Viva Health leuprolide coverage Prior Auth

Initial Therapy — Prior authorization validity is provided when ALL of the following indication-specific criteria are met per the listed indication:

Prior authorization validity is provided when ALL of the following indication-specific criteria are met per the listed indication:

General requirement: Patient is at least 18 years of age unless otherwise specified by the indicationage >=18 unless specified

Applies unless indication-specific age limits provided

Central Precocious Puberty (CPP): Patient is less than 13 years of age; onset of secondary sexual characteristics earlier than age 8 (females) or 9 (males); diagnosis confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation; bone age advanced >2 SD beyond chronological age; tumor excluded by appropriate imaging/labs; documented contraindication, intolerance, or failure to Leuprolide Depot-Ped, Supprelin LA, AND Triptodur prior to consideration of Fensolvi; will not be used in combination with growth hormoneage <13

References J1950 and J1951

Endometriosis: Diagnosis confirmed by workup/evaluation (not presumptive treatment)

Uterine Leiomyomata (fibroids): Diagnosis confirmed by workup/evaluation; patient is receiving iron therapy

Breast Cancer: Premenopausal woman with hormone receptor–positive disease used in combination with adjuvant or recurrent endocrine therapy OR male patient used in combination with aromatase inhibitor therapy

Ovarian/Fallopian Tube/Primary Peritoneal Cancer: Used as a single agent for stage II–IV granulosa cell tumors with relapse OR for specified ovarian tumor histologies (mucinous, clear cell, carcinosarcoma, grade 1 endometrioid) with persistent or recurrent disease

Prostate Cancer: Documented contraindication, intolerance, or failure to Camcevi, Eligard, AND Firmagon prior to consideration of Lupron

Uterine Sarcoma: Diagnosis of low-grade endometrial stromal sarcoma (ESS) or adenosarcoma without sarcomatous overgrowth; patient is premenopausal and not suitable for surgery; small tumor volume or indolent growth; used in combination with anastrozole, letrozole, or exemestane

Head and Neck Cancer (salivary gland): Salivary gland tumors used as single agent or in combination with abiraterone and prednisone for androgen-receptor–positive recurrent disease with distant metastases or unresectable locoregional recurrence/second primary with prior radiation therapy

Prevention/Management of Menstrual Bleeding Associated with HCT: Patient is premenopausal and will receive myeloablative cytotoxic conditioning OR has menorrhagia due to thrombocytopenia related to delayed platelet engraftment

Fertility preservation while receiving chemotherapy: Patient is premenopausal, receiving cytotoxic chemotherapy with potential ovarian toxicity, and has failed or is not a candidate for other fertility preservation methods

Gender dysphoria: Patient has reached at least Tanner stage 2 if <18; diagnosis confirmed by a qualified mental health professional or meets DSM-5-TR criteria; qualified MHP documents long‑lasting/intense gender dysphoria worsened with puberty, coexisting issues addressed, capacity to consent; patient informed of effects/side effects including fertility implications and has provided informed consent (and parental/guardian consent/support where adolescent lacks legal consent); for adolescents a pediatric endocrinologist or clinician experienced in pubertal assessment confirms agreement in indication and absence of medical contraindicationsTanner stage >=2

Includes informed consent, fertility preservation discussion, and multidisciplinary confirmation

Initial therapy — Gender Dysphoria

Gender Dysphoria — Covered when ALL of the following are met

Gender dysphoria initiation criteria: Patient has experienced puberty development to at least Tanner stage 2 (if <18); has a diagnosis of gender dysphoria confirmed by a qualified mental health professional or meets DSM-5-TR criteria; a qualified MHP has confirmed long‑lasting/intense gender nonconformity or dysphoria, worsening with puberty, addressed coexisting psychological/medical/social issues, and assessed capacity to consent; patient has been informed of effects/side effects including potential loss of fertility and options for fertility preservation and has given informed consent; parents/guardians have consented and are involved when adolescent lacks legal medical consent; for adolescents a pediatric endocrinologist or clinician experienced in pubertal assessment confirms agreement in indication and no medical contraindicationsTanner stage >=2

Based on provider assessments and DSM-5-TR; includes informed consent and multidisciplinary confirmation.

Cancer (e.g., prostate, head and neck, breast/ovarian, uterine) therapy criteria

Oncology indications — Covered when ALL of the following are met

Breast cancer criteria: Premenopausal women with hormone receptor–positive disease used in combination with adjuvant endocrine therapy or for recurrent unresectable/stage IV disease in combination with endocrine therapy; OR male patients when used with aromatase inhibitor therapy

Ovarian/fallopian tube/primary peritoneal cancer criteria: Used as a single agent for stage II–IV granulosa cell tumors with relapse OR for specified histologies (mucinous ovarian neoplasms, clear cell carcinoma, carcinosarcoma, grade 1 endometrioid carcinoma) with persistent or recurrent disease

Prostate cancer criteria: Patient must have documented contraindication, intolerance, or failure to Camcevi, Eligard, AND Firmagon prior to consideration of Lupron

Uterine sarcoma criteria: Diagnosis of low‑grade ESS or adenosarcoma without sarcomatous overgrowth; patient is premenopausal and not suitable for surgery; small tumor volume or indolent growth; used in combination with anastrozole, letrozole, or exemestane

CPP

Central Precocious Puberty (CPP) — Covered when ALL of the following are met

CPP initiation/continuation: Patient is less than 13 years of age; disease response evidenced by lack of progression or stabilization of secondary sexual characteristics, decreased height velocity, decreased ratio of bone age to chronological age, and improvement in predicted final height; absence of unacceptable toxicity; will not be used in combination with growth hormone

Dosing specifics provided in dosage section.

Endometriosis

Endometriosis — Covered when ALL of the following are met

Endometriosis retreatment criteria: Patient has not received a total of 12 months of GnRH‑agonist therapy; continues to have symptoms or symptoms recur after an initial 6‑month course; bone density assessment is performed prior to retreatment; extended GnRH‑agonist therapy will be used with norethindrone add‑back therapy; absence of unacceptable toxicity

Explicit requirement for bone density assessment and add‑back therapy.

Fertility preservation while receiving chemotherapy

Fertility preservation during chemotherapy — Covered when ALL of the following are met

Fertility preservation criteria: Patient is premenopausal, is receiving cytotoxic chemotherapy with potential to cause ovarian damage/toxicity, is still receiving concomitant chemotherapy at time of request, and has failed or is not a candidate for other fertility preservation methods; absence of unacceptable toxicity

Intended to preserve fertility during ongoing chemotherapy.

Per the CPP coverage criteria, leuprolide will not be used in combination with growth hormone. This exclusion is stated explicitly in the Central Precocious Puberty requirements and applies to authorization decisions for CPP indications.

Different depot formulations have distinct release characteristics; therefore, do not administer concurrent fractional doses or combine different depot formulations. The policy specifies that fractional dosing or combining depot products concurrently is not acceptable because of these differing pharmacokinetic profiles.

The NQTL Factor Checklist describes why prior authorization may be applied (for example, indication and drug cost) and outlines the utilization management factors considered. However, the checklist in the appendix addresses PA application and does not list explicit clinical exclusion criteria for the drug group within the excerpted material.

Medicare guidance referenced in Appendix 2 clarifies that Medicare Part B rules, NCDs/LCDs/LCAs, and the Medicare Benefit Policy Manual govern coverage for outpatient drugs. The document notes that additional indications may be applied at the discretion of the health plan, subject to applicable Medicare coverage determinations where relevant.

For endometriosis, treatment without objective confirmation is not acceptable for authorization: the policy requires that the patient's diagnosis be confirmed by a diagnostic workup/evaluation (not presumptive treatment). For retreatment beyond initial therapy, the policy further requires bone density assessment and use of norethindrone add-back during extended GnRH-agonist therapy.

The policy explicitly states that use of leuprolide for CPP is not allowed in combination with growth hormone. This restriction appears in the CPP initiation criteria and is reiterated among the Endometriosis/CPP not-medically-necessary statements.

Initial Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization may be required. Medicare Part B covered diagnosis linkage must be documented on the prior authorization and on claims to ensure correct adjudication; Medicare coverage rules and benefit category determinations may affect claim adjudication and payment.

Prior authorization may be required for the requested agent.
When the service is Medicare Part B-covered, include the Medicare-covered diagnosis linkage on the prior authorization request and on claims to support coverage.
Medicare coverage compliance (e.g., whether a diagnosis is considered Part B covered) affects claim adjudication and payment; if Medicare conditions are not met, claims may be denied or processed under different benefit rules.

Denial Risk

Denial Triggers

Denial may be triggered if required documentation or prior therapies are not provided, if diagnosis coding on the claim does not match the approved indication, or if dose/route/frequency exceed the approved parameters.

Absence of required clinical documentation or behavioral health documentation where applicable.
Lack of documented prior trial, intolerance, or contraindication to required alternative therapies for specified indications (see step therapy criteria).
Claims submitted with diagnosis codes that do not match the approved indication or without the required Medicare linkage when applicable.
Use of product in combination with contraindicated agents (e.g., growth hormone with CPP agents when prohibited).

Denial Risk

Renewal Denial Triggers

Renewal may be denied if ongoing clinical documentation does not support continued medical necessity, if the member fails to meet response criteria, or if required follow-up testing or MH documentation is not provided.

Failure to provide required interval clinical assessments supporting continued benefit.
Absence of documented improvement or stabilization when clinically expected for the indication.
Missing required monitoring labs, imaging, or specialist follow-up.
For gender dysphoria and behavioral health–related care, missing mental health professional documentation and treatment plans.

Documentation Required

Clinical Documentation Requirements

Include the following documentation with the prior authorization request and retain copies for audits: detailed clinical notes, diagnostic test results, prior therapy documentation (including dates, doses, and reason for discontinuation), treatment plan, and expected clinical benefit. For gender dysphoria, provide specialty-specific documentation as listed below.

Relevant clinical history and physical examination findings supporting the diagnosis.
Diagnostic test results (e.g., hormone levels, GnRH stimulation results, bone age radiograph, imaging studies to exclude tumor where indicated).
Complete medication history and documentation of prior trials, intolerance, or contraindications to alternative agents when required (see step therapy table).
Specification of requested agent, dose, route, and frequency and planned duration of therapy.
For Medicare Part B cases, documentation linking the diagnosis to the Medicare-covered benefit on the request and claim.
For claims: include the required diagnosis code(s) that match the approved indication; submission of incorrect or non-specific ICD-10 codes may result in denial.

Documentation Required

Mental Health Professional Documentation

For indications where mental health assessment or support is relevant (for example, gender dysphoria), include documentation from a licensed mental health professional. Documentation should describe diagnostic assessment, any concurrent mental health diagnoses, informed consent discussion, and an ongoing treatment plan.

Letter or evaluation from a licensed mental health professional describing diagnosis, assessment, and recommendation for gender-affirming hormone therapy when applicable.
Documentation of informed consent, assessment of capacity, and discussion of risks/benefits.
Ongoing mental health treatment plan or notes showing follow-up and symptom monitoring.

Documentation Required

Documentation for Gender Dysphoria

For gender dysphoria indications, include specialty documentation demonstrating diagnosis and treatment planning: history of gender dysphoria, results of relevant assessments, documentation of informed consent, treatment goals, and the role of hormone therapy in the overall plan.

Diagnostic statement of gender dysphoria from an appropriate clinician.
Description of treatment goals and how hormone therapy supports those goals.
Evidence of informed consent and discussion of risks/benefits.
If applicable, documentation of mental health professional assessment and recommendation.

Billing Rule

Required Diagnosis Coding on Claims

Claims must include the ICD-10 diagnosis code(s) that correspond to the approved indication. For Medicare Part B services, ensure the claim links the diagnosis to the covered service and uses the appropriate HCPCS/CPT codes as authorized.

Submit claims with the specific ICD-10 code(s) that match the approved indication.
Include Medicare Part B diagnosis linkage when applicable to facilitate correct benefit assignment.
Use the authorized HCPCS/CPT and modifier codes consistent with the approved administration route and setting.

Step Therapy

Required Prior Therapy for Selected Indications

Some indications require documented prior therapy (or documented contraindication/intolerance to specified alternatives) before coverage of the requested agent. See the step therapy table for required agents and acceptable alternatives. Add-back therapy may be required when clinically indicated—document plans for add-back therapy and monitoring.

When required, document prior trials of the specified agents with dates, doses, and reasons for discontinuation or intolerance.
Central Precocious Puberty (CPP): must have contraindication, intolerance, or failure to Leupron Depot-Ped, Supprelin LA, AND Triptodur prior to certain agents.
Prostate Cancer: must have contraindication, intolerance, or failure to Camcevi, Eligard, AND Firmagon prior to certain agents.
If add-back therapy is clinically indicated (e.g., to reduce hypoestrogenic symptoms), document the proposed add-back regimen and monitoring plan.

Note

Prior Authorization Considerations

Prior authorization considerations: confirm member eligibility and benefit coverage (medical vs pharmacy), verify appropriate provider specialty and site of service, document all prior therapies and relevant testing, and include Medicare linkage when applicable. Failure to follow these considerations may delay or prevent approval.

Verify member eligibility and whether the agent is covered under medical benefit vs pharmacy benefit.
Confirm submitting provider has appropriate specialty or is consulting with the specialist required by policy.
Include all relevant diagnostic tests and prior therapy documentation in the request.
If the member is Medicare-eligible, include Medicare Part B coverage linkage and supporting documentation.

Renewal and Continuation Requirements

Continuation therapy / Renewal

Renewal/Continuation — Covered when ALL of the following are met

General renewal criteria: Patient continues to meet the indication‑specific criteria in Section III; duration of authorization has not been exceeded; evidence of disease response or stabilization as applicable to the indication; absence of unacceptable toxicityduration limits per Section I

Examples of disease response and unacceptable toxicities are indication‑specific and listed in the policy.

Renewal criteria

Renewal rules vary by indication.

General renewal: Renewal may be provided every 12 months unless otherwise specified

Endometriosis renewal: May be renewed one time only for 6 months (retreatment beyond initial course requires bone density assessment and add‑back therapy)

HCT‑related bleeding renewal: May NOT be renewed

Uterine leiomyomata renewal: May NOT be renewed

Fertility preservation renewal: May be renewed every 12 months while patient is receiving concomitant cytotoxic chemotherapy

Continuation therapy

Continuation requirements across indications

Continuation — general: Patient has shown beneficial response to treatment based on routine monitoring of clinical development and labs; absence of unacceptable toxicity; duration limits not exceeded

Applies to gender dysphoria and other indications as specified.

Prior Authorization

Obtain prior authorization and meet renewal criteria

Prior authorization is required for these agents and may be renewed only when the indication-specific criteria are met, duration limits are not exceeded, and monitoring demonstrates benefit with acceptable toxicity.

Initial authorizations follow indication-specific length limits (see Duration block) and renewals require continued fulfillment of Section III criteria.
Renewals require evidence of benefit and absence of unacceptable toxicity per the indication-specific renewal rules.

Denial Risk

Renewal may be denied if indications or duration not met

A prior authorization renewal may be denied if the patient no longer meets the indication‑specific criteria or if the duration of authorization has been exceeded.

Verify patient still meets the Section III criteria and that duration limits per Section I have not been exceeded before requesting renewal.

Step Therapy

Require norethindrone add‑back with endometriosis retreatment

For endometriosis retreatment beyond the initial 6‑month course, authorization requires that extended GnRH‑agonist therapy be administered together with norethindrone add‑back therapy.

Before approving retreatment, document prior 6‑month course status, bone density assessment, and plan for norethindrone add‑back therapy.

Denial Risk

Denial risk if medical necessity criteria not documented

Requests that fail to meet the listed medical necessity criteria may be denied — common triggers include not meeting age or diagnostic confirmation requirements or lacking required prior trials/contraindications.

Age criteria (e.g., CPP <13 yrs; general rule age ≥18 unless specified) must be met.
Diagnostic confirmation (e.g., workup for endometriosis/fibroids, LH stimulation for CPP) must be documented.
Required prior trials or documented contraindications/intolerances to alternative agents must be present where specified.

What Providers Must Submit / Watch For

Billing Rule

Authorization durations and indication exceptions

Initial prior authorization is generally valid for 12 months, with shorter initial authorization periods for specified indications (endometriosis and HCT‑related bleeding: 6 months; fibroids: 3 months).

Endometriosis initial auth: 6 months (may be renewed one time only for 6 months).
HCT‑related bleeding initial auth: 6 months (not renewable).
Uterine leiomyomata (fibroids) initial auth: 3 months (not renewable).

Note

PA may be required based on indication and drug cost (NQTL)

The policy identifies indication and drug cost as factors for applying prior authorization per the NQTL factor checklist; prior authorization may therefore be required based on those considerations.

NQTL checklist notes 'Indication' and 'Cost of drug' as reasons to consider PA.
Providers should expect PA requirements for this drug group when submitted for indicated, higher‑cost uses.

Billing Rule

Link J‑codes to Medicare Part B diagnosis and NCD/LCD guidance

Specific J‑codes in the policy (e.g., J1950, J9217, J1952, J1954) are linked with Medicare Part B covered diagnosis codes and referenced NCD/LCA/LCD documents; follow applicable Medicare contractor guidance for those claims.

Consult the cited NCD/LCA/LCD documents (e.g., A52453, A59160) and contractor guidance when billing Medicare Part B.
Ensure submitted diagnosis codes match the Medicare‑listed covered indications for the J‑code used.

Documentation Required

Provide diagnostic workup (endometriosis) and iron therapy documentation (fibroids)

For endometriosis and fibroids, authorization requires confirmation of diagnosis by appropriate workup/evaluation; for fibroids, also document that the patient is receiving iron therapy where applicable.

Endometriosis: provide diagnostic workup documentation (no presumptive treatment).
Fibroids: provide diagnostic workup plus documentation of iron therapy.

Documentation Required

Obtain qualified mental health professional confirmation for gender dysphoria

For gender dysphoria initiation, documentation must include confirmation of diagnosis by a qualified mental health professional and a supporting mental health evaluation as defined in policy.

MHP must confirm long‑lasting/intense dysphoria, address coexisting issues, and assess capacity to consent.
Provide MHP credentials/assessment per the policy's qualified MHP definition.

Documentation Required

Documentation elements required for gender dysphoria

Required gender dysphoria documentation includes puberty status (Tanner ≥2 for patients <18), DSM‑5‑TR or equivalent diagnostic confirmation, MHP assessment addressing duration/severity and capacity to consent, informed consent (and guardian consent when applicable), and pediatric endocrinology confirmation for adolescents.

Document Tanner stage ≥2 for patients <18.
Include DSM‑5‑TR criteria or MHP diagnosis and informed consent documentation.
For adolescents, include pediatric endocrinologist confirmation of indication and absence of contraindications.

Documentation Required

Document disease response/stability for renewals

For renewals across indications, provide documentation of disease response or stability (e.g., tumor stabilization or decreased size for cancers; stabilization of secondary sexual characteristics, decreased height velocity and improved predicted final height for CPP; symptom recurrence/status and prior duration for endometriosis).

Include objective measures of response as applicable to the indication when requesting renewal.
Document absence of unacceptable toxicity.

Billing Rule

Include appropriate ICD‑10 diagnosis codes on claims

Claims must include an appropriate ICD‑10 diagnosis code from the enumerated lists (e.g., malignant neoplasms, endometriosis, precocious puberty, gender identity codes) to support medical necessity for the J‑code billed.

Ensure the diagnosis code submitted corresponds to the J‑code's listed associated ICD‑10 codes in the policy.

Documentation Required

Follow Medicare Benefit Policy Manual and NCD/LCD/LCA requirements

For Medicare Part B drugs, providers must follow the Medicare Benefit Policy Manual and applicable NCDs/LCDs/LCAs; use the CMS Medicare Coverage Database to locate relevant documents.

Search https://www.cms.gov/medicare-coverage-database/search.aspx for applicable NCD/LCD/LCA guidance.
Compliance with Medicare coverage rules is required where applicable.

Note

PA considerations per NQTL checklist (indication and cost)

Prior authorization consideration is driven by indication and drug cost per the NQTL Factor Checklist; reviewers should apply PA rules consistent with those factors.

NQTL checklist identifies 'Indication' and 'Cost of drug' as reasons to consider PA for this drug group.

Denial Risk

Medicare coverage compliance may affect adjudication

Medicare coverage requirements and contractor‑specific NCD/LCD/LCA documents may affect claim adjudication; noncompliance with applicable Medicare coverage rules can lead to claim denials.

Verify compliance with the listed NCD/LCA/LCD documents (e.g., A52453, A59160) and contractor guidance when submitting Medicare Part B claims.
Non‑Medicare requests are subject to the policy but Medicare‑covered uses must follow CMS rules.

HCPCS and ICD-10 Codes, Quantity Limits

Covered HCPCS (examples)HCPCSCovered

J1950

Leuprolide acetate, per 3.75 mg

Covered HCPCS (examples)HCPCSCovered

J1951

Leuprolide acetate, per 7.5 mg

Covered HCPCS (examples)HCPCSCovered

J1954

Leuprolide acetate, per 11.25 mg

Covered HCPCS (oncology)HCPCSCovered

J9217

Leuprolide acetate (for oncology dosing), per unit

Billing HCPCS codes referencedHCPCS

J1950	Lupron Depot 1-Month and other leuprolide depot formulations (various strengths listed)
J9217	Leuprolide acetate (for depot suspension), 7.5 mg
J1951	Injection, leuprolide acetate for depot suspension (Fensolvi), 0.25 mg
J1952	Leuprolide injectable, Camcevi, 1 mg
J1954	Injection, leuprolide acetate for depot suspension (Lutrate Depot), 7.5 mg

Drug HCPCS CodesHCPCSCovered

J1950

Leuprolide acetate or mesylate (listed repeatedly as the HCPCS drug code in this section)

Malignant neoplasm — peritoneum and breast (sample of long list)ICD-10Covered

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

Gynecologic malignant neoplasms, fibroids, and pubertyICD-10Covered

C54.0	Malignant neoplasm of isthmus uteri
C56.1	Malignant neoplasm of right ovary
D25.0	Submucous leiomyoma of uterus
E30.1	Precocious puberty

Endometriosis, bleeding, fertility preservation, and gender identityICD-10Covered

F64.0	Transsexualism
N80.00	Endometriosis of the uterus, unspecified
N80.3A1	Superficial endometriosis of the right uterosacral ligament
N80.50	Endometriosis of intestine, unspecified
N93.8	Other specified abnormal uterine and vaginal bleeding
Z31.84	Encounter for fertility preservation procedure

J1950 - Associated ICD-10 codesHCPCS | ICD-10

J1950

HCPCS J1950 referenced alongside numerous ICD-10 codes for endometriosis and other gynecologic and related conditions (see listed ICD-10 codes in chunks 48-55)

J9217 - Associated ICD-10 codesHCPCS | ICD-10

J9217

HCPCS J9217 referenced alongside extensive ICD-10 malignant neoplasm codes for mouth, salivary glands, peritoneum, breast, uterus, ovary, fallopian tube, prostate, and related history codes (see chunks 57-62 for full list)

J1951 - Associated ICD-10 codesHCPCS | ICD-10

J1951

HCPCS J1951 associated with ICD-10 codes including E30.1, E30.8 (precocious puberty/other puberty disorders) and F64.x series (gender identity disorders)

J1952 and J1954 - Associated ICD-10 codesHCPCS | ICD-10

J1952	HCPCS J1952 referenced with malignant neoplasm codes including C06.9, C07, C08.x and C61 (prostate) and history Z85.46
J1954	HCPCS J1954 referenced in same grouping as J1952 for certain malignant neoplasms

Max units per indication

J1950 — Endometriosis / Fibroids / Gender Dysphoria3 billable units every 84 days

J1950 — Breast / Ovarian / Uterine Sarcoma6 billable units every 84 days

J1950 — Central Precocious Puberty (CPP)24 billable units every 168 days

J1950 — HCT-related bleeding / Fertility preservation1 billable unit every 28 days

J1951 — CPP / Gender Dysphoria180 billable units every 168 days

J1952 — Prostate / Head and Neck Cancer42 billable units every 168 days

J1954 — Prostate / Head and Neck Cancer3 billable units every 84 days

J9217 — Breast / Head and Neck / Ovarian / Uterine Sarcoma

Pubertal stage for adolescents

Pubertal stage requirement (adolescents)Tanner stage ≥ 2 (applies to patients under 18 years)

Clinical confirmationPubertal status must be documented by treating clinician and pediatric endocrinologist involvement for adolescents

Applies toGender dysphoria initiation criteria involving puberty suppression

NQTL considerations

Primary NQTL driversPrior authorization consideration driven by indication and drug cost per NQTL Factor Checklist

Comparable applicationUtilization management NQTL applies comparably to MH/SUD and M/S prescription drugs

Examples of NQTLsMay include utilization review, prior authorization, standards of evidence and other limits on extent/duration of benefits

Step	Prior therapy requirement
1
Prior trial or documented contraindication/intolerance required before coverage of requested agent. Examples: CPP — failure/intolerance to Leupron Depot-Ped, Supprelin LA, and Triptodur required before Fensolvi (J1950/J1951). Prostate cancer — failure/intolerance to Camcevi, Eligard, and Firmagon required before Lupron (J9217/J1952/J1954).

Condition	Retreatment requirement
Endometriosis
Retreatment beyond the initial 6-month course requires bone density assessment prior to retreatment and that extended GnRH-agonist therapy be used in combination with norethindrone add-back therapy; patient must not have received a total of 12 months of prior GnRH-agonist therapy and must have absence of unacceptable toxicity.

Policy design consideration	Implication
NQTL checklist factors considered
Prior authorization was considered based on indication and drug cost per the NQTL Factor Checklist; the excerpt does not provide an explicit step therapy sequence.

Key Definitions

Qualified mental health professional — summary

DefinitionLicensed clinician, licensed by statutory body, holding at minimum a master's degree or equivalent in a relevant clinical field

Clinical capabilitiesAble to identify coexisting mental health or psychosocial concerns and distinguish these from gender dysphoria

CompetenceCompetent in diagnosis using ICD (where required) and assesses capacity to consent; engages in continuing education related to gender diversity

Qualified mental health professional — licensed clinician minimum degree details

Minimum degree requirementHolds, at a minimum, a master's degree or equivalent training in a clinical field from a nationally accredited institution

LicensureLicensed by their statutory body to practice in their jurisdiction

Relevant skillsExperience assessing gender dysphoria, capacity to consent, and identifying coexisting mental health issues

DSM-5-TR Gender Dysphoria criteria (adolescents/adults)

Core DSM-5-TR duration criterionMarked incongruence between experienced/expressed gender and natal gender for at least 6 months

Required manifestationsAt least two specified manifestations (e.g., incongruence with sex characteristics, strong desire to be other gender, desire to be rid of sex characteristics)

Associated impactCondition associated with clinically significant distress or impairment in functioning

LHRH (GnRH) analogs / agonists — drug class description

Drug classLHRH (GnRH) analogs / agonists (e.g., leuprolide mesylate/acetate)

MechanismSuppress gonadal steroidogenesis through sustained GnRH receptor agonism leading to downregulation of gonadotropin secretion

Clinical usesUsed for cancer therapy, gynecologic conditions, puberty modulation (CPP), fertility preservation, and gender-affirming care

J-code (HCPCS) definition

DefinitionHCPCS J-code: a billing code indicating a specific injectable drug or biologic for outpatient/administered drugs

Usage in policyJ-codes (e.g., J1950, J1951, J9217) are used to identify leuprolide products and link to covered ICD-10 diagnoses

RelevanceFacilitates claims adjudication and application of quantity limits and Medicare coverage rules

NCD/LCD/LCA definition — Medicare coverage document types

DefinitionNCD/LCD/LCA: Medicare National Coverage Determinations, Local Coverage Determinations, or Local Coverage Articles governing Part B outpatient drug coverage

Provider obligationProviders must follow Medicare Benefit Policy Manual and applicable NCDs/LCDs/LCAs where relevant

UtilityCMS Medicare Coverage Database link can be used to search for applicable documents

OpenPayer

Leuprolide Suspension (IM/SC) — Coverage Criteria

Coverage and Medical Necessity Criteria

Initial Authorization Requirements

Renewal and Continuation Requirements

What Providers Must Submit / Watch For

HCPCS and ICD-10 Codes, Quantity Limits

Quantity and Unit Limits by HCPCS

Step Therapy and Prior Treatment Requirements

Administration Site Requirements

Key Definitions

Background and Rationale