657 Form

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Medical Policy Noncontact Ultrasound Treatment for Wounds Table of Contents
• Policy: Commercial • Description • Information Pertaining to All Policies
• Authorization Information • Policy History •

• Coding Information • References

Policy Number: 657 BCBSA Reference Number: 2.01.79 (For Plan internal use only)

Related Policies • Electrostimulation and Electromagnetic Therapy for Treating Wounds, #655 • Negative Pressure Wound Therapy in the Outpatient Setting, #543 • Noncontact Radiant Heat Bandage for the Treatment of Wounds, #656 Policy
Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

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

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CPT Codes

CPT codes: Code Description 97610 Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day

Description Ultrasound (US) delivers mechanical vibration above the upper threshold of human hearing (>20 kHz). US in the megahertz range (1-3 MHz) has been used to treat musculoskeletal disorders, often by physical therapists. Although the exact mechanism underlying its clinical effects is not known, therapeutic US has been shown to have a variety of effects at a cellular level, including angiogenesis, leukocyte adhesion, growth factor, collagen production, and increases in macrophage responsiveness, fibrinolysis, and nitric oxide levels. The therapeutic effects of US energy in the kilohertz range have also been examined. Although the precise effects are not known, the low-frequency US in this range may improve wound healing via the production, vibration, and movement of micron-sized bubbles in the coupling medium and tissue. The mechanical energy from the US is typically transmitted to the tissue through a coupling gel. Several high-intensity US devices with contact probes are currently available for wound débridement. Low- intensity US devices have been developed that do not require coupling gel or other direct contact. The MIST Therapy System delivers a saline mist to the wound with low-frequency US (40 KHz). A second device, the Qoustic Wound Therapy System, also uses sterile saline to deliver US energy (35 KHz) for wound débridement and irrigation. US is intended as an adjunct to standard wound care. Therefore, the evidence is needed that demonstrates US plus standard wound care provides superior wound closure outcomes compared with standard wound care alone. The primary endpoints of interest for trials of wound closure are as follows, consistent with 2006 guidance from the U.S. Food and Drug Administration (FDA) for the industry in developing products for the treatment of chronic cutaneous ulcer and burn wounds1,: • Incidence of complete wound closure. • Time to complete wound closure (reflecting accelerated wound closure). • Incidence of complete wound closure following surgical wound closure. • Pain control. Summary Low-frequency ultrasound in the kilohertz range may improve wound healing. Several noncontact low- frequency ultrasound (NLFU) devices have received regulatory approval for wound treatment.

For individuals who have any wound type (acute or nonhealing) who receive noncontact low-frequency ultrasound therapy (NLFU) plus standard wound care, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. The single, double-blinded, sham-controlled randomized trial, which included patients with nonhealing diabetic foot ulcers, had substantial methodologic flaws (eg, high dropout rate, baseline differences between groups) that limit the validity of the findings. In the remaining studies comprising the evidence base, all but 1 RCT comparing NLFU with standard wound care reported improved (statistically significant) results on the primary outcome with NLFU. However, these studies also had several methodologic limitations. Complete healing is the most clinically relevant outcome. None of the RCTs evaluating venous leg ulcers reported complete healing as its primary outcome measure, and none had blinded outcome assessment. Only 1 RCT, which addressed split-thickness graft donor sites, reported on the proportion of patients with complete healing and had blinded outcome assessment. Another limitation of the body of evidence is that some standard of care

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interventions involved fewer visits than the NLFU intervention, and the differences in intensity of care resulting from this differential in face-to-face contact could partially explain the difference in findings between intervention and control groups. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Policy History Date Action 3/2026 Annual policy review. Policy updated with literature review through November 25, 2025; references added. Policy statement unchanged. 3/2025 Annual policy review. References updated. Policy statements unchanged. 3/2024 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 3/2023 Annual policy review. References updated. Policy statements unchanged. 1/2023 Annual policy review. PA information section clarified to include Medicare.
2/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 3/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.
3/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 3/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 2/2018 Annual policy review. New references added. 2/2017 Annual policy review. New references added. 12/2016 Annual policy review. New references added. 3/2016 Annual policy review. New references added. 12/2014 Annual policy review. New references added. 2/2014 Annual policy review. New references added. 1/2014 Updated to add new CPT code 97610 and remove deleted code 0183T. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements.
12/2011 Annual policy review. Changes to policy statements. 11/2011 Reviewed - Medical Policy Group - Plastic Surgery and Dermatology. No changes to policy statements. 4/2011 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 12/2010 Reviewed - Medical Policy Group - Plastic Surgery and Dermatology. No changes to policy statements. 3/2010 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 12/2009 Reviewed - Medical Policy Group - Plastic Surgery and Dermatology. No changes to policy statements. 9/2009 Annual policy review. No changes to policy statements. 6/2009 Annual policy review. No changes to policy statements. 4/2009 Annual policy review. No changes to policy statements. 3/2009 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 1/2009 Annual policy review. No changes to policy statements. 12/2008 Reviewed - Medical Policy Group - Plastic Surgery and Dermatology. No changes to policy statements. 10/2008 Annual policy review. No changes to policy statements. 7/2008 Annual policy review. Changes to policy statements.

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5/2008 Annual policy review. Changes to policy statements. 3/2008 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. No changes to policy statements. 2/2008 Annual policy review. Changes to policy statements. 8/2007 Annual policy review. No changes to policy statements. 3/2007 Annual policy review. No changes to policy statements. 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. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds -
   • Developing Products for Treatment. Rockville, MD: Food and Drug Administration; 2006 June.
2. Food and Drug Administration. MIST[TM] Therapy System: 510(k) Premarket Notification: K050129. https://www.accessdata.fda.gov/cdrh_docs/pdf5/K050129.pdf. Accessed November 24, 2025.
3. Food and Drug Administration. 510(k) Summary: 510(k) -AR1000 Series K131096, Arobella Medical, LLC. 2014; https://www.accessdata.fda.gov/cdrh_docs/pdf13/K131096.pdf. Accessed November 23,
5. Tricco AC, Antony J, Vafaei A, et al. Seeking effective interventions to treat complex wounds: an overview of systematic reviews. BMC Med. Apr 22 2015; 13: 89. PMID 25899006
6. Voigt J, Wendelken M, Driver V, et al. Low-frequency ultrasound (20-40 kHz) as an adjunctive therapy for chronic wound healing: a systematic review of the literature and meta-analysis of eight randomized controlled trials. Int J Low Extrem Wounds. Dec 2011; 10(4): 190-9. PMID 22184750
7. Ennis WJ, Foremann P, Mozen N, et al. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage. Aug 2005; 51(8): 24-39. PMID 16234574
8. Peschen M, Weichenthal M, Schöpf E, et al. Low-frequency ultrasound treatment of chronic venous leg ulcers in an outpatient therapy. Acta Derm Venereol. Jul 1997; 77(4): 311-4. PMID 9228227
9. Chang YR, Perry J, Cross K. Low-Frequency Ultrasound Debridement in Chronic Wound Healing: A Systematic Review of Current Evidence. Plast Surg (Oakv). Feb 2017; 25(1): 21-26. PMID 29026808
10. Kavros SJ, Miller JL, Hanna SW. Treatment of ischemic wounds with noncontact, low-frequency ultrasound: the Mayo clinic experience, 2004-2006. Adv Skin Wound Care. Apr 2007; 20(4): 221-6. PMID 17415030
11. Hu X, Meng H, Liang J, et al. Comparison of the efficacy of 12 interventions in the treatment of diabetic foot ulcers: a network meta-analysis. PeerJ. 2025; 13: e19809. PMID 40821981
12. Beheshti A, Shafigh Y, Parsa H, et al. Comparison of high-frequency and MIST ultrasound therapy for the healing of venous leg ulcers. Adv Clin Exp Med. 2014; 23(6): 969-75. PMID 25618125
13. Olyaie M, Rad FS, Elahifar MA, et al. High-frequency and noncontact low-frequency ultrasound therapy for venous leg ulcer treatment: a randomized, controlled study. Ostomy Wound Manage. Aug 2013; 59(8): 14-20. PMID 23934374
14. White J, Ivins N, Wilkes A, et al. Non-contact low-frequency ultrasound therapy compared with UK standard of care for venous leg ulcers: a single-centre, assessor-blinded, randomised controlled trial. Int Wound J. Oct 2016; 13(5): 833-42. PMID 25619411
15. Gibbons GW, Orgill DP, Serena TE, et al. A prospective, randomized, controlled trial comparing the effects of noncontact, low-frequency ultrasound to standard care in healing venous leg ulcers. Ostomy Wound Manage. Jan 2015; 61(1): 16-29. PMID 25581604
16. Prather JL, Tummel EK, Patel AB, et al. Prospective Randomized Controlled Trial Comparing the Effects of Noncontact Low-Frequency Ultrasound with Standard Care in Healing Split-Thickness Donor Sites. J Am Coll Surg. Aug 2015; 221(2): 309-18. PMID 25868409

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16. Gottrup F, Apelqvist J, Price P. Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management. J Wound Care. Jun 2010; 19(6): 237-68. PMID 20551864
17. Association for the Advancement of Wound Care (AAWC). Guideline of Pressure Ulcer Guidelines. 2010; https://s3.amazonaws.com/aawc- new/memberclicks/AAWCPressureUlcerGuidelineofGuidelinesAug11.pdf. Accessed November 23,
19. Association for the Advancement of Wound Care (AAWC). International Consolidated Venous Ulcer Guideline (ICVUG) 2015 (Update of AAWC Venous Ulcer Guideline, 2005 and 2010). 2015; https://aawconline.memberclicks.net/assets/appendix%20c%20guideline%20icvug- textformatrecommendations-final%20v42%20changessaved18aug17.pdf. Accessed November 24,
21. National Institute for Health and Care Excellence. Medical technologies guidance (MTG5): The MIST Therapy system for the promotion of wound healing. July 25, 2011; https://www.nice.org.uk/guidance/mtg5/chapter/1-Recommendations. Accessed November 23, 2025.
22. O'Donnell TF, Passman MA, Marston WA, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery ® and the American Venous Forum. J Vasc Surg. Aug 2014; 60(2 Suppl): 3S-59S. PMID 24974070
23. Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. Feb 2016; 63(2 Suppl): 3S-21S. PMID 26804367
24. Gould LJ, Alderden J, Aslam R, et al. WHS guidelines for the treatment of pressure ulcers-2023 update. Wound Repair Regen. 2024; 32(1): 6-33. PMID 37970711