Archived Policies - DME


Noncontact Wound Therapy

Number:DME101.044

Effective Date:01-01-2008

End Date:03-31-2010

Coverage:

The use of noncontact, normothermic, wound therapy, either as a primary intervention or as an adjunct to other wound therapies, is considered experimental, investigational and unproven.

Noncontact, low-frequency ultrasound wound therapy is considered experimental, investigational and unproven.

Description:

An optimal environment for wound healing is thought to include a moist normo-thermic (normal body temperature) environment enhancing the subcutaneous oxygen tension and increasing the blood flow to the wound.  A device called Warm-Up Active Wound Therapy®, approved by the United States Food and Drug Administration (FDA), attempts to create this environment.  Contents include a noncontact bandage and warming unit designed to maintain 100% relative humidity, producing normothermia in the wound and surrounding tissues.  The bandage is composed of a sterile foam collar that adheres to the periwound (peripheral) skin, and a sterile transparent film covering the top of the wound, without making contact.  An infrared warming card is inserted into a pocket of the film covering.  Treatments are administered three times a day in one hour increments.

A similar type of wound therapy—noncontact, low-frequency ultrasound—is promoted for healing chronic wounds, such as pressure ulcers, diabetic foot ulcers, and vascular ulcers.  This therapy uses continuous, low-frequency ultrasonic energy to atomize saline and deliver continuous low-frequency ultrasound through the mist to the wound bed.  This is thought to result in cavitation and acoustic microstreaming, which in turn promote wound healing by stimulating fibroblast activity, increased blood flow, and tissue regeneration, and by debridement via removal of yellow slough, fibrin, tissue exudates, and bacteria.  In June 2005, Celleration, Inc., received FDA 501(k) clearance to market the MIST® Therapy System, which is a device that delivers low-frequency ultrasound-generated mist for wound therapy.

Rationale:

Normal components of wound therapy include:

  • Sharp debridement of devitalized tissue;
  • Infection control;
  • Non-weight bearing; and
  • Treatment of underlying comorbidities.

Therefore, substantiation of any adjunct to standard wound management requires a randomized controlled trial to isolate the contribution of the intervention compared to underlying wound management.

A review of literature identified one small randomized crossover trial of Warm-Up Active Wound Therapy® involving 13 patients who were followed for two weeks.  Compared to the control group more patients in the treatment group improved (62.5% vs. 37.5%).  However, the term “improvement” was not fully defined, and no statistical analysis was provided.  Stantilli and colleagues reported a two week trial of Warm-Up Active Wound Therapy® in which 17 patients with 31 wounds served as their own control.  Almost half of these patients, all refractory to prior therapy, reported complete healing within 12 weeks after treatment.  While studies of wound healing therapies frequently use patients as their own control, this trial design cannot isolate the contribution of the intervention.  It is possible that the wound-healing effect may be in part due to increased attentiveness to underlying wound care rather than to the Warm-Up Active Wound Therapy® itself.  Finally, Cherry and Wilson reported on a case series of five patients who received a two-week trial of Warm-Up Active Wound Therapy®.  Although four of the five patients reported complete healing at six to fourteen weeks after treatment, again a case series does not permit isolation of the contribution of the Warm-Up Therapy.  In addition, both in this trial and in the previous trial reviewed, it should be noted that wound healing occurred several weeks after discontinuation of the Warm-Up Therapy, further confounding any evaluation of the therapy. 

A review of the literature through July 2006 did not identify any studies that would address the limitations noted above.  In January 2002, the Centers for Medicare and Medicaid Services (CMS) published a review of the available literature of noncontact normothermic wound therapy, specifically literature focusing on the Warm-Up Active Wound Therapy® device.  CMS identified articles that met their selection criteria, including five randomized studies (two of which were not yet published) and three case series.  Data were separately analyzed for different types of wounds, i.e., pressure ulcers, venous stasis ulcers, diabetic/neuropathic ulcers, non-healing surgical incisions, and other types of chronic wounds.  The CMS review identified methodologic flaws in the trials in ensuring standard wound care in all patients, reporting of outcomes, or reporting statistical or clinical significance of outcomes.  The CMS assessment offered the following conclusion:

“In summary, the medical literature does not support a finding that noncontact normothermic wound therapy (NNWT) heals any wound type better than conventional treatment.  While the submitted studies purport better healing, due to serious methodologic weaknesses, inadequate controls, and a variety of biases the improved outcomes could also easily disappear in a properly controlled randomized trial.  Furthermore, there is no reason why such a trial could not be readily performed.  A trial that would best answer our coverage concerns would be one in which there was randomization to three arms:

  1. experimental arm which would receive NNWT;
  2. experimental arm which would receive NNWT, but with the healing element turned off; and
  3. control arm, which would only receive conventional therapy.

Conventional therapy should be standardized across all three arms as applicable”.

Several studies evaluating the MIST® Therapy System have been published.  However, the studies are small, the data is limited for proving its effectiveness to reduce wound volumes and time to wound healing, and comparison wound management is inconsistent across the studies.  The evidence is insufficient to conclude that the system improves net health outcomes, or is as effective as established wound management strategies.

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:

None


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.

Medicare (CMS) does have a national coverage position.

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

References:

Robinson, C., and S.M. Santilli.  Warm-Up Active Wound Therapy®: a novel approach to the management of chronic venous stasis ulcers.  Journal of Vascular Nursing (1998) 16(2):38-42.

Santilli, S., and Valusek, P., et al.  Use of a noncontact radiant heat bandage for the treatment of chronic venous stases ulcers.  Advance Wound Care (1999 March) 12(2):89-93.

Cherry, G.W., and J. Wilson.  The treatment of ambulatory venous ulcer patients with warming therapy.  Ostomy Wound Management (1999) 45(9):65-70.

Whitney, J.D., Salvadalena G., et al.  Treatment of pressure ulcers with noncontact normothermic wound therapy:  healing and warming effects.  Journal of Wound Ostomy Continence Nursing (2001) 28(5):244-52.

Noncontact Radiant Heat Bandage for the Treatment of Wounds.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2002 April 15) Medicine:2.01.41.

CMS – Medicare Coverage Database.  Normothermic Wound Therapy (NNWT). Centers for Medicare and Medicaid Services (2002 July 1) Durable Medical Equipment 270.2 (100-3):1. <http://www cms.hhs.gov>.

McCulloch, J., and C. A. Knight.  Noncontact normothermic wound therapy and offloading in the treatment of neuropathic foot ulcers in patients with diabetes.  Ostomy Wound Management (2002) 48(3):38-44.

Kloth, L., Berman, J., et al.  A randomized controlled clinical trial to evaluate the effects of noncontact normothermic wound therapy on chronic full-thickness pressure ulcers.  Advance Skin and Wound Care (2002 November-December) 15(6):270-6.

Alvarez, O.M., Rogers, R.S., et al.  Effect of noncontact normothermic wound therapy on the healing of neuropathic (diabetic) food ulcers:  an interim analysis of 20 patients.  Journal of Foot and Ankle Surgery (2003) 42(1):30-5.

Karr, J.C.  External thermoregulation of wounds associated with lower extremity osteomyelitis.  A pilot study.  Journal of American Podiatric Medical Association (2003) 63(1):18-22.

Ennis, W.J., Foremann,.P., et al.  Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study.  Ostomy Wound Management (2005 August) 51(8):24-39.

Ennis, W.J., Valdes, W., et al.  Evaluation of clinical effectiveness of MIST ultrasound therapy for the healing of chronic wounds.  Advanced Skin and  Wound Care (2006 October) 19(8):437-46.

MIST Therapy System, Proven healing-an advanced bioactive modality for modern wound care.  Celelration, Incorporated (2006 April 1) Available at >http://www.celleration.com> (accessed 2007 October 12).

Gehling, M.L., and J.H. Samies.  The effect of noncontact, low-intensity, low-frequency therapeutic ultrasound on lower-extremity chronic wound pain: a retrospective chart review.  Ostomy Wound Management (2007 March) 53(3):44-50.

Kavros, J.J., and E.C. Schenck.  Use of noncontact low-frequency ultrasound in the treatment of chronic foot and leg ulcerations: a 51-patient analysis.  Journal of American Podiatric Medical Association (2007 March-April) 97(2):95-101.

Kavros, S.J., Miller, J.L., et al.  Treatment of ischemic wounds with noncontact, low-frequency ultrasound: the Mayo Clinic experience, 2004-2006.  Advanced Skin and Wound Care (2007 April) 20(4):221-6.

Policy History:

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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