Currentblue cross blue shield - michiganPolicy N/A

Denosumab medical benefit prior authorization and preferred product update

Provider alert describing Medicare Advantage changes to preferred denosumab products, prior authorization requirements, and submission instructions for drugs billed under the medical benefit affecting providers administering denosumab to Medicare Advantage members.

Policy Summary

Payerblue cross blue shield - michigan

PolicyDenosumab medical benefit prior authorization and preferred product update

Policy CodePolicy N/A

Change TypePreferred-product and PA requirement updates

Effective DateDec. 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests for medical‑benefit denosumab via the Medical and Pharmacy Drug PA Portal.

SourceLink

POLICY UPDATE CHANGES

Osenvelt will not require prior authorization for dates of service on or after Dec. 1, 2025.

Stoboclo and Osenvelt designated as preferred denosumab products for Medicare Advantage members starting Dec. 1, 2025 with differing PA requirements.

Certain denosumab products for oncology and other bone conditions will require prior authorization for dates of service on or after Dec. 1, 2025 and are part of the medical benefit.

Dec. 1, 2025effective date for preferred product and PA changes

Stoboclopreferred denosumab that requires prior authorization

Osenveltpreferred denosumab that does NOT require prior authorization

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Coverage and Benefit Rules

These denosumab products are billed under the medical benefit when administered in provider settings (for example, outpatient facilities, infusion centers, or physician offices) and submitted on professional (837P/CMS‑1500) or hospital outpatient/institutional (837I/UB04) claims. Submit prior authorization requests for medical‑benefit denosumab through the Medical and Pharmacy Drug PA Portal.

For Medicare Plus Blue and BCN Advantage members, specified denosumab drugs used for skeletal‑related events, bone metastases, hypercalcemia of malignancy, and other bone conditions are part of the medical benefit and, for dates of service on or after Dec. 1, 2025, require prior authorization as listed in this policy.

Requests for non‑preferred denosumab products will require documentation that the member has tried and failed the preferred denosumab options and a bisphosphonate. For osteoporosis indications, providers must document a trial and failure of one of the preferred products (for example, Prolia (J0897), Jubbonti (Q5136), Conexxence (Q5158), or Ospomyv (Q5159)) and an oral or IV bisphosphonate. Failure to provide this documentation may result in the request being denied or not considered medically necessary.

Drug Codes and Billing

Preferred and referenced denosumab productsHCPCS

J3590	Stoboclo ® (denosumab-bmwo) – Q5157 effective Oct. 1, 2025; requires prior authorization for DOS on/after Dec. 1, 2025
J3590	Osenvelt ® (denosumab-bnwo) – Q5157 effective Oct. 1, 2025; does not require prior authorization for DOS on/after Dec. 1, 2025
J0897	Prolia ® (denosumab)
Q5136	Jubbonti ® (denosumab-bbdz)
Q5158	Conexxence ® (denosumab-bnht) – requires prior authorization for dates of service on/after Oct. 1, 2025
Q5159	Ospomyv™ (denosumab-dssb) – requires prior authorization for dates of service on/after Oct. 1, 2025

Denosumab products for oncology and other bone conditionsHCPCS

J0897	Xgeva ® (denosumab)
Q5158	Bomyntra ® (denosumab-bnht)
Q5136	Wyost ® (denosumab-bbdz)
Q5159	Xbryk™ (denosumab-dssb)

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for certain denosumab products when administered under the medical benefit and billed on professional (CMS-1500 / 837P) or hospital outpatient (UB04 / 837I) claims. Submit PA requests through the Medical and Pharmacy Drug PA Portal in the provider portal (Availity → Payer Spaces → BCBSM and BCN → Medical and Pharmacy Benefit Drug Prior Auth tile).

Applicable codes: HCPCS J0897 and Q5xxx denosumab product codes as listed on the Medical Drug and Step Therapy Prior Authorization List (see PA Portal).
PA applies to drugs administered in outpatient facilities or physician offices and billed via 837P/1500 or 837I/UB04 (hospital outpatient 013x).

Step Therapy

Step Therapy Required Before Non‑Preferred Denosumab

Before requesting a non-preferred denosumab product for osteoporosis, bone metastases, hypercalcemia of malignancy, multiple myeloma, or other covered bone-health conditions, providers must document that the member tried and failed both: 1) the preferred denosumab products (Stoboclo and Osenvelt per effective dates noted in the PA list) and 2) an oral or IV bisphosphonate (examples: alendronate/Fosamax, zoledronic acid/Reclast or Zometa, ibandronate/Boniva). IV bisphosphonates do not require prior authorization.

Initial Therapy Requirements

Continuation and Renewal

Step Therapy Table

Step	Requirement	Supporting codes / notes
1	Member must try and fail one of the preferred denosumab products before a non-preferred denosumab will be authorized.	Preferred denosumab options include Stoboclo (denosumab‑bmwo) and Osenvelt (denosumab‑bnwo); see note about differing PA requirements below.
2	Member must try and fail an oral or IV bisphosphonate (e.g., Fosamax, Reclast, Boniva). IV bisphosphonates do not require prior authorization.	Oral or IV bisphosphonates listed as examples in policy; IV formulations (e.g., Reclast) are PA‑exempt.
3	Documentation of trials and failures for the required preferred denosumab and a bisphosphonate must be provided with the prior authorization request.	Use Medical Drug and Step Therapy prior‑authorization processes as described in the policy communications.
Note	Stoboclo (J3590; Q5157 effective Oct. 1, 2025) is preferred but requires prior authorization for DOS on/after Dec. 1, 2025; Osenvelt (J3590; Q5157 effective Oct. 1, 2025) is preferred and does not require prior authorization for DOS on/after Dec. 1, 2025.	Policy update effective Dec. 1, 2025. Preferred product PA differences explicitly stated in the communication.

Applicable Sites of Care

Note

PA applies for drugs administered in outpatient/provider sites and billed on pro/hop claims

Prior authorization requirements apply when denosumab is administered in outpatient facilities, infusion centers, hospital outpatient departments, or physician offices and billed on professional or hospital outpatient claims.

Billed electronically via 837P/CMS‑1500 or 837I/UB04 (hospital outpatient bill type 013x).

Preferred Product Designations

Billing Rule

Preferred product (Stoboclo) — PA required on/after Dec. 1, 2025

Stoboclo (denosumab‑bmwo) is a preferred denosumab product for Medicare Advantage members effective Dec. 1, 2025 and requires prior authorization for dates of service on or after that date.

HCPCS: J3590 (Q5157 effective Oct. 1, 2025).

Billing Rule

Preferred product (Osenvelt) — no PA required on/after Dec. 1, 2025

Osenvelt (denosumab‑bnwo) is a preferred denosumab product for Medicare Advantage members effective Dec. 1, 2025 and does not require prior authorization for dates of service on or after that date.

HCPCS: J3590 (Q5157 effective Oct. 1, 2025).

Key Definitions

Medical benefit (definition and implications)

DefinitionDrugs administered in provider settings (e.g., outpatient facilities, physician offices) billed on professional (837P/CMS‑1500) or hospital outpatient/institutional (837I/UB‑04 outpatient) claims are covered under the medical benefit.

Applies toDenosumab products used for skeletal‑related events, bone metastases, hypercalcemia of malignancy, and other bone health conditions (e.g., Xgeva, Bomyntra, Wyost, Xbryk).

Implication for billingThese drugs should be billed on medical claims rather than pharmacy claims when administered by a provider in a clinic, infusion center, or hospital outpatient setting.

Prior authorization routeSubmit PA requests through the Medical and Pharmacy Drug PA Portal.

Note on bisphosphonatesMembers must also try and fail a bisphosphonate (e.g., Zometa); IV bisphosphonates do not require prior authorization.

Clinical Background

Denosumab is a RANKL‑inhibitor used to treat osteoporosis and multiple oncology‑related bone conditions, including skeletal‑related events from multiple myeloma, bone metastases, and hypercalcemia of malignancy. For osteoporosis, denosumab options include Prolia (J0897) and various denosumab biosimilars; for oncology and other bone conditions, denosumab products such as Xgeva (J0897) and listed biosimilars are used. Intravenous bisphosphonates are alternative therapies for some indications and, where noted, do not require prior authorization.