HCPCS
J9201
200 mg = 1 unit
Phase 1
Identify what you're billing
Confirm the indication, regimen, and BSA-based dose before billing.
Multi-indication dosing matrix FDA + NCCN verified May 2026
Gemcitabine has six common indication-regimen combinations. Each has its own dose, schedule, and combo partners. Verify the regimen documented in the order set before calculating units.
| Indication | Dose | Schedule | Combo partner | Cycle |
|---|---|---|---|---|
| Pancreatic 1L (combo) | 1,000 mg/m² | D1, D8, D15 | nab-paclitaxel (Abraxane) 125 mg/m² | 28 days |
| Pancreatic single-agent | 1,000 mg/m² | Weekly × 7, then 1 wk off; then weekly × 3 q4w | None | Variable |
| NSCLC 1L | 1,000–1,250 mg/m² | D1, D8 | cisplatin 75–100 mg/m² D1 | 21 days |
| Breast (post-anthracycline) | 1,250 mg/m² | D1, D8 | paclitaxel 175 mg/m² D1 | 21 days |
| Ovarian (post-platinum) | 1,000 mg/m² | D1, D8 | carboplatin AUC 4 D1 | 21 days |
| Bladder | 1,000 mg/m² | D1, D8, D15 | cisplatin 70 mg/m² D2 (or carboplatin if cis-ineligible) | 28 days |
| Biliary tract (NCCN) | 1,000 mg/m² | D1, D8 | cisplatin 25 mg/m² D1, D8 | 21 days |
BSA matters. All gemcitabine dosing is per m². A 1.5 m² patient on 1,000 mg/m²
gets 1,500 mg (8 units). A 2.0 m² patient on 1,250 mg/m² gets 2,500 mg (13 units). Recompute BSA
per cycle if weight changes >10%.
FOLFIRINOX is NOT a gemcitabine regimen. Don't confuse the two. FOLFIRINOX (5-FU,
leucovorin, irinotecan, oxaliplatin) is the competing pancreatic 1L regimen, often used in younger
fitter patients. Gem + nab-paclitaxel is preferred for ECOG 1+ or older patients.
Dosing & unit math FDA label verified May 2026
From FDA prescribing information, label revised February 2024 for Gemzar (Eli Lilly NDA 020509). Generic labels are equivalent.
Unit math is the most important thing on this page
J9201 is billed in 200 mg units. To convert mg administered to billable units: units = ceil(mg ÷ 200). Round up because partial units are not billable.
| BSA | Dose @ 1,000 mg/m² | Units (200 mg) | Vial selection | Waste |
|---|---|---|---|---|
| 1.5 m² | 1,500 mg | 8 units (exact) | 1 × 2 g | 500 mg (JW: 2.5 units) |
| 1.6 m² | 1,600 mg | 8 units (exact) | 1 × 2 g | 400 mg (JW: 2 units) |
| 1.7 m² | 1,700 mg | 9 units (round up from 8.5) | 1 × 2 g | 300 mg (JW: 1.5 units) |
| 1.8 m² | 1,800 mg | 9 units (exact) | 1 × 2 g | 200 mg (JW: 1 unit) |
| 2.0 m² | 2,000 mg | 10 units (exact) | 1 × 2 g | 0 (JZ) |
| 2.0 m² @ 1,250 | 2,500 mg | 13 units (round up from 12.5) | 1 × 2 g + 1 × 1 g | 500 mg (JW: 2.5 units) |
Worked example — pancreatic 1L combo (Gem + Abraxane), 1.7 m² patient, first cycle
# Single dose calculation (D1 of 28-day cycle)
Dose: 1,000 mg/m² × 1.7 m² = 1,700 mg
Units billed: ceil(1,700 / 200) = 9 units (J9201)
Vial: 1 × 2 g single-dose vial (Hospira NDC 00409-0183-01)
Waste: 2,000 − 1,700 = 300 mg = 1.5 units JW (separate line)
Admin: 96413 (30-min chemo IV)
Modifier on admin line: JW (waste documented)
# Cycle 1 totals (D1 + D8 + D15 = 3 doses)
Total drug units: 27 (3 × 9)
Total drug cost (Q2 2026 ASP+6%): ~$87.40 for gemcitabine alone
+ Abraxane (J9264): separate billing, ~$1,360/dose at 125 mg/m² × 1.7 m²
Dose: 1,000 mg/m² × 1.7 m² = 1,700 mg
Units billed: ceil(1,700 / 200) = 9 units (J9201)
Vial: 1 × 2 g single-dose vial (Hospira NDC 00409-0183-01)
Waste: 2,000 − 1,700 = 300 mg = 1.5 units JW (separate line)
Admin: 96413 (30-min chemo IV)
Modifier on admin line: JW (waste documented)
# Cycle 1 totals (D1 + D8 + D15 = 3 doses)
Total drug units: 27 (3 × 9)
Total drug cost (Q2 2026 ASP+6%): ~$87.40 for gemcitabine alone
+ Abraxane (J9264): separate billing, ~$1,360/dose at 125 mg/m² × 1.7 m²
Schedule importance — keep at 30 minutes
Standard infusion is exactly 30 minutes. The FDA label warns that infusions ≥60 minutes are associated with increased toxicity (especially myelosuppression and pulmonary AEs). Do not extend the infusion to manage symptoms — treat the underlying cause and consider dose reduction or hold per CBC.
Reconstitution
- 200 mg vial: reconstitute with 5 mL 0.9% NaCl preservative-free → 38 mg/mL
- 1 g vial: reconstitute with 25 mL 0.9% NaCl → 38 mg/mL
- 2 g vial: reconstitute with 50 mL 0.9% NaCl → 38 mg/mL
- Final dose dilution: in 0.9% NaCl to 0.1–38 mg/mL for IV infusion
- Stable 24 hours at controlled room temp post-reconstitution; do NOT refrigerate (precipitation)
Combo regimens — what to bill alongside J9201 NCCN verified May 2026
Gemcitabine is rarely billed alone in 2026. Most claims include a partner drug with its own HCPCS, PA, and admin sequence.
| Regimen | Indication | Partner HCPCS | PA notes |
|---|---|---|---|
| Gem + nab-paclitaxel | Pancreatic 1L | Abraxane J9264 | Concurrent PA on Abraxane (commercial); Medicare LCDs cover both for pancreatic 1L |
| Gem + cisplatin | NSCLC, biliary, bladder | cisplatin J9060 | Cisplatin generic, low-cost; hydration regimen adds chair time (96365 + 96366 for additional hours) |
| Gem + carboplatin | Ovarian, NSCLC (cis-ineligible) | carboplatin J9045 | Carboplatin generic; AUC-based dosing per Calvert formula; less hydration than cisplatin |
| Gem + paclitaxel | Breast (post-anthracycline) | paclitaxel J9267 | Paclitaxel generic; pre-medicate for hypersensitivity (steroid + H1/H2 blocker) |
| Gem + cisplatin + durvalumab | Biliary 1L (TOPAZ-1) | + Imfinzi J9173 | Triplet regimen approved Sep 2022; concurrent PA on durvalumab |
| Gem + cisplatin + pembrolizumab | Biliary 1L (KEYNOTE-966) | + Keytruda J9271 | Approved Oct 2023; alternative to TOPAZ-1 regimen |
Sequence matters for billing admin codes. When gemcitabine is the initial drug, bill
96413 (initial chemo). When it follows another chemo (e.g., cisplatin first), bill
96417 (each additional sequential infusion, different drug) for gemcitabine. Document the
sequence in the medical record.
NDC reference — multi-generic landscape FDA NDC Directory verified May 2026
Gemzar (originator) patent expired November 2010. The market is now dominated by generic gemcitabine HCl from multiple manufacturers. Use the actual NDC of the vial dispensed — do not substitute another manufacturer's NDC.
| Manufacturer | 200 mg vial NDC | 1 g vial NDC | 2 g vial NDC |
|---|---|---|---|
| Hospira (Pfizer) | 00409-0181-01 |
00409-0182-01 |
00409-0183-01 |
| Mylan (Viatris) | 67457-0438-01 |
67457-0439-01 |
67457-0440-01 |
| Sandoz | 00781-3417-94 |
00781-3418-94 |
00781-3419-94 |
| Fresenius Kabi | 63323-0703-12 |
63323-0703-50 |
63323-0703-99 |
| Apotex | 60505-6128-00 |
60505-6129-00 |
60505-6130-00 |
| Eli Lilly Gemzar (originator) | 00002-7501-01 |
00002-7502-01 |
00002-7503-01 |
Verify NDC at dispense. Generic NDCs change with manufacturer reformulation, label
revisions, and packaging changes. The NDCs above are illustrative — always confirm against the
actual vial label and the current FDA NDC Directory before submitting the claim.
NOS code: J9201 is the not-otherwise-specified (NOS) code applicable to all generic
manufacturers and the originator Gemzar. There is no manufacturer-specific HCPCS for gemcitabine.
Phase 2
Code the claim
200 mg unit basis is the #1 error. JW for BSA-based waste is the #2 error.
Administration codes CPT verified May 2026
Gemcitabine is a true cytotoxic chemotherapy — classic 96413 admin coding applies.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for gemcitabine. 30-min standard infusion fits within 1-hour window. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Not needed for 30-min gemcitabine itself. Applies to combo partner drugs that extend chair time (e.g., cisplatin hydration). |
96417 |
Chemotherapy administration, IV infusion; each additional sequential infusion (different substance/drug), up to 1 hour | When gemcitabine follows another chemo in same chair-time visit (e.g., cisplatin then gem). |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Gemcitabine is a true cytotoxic chemotherapy; chemo admin codes are correct and pay materially more. |
96360 / 96361 |
IV hydration | For pre/post-chemo hydration (especially with cisplatin combos). Bill in addition to chemo admin codes. |
Combo admin sequence example (Gem + cisplatin NSCLC, D1):
96413 (cisplatin, initial chemo, 1 hr) + 96415 (cisplatin extended hydration, additional hr) + 96417 (gemcitabine, sequential 30 min) + 96360/96361 (post-cisplatin hydration). Document each drug start/stop time in the chair-time note.
96413 (cisplatin, initial chemo, 1 hr) + 96415 (cisplatin extended hydration, additional hr) + 96417 (gemcitabine, sequential 30 min) + 96360/96361 (post-cisplatin hydration). Document each drug start/stop time in the chair-time note.
Modifiers CMS verified May 2026
JW — required on most gemcitabine claims (BSA-based waste)
Because gemcitabine dosing is BSA-based (mg/m²), the calculated dose almost never matches a whole-vial multiple. JW reports the discarded portion of a single-dose vial. JW applies on most adult gemcitabine claims. Bill the administered amount on the main line; bill the wasted units on a separate JW line.
Example: 1,700 mg administered + 300 mg wasted from a 2 g vial → main line = 9 units (J9201) for administered amount + JW line = 1.5 units (or rounded per MAC convention) for waste.
JZ — only when dose lands on whole-vial multiple
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. For gemcitabine, this only applies when the BSA-based dose happens to land on a whole-vial multiple (e.g., a 2.0 m² patient at 1,000 mg/m² = 2,000 mg = exactly one 2 g vial → JZ). One of JZ or JW must be on every J9201 claim.
Common error: Failing to round wasted units to MAC-specific convention. Some MACs accept
fractional units (1.5); others require rounding up to whole units (2). Check your MAC's policy before
submission. CMS audits frequently catch JW omissions on BSA-based chemo — if your dose is not a
whole-vial multiple and you didn't bill JW, expect a recoupment.
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 gemcitabine, follow your MAC's current 340B modifier policy. Generic gemcitabine is often excluded from 340B due to its low cost, but verify per your 340B program.
ICD-10-CM by indication FY2026 verified May 2026
Multi-indication; use the most specific ICD-10 code supported by encounter documentation.
| Indication | ICD-10 family | Notes |
|---|---|---|
| Pancreatic adenocarcinoma (primary) | C25.x | C25.0 head, C25.1 body, C25.2 tail, C25.3 duct, C25.9 unspecified |
| NSCLC | C34.x | Histology-specific 4th character; typically combo with cisplatin |
| Metastatic breast cancer | C50.x | Post-anthracycline failure; combo with paclitaxel |
| Advanced ovarian cancer | C56.x | Post-platinum failure; combo with carboplatin |
| Bladder cancer | C67.x | Combo with cisplatin (or carboplatin if cis-ineligible) |
| Biliary tract cancers (NCCN) | C24.x, C22.1, C23 | Cholangiocarcinoma, ampulla of Vater, gallbladder; combo with cisplatin |
| Soft tissue sarcoma (off-label NCCN) | C49.x | Often combo with docetaxel (Gem-Tax regimen) |
| Hodgkin lymphoma (off-label NCCN) | C81.x | Salvage regimens |
| Cervical cancer (off-label NCCN) | C53.x | Recurrent/metastatic combo regimens |
| Mesothelioma (off-label NCCN) | C45.0 | Less common; pemetrexed-cis is standard |
Medicare coverage of off-label uses: Per Section 1861(t)(2) of the Social Security Act,
Medicare covers off-label oncology uses of FDA-approved drugs if listed in CMS-recognized compendia (NCCN,
AHFS-DI, Lexi-Drugs, Clinical Pharmacology). NCCN-listed gemcitabine combos for biliary, sarcoma, and
cervical are generally covered with appropriate ICD-10 documentation.
Site of care & place of service Verified May 2026
UnitedHealthcare, Aetna, and most major BCBS plans run site-of-care UM for cytotoxic chemotherapy. Generic gemcitabine is typically NOT a site-of-care steering target (low drug cost; admin code drives the steering decision more than drug acquisition cost). Combo regimens with high-cost partners (Abraxane, Imfinzi, Keytruda) ARE subject to site-of-care UM via the partner drug's policy.
| 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 for combo regimens after first 3 months |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored for combo regimens after first 3 months |
Claim form field mapping Verified May 2026
CMS-1500 / 837P claim form fields for J9201 + admin codes.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + actual vial NDC + ML + total volume reconstituted (e.g., 50 mL for one 2 g vial) |
| HCPCS J9201 (administered) + JZ or JW | 24D (drug line) | Most adult claims need JW |
| Drug units (administered) | 24G | 200 mg basis — ceil(mg / 200) |
| HCPCS J9201 + JW (waste) | 24D (separate waste line) | Wasted units only; from same SDV |
| CPT 96413 (admin line) | 24D (admin line) | 30-min infusion fits within 1-hour window |
| ICD-10 | 21 | Indication-specific (see ICD-10 table) |
| PA number | 23 | Generic gemcitabine often NOT PA-restricted; combo partners typically are |
Phase 3
Get paid
Generic gemcitabine itself is rarely PA-restricted. Combo partners are.
Payer policy snapshot Reviewed May 2026
Generic gemcitabine (J9201 NOS) is typically not PA-restricted at major payers. The PA burden falls on combo agents.
| Payer | PA on J9201? | Combo partner PA | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Generally no | Yes for Abraxane, Imfinzi, Keytruda; indication-specific docs required | Yes via combo partner; aggressive Optum-managed program |
| Aetna Oncology drug policies |
Generally no | Yes for high-cost combo partners | Yes via combo partner; ICIs steered out of HOPD after 3 months |
| BCBS plans Vary by plan |
Plan-specific; mostly no | Generally aligned with NCCN guidelines | Plan-specific; most have site-of-care steering for high-cost combos |
| Medicare (LCDs) | No PA | Coverage per LCD + NCCN compendia | N/A |
Step therapy
Generally NOT required for FDA-labeled and NCCN-listed gemcitabine indications. Some payers in the breast indication require prior anthracycline failure documentation (per 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 — J9201
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$3.237
per 200 mg unit (~$0.016/mg)
1,700 mg dose (typical)
$29.13
9 units × ASP+6%
2,000 mg dose
$32.37
10 units × ASP+6%
Annualized cost (drug only): Pancreatic 1L combo (Gem D1+D8+D15 q4w, 13 cycles/year →
39 doses) at 1,700 mg/dose: ~$1,140/year for gemcitabine at Medicare ASP+6%. The combo
partner Abraxane is the dominant cost (~$50,000+/year). After ~2% sequestration: actual paid is ~ASP + 4.3%.
Why is gemcitabine so cheap? Gemzar originator patent expired November 2010. Multiple
generic manufacturers (Hospira, Mylan, Sandoz, Fresenius Kabi, Apotex) compete on price. Per-mg cost is
among the lowest in cytotoxic chemotherapy — about 0.005% of monoclonal antibody costs (Opdivo
~$33/mg vs gemcitabine ~$0.016/mg = ~2,000× difference).
Coverage
No NCD specific to gemcitabine. Coverage falls under MAC LCDs for chemotherapy + the off-label oncology framework (Section 1861(t)(2), CMS-recognized compendia). All MACs cover J9201 for FDA-approved on-label indications and NCCN-listed off-label uses with appropriate ICD-10 documentation.
Code history
- J9201 — permanent code, in effect since 1996. NOS designator captures all generic manufacturers under one code.
- Unit basis: 200 mg has been the J9201 unit basis since the code was created. Has not changed.
Patient assistance Verified May 2026
- Lilly Cares Foundation (Gemzar legacy): 1-800-545-6962 / lillycares.com — free product for uninsured/underinsured patients meeting income requirements (Gemzar branded only)
- Generic manufacturer programs: Hospira, Mylan, Sandoz, Fresenius Kabi all have manufacturer assistance programs — varies by manufacturer; check the dispensed vial's manufacturer for current program
- CancerCare Co-Payment Assistance Foundation: 1-866-552-6729 / cancercare.org — copay support for diagnosis-specific funds (pancreatic, NSCLC, breast, ovarian, bladder — verify open funds quarterly)
- PAN Foundation: 1-866-316-7263 / panfoundation.org — disease-specific copay funds (pancreatic, NSCLC, biliary tract often open)
- HealthWell Foundation: 1-800-675-8416 / healthwellfoundation.org — disease-specific copay funds
- Pharmaceutical Manufacturer Co-Pay Programs: Generic gemcitabine has no manufacturer copay program (price too low to support); rely on charity foundations
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J9201 pre-loaded.
Phase 4
Fix problems
Wrong unit basis (1 mg vs 200 mg) and missing JW are the top two errors.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Excessive units | Billed mg as units (e.g., 1,700 instead of 9) — 200× overbilling | Recalculate: units = ceil(mg / 200). Resubmit corrected claim. Be aware: this can trigger a fraud audit if not caught early. |
| JW missing | BSA-based dose with partial-vial waste, not reported | Add JW line for discarded units. JZ on the administered units; JW on the wasted units. Required since 7/1/2023. |
| JZ missing on whole-vial-multiple dose | SDV claim without JZ when no waste occurred | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413. Gemcitabine is true cytotoxic chemo — chemo admin codes are correct and pay materially more. |
| NDC not on file / outdated | Generic NDC changed; old NDC submitted | Verify current NDC against actual vial label. Resubmit with current NDC. |
| Indication not covered | Off-label indication without compendia citation | Submit with NCCN compendia citation in PA. Most off-label oncology uses are covered if NCCN-listed. |
| Combo partner PA missing | Abraxane / Imfinzi / Keytruda PA not in place | Submit concurrent PA on combo partner. Generic gemcitabine itself rarely needs PA, but the partner does. |
| Excessive infusion duration billed | 96415 billed for additional hour on gemcitabine when infusion was 30 min | 96415 only applies for true >1 hr infusions. Standard gem is 30 min — 96413 alone covers it. Document chair time. |
Frequently asked questions
What is the HCPCS code for gemcitabine?
Gemcitabine (Gemzar and generics) is billed under HCPCS J9201 — "Injection, gemcitabine
hydrochloride, not otherwise specified, 200 mg." The unit basis is 200 mg per unit, NOT
1 mg per unit — this is unusual and a frequent biller error. J9201 is the NOS code applicable to all
generic manufacturers (Hospira, Mylan, Sandoz, Fresenius Kabi, Apotex) and the originator Eli Lilly Gemzar.
How many units do I bill for a 1,700 mg gemcitabine dose?
A 1,700 mg dose = 8.5 × 200 mg units. Bill 9 units total: round up because partial units are not billable, and document the wasted portion. Vial selection: one 2 g vial yields 1,700 mg administered + 300 mg wasted (bill JW for the waste = 1.5 units, JZ inappropriate when waste occurs).
What administration CPT do I use for gemcitabine?
CPT 96413 — "Chemotherapy administration, IV infusion technique; up to 1 hour, single
or initial substance/drug." Standard infusion is exactly 30 minutes, fitting within the 1-hour 96413
window. Important: infusions ≥60 minutes are associated with increased toxicity per
FDA label — keep at 30 minutes. Do NOT bill 96365 (therapeutic IV) — gemcitabine is true
cytotoxic chemo.
Do I bill JZ or JW for gemcitabine?
Almost always JW because gemcitabine dosing is BSA-based (mg/m²), so the calculated dose
rarely matches whole-vial multiples. Example: 1,000 mg/m² for a 1.7 m² patient = 1,700 mg. One
2 g (2,000 mg) single-dose vial yields 1,700 mg administered + 300 mg waste — bill JW with 1.5 units
of waste on a separate line. JZ alone applies only when the dose happens to land on a
whole-vial multiple (e.g., 2.0 m² × 1,000 mg/m² = 2,000 mg = exactly one 2 g vial).
What is the Medicare reimbursement for J9201?
For Q2 2026, the Medicare Part B payment limit for J9201 is approximately $3.237 per 200 mg unit (ASP + 6%) — equivalent to roughly $0.016 per mg. A typical 1,700 mg dose reimburses at approximately $29.13 (9 units × ASP+6%). Gemcitabine is among the lowest per-mg cytotoxic chemotherapy agents because the originator Gemzar patent expired in 2010.
What indications does gemcitabine cover?
FDA-approved indications: pancreatic adenocarcinoma (1L combo with nab-paclitaxel/Abraxane or single-agent), NSCLC (1L combo with cisplatin), metastatic breast cancer (post-anthracycline failure, combo with paclitaxel), advanced ovarian cancer (combo with carboplatin post-platinum failure), and bladder cancer (combo with cisplatin). NCCN-recommended off-label uses include biliary tract cancers (combo with cisplatin), soft tissue sarcomas, and many other solid tumors.
Is there a boxed warning for gemcitabine?
No boxed warning, but the FDA label carries serious warnings & precautions: severe myelosuppression (neutropenia, thrombocytopenia, anemia — dose modify per CBC), pulmonary toxicity (rare but serious — pneumonitis, pulmonary edema, ARDS — discontinue if severe), hemolytic uremic syndrome (HUS — rare but life-threatening, monitor renal function), severe hepatotoxicity, capillary leak syndrome, posterior reversible encephalopathy syndrome (PRES), and radiation recall in patients with prior RT.
What are the most common gemcitabine combo regimens?
Most-cited NCCN-recommended combos: Gem + nab-paclitaxel (Abraxane) for pancreatic 1L; Gem + cisplatin for NSCLC, biliary tract, and bladder; Gem + carboplatin for ovarian and NSCLC. Recent triplet additions: Gem + cisplatin + durvalumab (Imfinzi) for biliary 1L (TOPAZ-1, Sep 2022); Gem + cisplatin + pembrolizumab (Keytruda) for biliary 1L (KEYNOTE-966, Oct 2023). Concurrent PA on combo agents is the norm.
Is FOLFIRINOX a gemcitabine regimen?
No. FOLFIRINOX (5-FU, leucovorin, irinotecan, oxaliplatin) is a competing pancreatic regimen and contains no gemcitabine. The two regimens are often compared head-to-head: FOLFIRINOX is preferred for younger fitter patients (ECOG 0–1, age <75, good organ function); Gem + nab-paclitaxel (Abraxane) is preferred for ECOG 1+, older, or less fit patients. Don't confuse the two on a chemo order.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- DailyMed — Gemcitabine HCl Prescribing Information
- FDA Gemzar label PDF (current revision)
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J9201 reference
- NCCN Clinical Practice Guidelines — Pancreatic Adenocarcinoma v3.2026
- NCCN Guidelines — NSCLC v4.2026
- NCCN Guidelines — Breast Cancer v3.2026
- NCCN Guidelines — Ovarian Cancer v2.2026
- NCCN Guidelines — Bladder Cancer v2.2026
- NCCN Guidelines — Biliary Tract Cancers v3.2026
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- FDA National Drug Code Directory
- Lilly Cares Foundation — Gemzar (originator) PAP
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, NCCN guideline updates | Event-driven | Tied to manufacturer document version, FDA label revision date, and NCCN guideline revision. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS, NCCN,
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. FDA label: Feb 2024 revision (Gemzar NDA 020509). NCCN guidelines current as of May 2026 (Pancreatic v3.2026, NSCLC v4.2026, Breast v3.2026, Ovarian v2.2026, Bladder v2.2026, Biliary v3.2026). Multi-indication coverage including TOPAZ-1 (durvalumab combo, Sep 2022) and KEYNOTE-966 (pembrolizumab combo, Oct 2023) for biliary 1L.
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 and NCCN compendia. We do not paraphrase from billing-software vendor blogs.