About paclitaxel J9267 FDA label verified May 2026
Paclitaxel (conventional, solvent-based) is one of the original taxane cytotoxic chemotherapies and one of the most widely-used drugs in solid-tumor oncology. The molecule was first isolated from the Pacific yew (Taxus brevifolia) bark, and the originator brand Taxol was approved by FDA in December 1992 (NDA 020262) by Bristol Myers Squibb. BMS subsequently discontinued the Taxol brand, and the U.S. market is now entirely generic, supplied by multiple ANDA holders — Hospira (Pfizer), Teva, Accord, Fresenius Kabi, Hikma, Athenex, and others. All commercial U.S. paclitaxel for injection is the solvent-based formulation, dissolved in polyoxyethylated castor oil (Cremophor EL) and approximately 50% v/v dehydrated alcohol, and concentrated at 6 mg/mL in 30 mg / 100 mg / 300 mg multi-dose vials.
Mechanism: paclitaxel stabilizes microtubules, blocking the M-phase of mitosis. It is FDA-approved for ovarian cancer (first-line and second-line), breast cancer (adjuvant and metastatic, including post- anthracycline relapse), non-small-cell lung cancer (in combination with cisplatin for patients who are not surgical candidates), and AIDS-related Kaposi sarcoma (second-line). NCCN compendium support adds head-and-neck squamous cell carcinoma, cervical cancer, esophageal/gastric cancers, pancreatic cancer (in specific combos), endometrial cancer, urothelial cancer, and others — making J9267 one of the most broadly-indicated J-codes in the catalog. Common cytotoxic combo regimens include TC (paclitaxel + carboplatin), TCH (TC + trastuzumab for HER2+ breast), paclitaxel + carboplatin + bevacizumab (ovarian, NSCLC), and the immune-oncology combo paclitaxel + Keytruda (J9271) for 1L PD-L1+ metastatic triple-negative breast cancer per KEYNOTE-355.
The defining operational features of J9267 — and the things billers must internalize to avoid denials — all derive from the Cremophor EL vehicle: mandatory premedication protocol (dexamethasone + diphenhydramine + H2 blocker) to prevent severe hypersensitivity reactions; 3-hour standard infusion (q3w 175 mg/m²) or 1-hour weekly (80 mg/m²); 0.22 micron in-line filter required to capture vehicle particulate; and non-PVC infusion bags and tubing to prevent DEHP plasticizer from leaching into the infusate. These are all label requirements, not optional practice, and missing documentation of any of them is grounds for denial or audit recoupment. None of these apply to Abraxane (J9264, nab-paclitaxel), which is the most common source of confusion on this code.
Two paclitaxel formulations — J9267 vs J9264 disambiguation CMS HCPCS verified May 2026
Same active drug, two completely different billable products. This is the most common paclitaxel coding error in the industry.
Paclitaxel exists in two distinct U.S.-billable forms. The FDA, CMS, and every major payer treat them as separate products with separate HCPCS codes, separate ASPs, separate prior authorizations, and separate clinical protocols. They cannot be substituted bedside, and a claim coded for the wrong formulation will either be denied outright or audited and recouped.
| Paclitaxel (J9267) — this page | Abraxane (J9264) — separate page | |
|---|---|---|
| HCPCS | J9267 — "Injection, paclitaxel, 1 mg" | J9264 — "Inj, paclitaxel protein-bound, 1 mg" |
| Brand | Originator Taxol (BMS) discontinued; multi-generic market | Abraxane (Bristol Myers Squibb / Celgene) — single source, no generic |
| Formulation | Solvent-based in Cremophor EL (polyoxyethylated castor oil) + ~50% v/v dehydrated alcohol | Albumin-bound nanoparticles (nab-paclitaxel) — reconstituted in saline; no Cremophor, no ethanol |
| Premedication for hypersensitivity | Required — dexamethasone + diphenhydramine + H2 blocker | Not required |
| Standard q3w breast dose | 175 mg/m² q3w (or 80 mg/m² weekly) | 260 mg/m² q3w (or 100–125 mg/m² weekly per indication) |
| Infusion duration (q3w) | 3 hours (96413 + 96415 × 2) | 30 minutes (96413 only) |
| In-line filter | 0.22 µm in-line filter required (captures Cremophor particulate; DEHP) | Do not use in-line filter (would trap albumin nanoparticles) |
| Tubing & bag | Non-PVC tubing + non-PVC bag (DEHP leaches from PVC) | Standard PVC OK |
| Vial format | 30 / 100 / 300 mg multi-dose vials, 6 mg/mL liquid | 100 mg lyophilized single-dose vial |
| ASP per mg (Q2 2026) | ~$0.147 | ~$6.020 |
| JW/JZ pattern | Multi-dose vial — JZ on most claims; JW only when residual is wasted from a partially-used vial that is then discarded | Single-dose vial — JW on virtually every claim (BSA dosing wastes partial vials) |
| Pediatric use | Contraindicated / not approved — deaths reported, attributed in part to vehicle ethanol toxicity | Not FDA-approved in pediatric; vehicle is safer for pediatric experimental use |
| Approved indications | Ovarian (1L & 2L), breast (adjuvant & metastatic), NSCLC, AIDS-KS, plus extensive NCCN off-label | Metastatic breast (post-anthracycline), NSCLC (1L combo), pancreatic adeno (1L combo) |
Dosing, premed protocol & unit math FDA label verified May 2026
All regimens are BSA-based, given IV over 1–3 hours depending on cycle frequency. Premedication is mandatory per FDA label.
Multi-indication dosing matrix
| Indication / regimen | Dose | Schedule | Combo partner(s) |
|---|---|---|---|
| Ovarian 1L (+ carboplatin) | 175 mg/m² | 3-hr IV q3w × 6 cycles | Carboplatin AUC 5–6 Day 1 (J9264 alternate combo on relapse) |
| Ovarian 2L | 135–175 mg/m² | 3-hr IV q3w | Monotherapy or ± carboplatin |
| Breast adjuvant (TC) | 175 mg/m² | 3-hr IV q3w × 4–6 cycles | Carboplatin AUC 6 Day 1 |
| Breast adjuvant (TCH, HER2+) | 175 mg/m² (or 80 wkly) | q3w × 6 (or weekly × 12) | Carboplatin + trastuzumab (J9355) |
| Metastatic breast (1L, weekly) | 80 mg/m² | 1-hr IV weekly | Monotherapy or + bevacizumab |
| Metastatic breast (post-anthracycline, q3w) | 175 mg/m² | 3-hr IV q3w | Monotherapy |
| mTNBC 1L (PD-L1+, KEYNOTE-355) | 90 mg/m² | 1-hr IV D1, D8, D15 q28d | + pembrolizumab (J9271) 200 mg q3w or 400 mg q6w |
| NSCLC 1L (+ cisplatin) | 135 mg/m² | 24-hr IV q3w (historic) or 3-hr q3w (modern) | Cisplatin 75 mg/m² (J9060) |
| NSCLC 1L (+ carbo + bev) | 200 mg/m² | 3-hr IV q3w | Carbo AUC 6 + bevacizumab (J9035) |
| Head & neck SCC (NCCN) | 40–100 mg/m² | Weekly × 6–7 (concurrent with RT) | ± cetuximab or carboplatin |
| Esophageal / gastric (NCCN) | 50 mg/m² | Weekly | + ramucirumab 2L gastric |
| Cervical (NCCN, recurrent) | 135–175 mg/m² | q3w | + cisplatin or carbo + bev |
| AIDS-related Kaposi sarcoma | 135 mg/m² | 3-hr IV q3w | Monotherapy (2L) |
Mandatory premedication protocol (per FDA label)
| Drug | Dose & timing | Billing |
|---|---|---|
| Dexamethasone | 20 mg PO at 12 and 6 hours before paclitaxel (preferred), or 10–20 mg IV 30–60 min before | PO at home = patient-supplied, not billable. IV (J1100 1 mg) billable with 96365/96366. |
| Diphenhydramine | 50 mg IV 30–60 min before | J1200 diphenhydramine HCl up to 50 mg + 96365 or 96366 |
| H2 blocker | Cimetidine 300 mg IV, ranitidine 50 mg IV (if available), or famotidine 20 mg IV 30–60 min before | Famotidine J3590 (NOC) or S0028; cimetidine J3490 NOC; ranitidine J2780 if used + 96366 |
Worked example — ovarian 1L q3w (BSA 1.7 m², 175 mg/m²)
Dose: 175 mg/m² × 1.7 m² = 297.5 mg → round to 300 mg per practice protocol
Vial draw: 1 × 300 mg vial (multi-dose) — full vial used, no waste
# Drug claim line
Line 1: J9267 · 300 units · modifier JZ (no waste, whole vial)
# Premed claim lines (in-chair IV)
J1200 · 1 unit (50 mg diphenhydramine) + 96365 (initial therapeutic IV)
Famotidine 20 mg IV + 96366 (each additional substance)
Dexamethasone 10 mg IV · J1100 · 10 units + 96366 (if not given PO at home)
# Admin claim lines (3-hour paclitaxel infusion)
96413 (initial chemo IV, up to 1 hour) — replaces any prior 96365
96415 × 2 (each additional hour — covers hours 2 and 3)
# Drug reimbursement (Q2 2026)
J9267: 300 units × $0.147 = ~$44.10 (drug only)
Note: the carboplatin (J9045) combo partner and admin time drive the actual claim economics.
Worked example — weekly mTNBC + Keytruda (BSA 1.7 m², 90 mg/m²)
Dose: 90 mg/m² × 1.7 m² = 153 mg per weekly infusion
Vial draw: 1 × 100 mg + partial of 100 mg vial (multi-dose) — 53 mg used from second vial
# Drug claim line(s)
Line 1: J9267 · 153 units · modifier JZ (multi-dose vial — residual returned to pharmacy stock for next patient; no JW)
# If residual is discarded (single-patient day, end of stock):
Line 1: J9267 · 153 units · JZ (administered)
Line 2: J9267 · 47 units · JW (discarded from 200 mg drawn)
# Admin claim lines (1-hour weekly infusion)
96413 only (1-hour weekly fits within initial chemo IV window) — no 96415 needed
D1 of each cycle: + Keytruda 200 mg q3w (J9271, 96413/96417 as sequential)
# Annual exposure (~12 weekly + 4 Keytruda doses)
Paclitaxel weekly × 52 = 52 infusions/yr if continuous; usually D1/D8/D15 q28d = 39/yr
NDC reference — multi-generic FDA NDC Directory verified May 2026
U.S. market is generic-only. Originator Taxol (BMS NDC 00015-xxxx) is discontinued. Use the actual NDC of the vial dispensed; generic NDCs change with manufacturer/packaging revisions.
| NDC (11-digit) | Strength | Package Size | Units/Vial | Manufacturer |
|---|---|---|---|---|
00409-0201-02 | 30 mg / 5 mL | Multi-dose vial, 6 mg/mL | 30 units (1 mg = 1 unit) | Hospira / Pfizer |
00409-0201-22 | 100 mg / 16.7 mL | Multi-dose vial, 6 mg/mL | 100 units | Hospira / Pfizer |
00409-0201-32 | 300 mg / 50 mL | Multi-dose vial, 6 mg/mL | 300 units | Hospira / Pfizer |
00703-3215-01 | 30 mg / 5 mL | Multi-dose vial | 30 units | Teva |
00703-3216-01 | 100 mg / 16.7 mL | Multi-dose vial | 100 units | Teva |
00703-3218-01 | 300 mg / 50 mL | Multi-dose vial | 300 units | Teva |
16729-0337-50 | 30 mg / 5 mL | Multi-dose vial | 30 units | Accord Healthcare |
16729-0338-08 | 100 mg / 16.7 mL | Multi-dose vial | 100 units | Accord Healthcare |
16729-0339-09 | 300 mg / 50 mL | Multi-dose vial | 300 units | Accord Healthcare |
63323-0763-05 | 30 mg / 5 mL | Multi-dose vial | 30 units | Fresenius Kabi |
63323-0763-17 | 100 mg / 16.7 mL | Multi-dose vial | 100 units | Fresenius Kabi |
63323-0763-50 | 300 mg / 50 mL | Multi-dose vial | 300 units | Fresenius Kabi |
00641-6195-25 | 30 mg / 5 mL | Multi-dose vial | 30 units | Hikma (West-Ward) |
00641-6196-25 | 100 mg / 16.7 mL | Multi-dose vial | 100 units | Hikma (West-Ward) |
Administration codes CPT verified May 2026
Paclitaxel is true cytotoxic chemotherapy. Use chemo admin codes (96413 / 96415 / 96417), not therapeutic IV codes (96365 / 96366) for the paclitaxel itself.
| Code | Description | When to use for J9267 |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for paclitaxel. Bill once per encounter as the initial chemo agent. For weekly 80–90 mg/m² (1-hr infusion), 96413 alone is sufficient. |
96415 |
Chemotherapy administration, IV infusion; each additional hour (List separately) | Bill × 2 for the standard 3-hour q3w infusion. 96413 covers hour 1; 96415 covers hours 2 and 3. Document infusion start/stop times in the MAR. |
96417 |
Chemo IV infusion, each additional sequential infusion (different drug, up to 1 hour) | For the sequential combo agent (carboplatin in TC/TCH; cisplatin in NSCLC). List separately from 96413/96415. |
96365 |
Therapeutic, prophylactic, or diagnostic IV infusion; initial, up to 1 hour | NOT appropriate for paclitaxel itself. Use for the initial premed (diphenhydramine, dexamethasone, H2 blocker) when given before paclitaxel. |
96366 |
Therapeutic IV infusion, each additional sequential substance (over 15 min) | For each additional premed agent given sequentially before paclitaxel. |
96375 |
Therapeutic IV push, each additional substance | For IV-push premeds (e.g., diphenhydramine 50 mg slow push instead of infusion). |
Modifiers (JZ, JW, 25, 340B) CMS verified May 2026
JZ vs JW — multi-dose vial pattern
Paclitaxel is supplied in multi-dose vials, unlike Abraxane (single-dose). CMS's July 2023 single-dose container JW/JZ rule technically applies only to single-dose vials — but most payers (and many MAC LCDs) extend the reporting expectation to require either JZ (no waste) or JW (waste reported) on every chemo claim. For paclitaxel multi-dose vials, the default pattern is:
- JZ on the administered line when the residual goes back to pharmacy stock for another patient within BUD.
- JW on a separate waste line only when the residual is actually discarded (end-of-day stock turnover, single-patient practice, contamination, BUD expiration).
Worked example — JW for end-of-day discard
Last patient of the day: weekly mTNBC dose 153 mg (BSA 1.7, 90 mg/m²).
Drew from 1 × 100 mg vial (used 100 mg) + 1 × 100 mg vial (used 53 mg).
Second vial: 47 mg residual, BUD won't survive overnight per USP <797> storage.
Pharmacy disposes of residual at end of shift.
# Claim lines
Line 1: J9267 · 153 units · JZ (administered)
Line 2: J9267 · 47 units · JW (discarded)
Both lines pay at ASP+6% · total drug reimbursement: 200 × $0.147 = ~$29.40
Modifier 25 — same-day E/M
Use modifier 25 on the E/M code only when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion (e.g., physician called for hypersensitivity reaction rescue, or a separate post-cycle evaluation). Routine pre-infusion clinical assessment is bundled into the chemo admin code.
340B modifiers (JG, TB)
For 340B-acquired paclitaxel, follow your MAC's current 340B modifier policy. Note: because generic paclitaxel ASP is so low, the 340B economic spread on J9267 is minimal (cents per mg) — the 340B reporting effort is essentially compliance work, not margin work.
NU/UN/UP — not applicable
Quantity-of-supply modifiers (NU/UN/UP) do not apply to J9267. Drug units are reported in 24G as mg administered.
ICD-10-CM by indication FY2026 verified May 2026
Paclitaxel has broad on-label and NCCN compendium coverage. Pair with secondary metastatic codes (C77–C79) where applicable.
| Indication | ICD-10 family | Notes |
|---|---|---|
| Ovarian cancer (1L & 2L) | C56.1 / C56.2 / C56.9 | Right / left / unspec ovary; FDA on-label |
| Fallopian tube cancer | C57.00 / C57.01 / C57.02 | Often coded alongside ovarian; FDA on-label |
| Primary peritoneal carcinoma | C48.1 / C48.2 / C48.8 | NCCN compendium |
| Breast cancer — female | C50.011 – C50.929 | 5th character = laterality; 4th = quadrant; FDA on-label adjuvant + metastatic |
| Breast cancer — male | C50.021 / C50.121 / etc. | NCCN compendium |
| TNBC / PD-L1+ metastatic | C50.x + ER/PR/HER2-negative documented | KEYNOTE-355 + Keytruda (J9271) regimen |
| NSCLC — upper lobe | C34.10 / C34.11 / C34.12 | Unspec / right / left upper lobe |
| NSCLC — middle lobe | C34.2 | Right middle lobe (no left middle lobe) |
| NSCLC — lower lobe | C34.30 / C34.31 / C34.32 | Unspec / right / left lower lobe |
| NSCLC — main bronchus / overlap / unspec | C34.0x / C34.8x / C34.9x | Use when lobe documentation incomplete |
| Head & neck SCC (oral, pharynx, larynx) | C00–C14 | NCCN; concurrent with RT |
| Laryngeal SCC | C32.0 / C32.1 / C32.2 / C32.9 | NCCN H&N |
| Cervical cancer (recurrent / metastatic) | C53.0 / C53.1 / C53.8 / C53.9 | NCCN; carbo + paclitaxel + bev |
| Endometrial cancer (advanced / recurrent) | C54.1 | NCCN; carbo + paclitaxel |
| Esophageal / GE junction (advanced) | C15.x / C16.0 | NCCN; + ramucirumab in 2L |
| Gastric (2L, + ramucirumab) | C16.x | NCCN compendium |
| Pancreatic adenocarcinoma (combo) | C25.0 / C25.1 / C25.2 / C25.9 | NCCN; head / body / tail / NOS (note: Abraxane J9264 is the FDA-on-label nab-paclitaxel for pancreatic) |
| AIDS-related Kaposi sarcoma | C46.0 – C46.9 | FDA on-label 2L; pair with HIV B20 |
| Urothelial / bladder | C67.x | NCCN; salvage regimens |
| Secondary malignancy (paired) | C77–C79 | Add nodal (C77.x), respiratory/digestive (C78.x), or other site (C79.x) mets where applicable |
Site of care & place of service Verified May 2026
Conventional paclitaxel is administered in oncology offices, ambulatory infusion centers, and hospital outpatient departments. The 3-hour q3w infusion + 60-minute premed pre-load means a typical chair commitment of 4–5 hours per cycle, plus monitoring during the first 15 minutes of each infusion for hypersensitivity reactions. Weekly 1-hour infusions are shorter (~2 hours total including premed). This chair-time profile makes J9267 less throughput-friendly than Abraxane (J9264, 30 min, no premed) and is a routine reason practices switch to nab-paclitaxel when payer formulary allows.
| Setting | POS | Claim form | Notes |
|---|---|---|---|
| Physician oncology office | 11 | CMS-1500 / 837P | Preferred — chair time accommodates 3-hr infusion + monitoring |
| Ambulatory infusion suite (AIC / freestanding) | 49 | CMS-1500 / 837P | Preferred — commercial payers often steer here |
| Oncology ASC | 24 | CMS-1500 / 837P | Acceptable; verify ASC chemo coverage policy |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored by commercial site-of-care UM after first cycles; HOPD facility fee adds substantially |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored |
| Patient home | 12 | CMS-1500 (home infusion) | Rare and not recommended — first-infusion hypersensitivity risk + filter/premed monitoring make home administration unsafe; few home infusion benefits cover J9267 |
Claim form field mapping CMS-1500 standard 2026
CMS-1500 (837P) field mapping for a typical TC (paclitaxel + carboplatin) ovarian 1L encounter.
| Information | CMS-1500 box | Example value |
|---|---|---|
| NPI (rendering) | 17b / 24J | Rendering oncologist NPI |
| NDC qualifier + 11-digit NDC + UoM + qty (paclitaxel) | 24A shaded | N4 + 00409-0201-32 + ML + 50 (for one 300 mg vial) |
| HCPCS J9267 (administered) | 24D drug line | J9267 with modifier JZ (no waste, whole multi-dose vial) |
| Drug units (24G) | 24G | 300 (= mg administered) |
| HCPCS J9267 JW (only if waste) | 24D waste line | J9267 + modifier JW, units = mg discarded |
| CPT 96413 (initial chemo IV) | 24D admin line | 1 unit; covers hour 1 of paclitaxel |
| CPT 96415 × 2 (each additional hour) | 24D admin line | Quantity 2; covers hours 2 and 3 of paclitaxel |
| CPT 96417 (sequential chemo) | 24D admin line | For carboplatin (J9045) after paclitaxel |
| CPT 96365 (initial premed therapeutic IV) | 24D premed line | For diphenhydramine / H2 blocker pre-paclitaxel |
| CPT 96366 (each additional sequential premed) | 24D premed line | For dexamethasone IV or H2 blocker as sequential premed |
| J-codes for premeds | 24D | J1200 diphenhydramine, J1100 dexamethasone (per mg), famotidine NOC |
| ICD-10 (primary diagnosis) | 21 | C56.1 (right ovary) or applicable indication code |
| Diagnosis pointer | 24E | Link J9267 + admin codes to ICD-10 line |
| PA / authorization number | 23 | Required by most commercial; rarely by Medicare (J9267 is non-PA on most LCDs) |
Payer policy snapshot Reviewed May 2026
Generic paclitaxel itself is generally not PA-restricted — PA burden falls on combo partners (Keytruda, trastuzumab, bevacizumab) and on indication-specific NCCN documentation.
| Payer | PA on J9267 | Documentation requirements | Site-of-care UM |
|---|---|---|---|
| Medicare MAC LCDs (Part B) |
No | FDA-approved + NCCN compendium-supported indications covered. ICD-10 + on-label or NCCN reference in chart sufficient. | OPPS for HOPD; office-based not steered |
| UnitedHealthcare Oncology Med Coverage Policy |
Generally no | NCCN regimen support; combo partner PA (carboplatin J9045 is also non-PA; bev J9035, Keytruda J9271, trastuzumab J9355 are PA-required) | Aggressive: chemo steered out of HOPD via Optum-managed program |
| Aetna CPB + Medical Drug policies |
Generally no | NCCN-aligned; combo partner PA | Yes (separate Site-of-Care policy) |
| BCBS plans Vary by plan |
Plan-specific (mostly no) | NCCN compendium aligned; some plans require step through specific 1L regimens | Plan-specific; most have oncology site-of-care steering |
| Medicaid (state) Varies by state |
Generally no | State-specific MAC LCD alignment | Varies |
Step therapy
Generic paclitaxel is itself almost always the first step in step-therapy chains for taxane-eligible indications — payers steer toward J9267 before approving the more expensive Abraxane (J9264). To overcome step and get J9264 approved, document documented paclitaxel hypersensitivity (prior reaction requiring discontinuation), Cremophor EL contraindication, or specific clinical rationale (e.g., need to avoid ethanol vehicle).
NCCN compendium support
J9267 is one of the most broadly NCCN-supported drugs in the catalog (Category 1 in many regimens). NCCN Breast (v3.2026), Ovarian (v2.2026), NSCLC (v4.2026), Cervical, Endometrial, Head & Neck, Esophageal/ Gastric, AIDS-KS guidelines all include paclitaxel-based regimens. Compendium support extends Medicare coverage to NCCN-listed off-label uses (CMS recognizes NCCN compendium as primary).
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9267
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
Coverage
No NCD specific to paclitaxel. Coverage falls under MAC LCDs for chemotherapy + the generic drug coverage framework. All MACs cover J9267 for FDA-approved on-label indications with appropriate ICD-10 and clinical documentation. NCCN compendium support extends Medicare coverage to additional NCCN-listed regimens.
Code history
- J9267 — permanent code, "Injection, paclitaxel, 1 mg." Replaced the older unit-based descriptors used before HCPCS harmonization to per-mg billing.
- J9264 (Abraxane / nab-paclitaxel) is a separate permanent code — do not confuse.
Patient assistance — foundation-based Verified May 2026
Because conventional paclitaxel is generic (originator Taxol discontinued), there is no manufacturer copay assistance program — the drug is too cheap for a manufacturer-sponsored program. Patient financial assistance for J9267 is therefore entirely foundation-based. The good news: most paclitaxel-treated cancers (breast, ovarian, lung, head/neck, cervical) have multiple open foundation funds because of the drug's broad use across high-volume diagnoses.
- CancerCare Co-Payment Assistance Foundation: 1-866-552-6729 / cancercare.org/copayfoundation — eligibility 500% FPL; funds for breast, ovarian, NSCLC, head & neck, cervical typically open
- PAN Foundation (Patient Access Network): 1-866-316-7263 / panfoundation.org — eligibility 400–500% FPL; rotating disease funds; check fund status before enrollment
- HealthWell Foundation: 1-800-675-8416 / healthwellfoundation.org — eligibility 500% FPL; oncology funds for breast, ovarian, lung, head & neck typically open
- The Assistance Fund (TAF): 1-855-845-3663 / tafcares.org — disease-specific funds
- Patient Advocate Foundation Co-Pay Relief: 1-866-512-3861 / copays.org — disease-specific eligibility 400% FPL
- Good Days: 1-877-968-7233 / mygooddays.org — varying disease-specific oncology funds
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong HCPCS (J9264 billed for J9267 administration or vice versa) | Order said "paclitaxel" without specifying nab- / Abraxane; biller defaulted to wrong code | Reconcile chemo order ↔ pharmacy dispense record ↔ MAR. Resubmit corrected J-code. The two are not interchangeable; ~55× price difference makes this a routine audit catch. |
| Missing premedication documentation in MAR | Premed protocol not charted (dex / diphenhydramine / H2 blocker) | Chart correction with attestation. FDA label requires premed; missing documentation is grounds for medical-necessity denial and quality citation. Educate infusion staff on MAR completion. |
| Missing in-line filter / non-PVC tubing documentation | 0.22 µm filter and non-PVC infusion bag/tubing used but not charted | Chart correction. Joint Commission medication-management standards require filter documentation for paclitaxel. Update infusion supply checklist to default-document filter and tubing type. |
| Wrong admin code (96365 instead of 96413) | Therapeutic IV billed instead of chemo IV for paclitaxel itself | Resubmit with 96413 (+ 96415 × 2 for 3-hr q3w). Paclitaxel is cytotoxic chemotherapy. 96365/96366 IS appropriate for the premeds, not for the paclitaxel. |
| Missing 96415 hours for 3-hr infusion | Only 96413 billed; the additional 2 hours unbilled | Resubmit with 96415 × 2. Document precise infusion start/stop times in MAR — required for hour-counting under CPT. |
| JW billed without actual waste | Biller applied Abraxane JW pattern to multi-dose paclitaxel vial | Use JZ when residual returns to stock; JW only when discarded. Multi-dose ≠ single-dose. Document vial disposition. |
| Site of care (HOPD) | HOPD administration on commercial plan with site-of-care UM after cycle 1 | Move stable patients to office (POS 11) or AIC (POS 49). Submit medical-necessity letter if HOPD clinically required (severe prior reaction, complex comorbidity). |
| Combo agent PA missing | Bev / trastuzumab / Keytruda / cetuximab PA not in place for the regimen | Submit combo partner PA in parallel. J9267 itself is rarely PA-restricted — the burden is on combo partners. Verify each agent's PA status separately. |
| Wrong NDC format | 10-digit NDC or vial NDC submitted; manufacturer changed packaging | Use 11-digit NDC of vial actually dispensed with N4 qualifier in 24A shaded area. Verify current NDC at the time of fill, not at billing. |
| Pediatric patient denied without protocol documentation | J9267 in a pediatric patient flagged by payer edit | Submit NCCN- or COG-protocol documentation + informed consent. Note that paclitaxel is not FDA-approved pediatric and the Cremophor vehicle has caused pediatric fatalities — pediatric oncologists usually prefer Abraxane (J9264) where available. |
| Hypersensitivity rescue not separately billed | Mid-infusion reaction; rescue drugs given but not coded | Add J-codes for rescue agents (J1200 diphenhydramine, J1100 dex, J0171 epinephrine, J7050 NS) with 96366 (sequential substance) and document reaction grade in MAR. |
Frequently asked questions
Paclitaxel vs Abraxane — which J-code do I use?
These are two different billable products with the same active ingredient. Conventional
solvent-based paclitaxel (the generic Taxol formulation in Cremophor EL + dehydrated alcohol) is
J9267 — "Injection, paclitaxel, 1 mg." Abraxane
(paclitaxel protein-bound, nab-paclitaxel) is J9264 — "Injection, paclitaxel
protein-bound particles, 1 mg." The two are NOT interchangeable on the claim. Verify which formulation was
actually dispensed and administered — check the chemo order, the MAR, and the pharmacy dispense
record. ASP per mg differs by ~55×. See the disambiguation table for
the full comparison.
Why is paclitaxel a 3-hour infusion?
Per the FDA label, the standard q3-week monotherapy paclitaxel dose (175 mg/m²) is infused over
3 hours. The duration is fixed because hypersensitivity reactions from the Cremophor EL
(polyoxyethylated castor oil) vehicle are concentration- and rate-dependent; shortening the infusion
increases reaction risk. Weekly low-dose paclitaxel (80 mg/m²) is infused over 1 hour. For 3-hour
infusions bill CPT 96413 (initial up-to-1-hour chemo IV) plus 96415 × 2
(each additional hour). Abraxane (J9264), by contrast, is a 30-minute infusion with no premed because
it has no Cremophor EL vehicle.
How do I bill the hypersensitivity premedication?
The standard pre-paclitaxel premed cocktail per FDA label is dexamethasone 20 mg PO 12 and 6
hours before infusion (or IV 30–60 min before), diphenhydramine 50 mg IV 30–60 min
before, and an H2 blocker (cimetidine 300 mg IV or famotidine 20 mg IV) 30–60
min before. Oral dexamethasone is patient-supplied — not separately billable. IV premeds given in the
chair are billed as 96365 (initial therapeutic IV) and 96366 (each additional
substance) with their respective J-codes (J1200 diphenhydramine, J1100
dexamethasone per mg, famotidine NOC). Do NOT bill premed lines for Abraxane (J9264) — no premed
required.
Is the in-line filter billable?
No — the 0.22 micron in-line filter required for paclitaxel infusions (to prevent particulate from the Cremophor EL vehicle and to prevent DEHP plasticizer leaching from PVC tubing) is supply, not a separately billable item under Part B. It is bundled into the chemo administration code (96413/96415) and the facility fee. However, documentation that an in-line filter and non-DEHP/non-PVC tubing were used should appear in the MAR — payers and CMS audits flag missing filter documentation as a quality/safety issue, and Joint Commission medication-management surveys cite it. The same goes for non-PVC infusion bags (glass or polyolefin).
How do I bill a hypersensitivity rescue mid-infusion?
If the patient develops a hypersensitivity reaction during the paclitaxel infusion and the infusion is
paused for rescue therapy (additional IV diphenhydramine, IV dexamethasone, IV epinephrine, fluids),
bill the rescue drugs with their J-codes plus a sequential infusion code (96366 for each
additional sequential substance) and document the reaction grade (CTCAE) in the MAR. If the infusion is
then resumed after symptom resolution, the total paclitaxel chair time still bills as 96413 + 96415
hours based on actual infusion minutes. Do NOT add a separate evaluation code — the chemo admin
codes include routine reaction monitoring; bill 99211–99215 with modifier 25 only if a physician
was called and performed a separately documented E/M.
What are the pediatric uses of paclitaxel?
Paclitaxel is not FDA-approved for pediatric use — the prescribing information explicitly states "safety and effectiveness in pediatric patients have not been established," and there is a contraindication note that fatalities have occurred in pediatric patients receiving the Cremophor EL formulation, attributed in part to ethanol toxicity from the vehicle (paclitaxel injection contains ~50% v/v dehydrated alcohol). Pediatric oncology protocols that include a taxane generally use Abraxane (J9264, Cremophor- and alcohol-free) or off-label paclitaxel under institutional COG/CCG protocol with informed consent. For billing, J9267 in a pediatric patient may trigger payer review — submit with NCCN- or COG-protocol documentation.
What is the Medicare reimbursement for J9267?
For Q2 2026, the Medicare Part B payment limit for J9267 is approximately $0.147 per mg (ASP + 6%). A standard 300 mg dose (175 mg/m² × 1.7 BSA) reimburses at roughly $44.10 — paclitaxel is one of the cheapest generic chemo drugs in the catalog (vs Abraxane J9264 at ~$6.02/mg, ~41× higher). Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%. ASP is updated quarterly by CMS. The low ASP means most of the financial risk in a paclitaxel claim is on the chair-time/administration side, not the drug — code 96413 + 96415 hours carefully.
What ICD-10 codes do I use for paclitaxel?
Paclitaxel has broad on-label and NCCN-compendium coverage. Breast cancer (including
TNBC): C50.x (laterality + quadrant) — used in adjuvant TC, TCH, and metastatic regimens.
Ovarian / fallopian / primary peritoneal: C56.x / C57.0x /
C48.x — first-line with carboplatin q3w. NSCLC: C34.x
(lobe-specific) — combo with carboplatin. Head & neck SCC: C00–C14
family — combo with carboplatin or cisplatin + RT. Pancreatic, gastric, esophageal, and cervical
cancers also have label or NCCN support. Pair with secondary metastatic codes (C77–C79) where
applicable.
Can I use J9267 with Keytruda for triple-negative breast cancer?
Yes. The KEYNOTE-355 regimen approved pembrolizumab (Keytruda, J9271) in combination with chemotherapy (including paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin) for first-line metastatic triple-negative breast cancer in patients with PD-L1+ tumors (CPS ≥ 10). Paclitaxel 90 mg/m² weekly D1/D8/D15 q28d + Keytruda 200 mg q3w (or 400 mg q6w) is one of the chemo backbones. Bill J9267 for paclitaxel + J9271 for Keytruda separately; both have their own admin codes (96413 + 96417 sequential) and Keytruda requires PA in its own right.
Source documents
- DailyMed — PACLITAXEL injection prescribing information (multiple generic ANDAs)
- FDA — TAXOL (paclitaxel) original NDA 020262 prescribing information (BMS)
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J9267 reference
- FDA National Drug Code Directory — paclitaxel injection
- NCCN Clinical Practice Guidelines in Oncology — Breast (v3.2026), Ovarian (v2.2026), NSCLC (v4.2026), Cervical, Endometrial, Head & Neck, Esophageal/Gastric
- Cortes J et al. KEYNOTE-355: Pembrolizumab plus chemotherapy in advanced TNBC (NEJM 2022)
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna Clinical Policy Bulletins — Antineoplastic agents
- CMS HCPCS Level II Quarterly Updates
- CMS — JW/JZ modifier policy (CR 12056, eff. July 2023)
- FDA — DEHP plasticizer safety (rationale for non-PVC tubing for paclitaxel)
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 | Event-driven | Tied to manufacturer ANDA / FDA label revision date. |
Reviewer
Change log
- — Initial publication. ASP data: Q2 2026. Multi-generic NDC reference (Hospira/Pfizer, Teva, Accord, Fresenius Kabi, Hikma). Premed protocol + 3-hr infusion + in-line filter + non-PVC tubing requirements documented. Disambiguation from Abraxane (J9264) made prominent.
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 dosing are verified against current FDA-approved generic labels and NCCN guideline references. We do not paraphrase from billing-software vendor blogs.