BlueCross BlueShield of Tennessee Medical Policy Manual

Negative Pressure Wound Therapy in the Outpatient Setting

DESCRIPTION

Negative pressure wound therapy is intended to promote healing of acute or chronic wounds. It is used as an adjunct to or an alternative to surgery for individuals who have failed a complete wound therapy program, are debilitated and cannot have surgery, or for whom the use of such a program has been ruled out.

Negative pressure wound therapy involves either a powered or non-powered suction apparatus device:

• Powered suction apparatus device consists of low powered, battery operated/electromechanical pumps (see the table listed under additional information for examples) to aspirate and remove excess interstitial fluids, debris, and infectious materials from the wound bed. The system consists of a foam dressing that is sealed with an occlusive dressing. An evacuation tube leads from the wound to a canister that is attached to a negative pressure pump. The negative pressure removes excessive interstitial fluid from the wound either intermittently or continuously. This increases the wound vascularity promoting the formation of granulation tissue that draws the edges of the wound closer together promoting healing. This device is also known as vacuum assisted wound closure device.

• Non-powered suction apparatus device (e.g., Smart Negative Pressure (SNaP) Wound Care System) consists of a disposable suction cartridge which maintains a constant negative pressure within the chamber for the removal of small amounts of exudate from the wound. The system consists of the cartridge, which weighs less than 3 oz and has a 60 cc capacity; a thin hydrocolloid dressing with an integrated check-valve that prevents reflux of exudate to the wound; and a leg strap for an individual’s mobility.

A conventional wound therapy program consists of all the following: evaluation, care and routine wound measurements by a licensed medical professional; application of dressings to maintain a moist wound environment; debridement of necrotic tissue if present; evaluation and provision for adequate nutritional status; appropriate turning and positioning of the individual who is incapable of doing this on their own; use of a support surface for pressure ulcers on the posterior trunk or pelvis; appropriate management of moisture and incontinence; adherence to a comprehensive diabetic management program if diabetic; accomplishment of reduction in pressure on a foot ulcer with appropriate modalities; consistent application of compression bandages and/or garment for individuals with venous insufficiency ulcers; encouragement of leg elevation and ambulation for individuals with venous insufficiency ulcers.

In November 2009, the FDA issued an alert concerning complications and deaths that had been associated with negative pressure wound therapy systems.

POLICY

• The initiation of negative pressure wound therapy for the treatment of acute and chronic wounds is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

• Continued therapy using negative pressure wound therapy for the treatment of acute and chronic wounds is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

• Continuation of the negative pressure wound therapy system  is considered not medically necessary when any of the following occurs:

• The therapeutic trial or subsequent treatment period has not resulted in documented objective improvement in the wound, within 90 days

• The wound has developed evidence of wound complications contraindicating continued negative pressure wound therapy

• The wound has healed to an extent that grafting can be performed  

• The wound can be anticipated to heal completely with other wound care treatments

• Therapeutic trials of negative pressure wound therapy systems for the treatment of other acute or chronic wounds except as noted above are considered not medically necessary.

• Non-powered negative pressure wound therapy systems for the treatment of acute or chronic wounds is considered investigational.

• Any device utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.

See also:  Hyperbaric Oxygen Pressurization / Therapy (HBO2)

MEDICAL APPROPRIATENESS

• Negative pressure wound therapy system for the treatment of acute and chronic wounds is considered medically appropriate if ALL of the following criteria are met:

• ABSENCE of but not limited to ALL of the following:

• Necrotic tissue with eschar

• Untreated osteomyelitis

• Non-enteric and unexplored fistulas

• Malignancy in the wound

• Exposed nerve

• Exposed anastomotic site

• Exposed organ

• Urinary infection

• Wound infection

• Pneumonia

• Albumin less than 2.0g/dl

• Chronic disease requiring stabilization (e.g. renal, or pulmonary)

• Uncontrolled diabetes mellitus

• Thyroid disease

• Uncontrolled hypertension

• Use of systemic steroids

• Pregnancy or breast feeding

• Inability to comply with dressing changes

• Active bleeding

• Current anticoagulation therapy

• Difficult wound hemostasis

• An initial 2 week therapeutic trial for ANY ONE of the following:

• The individual has chronic (> 90 days) stage III or IV pressure ulcers that failed to heal with ANY ONE of the following:

• Individual has failed optimal conventional wound care

• High volume of drainage is interfering with healing

• The individual has traumatic or surgical wounds with failure of immediate or delayed primary closure

• The individual’s wounds have failed optimal conventional wound care with ALL of the following:

• The individual has an underlying clinical disease/ condition that impede healing. (Examples include but are not limited to the following: diabetes, malnutrition, small vessel disease, and morbid obesity.)

• Absence of documented wound improvement with optimal treatment for at least 30 days

• Continuation of negative pressure wound therapy systems for ALL of the following:

• Initial 2 week therapeutic trial with subsequent treatment that has resulted in documented wound improvement

• Documentation includes ALL of the following at least every 14 days:

• Development and presence of healthy granulation tissue

• Progressive wound contracture

• Decreasing depth

• Commencement of epithelial spread from the wound margins

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member’s health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION

Contraindications for the use of negative pressure wound therapy systems include the following conditions as noted by a February 2011 safety communication: necrotic tissue with eschar, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, exposed nerve, exposed anastomotic site, and exposed organ.

Additional contraindications include but are not limited to the following: Urinary/wound infection; pneumonia; albumin less than 2.0g/dl; renal; pulmonary; or other chronic disease requiring stabilization; uncontrolled diabetes mellitus; thyroid disease; or hypertension; use of systemic steroids; pregnancy or breast feeding; inability to comply with dressing changes; active bleeding; or the individual is on anticoagulation therapy; and difficult wound hemostasis.

Complete healing of a wound would normally be anticipated if all bone, cartilage, tendons, and foreign material were completely covered, healthy granulation were present to within 5 mm of the surface, and the wound edges were reduced to 2 cm in width or diameter.

The literature reviewed does not show the benefit of continuing negative pressure wound therapy for more than three (3) months, if there is a lack of improvement in the condition of the wound.

Lack of improvement of a wound is defined, as lack of progress in quantitative measurements of wound characteristics (i.e., wound length, width, or surface area, and/or depth).

Negative pressure therapy systems should be used as part of a comprehensive wound care program that includes attention to other factors that impact wound healing including but not limited to diabetes control, nutritional status, and relief of pressure.

Examples of the powered negative pressure wound therapy or suction devices cleared by the U.S. Food and Drug Administration include, but are not limited to the following:

The lack of well-designed comparative studies with large number of individuals using the non-powered negative pressure wound therapy system is insufficient to draw conclusions about its impact on net health outcomes with the device and in comparison with current care.

SOURCES

Agency for Healthcare Research and Quality. (2009 July). Negative pressure wound therapy devices. Retrieved July 23, 2010 from http://www.ahrq.gov/clinic/ta/negpresswtd/negpresswtd.pdf.

Armstrong, D. G., Marston, W. A., Reyzelman, A. M., & Kirsner, R. S. (2011). Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: A multicenter randomized-controlled trial. Wound Repair and Regeneration, 19 (2), 173-180. (Level 2 Evidence - Industry sponsored)

Baharestani, M., Houliston-Otto, D., & Barnes, S. (2008). Early versus late initiation of negative pressure wound therapy: Examining the impact on home care length of stay. Ostomy Wound Management, 54 (11), 48-53.

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011). Negative pressure therapy for the treatment of chronic wounds (1.01.16). Retrieved June 14, 2011 from BlueWeb. (42 articles and/or guidelines reviewed)

BlueCross BlueShield of Tennessee network physicians. May, 2000.

Blume, P., Walters, J., Payne, W., Ayala, J., & Lantis, J. (2008). Comparison of negative pressure wound therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: A multicenter randomized controlled trial. Diabetes Care, 31 (4), 631-636. (Level 1 Evidence - Industry sponsored)

ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2009, June). Negative-pressure wound therapy for chronic wounds. Retrieved July 23, 2010 from ECRI Institute. (19 articles and/or guidelines reviewed)

Fonder, M. A., Lazarus, G. S., Cowan, D. A., Aronson-Cook, B., Kohli, A. R., & Mamelak, A. J. (2008). Treating the chronic wound: A practical approach to the care of nonhealing wounds and wound care dressings. Journal of the American Academy of Dermatology, 58 (2), 185-206.

Gregor, S., Maegele, M., Sauerland, S., Krahn, J., Peinemann, F., & Lange, S. (2008). Negative pressure wound therapy: A vacuum of evidence? Archives of Surgery, 143 (2), 189-196.

Institute for Clinical Systems Improvement (ICSI). (2010, April). Health care protocol. Pressure ulcer prevention and treatment protocol. Retrieved July 23, 2010 from http://www.icsi.org/pressure_ulcer_treatment_protocol__review_and_comment_/pressure_ulcer_treatment__protocol__.html.

Lerman, B., Olenbrook, L., Ryu, J., Fong, K. D., & Schubart, P. J. (2011). The SNaP Wound Care System: A case series using a novel ultraportable negative pressure wound therapy device for the treatment of diabetic lower extremity wounds. Journal of Diabetes Science and Technology, 4 (4), 825-830. (Level 4 Evidence - Industry sponsored)

National Institute for Health and Clinical Excellence (NICE). (2009, December). Negative pressure wound therapy for the open abdomen. Retrieved July 27, 2010 from http://www.nice.org.uk/nicemedia/live/12102/46576/46576.pdf.

U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. LCDs for CIGNA Government Services. (2009, October). LCD for negative pressure wound therapy pumps (L5008). Retrieved July 23, 2010 from http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=5008&ContrId=140&ver=41&ContrVer=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Tennessee&KeyWord=negative+pressure+wound+therapy&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAA&.

U. S. Food and Drug Administration. U. S. Department of Health & Human Services. (2010, November). Medical devices; general and plastic surgery devices; classification of non-powered suction apparatus device intended for negative pressure wound therapy. Federal Register, 75 (221), 70112-70114.

U.S. Food and Drug Administration. (2008, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K081406. Retrieved June 15, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081406.pdf.

U.S. Food and Drug Administration. (2008, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K080275. Retrieved June 15, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080275.pdf.

U.S. Food and Drug Administration. (2011, February). Center for Devices and Radiological Health. FDA safety communication: UPDATE on serious complications associated with negative pressure wound therapy systems. Retrieved June 16, 2010 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm.

U.S. Food and Drug Administration. (2011, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K103156. Retrieved June 15, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf10/K103156.pdf.

Vuerstaek, J., Vainas, T., Wuite, J., Nelemans, P., Neumann, M., & Veraart J. (2006). State-of the-art treatment of chronic leg ulcers: A randomized controlled trial comparing vacuum-assisted closure (V.A.C.) with modern wound dressings. Journal of Vascular Surgery, 44 (5), 1029-1037. (Level 2 Evidence - Industry sponsored)

Winifred S. Hayes, Inc. Medical Technology Directory. (2007, November). Negative pressure wound therapy for wound healing. Retrieved July 23, 2010 from www.Hayesinc.com/subscribers. (81 articles and/ or guidelines reviewed)

Zelen, C. M., Stover, B., Nielson, D., & Cunningham, M. (2011). A prospective study of negative pressure wound therapy with integrated irrigation for the treatment of diabetic foot ulcers. Eplasty, 11, e5. (Level 4 Evidence - Independent study)

ORIGINAL EFFECTIVE DATE:  5/1998  

MOST RECENT REVIEW DATE:  11/12/2011

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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