Denial risk: hypocalcemia, missing supplementation, and prohibited combinations

Prior authorization may be denied if the member has untreated hypocalcemia or is not receiving required calcium and vitamin D supplementation; denials also apply if denosumab is used concurrently with other denosumab products, bisphosphonates, romosozumab, or parathyroid hormone analogs/related peptides.

• Member must not have hypocalcemia.
• Member will receive calcium and vitamin D as necessary to treat or prevent hypocalcemia.
• Denosumab will not be used in combination with other denosumab products, bisphosphonates, romosozumab, or parathyroid hormone analogs/related peptides.

Initial prior authorization period and site-of-care requirements

Prior authorization is issued for an initial 12-month period (365 days) and may be renewed every 12 months. Site-of-care specialty infusion program requirements apply for groups in scope.

• Initial PA validity: 12 months (365 days).
• Renewals: may be renewed every 12 months (365 days).
• Site-of-care: SOC specialty infusion program requirements apply where indicated.

Prior authorization required when universal criteria are met

Prior authorization is required and will only be valid when the universal criteria are met, including documented calcium and vitamin D supplementation, absence of hypocalcemia, pregnancy ruled out in biologic females of child-bearing potential, and exclusion of prohibited concomitant denosumab or related therapies.

• PA applies only when universal criteria are satisfied (calcium/Vit D supplementation, no hypocalcemia).
• Pregnancy must be ruled out in biologic females of child-bearing potential prior to administration.
• Denosumab must not be used in combination with other denosumab products, bisphosphonates, romosozumab, or parathyroid hormone analogs/related peptides.

PA applies to denosumab products; biosimilar and J‑code considerations

Prior authorization is applied to denosumab products per the plan’s utilization management approach; specific HCPCS/Q-codes and J3590 entries are listed for biosimilars and unclassified biologics and are considered in PA decisions.

• PA considerations include listed biosimilar Q‑codes (e.g., Q5159, Q5161, Q5162, Q5167) and J3590 (unclassified biologics).
• Utilization management (NQTL) factors inform when PA is required or how it is applied.

Verify Medicare NCD/LCD/Article applicability for outpatient denosumab

When billing Medicare Part B patients, providers must verify and follow applicable Medicare NCDs, LCDs, and Articles, since outpatient denosumab coverage is governed by CMS guidance where applicable.

• Medicare Part B outpatient drug coverage is subject to the Medicare Benefit Policy Manual and applicable NCDs/LCDs/Articles.
• Providers should consult CMS coverage database and local contractor policies for applicable rules.

Step therapy: minimum 12‑month bisphosphonate trial required (unless contraindicated)

For osteoporosis and glucocorticoid‑induced osteoporosis indications, members must have documented treatment failure after at least a 12‑month trial of bisphosphonates, unless there is a documented contraindication or intolerance to both oral and IV bisphosphonates.

• Minimum bisphosphonate trial: 12 months (oral or IV) with documented treatment failure or ineffective response.
• Alternatively, documented contraindication or intolerance to BOTH oral and IV bisphosphonates satisfies the prerequisite.

Prerequisite therapy: try bisphosphonates or document contraindication/intolerance

Certain indications require prior use of and inadequate response to bisphosphonates (or documented contraindication/intolerance). Examples include a ≥3‑month trial of zoledronic acid for prevention of skeletal‑related events and prior bisphosphonate therapy for osteoporosis or GIOP.

• Prevention of skeletal‑related events: trial of zoledronic acid ≥3 months with inadequate response, contraindication, or intolerance.
• Osteoporosis/GIOP: documented failure or intolerance to oral and IV bisphosphonates as specified in indication criteria.

Step therapy algorithm not specified in this section

The policy segment does not provide a detailed stepwise algorithm beyond the listed prerequisite and exception statements; no explicit multi‑step flow is specified here.

• No explicit step therapy algorithm is present in this document segment; prerequisites and exceptions are described, but a full stepwise sequence is not included.

Document calcium/Vitamin D supplementation and evidence of osteoporosis

Document that the member is supplementing with 1,000 mg calcium and at least 400 IU vitamin D daily and include evidence of osteoporosis or other covered indication (e.g., DXA T‑score, history of fragility fracture, or FRAX score) when requesting authorization.

• Calcium supplementation: 1,000 mg daily.
• Vitamin D supplementation: at least 400 IU daily.
• Evidence of osteoporosis: T‑score ≤ −2.5, fragility hip/spine fracture history, or qualifying FRAX thresholds as listed.

Renewal: document continued benefit and absence of unacceptable toxicity

For renewal requests, provide documentation that the member continues to meet universal and indication‑specific criteria, has not experienced unacceptable toxicity, and demonstrates continued benefit (e.g., absence of new fractures, improved BMD, disease stabilization, or corrected serum calcium targets for hypercalcemia).

• Renewal requires continued fulfillment of universal and indication‑specific criteria (excluding prior prerequisite therapy).
• Document absence of unacceptable toxicity (examples provided) and evidence of therapeutic benefit per indication.

Include correct product NDC and HCPCS/Q/J code when billing

Include the appropriate product identifiers when billing: the product NDC(s) and the correct HCPCS/Q‑code or J‑code for the denosumab formulation administered per the policy appendices.

• List the applicable NDC from Appendix 1 for the product administered (Prolia/Xgeva and biosimilars listed).
• Use the correct HCPCS (e.g., J0897) or biosimilar Q‑code when submitting claims.

Use listed ICD‑10 diagnosis codes to support coverage

Ensure an appropriate ICD‑10 diagnosis code from the policy appendices is present on the claim or in the medical record to support medical necessity (examples include M80.*, M81.*, M85.*, malignancy code ranges, and history codes listed in Appendix 1).

• Use one of the listed ICD‑10 codes or code ranges from Appendix 1 that correspond to the denosumab product grouping.
• Presence of a covered diagnosis code on the claim or documentation supports coverage.

Denial risk: hypocalcemia, lack of supplementation, or pregnancy not ruled out

There is a risk of denial if the member has hypocalcemia, is not supplementing with calcium and vitamin D as required, or if pregnancy in biologic females of child‑bearing potential has not been ruled out prior to administration.

• Administration is not appropriate when the member has hypocalcemia.
• Denial risk if required calcium (1,000 mg) and vitamin D (≥400 IU) supplementation are not documented.
• Pregnancy must be ruled out in biologic females of child‑bearing potential to avoid denial risk.

PA application informed by NQTL assessment

Prior authorization is applied based on the plan’s NQTL assessment; factors considered include indication, safety/efficacy, and drug cost, which inform utilization management and PA decisions.

• Appendix A NQTL checklist documents the factors considered when designing and applying PA.
• Factors include indication relevance, safety/efficacy, and cost.

Claims may be subject to Medicare NCDs/LCDs/Articles — verify contractor rules

Claims for outpatient denosumab drugs may be subject to Medicare NCDs, LCDs, or Articles; providers billing Medicare should consult applicable contractor policies and the CMS coverage database to ensure compliance.

• Medicare Part B outpatient drug coverage follows the Medicare Benefit Policy Manual and applicable NCDs/LCDs/Articles.
• Providers should search the CMS coverage database for relevant NCD/LCD/Article guidance for the MAC jurisdiction.