MEDICAL POLICY

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Electrical Stimulation Devices

Number 1.01.507*

Effective Date June 9, 2014

Revision Date(s) 06/09/14; 05/12/14; 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.

Policy

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Eligible Services

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

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

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1.01.24

Interferential Current Stimulation

1.01.27

Electrical Stimulation for the Treatment of Arthritis

2.01.57

Electrostimulation and Electromagnetic Therapy for Treating Wounds

7.01.29

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

7.01.125

Occipital Nerve Stimulation

7.01.522

Gastric Electrical Stimulation

7.01.546

Spinal Cord Stimulation

7.01.553

Posterior Tibial Nerve Stimulation (PTNS) for Voiding Dysfunction

8.01.58

Cranial Electrotherapy Stimulation (CES) and Auricular Electrostimulation

8.03.01

Functional Neuromuscular Electrical Stimulation

Policy Guidelines

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N/A

Description

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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. http://www.calmarett.com/.

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.

Scope

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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. This medical policy does not apply to Medicare Advantage.

Benefit Application

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N/A

Rationale

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This policy was originally developed in 2002 and has undergone annual updates.

Sympathetic Therapy

In 2002 Guido and colleagues studied 20 individuals with chronic pain and peripheral neuropathies treated daily with Dynatron STS for 28 days. Pain was reported as moderate to severe by 11 of 15 individuals prior to treatment, with a decrease in pain reported by six of the individuals at conclusion of the treatment. The author did not report on the reason why five of the 20 individuals did not provide self-reports of pain severity. The 15 individuals who remained in the study, the authors reported the mean cumulative VAS scores for multiple locations of pain decreased from 107.8 to 45.3. However, drawing conclusions concerning the efficacy of Dynatron STS for the management of chronic, intractable pain is limited due to the small participant population, lack of a randomized control group, placebo effects and lack of data on pain severity in a quarter of the subjects. There is a lack of peer-reviewed literature concerning the efficacy of sympathetic therapy in terms of pain relief or for another indication. Microcurrent Stimulation Bertolucci and Grey (1995) compared the efficacy of MENS therapy to mid-laser and laser placebo treatment of 48 individuals with TMJ pain. There was a difference in pain and functional outcomes between laser and MENS therapy with laser being slightly higher; however, the difference was not statistically significant. There was no data to suggest whether the effect was durable and whether the effects continued with repeated use.

There is a lack of large controlled clinical trials testing the clinical effectiveness of microcurrent electrical nerve stimulation against placebo devices. Therefore, this treatment remains investigational

Galvanic Stimulation

A 2009 Cochrane review of electrotherapy concluded that the evidence was of low quality and more studies are needed to reliably establish effectiveness.

References

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  1. Guido EH. Effects of sympathetic therapy on chronic pain in peripheral neuropathy subjects. Am J Pain Manage 2002; 12(1):31-4.
  2. 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.
  3. Brosseau, LU, Pelland, LU, Casimiro, LY, Robinson, VI, Tugwell, PE, Wells, GE. Electrical stimulation for the treatment of rheumatoid arthritis. Cochrane Database Syst Rev. 2002(2):CD003687. PMID: 12076504
  4. Bertolucci LE< Grey T. Clinical comparative study of microcurrent electrical stimulation to mid-laser and placebo treatment in degenerative joint disease of the temporomandibular joint. Cranio. 1995; 13(2):116-120.
  5. Hayes, Inc. Hayes Search & Summary. CALMARE® Pain Therapy Treatment. Lansdale, PA: Hayes, Inc.; February, 2012.

Coding

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Codes

Number

Description

CPT

64550

Application of surface (transcutaneous) neurostimulator

 

64553

Percutaneous implantation of neurostimulator electrodes; cranial nerve

 

64555

peripheral nerve (excludes sacral nerve)

 

64590

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

 

97014

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

 

0278T

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

ICD-9 Procedure

04.92

Implantation or replacement of peripheral neurostimulator lead(s)

 

86.09

Other incision of skin and subcutaneous tissue

 

93.39

Other physical therapy

HCPCS

E0745

Neuromuscular stimulator, electronic shock unit

 

E0770

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

 

E1399

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.)

 

G0283

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

 

L8680

Implantable neurostimulator electrode, each

 

S8130

Interferential current stimulator, 2 channel

 

S8131

Interferential current stimulator, 4 channel

Type of Service

Durable Medical Equipment

 

Place of Service

Home
Inpatient/
Outpatient

 

Appendix

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N/A

History

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Date

Reason

09/10/02

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)

04/15/03

Replace Policy - Policy reviewed with references added.

05/13/03

Replace Policy - Policy section revised for clarification only.

10/16/03

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

01/13/04

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

06/08/04

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

07/13/04

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.

09/01/04

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

09/14/04

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.

12/14/04

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

02/08/05

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

05/31/05

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

09/13/05

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

02/06/06

Codes updated - No other changes.

05/26/06

Update Scope and Disclaimer - No other changes.

07/11/06

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

04/10/07

Cross Reference Update - No other changes.

06/12/07

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

05/13/08

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.

01/13/09

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

08/11/09

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

04/13/10

Cross Reference Update - No other changes.

06/08/10

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.

06/13/11

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

01/25/12

HCPCS codes S8130 and S8131 added to policy.

01/26/12

CPT code 0278T added.

03/13/12

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.

04/17/12

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

08/24/12

Update Related Policies – Change title for 7.01.106

11/20/12

Update Related Policies. Add 8.01.58.

12/19/12

Update Related Policy title for 2.01.57.

02/11/13

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

12/30/13

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.

03/21/14

Update Related Policies. Delete 7.01.106 and replace with 7.01.553.

05/12/14

Annual Review. TENS policy statements and information removed. Added references 3 and 4.

06/09/14

Interim update. HCPCS codes E0720, E0730 and E0731 are no longer reviewed and from the policy. The Policy section has been updated with removal of the policy statement related to code E0730 and the TENS unit.


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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