J9217, Leuprolide acetate (for depot suspension), 7.5 mg
HCPCS/CPT
Prior Authorization
Prior Auth Required
Code explicitly requires prior authorization (high confidence)
Medicare Pricing
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.
- 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)
20 Active Policies
A52453, Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs
J6
PALMETTO-JJ-L39387, Luteinizing Hormone-Releasing Hormone (LHRH) Analogs
JJ
NGS-L33394, Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
JK
PALMETTO-JM-L39387, Luteinizing Hormone-Releasing Hormone (LHRH) Analogs
JM
AETNA-CPB-0788, Alzheimer's Disease: Experimental, Investigational, or Unproven Treatments
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
BCBSOK-RX502.061, Oncology Medications
UMR-POL-UMR-gonadotropin-releasing-hormone-analogs, Gonadotropin Releasing Hormone Analogs
UMR-POL-UMR-oncology-medication-clinical-coverage-policy, Oncology Medication Clinical Coverage
SUREST-POL-SUREST-gonadotropin-releasing-hormone-analogs, Gonadotropin Releasing Hormone Analogs
SUREST-POL-SUREST-oncology-medication-clinical-coverage-policy, Oncology Medication Clinical Coverage
EVICORE-HPLAN-CIGNA-91DEEEDD92F8, Cigna MedOnc Master Drug List
Related Codes
Have a follow-up question?
Ask Verity about documentation requirements, denial risks, or coverage in your state.