Notification

Home Use of Interferential and Sequential Stimulation Devices


Notification Issue Date: 10/01/2014

The new Medicare Advantage policy portfolio that includes this policy bulletin will become effective on 01/01/2015.



Medicare Advantage Policy

Title:Home Use of Interferential and Sequential Stimulation Devices
Policy #:MA05.061

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

Interferential and sequential stimulation devices are not covered by the Company because they are an item not covered by Medicare. They do not meet Medicare's definition of durable medical equipment because these devices are not used in the home. Therefore, interferential and sequential stimulation devices are not eligible for reimbursement consideration.
Policy Guidelines

This policy is consistent with Medicare's coverage determination.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for interferential and sequential stimulation.

BENEFIT APPLICATION

Subject to the applicable Evidence of Coverage, interferential and sequential stimulation devices are not eligible for payment under the medical benefits of the Company’s Medicare Advantage products because the service is considered not covered.

Description

Interferential stimulation devices involve the transcutaneous application of an electrical current to an injured or painful area of the body. These devices have been investigated as a modality to achieve a variety of goals, including pain relief, improved range of motion, and the promotion of healing following a soft tissue injury or bone fracture.


Sequential stimulation devices combine interferential current and muscle stimulation features. The goal of the muscle stimulation component is to restore muscle function and prevent disuse atrophy. For example, the RS-4i Muscle Stimulator (RS Medical, Vancouver, WA) is used in two phases because only one modality may be operated at a time. First, the device delivers an interferential current for muscle pain relief. Next, the device's muscle stimulation feature is applied to treat the affected muscle.

Interferential and sequential stimulation devices require constant professional supervision for proper operation.


References

American College of Occupational and Environmental Medicine. Chronic pain. Available at: https://www.nhms.org/sites/default/files/Pdfs/ACOEM%202011-Chronic%20Pain%20Opioid%20.pdf. Accessed June 2, 2015.

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):748-56.

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 Med. 2007; 147(7):478-91.

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):1268-72; discussion 72.

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.

Defrin R, Ariel E, Peretz C. Segmental noxious versus innocuous electrical stimulation for chronic pain relief and the effect of fading sensation during treatment. Pain. 2005;115(1-2):152-160.

Facci LM, Nowotny JP, Tormem F, et al. Effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical 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. Am J Phys Med Rehabil. 2012; 91(2):107-13.

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.

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):961-8.

Novitas Solutions, Inc.. Local Coverage Determination (LCD). Physical medicine and rehabilitation services, Physical Therapy and Occupational Therapy. [Novitas Solutions, Inc Web site]. Original: 07/11/2008. (Revised: 04/02/12). Available at: https://www.novitas-solutions.com/policy/mac-ab/l27513-r13.html. Accessed June 5, 2015.

RS Medical. RS-4M Muscle Stimulator fact sheet. [RS Medical Web site]. 09/10/04. Available at: http://www.rsmedical.com/documents/fact_sheet_RS4m.pdf. Accessed June 5, 2015.

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.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. MEDSTAR™ 100 Interferential Stimulator. 510(K) summary and premarket approval letter. [FDA website]. 11/16/2001. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/K013082.pdf. Accessed June 5, 2015.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. IF 3Wave Interferential Muscle Stimulator System, Model 7110S. Summary of safety and effectiveness/premarket approval letter. [FDA Web site]. 04/13/05. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050046.pdf http://www.fda.gov/cdrh/pdf5/k050046.pdf. Accessed June 5, 2015.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. IF series True sine interferential stimulator/Model WL-2206A. 510(k) summary and premarket approval letter. [FDA Web site]. 06/17/05. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050847.pdf http://www.fda.gov/cdrh/pdf5/k050847.pdf. Accessed June 5, 2015.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Interferential Stimulator, Model BMLS02-6. Premarket approval letter. [FDA Web site]. 07/07/04. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040007.pdf http://www.fda.gov/cdrh/pdf4/k040007.pdf. Accessed June 5, 2015.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. RS-4i Muscle Stimulator family. 510(k) summary and premarket approval letter. [FDA Web site]. 09/12/03. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/k032652.pdf http://www.fda.gov/cdrh/pdf3/k032652.pdf. Accessed June 5, 2015.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. RS Medical RS-4i Sequential Stimulator. 510(K) summary and premarket approval letter. [FDA website]. 04/13/07. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062325.pdf http://www.fda.gov/cdrh/pdf6/K062325.pdf. Accessed June 5, 2015.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)



S8130 Interferential current stimulator, 2 channel

S8131 Interferential current stimulator, 4 channel



Revenue Code Number(s)

N/A

Coding and Billing Requirements

Electrical stimulation as a physical therapy modality is reported with Current Procedural Terminology (CPT) code 97032.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.




Policy History

06/24/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on interferential and sequential stimulation devices.
01/01/2015This is a new policy.




Version Effective Date: 01/01/2015
Version Issued Date: 01/01/2015
Version Reissued Date: 06/24/2015