Pending Policies - Medicine


Sympathetic Therapy

Number:MED201.043

Effective Date:12-01-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Sympathetic therapy is considered experimental, investigational and/or unproven for any indication, including but not limited to pain.

Description:

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 (transcutaneous electrical nerve stimulation) 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 4 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 manufacturer, 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 1000 Hz. Treatment may include daily 1-hour treatments in the physician's office, followed by home treatments, if the initial treatment is effective.

The Dynatron STS device and a companion home device, Dynatron STS Rx (Dynatronics Corporation), are devices that deliver sympathetic therapy. These devices received U.S. Food and Drug Administration (FDA) clearance in March 2001 through a 510(k) process. The FDA-labeled indication is as follows: "Electrical stimulation delivered by the Dynatron STS and Dynatron STS Rx is indicated for providing symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain."

Rationale:

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 (VAS), 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.

An information packet from the manufacturer Dynatronics (Salt Lake City, UT) (1) includes 2 articles also referenced in their promotional material. These 2 articles are briefly reviewed below.

1. Sacks and colleagues reported on a retrospective study of 197 patients with chronic pain of various origins including upper and lower extremity pain and migraine. Some patients reported multiple sites of pain, and each different site of pain was registered as a separate pain complaint, resulting in 227 patient records. Of these, 91% reported mild pain relief, with 33% reporting complete pain relief. A total of 78% reported an increase in their daily living activities by 50% or more, and 69% reported a decrease in medications. No data were reported regarding the various etiologies of pain, prior treatment including baseline drug requirements, exact treatment protocol, the number of treatments, or how pain relief, activities of daily living, or other treatment outcomes were evaluated. There was no control group. This study has not been published.

2. Guido (2) reported on the effects of sympathetic therapy in 20 volunteers suffering from chronic pain related to peripheral neuropathy. The treatment protocol varied with the site of pain, i.e., upper versus lower extremity, and could vary from day to day. Patients underwent daily therapy for 28 days. At the end of the study, the mean global VAS scores were significantly reduced, although these data are not presented in a table or figure. There was no control group.

Updated guidelines from the Work Loss Data Institute list sympathetic therapy as an intervention that is currently under study and not specifically recommended. (3)

2014 Update

A search of peer reviewed literature identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

2016 Update

A search of peer reviewed literature identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

97014, 97032

HCPCS Codes

A9900, E0730

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Dynatronics. Salt Lake City, UT. Available at: <www.chronicpainrx.com> (reaffirmed November 9, 2016).

2. Guido EH. Effects of sympathetic therapy on chronic pain in peripheral neuropathy subjects. Am J Pain Manage 2002; 12(1):31-4.

3. Work Loss Data Institute. Pain 2006; National Guideline Clearinghouse. Available at: <www.guideline.gov> (accessed 2008).

4. Sympathetic Therapy for the Treatment of Pain. (Archived 2009) Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual. Durable Medical Equipment 1.04.03.

5. Dynatronics. STS Chronic Pain Therapy- Legacy Products. Available at: <http://www.dynatronics.com> (accessed November 9, 2016).

Policy History:

DateReason
12/1/2017 Reviewed. No changes.
1/1/2017 Document updated with literature review. Coverage unchanged.
4/15/2015 Reviewed. No changes.
6/1/2014 New medical document. Coverage is unchanged: Sympathetic therapy for the treatment of pain is considered experimental, investigational and/or unproven This topic was previously addressed on MED201.026 Surface Electrical Stimulation.

Archived Document(s):

Title:Effective Date:End Date:
Sympathetic Therapy02-01-202211-30-2022
Sympathetic Therapy05-01-202101-31-2022
Sympathetic Therapy09-15-202004-30-2021
Sympathetic Therapy02-15-201909-14-2020
Sympathetic Therapy12-01-201702-14-2019
Sympathetic Therapy01-01-201711-30-2017
Sympathetic Therapy04-15-201512-31-2016
Sympathetic Therapy06-01-201404-14-2015
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