Prior authorization validity periods

Initial authorizations are valid for 12 months (365 days) unless otherwise specified. Initial prior authorizations for endometriosis and HCT-related menstrual bleeding are valid for 6 months (180 days), and for uterine leiomyomata (fibroids) are valid for 3 months (90 days). Renewals are generally every 12 months (365 days) unless the policy lists a different renewal interval for the indication.

• Endometriosis initial validity: 6 months (180 days)
• HCT prevention/management initial validity: 6 months (180 days)
• Uterine leiomyomata initial validity: 3 months (90 days)
• Standard renewal interval: 12 months (365 days)
• Endometriosis renewal: may be renewed one time only for 6 months (180 days)
• HCT and uterine leiomyomata: may NOT be renewed

Prior authorization and renewal requirements

Both initial authorizations and renewals require that the member meets the indication‑specific medical criteria and that there is absence of unacceptable toxicity; renewals require documented continued benefit and that duration limits have not been exceeded.

• Renewal requires continued benefit (stabilization or decrease in tumor burden for cancer indications)
• Renewal denied if unacceptable toxicity present (examples listed in policy)
• Member must continue to meet the indication‑specific criteria listed in Section III

Prior authorization documentation and billing

Document NQTL considerations per Appendix A when requesting prior authorization and bill claims using the listed HCPCS code(s) — notably J1950 for leuprolide suspension — with an appropriate ICD‑10 diagnosis code from Appendix 1 to support medical necessity.

• Appendix A (NQTL checklist) documents factors considered for PA
• Use HCPCS J1950 for leuprolide suspension billing where applicable
• Include an appropriate ICD‑10 diagnosis code from Appendix 1 to support the PA/claim

Diagnosis linkage required for J1950 claims

When billing HCPCS J1950, include one of the ICD‑10 diagnosis codes enumerated in the policy’s Appendix 1 that corresponds to the clinical indication (Appendix 1 provides the full list of ICD‑10 codes mapped to J1950).

• Appendix 1 lists ICD‑10 codes supporting J1950 (e.g., many N80.* endometriosis codes and oncologic codes)
• Submit the appropriate ICD‑10 code on the claim to link diagnosis to J1950 billing

J‑code jurisdiction and Medicare coverage rules

Coverage and prior authorization for listed J‑codes (for example J1950, J9217, J1952, J1954) may be subject to Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs), and MAC jurisdictional rules; follow applicable contractor guidance for Medicare Part B claims.

• Jurisdictional Medicare contractor rules apply to J1950, J9217, J1952, J1954
• Search CMS coverage database for applicable NCDs/LCDs/LCAs

Behavioral and specialist assessment prerequisites for gender dysphoria

For gender dysphoria treatment authorization, obtain documentation that a qualified mental health professional has confirmed the DSM‑5‑TR diagnosis and the listed psychosocial assessments, and for adolescents a pediatric endocrinologist (or clinician experienced in pubertal assessment) has confirmed the indication and absence of medical contraindications.

• Qualified MHP must confirm long‑lasting/intense gender dysphoria, worsening with puberty, addressed coexisting problems, capacity to consent, and informed consent obtained
• Pediatric endocrinologist must confirm indication and absence of medical contraindications for adolescents

Fertility preservation prerequisite documentation

For fertility preservation during chemotherapy, document that the member is premenopausal, is receiving cytotoxic chemotherapy with potential ovarian toxicity, and has failed or is not a candidate for other fertility preservation methods (e.g., cryopreservation).

• Member must be premenopausal
• Member must be receiving cytotoxic chemotherapy with potential to cause ovarian damage
• Document failure of or ineligibility for other fertility preservation methods

Step therapy rules

No step therapy (medication‑sequencing) rules are specified in the provided policy excerpt.

CPP required clinical documentation

For CPP prior authorization, provide documentation of age of onset, pubertal gonadal steroid and a pubertal LH response to stimulation, bone age advanced >2 SD beyond chronological age, imaging/labs to exclude tumor, and a statement that therapy will not be used concurrently with growth hormone.

• Member <13 years and onset of secondary sexual characteristics earlier than age 8 (females) or 9 (males)
• Biochemical confirmation including pubertal LH response to stimulation
• Bone age >2 SD advanced beyond chronological age
• Imaging and labs to exclude intracranial or steroid‑secreting tumors
• Document therapy will not be combined with growth hormone

Gynecologic diagnosis documentation requirements

For endometriosis and uterine leiomyomata (fibroids) prior authorization, submit documentation confirming the diagnosis by workup/evaluation (not presumptive treatment); for uterine leiomyomata also document that the member is receiving iron therapy.

• Endometriosis: confirmed diagnosis by diagnostic workup/evaluation
• Uterine leiomyomata: confirmed diagnosis by workup/evaluation and documentation of iron therapy

Required documentation for gender dysphoria authorizations

Authorization for gender dysphoria requires documentation from a qualified mental health professional confirming DSM‑5‑TR criteria and the MHP’s assessments (duration/severity, puberty‑related worsening, addressed coexisting problems, capacity to consent), plus informed consent and, for adolescents, pediatric endocrinologist confirmation.

• Qualified MHP documentation confirming DSM‑5‑TR diagnosis and listed assessments
• Evidence of informed consent and fertility preservation discussion
• For adolescents, pediatric endocrinologist confirmation of indication and no contraindications

Diagnosis and HCPCS code requirements for PA and claims

Include an Appendix 1 ICD‑10 diagnosis code that supports medical necessity on the prior authorization and claim; the policy lists HCPCS J1950 (leuprolide) as the billing code associated with those diagnosis linkages.

• Use an ICD‑10 code from Appendix 1 to support medical necessity
• Use HCPCS J1950 for leuprolide suspension billing where applicable

Diagnosis coding required on claim submissions

When submitting claims for leuprolide (e.g., J1954/J1950), include the appropriate ICD‑10 diagnosis code from the policy’s listed malignant neoplasm and gender identity code series to link the service to a covered indication.

• Submit the ICD‑10 code from the policy’s listed oncologic or gender identity codes on the claim
• Ensure diagnosis‑to‑J‑code linkage matches Appendix 1 entries

Denial risk: CPP documentation omissions

CPP authorizations risk denial if documentation does not demonstrate the age, biochemical confirmation (pubertal LH response to stimulation), advanced bone age, tumor exclusion, and that therapy will not be combined with growth hormone.

• Failure to document tumor exclusion, biochemical confirmation, or advanced bone age may lead to denial
• Concurrent use with growth hormone is not permitted and may cause denial

Denial risk: fibroids documentation missing

For uterine leiomyomata (fibroids), failure to provide a confirmed diagnosis by workup/evaluation and evidence the member is receiving iron therapy may lead to denial of coverage.

• Confirmed diagnostic workup required (not presumptive treatment)
• Document that member is receiving iron therapy to support the indication

Renewal denial triggers

Renewal requests may be denied if the member does not demonstrate disease response or if unacceptable toxicity from the drug is present; oncology and other indications require documented stabilization or decrease in tumor burden as applicable.

• Renewal requires evidence of clinical benefit (e.g., stabilization or tumor decrease for cancer)
• Renewal denied if unacceptable toxicity is present (policy lists examples)

PA consideration for indication and cost (NQTL)

Prior authorization may be applied based on the indication and drug cost as documented in the NQTL checklist (Appendix A); include relevant clinical documentation to support medical necessity and cost‑based PA considerations.

• Appendix A notes cost of drug as a factor considered for PA
• Provide indication‑specific documentation to support PA when cost is a consideration

Medicare Part B coverage compliance

Noncompliance with applicable Medicare NCDs, LCDs, or LCAs for Part B drugs may result in coverage denial; providers must follow applicable Medicare contractor guidance for J‑code claims.

• Medicare Part B coverage governed by CMS manuals and NCD/LCD/LCA policies
• Follow the applicable MAC/LCD/NCD guidance for jurisdictional J‑code coverage

Site‑of‑care: provider‑administered products (office/infusion)

Certain products (Camcevi, Camcevi ETM, Eligard, Vabrinty, Fensolvi, Lupron Depot‑Ped) must be administered by a healthcare provider in an office or infusion center setting.

• Camcevi, Camcevi ETM, Eligard, Vabrinty, Fensolvi, Lupron Depot‑Ped require provider administration
• Administration routes: IM for some products (Lupron Depot family) and SQ for others (Eligard, Vabrinty, Fensolvi, Camcevi)

Medicare outpatient administration and jurisdictional rules

For Medicare outpatient administration, follow Medicare Part B outpatient coverage rules and the applicable MAC/jurisdictional contractor guidance when billing and seeking coverage for outpatient administrations.

• Medicare Part B outpatient coverage guidance applies to outpatient administrations
• Consult the CMS Medicare Coverage Database and applicable contractor for jurisdictional rules

505(b)(2) leuprolide depot products — single‑source designation

The policy identifies several 505(b)(2) leuprolide depot products designated with Ψ and notes they are single‑source products not rated as therapeutically equivalent in the FDA Orange Book.

• Ψ designates FDA 505(b)(2) NDA innovator products
• These products are considered single‑source and not rated therapeutically equivalent in the Orange Book