CurrentViva HealthPolicy IC-0080

Leuprolide (Depot) prior authorization and medical necessity criteria

Defines prior authorization length, renewal rules, indication-specific initial and renewal medical necessity criteria, maximum billable HCPCS units per indication, dosing/administration guidance, billing HCPCS/NDC mappings, and ICD-10 code mappings for leuprolide depot products.

Policy Summary

PayerViva Health

PolicyLeuprolide (Depot) prior authorization and medical necessity criteria

Policy CodePolicy IC-0080

Change TypeNo material change

Effective Date

Next Review Date

Key ActionDocument diagnostic confirmation and submit prior authorization per indication-specific lengths and renewal rules.

POLICY UPDATE CHANGES

No material changes

12Listed Indications

5HCPCS codes referenced

100+ICD-10 codes listed (partial)

MultipleJ-codes referenced

Coverage Summary

This policy (Policy #: IC-0080) defines prior authorization and medical necessity criteria for leuprolide acetate depot formulations (multiple brand and generic depot products) used across pediatric and adult indications. The policy stance is covered with criteria, providing indication-specific initial and renewal rules, maximum billable HCPCS unit limits, dosing/administration guidance, and ICD-10 code mappings. Key authorized indications include central precocious puberty (CPP), endometriosis, uterine leiomyomata (fibroids), various hormone-sensitive cancers (breast, prostate, ovarian/fallopian/primary peritoneal, uterine sarcoma), gender dysphoria, prevention/management of menstrual bleeding with HCT, and fertility preservation during chemotherapy.

Medical-Necessity Criteria (Initial + Renewal)

General Initial Criteria

Prior authorization validity is provided when ALL of the following are met:

Age requirement: Patient is at least 18 years of age (unless otherwise specified)

Central Precocious Puberty (CPP) - Initial Therapy (J1950, J1951)

Covered when ALL of the following are met:

Comparator requirement: Patient must have a contraindication, intolerance, or failure to Leupron Depot-Ped®, Supprelin® LA, AND Triptodur® prior to consideration of Fensolvi®
Age: Patient is less than 13 years of age< 13 years
Onset of puberty: Onset of secondary sexual characteristics earlier than age 8 for females and 9 for males associated with pubertal pituitary gonadotropin activationFemales <8 years; Males <9 years
Diagnostic confirmation: Diagnosis is confirmed by pubertal gonadal sex steroid levels and a pubertal luteinizing hormone (LH) response to stimulation by native growth hormone-releasing hormone (GnRH)
Bone age advanced greater than 2 standard deviations (SD) beyond chronological age> 2 SD
Tumor exclusion: Tumor has been ruled out by lab tests such as diagnostic imaging of the brain, pelvic/testicular/adrenal ultrasound, and human chorionic gonadotropin levels
Concomitant therapy prohibition: Will not be used in combination with growth hormone

Endometriosis - Initial Therapy (J1950)

Covered when ALL of the following are met:

Diagnostic confirmation: Patient's diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment)

Uterine Leiomyomata (fibroids) - Initial Therapy (J1950)

Covered when ALL of the following are met:

Diagnostic confirmation: Patient's diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment)
Adjunct therapy: Patient is receiving iron therapy

Breast Cancer - Initial Therapy (J9217, J1950)

Covered when ONE of the following clinical scenarios is met:

Premenopausal woman
- Sex and receptor status: Patient is a premenopausal woman
- Hormone receptor: Disease is hormone receptor-positive
- Use context
  - Adjuvant: Used in combination with adjuvant endocrine therapy
  - Recurrent/metastatic:

Ovarian/Fallopian Tube/Primary Peritoneal Cancer - Initial Therapy (J9217, J1950)

Covered when ALL of the following are met (multiple possible histologies):

Granulosa cell tumors
- Single agent: Used as a single agent
- Stage: Patient has a diagnosis of stage II-IV granulosa cell tumors
- Disease status
  - Relapsed: Patient has relapsed disease
Other specified ovarian histologies

Prostate Cancer - Initial Therapy (J9217, J1952, J1954)

Covered when ALL of the following are met:

Comparator requirement: Patient must have a contraindication, intolerance, or failure to Camcevi®, Eligard®, AND Firmagon® prior to consideration of Lupron®

Uterine Neoplasms - Uterine Sarcoma (J9217, J1950)

Covered when ALL of the following are met:

Histology: Patient has a diagnosis of low-grade endometrial stromal sarcoma (ESS) or adenosarcoma without sarcomatous overgrowth
Surgical suitability: Patient is premenopausal and not suitable for surgery (i.e., bilateral salpingo-oophorectomy)
Tumor characteristics: Used for patients with small tumor volume or an indolent growth pace
Combination therapy: Used in combination with anastrozole, letrozole, or exemestane

Head and Neck Cancer - Initial Therapy (J9217, J1952, J1954)

Covered when ALL of the following are met:

Tumor type: Patient has salivary gland tumors
Use context: Used as a single agent OR in combination with abiraterone and prednisone
Disease extent (one of)
- Distant metastases
- Unresectable locoregional recurrence with prior radiation therapy (RT)

Fertility Preservation While Receiving Chemotherapy (J1950)

Covered when ALL of the following are met:

Premenopausal requirement: Patient is premenopausal
Chemo risk: Patient is receiving treatment with cytotoxic chemotherapy with the potential to cause ovarian damage/toxicity (e.g., cyclophosphamide, melphalan, procarbazine, vinblastine, imatinib, etc.)
Failed other methods: Patient has failed or is not a candidate for other fertility preservation methods (e.g., cryopreservation)

Gender Dysphoria (J1950, J1951) - Initial Therapy

Covered when ALL of the following are met:

Pubertal stage: Patient has experienced puberty development to at least Tanner stage 2 (applies only to patients <18 yrs of age)
Diagnosis confirmation: Patient has a diagnosis of gender dysphoria as confirmed by a qualified mental health professional (MHP) OR meets DSM-5-TR criteria
MHP assessment: A qualified MHP has confirmed long-lasting/intense pattern of gender nonconformity or dysphoria, worsening with puberty onset, addressed coexisting issues, and sufficient capacity to consent
Informed consent: Patient has been informed of effects and side effects (including potential loss of fertility) and options to preserve fertility

Renewal Criteria - General

Prior authorization validity may be renewed when ALL of the following are met:

Continued eligibility: Patient continues to meet the indication-specific relevant criteria identified in section III
Duration limit: Duration of authorization has not been exceeded (refer to Section I)

Renewal Criteria - Cancer and Sarcoma (J9217, J1952, J1954, J1950)

Covered when ALL of the following are met:

Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread
Toxicity: Absence of unacceptable toxicity from the drug (examples provided)

Renewal Criteria - CPP (J1950, J1951)

Covered when ALL of the following are met:

Age: Patient is less than 13 years of age< 13 years
Disease response as indicated by lack of progression or stabilization of secondary sexual characteristics, decrease in height velocity, decrease in the ratio of bone age to chronological age (BA:CA), and improvement in final height prediction
Toxicity: Absence of unacceptable toxicity from the drug (examples provided)
Concomitant therapy prohibition: Will not be used in combination with growth hormone

Renewal Criteria - Gender Dysphoria (J1950, J1951)

Covered when ALL of the following are met:

Clinical benefit: Patient has shown a beneficial response to treatment as evidenced by routine monitoring of clinical pubertal development (if applicable) and applicable laboratory parameters
Toxicity: Absence of unacceptable toxicity from the drug (examples provided)

Renewal Criteria - Endometriosis (J1950)

Covered when ALL of the following are met:

Treatment duration limit: Patient has not received a total of 12 months of therapy of a GnRH-agonist< 12 months total
Ongoing symptoms: Patient continues to have symptoms of endometriosis or symptoms recur after the initial 6-month course of therapy
Bone density assessment: Patient will have bone density assessment prior to retreatment
Add-back therapy: Extended GnRH-agonist treatment will be used in combination with norethindrone add-back therapy

Renewal Criteria - Fertility Preservation While Receiving Chemotherapy (J1950)

Covered when ALL of the following are met:

Ongoing chemo: Patient is still receiving treatment with cytotoxic chemotherapy
Toxicity: Absence of unacceptable toxicity from the drug (examples provided)

Coding (HCPCS / ICD-10 / NDC mappings)

Covered HCPCS CodesHCPCSCovered

J1950	Leuprolide acetate, per 1 mg
J1951	Leuprolide acetate, 3.75 mg depot
J1952	Leuprolide acetate, 7.5 mg depot
J1954	Leuprolide acetate, 22.5 mg depot
J9217	Leuprolide acetate, for injection, per 1 mg (GnRH analogue)

Covered HCPCS Codes (alternate descriptors)HCPCSCovered

J1950	Leuprolide acetate injection (unit definition per policy)
J1951	Leuprolide depot pediatric/CPP dosing units
J1952	Leuprolide depot - intermediate dose
J1954	Leuprolide depot - high dose
J9217	Leuprolide for oncologic indications

Covered ICD-10 Codes mapped to J1950/J9217 and other J-codesICD-10Covered

C50.621	Malignant neoplasm of upper-inner quadrant of right female breast
C50.622	Malignant neoplasm of upper-inner quadrant of left female breast
C50.629	Malignant neoplasm of upper-inner quadrant of unspecified female breast
C50.811	Malignant neoplasm of lower-outer quadrant of right female breast
C50.812	Malignant neoplasm of lower-outer quadrant of left female breast
C50.819	Malignant neoplasm of lower-outer quadrant of unspecified female breast
C50.821	Malignant neoplasm of lower-inner quadrant of right female breast
C50.822	Malignant neoplasm of lower-inner quadrant of left female breast
C50.829	Malignant neoplasm of lower-inner quadrant of unspecified female breast
C50.911	Malignant neoplasm of unspecified site of right female breast

1–10 of 175

1/18

HCPCS / NDC Product Mappings (examples)mixed

J1950 -> NDC 00074-3100-01	Example mapping: leuprolide acetate 1 mg vial NDC (illustrative only)
J1951 -> NDC 00074-3110-02	Example mapping: leuprolide depot 3.75 mg kit NDC (illustrative only)
J1952 -> NDC 00074-3120-03	Example mapping: leuprolide depot 7.5 mg kit NDC (illustrative only)
J1954 -> NDC 00074-3130-04	Example mapping: leuprolide depot 22.5 mg kit NDC (illustrative only)
J9217 -> NDC 00074-3140-05	Example mapping: oncologic leuprolide NDC (illustrative only)

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required. Default initial authorization is 12 months unless an indication-specific shorter initial period applies. Specific initial authorization lengths and renewal allowances vary by indication (see items).

Default initial authorization: 12 months
Endometriosis: initial 6 months; may be renewed one time for 6 months
Prevention/Management of Menstrual Bleeding Associated with HCT: initial 6 months; NOT renewable
Uterine leiomyomata (fibroids): initial 3 months; NOT renewable
Fertility preservation while receiving chemotherapy: initial 12 months; may be renewed every 12 months while receiving chemotherapy

Documentation Required

Document diagnostic confirmation

Document diagnostic confirmation and relevant workup prior to coverage where required. The policy specifies the diagnostic evaluations or qualified assessments that must be documented for each relevant indication.

Central precocious puberty (CPP): confirm with pubertal gonadal sex steroid levels, pubertal LH response to stimulation (GnRH), advanced bone age >2 SD, and tumor exclusion by brain imaging, pelvic/testicular/adrenal ultrasound, and hCG levels
Endometriosis: diagnosis confirmed by workup/evaluation (not presumptive treatment)
Uterine leiomyomata (fibroids): diagnosis confirmed by workup/evaluation and documentation patient is receiving iron therapy
Gender dysphoria: diagnosis confirmed by a qualified mental health professional (MHP) or DSM-5-TR criteria, documentation of informed consent, counseling on fertility preservation, and pediatric endocrinologist assessment for adolescents
Fertility preservation: document indication (receiving cytotoxic chemotherapy with ovarian toxicity risk) and that patient failed or is not candidate for other fertility preservation methods

Billing Rule

HCPCS unit limits

HCPCS billing unit maximums are specified by code and indication. Bill according to the per-code unit limits and time windows provided.

J1950: 3 units every 84 days (endometriosis, fibroids, gender dysphoria)
J1950: 6 units every 84 days (breast, ovarian/primary peritoneal cancer, uterine sarcoma)
J1950: 24 units every 168 days (central precocious puberty)
J1950: 1 unit every 28 days (HCT bleeding prevention, fertility preservation)
J1951: 180 units every 168 days (CPP, gender dysphoria)
J1952: 42 units every 168 days (prostate, head & neck)
J1954: 3 units every 84 days (prostate, head & neck)
J9217: 3 units every 84 days (breast, head & neck, ovarian/primary peritoneal cancer, uterine sarcoma)
J9217: 12 units every 336 days (prostate)

Documentation Required

Bone density assessment for endometriosis retreatment

Before retreatment for endometriosis beyond the initial course, document that the patient will have a bone density assessment prior to retreatment and that extended GnRH-agonist treatment will be used with norethindrone add-back therapy.

Patient has not received a total of 12 months of GnRH-agonist therapy
Document bone density assessment prior to retreatment
Plan for norethindrone add-back therapy with extended GnRH-agonist retreatment

Documentation Required

Contraindication/intolerance/failure requirements for CPP and prostate cancer

For consideration of certain products in CPP and prostate cancer, document prior contraindication, intolerance, or treatment failure to specified comparator products per policy before coverage is considered.

CPP (consideration of Fensolvi): document contraindication, intolerance, or failure to Leupron Depot-Ped, Supprelin LA, AND Triptodur
Prostate cancer (consideration of Lupron): document contraindication, intolerance, or failure to Camcevi, Eligard, AND Firmagon

Billing Rule

Administration route and provider administration requirement

Observe administration route and provider administration requirements for specific formulations. Some depot formulations must be administered by a healthcare provider; the policy also distinguishes intramuscular (IM) versus subcutaneous (SQ) products.

Products that must be administered by a healthcare provider: Camcevi, Eligard, Vabrinty, Fensolvi, and Lupron Depot-Ped
IM administered products include: Lupron Depot, Lupron Depot-Ped, Lutrate Depot, Leuprolide Acetate Depot
SQ administered products include: Eligard, Vabrinty, Fensolvi, and Camcevi

Billing Rule

Use of listed ICD-10 codes for Medicare Part B J-codes

When billing Medicare Part B for the listed J-codes, use the mapped ICD-10 diagnosis codes provided in the appendix to support medical necessity and comply with applicable NCD/LCD/LCA requirements.

Mapped ICD-10 code lists for J1950, J9217, J1951, J1952, and J1954 are included in the appendix for use in Medicare Part B claims
Follow contractor-specific guidance and applicable NCD/LCD/LCA documents when submitting Part B claims

Documentation Required

Reference NCD/LCD/LCA applicability

Claims must comply with applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs). The policy directs providers to the Medicare Coverage Database and references contractor documents for Part B coverage and billing guidance.

Refer to the Medicare Coverage Database (https://www.cms.gov/medicare-coverage-database/search.aspx) for applicable NCD/LCD/LCA documents
Contractor documents referenced include A52453 and A59160 for LHRH analogs billing and coding

effective date	name	number	type
2023-01-01	Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A52453)	A52453	LCD
2024-03-15	Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A59160)	A59160	LCD
	Medicare Part B Covered Diagnosis Codes	A52453	LCA/NCD
	Medicare Part B Covered Diagnosis Codes	A59160	LCA/NCD

Background and Evidence

Leuprolide acetate depot formulations (listed examples: Camcevi, Eligard, Fensolvi, Leuprolide Acetate Depot, Lupron Depot, Lupron Depot-Ped, Lutrate Depot, Vabrinty) are gonadotropin-releasing hormone (GnRH) agonist depot products administered intramuscularly or subcutaneously for multiple pediatric and adult indications, including central precocious puberty (CPP), endometriosis, uterine fibroids, various hormone-sensitive cancers (breast, prostate, ovarian/fallopian/primary peritoneal), gender dysphoria, prevention/management of menstrual bleeding associated with hematopoietic stem cell transplant (HCT), and fertility preservation during cytotoxic chemotherapy.

The policy references FDA-approved product labeling (package inserts for multiple formulations, 2023–2025) and compendia guidance (NCCN Drugs & Biologics Compendium 2025 and NCCN Guidelines 2025) as primary sources. It also cites randomized controlled trials, prospective CPP studies, oncology reports, and specialty society guidance (e.g., Endocrine Society and WPATH) to support indications, dosing, and monitoring recommendations. Administration routes and provider administration requirements are specified by product (IM vs SQ; some formulations must be administered by a healthcare provider).

Evidence & References

Last review date2025-09-04

Key references - package insertsLupron Depot GYN 2023; Lupron Depot-Ped 2025; Eligard 2025; Fensolvi 2024; Camcevi 2025 (package inserts listed)

Key references - compendia/guidelinesNCCN Drugs & Biologics Compendium 2025; NCCN AYA Guidelines 2025; Endocrine Society and WPATH guidance

Key references - trials/reviewsPhase 3 CPP 6-month depot study (J Endocr Soc 2023); Lupron efficacy/safety studies (J Pediatr 1989; J Clin Endocrinol Metab 2014); meta-analyses on ovarian preservation (J Womens Health 2009)

OpenPayer

Leuprolide (Depot) prior authorization and medical necessity criteria

Coverage Summary

Medical-Necessity Criteria (Initial + Renewal)

Coding (HCPCS / ICD-10 / NDC mappings)

Provider Actions & Billing Rules

Medicare Determinations / Local Coverage Documents

Background and Evidence

Definitions

Revision History