Surgery Section - Percutaneous Neuromodulation Therapy (PNT)

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

Description

Percutaneous neuromodulation therapy is an electrical stimulation therapy in which ten fine filament electrodes are temporarily placed at specific anatomical landmarks in the back.  Treatment regimens consist of 30-minute sessions, once or twice a week for eight to ten sessions. PNT differs from percutaneous electrical nerve stimulation (PENS) in the varying length of the needles and its placement at specific anatomical landmarks, instead of specifically at the site of pain.

Percutaneous Neuromodulation Therapy™ (Vertis Neurosciences) received approval to market by the U.S. Food and Drug Administration (FDA) through the 510(k) process in 2002. The labeled indications reads as follows:

“Percutaneous neuromodulation therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable pain and/or as an adjunct treatment in the management of post-surgical pain and post-trauma pain.”

The Deepwave Percutaneous Neuromodulation Pain Therapy System (Biowave) received 510(k) approval in 2006, listing the Vertis Neuromodulation system and a Biowave TENS unit as predicate devices. The Deepwave system includes a sterile single-use percutaneous electrode array that contains 1014 microneedles in a 1.5 inch diameter area. The needles are 736 microns (0.736 millimeters) in length; the patch is reported to feel like sandpaper or Velcro.

Policy/Criteria

Percutaneous neuromodulation therapy (PNT) is considered investigational.

Scientific Background

Percutaneous Neuromodulation Therapy (PNT)

A literature search identified one abstract focusing on neuromodulation. This study was an uncontrolled case series of 83 patients with low back pain. While pain improved at 5-week follow-up, the lack of a control group precludes scientific assessment. (2)  Two additional earlier abstracts describe studies examining the importance of electrode placement for effective neuromodulation therapy.  These preliminary reports do not offer data on outcomes in pain management. (3,4)

Updated searches of the literature through December 15, 2008 did not return any new clinical studies on percutaneous neuromodulation therapy.

References

1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 7.01.29
2. Condon JE, Borg-Stein J, Revord J et al. A multicenter trial of percutaneous neuromodulation therapy for low back pain patients with a subacute duration of lower extremity pan. Presented at the American Academy of Pain Medicine Annual Meeting. San Francisco, CA, March 1, 2002
3. White PF, Ghoname EA, Ahmed HE et al. The effect of montage on the analgesic response to percutaneous neuromodulation therapy. Anesth Analg 2001;92(2):483-7
4. White PF, Craig WF, Vakharia AS et al. Percutaneous neuromodulation therapy: does the location of electrical stimulation effect the acute analgesic response? Anesth Analg 2000;91(4):949-54

Cross References

Electrical Stimulation Devices for Home Use, Regence Medical Policy Manual, DME, Policy No. 11

Threshold Electrical Stimulation as a Treatment of Motor Disorders, Regence Medical Policy Manual, DME, Policy No. 57

Sympathetic Therapy for the Treatment of Pain, Regence Medical Policy Manual, DME, Policy No. 65

Interferential Stimulation, Regence Medical Policy Manual, DME, Policy No. 66

Electrical Stimulation for the Treatment of Arthritis, Regence Medical Policy Manual, DME, Policy No. 70

Spinal Cord Stimulation for Treatment of Pain, Regence Medical Policy Manual, Surgery, Policy No. 45

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