial driver.
Phase 2
Code the claim
Chemo admin codes apply (despite ICI being immunotherapy, not chemotherapy clinically).
Administration codes CPT verified May 2026
Durvalumab is billed as chemotherapy administration despite being immunotherapy (anti-PD-L1 mAb).
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for Imfinzi. First dose 60 min fits within the 1-hour window; subsequent ≥30 min infusions also. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Add when chair time exceeds 1 hour — common for Imfinzi+chemo combo regimens (CASPIAN, TOPAZ-1, DUO-E, AEGEAN, POSEIDON). |
96417 |
Chemotherapy administration, IV infusion; each additional sequential infusion (different substance/drug), up to 1 hour | For Imfinzi+Imjudo same-day sequencing (HIMALAYA / POSEIDON Day 1) or Imfinzi+chemo same-day; pair with primary 96413. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. CPT classifies ICI mAb administration under chemo codes per AMA guidelines for complex monoclonal antibody immunotherapy. |
Why chemo admin for immunotherapy: CPT chemotherapy administration codes (96409–96425) apply to
complex monoclonal antibody administration regardless of mechanism of action. Imfinzi (and other immune
checkpoint inhibitors) bill under chemo admin codes per AMA classification. This pays materially more
than 96365 therapeutic infusion.
Modifiers CMS verified May 2026
JZ — required on flat-dose adult claims
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. The 1,500 mg Imfinzi flat dose uses three 500 mg single-dose vials with zero waste — JZ applies to every flat-dose Imfinzi claim. The 120 mg vial is also single-dose; any combinations that exactly match the prescribed mg should bill JZ.
JW — weight-based dosing only
JW reports the discarded portion of a single-dose vial. For Imfinzi, JW applies to weight-based 10 mg/kg dosing (PACIFIC alternate, urothelial post-platinum) where partial-vial waste is the norm. Example: a 70 kg patient receiving 700 mg uses one 500 mg vial and one 120 mg vial plus 80 mg from a second 120 mg vial, with 40 mg discarded — bill JW for 4 units (40 mg / 10) of waste on a separate claim line. One of JZ or JW must be on every J9173 claim.
Common error: using JZ for a 10 mg/kg weight-based dose when partial-vial waste actually
occurred. CMS audits catch this — bill the JW line with the actual discarded units alongside the
administered units. Wasted drug is reimbursable but must be reported to be paid.
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 is bundled.
340B modifiers (JG, TB)
For 340B-acquired Imfinzi, follow your MAC's current 340B modifier policy. AstraZeneca Access 360 does not provide 340B-specific instructions; defer to your MAC's published guidance.
ICD-10-CM by indication group FY2026 verified May 2026
Multi-indication. Use the most specific code supported by encounter documentation. Pair with line-of-therapy and prior-CRT documentation in the PA submission.
| Indication | ICD-10 family | Notes |
|---|---|---|
| Stage III NSCLC (PACIFIC) | C34.x | Lobe-specific 4th character; PA requires post-CRT documentation, no progression after concurrent platinum-based CRT |
| Limited-stage SCLC (ADRIATIC) | C34.x (small cell histology) | 2024 approval; PA requires post-CRT documentation |
| Extensive-stage SCLC (CASPIAN) | C34.x (small cell histology) | 1L combo with platinum-etoposide |
| HCC (HIMALAYA) | C22.0 | 1L; combo with Imjudo priming dose |
| Biliary tract / cholangiocarcinoma (TOPAZ-1) | C22.1 (intrahepatic), C23 (gallbladder), C24.0 (extrahepatic), C24.1 (Vater), C24.8, C24.9 | 1L combo with gemcitabine + cisplatin |
| Endometrial (DUO-E) | C54.x (esp. C54.1 endometrium) | 1L combo with carboplatin/paclitaxel; +/- olaparib maintenance based on dMMR/pMMR |
| Resectable NSCLC (AEGEAN, neoadj+adj) | C34.x | 2024 approval; combo with platinum doublet neoadjuvant; T4 not eligible per label |
| Locally advanced/metastatic urothelial (post-platinum) | C67.x | Original 2017 indication; less used in 2026 vs Keytruda/avelumab in this setting |
Indication-specific PA criteria are the norm. The ICD-10 code alone is not sufficient.
PACIFIC requires evidence of recent concurrent platinum-based CRT for Stage III NSCLC. ADRIATIC requires
evidence of recent concurrent platinum-based CRT for LS-SCLC. AEGEAN requires resectable disease (T1-T3,
N0-N2; T4 explicitly excluded) and intent to surgical resection. Submit the staging note and CRT/surgery
plan with the PA.
Site of care & place of service Verified May 2026
UnitedHealthcare, Aetna, and most major BCBS plans run site-of-care UM for immune checkpoint inhibitors. Aetna CPB explicitly steers ICIs out of HOPD after the first 3 months unless on combo chemo or active toxicity management.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician oncology office | 11 | CMS-1500 / 837P | Preferred by commercial UM |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM |
| Oncology ASC | 24 | CMS-1500 / 837P | Acceptable |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored after first 3 months (combo chemo cycles often allowed) |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored after first 3 months |
| Patient home | 12 | CMS-1500 (with home infusion) | Rare for IV oncology IO; not labeled for Imfinzi |
Combo phase exception: Commercial site-of-care UM typically grants HOPD or ASC during the
chemo combo phase (CASPIAN/TOPAZ-1/DUO-E/AEGEAN-neoadjuvant cycles 1-4) because chemotherapy-related
toxicity monitoring is more intensive. The maintenance phase (q4w mono) is the typical inflection point
where commercial plans push to office or AIC.
Claim form field mapping AZ Access 360 Apr 2026
From the AstraZeneca Access 360 Imfinzi coding guide.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 00310-4611-50 + ML + 30 (for 1,500 mg = 3 × 10 mL vials) |
| HCPCS J9173 + JZ (or JW for weight-based waste) | 24D (drug line) | JZ on flat dose; JW on the discarded units when 10 mg/kg |
| Drug units | 24G | 150 for 1,500 mg flat; actual mg/10 for weight-based |
| CPT 96413 (admin line) | 24D (admin line) | +96415 for each addl hr; +96417 for sequential drugs (Imjudo combo, chemo combo) |
| HCPCS J9347 + JZ (Imjudo, when applicable) | 24D (separate drug line) | HIMALAYA Day 1: 30 units (300 mg / 10 mg/unit ... wait, J9347 = 1 mg/unit, so 300 units) |
| ICD-10 | 21 | Indication-specific (see ICD-10 table) |
| PA number | 23 | Required by all major payers |
Imjudo unit-math caution: J9173 is 10 mg = 1 unit (Imfinzi). J9347 is 1 mg = 1 unit
(Imjudo). On HIMALAYA Day 1, you bill 150 units of J9173 (Imfinzi 1,500 mg) and 300 units of J9347
(Imjudo 300 mg). Mixing up the units-per-mg conversion is the most common Day 1 HIMALAYA billing error.
Phase 3
Get paid
Indication-specific documentation (CRT date, staging, line of therapy) is the gating factor.
Payer policy snapshot Reviewed May 2026
All major payers require indication-specific clinical documentation. Get the CRT/staging note packaged with the PA before submission.
| Payer | PA? | Indication enforcement | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes | PACIFIC = Stage III NSCLC + recent chemoradiation evidence; ADRIATIC = LS-SCLC + recent CRT; HIMALAYA requires HCC stage + Child-Pugh A | Aggressive: ICI steering away from HOPD via Optum-managed program after combo phase |
| Aetna CPB ICI policy + Medical Drug |
Yes | Step from chemotherapy may apply for some indications; PD-L1 IHC not formally required for Imfinzi (unlike Keytruda 1L NSCLC mono) | Yes (separate Site-of-Care policy; ICIs steered out of HOPD after 3 months) |
| Carelon / Anthem Oncology medical drug policy |
Yes | NCCN-aligned; AEGEAN added to policy in 2024 with resectability documentation requirement | Plan-specific; most have ICI site-of-care steering |
| BCBS plans Vary by plan |
Yes | Generally aligned with NCCN guidelines + FDA label indications | Plan-specific |
| Medicare (MAC LCDs) | No (MAC LCD) | All MACs cover all FDA-approved indications with appropriate ICD-10 + indication documentation | None |
Biomarker testing
Unlike Keytruda (PD-L1 22C3 IHC for NSCLC 1L mono and others), Imfinzi does not require PD-L1 biomarker testing for any current FDA-approved indication. PA submissions are gated on stage, line of therapy, prior CRT, and resectability — not on PD-L1 expression. This is a meaningful practice-flow simplification vs the Keytruda program.
Step therapy
Step therapy through other PD-(L)1 inhibitors is generally not required when the indication is FDA-labeled for Imfinzi specifically (e.g., PACIFIC, ADRIATIC, HIMALAYA, AEGEAN have no equivalent label on Keytruda or Opdivo). Some payers require prior chemotherapy or chemoradiation as a prerequisite (PACIFIC, ADRIATIC) consistent with the FDA label.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9173
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$86.146
per 10 mg / per unit
1,500 mg dose (q4w)
$12,921.90
150 units × ASP+6%
Annual q4w (13 doses)
$167,985
Maintenance year
Annualized cost depends on regimen phase: Pure q4w maintenance year (PACIFIC, ADRIATIC) =
~$167,985 (13 × $12,921.90). Combo year that includes a q3w + chemo loading phase (CASPIAN, TOPAZ-1,
DUO-E, AEGEAN-neoadjuvant) runs ~$180,000–$195,000 due to more frequent dosing. HIMALAYA Year 1 adds
a one-time Imjudo charge of ~$11,000 (300 mg J9347). After ~2% sequestration, actual paid is roughly ASP +
4.3%.
Coverage
No NCD specific to durvalumab. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9173 for FDA-approved on-label indications with appropriate ICD-10 and clinical documentation (CRT date, staging, line of therapy).
Code history
- J9173 — permanent code, "Injection, durvalumab, 10 mg" (assigned shortly after FDA approval; pre-permanent-code period used unclassified J3490 / C9491 transitional)
Patient assistance — AstraZeneca Access 360 AZ verified May 2026
- AstraZeneca Access 360: 1-844-275-2360 / myaccess360.com — benefits investigation, prior authorization assistance, appeal support
- Imfinzi Co-pay Program: commercial copay support — $0 first dose for eligible commercially-insured patients; ongoing copay assistance up to $25,000/yr (excludes Medicare, Medicaid, federal program patients per Anti-Kickback Statute)
- AstraZeneca Patient Assistance Foundation (AZ&Me): free product for uninsured / underinsured patients meeting income requirements (administered through 501(c)(3))
- Foundations: for Medicare patients, refer to PAN, HealthWell, CancerCare — verify open oncology funds quarterly (lung, HCC, biliary, endometrial, urothelial)
- Web: myaccess360.com · azandmeapp.com
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J9173 pre-loaded.
Phase 4
Fix problems
irAE management, regimen mismatches, and Imjudo-line errors are the top three.
Immune-mediated adverse reactions (irAEs) FDA W&P verified May 2026
Imfinzi has no formal Boxed Warning, but the FDA W&P irAE profile should be treated as a Boxed analog operationally.
irAE WARNINGS — Boxed analog: immune-mediated pneumonitis,
colitis, hepatitis, endocrinopathies (hypothyroidism most
common; also hyperthyroidism, T1DM, adrenal insufficiency, hypophysitis), nephritis,
dermatologic reactions (including SJS/TEN), infusion reactions, and rare
but severe events (myocarditis, encephalitis, myositis, GBS). irAEs can occur during therapy or weeks-to-months
after discontinuation.
PACIFIC pneumonitis — the highest-rate setting
Patients receiving Imfinzi after concurrent platinum-based chemoradiation for Stage III NSCLC (PACIFIC indication) have a materially higher pneumonitis rate — both any-grade and grade ≥3 — than Imfinzi monotherapy in other indications. The combination of radiation-induced pulmonary inflammation and PD-L1 blockade amplifies pneumonitis risk. Expect a meaningful subset of PACIFIC patients to discontinue for grade 3+ pneumonitis. The label specifies steroid escalation (prednisone 1–2 mg/kg/day) for grade 2+, with permanent discontinuation for grade 3-4. Document baseline imaging, surveillance imaging, and steroid initiation in the chart for any subsequent PA renewals or appeal documentation.
ADRIATIC pneumonitis
Same chemoradiation-amplified mechanism applies for the LS-SCLC ADRIATIC setting (2024 approval). Treat pneumonitis surveillance with the same intensity as PACIFIC.
HIMALAYA endocrine + colitis
The HIMALAYA STRIDE regimen (Imfinzi + Imjudo single dose) carries the additional CTLA-4 toxicity profile from Imjudo — expect higher rates of immune-mediated colitis, hepatitis, and endocrinopathies than Imfinzi monotherapy. Most events occur after the Day 1 priming dose. Endocrine workup (TSH, AM cortisol) before each cycle is appropriate.
Practical billing implication
irAE workup is separately billable: relevant E/M with modifier 25 if same-day as infusion; chest CT
(CPT 71250 / 71260 with contrast) for pneumonitis; basic chemistry, LFTs, TSH, cortisol panels per encounter
documentation. ICD-10: T80.52XA (anaphylactic reaction due to vaccination), T88.7XXA
(unspecified adverse effect of drug), or specific irAE diagnosis codes (e.g., J70.2 acute drug
pneumonitis, K52.81 eosinophilic colitis, E03.9 hypothyroidism). Document irAE
attribution in the chart for both clinical and audit-defensibility purposes.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Indication documentation insufficient | PA submitted without CRT date (PACIFIC/ADRIATIC) or staging note (AEGEAN) | Submit CRT completion date + staging note + line-of-therapy attestation. Schedule PA only after the full clinical packet is assembled. |
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413. Durvalumab is chemo admin per CPT classification despite being immunotherapy. |
| JZ used for weight-based dose | 10 mg/kg PACIFIC dose billed as flat / no waste reported | Resubmit with JW line for the discarded units. JZ only when zero waste; JW for any partial-vial waste. |
| Imjudo billed under J9173 | HIMALAYA Day 1 priming dose mis-coded | Imjudo bills under J9347 only (1 mg = 1 unit; 300 mg = 300 units). Submit corrected claim with separate J9347 line. |
| JZ missing on flat-dose claim | Single-dose vial claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Wrong unit math (mg instead of /10) | 1,500 mg billed as 1,500 units instead of 150 | Resubmit with 150 units. 10 mg = 1 unit for J9173 (not 1 mg/unit like Opdivo/Keytruda). |
| Site of care (HOPD) after combo phase | Maintenance dose at HOPD on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49) once the patient transitions to q4w mono. Submit medical necessity letter if HOPD truly required. |
| Step therapy assertion | Payer asserts step from PD-1 agent before Imfinzi | Cite FDA label: PACIFIC, ADRIATIC, HIMALAYA, AEGEAN have no equivalent label on Keytruda or Opdivo. Step therapy is not appropriate when Imfinzi is the only labeled agent. |
| NDC / dose volume mismatch | 3 mL volume reported in 24A for a 1,500 mg dose (correct = 30 mL) | Resubmit with N4 00310-4611-50 ML 30 (3 vials × 10 mL). |
Frequently asked questions
What is the HCPCS code for Imfinzi?
Imfinzi (durvalumab) is billed under HCPCS J9173 — "Injection, durvalumab, 10 mg." One
billable unit equals 10 mg, so the standard 1,500 mg q4w flat dose is billed as 150 units. The weight-based
10 mg/kg q2w PACIFIC dose is billed as actual mg administered divided by 10. J9173 is a permanent code;
AstraZeneca pairs it with Imjudo (tremelimumab-actl, J9347) in HCC and metastatic NSCLC combination
regimens — Imjudo bills under its own HCPCS.
How many units do I bill for a 1,500 mg Imfinzi dose?
Bill 150 units of J9173 per 1,500 mg dose (1,500 mg / 10 mg/unit = 150 units).
The 1,500 mg dose uses three 500 mg vials with zero waste — JZ modifier required. For
weight-based 10 mg/kg q2w PACIFIC dosing, bill the actual mg administered divided by 10; expect partial-vial
JW waste and report it on a separate claim line.
What administration CPT do I use for Imfinzi?
CPT 96413 — "Chemotherapy administration, IV infusion technique; up to 1 hour, single
or initial substance/drug." Add 96415 for each additional hour when chair time exceeds 60
minutes (rare for Imfinzi monotherapy at the ≥30-min subsequent rate; common for Imfinzi+chemo combo
regimens). Despite being immunotherapy, Imfinzi bills under chemo admin codes per AMA classification for
complex monoclonal antibodies. Do NOT use 96365.
Do I bill JZ or JW for Imfinzi?
For the 1,500 mg flat dose: bill JZ. Three 500 mg single-dose vials = 1,500 mg
with zero waste. For weight-based 10 mg/kg dosing (PACIFIC q2w or older urothelial): bill
the administered units with a standard claim line and JW with the discarded units on a
separate line. One of JZ or JW must appear on every J9173 claim per CMS's July 2023 single-dose container
policy.
What is the Medicare reimbursement for J9173?
For Q2 2026, the Medicare Part B payment limit for J9173 is $86.146 per 10 mg unit (ASP + 6%). The standard 1,500 mg q4w dose reimburses at approximately $12,921.90 per infusion (150 units × ASP+6%). Annualized maintenance phase (q4w × 13 doses): approximately $167,985. Combo years that include a q3w + chemo loading phase run higher (~$180,000–$195,000). Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
What regimens does Imfinzi support?
Imfinzi supports multiple regimens by indication: PACIFIC (Stage III NSCLC post-CRT, 10 mg/kg q2w or 1,500 mg q4w), ADRIATIC (LS-SCLC post-CRT, 1,500 mg q4w — 2024 approval), ES-SCLC 1L (1,500 mg + chemo q3w → 1,500 mg q4w), HIMALAYA (HCC; Imfinzi 1,500 mg + Imjudo 300 mg single dose, then Imfinzi 1,500 mg q4w), biliary tract 1L (1,500 mg + gem/cis q3w → q4w), endometrial 1L (1,500 mg + chemo q3w → q4w), AEGEAN (resectable NSCLC neoadj+adj, 1,500 mg + chemo q3w × 4 → 1,500 mg q4w × 12), and post-platinum urothelial (10 mg/kg q2w, older indication).
What is the difference between Imfinzi and Imjudo?
Both drugs are AstraZeneca immune checkpoint inhibitors but they target different checkpoints. Imfinzi (durvalumab, J9173) is anti-PD-L1, given as primary therapy or maintenance. Imjudo (tremelimumab-actl, J9347) is anti-CTLA-4, used as a single priming dose in combination with Imfinzi (the HIMALAYA STRIDE regimen for HCC and the POSEIDON regimen for metastatic NSCLC). They have separate HCPCS codes, separate ASP, and separate billing lines on the claim form. Do NOT bill Imjudo under J9173.
What are the most important irAEs to watch for with Imfinzi?
Imfinzi carries the full PD-L1 immune-mediated adverse reaction profile: pneumonitis, colitis, hepatitis, endocrinopathies (hypothyroidism is the most common; also T1DM, adrenal insufficiency, hypophysitis), nephritis, dermatologic reactions, and infusion reactions. The PACIFIC regimen (post-chemoradiation Stage III NSCLC) carries a higher pneumonitis rate than monotherapy in other settings — surveillance imaging plus rapid steroid escalation per FDA label is essential. Document irAE workup and steroid initiation in the chart for any subsequent PA renewals.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- AstraZeneca Access 360 — Imfinzi Coding & Billing HCP page
- DailyMed — IMFINZI (durvalumab) Prescribing Information
- DailyMed — IMJUDO (tremelimumab-actl) Prescribing Information
- FDA Imfinzi label PDF (2024 revision)
- AstraZeneca press releases — ADRIATIC LS-SCLC (2024), AEGEAN resectable NSCLC (2024)
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J9173 reference
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna CPB 0892 — Immune Checkpoint Inhibitors (covers Imfinzi + Imjudo + class)
- AstraZeneca Access 360 — benefits investigation, PA assistance, copay program
- NCCN Guidelines — NSCLC, SCLC, HCC, Biliary Tract, Endometrial, Bladder
- 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, Carelon, 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 | Event-driven | Tied to manufacturer document version + FDA label revision date. Imfinzi gained ADRIATIC + AEGEAN in 2024; expect 1-2 indication additions per year. |
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: AZ Access 360 (Apr 2026). FDA label: most recent revision incl. ADRIATIC LS-SCLC (2024) and AEGEAN resectable NSCLC (2024). Multi-indication: PACIFIC, ADRIATIC, CASPIAN, HIMALAYA, TOPAZ-1, DUO-E, AEGEAN, post-platinum urothelial. Imjudo (J9347) cross-referenced for HIMALAYA + POSEIDON combo billing.
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 and regimen schedules are verified against the current FDA label revision and manufacturer dosing guides. We do not paraphrase from billing-software vendor blogs.