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DESCRIPTIONPercutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) are therapies that combine the features of electroacupuncture and transcutaneous electrical nerve stimulation (TENS). PENS is performed with a few needle electrodes while PNT uses very fine needle-like electrode arrays that are placed in close proximity to the painful area to stimulate peripheral sensory nerves in the soft tissue.
PENS is similar in concept to TENS, but differs in that needles are inserted either around or immediately adjacent to the nerves serving the painful area and are then stimulated. PENS is generally reserved for patients who fail to get pain relief from TENS. PENS 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 PENS, the location of stimulation is determined by proximity to the pain rather than the theories of energy flow that guide placement of stimulation for acupuncture.
Percutaneous neuromodulation therapy is a variant of PENS in which fine filament electrode arrays are placed near the area that is causing pain. Some use the terms PENS and PNT interchangeably. It is proposed that PNT inhibits pain transmission by creating an electrical field that hyperpolarizes C-fibers, thus preventing action potential propagation along the pain pathway.
Percutaneous Neuromodulation TherapyTM (Vertis Neurosciences) received approval to market by the U.S. Food and Drug Administration (FDA) through the 510(k) process in 2002. The labeled indication reads as follows, "Percutaneous neuromodulation therapy (PNT) is indicated 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." 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 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.
See separate policy for Transcutaneous Electrical Nerve Stimulator (TENS)
POLICYPercutaneous electrical neurostimulation or neuromodulation is considered investigational.
POLICY EXCEPTIONSFederal 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.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/1993: 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 added.
SOURCE(S)Blue Cross & Blue Shield Association policy # 7.01.29
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.