Latest Review Date: January 2024

Category:  Medical                                                                

POLICY:

Non-contact ultrasound treatment for wounds is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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.

Ultrasound (US) delivers mechanical vibration above the upper threshold of human hearing (greater than 20 kHz). US in the megahertz (MHz) range (1–3 MHz) have been used for the treatment of musculoskeletal disorders, primarily 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 and collagen production, and increases in macrophage responsiveness, fibrinolysis, and nitric oxide levels. The therapeutic effects of US energy in the KHz range have also been examined. Although the precise effects are not known, 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 US is typically transmitted to tissue through a coupling gel. Several high-intensity US devices with contact probes are currently available for wound debridement. Low-intensity US devices have been developed that do not require use of a 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 ultrasound 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.

The primary end points of interest for trials of wound closure are as follows, consistent with 2006 guidance from the U.S. Food and Drug Administration for industry in developing products for treatment of chronic cutaneous ulcer and burn wounds:

1. Incidence of complete wound closure.
2. Time to complete wound closure (reflecting accelerated wound closure).
3. Incidence of complete wound closure following surgical wound closure.
4. Pain control

KEY POINTS:

The most recent literature search was performed through December 29, 2023.  

Summary of Evidence

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.

Practice Guidelines and Position Statements 

Association for the Advancement of Wound Care

In 2010, the Association for the Advancement of Wound Care (AAWC) published guidelines on the care of pressure ulcers. Noncontact low-frequency ultrasound therapy was included as a potential second-line intervention if first-line treatments did not result in wound healing.

The AAWC guidelines on the treatment of venous ulcers, updated in 2015, stated that low-frequency ultrasound treatment requires additional evidence before it can be considered an appropriate treatment.

National Institute for Health and Care Excellence

In 2011, the National Institute for Health and Care Excellence published a medical technologies guidance on the MIST Therapy system for the promotion of wound healing. The assessment concluded that "the amount and quality of published evidence on the relative effectiveness of the MIST Therapy system is not sufficient, at the time of writing, to support the case for routine adoption of the MIST Therapy system in the NHS." This guidance was last reviewed in 2016 with no changes to the recommendations. NICE states that the guidance will be reviewed in the future if there is new evidence that is likely to change the recommendations.

Society for Vascular Surgery, American Venous Forum, American Podiatric Medical Association

In 2014, the Society for Vascular Surgery in collaboration with the American Venous Forum published joint guidelines on the management of venous leg ulcers. The guidelines recommended adjuvant wound therapy options for venous leg ulcers that fail to demonstrate improvement after 4 to 6 weeks of standard wound therapy (strength of recommendation: grade 1; quality of evidence: level B), but recommended against routine ultrasound therapy for venous leg ulcers (strength of recommendation: grade 2; quality of evidence: level B). This guideline is currently archived.

In 2016, the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association published joint guidelines on the management of diabetic foot ulcers. The guidelines recommended adjuvant therapy for diabetic foot ulcers that fail to demonstrate more than 50% wound area reduction after 4 weeks of standard wound therapy. The adjunctive wound therapy options listed in the guidelines included negative pressure therapy, biologics (platelet-derived growth factor, living cellular therapy, extracellular matrix products, amniotic membrane products), and hyperbaric oxygen therapy. Ultrasound therapy was not mentioned as a recommended adjuvant option.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Non-contact ultrasound treatment for wounds, non-contact low-frequency ultrasound, MIST Therapy®System, AR100 Ultrasonic Wound Therapy System, Celleration MIST Therapy, Qoustic Wound Therapy System™

APPROVED BY GOVERNING BODIES:

In 2005, the MIST Therapy®device (Celleration) was cleared for marketing by the FDA 510(k) process, “to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.” In February 2015, Celleration was acquired by Alliqua Biomedical (Langhorne, PA). In August 2020, Sanuwave acquired related UltraMist System assets.

In 2007, the AR1000 Ultrasonic Wound Therapy System (Arobella Medical, Minnetonka, MN) was cleared for marketing by FDA through the 510(k) process, listing the MIST Therapy®device 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, burns) 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™ (K131096).

BENEFIT APPLICATION:

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

ITS: Home Policy provisions apply

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

CURRENT CODING: 

CPT Codes:

REFERENCES:

1. Association for the Advancement of Wound Care (AAWC). Guideline of Pressure Ulcer Guidelines. 2010; s3.amazonaws.com/aawcnew/memberclicks/AAWCPressureUlcerGuideline of Guidelines Aug11.pdf.
2. 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; aawconline.memberclicks.net/assets/appendix%20c%20guideline%20icvug-textformatrecommendations- final%20v42%20changessaved18aug17.pdf.
3. 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. Nov-Dec 2014; 23(6):969-975.
4. 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.
5. 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.
6. Chen H, Yu Z, Liu N, Huang J, Liang X, Liang X, Liang M, Li M, Ni J. The efficacy of low-frequency ultrasound as an added treatment for chronic wounds: A meta-analysis. Int Wound J. 2023 Feb;20(2):448-457. doi: 10.1111/iwj.13893. Epub 2022 Jul 19.
7. Driver VR, Yao M, Miller CJ. Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: A meta-analysis. Wound Rep Reg 2011; 19(4):475-80.
8. 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
9. Food and Drug Administration. 510(k) Summary: 510(k) -AR1000 Series K131096, Arobella Medical, LLC. 2014; www.accessdata.fda.gov/cdrh_docs/pdf13/K131096.pdf.
10. Food and Drug Administration. MIST[TM] Therapy System: 510(k) Premarket Notification: K050129. www.accessdata.fda.gov/cdrh_docs/pdf5/K050129.pdf.
11. 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.
12. 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): 237-268
13. Guidance for Industry, Chronic Cutaneous Ulcer and Burn Wounds -- Developing Products for Treatment. In: Administration FaD, ed2006.
14. 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.
15. Honaker JS, Forston MR, Davis EA et al. Effects of non contact low-frequency ultrasound on healing of suspected deep tissue injury: a retrospective analysis. Int Wound J 2012.
16. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
17. 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): 221-226
18. O'Donnell TF, Jr., Passman MA, Marston WA, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (R) and the American Venous Forum. J Vasc Surg. Aug 2014; 60(2 Suppl):3s-59s.
19. 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 2013; 59(8):14-20.
20. 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): 311-314
21. 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):309-318.
22. 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.
23. 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 2011; 10(4):190-199.
24. 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):833-842.

POLICY HISTORY:

Medical Policy Group, December 2007 (2)

Medical Policy Administration Committee, January 2008

Available for comment January 5-February 20, 2008

Medical Policy Group, December 2009 (1)

Medical Policy Panel, October 2010

Medical Policy Group, November 2010 (2)

Medical Policy Group, June 2012 (4): Updated Key Points and References.

Medical Policy Panel, October 2012

Medical Policy Group, January 2013 (4): Updates to Key Points and References; Policy statement remains unchanged.

Medical Policy Group, December 2013 (3):  2014 Coding Update – added new code 97610 to current coding (effective 01/01/2014); moved code 0183T to previous coding (deleted effective 01/01/2014)

Medical Policy Panel, November 2013: 2014 Coding Update: Added code 97610 and deleted 0183T.

Medical Policy Group, January 2014 (2): policy updated with literature review through September 2013.  Policy statement unchanged.  Description, Key Words, Key Points, and References updated. 

Medical Policy Panel, November 2014

Medical Policy Group, November 2014 (4):  Update to Key Points.  No change in policy statement.

Medical Policy Panel, January 2016

Medical Policy Group, February 2016 (2): 2016 Updates to Description, Key Points, Approved by Governing Bodies, and References; no change to policy statement.

Medical Policy Panel, January 2017

Medical Policy Group, January 2017 (7): Updates to Description, Key Points & References. No change to policy statement.

Medical Policy Panel, January 2018

Medical Policy Group, January 2018 (7):  Updates to Description, Key Points, Coding, and References; removed Previous Coding section, including CPT code 0183T that was deleted 1/1/14.

Medical Policy Panel, January 2019

Medical Policy Group, February 2019 (7): Minor update to Key Points. No new literature to add. No change in Policy Statement.

Medical Policy Panel, January 2020

Medical Policy Group, January 2020 (5): Minor update to Key Points. No change to Policy Statement.

Medical Policy Panel, February 2021

Medical Policy Group, February 2021 (5): Update to Description, Key Points, Practice Guidelines and Position Statements, and References. Retiring policy; no change to Policy Statement. Retired: Effective February 22, 2021.

Medical Policy Panel, January 2022

Medical Policy Group, January 2022 (5): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to policy statement.

Medical Policy Panel, January 2023

Medical Policy Group, January 2023 (5): Updates to Key Points, Practice Guidelines and Position Statements, Benefit Application, and References. No change to Policy Statement.

Medical Policy Panel, January 2024

Medical Policy Group, January 2024 (9): Updates to Key Points, Approved by Governing Bodies, Benefit Application, and References. No change to Policy Statement.

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.