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DESCRIPTIONPercutaneous electrical nerve stimulation is a therapy that combines the features of electroacupuncture and transcutaneous electrical nerve stimulation (TENS). PENS therapy uses fine needle-like electrodes that are placed in close proximity to the painful area and stimulate peripheral sensory nerves in the soft tissue.
PENS is used to relieve pain and is essentially the same as TENS but differs in that needles are inserted to a depth of 1 to 4 cm either around or immediately adjacent to the nerve serving the painful area and then stimulated. PENS is generally reserved for patients who fail to get pain relief from TENS, apparently due to obvious physical barriers to the conduction of the electrical stimulation (e.g. scar tissue, obesity). PENS must be 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. Thus 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 electrodes are temporarily placed at specific anatomical landmarks in the deep tissues near the area of the spine that is causing pain (with or without radiating lower extremity pain). Treatment regimens consist of 30-minute sessions, once or twice a week for 8 to 10 sessions.
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 and 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 service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
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 an d 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.
SOURCE(S)Blue Cross & Blue Shield Association policy # 7.01.29
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.