This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions

Medical Policy Search
Printer Friendly Version Leuprolide (Lupron®)

Leuprolide (Lupron®)

 

DESCRIPTION

Leuprolide, (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 (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

  • Endometriosis
  • Precocious puberty
  • Prostate cancer, Palliative treatment of advanced disease
  • Uterine leiomyoma

 

IDENTIFICATION

Generic Name: Leuprolide
Brand Name: Lupron®

 

POLICY

Leuprolide (Lupron®) is considered medically necessary for the following disease states:
  • Endometriosis
  • Uterine leiomyoma
  • Precocious puberty
  • Prostate cancer
  • Breast cancer
  • Endometrial cancer

Leuprolide (Lupron®) is considered not medically necessary for ovarian stimulation (256.0 - 256.9)

 

POLICY EXCEPTIONS

None

 

POLICY GUIDELINES

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.

 

POLICY HISTORY

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

 

SOURCE(S)

American Hospital Formulary Services 1998

Fact and Comparisons October, 1999

Micromedex, 1998, 2006

 

CODE REFERENCE

This is not intended to be a comprehensive list of codes. Some codes may be variable, and coverage will be based on the clinical indication for the service.

Covered Codes

Code Number

Description

CPT-4

 

 

ICD-9 Procedure

 

 

ICD-9 Diagnosis

173.5Other malignant neoplasm of skin of trunk, except scrotum (added 9-10-2004) (re-added 7-12-2007)
174.0, 174.1, 174.2, 174.3, 174.4, 174.5, 174.6, 174.8, 174.9Malignant neoplasm of female breast (added 4-9-2001) (re-added 7-12-2007)
175.0, 175.9Malignant neoplasm of male breast (added 4-9-2001) (re-added 7-12-2007)
182.0Malignant neoplasm of corpus uteri, except isthmus (endometrial cancer) (re-added 7-12-2007)

185

Malignant neoplasm of prostate

198.2Secondary malignant neoplasm of skin (added 9-10-2004) (re-added 7-12-2007)
198.81Secondary malignant neoplasm of breast (added 9-10-2004) (re-added 7-12-2007)

198.82

Secondary malignant neoplasm of genital organs (added 9-10-2004)

218.0, 218.1, 218.2, 218.9

Uterine leiomyoma

232.5Carcinoma in situ of skin of trunk, except scrotum (added 9-10-2004) (re-added 7-12-2007)
233.0Carcinoma in situ of breast (added 9-10-2004) (re-added 7-12-2007)

233.2

Carcinoma in situ of other and unspecified parts of uterus (added 9-10-2004)

233.4

Carcinoma in situ of prostate (added 9-16-2005)

259.1

Precocious sexual development and puberty, not elsewhere classified

617.0, 617.1, 617.2, 617.4, 617.5, 617.6, 617.8, 617.9

Endometriosis

HCPCS

J1950

Injection, leuprolide acetate (for depot suspension), per 3.75 mg.

J9217

Leuprolide acetate (for depot suspension), 7.5 mg.

J9218

Leuprolide acetate, per 1 mg.

J9219

Leuprolide acetate implant, 65 mg (effective 1-1-2001) (added 1-17-2001)

S9560

Home injectable therapy; hormonal therapy (e.g.; leuprolide, goserelin), including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem (added 9-10-2004)

 

 

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