The EXOGEN Performance Program is a Bioventus program that refunds patients their out-of-pocket payment for EXOGEN if progression of healing is not shown per criteria below. It is also designed to help reinforce patients’ adherence to the prescribed treatment.
Criteria
All patients who have purchased an EXOGEN designed for the treatment of a fracture, which was prescribed by a qualified physician to treat a stable, non-displaced, established nonunion,* delayed union or acute fracture with a fracture gap less than 10 millimeters (excluding vertebra and skull fractures) are eligible. All patients will automatically be enrolled in the program.
Patients must treat their fracture with EXOGEN per product instructions, for a minimum of 120 days and achieve a minimum adherence of at least 90%.
Evaluation
To be eligible, your prescribing physician must determine that your bone has not healed, or progressed to a bony union. The prescribing physician must provide two X-rays of your affected bone, one prior to using EXOGEN, and another taken after 120 days or more of EXOGEN treatment that shows a lack of bony union.
The EXOGEN device contains an internal patient usage monitor that records the date, time and duration of each treatment session. This monitor will be used by Bioventus to confirm that at least 90% treatment adherence is met.
Exclusions
- Fracture types:
- Unstable
- Displaced
- Greater than 10-millimeter fracture gap
- Vertebra and skull
- Pathological
- Modified or altered devices
- Patient treated with EXOGEN 4000+ model
- The EXOGEN Performance Program is void if alternative interventions occur during the 120-day treatment period. If alternative intervention is needed, a new 120-day treatment period begins
- EXOGEN must be purchased and received by the patient directly from Bioventus
- The EXOGEN Performance Program applies only to patients for whom the device was prescribed
- Any other costs associated with the purchase – only the patient’s out-of-pocket payment to Bioventus will be refunded
You may contact Bioventus Customer Care for assistance. All claims must be accompanied by the following:
- Prescribing physician’s assessment: completion of the EXOGEN Performance Program evaluation form
- Letter from the patient requesting a refund (including name, address and payment method)
- Prescribed EXOGEN device returned to Bioventus
Claims must be received by Bioventus within one year of first EXOGEN treatment date.
Bioventus reserves the right to amend or cancel the program at any time.
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Summary of Indications for Use
EXOGEN is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes the treatment of delayed unions, nonunions,* stress fractures and joint fusion. EXOGEN is also indicated for the acceleration of fresh fracture heal time, repair following osteotomy, repair in bone transport procedures and repair in distraction osteogenesis procedures.
There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel.
Full prescribing information can be found in product labeling, at EXOGEN.com, or by calling Bioventus Customer Service.
*A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.