Percutaneous Electrical Nerve Stimulation, Percutaneous Neuromodulation Therapy, and Restorative Neurostimulation Therapy

POLICY NUMBER

A.7.01.29

DESCRIPTION

Percutaneous electrical nerve stimulation, percutaneous neuromodulation therapy, and restorative neurostimulation therapy (ReActiv8) combine the features of electroacupuncture and transcutaneous electrical nerve stimulation. Percutaneous electrical nerve stimulation is performed with needle electrodes while percutaneous neuromodulation therapy uses very fine needle-like electrode arrays placed near the painful area to stimulate peripheral sensory nerves in the soft tissue. ReActiv8 is an implantable electrical neurostimulation system that stimulates the nerves that innervate the lumbar multifidus muscles.

Chronic Pain

A variety of chronic musculoskeletal or neuropathic pain conditions, including low back pain, neck pain, diabetic neuropathy, chronic headache, and surface hyperalgesia, present a substantial burden to patients, adversely affecting function and quality of life. 

TreatmentThese chronic pain conditions have typically failed other treatments, and percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) have been evaluated as treatments to relieve unremitting pain.

Percutaneous electrical nerve stimulation is similar in concept to transcutaneous electrical nerve stimulation (TENS), but differs in that needles are inserted either around or immediately adjacent to the nerves serving the painful area and are then stimulated. Percutaneous electrical nerve stimulation is generally reserved for patients who fail to get pain relief from transcutaneous electrical nerve stimulation. Percutaneous electrical nerve stimulation is also distinguished from acupuncture with electrical stimulation. In electrical acupuncture, needles are also inserted just below the skin, but the placement of needles is based on specific theories regarding energy flow throughout the human body. In percutaneous electrical nerve stimulation, the location of stimulation is determined by proximity to the pain.

Percutaneous neuromodulation therapy is a variant of percutaneous electrical nerve stimulation in which fine filament electrode arrays are placed near the area causing pain. Some use the terms percutaneous electrical nerve stimulation and percutaneous neuromodulation therapy interchangeably. It is proposed that percutaneous neuromodulation therapy inhibits pain transmission by creating an electrical field that hyperpolarizes C fibers, thus preventing action potential propagation along the pain pathway.

Restorative neuromodulation therapy (ReActiv8) uses an implanted device to deliver electrical stimulation to the nerves controlling the multifidus muscles of the lumbar spine. It is proposed that restorative neuromodulation reduces pain by triggering contractions of the multifidus muscles to restore neuromuscular control and help stabilize the spine. It is intended for individuals with intractable chronic low back pain associated with multifidus dysfunction for whom available low back pain treatments do not provide sufficient or durable symptom relief.

In 2002, the Percutaneous Neuromodulation Therapy^TM (Vertis Neuroscience) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The labeled indication is: "... for the symptomatic relief and management of chronic or intractable pain and/or as an adjunctive treatment in the management of post-surgical pain and post-trauma pain."

In 2006, the Deepwave® Percutaneous Neuromodulation Pain Therapy System (Biowave) was cleared for marketing by the FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to the Vertis neuromodulation system and a Biowave neuromodulation therapy unit. The Deepwave® system includes a sterile single-use percutaneous electrode array that contains 1,014 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.

In 2020, the ReActiv8 (Mainstay Medical) was FDA approved through the Premarket Approval (PMA) process (PMA P190021) for individuals with intractable chronic low back pain associated with multifidus dysfunction for whom available low back pain treatments do not provide sufficient or durable symptom relief.

See separate policy for Transcutaneous Electrical Nerve Stimulator (TENS) .

POLICY

Percutaneous electrical neurostimulation is considered investigational.

Percutaneous neuromodulation therapy is considered investigational.

Restorative neurostimulation therapy (ReActiv8) is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all devices approved by the FDA may not be considered investigational. Therefore, FDA-approved devices may be assessed on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

7/1993: Approved by Medical Policy Advisory Committee (MPAC).

4/5/2001: Policy reviewed; Policy Exceptions updated, Managed Care Requirements deleted, Sources updated.

8/2001: TENS reviewed by MPAC.

2/14/2002: Investigational definition added.

3/6/2002: Individual consideration requirement deleted.

5/2/2002: Type of Service and Place of Service deleted.

1/20/2004: Code Reference section updated.

3/9/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy.

10/3/2006: Policy updated. Changed to investigational. ICD-9 diagnosis codes 723.1, 724.1, 724.2, 724.3, 724.4, 724.5 deleted from policy.

11/9/2006: HCPC codes: E0752 and L8680 deleted from policy. CPT code 64999 added to policy.

1/8/2009: Policy reviewed, no changes.

4/27/2010: Policy Description section revised to add Deepwave® system. FEP verbiage was added to the Policy Exceptions section. Removed outdated sources. Policy statement unchanged. 

07/29/2011: Policy reviewed; no changes.

11/10/2011: Policy reviewed; no changes.

09/27/2012: Policy reviewed; no changes.

10/22/2013: Policy reviewed; no changes.

08/27/2014: Policy reviewed; description updated. Policy statement unchanged.

08/04/2015: Code Reference section updated for ICD-10.

11/02/2015: Policy reviewed. Policy statement unchanged. Investigative definition updated in policy guidelines section.

05/31/2016: Policy number A.7.01.29 added.

03/28/2017: Policy description updated regarding the use of PENS and PNT for chronic pain conditions. Policy statement updated to change "neuromodulation" to "percutaneous neuromodulation therapy."

05/29/2018: Medical policy link updated in policy description.

07/18/2018: Policy description updated. Policy statement unchanged.

07/16/2019: Policy reviewed; no changes.

07/15/2020: Policy reviewed; no changes.

08/26/2021: Policy reviewed; no changes.

06/27/2022: Code Reference section updated to add new CPT code 0720T, effective 07/01/2022.

08/23/2022: Policy description updated regarding racial and ethnic groups at risk of developing diabetes. Policy statement unchanged.

08/25/2023: Policy title changed from "Percutaneous Electrical Nerve Stimulation and Percutaneous Neuromodulation Therapy" to "Percutaneous Electrical Nerve Stimulation, Percutaneous Neuromodulation Therapy, and Restorative Neurostimulation Therapy." Policy description updated regarding devices. Policy statements separated for clarity. Added statement that restorative neurostimulation therapy (ReActiv8) is considered investigational.

03/27/2024: Code Reference section updated to add new HCPCS codes A4593 and A4594, effective 04/01/2024.

07/24/2024: Policy reviewed; no changes.

08/25/2025: Policy description updated regarding chronic pain and restorative neuromodulation therapy. Policy statements unchanged.

01/01/2026: Code Reference section updated to add new CPT code 64567.

SOURCE(S)

Blue Cross & Blue Shield Association policy # 7.01.29

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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