J3111 — Injection, romosozumab-aqqg, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Documentation that supports diagnosis of postmenopausal osteoporosis (examples in Background: fragility fracture in absence of other metabolic bone disorders; T-score ≤ -2.5 SD at lumbar spine, femoral neck, total hip, or one-third radius; or T-score between -1.0 and -2.5 with increased fracture risk by FRAX).
- Documentation that patient is at high risk for fracture, e.g., records showing history of osteoporotic fracture, multiple fracture risk factors, or that the patient has failed or is intolerant to other available osteoporosis therapy (policy Coverage Rationale criteria: "Patient is at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture, patients who have failed or are intolerant to other available osteoporosis therapy)").
- Documentation of dosing consistent with FDA approved labeling (dose/administration records showing conformity with labeling and duration not exceeding 12 monthly doses).
Key Coverage Criteria
- Evenity is proven for the treatment of osteoporosis in postmenopausal patients at high risk for fracture when all of the following criteria are met: Diagnosis of postmenopausal osteoporosis; and Patient is at high risk for fracture (e.g., history of osteoporotic fracture, multiple risk factors for fracture, patients who have failed or are intolerant to other available osteoporosis therapy); and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and Aut [...]
- FDA indication (informational): Evenity (romosozumab-aqqg) is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
- Covered/Referenced HCPCS: J3111 Injection, romosozumab-aqqg, 1 mg (listed in Applicable Codes table)
- Covered/Referenced diagnosis codes (policy lists many ICD-10-CM codes used for osteoporosis and pathological fractures): examples include M80.* (age-related and other osteoporosis with current pathological fracture codes listed in detail), M81.0 (Age-related osteoporosis without current pathological fracture), M81.8 (Other osteoporosis without current pathological fracture), and Z78.310 (Personal history of (healed) osteoporosis fracture). [...]
- Drug therapy that is proven effective for the relevant diagnosis or procedure.
- Drug therapy when the proposed dose, frequency, and duration are consistent with recommendations in at least one authoritative source.
12 Active Policies
UHC-POL-evenity-romosozumab-aqqg — Evenity (Romosozumab-Aqqg)
UMR-POL-UMR-evenity-romosozumab-aqqg — Evenity (Romosozumab-Aqqg)
SUREST-POL-SUREST-evenity-romosozumab-aqqg — Evenity (Romosozumab-Aqqg)
BCBSIL-RX501.159 — Romosozumab-aqqg
BCBSMT-RX501.159 — Romosozumab-aqqg
Related Codes
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