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Clinical Policy Bulletin:
NeuroControl Freehand System
Number: 0378


Policy

  1. Aetna considers the NeuroControl Freehand System medically necessary for members with paralyzed hand(s) who meet all of the following criteria:

    1. Member must have use of their shoulder, upper arm and elbow; and
    2. Member must have adequate range of motion with forearm and hand muscles that respond to stimulation with electrical impulses; and

    3. Neurological stability is established by means of serial neurological examinations over a period of 3 to 6 months that do not show progression of signs and symptoms referable to the area of injury, or serial imaging of the spine that excludes the presence of a progressive lesion.

  2. Aetna considers the NeuroControl Freehand System for members not meeting the afore-mentioned criteria experimental and investigational.



Background

The NeuroControl Freehand System is a surgically implanted device that restores hand function in people with quadriplegia by neuroelectric stimulation of forearm and hand muscles.

The NeuroControl Freehand System involves transfers of multiple tendons together with the implantation of up to eight electrodes in the muscles of the forearm and hand of patients with quadriplegia (Johnson and Whitworth, 2002).  The electrode wires are tunneled up the arm to a control box located under the skin in the pectoral region.  A movement detector is placed externally on the opposite shoulder.  When the patient elevates and depresses or protracts and retracts this shoulder the movement is relayed to the control box, which is programmed to coordinate the activity in the electrodes and cause the hand to open and close.  The NeuroControl Freehand System allows for 2 different hand grasp positions.  The lateral prehension grasp (key pinch) is designed to help with activities such as writing, editing, and grasping small objects.  The palmar prehension grasp is designed to help people hold and release a large object, such as a cup, ball, or book.

Appropriate candidates for the NeuroControl Freehand System must have use of their shoulder, upper arm, and elbow; they may or may not have use of their wrist, and limited use of their hands.  The patient must have adequate range of motion with forearm and hand muscles that respond to stimulation with electrical impulses.  The person must be skeletally mature.  Medically, these patients have injuries at the C5 and/or C6 level.  It is also recommended that neurological stability be established.  This can be done by means of serial neurological examinations over a period of 3 to 6 months, which fail to show progression of signs and symptoms referable to the area of injury or imaging of the spine that excludes the presence of a progressive lesion.
 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
64565
64580
Other CPT codes related to the CPB:
24301, 25310 - 25312, 25316, 26480 - 26498, 26510, 27098, 27400, 27690 - 27692
HCPCS codes covered if selection criteria are met:
C1767 Generator, neurostimulator (implantable), non-rechargeable
C1778 Lead, neurostimulator (implantable)
L8680 Implantable neurostimulator electrode, each
L8682 Implantable neurostimulator radiofrequency receiver
L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686 Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension
L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688 Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension
L8689 External recharging system for battery (internal) for use with implantable neurostimulator
L8695 External recharging system for battery (external) for use with implantable neurostimulator
ICD-9 codes covered if selection criteria are met:
344.04 Quadriplegia and quadriparesis, C5-C7 incomplete
344.2 Dilpegia of upper limbs
344.40 - 344.42 Monoplegia of upper limb


The above policy is based on the following references:
  1. Stroh Wuolle K, Van Doren CL, Bryden AM, et al. Satisfaction with and usage of a hand neuroprosthesis. Arch Phys Med Rehabil. 1999;80:206-213.
  2. Kilgore KL, Peckham PH, Keith MW, et al. An implanted upper-extremity neuroprosthesis. J Bone Joint Surg Am. 1997;79A(4):533-541.
  3. Mulcahey MJ, Betz RR, Smith BT, et al. Implanted functional electrical stimulation hand system in adolescents with spinal injuries: An evaluation. Arch Phys Med Rehabil. 1997;78:597-607.
  4. Keith MW, Kilgore KL, Peckham PH, et al. Tendon transfers and functional electrical stimulation for restoration of hand function in spinal cord injury. J Hand Surg [Am]. 1996;21(1):89-99.
  5. Wijman CA, Stroh C, Van Doren CL, et al. Functional evaluation of quadriplegic patients using a hand neuroprosthesis. Arch Phys Med Rehabil. 1990;71:1057-1063.
  6. Keith MW, Peckham PH, Thrope GB, et al. Implantable functional neuromuscular stimulation in the paralyzed upper extremity. J Hand Surg [Am]. 1989;14(3):524-530.
  7. Keith MW, Peckham PH, Thrope GB, et al. Functional neuromuscular stimulation neuroprostheses for the tetraplegic hand. Clin Orthop. 1988;233:25-33.
  8. Peckham PH, Keith MW, Freehafer AA. Restoration of functional control by electrical stimulation in the upper extremity of the quadriplegic patient. J Bone Joint Surg Am. 1988;70 (1):144-148.
  9. Hobby J, Taylor PN, Esnouf J. Restoration of tetraplegic hand function by use of the neurocontrol freehand system. J Hand Surg [Br]. 2001;26(5):459-464.
  10. Taylor P, Esnouf J, Hobby J. Pattern of use and user satisfaction of Neuro Control Freehand system. Spinal Cord. 2001;39(3):156-160.
  11. Johnson D, Whitworth H. Recent developments in plastic surgery. Br Med J. 2002;325:319-322.
  12. Taylor P, Esnouf J, Hobby J. The functional impact of the Freehand System on tetraplegic hand function. Clinical Results. Spinal Cord. 2002;40(11):560-566.
  13. NeuroControl Corporation. The Freehand System [website]. Cleveland, OH: NeuroControl Corp.; 2004. Available at: http://remote-ability.com/unique/freehand.htm. Accessed June 14, 2004.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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