199 Form

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Medical Policy Stationary Ultrasonic Diathermy Devices
Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 199 BCBSA Reference Number: 7.01.174 (For Plan internal use only) NCD/LCD: N/A Related Policies
Dry Hydrotherapy for chronic pain conditions, #164 Biofeedback as a Treatment of Chronic Pain, #210 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Ultrasonic diathermy devices for the treatment of musculoskeletal pain are considered INVESTIGATIONAL.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service. Medicare HMO BlueSM This is not a covered service. Medicare PPO BlueSM This is not a covered service.

CPT Codes / HCPCS Codes / ICD Codes
Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

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Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following HCPCS codes are considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: HCPCS Codes HCPCS codes:

Code Description K1004 Low frequency ultrasonic diathermy treatment device for home use, includes all components and accessories K1036 Supplies and accessories (e.g., transducer) for low frequency ultrasonic diathermy treatment device, per month Description Therapeutic Ultrasound Therapeutic ultrasound is a noninvasive method used to treat a variety of musculoskeletal conditions.1, Therapeutic ultrasound produces acoustic vibrations of high frequency (≥20 kilohertz) that are outside the range of human hearing.2, 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.1,2, In this setting, the ultrasound is transmitted through a wand that is applied to the skin with gentle, circular movements. A hypo-allergenic 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.1, 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.3, 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.

Summary
Description 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.

Summary of Evidence

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For individuals with musculoskeletal pain treated with stationary ultrasonic diathermy devices, the evidence includes a meta-analysis and 3 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 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. An additional RCT reported that treatment with a SAM device for 4 hours daily for 8 weeks demonstrated improvements in pain scores in individuals with chronic lower back pain. Limitations of the available data include heterogeneity in treatment areas, treatment implementation, and clinical outcomes, small sample sizes, and short follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Policy History Date Action 2/2026 Annual policy review. References updated. Policy statements unchanged. 3/2025 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 3/2024 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 10/2023 Clarified coding information. 3/2023 New medical policy describing ongoing investigational indications. Policy was transferred from MP #400 Medical Technology Assessment Noncovered Services.
Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines References

1. U.S. Food and Drug Administration. Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices. https://www.fda.gov/regulatory-information/search- fda-guidance-documents/policy-clarification-and-premarket-notification-510k-submissions-ultrasonic- diathermy-devices. Updated February 21, 2023. Accessed November 25, 2025.
2. Matthews MJ, Stretanski MF. Ultrasound Therapy. In: StatPearls [Internet]. StatPearls Publishing;
4. 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). PMID 34207333
5. U.S. Department of Health and Human Services. Pain management best practices. May 2019. https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf. Accessed December 1, 2025.
6. 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):
7. PMID 34922606
8. 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. PMID 23743101
9. 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. PMID 32606899

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8. 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;
9. PMID 30078928
10. 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. PMID 30326947
11. 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. PMID 26509683
12. 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.
13. Ortiz R, Motyka T, Petterson S, et al. Sustained acoustic medicine treatment of discogenic chronic low back pain: A randomized, multisite, double-blind, placebo-controlled trial. J Back Musculoskelet Rehabil. 2024; 37(5): 1321-1332. PMID 38905030