Prior authorization duration

Initial prior authorization is valid for 12 months (365 days) by default; exceptions: endometriosis and prevention/management of menstrual bleeding associated with HCT are initially authorized for 6 months (180 days), and uterine leiomyomata (fibroids) is initially authorized for 3 months (90 days). Renewals are generally every 12 months (365 days) unless an indication-specific limit applies (endometriosis may be renewed one time only for 6 months; HCT-related bleeding and uterine fibroids may NOT be renewed; fertility preservation may be renewed every 12 months while receiving cytotoxic chemotherapy).

• Initial: 12 months (365 days) standard
• Endometriosis: initial 6 months (180 days)
• HCT bleeding prevention/management: initial 6 months (180 days)
• Uterine fibroids: initial 3 months (90 days)
• Renewal: generally every 12 months; endometriosis renew once for 6 months; HCT and fibroids not renewable; fertility preservation renewable yearly while on chemo

Prior authorization must meet indication-specific criteria for renewal

Prior authorization must be obtained prior to therapy and may be renewed only when the indication-specific criteria in Section III are still met and treatment duration limits from Section I have not been exceeded; renewal requires documentation of disease response and absence of unacceptable toxicity.

• PA required before treatment; renew only if indication criteria met
• Renewal contingent on duration limits not exceeded (see Length of Authorization)
• Documentation must show disease response and no unacceptable toxicity

Prior authorization applied to J1950 (cost-based NQTL)

Prior authorization is applied to HCPCS J1950 as a utilization management NQTL because cost of the drug was identified as a factor in the NQTL checklist.

• J1950 specifically listed in NQTL considerations
• Cost of drug noted as rationale to consider PA

J1950 listed with diagnosis-specific PA rules

HCPCS J1950 appears in the policy with multiple ICD-10 diagnosis codes (including numerous endometriosis codes) and is subject to the policy's prior authorization rules; see the J1950 listings and indication sections for specific PA requirements and ICD-10 support.

• J1950 listed with extensive ICD-10 codes for endometriosis and oncology
• PA requirements for J1950 are governed by the policy's prior authorization sections

Reference correct HCPCS/J-code and supporting ICD-10 when requesting PA

When requesting coverage or billing for leuprolide J‑codes (e.g., J1950, J1951, J1952, J1954, J9003, J9217), providers must reference the listed HCPCS/J-codes with the appropriate supporting ICD-10 diagnosis codes; Medicare Part B coding/coverage rules (NCD/LCD/LCA) may apply depending on jurisdiction.

• Use the HCPCS/J-code that matches the product and indication
• Include the supporting ICD-10 diagnosis code from the policy lists
• Follow applicable Medicare Part B NCD/LCD/LCA rules in your jurisdiction

Required trial of listed alternatives before coverage

For CPP and for prostate cancer, the policy requires documentation of prior intolerance, contraindication, or treatment failure to the specified alternative agents before coverage will be considered for the requested leuprolide product.

• CPP: must show contraindication, intolerance, or failure to Leupron Depot‑Ped, Supprelin LA, AND Triptodur before Fensolvi consideration
• Prostate cancer: must show contraindication, intolerance, or failure to Camcevi, Eligard, AND Firmagon before Lupron consideration

Endometriosis retreatment requires bone density check and add-back therapy

For endometriosis retreatment or extended GnRH-agonist therapy beyond the initial 6-month course, providers must document a bone density assessment prior to retreatment and plan to use norethindrone add-back therapy for the extended course.

• Patient has not received a total of 12 months of GnRH-agonist therapy
• Bone density assessment required before retreatment
• Extended therapy must be given with norethindrone add-back therapy

NQTL checklist: PA considered for cost; step therapy not prioritized

The NQTL factor checklist documents that step therapy was not prioritized for safety or misuse reasons, but prior authorization was considered primarily because of drug cost.

• Checklist: indication considered = yes; safety/efficacy and misuse not prioritized; cost = yes (consider PA)

Denial risk if CPP diagnostic confirmation is not documented

Failure to provide the required CPP diagnostic documentation (pubertal steroid levels, LH stimulation test results, bone age assessment >2 SD, and tumor exclusion testing) may result in denial of the request.

• Missing LH stimulation test or pubertal steroid levels risks denial
• Missing bone age >2 SD or absence of tumor exclusion testing risks denial

Provide documented diagnostic workup to confirm listed diagnoses

For indications that require diagnosis confirmation (for example, endometriosis and uterine leiomyomata), providers must submit objective diagnostic workup or evaluation documentation rather than presumptive treatment notes.

• Endometriosis: diagnosis confirmed by workup/evaluation (not presumptive)
• Uterine fibroids: diagnosis confirmed by workup/evaluation and member must be receiving iron therapy

Evidence required for renewal: document clinical benefit and safety

For renewal requests, submit objective evidence of beneficial response to treatment (examples include monitoring of pubertal development and laboratory parameters for gender dysphoria; stabilization or decrease in tumor size/spread for oncology; for CPP, decrease in height velocity, decreased BA:CA ratio, and improved final height prediction) and documentation of absence of unacceptable toxicity.

• Document clinical monitoring results demonstrating benefit (per-indication examples in continuation criteria)
• State absence of unacceptable toxicity as listed in renewal criteria

Follow CMS/Medicare Part B coverage and documentation guidance when applicable

Medicare Part B coverage and documentation requirements may apply; providers should follow the Medicare Benefit Policy Manual Chapter 15 §50 and search the CMS Medicare Coverage Database for applicable NCDs, LCDs, or LCAs that may affect Part B outpatient drug coverage and billing.

• Follow Medicare Benefit Policy Manual (Pub. 100-2) Chapter 15 §50 for Part B outpatient drugs
• Search CMS Medicare Coverage Database for NCD/LCD/LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx
• Compliance with applicable NCDs/LCDs/LCAs is required where applicable

Use ICD-10 diagnosis codes from the policy to support medical necessity

Diagnosis code(s) submitted to support medical necessity must match the ICD-10 codes listed in the policy (examples shown include C06.9, C07, C61, F64.x series, Z85.46, and numerous N80.* endometriosis codes) for the indicated use.

• Use the ICD-10 diagnosis codes listed in the policy that correspond to the indication (e.g., N80.* for endometriosis)
• Ensure submitted diagnosis matches policy-supported codes for the HCPCS/J-code billed

Submit CPP diagnostic confirmation (steroids, LH stimulation, bone age, tumor exclusion)

Documentation to support CPP must include diagnostic confirmation such as pubertal gonadal sex steroid levels, a pubertal LH response to stimulation by native GnRH (LH stimulation test), bone age advanced >2 SD beyond chronological age, and evidence that tumor has been ruled out (imaging and labs).

• Pubertal gonadal sex steroid levels and pubertal LH response to native GnRH stimulation
• Bone age >2 standard deviations beyond chronological age
• Imaging/labs to rule out intracranial or steroid-secreting tumors (brain imaging, pelvic/testicular/adrenal ultrasound, hCG)

Renewal may be denied for exceeded duration or unacceptable toxicity

Renewals may be denied if the duration of the authorization has been exceeded or if the member has unacceptable toxicity from the drug (examples include tumor flare, metabolic syndrome, cardiovascular events, QT/QTc prolongation, convulsions, severe cutaneous adverse reactions, hypersensitivity, significant loss of bone mineral density, or new/worsening psychiatric symptoms).

• Denial triggers: authorization duration exceeded
• Denial triggers: presence of listed unacceptable toxicities (examples provided in renewal/continuation criteria)

Expect prior authorization because cost was identified in NQTL checklist

Prior authorization may be considered for this drug group due to cost, per the NQTL factor checklist; providers should anticipate PA requirements when prescribing leuprolide depot/suspension products.

• NQTL checklist identifies cost of drug as reason to consider PA
• Expect prior authorization processes for leuprolide products

Medicare coverage determinations may affect coverage and must be followed

Medicare coverage determinations (NCDs/LCDs/LCAs) may supersede or apply to coverage decisions for Part B drugs; providers must comply with applicable Medicare coverage documents where relevant, and non‑Medicare determinations are also subject to CMS NCD/LCD/LCA guidance.

• Medicare coverage may supersede non‑Medicare policy where applicable
• Compliance with NCDs/LCDs/LCAs is required for Medicare Part B claims

Administration site and provider‑administered products

Leuprolide products such as Camcevi, Camcevi ETM, Eligard, Vabrinty, Fensolvi, and Lupron Depot-Ped must be administered by a healthcare provider; administration routes vary by product (IM or SQ) and site‑of‑care requirements are noted in the dosing/administration section.

• Administered by a healthcare provider: Camcevi, Camcevi ETM, Eligard, Vabrinty, Fensolvi, Lupron Depot-Ped
• Routes: IM for Lupron Depot/Lutrate/Leuprolide Acetate Depot; SQ for Eligard, Vabrinty, Fensolvi, Camcevi, Camcevi ETM

Medicare Part B site‑of‑care and billing rules may apply

Where Medicare Part B applies, site-of-care and billing rules for office, infusion center, or hospital outpatient settings follow NCD/LCD/LCA jurisdiction guidance and applicable Medicare Part B contractor policies.