Evenity (romosozumab-aqqg) (Subcutaneous) — Coverage Criteria
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Defines prior authorization, dosing limits, eligibility, and billing/coding for Evenity (romosozumab-aqqg) for treatment of osteoporosis, primarily in postmenopausal women, for Viva Health members.
Coverage Criteria for Evenity (romosozumab-aqqg)
Initial Therapy — Postmenopausal Osteoporosis
Covered when ALL of the following are met
In members with other cardiovascular disease and/or risk factors, consider whether benefits of therapy outweigh the risks
Specific sites include lumbar spine, femoral neck, total hip, or forearm (33% radius)
Members with very high risk are not subject to prior trial requirements
Members with very high risk are not subject to prior trial requirements
Renewal Therapy — Renewal covered when ALL of the following are met
Renewal covered when ALL of the following are met
Coverage is excluded when the member has documented pre-existing hypocalcemia or documented hypersensitivity to romosozumab or its excipients. Evenity will not be used concurrently with bisphosphonates, denosumab, or parathyroid hormone analogs/related peptides. Requests may also be denied for members with FDA‑labeled contraindications or recent cardiovascular events as specified in policy (see cardiovascular safety considerations).
Providers must ensure documentation of these exclusions is present in the medical record before authorization is approved, since these contraindications and concurrent‑use restrictions are explicit criteria for denial.
Medicare Part B Covered Diagnosis Codes: N/A. No additional Medicare‑specific diagnosis codes are listed for Evenity in Appendix 3 of this policy; providers billing Medicare should follow applicable NCDs, LCDs, and LCAs as instructed by CMS and the member’s Medicare Administrative Contractor.
Continuation of Evenity beyond the prescribed treatment course is not covered. Initial prior authorization is valid for 12 months (365 days) and may NOT be renewed; therefore continuation beyond 12 monthly doses will not be authorized.
Prior authorization requests should reflect the maximum authorized duration and number of doses; renewal requests for additional months or doses beyond the initial 12‑month authorization will be denied per policy.
Billing, HCPCS, NDCs, and Diagnosis Codes
| J3111 | Injection, romosozumab-aqqg, 1 mg; 1 billable unit = 1 mg |
| 55513-0880-xx | Evenity 105 mg/1.17 mL single-use plastic prefilled syringe (carton of two) |
| 55513-0998-xx | Evenity 105 mg/1.17 mL single-use glass prefilled syringe (carton of two) |
| 55513-0509-xx | Evenity 105 mg/1.17 mL single-use glass prefilled syringe with automatic needle guard (carton of two) |
| M80.00XA-M80.08XS | Age-related osteoporosis with current pathological fracture |
| M81.0 | Age-related osteoporosis without current pathological fracture |
| M80.00XA-M80.08XS | Age-related osteoporosis with current pathological fracture |
| M81.0 | Age-related osteoporosis without current pathological fracture |
| No codes listed |
Prior Authorization, Documentation, and Provider Requirements
Prior authorization validity
Prior authorization is required for Evenity. Initial prior authorizations are valid for 12 months (365 days) and may NOT be renewed; continuation beyond 12 monthly doses is not covered.
- Initial authorization: 12 months (365 days)
- Renewal: prior authorization may NOT be renewed — continuation beyond 12 doses is not covered
Prior authorization and Medicare compliance
For non‑Medicare members, coverage determinations follow this policy. For Medicare Part B claims, providers must comply with applicable Medicare resources — the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15 §50, and any relevant NCDs, LCDs, or LCAs available via the CMS coverage database; failure to follow applicable NCDs/LCDs/LCAs may affect payment/coverage.
- Non‑Medicare determinations follow this policy text
- Medicare Part B: follow Medicare Benefit Policy Manual and any applicable NCDs/LCDs/LCAs via https://www.cms.gov/medicare-coverage-database/search.aspx
Step therapy / prior agent trials
Prior therapy requirements generally require documented trials with failure or intolerance to specified agents unless the member is very high risk. Documented treatment failure or ineffective response (minimum 12-month trial) to both bisphosphonates (oral or IV) and to RANKL‑blocking agents (e.g., denosumab) — or documented contraindication/intolerance to those agents — must be provided, unless member meets 'very high risk' criteria.
- Minimum 12-month trial and documented treatment failure or ineffective response for bisphosphonates (oral or IV) OR documented contraindication/intolerance to BOTH oral and IV bisphosphonates
- Minimum 12-month trial and documented treatment failure or ineffective response for RANKL‑blocking agents (e.g., denosumab) OR documented contraindication/intolerance to RANKL‑blocking agents
- Prior trial requirements may be waived for members with very high fracture risk (see policy for definitions)
Clinical documentation of diagnosis, risk, and prior therapy
Provide all clinical documentation that supports the requested therapy: diagnostic evidence of osteoporosis, fracture risk assessment, and prior therapy records. Include DXA T‑score reports, history of fragility fracture documentation, and FRAX or equivalent fracture‑risk calculations; and records showing prior therapy trials, durations (e.g., 12 months), and outcomes or documented contraindications/intolerances.
- DXA T-score at lumbar spine, femoral neck, total hip, or 33% radius when applicable (e.g., ≤ -2.5 or -1.0 to -2.5 with additional criteria)
- History of fragility fracture to hip or spine regardless of T‑score
- FRAX 10‑year probability when used (policy specifies thresholds)
- Documentation of prior therapy trials including duration (minimum 12 months), response/failure, or documented contraindication/intolerance
Billing and coding documentation
Include coding and billing details with the prior authorization and on claims. Use HCPCS code J3111 (Injection, romosozumab-aqqg, 1 mg) and the applicable Evenity NDCs for the supplied prefilled syringes when billing.
- HCPCS: J3111 — Injection, romosozumab-aqqg, 1 mg (1 billable unit = 1 mg)
- NDCs: 55513-0880-xx; 55513-0998-xx; 55513-0509-xx (Evenity 105 mg prefilled syringes, carton of two)
Documented diagnosis must match covered ICD‑10 codes
Ensure the documented diagnosis on the prior authorization and claim matches one of the covered ICD‑10 codes listed in Appendix 1. Accepted codes include the age‑related osteoporosis ranges provided by the policy.
- Appendix 1 covered ICD‑10 codes: M80.00XA–M80.08XS (age‑related osteoporosis with current pathological fracture) and M81.0 (age‑related osteoporosis without current pathological fracture)
Contraindications and recent MI/stroke — denial risk
Requests will be denied if the member has FDA‑labeled contraindications or recent cardiovascular events. Do not proceed if there is documented pre‑existing hypocalcemia, known hypersensitivity to Evenity or its excipients, or a myocardial infarction or stroke within the preceding year.
- FDA‑labeled contraindications example: documented hypocalcemia or hypersensitivity to Evenity/excipients
- Recent MI or stroke within the prior year — authorization may be denied
Failure to meet diagnostic or prior‑therapy requirements — denial risk
Authorization may be denied if diagnostic criteria or prior therapy requirements are not met. Specifically, if the member does not meet osteoporosis diagnostic criteria or is not at high risk for fracture and has not had the required trials of bisphosphonates and RANKL‑blocking agents (or documented contraindications/intolerances), coverage may be denied unless the member is 'very high risk.'
- Denial risk when diagnostic criteria (DXA, fragility fracture, or FRAX thresholds) are not met
- Denial risk when prior trials of bisphosphonates and/or RANKL‑blocking agents are not documented and member is not very high risk
Medicare vs non‑Medicare determinations — provider action
For Medicare patients, follow Medicare-specific coverage and claims guidance. Non‑Medicare determinations should follow this policy, but Medicare Part B coverage and payment are subject to the Medicare Benefit Policy Manual and applicable NCDs/LCDs/LCAs; noncompliance with those Medicare directives may result in denial or payment issues.
- Non‑Medicare: apply this policy for coverage determinations
- Medicare Part B: comply with Medicare Benefit Policy Manual (Pub.100-2), Chapter 15 §50 and any applicable NCDs/LCDs/LCAs
Definitions and Dosing
Background
Evenity (romosozumab‑aqqg) is administered as a monthly subcutaneous regimen consisting of 210 mg per month delivered as two 105 mg injections given by a healthcare provider. The treatment course is limited to a maximum of 12 monthly doses because the anabolic effect wanes after 12 months and the policy does not permit continuation beyond that duration.
Therapy should be given with appropriate calcium and vitamin D supplementation when dietary intake is inadequate, and providers must confirm the member meets diagnostic and risk criteria (e.g., osteoporosis by DXA or fragility fracture history) prior to initiating the monthly injections.
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