Covered Patient Indications
Medicare Coverage*
Coverage for Manafuse is indicated when all of the following criteria are met:
- A nonunion of a fracture, defined as radiographic evidence that fracture healing has ceased for ≥ 3 months before treatment begins.
- Fracture involves a short or long bone (i.e., not skull or vertebrae).
- Fracture is not related to a tumor process.
United Healthcare (UHC) Coverage
Coverage is approved when all of the following are present:
Confirmed nonunion of a long bone fracture with:
- Fracture gap ≤ 1 cm
- Persistent fracture line without bridging callus visible on imaging for ≥ 3 months
- Fracture has been reduced and immobilized
- < 6 months have elapsed since the most recent surgical operation on the fracture site
- Fracture is not pathological or associated with malignancy
- Radiographic evidence confirms skeletal maturity
Order Processing Requirements
- Signed Prescription for the Manafuse device
- Patient demographics: full name, date of birth, insurance details
- Relevant medical records, including:**
- Documentation of initial diagnosis or injury
- Most recent progress note supporting the lack of healing
- Radiology reports/images demonstrating:
- Cessation of healing at ≥ 3 months (Medicare/UHC)
- Fracture gap measurement and bridging status (UHC)
- Operative report (if surgical procedure performed)
- Fracture reduction and immobilization records (e.g., notes, casting documentation)
- Timeline documentation, especially noting the date of the most recent surgery
Additional Considerations
- Fracture location. Short and long bone fractures are eligible for coverage, depending on the specific carrier. Skull, vertebral, tumor-related, or flat bone nonunions are excluded.
- Pathological nonunion (e.g., malignancy-related) is not covered by either Medicare or UHC.
- For UHC, device use is permitted only if < 6 months have passed since the latest fracture surgery
* Consult your local rep for coverage information about other insurance plans.