mp-073 - Medical Policies - Florida
Interferential Stimulator/Stimulation Devices
Policy Number: MP-073
Latest Review Date: June 2020
Policy Grade: B
The IFS or IFS Sequential Stimulator unit for home use is considered not medically necessary and investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
Interferential current stimulation (IFS) is a type of electrical stimulation used to reduce pain. The technique has been proposed to decrease pain and increase function in patients with osteoarthritis and to treat other conditions such as constipation, irritable bowel syndrome, dyspepsia, and spasticity.
Interferential current stimulation (IFS) is a type of electrical stimulation that has been investigated as a technique to reduce pain, improve function and range of motion, and treat gastrointestinal disorders.
IFS uses paired electrodes of 2 independent circuits carrying high-frequency and medium-frequency alternating currents. The superficial electrodes are aligned on the skin around the affected area. It is believed that IFS permeates the tissues more effectively and with less unwanted stimulation of cutaneous nerves, is more comfortable than transcutaneous electrical nerve stimulation. There are no standardized protocols for the use of IFS; IFS may vary by the frequency of stimulation, the pulse duration, treatment time, and electrode-placement technique.
The most recent literature was reviewed through April 17, 2020. Following is a summary of the key literature to date.
SUMMARY OF EVIDENCE:
For individuals who have musculoskeletal conditions who receive IFS, the evidence includes randomized controlled trials (RCTs) and meta-analyses. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Placebo-controlled RCTs of IFS for treating musculoskeletal pain and impaired function have mostly found that it does not significantly improve outcomes and a meta-analysis of placebo-controlled trials did not find a significant benefit of IFS for decreasing pain or improving function. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have gastrointestinal disorders who receive IFS, the evidence includes RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use and treatment-related morbidity. IFS has been tested for a variety of gastrointestinal conditions, with a small number of trials completed for each condition. Trials results are mixed, with some reporting benefit and others not. This body of evidence is inconclusive on whether IFS is an efficacious treatment for gastrointestinal conditions. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have poststroke spasticity who receive IFS, the evidence includes RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The RCTs had small sample sizes and very short follow-up (immediately posttreatment to 5 weeks). The evidence is insufficient to determine the effects of the technology on health outcomes.
PRACTICE GUIDELINES AND POSITION STATEMENTS:
American College of Physicians and the American Pain Society
Clinical practice guidelines from the American College of Physicians and the American Pain Society, published in 2009, concluded that there was insufficient evidence to recommend interferential stimulation for the treatment of low back pain. An update of these guidelines by the American College of Physicians (2017) confirmed the 2009 findings that there was insufficient evidence to determine the effectiveness of interferential current stimulation (IFS) for the treatment of low back pain.
American College of Occupational and Environmental Medicine
The American College of Occupational and Environmental Medicine published several relevant guidelines. For shoulder disorders, guidelines found the evidence on IFS to be insufficient and, depending on the specific disorder, either did not recommend IFS or were neutral on whether to recommend it. For low back disorders, guidelines found the evidence on IFS to be insufficient and did not recommend it. The sole exception was that IFS could be considered as an option on a limited basis for acute low back pain with or without radicular pain. For knee disorders, guidelines recommended IFS for postoperative anterior cruciate ligament reconstruction, meniscectomy, and knee chondroplasty immediately postoperatively in the elderly. This was a level C recommendation.
National Institute for Health and Care Excellence
In 2016, the National Institute for Health and Care Excellence had a guideline (NG59) on assessment and management of low back pain and sciatica in people aged 16 and over. The guideline states “Do not offer interferential therapy for managing low back pain with or without sciatica”.
U.S. Preventive Services Task Force Recommendations
Interferential current therapy (IF), interferential stimulation (IF), interferential stimulator, transcutaneous electrical nerve stimulation (TENS), sequential stimulator, RS-4i Sequential stimulator, Medstar™ 100, RS-4i®
APPROVED BY GOVERNING BODIES:
A number of IFS devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process, including the Medstar™ 100 (MedNet Services) and the RS-4i® (RS Medical). IFS may be included in multimodal electrotherapy devices such as transcutaneous electrical nerve stimulation and functional electrostimulation.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
|97014||Application of a modality to 1 or more areas; electrical stimulation (unattended)|
|97032||Application of modality or one or more areas; electrical stimulation (manual), each 15 minutes (attended)|
|G0283||Electrical stimulation (unattended, to 1 or more areas for indications other than wound care, as part of a therapy plan of care|
|S8130||Interferential current stimulator, 2 channel|
|S8131||Interferential current stimulator, 4 channel|
Albornoz-Cabello M, Maya-Martin J, Dominguez-Maldonado G, et al. Effect of interferential current therapy on pain perception and disability level in subjects with chronic low back pain: A randomized controlled trial. Clin Rehabil. Mar 14 2016.
American College of Occupational and Environmental Medicine. (ACOEM) Chronic pain. Available online at: www.guidelines.gov.
American College of Occupational and Environmental Medicine (ACOEM). Shoulder Disorders. Available online at: www.guideline.gov Accessed May 15, 2016.
American College of Occupational and Environmental Medicine (ACOEM). Low Back Disorders. Available online at: www.guideline.gov. Accessed May 15, 2016.
American College of Occupational and Environmental Medicine (ACOEM). Knee Disorders. Available online at: www.guideline.gov. Accessed May 15, 2016.
Atamaz FC, Durmaz B, Baydar M et al. Comparison of the efficacy of transcutaneous electrical nerve stimulation, interferential currents, and shortwave diathermy in knee osteoarthritis: a double-blind, randomized, controlled, multicenter study. Arch Phys Med Rehabil 2012; 93(5):748-5
Awbrey, Brian J. Reduction of postoperative knee arthroscopy pain and swelling by patient-controlled interferential therapy. Massachusetts General Hospital, 1994.
Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Medicine 2007; 147(7): 478-491.
Chou R, Atlas SJ, Stanos SP, et al. Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline. Spine (Phila Pa 1976). May 1 2009; 34(10):1078-1093.
Clarke MC, Chase JW, Gibb S et al. Improvement of quality of life in children with slow transit constipation after treatment with transcutaneous electrical stimulation. J Pediatr Surg 2009; 44(6):1268-1272; discussion 1272.
Coban S, Akbal E, Koklu S et al. Clinical trial: transcutaneous interferential electrical stimulation in individuals with irritable bowel syndrome - a prospective double-blind randomized study. Digestion 2012; 86(2):86-93.
Correa JB, Costa LO, de Oliveira NT et al. Effects of the carrier frequency of interferential current on pain modulation in patients with chronic nonspecific low back pain: a protocol of a randomized controlled trial. BMC Musculoskelet Disord 2013; 14:195.
Davis, Samuel. A versatile electrotherapy method—Interferential current therapy. Physical Therapy Products, 1994.
Defrin R, Ariel E and Peretz C. Segmental noxious versus innocuous electrical stimulation for chronic pain relief and the effect of fading sensation during treatment. Pain, May 2005; 115(1-2): 152-160.
Dissanayaka TD, Pallegama RW, Suraweera HJ, et al. Comparison of the effectiveness of transcutaneous electrical nerve stimulation and interferential therapy on the upper trapezius in myofascial pain syndrome: a randomized controlled study. Am J Phys Med Rehabil. Mar 4 2016.
Excellus Health Plan, Inc. Electrical Stimulation. Medical Policy, March 2002.
Facci LM, Nowotny JP, Tormem F et al. Effects of transcutaneous electrical nerve stimulation (TENS) an interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized controlled trial. Sao Paulo Med J 2011; 129(4):206-16.
Fuentes JP, Armijo Olivo S, Magee DJ et al. Effectiveness of interferential current therapy in the management of musculoskeletal pain: a systematic review and meta-analysis. Phys Ther 2010; 90(9):1219-38.
Gundog M, Atamaz F, Kanyilmaz S, et al. Interferential current therapy in patients with knee osteoarthritis: comparison of the effectiveness of different amplitude-modulated frequencies. Am J Phys Med Rehabil. Feb 2012; 91(2):107-113.
Hou CR, Tsai LC, Cheng KF et al. Immediate effects of various physical therapeutic modalities on cervical myofascial pain and trigger-point sensitivity. Arch Phys Med Rehabil 2002; 83(10):1406-14.
Hurley DA, Minder PM, McDonough SM et al. Interferential therapy electrode placement technique in acute low back pain: a preliminary investigation. Arch Phys Med Rehabil 2001; 82(4): 485-93.
Johnson MI. A single-blind placebo-controlled investigation into the analgesic effects of interferential currents on experimentally induced ischemic pain in healthy subjects. Clinical Physiology and Functional Imaging, May 2002; 22(3): 187-96.
Johnson MI. An investigation into the analgesic effects of interferential currents and transcutaneous electrical nerve stimulation on experimentally induced ischemic pain in otherwise pain-free volunteers. Physical Therapy; March 2003; 83(3): 208-23.
Kajbafzadeh AM, Sharifi-Rad L, Nejat F et al. Transcutaneous interferential electrical stimulation for management of neurogenic bowel dysfunction in children with myelomeningocele. Int J Colorectal Dis 2012; 27(4):453-8.
Koca I, Boyaci A, Tutoglu A, et al. Assessment of the effectiveness of interferential current therapy and TENS in the management of carpal tunnel syndrome: a randomized controlled study. Rheumatol Int. Apr 12 2014.
Koca I, Boyaci A, Tutoglu A, et al. Assessment of the effectiveness of interferential current therapy and TENS in the management of carpal tunnel syndrome: a randomized controlled study. Rheumatol Int. Dec 2014; 34(12):1639-1645.
Koklu S, Koklu G, Ozguclu E et al. Clinical trial: interferential electric stimulation in functional dyspepsia patients - a prospective randomized study. Aliment Pharmacol Ther 2010; 31(9):961-968.
Lara-Palomo IC, Aguilar-Ferrandiz ME, Mataran-Penarrocha GA, et al. Short-term effects of interferential current electro-massage in adults with chronic non-specific low back pain: a randomized controlled trial. Clin Rehabil. May 2013; 27(5):439-449.
Latzanich, Carol M., et al. Interferential current therapy for post-operative pain management. Contemporary Podiatric Physician, November 1993.
Minder PM. Interferential therapy: Lack of effect upon experimentally induced delayed onset muscle soreness. Clinical Physiology and Functional Imaging, September 2002; 22(5): 339-47.
Poitras S and Brosseau L. Evidence-informed management of chronic low back pain with transcutaneous electrical nerve stimulation, interferential current, electrical muscle stimulation, ultrasound, and thermotherapy. Spine J 2008; 8(1): 226-233.
Suh HR, Han HC, Cho HY. Immediate therapeutic effect of interferential current therapy on spasticity, balance, and gait function in chronic stroke patients: a randomized control trial. Clin Rehabil. Sep 2014; 28(9):885-891.
The Regence Group. Electrical Stimulation Devices. Medical Policy, March 2002.
Taylor K, Newton RA, Personius WJ et al. Effects of interferential current stimulation for treatment of subjects with recurrent jaw pain. Phys Ther 1987; 67(3):346-50.
Van der Heijden GJ, Leffers P, Wolters PJ et al. No effect of bipolar interferential electrotherapy and pulsed ultrasound for soft tissue disorders: a randomized controlled trial. Ann Rheum Dis 1999; 58(9):530-50.
Werners R, Pynsent PB, Bulstrode CJ. Randomized trial comparing interferential therapy with motorized lumbar traction and massage in the management of low back pain in a primary care setting. Spine 1999; 24(15):1579-84.
Zambito A, Bianchini D, Gatti D, et al. Interferential and horizontal therapies in chronic low back pain due to multiple vertebral fractures: A randomized, double blind, clinical study. Osteoporos Int 2007; 18(11): 1541-1545.
Zeng C, Li H, Yang T, et al. Electrical stimulation for pain relief in knee osteoarthritis: systematic review and network meta-analysis. Osteoarthritis Cartilage. Feb 2015; 23(2):189-202.
Medical Policy Group, October 2002
Medical Policy Administration Committee, October 2002
Available for comment December 18, 2002-February 3, 2003
Medical Policy Group, November 2004 (4)
Medical Policy Group, June 2005 (3)
Medical Review Committee, June 2005 (2)
Medical Policy Administration Committee, July 2005
Available for comment July 28-September 10, 2005
Medical Policy Group, November 2006 (1)
Medical Policy Group, November 2008 (1)
Medical Policy Group, September 2010 (1)
Medical Policy Administration Committee, September 2010
Available for comment September 14-October 28, 2010
Medical Policy Group, November 2010
Medical Policy Group, December 2011 (3): 2012 Code Updates – Added Codes S8130 & S8131
Medical Policy Group, March 2012 (3): 2011 Literature Update, updated Key Points and References
Medical Policy Panel, December 2012
Medical Policy Group, December 2012 (3): 2012 Literature Update, updated Key Points and References. Policy statement remains unchanged
Medical Policy Panel, December 2013
Medical Policy Group, January 2014 (3): 2013 Updates to Key Points and References; no change in policy statement; removed policy statements greater than 3 years old
Medical Policy Panel, December 2014
Medical Policy Group, January 2015 (3): 2014 Updates to Key Points and References, no change in policy statement
Medical Policy Panel, June 2016
Medical Policy Group, July 2016 (6): Updates to Description of Procedure or Services, Policy, Key Points, Summary, Approved by Governing Bodies and References, removed 2012 previous coding; no change in policy intent.
Medical Policy Panel, September 2017
Medical Policy Group, September 2017 (6): Updates to Key Points and Coding.
Medical Policy Group, December 2017: Annual Coding Update 2018. Updated verbiage for revised CPT code 64550.
Medical Policy Panel, June 2018
Medical Policy Group, June 2018 (6): Updates to Key Points, Practice Guidelines, Governing Bodies and References.
Medical Policy Group, December 2018: 2019 Annual Coding Update. Moved CPT code from Current coding section to Previous coding. Created Previous coding section to include code 64550.
Medical Policy Panel, June 2019
Medical Policy Group, June 2019 (6): Updates to Key Points.
Medical Policy Panel, June 2020
Medical Policy Group, June 2020 (6): Updates to Key Points, Key Words (Medstar™ 100, RS-4i®) Governing Bodies and Practice Guidelines.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.