Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Gonadotropin-Releasing Hormone Agonist (Eligard«, Lupron Depot«)

Policy #:08.01.33b



The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

The Company's products contain a definition of medical necessity that includes a requirement that a service not be more costly than an alternative service that is at least as likely to produce equivalent therapeutic or diagnostic results for the treatment of an individual's illness, Leuprolide acetate, 3.75 mg (HCPCS J1950) and Leuprolide acetate, 7.5 mg (HCPCS J9217) are covered as follows, when the medical necessity criteria are met:
  • Leuprolide acetate, 3.75 mg (HCPCS J1950) represents Lupron Depot« and will only be covered for non-oncologic diagnoses as described in this policy. Although Lupron Depot« (leuprolide acetate) has been approved by the US FDA for prostate cancer and Compendia supports the use of Lupron Depot for certain cancers, Eligard« (leuprolide acetate) is considered to be the lower-cost alternative.
  • Leuprolide acetate, 7.5 mg (HCPCS J9217) represents Eligard« and Lupron Depot« will be covered for both oncologic and non-oncologic diagnoses as described in this policy.

HEAD AND NECK CANCERS
Salivary Gland Tumors

Leuprolide acetate for injection is considered medically necessary and, therefore, covered for the treatment of androgen receptor--positive recurrent disease with distant metastases in individuals with a performance status (PS) of 0-3.

ENDOMETRIOSIS
Leuprolide acetate for injection is considered medically necessary and, therefore, covered for:
  • Management of endometriosis, including pain relief and reduction of endometriotic lesions. According to the FDA-approved label, duration of therapy should be limited to 6 months.
  • Initial management of endometriosis and for management of recurrence of symptoms with norethindrone acetate, 5 mg daily. According to the FDA-approved label, duration of therapy should be limited to 6 months.

GENDER DYSPHORIA
Leuprolide acetate for injection is considered medically necessary and, therefore, covered for puberty suppression when all of the following criteria are met:
  • The adolescent has demonstrated a long-lasting and intense pattern of gender nonconformity or gender dysphoria (whether suppressed or expressed), in accordance with criteria established in the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition, [DSM-5].
  • Gender dysphoria emerged or worsened with the onset of puberty.
  • The individual has reached at least Tanner stage 2 of development.

INVASIVE BREAST CANCER
Leuprolide acetate for injection is considered medically necessary and, therefore, covered for:
  • Treatment of premenopausal females* with hormone receptor--positive invasive breast cancer in combination with any of the following:
    • Adjuvant endocrine therapy
    • Endocrine therapy for recurrent or stage IV (M1) disease

OVARIAN CANCER
Leuprolide acetate for injection is considered medically necessary and, therefore, covered:
  • As a single agent for persistent disease or recurrence of epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer (clinical relapse)
  • As a single agent for clinical relapse in individuals with stage II-IV granulosa cell tumors

PRECOCIOUS PUBERTY
Leuprolide acetate for injection is considered medically necessary and, therefore, covered for children with a clinical diagnosis of central precocious puberty confirmed by all of the following criteria:
  • An increased pubertal luteinizing hormone response to a GnRH stimulation test
  • A bone age greater than at least 1 year compared to chronological age

PROSTATE CANCER
Leuprolide acetate for injection is considered medically necessary and, therefore, covered for:
  • Palliative treatment for individuals with advanced prostate cancer
  • Adjuvant androgen deprivation treatment (ADT) as a single agent or in combination with a first-generation antiandrogen, with or without external beam radiation therapy (EBRT) if lymph node metastasis found during pelvic lymph node dissection
    • in the favorable or unfavorable intermediate risk group and ≥10 year expected survival
    • in the high or very high risk groups and >5 year expected survival
  • ADT as a single agent or in combination with first-generation antiandrogen if life expectancy ≤5 years and asymptomatic in selected individuals with high risk, very high risk, or regional risk (any T, N1, M0) where complications such as hydronephrosis or metastasis can be expected within 5 years
  • ADT as a single agent or in combination with a first-generation antiandrogen for M0 Prostate-Specific Antigen (PSA) persistence/recurrence:
    • after radical prostatectomy in combination with EBRT if studies negative for distant metastatic disease
    • or positive digital rectal examination (DRE) after EBRT if biopsy negative and studies negative for distant metastatic disease
    • or positive DRE after EBRT in individuals who are not candidates for local therapy (especially if bone scan positive)
  • Initial ADT as a single agent or in combination with a first-generation antiandrogen if life expectancy >5 years or symptomatic:
    • for 4 months in combination with external beam radiation therapy (EBRT) with or without brachytherapy for individuals in the unfavorable intermediate risk group
    • for 1.5-3 years in combination with EBRT for individuals in the high or very high risk group
    • for 1-3 years in combination with EBRT and brachytherapy for individuals in the high or very high risk group
    • for individuals in the regional risk group (any T, N1, M0)
  • Adjuvant ADT as a single agent or in combination with a first-generation antiandrogen for 6 months with EBRT if adverse features (i.e. positive margins, seminal vesicle invasion, extracapsular extension, or detectable PSA) noted after radical prostatectomy (RP) for patients
    • in the very low risk group and ≥20 year expected survival
    • in the low risk group and ≥10 year expected survival
    • with or without pelvic lymph node dissection (PLND) in the favorable or unfavorable intermediate risk group and ≥10 year expected survival
    • with or without PLND in the high risk group and >5 year expected survival or symptomatic
  • Single-agent treatment for individuals who progressed on observation of localized disease
  • Initial androgen deprivation therapy (ADT) with abiraterone and prednisone for individuals in the regional risk group (any T, N1, M0) if life expectancy >5 years or symptomatic
  • For castration-na´ve disease
    • As a single agent for M0 or M1 disease (Note per National Comprehensive Cancer Network [NCCN]: A first-generation antiandrogen must be given for ≥7 days to prevent testosterone flare if metastases are present in weight-bearing bone)
    • In combination with a first-generation antiandrogen for M0 or M1 disease
    • in combination with docetaxel and concurrent steroid with or without a first-generation antiandrogen for M1 disease
    • in combination with either apalutamide or enzalutamide for M1 disease
    • in combination with abiraterone and prednisone for M1 disease
    • as a single agent or in combination with a first-generation antiandrogen and external beam radiation therapy (EBRT) to the primary tumor for low volume M1 disease
  • For M0 or M1 castration-resistant disease as androgen deprivation therapy (ADT) to maintain castrate levels of serum testosterone (less than 50 ng/dL)

UTERINE LEIOMYOMATA (UTERINE FIBROIDS)
Leuprolide acetate for injection is considered medically necessary and, therefore, covered for the preoperative hematologic improvement of individuals with anemia caused by uterine leiomyomata concomitantly with iron therapy. According to the FDA-approved label, duration of therapy should be limited to up to 3 months.

* Men with breast cancer should be treated similarly to postmenopausal women, except that
use of an aromatase inhibitor is ineffective without concomitant suppression of testicular
steroidogenesis.

According to National Comprehensive Cancer Network guidelines:

  • very low risk refers to individuals with clinical stage T1c, Grade Group 1, PSA less than 10 ng/mL, fewer than three prostate biopsy fragments/cores positive with 50% or less cancer in each fragment/core, and PSA density less than 0.15 mg/mL/g.
  • low risk refers to individuals with clinical stage T1 to T2a, Grade Group 1, and PSA less than 10 ng/mL.
  • intermediate risk refers to individuals
    • who have no high- or very-high-risk features and has one or more intermediate risk factors (IRF):
      • clinical stage T2b to T2c
      • Grade Group 2 or 3
      • PSA 10 ng/mL to 20 ng/mL
    • favorable intermediate risk refers to individuals with 1 IRF, Grade Group 1 or 2, and <50% biopsy cores positive
    • unfavorable intermediate risk refers to individuals with 2 or 3 IRFs, and/or Grade Group 3, and/or 50% or more biopsy cores positive
  • high risk refers to individuals with clinical stage T3a, Grade Group 4 or 5, or PSA greater than 20 ng/mL
  • very high-risk refers to individuals with clinical stage T3b to T4 , or primary Gleason pattern 5, or more than 4 biopsy cores with grade Group 4 or 5

NOT MEDICALLY NECESSARY

The Company's products contain a definition of medical necessity that includes a requirement that a service not be more costly than an alternative service that is at least as likely to produce equivalent therapeutic or diagnostic results for the treatment of an individual's illness.

Leuprolide acetate, 3.75 mg (HCPCS J1950) represents Lupron Depot« and is considered not medically necessary, and, therefore, not covered for oncologic conditions (e.g., breast, head and neck, ovarian and prostate cancers.)

Although Lupron Depot« (leuprolide acetate) has been approved by the FDA for prostate cancer and Compendia supports the use of Lupron Depot« for breast and ovarian cancers, Eligard« (leuprolide acetate)considered to be the lower-cost alternative.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for gonadotropin releasing hormone agonist (Eligard«, Lupron Depot«) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Guidelines

GLEASON SCORE

The Gleason Score is a grading system for prostate cancer tissue. This score is determined by characterizing the prostate cancer cells on a grade scale of 1 (most differentiated) to 5 (least differentiated) based on its appearance under a microscope. The two most prevalent grades are added up to equal the Gleason score. Generally prostate cancer with a Gleason score 2-4 is considered well-differentiated or low grade; Gleason score 5-7 is considered moderately differentiated; Gleason score 8-10 is considered poorly differentiated or high-grade.

GRADE GROUP

A revised grading system for prostate cancer tissue was created at the 2014 International Society of Urological Pathology Consensus Conference, which further assigns Grade Groups, derived from the the Gleason Score.

Grade Group
Gleason Score
Gleason Pattern
1
6
3 + 3
2
7
3 + 4
3
7
4 + 3
4
8
4 + 4, 3 + 5, 5 + 3
5
9 or 10
4 + 5, 5 + 4, 5 + 5

TANNER SCALE

Tanner Score is a scale of progression through puberty. Males are rated for genital development and pubic hair growth. Females are rated for breast development and pubic hair growth. Males and females are categorized into one of five stages, Stage 1 (preadolescent) to Stage 5 (adult).

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, gonadotropin-releasing hormone agonist (Eligard«, Lupron Depot«) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Leuprolide acetate (Eligard«) for injection, 7.5 mg for 1-month administration, 22.5 mg for a 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration was approved by the FDA on January 2002 for palliative treatment of advanced prostate cancer. The safety and effectiveness of leuprolide acetate (Eligard«) for injection in pediatric individuals have not been established.

Leuprolide acetate (Lupron Depot«) for injection, 7.5 mg for 1-month administration, 22.5 mg for a 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration was approved by the FDA on January 1989 for palliative treatment of advanced prostate cancer.

Leuprolide acetate (Lupron Depot«), for injection, 3.75 mg for 1-month administration and 11.25 mg for 3-month administration was approved by the FDA on October 1990 for
  • Management of endometriosis, including pain relief and reduction of endometriotic lesions
  • Preoperative hematologic improvement of individuals with anemia caused by uterine leiomyomata

Leuprolide acetate (Lupron Depot-PED«) for injection was approved by the FDA on April 1993 for treatment of children with central precocious puberty. The safety and effectiveness in pediatric individuals below the age of 2 years have not been established; therefore, its use in children under 2 years is not recommended.

Description

Gonadotropin-releasing hormone (GnRH) analog is a 10-amino acid peptide that stimulates the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). GnRH directly increases its own receptor number by pulsatile secretion. GnRH analogs have a greater potency than the natural hormone and have a longer half-life. Initially GnRH analogs stimulate the secretion of FSH and LH. With a continued secretion of GnRH analogs there is a decrease in the GnRH receptors leading to a decrease in FSH and LH secretion.

ELIGARD«

In January 2002, Leuprolide acetate (Eligard«) was FDA-approved for palliative treatment of advanced prostate cancer. Leuprolide acetate (Eligard«) is administered subcutaneously 7.5 mg every month, 22.5 mg every three months, 30 mg every four months, or 45 mg every 6 months.

LUPRON DEPOT«

Leuprolide acetate (Lupron Depot«) is a synthetic nonapeptide analog of the naturally occurring GnRH. The continuous administration results in suppression of ovarian and testicular steroidogenesis. Leuprolide acetate (Lupron Depot«), 7.5 mg for 1-month administration, was approved by the US Food and Drug Administration (FDA) in January 1989 for palliative treatment of advanced palliative prostatic cancer. Three additional doses of leuprolide acetate (Lupron Depot«) were approved: 22.5 mg for a 3-month administration (in January 1996), 30 mg for 4-month administration (in July 1997), and 45 mg for 6-month administration (in June 2011). Leuprolide acetate (Lupron Depot«), 3.75 mg for 1-month administration, was approved by the FDA for management of endometriosis, including pain relief and reduction of endometriotic lesions. Leuprolide acetate (Lupron Depot«) given monthly with norethindrone acetate 5 mg daily is also indicated for initial management of endometriosis and for management of recurrence of symptoms. According to the FDA- approved label, initial treatment or retreatment should be limited to 6 months. Leuprolide acetate (Lupron Depot«) was also FDA-approved for pre-operative hematologic improvement of individuals with anemia caused by uterine leiomyomata (uterine leiomyoma or uterine fibroid) when used with iron therapy. According to the FDA-approved label, the recommended duration of therapy is up to 3 months. A dosage of 11.25 mg every 3 months can also be administered for endometriosis and uterine leiomyomata.

In 1989, leuprolide acetate (Lupron Depot-PED«) was FDA approved for the treatment of children with central precocious puberty. The dosage is 7.5 mg, 11.25 mg, or 15 mg for 1-month administration, based on the child’s weight. Central precocious puberty is defined as early onset of secondary sexual characteristics (generally before the age of 8 for girls and before the age of 9 for boys) associated with pubertal pituitary gonadotropin activation. This can result in significantly advanced bone age and diminished adult height. Leuprolide acetate (Lupron Depot-PED«) treatment should be discontinued at the appropriate age of onset of puberty at the discretion of the professional provider.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References

American Hospital Formulary Services (AHFS) Drug Information 2019. Leuprolide Acetate. [ Lexi-Comp website]. 10/16/2017. Available at: http://online.lexi.com/lco/action/home# [via subscription only]. Accessed September 23, 2019.


American Association of Gynecologic Laparoscopists (AAGL): Advancing minimally invasive gynecology worldwide. AAGL Practice Report: Practice guidelines for the diagnosis and management of submucous leiomyomas. J Minim Invasive Gynecol. 2012;19(2):152-71

Burstein H, Lacchetti C, Anderson H, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American Society of Clinical Oncology Clinical Practice Guideline update on ovarian suppression. J Clin Oncol. 2016;34(14):1689-1701.

Clowse M, Behera M, Anders C, et. al. Ovarian preservation of GnRH agonists during chemotherapy: a meta-analysis. J Womens Health. 2009;18(3):311-19.

Company Benefit Contracts

ECRI Institute. Hormonal treatment with GnRH analogues to suppress puberty in transgender children and adolescents. Plymouth Meeting (PA): ECRI Institute; 2016 Jun 20. (Custom Rapid Responses).

Eligard« (Leuprolide acetate for injectable suspension). Tolmar Inc. 09/11/2019. Available at: http://eligard.com/. Accessed September 17, 2019.

Elsevier's Clinical Pharmacology Compendium. Leuprolide. [ClinicalKey Web site]. 04/30/2018. Available at: https://www.clinicalkey.com/pharmacology/. [via subscription only]. Accessed September 23, 2019.

Guss C, Shumer D, Katz-Wise S. Transgender and gender nonconforming adolescent care: Psychosocial and medical considerations. Curr Opin Pediatr. 2015;26(4):421-426

Hembree W, Cohen-Kettenis P, Delemarre-van de Waal H, et al. Endocrine treatment of transsexual persons: An Endocrine Society clinical practice guidelines. J Clin Endocrinol Metab.2009;94(9):3132-3154.

Lexi-Drugs Compendium. Leuprolide. [Lexicomp Online Web site]. 09/03/2019. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed September 23, 2019.

Lexi-Drugs Compendium: Pediatric and Neonatal. Leuprolide. [Lexicomp Online Web site]. 09/03/2019. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed September 23, 2019.

Lupron Depot« (Leuprolide acetate for depot suspension). AbbVie Inc. Prostate Cancer Indications: Updated 03/2019. Endometriosis and Fibroid Indications: updated 04/2018. Available at: http://www.lupron.com/. Accessed September 18, 2019.

Lupron Depot-PED« (Leuprolide acetate for depot suspension). AbbVie Inc. May 2017. Available at: http://www.lupron.com/. Accessed September 17, 2019.

Micromedex« Healthcare Series. Leuprolide Acetate. [Micromedex Web site]. Last modified 09/06/2019. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed September 23, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Leuprolide acetate. [NCCN Web site]. 2019. Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed September 16, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Leuprolide acetate for depot suspension. [NCCN Web site]. 2019. Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed September 16, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Breast Cancer V3.2019. [NCCN Web site]. 09/06/2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf [via subscription only]. Accessed September 16, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Head and Neck Cancers V3.2019. [NCCN Web site]. 09/16/2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf [via subscription only]. Accessed September 16, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Ovarian Cancer V1.2019. [NCCN Web site]. 03/08/2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf [via subscription only]. Accessed September 16, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Prostate Cancer V4.2019. [NCCN Web site]. 08/16/2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf [via subscription only]. Accessed September 16, 2019.

Novitas Solutions, Inc. Local Coverage determination (LCD). LCD L34822: Luteinizing Hormone-Releasing (LHRH) Analogs. Original: 10/01/2015. Updated: 08/08/2019. [Novitas Solutions, Inc. Medicare Services Web site]. Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=34822&ver=25&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=Luteinizing&KeyWordLookUp=Title&KeyWordSearchType=And&FriendlyError=NoLCDIDVersion&bc=gAAAACAAAAAA& . Accessed September 23, 2019.

Novitas Solutions, Inc. Local Coverage Article. A56776: Luteinizing Hormone-Releasing (LHRH) Analogs. Original: 08/08/2019. [Novitas Solutions, Inc. Medicare Services Web site]. Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=56776&ver=2&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=Luteinizing&KeyWordLookUp=Title&KeyWordSearchType=And&FriendlyError=NoLCDIDVersion&bc=gAAAACAAAAAA& . Accessed September 23, 2019.

Rugo H, Rumble B, Macrae E, et. al. Endocrine therapy for hormone receptor-positive metastatic breast cancer: American Society of Clinical Oncology guideline. J Clin Oncol. 2016;34(25):3069-103.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Leuprolide acetate for depot suspension (LUPRON DEPOT) prescribing information. [FDA Web site]. 03/04/2019. Available at: http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm . Accessed September 17, 2019.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Leuprolide acetate for depot suspension (LUPRON DEPOT-PED) prescribing information. [FDA Web site]. 05/19/2017. Available at: http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm . Accessed September 17, 2019.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Leuprolide acetate (ELIGARD« ) prescribing information. [FDA Web site]. Revised 02/2019. Available at: http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm . Accessed September 17, 2019.

World Professional Association for Transgender Health (WPATH). Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People. 7th version. 09/14/2011. Available at: https://www.wpath.org/publications/soc . Accessed September 23, 2019.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

LEUPROLIDE ACETATE 7.5 mg (J9217) IS CONSIDERED MEDICALLY NECESSARY FOR THE FOLLOWING DIAGNOSIS CODE(S):

C07 Malignant neoplasm of parotid gland

C08.0 Malignant neoplasm of submandibular gland

C08.1 Malignant neoplasm of sublingual gland

C08.9 Malignant neoplasm of major salivary gland, unspecified

C48.1 Malignant neoplasm of specified parts of peritoneum

C48.2 Malignant neoplasm of peritoneum, unspecified

C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C50.011 Malignant neoplasm of nipple and areola, right female breast

C50.012 Malignant neoplasm of nipple and areola, left female breast

C50.019 Malignant neoplasm of nipple and areola, unspecified female breast

C50.021 Malignant neoplasm of nipple and areola, right male breast

C50.022 Malignant neoplasm of nipple and areola, left male breast

C50.029 Malignant neoplasm of nipple and areola, unspecified male breast

C50.111 Malignant neoplasm of central portion of right female breast

C50.112 Malignant neoplasm of central portion of left female breast

C50.119 Malignant neoplasm of central portion of unspecified female breast

C50.121 Malignant neoplasm of central portion of right male breast

C50.122 Malignant neoplasm of central portion of left male breast

C50.129 Malignant neoplasm of central portion of unspecified male breast

C50.211 Malignant neoplasm of upper-inner quadrant of right female breast

C50.212 Malignant neoplasm of upper-inner quadrant of left female breast

C50.219 Malignant neoplasm of upper-inner quadrant of unspecified female breast

C50.221 Malignant neoplasm of upper-inner quadrant of right male breast

C50.222 Malignant neoplasm of upper-inner quadrant of left male breast

C50.229 Malignant neoplasm of upper-inner quadrant of unspecified male breast

C50.311 Malignant neoplasm of lower-inner quadrant of right female breast

C50.312 Malignant neoplasm of lower-inner quadrant of left female breast

C50.319 Malignant neoplasm of lower-inner quadrant of unspecified female breast

C50.321 Malignant neoplasm of lower-inner quadrant of right male breast

C50.322 Malignant neoplasm of lower-inner quadrant of left male breast

C50.329 Malignant neoplasm of lower-inner quadrant of unspecified male breast

C50.411 Malignant neoplasm of upper-outer quadrant of right female breast

C50.412 Malignant neoplasm of upper-outer quadrant of left female breast

C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast

C50.421 Malignant neoplasm of upper-outer quadrant of right male breast

C50.422 Malignant neoplasm of upper-outer quadrant of left male breast

C50.429 Malignant neoplasm of upper-outer quadrant of unspecified male breast

C50.511 Malignant neoplasm of lower-outer quadrant of right female breast

C50.512 Malignant neoplasm of lower-outer quadrant of left female breast

C50.519 Malignant neoplasm of lower-outer quadrant of unspecified female breast

C50.521 Malignant neoplasm of lower-outer quadrant of right male breast

C50.522 Malignant neoplasm of lower-outer quadrant of left male breast

C50.529 Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611 Malignant neoplasm of axillary tail of right female breast

C50.612 Malignant neoplasm of axillary tail of left female breast

C50.619 Malignant neoplasm of axillary tail of unspecified female breast

C50.621 Malignant neoplasm of axillary tail of right male breast

C50.622 Malignant neoplasm of axillary tail of left male breast

C50.629 Malignant neoplasm of axillary tail of unspecified male breast

C50.811 Malignant neoplasm of overlapping sites of right female breast

C50.812 Malignant neoplasm of overlapping sites of left female breast

C50.819 Malignant neoplasm of overlapping sites of unspecified female breast

C50.821 Malignant neoplasm of overlapping sites of right male breast

C50.822 Malignant neoplasm of overlapping sites of left male breast

C50.829 Malignant neoplasm of overlapping sites of unspecified male breast

C50.911 Malignant neoplasm of unspecified site of right female breast

C50.912 Malignant neoplasm of unspecified site of left female breast

C50.919 Malignant neoplasm of unspecified site of unspecified female breast

C50.921 Malignant neoplasm of unspecified site of right male breast

C50.922 Malignant neoplasm of unspecified site of left male breast

C50.929 Malignant neoplasm of unspecified site of unspecified male breast

C56.1 Malignant neoplasm of right ovary

C56.2 Malignant neoplasm of left ovary

C56.9 Malignant neoplasm of unspecified ovary

C57.00 Malignant neoplasm of unspecified fallopian tube

C57.01 Malignant neoplasm of right fallopian tube

C57.02 Malignant neoplasm of left fallopian tube

C57.10 Malignant neoplasm of unspecified broad ligament

C57.11 Malignant neoplasm of right broad ligament

C57.12 Malignant neoplasm of left broad ligament

C57.20 Malignant neoplasm of unspecified round ligament

C57.21 Malignant neoplasm of right round ligament

C57.22 Malignant neoplasm of left round ligament

C57.3 Malignant neoplasm of parametrium

C57.4 Malignant neoplasm of uterine adnexa, unspecified

C61 Malignant neoplasm of prostate

C79.81 Secondary malignant neoplasm of breast

C79.82 Secondary malignant neoplasm of genital organs

D25.0 Submucous leiomyoma of uterus

D25.1 Intramural leiomyoma of uterus

D25.2 Subserosal leiomyoma of uterus

D25.9 Leiomyoma of uterus, unspecified

E22.8 Other hyperfunction of pituitary gland

E30.1 Precocious puberty

F64.0 Transsexualism

F64.1 Dual role transvestism

F64.2 Gender identity disorder of childhood

F64.8 Other gender identity disorders

F64.9 Gender identity disorder, unspecified

N80.0 Endometriosis of uterus

N80.1 Endometriosis of ovary

N80.2 Endometriosis of fallopian tube

N80.3 Endometriosis of pelvic peritoneum

N80.4 Endometriosis of rectovaginal septum and vagina

N80.5 Endometriosis of intestine

N80.6 Endometriosis in cutaneous scar

N80.8 Other endometriosis

N80.9 Endometriosis, unspecified

LEUPROLIDE ACETATE 3.75 mg (J1950) IS CONSIDERED MEDICALLY NECESSARY FOR THE FOLLOWING DIAGNOSIS CODE(S)

D25.0 Submucous leiomyoma of uterus

D25.1 Intramural leiomyoma of uterus

D25.2 Subserosal leiomyoma of uterus

D25.9 Leiomyoma of uterus, unspecified

E22.8 Other hyperfunction of pituitary gland

E30.1 Precocious puberty

F64.0 Transsexualism

F64.1 Dual role transvestism

F64.2 Gender identity disorder of childhood

F64.8 Other gender identity disorders

F64.9 Gender identity disorder, unspecified

N80.0 Endometriosis of uterus

N80.1 Endometriosis of ovary

N80.2 Endometriosis of fallopian tube

N80.3 Endometriosis of pelvic peritoneum

N80.4 Endometriosis of rectovaginal septum and vagina

N80.5 Endometriosis of intestine

N80.6 Endometriosis in cutaneous scar

N80.8 Other endometriosis

N80.9 Endometriosis, unspecified



HCPCS Level II Code Number(s)

THE FOLLOWING HCPCS CODES ARE USED TO REPRESENT LEUPROLIDE ACETATE:


J1950 Injection, leuprolide acetate (for depot suspension), per 3.75 mg

J9217 Leuprolide acetate (for depot suspension), 7.5 mg



Revenue Code Number(s)

N/A



Coding and Billing Requirements


Cross References


Policy History

Revisions to 08.01.33b
12/02/2019This policy has undergone a routine review and the medical necessity criteria have been revised to reflect the updated coverage position from the National Comprehensive Cancer Network (NCCN) for head and neck cancers, breast cancer, ovarian cancer, and prostate cancer. Criteria changes have been made for the coverage of gender dysphoria.

Revisions to 08.01.33a
02/19/2018This policy has undergone a routine review, and the medical necessity criteria have been revised for the indication of Prostate Cancer.

Effective 10/05/2017 this policy has been updated to the new policy template format.
Version Effective Date: 12/02/2019
Version Issued Date: 12/02/2019
Version Reissued Date: N/A



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