Electrical Stimulation Devices

Number 1.01.507*

Effective Date February 11, 2013

Revision Date(s) 02/11/13; 03/13/12; 06/13/11; 06/08/10; 08/11/09; 05/13/08; 06/12/07; 07/11/06; 09/13/05; 02/08/05; 12/14/04; 09/14/04; 07/13/04; 06/08/04; 01/13/04; 10/16/03; 05/13/03; 04/15/03; 09/10/02

Replaces 1.01.09; 1.01.504; and 1.04.03

*Medicare has a policy.


Eligible Services

The use of TENS (CPT 64550) in the treatment of both acute postoperative pain and of chronic intractable musculoskeletal pain may be considered medically necessary.

A conductive garment (E0731) used with a TENS unit may be considered medically necessary when the patient has a skin condition (i.e., rash, allergy or irritation) that prevents the use of conventional electrodes.

Neuromuscular electrical stimulators (open loop system) (including but not limited to the RS 4m and RS 2m) may be considered medically necessary for disuse atrophy when the nerve supply to the muscle is intact and the patient has any of the following non-neurological reasons for disuse atrophy:

  • Previous casting or splinting of a limb
  • Contractures due to burn scarring or recent hip replacement surgery (up until the time physical therapy begins)
  • Previous major knee surgery, when there is a failure to respond to physical therapy.

NOTE: Functional neuromuscular electrical stimulators (closed loop systems) are addressed in a separate policy. (See Related Policies)

Services Not Eligible for Reimbursement

The use of TENS in the treatment of chronic headache, temporomandibular joint dysfunction (TMJ), abdominal pain, pelvic pain, and dementia is considered investigational.

Transcutaneous electrical modulation pain reprocessing (scrambler therapy) (0278T) is considered investigational.

Galvanic stimulation is considered investigational in the treatment of chronic pain.

Microcurrent Stimulation Devices are considered investigational.

Sympathetic Stimulation Devices are considered investigational.

Neuromuscular electrical stimulators (NMES) are considered investigational when used for general muscle strengthening in healthy individuals, for cardiac conditioning, or for the treatment of denervated muscles.

Related Policies


Interferential Current Stimulation


Electrical Stimulation for the Treatment of Arthritis


Electrostimulation and Electromagnetic Therapy for Treating Wounds


Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT)


Occipital Nerve Stimulation


Gastric Electrical Stimulation


Spinal Cord Stimulation


Posterior Tibial Nerve Stimulation (PTNS) for Voiding Dysfunction


Cranial Electrotherapy Stimulation (CES) and Auricular Electrostimulation


Functional Neuromuscular Electrical Stimulation

Policy Guidelines

Effective January 1, 2012 there is a specific category III temporary CPT code for scrambler therapy:

0278T Transcutaneous electrical modulation pain reprocessing (e.g., scrambler therapy), each treatment session (includes placement of electrodes)


Transcutaneous Electrical Nerve Stimulation Devices (TENS)

Transcutaneous electrical nerve stimulator (TENS) describes the application of electrical stimulation to the surface of the skin at the site of pain. TENS may be applied in a variety of settings (in the patient’s home, a physician’s office, or in an outpatient clinic).


TENS has been used to treat chronic intractable pain, post-surgical pain, and pain associated with active or post-trauma injury unresponsive to other standard pain therapies. TENS has also been used to treat dementia by altering neurotransmitter activity and increasing brain activity which is thought to reduce neural degeneration and stimulate regenerative processes. Percutaneous electrical nerve stimulation (PENS) is similar to TENS but uses microneedles that penetrate the skin instead of surface electrodes. PENS is addressed in a separate policy. Interferential stimulation uses a modulated waveform for deeper tissue stimulation and is believed to improve blood flow to the affected area. Interferential stimulation is addressed in a separate policy.

Regulatory Status

TENS devices consists of an electrical pulse generator, usually battery operated, connected by wire to two or more electrodes, which are applied to the surface of the skin at the site of the pain. Since 1977, a large number of devices have received marketing clearance through the U.S. Food and Drug Administration (FDA) 501(k) process. Marketing clearance via the 510(k) process does not require data regarding clinical efficacy; these devices are considered substantially equivalent to predicate devices marketed in interstate commerce prior to May 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified and do not require approval of a premarket approval application (PMA).

Neuromuscular Electrical Stimulation Devices (NMES)

These devices, through multiple channels, attempt to stimulate motor nerves and alternately causes contraction and relaxation of muscles, unlike a TENS device which is intended to alter the perception of pain. NMES are used to prevent or retard disuse atrophy, relax muscle spasm, increase blood circulation, maintain or increase range of motion, and re-educate muscles.

This policy address the use of open loop neuromuscular systems which are used for simple tasks such as muscle strengthening alone, and typically in healthy individuals with intact neural control.

Functional neuromuscular stimulators are closed loop systems, which provide feedback information on muscle force and joint position, thus allowing constant modification of stimulation parameters which are required for complex activities such as walking. (These are addressed in a separate policy, see Related Policies)

The RS 4m and RS 2m muscle stimulator are examples of devices that delivers neuromuscular electric stimulation.

Transcutaneous Electrical Modulation Pain Reprocessing (TEMPR) (CPT 0278T)

Scrambler Therapy/Calmare® device is also known as transcutaneous electrical modulation pain reprocessing (TEMPR). It is an electrocutaneous nerve stimulation device. It uses a biophysical rather than a biochemical approach. A “no-pain” message is transmitted to the nerve via disposable surface electrodes applied to the skin in the region of the patient’s pain. The perception of pain is cancelled when the no-pain message replaces that of pain, by using the same pathway through the surface electrodes in a non-invasive way. Regardless of pain intensity, a patient’s pain can be completely removed for immediate relief. Maximum benefit is achieved through follow-up treatments. The patient may be able to go for extended periods of time between subsequent treatments while experiencing significant pain control and relief. The period of time between treatments depends on the underlying cause and severity of the pain in addition to other factors. Treatment utilizing the Calmare® medical device is restricted to allopathic physicians and other qualified licensed healthcare professionals under their direct supervision who are certified in its use and application and are familiar with the principles, clinical applications, side effects and hazards associated with transdermal pain modulation. Calmare® Pain Therapy Medical Device is U.S. FDA 510(k)-cleared and European CE mark-certified for the treatment of oncologic and neuropathic pain through biophysical stimulation. The Device has five separate channels, convenient dial selectors with five corresponding channel meters, indicator lights and an LCD display to monitor operation.

Galvanic Stimulation Devices

Galvanic stimulation is characterized by high voltage, pulsed stimulation and is used primarily for local edema reduction through muscle pumping and polarity effect. Edema is comprised of negatively charged plasma proteins, which leak into the interstitial space. The theory of galvanic stimulation is that by placing a negative electrode over the edematous site and a positive electrode at a distant site, the monophasic high voltage stimulus applies an electrical potential which disperses the negatively charged proteins away from the edematous site, thereby helping to reduce edema.

Microcurrent Stimulation Devices (MENS)

MENS is characterized by subsensory current that acts on the body’s naturally occurring electrical impulses in an effort to decrease pain and facilitate the healing process. MENS differs from TENs in that it uses a significantly reduced level of electrical stimulation. TENS blocks pain, while MENS acts on the naturally occurring electrical impulses to decrease pain by stimulating the healing process.

Sympathetic Stimulation Devices

Sympathetic therapy describes a type of electrical stimulation of the peripheral nerves that is designed to stimulate the sympathetic nervous system in an effort to “normalize” the autonomic nervous system and alleviate chronic pain. Unlike TENS or interferential electrical stimulation, sympathetic therapy is not designed to treat local pain, but is designed to induce a systemic effect on sympathetically induced pain.

Sympathetic therapy uses four intersecting channels of various frequencies with bilateral electrode placement on the feet, legs, arms, and hands. Based on the location of the patient’s pain and treatment protocols supplied by the manufacturers, electrodes are placed in various locations on the lower legs and feet or the hands and arms. Electrical current is then induced with beat frequencies between 0 and 1000Hz. Treatment may include daily one-hour treatments in the physician’s office, followed by home treatments if the initial treatment is effective.


Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply.

Benefit Application



2004 Update

Transcutaneous Electrical Nerve Stimulation Devices (TENS)

In a 2003 Cochrane Review, Cameron, Lonergan, and Lee reviewed the use of TENS for treatment of dementia. The authors concluded that there was inadequate evidence to draw any conclusions as to the effects of TENS on dementia.

In a 2004 Cochrane Review, Bronfort and colleagues reviewed the use of TENS for treatment of chronic/recurrent headache. The authors concluded that there was only weak evidence that TENS was an effective treatment for migraine or chronic, tension-type headache.

Medicare Coverage Policy Position – TENS

The Centers for Medicare and Medicaid Services (CMS) currently has the following national coverage policy on TENS:

160.7.1 Assessing Patient’s Suitability for Electrical Nerve Stimulation Therapy

“Electrical nerve stimulation is an accepted modality for assessing a patient’s suitability for ongoing treatment with a transcutaneous or an implanted nerve stimulator. Accordingly, program payment may be made for the following techniques when used to determine the potential therapeutic usefulness of an electrical nerve stimulator:

Transcutaneous Electrical Nerve Stimulation (TENS) — This technique involves attachment of a transcutaneous nerve stimulator to the surface of the skin over the peripheral nerve to be monitored by the physician, or physical therapist. Generally, the physician or physical therapist is able to determine whether the patient is likely to derive a significant therapeutic benefit from continuous use of a transcutaneous stimulator within a trial period of 1 month; in a few cases this determination may take longer to make. Document the medical necessity for such services which are furnished beyond the first month. (see §45-25 for an explanation of coverage of medically necessary supplies for the effective use of TENS.)”

The above Medicare policy appears to be based on physician acceptance rather than an evidence-based analysis.

Sympathetic Therapy

Ideally, assessment of therapies designed to treat chronic pain should be based on placebo-controlled trials to assess the magnitude of the expected placebo effect and to isolate the contribution of the active treatment. Outcomes of interest might include changes in scores of a visual analog scale, quality of life measures such as an SF-36, reduction in pain medications, daily activity levels, or return to work. However, a MEDLINE search did not identify any studies published in the peer-reviewed literature regarding sympathetic therapy.

2006 Update


A search of the MEDLINE database for the period of April 2005 through December 2006 identified a number of publications on the use of TENS for acute and chronic pain syndromes. TENS continues to be an active and controversial topic of research.

One recent double-blind randomized study compared 10 days of TENS with sham TENS on pain intensity and willingness to continue treatment in 163 patients with chronic pain of various etiologies. (17) More patients were willing to continue treatment in the TENS group (58%) than in the sham TENS group (42.7%). Although pain intensity was significantly reduced over time for both groups, there was no difference in subjective pain scores between patients treated with TENS or sham controls. The authors noted that this discrepancy may be due to the fixed reporting time for the daily visual analog score (VAS), which might not reflect the patient’s experience during the treatment period. The significant improvement in the chronic-pain control group suggests a large placebo component for this treatment.

Several recent randomized studies suggest that TENS may alleviate acute pain. For example, 1 double-blind randomized sham-controlled trial found that during emergency transport of 101 patients, TENS reduced post-traumatic hip pain with a change in VAS from 89 to 59, whereas the sham-stimulated group remained relatively unchanged (86 to 79). Additional studies confirming these results are needed.

Eleven different Cochrane reviews have evaluated TENS over the past 6 years. One review found TENS and acupuncture like TENS to be effective for the treatment of knee osteoarthritis based on 7 mixed quality controlled trials; treatment duration (greater than 4 weeks) was found to be critical. Another review of 9 small controlled trials concluded that high frequency TENS is effective for the treatment of dysmenorrhea. Other Cochrane updates have concluded that there is limited and inconsistent evidence for the use of TENS as an isolated treatment for low back pain, and that results in patients with rheumatoid arthritis of the hand are conflicting. Efficacy of TENS for chronic pain, neck pain, headache, shoulder pain after stroke, and dementia were considered inconclusive in 4 other Cochrane reviews.

Results on the efficacy of TENS are mixed. This may be due to the wide variety of pain syndromes and treatment methods being examined. Two new systematic Cochrane reviews have been initiated to assess the use of TENS for cancer pain and acute pain. One of these will assess factors that may influence efficacy, such as the type of pain, the type of TENS used, duration of treatment, and whether the study measures acute or chronic outcomes.

2007 Update

A search of the MEDLINE database for the period of April 2005 through May 2007 retrieved no published studies on sympathetic therapy. Updated guidelines from the Work Loss Data Institute list sympathetic therapy as an intervention that is currently under study and not specifically recommended. Therefore, the policy is unchanged.

2009 Update


One double-blind randomized, sham-controlled trial found that during emergency transport of 101 patients, TENS reduced post-traumatic hip pain with a change in visual analog scale (VAS) from 89 to 59, whereas the sham-stimulated group remained relatively unchanged (86 to 79). (25) In another double-blind study, 40 patients undergoing inguinal herniorrhaphy were randomized to active or placebo TENS for post-surgical pain. (26) Pain scores measured prior to the first treatment were 5.2 on a 10 point scale for the active TENS group and 5.3 for the placebo TENS group. Two 30-minute sessions of TENS at 2 and 4 hours after surgery reduced both analgesic use and pain scores measured up to 24 h after surgery (mean pain score of 0 vs. 3.4). Blinding appears to have been maintained, as 95% of subjects from both groups reported that they would use TENS again in the future to treat their pain.

Medicare has a positive coverage decision for TENS for acute postoperative care:

National Coverage Determination (NCD) for Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Post-Operative Pain (10.2)

Indications and Limitations of Coverage:

“The use of TENS for the relief of acute post-operative pain is covered under Medicare. TENS may be covered whether used as an adjunct to the use of drugs, or as an alternative to drugs, in the treatment of acute pain resulting from surgery.”

2010 Update

Dubinsky (2010) performed a systematic literature search through April 2009 on TENS and found there are conflicting reports of TENS compared to sham TENS in the treatment of chronic low back pain, with 2 Class II studies showing benefit but 2 Class I studies and another Class II study not showing benefit. Because the Class I studies are stronger evidence, TENS is established as ineffective for the treatment of chronic low back pain. TENS is probably effective in treating painful diabetic neuropathy. The author recommends further research into the mechanism of action of TENS.

2011 Update

Fuentes et al. (2010) performed a systematic review and meta-analysis in order to analyze information regarding the efficacy of Interferential Stimulation (IFS) in the management of musculoskeletal pain. A total of 2,235 articles were found. Twenty studies fulfilled the inclusion criteria. The authors concluded that IFS as a supplement to another intervention seems to be more effective for reducing pain than a control treatment at discharge and more effective than a placebo treatment at the 3-month follow-up. However, it is unknown whether the analgesic effect of IFS is superior to that of the concomitant interventions. IFS current alone was not significantly better than placebo or other therapy at discharge or follow-up.

2013 Update

A search of PubMed did not identify randomized controlled trials comparing transcutaneous electrical modulation pain reprocessing (e.g., scrambler therapy) with sham therapy. The literature consists of case series and comparison against pharmacologic treatment.


  1. TEC Assessment 1996: Tab 21. Transcutaneous or Percutaneous Electrical Nerve Stimulation in the treatment of chronic and postoperative pain.
  2. Centers for Medicare & Medicaid Services (CMS). Medicare Coverage Determinations Manual. Section 35-46: Assessing Patient’s Suitability for Electrical Nerve Stimulation Therapy. Last accessed January 4, 2013.
  3. Guido EH. Effects of sympathetic therapy on chronic pain in peripheral neuropathy subjects. Am J Pain Manage 2002; 12(1):31-4.
  4. Stevens JE, Mizner RL, Snyder-Mackler L. Neuromuscular electrical stimulation for quadriceps muscle strengthening after bilateral total knee arthroplasty. J Orthop Sports Phys Ther 2004; 34(1):21-29.
  5. Cameron M, Lonergan E, Lee H. Transcutaneous electrical nerve stimulation (TENS) for dementia. Cochrane Database Syst Rev 2003; (3):CD004021.
  6. Luipen MW, Swaab DF, Sergaent JE, et al. Effects of transcutaneous electrical nerve stimulation (TENS) on memory in elderly with mild cognitive impairment. Behav Brain Res 2005 March 30; 158(2):349-57.
  7. Work Loss Data Institute. Pain 2006; National Guideline Clearinghouse, Last accessed January 4, 2013.
  8. Oosterhof J, De Boo TM, Oostendorp RA, et al. Outcome of transcutaneous electrical nerve stimulation in chronic pain: short-term results of a double-blind, randomized, placebo-controlled trial. J Headache Pain 2006; 7(4):196-205.
  9. Lang T, Barker R, Steinlechner B, et al. TENS relieves acute posttraumatic hip pain during emergency transport. J Trauma 2007; 62(1):184-8.
  10. Osiri M, Welch V, Brosseau L, et al. Transcutaneous electrical nerve stimulation for knee osteoarthritis. Cochrane Database Syst Rev. 2000; (4):CD002823.
  11. Proctor ML, Smith CA, Farquhar CM, et al. Transcutaneous electrical nerve stimulation for primary dysmenorrhoea. Cochrane Database Syst Rev 2002; (1):CD002123.
  12. Khadilkar A, Milne S, Brosseau L, et al. Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain. Cochrane Database Syst Rev 2005; (3):CD003008.
  13. Brosseau L, Judd MG, Marchand S, et al. Transcutaneous electrical nerve stimulation (TENS) for the treatment of rheumatoid arthritis in the hand. Cochrane Database Syst Rev 2003; (3):CD004377.
  14. Reviewed by practicing orthopedic surgeon in May 2007.
  15. Lang T, Barker R, Steinlechner B et al. TENS relieves acute posttraumatic hip pain during emergency transport. J Trauma 2007; 62(1):184-8.
  16. DeSantana JM, Walsh DM, Vance C et al. Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain. Curr Rheumatol Rep 2008; 10(6):492-9.
  17. Dubinsky RM, Miyasaki J. Assessment: efficacy of transcutaneous electric nerve stimulation in the treatment of pain in neurologic disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2010 Jan 12;74(2):104-5.
  18. Hayes, Inc. Hayes Search & Summary. CALMARE® Pain Therapy Treatment. Lansdale, PA: Hayes, Inc.; February, 2012.







Application of surface (transcutaneous) neurostimulator



Percutaneous implantation of neurostimulator electrodes; cranial nerve



peripheral nerve (excludes sacral nerve)



Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling



Application of modality to one or more areas; electrical stimulation, unattended



Transcutaneous electrical modulation pain reprocessing (e.g., scrambler therapy), each treatment session (includes placement of electrodes)

ICD-9 Procedure


Implantation or replacement of peripheral neurostimulator lead(s)



Other incision of skin and subcutaneous tissue



Other physical therapy

ICD-9 Diagnosis




Transcutaneous electrical nerve stimulation (TENS) device, two lead, localized stimulation



Transcutaneous electrical nerve stimulation (TENS) device, four or more leads, for multiple nerve stimulation



Form fitting garment for delivery of TENS or NMES, with conductive fibers separated from the patient’s skin by layers of fabric



Neuromuscular stimulator, electronic shock unit



Functional electrical stimulator, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified



Durable medical equipment, miscellaneous (Determine if an alternative HCPCS Level II or a CPT code better describes the service being reported. This code should be used only if a more specific code is unavailable.)



Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of care



Implantable neurostimulator electrode, each



Interferential current stimulator, 2 channel



Interferential current stimulator, 4 channel

Type of Service

Durable Medical Equipment


Place of Service









Add to Durable Medical Equipment Section - New Policy. Replaces 1.01.13 H-Wave Electrical Stimulation; 1.01.104 (1.01.09) Transcutaneous Electrical Nerve Stimulator (TENS); 1.04.03 Sympathetic Therapy for the Treatment of Pain; 7.01.29 Percutaneous Electrical Nerve Stimulation (PENS)


Replace Policy - Policy reviewed with references added.


Replace Policy - Policy section revised for clarification only.


Replace Policy - Interferential Stimulation Devices description updated; references added. No change to policy statement.


Replace Policy - TMJ as investigational for TENS was added. This is consistent with TMJ policy.


Replace Policy - Policy reviewed; No change to policy statement.


Replace Policy - Description of PENS revised; information on percutaneous neuromodulation included; policy statement revised to indicate that percutaneous neuromodulation considered investigational. No change in policy statement regarding PENS.


Replace Policy - Policy renumbered from PR.1.01.107. No date changes.


Replace Policy - Policy statement revised by adding pulsed electrical stimulation with the BioniCare® to be considered investigational as a treatment for osteoarthritis. Rationale Section updated.


Replace Policy - Description of TENS revised; information on dementia added; reference added; Medicare policy language on TENS added. No change to policy statement.


Replace Policy - RS-4i Sequential Stimulator information added. No change to policy statement.


Update only to web - HCPCS codes added only—no other changes and not presented to MPC.


Replace Policy - Interferential Stimulation and PENS/ PNT added to Rationale section. References updated; no change to policy statement.


Codes updated - No other changes.


Update Scope and Disclaimer - No other changes.


Replace Policy - Update description to include detail of RS 4M and RS 2M muscle stimulators; no change to policy statement.


Cross Reference Update - No other changes.


Replace Policy - Policy updated with literature review; references added. No changes in policy statement. Reviewed by practicing orthopedic surgeon in May 2007.


Replace Policy - Policy updated with literature search. Policy statement was updated to include cranial electrostimulation therapy is considered investigational for all indications listed. The manufacturer provided many articles to be reviewed. Many of them were from the 1990s and earlier. Most of the later studies were not regarding the FDA approved labeled indications. Additional and much larger double-blinded, sham controlled studies are needed to document long-term effects of CES. References and code added to support the update.


Code Update - Code E0770 added, effective 1/1/09.


Replace Policy - Policy updated with literature search; references added. No change to policy statement.


Cross Reference Update - No other changes.


Replace Policy - Policy updated with literature search, reference added. Added medically necessary statement re: conductive garment and TENS/IF. Also included Flex IT to investigational statement.


Replace Policy - Policy updated with literature search, reference added. No change to policy statement.


HCPCS codes S8130 and S8131 added to policy.


CPT code 0278T added.


Replace policy. Policy revised by removing indications, descriptions, and rationale addressed in separate policies: 1.01.13, 1.01.24, 1.01.27, 7.01.29, and 8.01.58. Policy now addresses TENS, open loop neuromuscular electrical stimulation, galvanic, microcurrent, cranial electrostimulation and sympathetic electrical stimulation devices.


Related Policies updated; 7.01.546 added to replace 7.01.25 which has been deleted.


Update Related Policies – Change title for 7.01.106


Update Related Policies. Add 8.01.58.


Update Related Policy title for 2.01.57.


Replace policy. Removed information on cranial electrostimulation which is addressed in Medical Policy 8.01.58. Added policy statement on scrambler therapy.


Coding update. HCPCS code E0762 removed; this is addressed in policy No. 1.01.27, Electrical Stimulation for the Treatment of Arthritis. Remove Related Policy 1.01.19; it was archived effective 12/9/13.


Update Related Policies. Delete 7.01.106 and replace with 7.01.553.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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