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

CMS National Coverage PolicyN/AArticle TextThis article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.Abstract:Synthetic luteinizing hormone-releasing hormone (LHRH) analogs (also called LHRH agonists) available in the United States include leuprolide acetate (Lupron, Eligard, Viadur, Lutrate), goserelin acetate (Zoladex), triptorelin (Trelstar Depot, TrelstarLA, Triptodur), and histrelin acetate (Vantas). These drugs may be administered by injection or placed as small implants under the skin monthly, or every 3, 4, 6, or 12 months, depending on the preparation. The FDA approved indications and recognized off-label uses (which meet criteria in LCD L33394) vary by product. Leuprolide mesylate (Cancevi) has been added effective for dates of service on or after 05/26/2021.Specific coding guidelines for this drug:Once yearly implants (J9219 and J9225) will not be reimbursed more often than once in a 12-month period and will be denied when submitted with a diagnosis that is not covered. In addition, once yearly implant therapy is not reasonable unless the physician expects the life expectancy of the patient to be longer than one year.Leuprolide AcetateHCPCS code J9218 (leuprolide acetate, per 1 mg.) describes ausuallyself-administered form of leuprolide acetate and is not covered under Medicare Part A/B. Please refer to the Self-Administered Drug Exclusion List  Medical Policy Articles (A53021 for J-K MAC and A53022 for J6 MAC).Claims for leuprolide acetate billed for prostate cancer at dosages (i.e. J1950 for 3.75 mg of leuprolide acetate) which are medically indicated for other diagnoses will be subject to review and possible denial.The 10.8 mg implant is not labeled for use in women (AHFS, 2007) and is considered contraindicated in women (Drugdex, 2009).Camcevi (leuprolide mesylate) is a ready-to-use, 6-month depot formulation of the approved gonadotropin releasing hormone (GnRH) agonist leuprolide.Lutrate (leuprolide acetate for depot suspension) a gonadotropin-releasing hormone (GnRH) agonist- 22.5 mg for 3 months administration.Documentation Requirements:The medical record documentation for patients receiving a once-yearly implant should support ongoing follow-up visits at least every three (3) to four (4) months. This documentation must be submitted upon request. Claims submitted without requested supporting evidence in the medical record will be denied as being not medically necessary.Utilization Guidelines:Drugs may be designed to deliver their respective agents at a controlled rate for a specified therapeutic period of time (e.g., those formulated in depot or implant form). Eligard, for example, (packaged as 22.5 mg /vial) is designed to deliver the 22.5 mg of leuprolide acetate at a controlled rate over a 3-month therapeutic period; Vantas (packaged as a 50 mg implant) is formulated to deliver histrelin continuously for 12 months. We would expect, therefore, to see the billing frequency for these drugs to match the particular drug formulation administered. For example, the Vantas 50 mg implant would only be billed once per 12 months.The leuprolide acetate and histrelin implants are designed to deliver their respective agents for 12 months at a controlled rate. Therefore, payment for these agents is usually limited to once in a 12-month period.Surgical implant forms of leuprolide acetate and histrelin acetate hormonal therapy must be removed after twelve months. When a surgical implant is removed, another surgical implant may be inserted to continue therapy.Coverage of leuprolide acetate and histrelin acetate, administered every 12 months in the surgical implant form for treatment of prostate cancer, is considered medically appropriate only for patients having a reasonable expectation of surviving at least 12 months.GnRH analogs are covered for the indicated diagnosis, with frequency of administration governed by the duration of action of the previously administered GnRH analog. Drugs administered at intervals exceeding these frequencies, and the associated administration services will be denied.FDA and Compendia Review:AHFS Drug Information 2009. Available at http://www.ahfsdruginformation.com/. Accessed 01/28/2009.Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 11/30/2022.FDA Web site:https://www.accessdata.fda.gov/scripts/cder/daf/Lexi-Drugs Web site. http://online.lexi.com. Accessed 11/30/2022Manufacturers drug inserts.Micromedex DrugDex. Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 11/30/2022National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp Accessed 11/30/2022