ORTHOFIX Bone Healing Therapy User Guide

June 12, 2024
ORTHOFIX

ORTHOFIX Bone Healing Therapy

AccelStimTM Bone Healing Therapy
AccelStimTM is a bone growth therapy device that utilizes Low-Intensity Pulsed Ultrasound (LIPUS) to activate the body’s natural healing process. It is a safe and non-surgical treatment prescribed by physicians to improve the opportunity for successful fusion or bone fracture healing. The Orthofix Bone Growth Therapy devices, including AccelStimTM, are FDA-approved and widely accepted by healthcare professionals.

Patient Guide to Insurance Coverage
Insurance coverage for bone growth therapy can vary widely with individual policies. Orthofix provides assistance in determining coverage by working with your insurance provider. However, it is important to note that coverage is subject to the specific terms and conditions of your insurance plan.

What happens after my physician prescribes the device?
Once your physician determines that you would benefit from bone growth therapy, they will provide Orthofix with a written prescription and other necessary information required by your insurance provider. Orthofix will then work with your insurer to determine coverage before you receive the device. This process may take several days or weeks.

What is Medical Necessity?
Health insurers, including Medicare, typically cover only those items and services that are deemed reasonable and necessary for treating specific medical conditions. To determine medical necessity, health insurers require providers such as Orthofix to provide information about your diagnosis.

Will my insurance company pay for the device?
The bone growth therapy device, including AccelStimTM, is accepted and approved by the majority of private and public health plans, including Medicare, Medicaid, and workers’ compensation plans. However, coverage may vary depending on your specific insurance plan.

Does Orthofix pre-authorize the device with my insurance company?
Orthofix will assist you in determining coverage by your health plan before you receive the device, in accordance with your patient benefit plan.

Is there financial responsibility for patients?
Even if the bone growth therapy device is considered medically necessary and covered by insurance, some health insurers may require patients to pay a portion of the cost. This could include a deductible, co-payment, or other coinsurance amount. The specific coinsurance amount varies depending on your insurer.

Can I pay my patient responsibility (coinsurance/deductible) online?
If your insurance has determined that you have a coinsurance or deductible, you will receive a bill with instructions for payment. You can visit BoneGrowthTherapy.com or contact a Patient Services Representative at 1-800-535-4492 for additional details on making payments. Please consult with your healthcare provider and insurance company for specific information regarding coverage and financial responsibility.

Coverage Information

Your physician has prescribed bone growth therapy, commonly known as bone growth stimulation, to improve your opportunity for a successful fusion or bone fracture healing. Bone growth therapy is a safe, non-surgical treatment that uses Low-Intensity Pulsed Ultrasound (LIPUS) to activate the body’s natural healing process that may be impaired. You have the assurance of knowing that the Orthofix Bone Growth Therapy devices are FDA-approved and widely accepted by health care professionals. However, insurance coverage is complex and can vary widely with individual policies. For patients whose insurance provider may not fully cover these devices or for patients without insurance, this brochure describes Orthofix billing practices, which are based on insurance and government requirements.

What happens after my physician prescribes the device?
After your physician determines that you would benefit from bone growth therapy, he or she provides Orthofix with a written prescription and other information required by your insurance provider to determine whether the device is covered under your plan. Orthofix then works with your insurer to determine coverage before you receive the device. This process can take a few days or even several weeks.

What is “Medical Necessity?”
Health insurers, including Medicare, typically cover only those items and services which are determined by their policy to be “reasonable and necessary” for treating specific medical conditions. To determine medical necessity, health insurers require providers such as Orthofix to provide information about your diagnosis to determine whether the device is covered by your insurance plan.

Will my insurance company pay for the device?
Insurance policies are different depending on the plan you have chosen. If guidelines are met, the bone growth therapy device is accepted and approved by the majority of private and public health plans, including Medicare, Medicaid and workers’ compensation plans.

Does Orthofix pre-authorize the bone growth therapy device with my insurance company?
In accordance with the patient’s benefit plan, Orthofix will assist you in determining coverage by your health plan before you receive the device.

Is there financial responsibility for patients?
Even if an item is considered medically necessary and, therefore, covered by insurance, some health insurers require you to pay a portion of the cost. These costs could include a deductible, co-payment or other coinsurance amount. For Medicare patients, the coinsurance amount for a bone growth therapy device is generally 20% of the Medicare allowable amount. For patients with other health insurance, the coinsurance amount varies by insurer.

Can I pay my patient responsibility (coinsurance/deductible) online?
Yes. If your insurance has determined that you have a coinsurance/deductible, you will receive a bill with instructions for payment. Please visit BoneGrowthTherapy.com or contact a Patient Services Representative at 1-800-535-4492 for additional details.

For Medicare patients, what is an “ABN?”
An ABN is an Advance Beneficiary Notice of Noncoverage for Medicare patients. This document gives patients advance notice that Medicare may not pay for the item prescribed by the physician for their condition. The ABN informs you of your financial responsibility if you choose to receive the device. If an ABN is required for your specific situation, you will be asked to sign it before you receive the bone growth therapy device.

What if I don’t have insurance?
Please contact our Patient Service Representatives at 1-800-535-4492 to discuss payment options. Orthofix also has a patient financial assistance program for people who demonstrate financial need based on established guidelines.

Is financial assistance available?
Patients with balances due resulting from limited or no insurance coverage may qualify for our patient financial assistance program. Upon request, an Orthofix Patient Service Representative will work with you to establish a payment plan or use established guidelines to assess your eligibility for a financial hardship waiver or reduction of the amount owed. If eligible, patients are required to complete a financial hardship application and return the signed application to Orthofix.

Can Orthofix waive my financial obligation?
Orthofix is required by law to collect a patient’s coinsurance or other amount owed for the bone growth therapy device. Under specific and limited circumstances, such as when we have verified a patient’s financial hardship, Orthofix may reduce a patient’s financial obligation for the device.

Who do I call if I have any questions?
Orthofix Patient Service Representatives are trained to answer your financial questions. For more information, please call 1-800-535-4492.

Guarantee Program
Orthofix Bone Growth Therapy is prescribed with a Guarantee Program which provides that if healing is not shown, then, as described in the terms and conditions below, either the fee paid for the unit will be refunded to the payer(s) of record** or, at the direction of the originally prescribing physician, a one-time replacement unit can be provided. This permits physicians to prescribe and insurance providers to approve our bone growth therapy devices with confidence, and most importantly, to assure our patients will have the maximum opportunity to heal. Subject to eligibility requirement.

Brief Prescribing Information

The AccelStimTM device is indicated for the non-invasive treatment of established nonunions excluding skull and vertebra, and for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature adult individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. There are no known contraindications for the AccelStim device. For all products, full prescribing can be found in product labeling on our patient education website BoneGrowthTherapy.com or by calling Patient Services at 1-800-535-4492.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Orthofix.com BoneGrowthTherapy.com
P/N 20126756 Rev. AB 2022-02-14 AS-2109 © Orthofix US LLC 02/2022

References

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