Archived Policies - DME


Ultrasound Wound Therapy

Number:DME101.044

Effective Date:06-15-2017

End Date:06-30-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Ultrasound wound therapy is considered experimental, investigational, and/or unproven.

Description:

Ultrasound (US) is defined as a mechanical vibration above the upper threshold of human hearing (>20 kHz). US in the megahertz range (1-3 MHz) have been used to treat 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 kilohertz 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 débridement. Recently, 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.

Regulatory Status

In 2005, the Celleration MIST Therapy device was cleared for marketing by the United States Food and Drug Administration (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.” In February 2015, Celleration was acquired by Alliqua Biomedical (Langhorne, PA).

In 2007, the AR1000 Ultrasonic Wound Therapy System (Arobella Medical, Minnetonka, MN) received marketing clearance, listing the Celleration MIST system and several other ultrasonic wound débridement and hydrosurgery systems as predicate devices. The AR1000 system uses a combination of irrigation and US with a contact probe to débride and cleanse wounds. The indications are similar to that of the MIST system, listed as: “selective dissection and fragmentation of tissue, wound débridement (acute and chronic wounds, burns, diseased or necrotic tissue), and cleansing irrigation of the site for the removal of debris, exudates, fragments, and other matter.” 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.

Rationale:

The literature review focused on comparative studies, preferably randomized, evaluating whether the addition of noncontact low-frequency ultrasound (NLFU) improves wound healing in comparison with standard treatment alone.

Systematic Reviews

Two systematic reviews were published in 2011. An industry-sponsored review by Driver et al. considered both controlled and uncontrolled studies on NLFU therapy for treating chronic wounds. (1) Eight studies with at least 4 weeks of follow-up were included; 1 was a randomized controlled trial (RCT) and the rest were observational studies. The major limitation of this meta-analysis was that there were no pooled comparisons of NLFU therapy to optimal wound care alone or to an alternative intervention. Thus conclusions cannot be drawn about the incremental benefit of NLFU treatment over optimal wound care alone.

The second systematic review, by Voigt et al. (2011), only included RCTs; studies used contact or noncontact US for treating chronic lower-limb wounds. (2) Five RCTs on NLFU were identified, 1 of which was unpublished. A pooled analysis of 2 sham-controlled trials found a significantly smaller proportion of non-healed wounds at 3 months in the NLFU group than in the control group (risk ratio, 0.74; 95% confidence interval, 0.58 to 0.95; p=0.02). This analysis included the Ennis et al. (2005) study, described in detail next, and a study from the 1990s that delivered US therapy during foot bathing (i.e., the study did not use a modern device).

Randomized Controlled Trials

One double-blind, multicenter, sham-controlled trial was identified. In 2005, Ennis et al published findings of MIST therapy for recalcitrant diabetic foot ulcers in 133 patients. (3) Patients were treated with active or sham MIST therapy 3 times per week, with débridement as needed and a weekly evaluation by an independent investigator. Twenty-four patients were lost to follow-up, and data from 54 patients were excluded from analysis due to protocol violations (5 centers inverted the treatment distances for the active and sham devices), leaving 55 (41%) patients for the per-protocol analysis. The investigators reported significant improvement in the active treatment group (11/27 [41%] patients) compared with the control group (4/28 patients [14%]) in the proportion of wounds healed (defined as complete epithelialization without drainage). However, intention-to-treat analysis showed no difference in wound healing (26% vs 22%, respectively) 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 cm2 vs 4.4 cm2, respectively) and chronicity of wounds (35 weeks vs 67 weeks, respectively) that favored MIST therapy in the per-protocol groups. Due to the serious limitations of this study, these results are considered inconclusive.

A number of unblinded RCTs comparing NLFU with standard wound care alone and including at least 25 patients have been published. (4-9) All RCTs used MIST therapy and, other than 2 trials (Beheshti et al. [7]; Olyaie et al. [9]) that did not report a funding source, all were industry funded. One study addressed diabetic foot ulcers, the population included in the 2005 RCT by Ennis et al., discussed above. Four RCTs included patients with venous leg ulcers and 1 RCT evaluated treatment of split-thickness graft donor sites. All studies except the 1 on split-thickness graft donor sites included patients with nonhealing wounds; eligibility criteria included wounds that had not healed after at least 4 weeks. In the White et al. (6) Gibbons et al. (4) and Prather et al. (5) studies, patients and providers were not blinded but outcome assessment was blinded. The other studies did not mention blinding. Standard care interventions varied somewhat, but generally consisted of wound cleaning, noncontact dressings, compression and, if deemed necessary by providers, débridement. In 2 studies (White et al., Gibbons et al.), authors mentioned following national guidelines for the standard care intervention. Prather et al. did not describe the standard care intervention and Beheshti et al. reported only that compression was used. Study characteristics and findings are summarized in Table 1.

All but 1 of the RCTs in Table 1 had statistically significantly better results for the primary outcome with NLFU than with standard of care. However, studies had methodologic limitation. In terms of outcome assessment, complete healing is generally considered the most clinically relevant outcome; a 50% reduction in wound area over time and time to heal are also considered to be acceptable outcomes. (10) A reduction of less than 50%, or wound area reduction without a predefined cutoff, is not considered acceptable. The largest number of trials included patients with venous leg ulcers. None of these RCTs had blinded outcome assessment, reported complete healing, or used one of the other acceptable measures as the primary outcome. Only 1 RCT (Prather study on split-thickness graft donor sites) met both of these criteria. Another limitation of the body of evidence is that some of the standard care interventions involved fewer visits than the NLFU intervention, and the nonspecific effects of this differential in face-to-face contact could partially explain the difference in findings between intervention and control groups.

Table 1: RCTs Comparing NLFU to Standard Care with at Least 25 Patients

Study

Initial N

Final N

Wounds included

Interventions

Primary Outcome and Was Outcome Assessment Blinded?

Results

White et al. (2015)

N=36

N=36

Venous leg ulcers (≥6 wk).

NLFU: 3x/week for 8 wk (after 2-wk run-in period).

SOC: >1 visit per week for 8 wks.

Percent wound area reduction at 13 weeks.

Yes.

NLFU + SOC: -46.6% (SD=38.1%).

SOC: -39.2% (SD=38.0%) p=0.565.

Gibbons et al. (2015)

N=81

N=74

Venous leg ulcers (≥30 d).

NLFU: 3x/week for 4 weeks.

SOC: 3x/wk for 4 weeks.

Percent wound area reduction at 4 weeks.

Yes.

NLFU + SOC: -61% (SD=28.9%).

SOC: -45% (SD=32.5%) p=0.002.

Beheshti et al. (2014)

N=90

N=90

Venous leg ulcers (≥4 wk).

NLFU: 3x/week until healed (same protocol for HFU).

SOC: Compression therapy (visit frequency not reported).

Time to wound healing (months).

NR.

NLFU + SOC: 5.70 (SD=1.57) HFU + SOC: 6.10 (SD=1.47).

SOC: 8.13 (SD=1.40) 3 groups: p<0.001.

HFU vs NLFU: p=0.22.

Olyaie et al. (2013)

N=90

N=90

Venous leg ulcers (≥4 wk).

NLFU: 3x/week for 3 months or until healed (same protocol for HFU).

SOC: 3x/week for 3 months or until healed.

Time to wound healing (months). a

NR.

NLFU + SOC: 6.65 (SD=1.59).

HFU + SOC: 6.86 (SD=2.04) SOC: 8.50 (SD=2.17).

3 groups: p=0.001.

HFU vs NLFU: p not reported.

Kavros et al. (2007)

N=70

N=70

Nonhealing foot, ankle, or leg wounds (≥8 weeks).

NLFU: 3x/week for 12 weeks.

SOC: Daily visits.

Proportion of patients with >50% wound healing healed at 12 weeks.

NR.

NLFU + SOC: 63%.

SOC: 29%.

p<0.001

Prather et al. (2015)

N=31

N=27

Split-thickness

graft donor sites.

NLFU: 1x/week for 5 consecutive days (after 2-week run-in period).

SOC: 1x/week for 5 consecutive days (after 2-week run-in period).

Time to wound healing (days).

Yes.

NLFU + SOC: 12.1 (SD=6.0).

SOC: 21.3 (SD=14.7).

p=0.04.

Table key: HFU: high-frequency ultrasound; NLFU: noncontact low-frequency ultrasound; NR: not reported; SOC: standard of care.

a Reported this outcome; did not specify primary outcome.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov did not identify any ongoing or unpublished trials that would likely influence this review.

Summary of Evidence

The evidence for noncontact low-frequency ultrasound (NLFU) in individual who have any wound type (acute or nonhealing) 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 RCT, which included patients with nonhealing diabetic foot ulcers, had substantial methodologic flaws that limit the validity of the findings (e.g., high dropout rate, baseline differences between groups). All but 1 RCT comparing NLFU to standard wound care had statistically significantly better results on the primary outcome with NLFU. However, studies had methodologic limitations. In terms of outcome assessment, complete healing is generally considered the most clinically relevant outcome; a 50% reduction in wound area over time and time to heal are also considered acceptable outcomes. The largest number of trials included patients with venous leg ulcers.

None of the RCTs on venous leg ulcers reported complete healing or another acceptable outcome as the primary outcome measure, and none had blinded outcome assessment. Only 1 RCT, which addressed split-thickness graft donor sites, met both criteria. Another limitation of the body of evidence is that some standard of care interventions involved fewer visits than the NLFU intervention, and the nonspecific effects of 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 the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

In 2010, the Association for the Advancement of Wound Care (AAWC) published a guideline on care of pressure ulcers. (11) NLFU therapy was included as a potential second-line intervention if first-line treatments did not result in wound healing.

The AAWC guideline on treatment of venous ulcers, updated in 2011, states that low-frequency US treatment requires additional evidence before it can be considered an appropriate treatment. (12)

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

97610

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. 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):475-480.

2. 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. December 2011; 10(4):190-199. PMID 22184750.

3. 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. 2005; 51(8):24-39.

4. 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. January 2015; 61(1):16-29. PMID 25581604.

5. 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. August 2015; 221(2):309-318. PMID 25868409.

6. 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. January 25 2015. PMID 25619411.

7. 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. November-December 2014; 23(6):969-975. PMID 25618125.

8. 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. 2007; 20(4):221-226.

9. 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. August 2013; 59(8):14-20. PMID 23934374.

10. Gottrup F, Apelqvist J, Price P, et al. Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management. J Wound Care. June 2010; 19(6):237-268. PMID 20551864.

11. Association for the Advancement of Wound Care (AAWC) (2010). Pressure Ulcer Guideline. Available at <http://www.guideline.gov> (accessed May 13, 2016).

12. Association for the Advancement of Wound Care (AAWC) (2011). Venous Ulcer Guideline. Available at <http://www.guideline.gov>. (accessed May 13, 2016).

13. Noncontact ultrasound treatment for Wounds. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (January 2017) 2.01.79.

Policy History:

Date Reason
6/15/2017 Reviewed. No changes.
7/1/2016 Document updated with literature review. The following change(s) were made: Coverage for noncontact normothermic wound therapy was moved to policy DME101.050. Coverage unchanged for ultrasound wound therapy. Document title changed from Noncontact Wound Therapy.
7/1/2015 Policy updated with literature review. Coverage unchanged.
11/1/2014 Document updated with literature review. Coverage unchanged.
4/15/2012 Document updated with literature review. Coverage unchanged.
4/1/2010 Document updated with literature review. Coverage unchanged.
1/1/2008 Document updated with literature review. The following change was made: Noncontact, low frequency ultrasound wound therapy is considered experimental, investigational and unproven.
10/1/2006 Document updated with literature review
7/1/2004 New medical document. .

Archived Document(s):

Title:Effective Date:End Date:
Ultrasound Wound Therapy07-01-201804-14-2019
Ultrasound Wound Therapy06-15-201706-30-2018
Ultrasound Wound Therapy07-01-201606-14-2017
Noncontact Wound Therapy07-01-201506-30-2016
Noncontact Wound Therapy11-01-201406-30-2015
Noncontact Wound Therapy04-15-201210-31-2014
Noncontact Wound Therapy04-01-201004-14-2012
Noncontact Wound Therapy01-01-200803-31-2010
Noncontact Normothermic Wound Therapy10-01-200612-31-2007
Noncontact Normothermic Wound Therapy07-01-200409-30-2006
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