Latest Review Date: January 2024

Category: Durable Medical Equipment (DME)

POLICY:

Ultrasonic Diathermy Devices for the treatment of all indications, including but not limited to musculoskeletal pain, are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

An ultrasonic diathermy device applies ultrasonic energy to specific body parts at a frequency higher than 20 kilohertz in order to generate deep heat within body tissues for the treatment of certain medical conditions, such as the alleviation of pain, muscle spasms, and joint contractures. Newer portable stationary devices can be self-applied and used at home to deliver diathermy via continuous low-intensity therapeutic ultrasound. Electrodes attached to adhesive bandages are applied to the skin over the desired treatment area. The continuous low-intensity ultrasound unit can provide treatment for several hours.

Therapeutic Ultrasound

Therapeutic ultrasound is a noninvasive method used to treat a variety of musculoskeletal conditions. Therapeutic ultrasound produces acoustic vibrations of high frequency (≥20 kilohertz) that are outside the range of human hearing. The vibrations generated during therapeutic ultrasound allow the body to generate heat in targeted tissues that are high in collagen (muscles, tendons, ligaments, etc.); this is referred to as ultrasound/ultrasonic diathermy. The increased vibrations and heat to the affected areas simulate soft tissue injury repair and pain relief.

Conventionally, high-frequency/high-intensity therapeutic ultrasound is provided in a clinic setting with an average length of treatment ranging from 5 to 10 minutes per session. In this setting, the ultrasound is transmitted through a wand that is applied to the skin with gentle, circular movements. A hypoallergenic gel aids in the transmission of ultrasonic energy and prevents overheating at the surface of the applicator.

It is important to note that individuals with implanted metal devices, including pacemakers, prostheses, and intrauterine devices, are at-risk of serious injury if they undergo diathermy. Furthermore, patients with certain medical conditions, including cancer and others, may not be appropriate candidates for diathermy.

Ultrasonic Diathermy Devices

Newer portable/wearable, stationary devices can be used at home to deliver diathermy via continuous low-intensity therapeutic ultrasound. Electrodes attached to adhesive bandages are self-applied to the skin over the desired treatment area. This type of treatment may also be referred to as sustained acoustic medicine. Similar to conventional high-frequency/high-intensity therapeutic ultrasound, a high-frequency/low-intensity ultrasonic diathermy device applies ultrasonic energy to specific body parts in order to generate deep heat within body tissues for the treatment of certain medical conditions, such as the alleviation of pain, muscle spasms, and joint contractures. The continuous low-intensity ultrasound device provides treatment for several hours.

KEY POINTS:

This evidence review was created with a search of the PubMed database. The most recent literature update was performed through December 29, 2023.

Summary of Evidence:

For individuals with musculoskeletal pain treated with stationary ultrasonic diathermy devices, the evidence includes a meta-analysis and 2 randomized controlled trials (RCTs). Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. The meta-analysis included 13 studies of participants with musculoskeletal injuries divided into 3 treatment areas: upper shoulder, neck, and back; knee joint; and soft tissue injuries of the musculoskeletal system. The following clinical outcomes were evaluated: pain, function, and diathermy. The meta-analysis demonstrated that therapy with a Sustained Acoustic Medicine (SAM) device reduced pain, improved overall health quality, and generated deep therapeutic heat. In 2 RCTs that are also included in the meta-analysis, treatment with a SAM device for 4 hours daily for 4 to 6 weeks improved pain scores in individuals with upper trapezius myofascial pain and mild to moderate knee osteoarthritis with moderate to severe associated pain. Limitations of the available data include heterogeneity in treatment areas, treatment implementation, and clinical outcomes, sample sizes, and length follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

No guidelines that discuss the role of stationary ultrasonic diathermy devices in individuals with musculoskeletal pain were identified.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Diathermy, Sustained Acoustic Medicine (sam), Manasport, PainShield, ultrasonic diathermy

APPROVED BY GOVERNING BODIES:

Several stationary ultrasonic diathermy devices have been granted 510(k) clearance by the United States Food and Drug Administration (FDA) including Manasport™ (ManaMed, Inc., Las Vegas, NV), Sustained Acoustic Medicine (sam®) (ZetrOZ™, Inc.,Trumbull, CT), and PainShield™ MD (NanoVibronix Inc., Elmsford, NY). The intended use of these devices is to supply ultrasound “to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, muscle spasms, joint contractures, and increase local circulation.”

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Covered if covered by the Participating Home Plan

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING: 

HCPCS codes:                

REFERENCES:

1. Draper DO, Klyve D, Ortiz R, et al. Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. J Orthop Surg Res. Oct 16 2018; 13(1): 257.
2. Langer MD, Lewis GK. Sustained Acoustic Medicine: A Novel Long Duration Approach to Biomodulation Utilizing Low Intensity Therapeutic Ultrasound. Proc SPIE Int Soc Opt Eng. May 2015; 9467.
3. Langer MD, Byrne HK, Henry T, et al. The effect of low intensity wear-able ultrasound on blood lactate and muscle performance after high intensity resistance exercise. J Exerc Physiol. 2017;20(4):132-146.
4. Lewis GK, Langer MD, Henderson CR, et al. Design and evaluation of a wearable self-applied therapeutic ultrasound device for chronic myofascial pain. Ultrasound Med Biol. Aug 2013; 39(8): 1429-39.
5. Matthews MJ, Stretanski MF. Ultrasound Therapy. In: Stat Pearls [Internet]. Stat Pearls Publishing; 2022.
6. Petterson S, Plancher K, Klyve D, et al. Low-Intensity Continuous Ultrasound for the Symptomatic Treatment of Upper Shoulder and Neck Pain: A Randomized, Double-Blind Placebo-Controlled Clinical Trial. J Pain Res. 2020; 13: 1277-1287.
7. Rigby JH, Taggart RM, Stratton KL, et al. Intramuscular Heating Characteristics of Multihour Low-Intensity Therapeutic Ultrasound. J Athl Train. Nov 2015; 50(11): 1158-64.
8. Uddin SMZ, Komatsu DE, Motyka T, et al. Low-Intensity Continuous Ultrasound Therapies—A Systematic Review of Current State-of-the-Art and Future Perspectives. J Clin Med. Jun 18 2021; 10(12).
9. U.S. Department of Health and Human Services. Pain management best practices. May 2019.https://www.hhs.gov/sites/default/files/pain-mgmt-best-practices-draft-final-report-05062019.pdf.
10. U. S. Food and Drug Administration. Ultrasonic Therapy Product or Ultrasonic Diathermy. Updated September 28, 2020.
11. Winkler SL, Urbisci AE, Best TM. Sustained acoustic medicine for the treatment of musculoskeletal injuries: a systematic review and meta-analysis. BMC Sports Sci Med Rehabil. Dec 18 2021; 13(1): 159.

POLICY HISTORY:

Medical Policy Panel, January 2023

Medical Policy Group, January 2023 (6): New medical policy. Ultrasonic diathermy devices previously investigational for dates of service prior to February 1, 2023 per MP 495 Investigational Criteria. On draft from 2/1/23-3/15/23.

MPAC February 2023

Medical Policy Group, September 2023 Quarterly HCPCS Coding Update. K1004 revised, K1036 added to Current Coding section.

Medical Policy Panel, January 2024

Medical Policy Group, January 2024 (6) Updates to Key Points and References.

Medical Policy Group, October 2024 (6): Updates to Current Coding (+E1399).

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.