J9264 — Injection, paclitaxel protein-bound particles, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- When reporting the JW modifier for discarded drug, the medical record must clearly show the amount administered and the amount wasted.
- Medical record must document prior anthracycline therapy for patients receiving albumin-bound paclitaxel, or clearly document a clinical contraindication to anthracycline therapy.
- For claims with no discarded amounts from single-dose containers or single-use packages, include the JZ modifier as evidence on the claim (effective July 1, 2023).
- Document dose and frequency as consistent with the FDA label or recognized compendia for the indication (including citations to the compendia if used for off-label indications).
Key Coverage Criteria
- Paclitaxel administered intravenously is covered for antineoplastic (cancer) indications when used in accordance with the FDA-approved labeling.
- Off-label uses of paclitaxel are covered when supported by recognized compendia (e.g., NCCN, AHFS, Clinical Pharmacology, Lexi-Drugs, Micromedex) and dosing/frequency follow those compendia.
- Albumin-bound paclitaxel (Abraxane) is covered when prior therapy included an anthracycline unless anthracycline therapy is clinically contraindicated.
- NGS covers leuprolide acetate (LHRH analog) as palliative treatment of advanced breast carcinoma in premenopausal and perimenopausal women.
- A drug use is covered if it is an FDA-approved labeled indication or is a medically accepted off-label indication supported by one of the accepted compendia at the specified levels (AHFS-DI supportive; NCCN Category 1 or 2A; Micromedex DrugDex Class I/IIa/IIb or Clinical Pharmacology supportive; Lexi-Drugs Evidence Level A) or by articles or LCDs published by National Government Services (NGS).
- Off-label uses in anti-cancer chemotherapeutic regimens are covered when they meet the Medicare definition of a medically accepted indication per the Medicare Benefit Policy Manual (Pub 100-02, Ch.15, §50.4.5).
2 Active Policies
A52450 — Billing and Coding: Paclitaxel (e.g., Taxol/Abraxane )
J06
L33394 — Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
J06
Related Codes
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