J9218 — Leuprolide acetate, per 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
- Medical records for patients receiving a once‑yearly implant must document ongoing follow‑up visits at least every 3 to 4 months and must be provided upon request; lack of requested documentation will result in denial as not medically necessary.
- Physician documentation supporting reasonable expectation of survival >12 months is required for coverage of once‑yearly implants for prostate cancer.
- Billing frequency should match the drug formulation administered (e.g., bill Vantas 50 mg implant once per 12 months, Eligard 22.5 mg billed per its 3‑month formulation); medical record must support billed frequency when requested.
- Coverage determinations for off-label use require supporting peer-reviewed literature, specialty consultant advice as indicated, and reference to accepted standards of medical practice; documentation of these sources must be provided for review.
Key Coverage Criteria
- GnRH/LHRH analogs (leuprolide, goserelin, triptorelin, histrelin, leuprolide mesylate/Camcevi) are covered for FDA‑approved indications and for recognized off‑label uses that meet the criteria of LCD L33394.
- Leuprolide acetate and histrelin implants administered every 12 months are covered for treatment of prostate cancer when the treating physician reasonably expects the patient to survive at least 12 months.
- GnRH analogs are covered when administered at frequencies consistent with the specific product's labeled duration of action (e.g., monthly, every 3, 4, 6, or 12 months).
- 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).
5 Active Policies
A52453 — Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs
J06
L33394 — Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
J06
AETNA-CPB-0079 — Benign Prostatic Hyperplasia
AETNA-CPB-0501 — Gonadotropin-Releasing Hormone Analogs and Antagonists
AETNA-CPB-0788 — Alzheimer's Disease: Experimental Treatments
Related Codes
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