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Medical Policy: 01.01.13
Original Effective Date: October 1999
Reviewed: December 2011
Revised: December 2011
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
The management and treatment of chronic wounds, including decubitus ulcers, remain a treatment challenge. Most chronic wounds heal only when the underlying cause, i.e., venous stasis, pressure, infection, etc. is addressed. In addition, cleaning the wound to remove non-viable tissue, microorganisms, and foreign bodies is essential to create the optimal conditions for either re-epithelialization (i.e., healing by secondary intention) or preparation for wound closer with skin grafts or flaps (i.e., healing by primary intention). Therefore, debridement, irrigation, whirlpool treatments, and wet-to-dry dressings are common components of chronic wound care.
Negative-pressure wound therapy (NPWT) consists of the use of a negative pressure therapy or suction device to aspirate and remove fluids, debris, and infectious materials from the wound bed to promote the formation of granulation tissue. The devices may be used as an adjunct to surgical therapy in a debilitated patient. Although the exact mechanism has not been elucidated, it is hypothesized that negative pressure contributes to wound healing by removing excess interstitial fluid, increasing the vascularity of the wound, and/or creating beneficial mechanical forces that draw the edges of the wound closer together. Several negative pressure therapy of suction devices have been cleared by the U.S. Food and Drug Administration (FDA) including, but not limited to: V.A.C.® (Negative-pressure therapy Assisted Closure®) Therapy™ (Kinetic Concepts Inc.); Versatile 1™ Wound Negative Pressure Therapy System (Blue Sky Medical), and RENASYS EZ and RENASYS GO systems (Smith-Nephew).
The FDA has issued multiple alerts since 2009 concerning serious complications and deaths that have been associated with NPWT systems.
A non-powered (mechanical) NPWT system has also been developed; one device is the Smart Negative Pressure (SNaP)® Wound Care System from Spiracur is a Class II device requiring notification to market but not having FDA premarket approval. It received 510(k) marketing clearance from the FDA in 2009 (K081406) and is designed to remove small amounts of exudate from chronic, traumatic, dehisced, acute, subacute wounds and diabetic and pressure ulcers. This device is portable and lightweight and can be worn underneath clothing. The system consists of a cartridge, dressing, and strap; the cartridge acts as the negative pressure source at 125 mmHg, 100 mmHg, or 75 mmHg with a proprietary spring mechanism creating steady pressure levels. The system is reported to generate negative pressure levels similar to other NPWT systems. The system is fully disposable.
The staging of pressure ulcers used in this policy is as follows:
Stage I: Non-blanchable erythema of intact light toned skin or a darker or violet hue in darkly pigmented skin
Stage II: Partial thickness skin loss involving epidermis or dermis
Stage III: Full thickness skin loss involving damage or necrosis of subcutaneous tissue that may extend down to, but not through underlying fascia
Stage IV: Full thickness skin loss with extensive destruction, tissue necrosis or damage to muscle, bone and supporting structures
Additional stages that may be encountered in the medical records are:
Unstageable: Full-thickness tissue loss in which the actual depth of the ulcer is completely obscured by slough (yellow, tan, grey, green or brown) and/or eschar (tan, brown, or black). Until enough slough and/or eschar are removed to expose the base of the wound, the true depth cannot be determined.
Suspected
deep tissue
injury: Purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying tissue due to pressure or shear. Evolution may include a thin blister over a dark wound bed and the potential development of thin eschar
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Prior Approval:
Effective October 1, 2009 Prior approval is recommended. Submit a prior approval now. 
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Policy:
For Initial Approval:
Vacuum-assisted closure of chronic wounds may be considered medically necessary for an initial approval period of six weeks in patients with one of the following types of wounds:
- chronic stage III or IV pressure ulcer
- neuropathic (e.g. diabetic) ulcer
- venous or arterial insufficiency ulcer
- chronic (being present for at least 30 days) ulcer of mixed etiology
A complete wound therapy program should have been tried for a minimum of 30 days and failed, or considered and ruled out as unfeasible prior to the application of negative pressure wound therapy. A complete wound therapy program consists of ALL of the following:
- Documentation in the patient’s medical record of evaluation, care, and wound measurements (width, length, and depth)
- Application of dressings to maintain a moist wound environment
- Debridement of necrotic tissue if present
- Evaluation of nutritional status to ensure adequate levels of nutrients to promote healing are being provided
- Assessment of patient’s compliance with the wound therapy program
For stage III and IV pressure ulcers, in addition to the complete wound therapy criteria above, documentation of the following:
- The patient has used a group 2 or 3 support surface (e.g., powered pressure-reducing air mattress, air-fluidized bed) for pressure ulcers located on the posterior pelvis or trunk
- The patient’s skin moisture and incontinence have been appropriately managed
- The patient has been appropriately turned and positioned
For neuropathic ulcers (e.g. diabetic), in addition to the complete wound therapy criteria above, documentation of the following:
- Patient has been on a comprehensive diabetes management program
- Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities.
For venous insufficiency ulcers, in addition to the complete wound therapy criteria above, documentation of the following:
- Compression bandages or compression garments have been consistently applied
- Leg elevation and ambulation have been encouraged
Vacuum-assisted wound closure may be considered medically necessary for treatment of surgically created or traumatic wounds. Documentation must indicate why normal wound healing would not be expected and why use of vacuum-assisted wound healing is superior to normal wound healing. Such documentation might include risk or co-morbidity expected to significantly prolong healing achievable with other topical wound treatments. Patients with other medical problems such as diabetes, coronary artery disease, or renal disease may be more susceptible to wound dehiscence or delayed wound healing.
Examples of surgically created wounds include but are not limited to the following:
- Post-sternotomy disunion with exposed sternal bone
- Post-sternotomy mediastinitis
- Post-operative disunion of the abdominal wall
- Flap or graft failure
- Dehisced wounds
Examples of traumatic wounds include but are not limited to the following:
- Degloving injuries that will require a graft or flap
- High-impact soft tissue injuries such as falls, motor vehicle or sports
- Wounds exposing tendons, bones, or joints
For Continued Approval:
Vacuum-assisted wound closure may be considered medically necessary for an additional period of six weeks when the following criteria are met:
- Wound care is performed or supervised by a licensed health care provider
- There is at least biweekly (every two weeks) documentation of quantitative measurements of wound characteristics including wound depth, length, and width (surface area)
- Recorded wound measurements demonstrate progressive wound healing between evaluations or after four weeks of therapy
The FDA considers the following conditions to be contraindications for the use of negative-pressure wound therapy. In addition to the aforementioned medical necessity criteria, ALL of the following must NOT be present:
- Necrotic tissue with eschar present
- Untreated osteomyelitis within the vicinity of the wound
- Malignancy present in the wound
- The presence of a fistula to an organ or body cavity within the vicinity of the wound
- Exposed nerves
- Exposed anastomotic site
- Exposed organs (Treatment may be appropriate after the organ has been covered by vicryl absorbable mesh and all medical necessity criteria are met)
- Untreated coagulopathy
- The wound is a stage I or II pressure ulcer
Vacuum-assisted wound closure is considered not medically necessary when one or more of the following conditions are present:
- Adequate wound healing has occurred to the degree that uniform granulation tissue has been obtained
- A measurable degree of wound healing has failed to occur after use of the device for one month
- The wound has developed evidence of wound complications contraindicating continued NPWT
The use of non-powered NPWT systems for the treatment of acute or chronic wounds is considered investigational.
Reports with small numbers of patients, including planned interim analysis of a comparative trial, using the non-powered (mechanical) gauze-based NPWT system are insufficient to reach conclusions about its impact on net health outcome, both for the device itself and in comparison with current care. There are important unanswered questions about efficacy and tolerability. Well-designed comparative studies with large numbers of patients are needed.
Note:
The majority of wounds achieve sufficient closure with six weeks of vacuum-assisted wound therapy; some wounds may require longer. However, use of vacuum-assisted wound closure is generally not medically necessary beyond four months. It is rarely necessary to continue using the device until a wound is completely healed. If the depth of a wound is less than 0.5 cm, then it would generally not be appropriate to continue use of the device.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- A6550 Dressing set for negative pressure wound therapy electrical pump
- 97605 Negative pressure wound therapy surface area less than or equal to 50 square centimeters
- 97606 Negative pressure wound therapy surface area greater than 50 square centimeters
- E2402 Negative pressure wound therapy electrical pump
- A9272 Mechanical wound suction, disposable, includes dressing and all accessories and components, each
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Selected References:
- Argenta, L.C., Morykwa,s M.J. Vacuum-assisted closure: A new method for wound control and treatment. Clinical experience. Annals of Plastic Surgery 1997; 38:563-76.
- Mooney, J.F., Argenta, L.C., Marks, M.W., Morykwas, M.J., DeFranzo, A.J. Treatment of soft tissue defects in pediatric patients using the V.A.C. system. Clinical Othropedics and Related Research 2000; No. 376:26-31.
- Tang, A.T.M., Ohri, S.K., Haw, M.P. Novel application of vacuum assisted closure technique to the treatment of sternotomy wound infection. European Journal of Cardio-thoracic Surgery, 2000; 17: 482-484.
- Ford CN, et al. Interim analysis of a prospective, randomized trial of vacuum-assisted closure versus the HealthPoint system in the management of pressure ulcers. Ann Plast Surg. 2002 Jul;49(1):55-61; discussion 61.
- Wanner MB, et al. Vacuum-assisted wound closure for cheaper and more comfortable healing of pressure sores: a prospective study. Scand J Plast Reconstr Surg Hand Surg. 2003;37(1):28-33
- Armstrong DG, Marston WA, Reyzelman AM et al. 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 Rep Regen 2011; 19(2):173-80.
- Leman B, Oldenbrook L, Eichstadt SL et al. Evaluation of chronic wound treatment with the SNaP wound care system versus modern dressing protocols. Plast Reconstr Surg 2010; 126(4):1253-61.
- Fong KD, Hu D, Eichstadt SL et al. Initial clinical experience using a novel ultraportable negative pressure wound therapy device. Wounds 2010; 22(9):230-6.
- Leman B, Oldenbrook L, Ryn J et al. 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. J Diabetes Sci Technol 2010; 4(4):825-30.
- Landsman A. Analysis of the SNaP Wound Care System, a negative pressure wound device for treatment of diabetic lower extremity wounds. J Diabetes Sci Technol 2010; 4(4):831-2.
- Vig S, Dowsett C, berg L et al. Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: Steps towards an international consensus. J Tissue Viability. 2011 Nov 24. [Epub ahead of print].
- Rahmanian-Schwarz A, Willkomm LM, Gonser P et al. A novel option in negative pressure wound therapy (NPWT) for chronic and acute wound care. Burns. 2011 Nov 17 [Epub ahead of print].
- Suissa D, Danino A, Nikolis A. Negative-pressure therapy versus standard wound care: a meta-analysis of randomized trials. Plast Reconstr Surg. 2011 Nov; 128(5):498e-503e.
- Damiani G, Pinnarelli I, Sommella L et al. Vacuum-assisted closer therapy for patients with infected sternal wounds: a meta-analysis of current evidence. J Plast Reconstr Aesthet Surg 2011 Jan 21 [Epub ahead of print].
- Schmelzle M, Alldinger I, Matthaei H et al. Long-term vacuum-assisted closer in open abdomen due to secondary peritonitis: a retrospective evaluation of a selected group of patients. Dig Surg 2010; 27(4):272-8.
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Policy History:
Date Reason Action
December 2010 Annual review Policy renewed
December 2011 Annual review Policy revised
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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