Leuprolide acetate (LUPRON) (J1950, J9217, J9218) is a synthetic analog of gonadotropin release hormone (GnRh). Although leuprolide has potent GnRh agonist properties during short-term or intermittent therapy, the principal effect of the drug during long-term administration is inhibition of gonadotropin (LH, FSH) secretion and suppression of ovarian and testicular steroidogenesis.

Coverage for leuprolide/leuprolide acetate treatment is determined according to individual or group customer benefits. Treatment is eligible for the following conditions:

• Breast cancer, advanced (174.0-174.9, 198.81)
• Endometriosis (617.0-617.9)
• Prostate cancer (185, 189.3, 198.1, 198.82, 233.4, 233.9)
• Central precocious puberty (259.1)
• Uterine leiomyomata (fibroids) (218.0-218.9)

Viadur (J9219), is an implantable form of leuprolide acetate which is used in the treatment of advanced prostate cancer (185, 189.3, 198.1, 198.82, 233.4, 233.9). It is implanted once every twelve months. The implantation and removal of this device is eligible for payment and should be reported with codes 11981, 11982, and 11983.

Leuprolide/leuprolide acetate used in the treatment of conditions other than those listed above, should be denied as not medically necessary and, therefore, not covered. Effective January 26, 2009, a participating, preferred or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost.  The member must agree in writing to assume financial responsibility, in advance of receiving the service.  The signed agreement should be maintained in the provider's records.

NOTE: See Medical Policy Bulletin G-16 for information on chemotherapy for malignant disease.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient’s condition. The use of the FDA approved drug Lupron for conditions other than those listed as eligible on this policy is considered eligible when determined medically necessary based on the patient’s condition.

Leuprolide, USPDI-Vol. I, Edition 21, 2001, Micromedex, Inc.