Negative Pressure Wound Therapy Pump for the Treatment of Acute and Chronic Wounds
DESCRIPTION
The negative pressure wound therapy pump (NPWTP) is a device 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 or for whom a program has been ruled out. 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 mechanism is intended to decrease edema and allow for increase blood flow in the wound bed and thereby promote healing. This device is also known as vacuum assisted wound closure device.
POLICY
The use of a negative pressure wound therapy pump 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 a negative pressure wound therapy pump for the treatment of acute and chronic wounds is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
The continued use of an NPWTP after three (3) months with a lack of improvement in the wound is considered investigational. 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).
MEDICAL APPROPRIATENESS
An NPWTP for treatment of acute and chronic wounds is considered medically appropriate if ALL of the following criteria are met:
A complete wound therapy program has been completed, tried and failed or considered and ruled out prior to the application of the device. (Note: A complete wound therapy program consists of all the following: evaluation, care and 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)
There is a written order for the NPWTP and supplies, signed and dated by the treating surgeon or physician who is responsible for managing the wound care accompanied by ALL the following criteria:
Nutritional status of the patient
History and previous treatment of the wound
Stabilization and management of all underlying medical conditions, including but not limited to ANY ONE of the following conditions:
Diabetes
Edema
Venous insufficiency
Arterial insufficiency
Incontinence
Dietary / nutritional deficiency
Wound description at the time NPWTP therapy is initiated, from the nurse or physician who changes the dressing to include ALL the following criteria:
Wound measurement, including length, width and depth
Description of the wound, including color, odor, etc.
Quantity and description of drainage
Presence of granulation and necrotic tissue
Debridement of necrotic tissue if present
ANY ONE of the following ulcers exist:
A stage III pressure ulcer which is full thickness skin loss involving damage or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia
A stage IV pressure ulcer which is full thickness skin loss with extensive destruction, tissue necrosis or damage to muscle, bone or supporting structures
Neuropathic ulcers (e.g., diabetic)
Venous or arterial insufficiency ulcers unresponsive to standard therapy
A surgically created wound (e.g., dehiscence)
A traumatic wound (e.g., pre-operative flap or graft)
ABSENCE of ALL of the following criteria:
Necrotic tissue with eschar present within the wound, if debridement is not attempted
Untreated osteomyelitis within the vicinity of the wound
Presence of cancer in the wound
Presence of a fistula to an organ or body cavity within the cavity of the wound
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, immunosuppressants, or anticoagulants
Pregnancy or breast feeding
Inability to comply with dressing changes
Active bleeding
The individual is on anticoagulation therapy
Difficult wound hemostasis
For continued therapy, a wound description will be submitted for review every two weeks by the nurse or physician who changes the dressing that is to include ALL the following criteria:
Wound measurement, including length, width and depth
Description of the wound, including color, odor, etc.
Quantity and description of drainage
Presence of granulation and necrotic tissue
Debridement of necrotic tissue if present
ADDITIONAL INFORMATION
Wound healing is defined as improvement in either surface area or depth measurements of the wound.
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.
SOURCES
Armstrong, D., & Lavery, L., (2005). Negative pressure wound therapy after partial diabetic foot amputation: a multicentre randomized controlled trial. Lancet, 366 (9498), 1704 - 1710. (Level 2 Evidence - Industry Sponsored)
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 2 Evidence - Industry Sponsored)
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2005). Negative pressure therapy for the treatment of chronic wounds (1.01.16). Retrieved January 9, 2009 from BlueWeb.
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2005, November). Negative-pressure wound therapy for chronic wounds. Retrieved January 15, 2009 from ECRI Institute. (19 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Assessment Information Service. Windows on Medical Technology™. (2000, October). Vacuum-assisted wound closure for chronic and acute wounds. Retrieved January 15, 2009 from ECRI Institute. (53 articles and/ or guidelines reviewed)
Hayes. Medical Technology Directory. (2007,November). Negative Pressure Wound Therapy for Wound Healing. Retrieved January 15, 2009 from http://www.hayesinc.com/hayes/. (26 articles and/ or guidelines reviewed)
Shirakawa, M., & Isseroff, R. R. (2005). Topical negative pressure devices: Use for enhancement of healing chronic wounds. Archives of Dermatology, 141 (11), 1449 - 1453. (Level 5 Evidence)
U.S. Food and Drug Administration. (2008, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K080275. Retrieved January 15, 2009 from http://www.fda.gov/cdrh/pdf8/K080275.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)
ORIGINAL EFFECTIVE DATE: 5/1998
MOST RECENT REVIEW DATE: 3/12/2009
ID_BT
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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