Mountain State Medical Policy Bulletin
Section: Durable Medical Equipment
Number: E-46
Topic: BioniCare Stimulator System
Effective Date: January 1, 2006
Issued Date: January 2, 2006
Date Last Reviewed: 01/2006

General Policy Guidelines

Indications and Limitations of Coverage

The BioniCare Stimulator System (e.g., Bio-1000 System) is considered experimental/investigational and not eligible for reimbursement. A member can be billed for the denied service. Despite the fact that this device has received FDA approval, there is a lack of long-term studies demonstrating the efficacy of this device.

NOTE:
At this time, the device is supplied directly from the manufacturer, BioniCare Medical Technologies, Inc.

Description

The BioniCare Stimulator System is a noninvasive chondrogenesis stimulator that is worn outside of the body on the joint requiring treatment.

It is intended for use as:

  • an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee as assessed by the physician’s evaluation, and

  • an adjunctive therapy in reducing the level of pain and stiffness associated with pain from rheumatoid arthritis of the hand.

The BioniCare System consists of a battery-powered electronic stimulator device with electrical leads that are placed over the affected area and held in place with a lightweight, flexible wrap and Velcro fasteners. According to manufacturer information, the device delivers pulsed electrical currents that can stimulate regrowth of cartilage. It is recommended that the device be worn for at least six hours every day, usually at night, although it can be worn during the day.


NOTE:
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Procedure Codes

E0762     

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient’s condition. The BioniCare Stimulator System is considered an eligible service when determined medically necessary based on the patient’s condition.

Also refer to General Policy Guidelines

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

PRN References

02/2005, BioniCare

References

The Treatment of Osteoarthritis of the Knee with Pulsed Electrical Stimulation, The Journal of Rheumatology, 1995; 22(9): 1757-61

The Treatment of Rheumatoid Arthritis of the Hand with Pulsed Electrical Fields, Electricity and Magnetism in Biology and Medicine, 1999, 939-942

BioniCare BIO-1000 Stimulator Review, TEC-Medical Policy Clearinghouse News, 10/15/2004

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[Version 001 of E-46]

Table Attachment

Text Attachment

Procedure Code Attachment


Glossary




This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Mountain State Blue Cross Blue Shield plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Mountain State Blue Cross Blue Shield (MSBCBS) retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of MSBCBS. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.