Medical Policy Bulletin

Section:	Injections
Number:	I-16
Topic:	Leuprolide/Leuprolide Acetate (Lupron, Lupron Depot, Lutrepulse, Viadur™)
Effective Date:	June 19, 2006
Issued Date:	September 10, 2007
Date Last Reviewed:	07/2006

General Policy Guidelines

Indications and Limitations of Coverage

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)

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. A participating, preferred, or network provider cannot bill the member for the denied service.

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 yearly. The implantation and removal of this device is eligible for payment and should be reported with codes 11981, 11982, and 11983.

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.

Procedure Codes

11981	11982	11983	J1950	J9217	J9218
J9219

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

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.

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

References

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

View Previous Versions

[Version 003 of I-16]

[Version 002 of I-16]

[Version 001 of I-16]

Table Attachment

Text Attachment

Procedure Code Attachment

Glossary

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.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Mountain State Blue Cross Blue Shield plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Mountain State Blue Cross Blue Shield (MSBCBS) retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of MSBCBS. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.