Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Ultrasound Treatment for Wounds, Non-Contact

Description:

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 (> 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 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 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 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 wounds (CDER, CBER, CDRH, 2006):

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.

Regulatory Status

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 débridement by the removal of yellow slough, fibrin, tissue exudates, and bacteria.” (FDA, 2005). 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."(FDA, 2014) 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.” (FDA, 2014). This device is now known as the Qoustic Wound Therapy System™.

Several other devices have been approved as being substantially equivalent to the earlier devices. FDA product code: NRB.

Coding

Beginning January 2014, there is a specific CPT code for this service. CPT 97610: Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day. Prior to 2014, a category III CPT code 0183T was used to identify this service.

Ultrasound for fracture healing is discussed separately in policy 1998023.

Policy/
Coverage:

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Non-contact ultrasound treatment for wounds does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, non-contact ultrasound treatment for wounds is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:

The objective of this review is to evaluate whether the addition of non-contact US with saline mist improves wound healing in comparison with standard treatment alone. Two industry-sponsored randomized controlled trials (RCTs) have assessed the incremental benefit of MIST therapy on wound healing.

One double-blind multicenter RCT used MIST therapy for recalcitrant diabetic foot ulcers. Most of the 133 patients (85%) were enrolled and treated at 17 different wound clinics/private practice centers. An additional 15% of patients were enrolled at 6 university medical clinics. Patients with recalcitrant foot ulcers were treated with active or sham saline mist therapy 3 times per week, with debridement as needed and a weekly evaluation by an independent investigator. Twenty-four patients were lost to follow-up, and data from 54 patients was excluded from analysis due to protocol violations (5 centers were found to have inverted the treatment distances for the active and sham devices), leaving 55 patients (41%) for the per-protocol analysis. The investigators reported significant improvement [11 of 27 patients (41%) vs. 4 of 28 patients (14%)] in the proportion of wounds healed (defined as complete epithelialization without drainage). However, intent-to-treat analysis showed no difference in wound healing (26% vs. 22%) between the active (n=70) and control (n= 63) groups. In addition to the 59% loss to follow-up, there was a difference in the ulcer area at baseline (1.7 vs. 4.4 cm2) and chronicity of wounds (35 vs. 67 weeks) that favored MIST therapy in the per-protocol groups. Due to the serious limitations of this study, these results are considered inconclusive.

A second trial randomized 70 patients with nonhealing (2 months) foot, ankle, or leg wounds to standard of care alone or standard of care plus MIST therapy for 12 weeks. To participate, patients with documented ischemia (transcutaneous oximetry of 40 mm Hg or less) had to agree to 3 times per week visits for therapy. This open-label (non-blinded) study found that a greater proportion of patients in the MIST therapy group (22/35, or 63%) achieved wound healing (defined as a reduction of wound area greater than 50%) in comparison with standard of care alone (10/35 or 29% of patients). Non-specific effects of the additional treatment sessions were not controlled for. In addition, although the study reported on the importance of baseline TcPO2 on wound healing, patients with low (1-20 mm Hg) and high (21-40 mm Hg) TcPO2 levels do not appear to be equally distributed between the groups. Well-designed and blinded studies with additional subjects, that include all relevant outcomes, are needed to evaluate this treatment.

2012 Update

In a retrospective analysis by Kavros and colleagues, wound healing in 163 patients treated with MIST therapy (3 times per week for 90 days) was found to be 53%, compared with 32% from 47 matched controls treated during the same period who were unable to undergo 3 weekly visits (Kavros, 2008).

An industry-sponsored meta-analysis, published in 2011, identified 10 studies evaluating non-contact low-frequency US therapy for treating chronic wounds (Driver, 2011). To be eligible for inclusion in the meta-analysis, studies had to have at least 4 weeks of follow-up (Driver, 2011). Two studies were excluded, 1 because data were not in a form suitable for pooling and the other because follow-up time was too short. Of the remaining 8 studies, 1 was a RCT, and the remainder were observational studies (5 retrospective analyses and 2 prospective studies). A pooled analysis of findings from 7 studies (total n=429) found that a mean of 32.7% (95% confidence interval [CI]: 23.3% to 42.1%) of patients had healed wounds by a mean of 6 weeks. A pooled analysis of 4 studies (total n=188) found a mean of 85.2% (95% CI: 64.7% to 97.6%) reduction in wound area by final follow-up. The major limitation of this meta-analysis was that there were no pooled comparisons of non-contact US therapy to optimal wound care alone, or to an alternative intervention. Thus conclusions cannot be drawn about the incremental benefit of non-contact ultrasound treatment over optimal wound care alone.

Other studies include a systematic review, published in 2008, that identified the 2 randomized trials described above and no additional studies (Ramundo, 2008). Non-contact US for treating wounds has also been evaluated in case series, such as a retrospective chart review involving 76 patients (Bell, 2008). In addition, use of non-contact ultrasound for burns has been reported in a small uncontrolled case series (Samies, 2008).

Practice Guidelines and Position Statements

In 2010, the Association for the Advancement of Wound Care (AAWC) published a guideline on care of pressure ulcers (AAWC, 2011). Non-contact ultrasound therapy was included as a potential second-line intervention if first-line treatments did not result in wound healing.

Summary

Currently available scientific evidence does not permit conclusions concerning the effect of this technology on health outcomes. There are two RCTs that report benefits on some outcomes, but both trials have substantial methodologic flaws that limit the validity of the findings. Well-designed, blinded studies that have adequate numbers of patients and that include all relevant outcomes are needed to further evaluate the efficacy of this treatment.

2013 Update

A literature search conducted through July 2013 did not reveal any new literature that would prompt a change in the coverage statement. The following is a summary of the key identified literature.

A systematic review, published in 2011, examined the literature on non-contact or contact ultrasound for treating chronic wounds (Voigt, 2011). Five RCTs were identified on non-contact ultrasound. One of these studies was unpublished, 2 were trials described in an earlier update (Ennis, 2005; Kavros, 2007), and 2 were older studies from the 1990s that involved the delivery of ultrasound while the wounded area was in a footbath. They conducted one pooled analysis of findings on efficacy of non-contact ultrasound. Two RCTs, the Ennis et al. study on MIST therapy (Ennis, 2005) and one on ultrasound delivered during foot bathing were included. The studies included a total of 75 patients; the Ennis study contributed 55 of these. A pooled analysis found a significantly smaller proportion of non-healed wounds at 3 months in the non-contact ultrasound group compared to the control group (risk ratio [RR]: 0.74, 95% CI: 0.58 to 0.95). There are several limitations of the Ennis study which are included in the above description of this trial e.g., high dropout rate, baseline differences between groups, etc. These potential biases also limit the ability to draw conclusions about the efficacy of treatment in the pooled analysis.

A recent non-randomized controlled study addressed non-contact low-frequency ultrasound for patients with suspected deep tissue injury (SDTI). SDTI is a new pressure ulcer stage (added to the staging system in 2007), which is characterized as purple or maroon-colored, localized of either intact skin or a blood-filled blister due to soft tissue damage from pressure ulcers and/or shear. In 2012, Honaker and colleagues retrospectively reported on 43 patients who received non-contact US with the MIST Therapy System in addition to usual care and 42 patients who received usual care only (Honaker, 2012). There were a total of 64 wounds in the treatment group and 63 in the control group. The treatment group received a mean of 10 US treatments. The authors noted that standardized severity scales are not available for SDTI; therefore, they assessed various attributes of the wounds and devised their own severity scale, which ranged from 3-18 points. The mean wound severity score for the usual care group was 9.6 at baseline and 10.7 at final assessment (mean increase of 1.1 points). In the treatment group, the mean wound severity score for the non-contact US group was 9.0 at baseline and 7.6 at final assessment (mean decrease of 1.4 points). The difference in severity at the final assessment differed significantly between groups. Among the individual outcomes assessed, data on total wound surface area at both initial and final assessment were reported. The median total surface area of the wounds at baseline was 8.25 cm in the treatment group and 11.25 cm in the comparison group. At final assessment, the median size was 2.1 cm in the treatment group (median change of 6.24 cm) and 8 cm in the control group (median change of 3.25 cm). Conclusions from this study are limited due to methodologic concerns. These include the retrospective study design, the lack of randomized treatment assignment, the lack of standardized instruments for outcome assessment, and failure to include the most relevant outcome measure of complete wound healing.

2014 Update

A literature search conducted using the MEDLINE database through July 2014 did not reveal any new literature that would prompt a change in the coverage statement.

2016 Update

A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement.

2017 Update

A literature search conducted using the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement. One systematic review (Tricco, 2015) was identified but did the conclusions were insufficient to determine the effects of the technology on health outcomes.

2018 Update

A literature search conducted using the MEDLINE database through January 2018 did not reveal any new information that would prompt a change in the coverage statement.

2019 Update

Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement.

2020 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2020. No new literature was identified that would prompt a change in the coverage statement.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2021. No new literature was identified that would prompt a change in the coverage statement.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2022. No new literature was identified that would prompt a change in the coverage statement.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement.

2024 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:

References:

Association for the Advancement of Wound Care (AAWC).(2012) Association for the Advancement of Wound Care guideline of pressure ulcer guidelines. Malvern, PA. Available online at: www.guideline.gov .

Bell AL, Cavorsi J.(2008) Noncontact ultrasound therapy for adjunctive treatment of nonhealing wounds: retrospective analysis. Phys Ther 2008; 88(12):1517-24.

Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH).(2006) Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds -- Developing Products for Treatment. Rockville (MD): Food and Drug Administration; 2006 June.

Chang YR, Perry J, Cross K.(2017) 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

Driver VR, Yao M, Miller CJ.(2011) Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: A meta-analysis. Wound Rep Reg 2011; 19(4):475-80.

Ennis WJ, Foremann P, et al.(2005) Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage, 2005; 51:24-39.

Food and Drug Administration (FDA).(2014) 510(k) Summary: 510(k) -AR1000 Series K131096, Arobella Medical, LLC. 2014; https://www.accessdata.fda.gov/cdrh_docs/pdf13/K131096.pdf. Accessed November 3, 2020

Food and Drug Administration (FDA).(2020) MIST[TM] Therapy System: 510(k) Premarket Notification: K050129. https://www.accessdata.fda.gov/cdrh_docs/pdf5/K050129.pdf. Accessed November 4, 2020.

Hingorani A, LaMuraglia GM, Henke P, et al.(2016) 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

Honaker JS, Forston MR, Davis EA et al.(2012) Effects of non contact low-frequency ultrasound on healing of suspected deep tissue injury: a retrospective analysis. Int Wound J 2012.

Kavros SJ, Liedl DA, Boon AJ et al.(2008) Expedited wound healing with noncontact, low-frequency ultrasound therapy in chronic wounds: a retrospective analysis. Adv Skin Wound Care 2008; 21(9):416-23.

Kavros SJ, Miller JL, Hanna SW.(2007) Treatment of ischemic wounds with noncontact, low-frequency ultrasound: the Mayo clinic experience, 2004-2006. Adv Skin Wound Care, 2007; 20:221-6.

O'Donnell TF, Jr., Passman MA, Marston WA, et al.(2014) 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. PMID 24974070

Ramundo J, Gray M.(2008) Is ultrasonic mist therapy effective for debriding chronic wounds? J Wound Ostomy Continence Nurs 2008; 35(6):579-83.

Samies J, Gehling M.(2008) Acoustic pressure wound therapy for management of mixed partial- and full-thickness burns in a rural wound center. Ostomy Wound Manage 2008; 54(3):56-9.

Tricco AC, Antony J, Vafaei A, et al.(2015) Seeking effective interventions to treat complex wounds: an overview of systematic reviews. BMC Med. Apr 22 2015;13:89. PMID 25899006

Voigt J, Wendelken M, Driver V et al.(2011) 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):190-9.

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association.