Non-Contact Ultrasound Treatment for Wounds Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 09|01|2019 POLICY LAST REVIEWED: 03|05|2025 OVERVIEW 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. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans Non-contact ultrasound treatment for wounds is considered not covered as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Commercial Products Non-contact ultrasound treatment for wounds is considered not medically necessary as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. COVERAGE Benefits may vary between groups/contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for limitations of benefits/coverage for not covered/not medically necessary. BACKGROUND 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 debridement 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. In 2005, the MIST Therapy® device (Celleration) was cleared for marketing by the FDA through the 510(k) process “to promote wound healing through wound cleansing and maintenance debridement by the removal Medical Coverage Policy | Non-Contact Ultrasound Treatment for Wounds

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

of yellow slough, fibrin, tissue exudates, and bacteria.”, In February 2015, Celleration was acquired by Alliqua Biomedical (Langhorne, PA).

In 2007, the AR1000 Ultrasonic Wound Therapy System (Arobella Medical, Minnetonka, MN) was cleared for marketing by the FDA through the 510(k) process, listing the MIST Therapy® system and several other ultrasonic wound débridement and hydrosurgery systems as predicate devices. The AR1000 system probe uses “contact or noncontact techniques to achieve intended wound therapy modalities to promote wound healing." Indications in the 510(k) summary are listed as “Selective and non-selective dissection and fragmentation of soft and or hard tissue” and “Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, bums) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and eschar, fibrin, tissue exudates, bacteria and other matter.” This device is now known as the Qoustic Wound Therapy System™.

For individuals who have any wound type (acute or nonhealing) who receive noncontact ultrasound therapy 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 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.

CODING Medicare Advantage Plans and Commercial Products The following CPT code(s) is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: 97610 Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day

RELATED POLICIES None

PUBLISHED Provider Update, May 2025 Provider Update, April 2024 Provider Update, April 2023 Provider Update, June 2022 Provider Update, May 2021

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 December 24, 2024.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

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 December 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 ExtremWounds. 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-
8. PMID 16234574
9. 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
10. 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
11. 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
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
17. 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
18. Association for the Advancement of Wound Care (AAWC). Guideline of Pressure Ulcer Guidelines. 2010; https://s3.amazonaws.com/aawc- new/memberclicks/AAWCPressureUlcerGuidelineofGuidelinesAug11.pdf. Accessed December 23,
20. 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 December 24, 2024.
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 December 23, 2024.
22. 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 VascularMedicine. J Vasc Surg. Feb 2016; 63(2 Suppl): 3S-21S. PMID 26804367
23. 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. PMID24974070 i

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS