Does J9218 require prior authorization?

Yes, J9218 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J9218?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J9218`, Leuprolide acetate, per 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires 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.

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.

Imaging and laboratory/biomarker data used in studies: brain CT or MRI, amyloid PET (e.g., florbetapir), cerebrospinal fluid (CSF) biomarkers (Aβ1-42, total tau, phospho-tau), and APOE ε4 genotyping when reported in trials.

For some interventional procedures/trials, pre-procedure evaluations included medical/neurological and psychological examinations, depression rating scales (e.g., Montgomery–Asberg Depression Rating Scale), and lumbar puncture with CSF analysis.

Documentation of prior/concurrent standard therapies (e.g., use of cholinesterase inhibitors and/or memantine) is often recorded in trials and may be relevant when considering investigational add-on therapies.

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).
None specified. This Clinical Policy Bulletin addresses experimental treatments for Alzheimer's disease and lists treatments considered experimental and investigational (i.e., not established as effective) for this indication.
No explicit covered indications are stated in this document. The document discusses potential therapeutic use in the following conditions:
Alzheimer's disease (AD)

16 Active Policies

A52453, Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs

NGS-J6-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

NGS-JK-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

AETNA-CPB-0079, Benign Prostatic Hyperplasia

AETNA-CPB-0501, Gonadotropin-Releasing Hormone Analogs and Antagonists

BCBSIL-RX501.041, Gonadotropin-Releasing Hormone (GnRH) Agonists and Antagonists

BCBSIL-RX502.061, Oncology Medications

BCBSMT-RX501.041, Gonadotropin-Releasing Hormone (GnRH) Agonists and Antagonists

BCBSMT-RX502.061, Oncology Medications

BCBSNM-RX501.041, Gonadotropin-Releasing Hormone (GnRH) Agonists and Antagonists

BCBSNM-RX502.061, Oncology Medications

BCBSOK-RX501.041, Gonadotropin-Releasing Hormone (GnRH) Agonists and Antagonists

EVICORE-HPLAN-CIGNA-729A536F50C8, Q3 - 2026 Cigna MedOnc Master Drug List.pdf

BCBSOK-RX502.061, Oncology Medications

EVICORE-HPLAN-HEALTH_PARTNERS_PLANS-4BC80209CCC5, Q3 - 2026 Jefferson Health Plans MedOnc Master Drug List

AETNA-CPB-0788, Alzheimer's Disease: Experimental, Investigational, or Unproven Treatments

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J9218, Leuprolide acetate, per 1 mg