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Leuprolide acetate (Lupron®), a luteinizing hormone-releasing hormone agonist, is a synthetic analog of naturally occurring gonadotropin-releasing hormone (GnRH) possessing greater potency than the natural hormone. Initially, leuprolide acetate (Lupron®) increases circulating levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH), leading to a transient increase in gonadal steroids (testosterone and dihydrotestosterone in males; estrone and estradiol in premenopausal females.) However, continuous daily administration results in decreased LH and FSH in all patients. In males, testosterone levels decrease to castrate levels, and in premenopausal females, estrogens are reduced to postmenopausal levels. These decreases occur within 2 to 4 weeks after initiation of therapy.
FDA approved indications are as follows:
Leuprolide (Lupron®) is considered medically necessary for the following disease states:
Leuprolide (Lupron®) is considered not medically necessary for ovarian stimulation.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
5/1999: Approval by Pharmacy & Therapeutics Committee (P & T)
11/1999: Revisions approved by P & T
1/17/2001: Added new HCPCS J9219 effective 1-01-2001
4/9/2001: Breast and Endometrial cancer added as covered indications, ICD-9 diagnosis code 174.0-174.9, 175.0-175.9, 182.0 added covered codes
1/30/2002: Prior authorization deleted
2/14/2002: Investigational definition added
5/1/2002: Type of Service and Place of Service deleted
11/13/2002: ICD-9 diagnosis codes moved to Code Reference section
9/10/2004: Code Reference section updated, ICD-9 diagnosis code range 174.0-174.9, 218.0-218.9, 617.0-617.9 listed separately, ICD-9 diagnosis code 173.5, 198.2, 198.81, 198.82, 232.5, 233.0, 233.2 added covered codes, ICD-9 diagnosis code 259.0 deleted covered codes, HCPCS S9560 added covered codes, non-covered codes table deleted, ICD-9 diagnosis code 256.4, 183.0, 198.6, 233.3 deleted non-covered codes, Catamenial pneumothorax, hypersexuality, ovarian stimulation deleted non-covered table
9/16/2005: Code Reference section updated, CPT code 90782 deleted, ICD-9 diagnosis code 233.4 added
10/29/2006: Dosing and off-label information removed
11/2/2006: Code Reference updated. ICD-9 diagnosis codes 173.5, 174-174.6, 174.8, 174.9, 175.0-175.9, 182.0, 198.2, 198.81, 232.5, 233.0 deleted from policy
7/12/2007: Code Reference updated. ICD-9 diagnosis codes 173.5, 174-174.6, 174.8, 174.9, 175.0-175.9, 182.0, 198.2, 198.81, 232.5, 233.0 added to policy. Breast and endometrial cancer added to policy statement as medically necessary. Ovarian stimulation (256.1) added to policy statement as not medically necessary.
8/25/2008: Added ICD-9 diagnosis code range 256.0 - 256.9 as not medically necessary for ovarian stimulation
04/01/2014: Policy title changed from "Leuprolide (Lupron®)" to "Leuprolide acetate (Lupron®)." Policy description updated to add "acetate" to Leuprolide (Lupron®). Policy statement intent unchanged.
09/01/2015: Code Reference section updated for ICD-10. Extended ICD-9 diagnosis code 173.5 to the fifth digit as 173.50, 173.51, 173.52, and 173.59.
American Hospital Formulary Services 1998
Fact and Comparisons October, 1999
Micromedex, 1998, 2006
Lupron® Prescribing Information
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.