Clinical Policy Title: Negative pressure wound therapy for ... · Clinical Policy Title: Negative pressure wound therapy for chronic ulcers . Clinical Policy Number: 16.03.03. Effective

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Clinical Policy Title: Negative pressure wound therapy for chronic ulcers

Clinical Policy Number: 16.03.03

Effective Date: October 1, 2014

Initial Review Date: March 19, 2014

Most Recent Review Date: March 16, 2016

Next Review Date: March 2017

Related policies:

None.

ABOUT THIS POLICY: AmeriHealth Caritas District of Columbia has developed clinical policies to assist with making coverage determinations.

AmeriHealth Caritas District of Columbia’s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas District of Columbia when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas District of Columbia’s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas District of Columbia’s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas District of Columbia will update its clinical policies as necessary. AmeriHealth Caritas District of Columbia’s clinical policies are not guarantees of payment.

Coverage policy AmeriHealth Caritas District of Columbia considers the use of negative pressure wound therapy (NPWT) to be clinically proven and, therefore, medically necessary when all of the following criteria in sections A, B, C, D and E are met.

A. Patient selection:

Appropriate candidate (all criteria must be met)

Presence of one or more nonhealing diabetic ulcers, vascular ulcers or stage III or IV pressure ulcers.

The individual’s medical record documents the wound assessments, care and wound measurements, as written by a professional provider, at least weekly.

Dressings have been used to maintain a moist wound environment.

Necrotic tissue, if present, has been debrided.

The individual's nutritional status has been evaluated and appropriately treated.

Policy contains:

Diabetic ulcers.

Vascular ulcers.

Pressure ulcers.

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Appropriate candidate (all criteria must be met)

No contraindications to NPWT are present (any of the following): • Necrotic tissue with eschar present if debridement has not been attempted. • Untreated osteomyelitis. • Untreated coagulopathy. • Non-enteric and unexplored fistulas. • Malignancy in the wound. • Exposed vasculature. • Exposed nerves. • Exposed anastomotic site. • Exposed organs.

B. Wound-specific therapeutic measures (if applicable) must be applied or considered and ruled out

by the individual's professional provider before the application of an NPWT system for the following specific types of ulcers and wounds:

Wound-specific requirements

Arterial insufficiency ulcers.

For stage III or IV pressure ulcers, all of the following criteria must be met: • The individual is being appropriately turned and positioned. • The individual is using a group two or three support surface for pressure

ulcers on the posterior trunk or pelvis. (A group two or three support surface is not required if the ulcer is not on the trunk or pelvis.)

• The individual's moisture and incontinence are being managed appropriately.

For neuropathic (diabetic) ulcers, all of the following criteria must be met: • Pressure on the foot ulcer has been reduced using appropriate modalities

(such as total contact casts; removable cast walkers; half shoes; saline wet-to-dry dressings; debridement of all necrotic, callus and fibrous tissue; or crutches).

• The beneficiary has been on a comprehensive diabetic management program.

• Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities.

For venous insufficiency ulcers, both criteria must be met:

• Compression bandages and/or garments have been consistently applied. • Leg elevation and ambulation have been encouraged.

C. Provider requirements:

Provider requirements for all wound types during NPWT (all criteria must be met)

Directly assess the wound(s) being treated with an NPWT system and document the findings.

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Supervise or directly perform the NPWT system dressing changes and document the findings.

Document changes in the wound's dimensions and characteristics (e.g., size, such as length, depth and width; color; exudate type and amount; odor; and evidence of healing) at least weekly.

D. NPWT system may be eligible for up to a maximum of four months (including the time the NPWT

was applied, regardless of the place of application, such as home, inpatient facility or skilled nursing facility).

If it is determined during the course of treatment for an initial wound that the NPWT system will be applied to additional wounds, all additional wounds must meet the criteria listed in this policy to determine medical necessity. In the case of additional wound occurrences after the initial NPWT is started, the four-month maximum will apply to each wound.

E. NPWT will be discontinued when:

Requirements for the discontinuation of NPWT (any of the following)

More than four months have elapsed using an NPWT system (including the time NPWT was applied, regardless of the place of application, such as at home, an inpatient facility or a skilled nursing facility).

Adequate wound healing has occurred.

Any measurable degree of wound healing has failed to occur during the prior month.

The NPWT equipment or supplies are no longer being used for the individual, regardless of the professional provider's orders to continue or discontinue use.

The professional provider fails to perform and document all of the following weekly: • Direct assessment of the wounds being treated with the NPWT system. • Supervising or directly performing the wound dressing changes. • Changes in the wound’s dimensions and characteristics (e.g., size, including

length, depth and width; color; exudate type and amount; odor; and evidence of healing).

Any contraindication listed in Part A has developed.

Necrotic tissue with eschar is present if debridement has not been attempted.

A nonpowered NPWT system is being used to treat a wound greater than 13 cm at its widest diameter, or when wound exudate production exceeds 60 cc in 24 hours.

Limitations:

• Provider proficiency, and patient proficiency if used at home, in the use of NPWT should be demonstrated prior to use.

• Patients and providers should demonstrate a clear understanding of the patient labeling from the NPWT system manufacturer and of the warnings associated with NPWT system use.

• A powered NPWT system (HCPCS code E2402) must be capable of accommodating more than one wound care set for multiple wounds on an individual. Therefore, more than one E2402 billed per individual for the same time period will be denied as not medically necessary.

• A licensed health care professional, for the purposes of this policy, may be a physician, physician’s assistant (P.A.), registered nurse (R.N.), licensed practical nurse (L.P.N.) or physical

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therapist (P.T.). The practitioner should be licensed to assess wounds and administer wound care within the state where the beneficiary is receiving NPWT.

• Coverage is provided up to a maximum of 15 dressing kits (A6550) per wound per month. • Coverage is provided up to a maximum of 10 canister sets (A7000) per month unless there is

documentation evidencing a large volume of drainage (greater than 90 ml of exudate per day). For high-volume exudative wounds, a stationary pump with the largest capacity canister must be used.

Note: The following CPT/HCPCS codes are not listed in the District of Columbia Medicaid fee schedule: 97605 - Negative pressure wound therapy (eg, vacuum assisted drainage collection), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters 97606 - Negative pressure wound therapy (eg, vacuum assisted drainage collection), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters G0456 - Negative pressure wound therapy, (e.g. vacuum assisted drainage collection) using a mechanically-powered device, not durable medical equipment, including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions for ongoing care, per session; total wounds(s) surface area less than or equal to 50 square centimeters G0457 - Negative pressure wound therapy, (e.g. vacuum assisted drainage collection) using a mechanically-powered device, not durable medical equipment, including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions for ongoing care, per session; total wounds(s) surface area greater than 50 square centimeters Alternative covered services:

Debridement of necrotic tissue.

Revascularization surgery.

Mechanical offloading.

Blood glucose management.

Foot care education.

Mechanical compression.

Limb elevation.

Saline-moistened cotton gauze (wet-to-moist) dressing.

Advanced dressings (e.g., hydrocolloid, foam, film, alginate, hydrofiber, hydrogel sheets and collagen-based dressings).

Background Chronic wounds are a major cause of morbidity leading to considerable disability and are often associated with increased mortality. Chronic wounds are wounds that do not heal within the natural cycle of healing (typically within 30 days) and have lost their ability to rebuild anatomical and functional integrity. (Lazarus, 1994). Diabetic foot ulcers, vascular ulcers and pressure ulcers are among the most common chronic wounds and are the focus of this policy.

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NPWT applies a localized vacuum to draw the edges of the wound together while providing a moist environment conducive to rapid wound healing. The development of negative pressure techniques for wound healing is based on two theories (Agency for Healthcare Research and Quality [AHRQ], 2009):

• The removal of excess interstitial fluid decreases edema and concentrations of inhibitory factors and increases local blood flow.

• Stretching and deformation of the tissue by the negative pressure is believed to disturb the extracellular matrix and introduce biochemical responses that promote granulation tissue and angiogenesis.

NPWT systems include a vacuum pump, drainage tubing and a dressing set. The pump may be stationary or portable, may rely on alternating current (AC) or battery power, allows for regulation of suction strength, has alarms to indicate loss of suction, and has a replaceable collection canister. The dressing sets may contain either foam or gauze dressing to be placed in the wound and an adhesive film drape for sealing the wound. The drainage tubes come in a variety of configurations depending on the dressings used or wound being treated. Several NPWT systems are commercially available in the United States (AHRQ, 2009). Diabetic ulcers, pressure ulcers and vascular leg ulcers may be treated with NPWT:

Diabetic foot ulcers are due to atherosclerosis that impedes blood flow to the extremities and peripheral neuropathy that prevents the sensation of discomfort associated with mechanical stress on or injury to the feet. Several systems exist for classifying diabetic foot ulcers. The Wagner Classification System was the first developed and is the most widely used. It consists of six wound grades (0 to 5) based primarily on wound depth, with grade 5 being the most severe (Wagner, 1987).

Pressure ulcers, also called decubitus ulcers, bed sores or pressure sores, are lesions caused by unrelieved pressure or shear resulting in damage of underlying tissue. According to the National Pressure Ulcer Advisory Panel (NPUAP), pressure ulcers are classified into four stages according to the depth of soft tissue and bone involvement, with stage 4 being the most severe. In 2007, NPUAP added “suspected deep tissue injury” and “unstageable” as pressure ulcer stages (NPUAP, 2014). Suspected deep tissue injury recognizes that some pressure ulcers begin with deep tissue damage and work their way to the surface rather than starting at the surface and working their way down. The designation “unstageable” is recommended when the base of an ulcer is covered by slough and/or eschar (NPUAP, 2014).

Vascular ulcers are the result of chronic venous insufficiency (80 percent to 95 percent of vascular ulcers) or arterial insufficiency (arterial leg ulcers, 5 percent to 10 percent). Venous ulcers may be due to a previous blood clot that destroys the valves, a comorbid medical problem (arterial disease) or a hereditary absence of the valves in the venous system. The underlying problem in venous leg ulcers is venous hypertension in the deep and superficial venous system caused by incompetent valves and the incomplete removal of blood from the venous system. Chronic venous disorders are classified according to a clinical severity score based on the clinical, etiology, anatomy and pathophysiology (CEAP) system (AVF, 2014). Arterial ulcers, also called ischemic ulcers, are caused by a reduced arterial blood supply in the extremities leading to tissue necrosis and/or ulceration.

Standard wound treatment involves removing necrotic tissue, keeping the wound moist and controlling infection. These treatments may be combined with other intervention modalities specific to wound and patient type. Standard treatment for chronic ulcers may include debridement of necrotic tissue, revascularization surgery, infection control, mechanical offloading, management of blood glucose, foot care education, mechanical compression and limb elevation. For most chronic wounds, standard treatment includes saline-moistened cotton gauze (wet-to-moist) dressing. Depending on the nature of the wound,

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other advanced dressings that maintain a moist wound healing environment may be applied, along with silver or other topical agents intended to limit infection and speed healing. These include hydrocolloid, foam, film, alginate, hydrofiber, hydrogel sheets and collagen-based dressings (AHRQ, 2009). There are no widely accepted standards for the optimal mode and intensity of wound treatment. Consequently, there is considerable variability in the treatment of chronic ulcers. Evidence-based guidelines recommend NPWT as an adjunct when the ulcer fails to heal using saline gauze or advanced moist wound therapy, while acknowledging a deficiency of quality studies supporting their recommendations (AAWC, 2010a and 2010b; Lipsky, 2012). For treatment of infected diabetic foot ulcers, the Infectious Diseases Society of America (IDSA) does not support using adjunctive treatments, such as NPWT, to treat infected diabetic foot ulcers, but for selected diabetic foot wounds that are slow to heal, the IDSA made a weak recommendation for using NPWT based on low-quality evidence from randomized controlled trials (RCTs) (Lipsky, 2012). The Association for the Advancement of Wound Care (AAWC) found fair to poor evidence supporting a weak recommendation for the use of NPWT as an adjunctive treatment for pressure ulcers (AAWC, 2010a). The AAWC made a weak recommendation for using NPWT for preparing venous ulcers for autologous pinch grafting or in venous ulcer graft management based on two poor-quality studies that found applying NPWT over skin grafts on chronic wounds may increase the graft quality without significantly affecting the quantity of graft take and may increase the rate of volume reduction compared to saline gauze (AAWC, 2010b). The Food and Drug Administration (FDA) classifies NPWT as a powered suction pump that is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system (21CFR878.4780). Several NPWT devices have received 510(k) FDA approval for treatment of chronic ulcers in adults. The safety and effectiveness of NPWT systems in newborns, infants and children has not been established at this time and, currently, there are no NPWT systems cleared for use in these populations (FDA, 2011). In November 2009, FDA issued a Preliminary Public Health Notification and Advice for Patients, which reported six deaths and 77 injuries associated with the use of NPWT in the past two years, and updated the notification in 2011 (FDA, 2011). Most of the deaths occurred at home or in long-term care facilities, and hemorrhage was a major cause. As a result, FDA issued recommendations for use of NPWT, focusing on optimal patient selection; provider proficiency, and patient proficiency if used at home, in the use of NPWT; and a clear understanding of the patient labeling from the NPWT system manufacturer and of the warnings associated with NPWT system use (FDA, 2011). NPWT should be used cautiously when there is active bleeding, when the patient is on anticoagulants, when there is difficult wound hemostasis or when placing the dressing in proximity to blood vessels. Patient selection should consider device labeling and instructions, patient risk factors and the following contraindications for certain wound types (FDA, 2011):

Necrotic tissue with eschar present.

Untreated osteomyelitis.

Non-enteric and unexplored fistulas.

Malignancy in the wound.

Exposed vasculature.

Exposed nerves.

Exposed anastomotic site.

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Exposed organs.

Searches AmeriHealth Caritas District of Columbia searched PubMed and the databases of:

• UK National Health Services Center for Reviews and Dissemination. • AHRQ’s National Guideline Clearinghouse and other evidence-based practice centers. • The Centers for Medicare & Medicaid Services (CMS).

We conducted searches on March 4, 2016. Search terms were: "vacuum wound closure (MeSH)" and "negative pressure wound therapy (MeSH)." We included:

• Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies.

• Guidelines based on systematic reviews. • Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple

cost studies), reporting both costs and outcomes — sometimes referred to as efficiency studies — which also rank near the top of evidence hierarchies.

Findings AmeriHealth Caritas District of Columbia found eight systematic reviews and one cost-effectiveness analysis based on results of a randomized controlled trial (RCT) for this policy. AmeriHealth Caritas District of Columbia included only the most recent and comprehensive systematic reviews, as they represent the most current evidence available. All systematic reviews found fair- to poor-quality evidence from a small number of RCTs that evaluated the safety and effectiveness of NPWT for chronic, non-infected ulcers. Few studies calculated the random sample size required to obtain a statistically significant result for an assumed relevant effect. All but one of the studies used the VAC® Therapy System (Kinetic Concepts Inc. [KCI]; San Antonio, TX). Infection-related outcomes were rarely reported. A number of shortcomings limited interpretation of the results. Variations that could affect the results include the type of wound, randomization by wound or by patient, wound care such as choice of dressing and dressing changes and end points for measuring change in wound dimensions or the time in which this change occurs.

For treatment of diabetic ulcers, the best available evidence is from two RCTs of fair quality. One RCT enrolled patients with post-amputation wounds, and the other enrolled patients with debrided foot ulcers. Both studies found a statistically significant increase in the proportion of ulcers healed in the NPWT group compared with the moist dressing group. In one RCT, NPWT reduced the median time for nursing care (2.9 hours) vs. standard dressing (6.3 hours) and improved pain quality. Three RCTs of poor quality enrolled mixed etiologies, and results were inconsistent. No studies compared NPWT to other advanced wound therapies.

For treatment of pressure ulcers, the best available evidence is from two RCTs of poor quality with a high risk of bias. One RCT compared NPWT to standard moist dressing, and the other compared NPWT to advanced gel dressings. There were no statistically significant differences in wound healing between the two groups with respect to reduction in wound volume.

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For treatment of vascular ulcers, no RCTs were identified. Therefore, no conclusions can be made.

Three systematic reviews compared the effectiveness of various NPWT systems for treatment of chronic ulcers. One RCT compared the SNaP® Wound Care System (Spiracur Inc.) and the VAC Therapy System with inconclusive results. The clinical research using either direct or indirect comparisons is insufficient to inform decisions on which NPWT system or component provides a significant therapeutic advantage.

One cost-effectiveness analysis of a study population with mixed wound etiologies compared NPWT to advanced dressings. The time to granulated wound, wound surface reduction or better bacterial clearance was not significantly different between groups, except for patients with cardiovascular disease and diabetics. However, patient comfort was an important advantage of NPWT. Overall costs were similar for both groups but time involvement and costs of nursing staff with NPWT resulted in a cost reduction of 25 percent to 30 percent for each hospitalized wound and more quality-adjusted life years (QALYs) gained. The advantage of NPWT is its comfort for patients and lower use of nursing staff resources.

Future research should address important study design features, such as randomization, use of power analysis to ensure adequate study size, blinding wound assessors and reporting of complete wound healing data, which will improve the internal validity and the informative nature of the studies.

Policy updates: As of March 16, 2016, AmeriHealth Caritas District of Columbia identified three new Cochrane reviews (Dumville, 2015a; Dumville, 2015b; Dumville, 2014), one update to a previous Cochrane review (Webster, 2014) and one new meta-analysis (Zhang, 2014) for this policy. A previously cited review (Zhang, 2014) compared the outcomes of NPWT and standard wound care in eight RCTs comprising 669 patients with diabetic foot ulcers. Overall NPWT resulted in a significantly higher proportion of healed ulcers (relative risk [RR], 1.52; 95 percent confidence interval [95 percent CI] 1.23 to 1.89; p < 0.001), more reduction of ulcer area (standardized mean difference [SMD], 0.89; 95 percent CI 0.41 to 1.37; p = 0.003), shorter time to wound healing (SMD, -1.10; 95 percent CI -1.83 to -0.37; p = 0.003) and significantly fewer major amputations (RR, 0.14; 95 percent CI, 0.04 to 0.51; p = 0.003), but the rate of minor amputations was not affected (p = 0.837). These results suggest NPWT appears to be an effective treatment for diabetic foot ulcers with a similar safety profile to standard wound care. These results would not alter the findings of the original policy; therefore, no changes to the policy are warranted. Three new Cochrane reviews found inconclusive evidence to support the use of NPWT for treating surgical wounds healing by secondary intention, pressure ulcers or partial thickness burns (Dumville, 2015a, Dumville, 2015b; Dumville, 2014). An updated Cochrane review of nine eligible trials (785 total patients) enrolled patients with surgical wounds associated with skin grafts, orthopedic procedures, and after general surgery and trauma surgery (Webster, 2012 and 2014). Seven trials compared NPWT with a standard dressing (two of these were “home-made” NPWT devices) and one trial compared one noncommercial NPWT with the commercially available VAC device. The frequency and severity of adverse events (of which the most common was wound infection) were similar in both treatment groups. Given that noncommercial systems are significantly less costly with no evidence of a negative effect on clinical outcomes, the authors found insufficient evidence to support NPWT for treating surgical wounds in these populations.

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Summary of clinical evidence:

Citation Content, methods, recommendations

Dumville (2015a) Cochrane review NPWT for treating surgical wounds healing by secondary intention

Key points:

Systematic review of two RCTs (69 participants). One study compared NPWT with an alginate dressing in the treatment of open, infected groin wounds, and one study compared NPWT with a silicone dressing in the treatment of excised pilonidal sinus.

Overall quality: low with high risk of bias.

The trials reported limited outcome data on healing, adverse events and resource use.

Inconclusive evidence of potential benefits and harms of NPWT.

Dumville (2015b) Cochrane review NPWT for pressure ulcers (stage II or above)

Key points:

Systematic review of four RCTs (149 total participants): NPWT versus dressings (two RCTs); NPWT versus gel treatments (one RCT); NPWT versus “moist wound healing” (one RCT).

Overall quality: low with high risk of bias. One study had a 24-week follow-up period, and two had six-week follow-up periods, the follow-up time was unclear for one study.

Only one study reported usable primary outcome data (complete wound healing), but this had only 12 participants and there were very few events (only one participant healed in the study).

Inconclusive evidence of comparative effectiveness of NPWT to alternatives.

Dumville (2014) Cochrane review NPWT for partial-thickness burns

Key points:

Review of one available RCT.

Overall quality: low with a high risk of bias.

Results are inconclusive.

Zhang (2014) Effectiveness and safety of NPWT for diabetic foot ulcers.

Key points:

• Meta-analysis of eight studies (669 total patients). • Compared with non-NPWT-treated diabetic foot ulcers, NPWT resulted in:

o Greater healing rate (relative risk [RR], 1.52; 95 %CI, 1.23 to 1.89; p<0.001).

o Greater reduction of ulcer area (standardized mean difference [SMD] 0.89; 95% CI 0.41 to 1.37; p=0.003).

o Shorter time to wound healing (SMD -1.10, 95% CI -1.83 to -0.37; p=0.003).

o Significantly fewer major amputations (RR 0.14; 95% CI, 0.04 to 0.51; p=0.003), but the rate of minor amputations was not affected (p = 0.837).

• NPWT is more effective for diabetic foot ulcers than non-NPWT with a similar safety profile.

Greer (2013) NPWT for diabetic ulcers, venous stasis ulcers and arterial ulcers

Key points:

• Systematic review of three RCTs (n = 418) with diabetic ulcers. • Overall quality — fair (one RCT) to poor (two RCTs). • Mostly middle-aged, white males with non-infected wounds. • Ulcer healing rate: 43% with NPWT versus 29% with standard care (RR 1.49, 95%

CI 1.11 to 2.01). • Inconsistent results for time-to-healing. • No RCTs identified for venous stasis ulcers or arterial ulcers.

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Dumville (2013) NPWT versus standard care for diabetic foot ulcers

Key points:

• Systematic review of five RCTs (605 total patients). • Overall quality: fair (two RCTs) to poor (three RCTs). • Post-amputation wounds: wound healing superior with NPWT vs. standard care (RR

1.44; 95% CI 1.03 to 2.01) with possible risk of performance bias (one RCT). • Debrided foot ulcers: wound healing superior with NPWT vs. standard care (RR 1.49;

95% CI 1.11 to 2.01) with possible risk of performance bias (one RCT). • Three remaining RCTs provided limited data, as they were small, with limited

reporting, as well as being at unclear risk of bias. • Further trials needed regarding the use of NPWT to treat diabetic foot wounds.

Webster (2012; updated 2014) Cochrane review NPWT versus standard care for skin grafts and surgical wounds healing by primary intention

Key points:

• Systematic review of nine eligible trials (785 total patients); three trials involved skin grafts, four included orthopedic patients and two included general surgery and trauma surgery patients.

• Seven trials compared NPWT with a standard dressing (two of these were “home-made” NPWT devices); one trial compared one noncommercial NPWT with a commercially available VAC device.

• Overall quality: low with unclear or high risk of bias for one or more of the quality indicators assessed.

• No between-group differences in the incidence of surgical site infections (SSI), wound dehiscence, re-operation (in incisional wounds), seroma/hematoma or failed skin grafts.

• Lower re-operation rates among skin graft patients in the noncommercial NPWT group (7/65; 10.8%) versus standard dressing group (17/66; 25.8%) (RR 0.42; 95% CI 0.19 to 0.92).

• Mean cost to supply equipment: VAC therapy USD $96.51/day versus noncommercial therapy USD $4.22/day (P = 0.01).

• Lower pain intensity score in the noncommercial group than VAC group (p = 0.02). • Inconclusive evidence. Noncommercial systems are less costly with no evidence of a

negative effect on clinical outcome. • Suitably powered, high-quality trials are needed to evaluate the effects of the newer

NPWT products designed for use on clean, closed surgical incisions.

Hayes (2012) NPWT

Key points:

• Systematic review of 14 RCTs, two randomized trials comparing NPWT with an alternative technology, one retrospective analysis of payer claims data, and one meta-analysis.

• The best evidence was available for chronic ulcers. • Compared to standard care, NPWT resulted in:

o Higher incidence of partial or complete wound closure, faster reduction in wound size, lower secondary foot amputation rates and improved granulation tissue formation.

o Lower ulcer recurrence rate (8% vs. 56%, respectively) (one RCT) o A retrospective analysis of CMS payer claims data found 34% to 35%

lower incidence of amputations with NPWT than standard therapy. o Improved quality of life (QOL) (two RCTs). o Reduced median time for nursing care (2.9 hours vs. 6.3 hours) in diabetic

patients (one RCT). o Equivalent safety profile.

• The evidence is sufficient to support the use of NPWT in adult patients with complex or difficult-to-heal wounds, but more evidence is needed to define definitive patient selection criteria.

• NPWT is contraindicated in the presence of exposed vasculature, nerves, anastomotic site and organs; malignancy in the wound; necrotic tissue with eschar;

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untreated osteomyelitis; non-enteric and unexplored fistulas; active bleeding; anticoagulant use; and difficult wound homeostasis.

Hayes (2012) SNaP Wound Care System (Spiracur Inc.) versus VAC

Key points:

• Systematic review of one small case series, a prospective, nonrandomized comparative study that employed patient-matched, historical controls (21 patients) and one RCT from two publications (132 patients).

• Overall quality: poor. • Inconclusive results: SNaP Wound Care System appears comparable to VAC system

with respect to adverse events and wound healing rates.

Rossi (2012) NPWT versus standard care or gel wound care

Key points:

• Systematic review of two RCTs. • Quality assessment: Poor with high risk of bias. • One RCT (28 patients) of NPWT vs. gels: reduction in volume (-51.8% vs. -42.1%,

respectively, p = 0.46). • One RCT (n = 22) of NPWT vs. saline gauze:

o Average reduction of 50% in the initial volume (mean difference -1.0, 95% CI -8.21 to 6.21).

o No statistically significant differences between groups. • Results are inconclusive with high uncertainty.

CADTH (2012) NPWT

Key points:

• Systematic review of studies of comparative effectiveness of NPWT at different pressures and of continuous vs. intermittent NPWT:

• No studies identified.

AHRQ (2009) Various NPWT systems

Key points:

• Systematic review comparing the effectiveness of NPWT systems. • No studies directly compared one NPWT system to another. • Nine RCTs identified for an indirect comparison, but all lacked sufficient information

to determine their comparability in patient characteristics, patient exclusion and inclusion criteria, methodology, outcome definitions, outcome measures, and application of the comparison treatment.

• Evidence for therapeutic distinction of NPWT systems is inconclusive.

Van den Boogaard (2008) NPWT vs. standard or advanced wound care

Key points:

• Systematic review of two RCTs. • Overall quality: Poor with high risk of bias. • No significant differences in wound healing between groups.

Braakenburg (2006) Cost-effectiveness analysis

Key points:

• Based on RCT in the Netherlands. • 65 patients with a chronic or acute wound randomized to initial treatment with NPWT

or modern dressings. • Primary endpoint: granulated wound or a wound ready for skin grafting or healing by

secondary intention. • Time to the primary endpoint for NPWT was not significantly shorter, except for

patients with cardiovascular disease and diabetics. • Overall costs were similar for both groups, but time involvement and costs of nursing

staff resulted in a cost reduction of 25% ‒ 30% for each hospitalized wound and more QALYs gained.

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Glossary Debride — To surgically excise dead, devitalized or contaminated tissue; to remove foreign matter from a wound. Dehiscence — Separation of a surgical incision or rupture of a wound closure. Eschar — Dry scab that forms on skin that has been burned or exposed to corrosive agents. Exudate — Clear liquid fluid that comes from diseased tissues. Granulation — Minute red granules of new capillaries formed on the surface of a wound in healing. Granulation tissue — Highly vascularized tissue that replaces the initial fibrin clot in a wound. Pressure ulcers/wound classifications, according to the National Pressure Ulcer Advisory Panel (NPUAP):

Stage I — Intact skin with non-blanchable (does not turn white) redness of a localized area, usually over a bony prominence. Darkly pigmented skin may not have visible blanching; its color may differ from the surrounding area. The area may be painful, firm, soft, warmer or cooler compared to adjacent tissue. Stage II — Partial-thickness skin loss presenting as a shallow open ulcer with a red pink wound bed, without slough. May also present as an intact or open/ruptured serum-filled blister. Bruising indicates suspected deep tissue injury. This stage should not be used to describe skin tears, tape burns, perineal dermatitis, maceration or excoriation. Stage III — Full-thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscles are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling. The depth of a stage III ulcer varies by anatomical location. The bridge of the nose, ear, occiput (the back part of the head or skull) and malleolus (the bony protuberance on either side of the ankle) do not have subcutaneous tissue and stage III ulcers can be shallow. In contrast, areas of significant adiposity can develop extremely deep stage III pressure ulcers. Bone/tendon is not visible or directly palpable. Stage IV — Full-thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present on some parts of the wound bed. Often includes undermining and tunneling. The depth of a stage IV pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and these ulcers can be shallow. Stage IV ulcers can extend into muscle and/or supporting structures (e.g., fascia, tendon or joint capsule) making osteomyelitis possible. Exposed bone/tendon is visible or directly palpable. Unstageable/unclassified; full-thickness skin or tissue loss; depth unknown — Full-thickness tissue loss in which actual depth of the ulcer is completely obscured by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed. Until enough slough and/or eschar are removed to expose the base of the wound, the true depth cannot be determined; but it will be either a stage III or IV. Stable (dry, adherent, intact without erythema or fluctuance) eschar on the heels serves as “the body’s natural (biological) cover” and should not be removed.

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Suspected deep tissue injury — depth unknown. Purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler compared to adjacent tissue. Deep tissue injury may be difficult to detect in individuals with dark skin tones. Evolution may include a thin blister over a dark wound bed. The wound may further evolve and become covered by thin eschar. Evolution may be rapid, exposing additional layers of tissue even with optimal treatment.

Support surfaces — Pressure-relieving devices designed to prevent capillary occlusion, which leads to skin cell death and pressure ulcers, by reducing the tissue interface sufficiently enough to prevent capillary closure; may also be designed for heat and moisture control. Medicare classifies support surfaces into three categories:

Group 1 — Pressure pads, certain mattresses and overlays for mattresses (foam, water and gel mattresses). Group 2 — Powered air flotation beds (low-air-loss therapy), powered pressure-reducing air mattresses, and nonpowered advanced pressure-reducing mattresses that can be placed directly over a hospital bed frame (foam, water and gel mattresses). Group 3 — Air fluidized beds.

Ulcer — Lesion of the skin accompanied by the formation of pus and necrosis of surrounding tissue usually resulting from inflammation or ischemia. Vacuum assisted wound therapy (VAWT) — A type of medical therapy that involves the use of suction underneath airtight wound dressings to promote the healing of open wounds that have resisted previous treatments. Venous insufficiency — Abnormal blood flow through the veins of the legs. References Professional society guidelines/other: Lipsky BA, Berendt AR, Cornia PB, et al. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. June 2012; 54(12): e132 – e173. Pressure Ulcer Guidelines 8.11. American Association for the Advancement of Wound Care (AAWC) website. http://aawconline.org/wp-content/uploads/2011/08/AAWCPressureUlcerGuidelineofGuidelinesAug11.pdf. Accessed March 4, 2016. Venous Ulcer Guideline. 3.12. American Association for the Advancement of Wound Care (AAWC) website. http://aawconline.org/wp-content/uploads/2014/02/AAWC-Venous-Ulcer-Guideline-Update+Algorithm-v28-updated-11Feb2014.pdf. Accessed March 4, 2016.

http://aawconline.org/wp-content/uploads/2011/08/AAWCPressureUlcerGuidelineofGuidelinesAug11.pdf

http://aawconline.org/wp-content/uploads/2011/08/AAWCPressureUlcerGuidelineofGuidelinesAug11.pdf

http://aawconline.org/wp-content/uploads/2014/02/AAWC-Venous-Ulcer-Guideline-Update+Algorithm-v28-updated-11Feb2014.pdf

http://aawconline.org/wp-content/uploads/2014/02/AAWC-Venous-Ulcer-Guideline-Update+Algorithm-v28-updated-11Feb2014.pdf

14

Peer-reviewed references: Braakenburg A, Obdeijn MC, Feitz R, van Rooij IA, van Griethuysen AJ, Klinkenbijl JH. The clinical efficacy and cost effectiveness of the vacuum-assisted closure technique in the management of acute and chronic wounds: a randomized controlled trial. Plast Reconstr Surg. August 2006; 118(2):390 – 397; discussion 8 – 400. CEAP & Venous Severity Scoring. American Venous Forum website. http://www.veinforum.org/uploadDocs/1/Revised-CEAP-Classification---May-2004.pdf. Accessed March 4, 2016. Dumville Jo C, Hinchliffe Robert J, Cullum N, et al. Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus. Cochrane Database of Systematic Reviews. 2013; (10): CD010318. Dumville JC, Munson C, Christie J. Negative pressure wound therapy for partial-thickness burns. Cochrane Database Syst Rev. 2014; 12: Cd006215. Dumville JC, Owens GL, Crosbie EJ, Peinemann F, Liu Z. Negative pressure wound therapy for treating surgical wounds healing by secondary intention. Cochrane Database Syst Rev. 2015; 6: Cd011278.(a) Dumville JC, Webster J, Evans D, Land L. Negative pressure wound therapy for treating pressure ulcers. Cochrane Database Syst Rev. 2015; 5: Cd011334.(b) FDA Safety Communication: UPDATE on Serious Complications Associated with Negative Pressure Wound Therapy Systems. FDA website. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm. Accessed March 4, 2016. Greer N, Foman NA, MacDonald R, et al. Advanced wound care therapies for nonhealing diabetic, venous, and arterial ulcers: a systematic review. Ann Intern Med. October 15, 2013; 159(8): 532 – 542. Hayes Inc., Hayes Medical Technology Report. Negative pressure wound therapy for wounds other than sternal wounds and skin grafts. Lansdale, Pa. Hayes Inc.; 2012. Hayes Inc., Hayes Medical Technology Report. SNaP wound care system (Spiracur Inc.) for treatment of lower extremity ulcers. Lansdale, Pa. Hayes Inc.; 2012. Lazarus GS, Cooper DM, Knighton DR, et al. Definitions and guidelines for assessment of wounds and evaluation of healing. Arch Dermatol. April 1994; 130(4): 489 – 493. Negative Pressure Wound Therapy Devices: Technology Assessment Report. November 2009. AHRQ website. http://www.ahrq.gov/research/findings/ta/negative-pressure-wound-therapy/index.html. Accessed March 4, 2016. Negative pressure wound therapy for patients with diabetic foot ulcers and pressure ulcers: a review of the clinical effectiveness. Canadian Agency for Drugs and Technologies in Health (CADTH) website. http://www.cadth.ca/media/pdf/htis/june-2012/RC0362%20Negative%20Pressure%20Wound%20Therapy%20Final.pdf. Accessed March 4, 2016.

http://www.veinforum.org/uploadDocs/1/Revised-CEAP-Classification---May-2004.pdf

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm

http://www.ahrq.gov/research/findings/ta/negative-pressure-wound-therapy/index.html

http://www.cadth.ca/media/pdf/htis/june-2012/RC0362%20Negative%20Pressure%20Wound%20Therapy%20Final.pdf

http://www.cadth.ca/media/pdf/htis/june-2012/RC0362%20Negative%20Pressure%20Wound%20Therapy%20Final.pdf

15

Pressure Ulcer Category/Staging Illustrations. National Pressure Ulcer Advisory Panel website. http://www.npuap.org/resources/educational-and-clinical-resources/pressure-ulcer-categorystaging-illustrations/. Accessed March 4, 2016. Rossi PG, Camilloni L, Todini AR, et al. Health technology assessment of the negative pressure wound therapy for the treatment of acute and chronic wounds: efficacy, safety, cost effectiveness, organizational and ethical impact. Ital Jour Public Health. 2012; 9(2): 46 – 66. Selvaggi F, Pellino G, Sciaudone G, et al. New advances in negative pressure wound therapy (NPWT) for surgical wounds of patients affected with Crohn's disease. Surg Technol Int. 2014; 24: 83 – 89. van den Boogaard M, Spauwen P, Schoonhoven L. The effectiveness of topical negative pressure in the treatment of pressure ulcers: a literature review. Eur J Plast Surg. 2008; 31(1): 1 – 7. Wagner FW, Jr. The diabetic foot. Orthopedics. January 1987; 10(1): 163 – 172. Webster J, Scuffham P, Sherriff KL, et al. Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochrane Database Syst Rev. 2012; (4): CD009261. Webster J, Scuffham P, Stankiewicz M, Chaboyer WP. Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochrane Database Syst Rev. 2014; 10: Cd009261. Zhang J, Hu ZC, Chen D, Guo D, Zhu JY, Tang B. Effectiveness and safety of negative-pressure wound therapy for diabetic foot ulcers: a meta-analysis. Plast Reconstr Surg. 2014; 134(1): 141 – 151. Clinical trials: Searched clinicaltrials.gov on March 4, 2016, using terms “vacuum wound closure” | Open Studies. 20 studies found, 7 relevant. Vacuum Assisted Closure for Cesarean Section. ClinicalTrials.gov website. https://ClinicalTrials.gov/show/NCT02390401. Published March 11 2015. Updated January 20, 2016. Accessed March 4, 2016. To Compare the Efficacy of NPWT PRO Versus KCI Ulta® NPWT and to Compare NPWT PRO Versus NPWT PRO With Simultaneous Irrigation on Wound Healing. ClinicalTrials.gov website. https://ClinicalTrials.gov/show/NCT02519621. Published June 1 2015. Updated December 3, 2015. Accessed March 4, 2016. Negative Pressure Wound Therapy in Post-Operative Incision Management. ClinicalTrials.gov website. https://ClinicalTrials.gov/show/NCT02682316. Published February 4 2016. Updated February 17, 2016. Accessed March 4, 2016. Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries. ClinicalTrials.gov website. https://ClinicalTrials.gov/show/NCT02127164. Published April 4 2014. Updated December 7, 2015. Accessed March 4, 2016.

http://www.npuap.org/resources/educational-and-clinical-resources/pressure-ulcer-categorystaging-illustrations/

http://www.npuap.org/resources/educational-and-clinical-resources/pressure-ulcer-categorystaging-illustrations/

https://clinicaltrials.gov/show/NCT02390401




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Incisional Negative Pressure Dressing on Clean Closed Groin Incisions. ClinicalTrials.gov website. https://ClinicalTrials.gov/show/NCT02006511. Published November 13 2013. Updated December 9, 2013. Accessed March 4, 2016. Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery. ClinicalTrials.gov website. https://ClinicalTrials.gov/show/NCT02389023. Published March 9 2015. Updated February 2, 2016. Accessed March 4, 2016. A Comparison of Incisional Negative-Pressure Wound Therapy Versus Conventional Dressings Following Abdominal Surgery. ClinicalTrials.gov website. https://ClinicalTrials.gov/show/NCT02534116. Published August 13 2015. Updated August 24, 2015. Accessed March 4, 2016. CMS National Coverage Determination (NCDs): No NCDs identified as of the writing of this policy. NPWT devices are considered durable medical equipment (DME) products and, therefore, in the absence of an NCD, coverage is left to the discretion of one of four contracted DME Medicare administrative contractors (MACs); the patient’s state of residence determines which DME MAC processes the claim. Local Coverage Determinations (LCDs): L33821 Negative Pressure Wound Therapy Pumps. CMS website. https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33821&ver=4. Accessed March 4, 2016. L34587 Wound Care. CMS website. https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=34587&ver=19. Accessed March 4, 2016. L35125 Wound Care. CMS website. https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35125&ver=15. Accessed March 4, 2016. L35139 Wound Care. CMS website. https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35139&ver=18. Accessed March 4, 2016. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly.

CPT Code Description Comment

97605

Negative pressure wound therapy (e.g., vacuum assisted drainage collection), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters.

97606

Negative pressure wound therapy (e.g., vacuum assisted drainage collection), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters.




https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33821&ver=4








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ICD-9 Code Description Comment

250.60 Diabetes, type II, not stated uncontrolled with neurological manifestations

250.61 Diabetes, type I, not stated uncontrolled with neurological manifestations

250.62 Diabetes, type II, uncontrolled with neurological manifestations

250.63 Diabetes, type I, uncontrolled with neurological manifestations

250.70 Diabetes, type II, not stated uncontrolled with peripheral circulatory disorder

250.71 Diabetes, type I, not stated controlled with peripheral circulatory disorder

250.72 Diabetes, type II, uncontrolled with peripheral circulatory disorder

250.73 Diabetes, type I, uncontrolled with peripheral circulatory disorder

250.80 Diabetes, type II, not stated uncontrolled with diabetic ulceration

250.81 Diabetes, type I, not stated controlled with diabetic ulceration

250.82 Diabetes, type II, uncontrolled with diabetic ulceration

250.83 Diabetes, type I, uncontrolled with diabetic ulceration

440.23

Atherosclerosis of the extremities with ulceration [chronic Stage III or IV neuropathic ulcers (e.g., diabetic ulcer), venous or arterial insufficiency ulcer, or a chronic ulcer of mixed etiology present for at least 30 days meeting specific criteria].

440.23 Atherosclerosis of the extremities with ulceration

454.0 Varicose veins of lower extremities with ulcer

707.23 Pressure ulcer stage III

707.24 Pressure ulcer stage IV

ICD-10 Code Description Comment

E08.51 Diabetes mellitus due to underlying condition with diabetic peripheral

angiopathy without gangrene

E08.52 Diabetes mellitus due to underlying condition with diabetic peripheral

angiopathy with gangrene

E09.51 Drug or chemical induced diabetes mellitus with diabetic peripheral angiopathy

without gangrene

E09.52 Drug or chemical induced diabetes mellitus with diabetic peripheral angiopathy

with gangrene

E10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecified E10.41 Type 1 diabetes mellitus with diabetic mononeuropathy E10.42 Type 1 diabetes mellitus with diabetic polyneuropathy E10.43 Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy E10.44 Type 1 diabetes mellitus with diabetic amyotrophy E10.49 Type 1 diabetes mellitus with other diabetic neurological complication E10.51 Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene E10.52 Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangrene E10.59 Type 1 diabetes mellitus with other circulatory complications

E10.610 Type 1 diabetes mellitus with diabetic neuropathic arthropathy E10.618 Type 1 diabetes mellitus with other diabetic arthropathy E10.621 Type 1 diabetes mellitus with foot ulcer E10.622 Type 1 diabetes mellitus with other skin ulcer E10.628 Type 1 diabetes mellitus with other skin complications E10.69 Type 1 diabetes mellitus with other specified complication

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E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified E11.41 Type 2 diabetes mellitus with diabetic mononeuropathy E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy E11.43 Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy E11.44 Type 2 diabetes mellitus with diabetic amyotrophy E11.49 Type 2 diabetes mellitus with other diabetic neurological complication E11.51 Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene E11.52 Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene E11.59 Type 2 diabetes mellitus with other circulatory complications

E11.610 Type 2 diabetes mellitus with diabetic neuropathic arthropathy E11.618 Type 2 diabetes mellitus with other diabetic arthropathy E11.621 Type 2 diabetes mellitus with foot ulcer E11.622 Type 2 diabetes mellitus with other skin ulcer E11.628 Type 2 diabetes mellitus with other skin complications E11.69 Type 2 diabetes mellitus with other specified complication E13.40 Other specified diabetes mellitus with diabetic neuropathy, unspecified E13.41 Other specified diabetes mellitus with diabetic mononeuropathy E13.42 Other specified diabetes mellitus with diabetic polyneuropathy E13.43 Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy E13.44 Other specified diabetes mellitus with diabetic amyotrophy E13.49 Other specified diabetes mellitus with other diabetic neurological complication

E13.51 Other specified diabetes mellitus with diabetic peripheral angiopathy without

gangrene

E13.52 Other specified diabetes mellitus with diabetic peripheral angiopathy with

gangrene

E13.59 Other specified diabetes mellitus with other circulatory complications E13.610 Other specified diabetes mellitus with diabetic neuropathic arthropathy E13.618 Other specified diabetes mellitus with other diabetic arthropathy E13.621 Other specified diabetes mellitus with foot ulcer E13.622 Other specified diabetes mellitus with other skin ulcer E13.628 Other specified diabetes mellitus with other skin complications E13.69 Other specified diabetes mellitus with other specified complication I70.231 Atherosclerosis of native arteries of right leg with ulceration of thigh I70.232 Atherosclerosis of native arteries of right leg with ulceration of calf I70.233 Atherosclerosis of native arteries of right leg with ulceration of ankle

I70.234 Atherosclerosis of native arteries of right leg with ulceration of heel and

midfoot

I70.235 Atherosclerosis of native arteries of right leg with ulceration of other part of foot

I70.238 Atherosclerosis of native arteries of right leg with ulceration of other part of

lower right leg

I70.239 Atherosclerosis of native arteries of right leg with ulceration of unspecified site I70.241 Atherosclerosis of native arteries of left leg with ulceration of thigh I70.242 Atherosclerosis of native arteries of left leg with ulceration of calf I70.243 Atherosclerosis of native arteries of left leg with ulceration of ankle I70.244 Atherosclerosis of native arteries of left leg with ulceration of heel and midfoot I70.245 Atherosclerosis of native arteries of left leg with ulceration of other part of foot































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I70.248 Atherosclerosis of native arteries of left leg with ulceration of other part of

lower left leg

I70.249 Atherosclerosis of native arteries of left leg with ulceration of unspecified site I70.25 Atherosclerosis of native arteries of other extremities with ulceration

I70.261 Atherosclerosis of native arteries of extremities with gangrene, right leg I70.262 Atherosclerosis of native arteries of extremities with gangrene, left leg I70.263 Atherosclerosis of native arteries of extremities with gangrene, bilateral legs I70.268 Atherosclerosis of native arteries of extremities with gangrene, other extremity

I70.269 Atherosclerosis of native arteries of extremities with gangrene, unspecified

extremity

I70.331 Atherosclerosis of unspecified type of bypass graft(s) of the right leg with

ulceration of thigh


ulceration of calf


ulceration of ankle


ulceration of heel and midfoot


ulceration of other part of foot


ulceration of other part of lower leg


ulceration of unspecified site

I70.341 Atherosclerosis of unspecified type of bypass graft(s) of the left leg with

ulceration of thigh


ulceration of calf


ulceration of ankle









I70.431 Atherosclerosis of autologous vein bypass graft(s) of the right leg with

ulceration of thigh


ulceration of calf


ulceration of ankle
































20





I70.441 Atherosclerosis of autologous vein bypass graft(s) of the left leg with ulceration

of thigh


of calf


of heel and midfoot


of other part of foot


of other part of lower leg


of unspecified site

I70.531 Atherosclerosis of nonautologous biological bypass graft(s) of the right leg with

ulceration of thigh


ulceration of calf


ulceration of ankle









I70.541 Atherosclerosis of nonautologous biological bypass graft(s) of the left leg with

ulceration of thigh


ulceration of calf


ulceration of ankle









I70.631 Atherosclerosis of nonbiological bypass graft(s) of the right leg with ulceration

of thigh


of calf

























21


of ankle


of heel and midfoot






of unspecified site

I70.641 Atherosclerosis of nonbiological bypass graft(s) of the left leg with ulceration of

thigh


calf


ankle


heel and midfoot


other part of foot


other part of lower leg


unspecified site

I70.731 Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration

of thigh


of calf


of ankle


of heel and midfoot






of unspecified site

I70.741 Atherosclerosis of other type of bypass graft(s) of the left leg with ulceration of

thigh


calf


ankle


heel and midfoot


other part of foot

























22


other part of lower leg


unspecified site

I83.001 Varicose veins of unspecified lower extremity with ulcer of thigh I83.002 Varicose veins of unspecified lower extremity with ulcer of calf I83.003 Varicose veins of unspecified lower extremity with ulcer of ankle I83.004 Varicose veins of unspecified lower extremity with ulcer of heel and midfoot I83.005 Varicose veins of unspecified lower extremity with ulcer other part of foot I83.008 Varicose veins of unspecified lower extremity with ulcer other part of lower leg I83.009 Varicose veins of unspecified lower extremity with ulcer of unspecified site I83.011 Varicose veins of right lower extremity with ulcer of thigh I83.012 Varicose veins of right lower extremity with ulcer of calf I83.013 Varicose veins of right lower extremity with ulcer of ankle I83.014 Varicose veins of right lower extremity with ulcer of heel and midfoot I83.015 Varicose veins of right lower extremity with ulcer other part of foot I83.018 Varicose veins of right lower extremity with ulcer other part of lower leg I83.019 Varicose veins of right lower extremity with ulcer of unspecified site I83.021 Varicose veins of left lower extremity with ulcer of thigh I83.022 Varicose veins of left lower extremity with ulcer of calf I83.023 Varicose veins of left lower extremity with ulcer of ankle I83.024 Varicose veins of left lower extremity with ulcer of heel and midfoot I83.025 Varicose veins of left lower extremity with ulcer other part of foot I83.028 Varicose veins of left lower extremity with ulcer other part of lower leg I83.029 Varicose veins of left lower extremity with ulcer of unspecified site

I83.201 Varicose veins of unspecified lower extremity with both ulcer of thigh and

inflammation

I83.202 Varicose veins of unspecified lower extremity with both ulcer of calf and

inflammation

I83.203 Varicose veins of unspecified lower extremity with both ulcer of ankle and

inflammation

I83.204 Varicose veins of unspecified lower extremity with both ulcer of heel and

midfoot and inflammation

I83.205 Varicose veins of unspecified lower extremity with both ulcer other part of foot

and inflammation

I83.208 Varicose veins of unspecified lower extremity with both ulcer of other part of

lower extremity and inflammation

I83.209 Varicose veins of unspecified lower extremity with both ulcer of unspecified

site and inflammation

I83.211 Varicose veins of right lower extremity with both ulcer of thigh and

inflammation

I83.212 Varicose veins of right lower extremity with both ulcer of calf and inflammation

I83.213 Varicose veins of right lower extremity with both ulcer of ankle and

inflammation

I83.214 Varicose veins of right lower extremity with both ulcer of heel and midfoot and

inflammation



































23

I83.215 Varicose veins of right lower extremity with both ulcer other part of foot and

inflammation

I83.218 Varicose veins of right lower extremity with both ulcer of other part of lower

extremity and inflammation

I83.219 Varicose veins of right lower extremity with both ulcer of unspecified site and

inflammation

I83.221 Varicose veins of left lower extremity with both ulcer of thigh and inflammation I83.222 Varicose veins of left lower extremity with both ulcer of calf and inflammation I83.223 Varicose veins of left lower extremity with both ulcer of ankle and inflammation

I83.224 Varicose veins of left lower extremity with both ulcer of heel and midfoot and

inflammation

I83.225 Varicose veins of left lower extremity with both ulcer other part of foot and

inflammation

I83.228 Varicose veins of left lower extremity with both ulcer of other part of lower

extremity and inflammation

I83.229 Varicose veins of left lower extremity with both ulcer of unspecified site and

inflammation

I87.011 Post thrombotic syndrome with ulcer of right lower extremity I87.012 Post thrombotic syndrome with ulcer of left lower extremity I87.013 Post thrombotic syndrome with ulcer of bilateral lower extremity I87.019 Post thrombotic syndrome with ulcer of unspecified lower extremity I87.031 Post thrombotic syndrome with ulcer and inflammation of right lower extremity I87.032 Post thrombotic syndrome with ulcer and inflammation of left lower extremity

I87.033 Post thrombotic syndrome with ulcer and inflammation of bilateral lower

extremity

I87.039 Post thrombotic syndrome with ulcer and inflammation of unspecified lower

extremity

I87.2 Venous insufficiency (chronic) (peripheral) I87.311 Chronic venous hypertension (idiopathic) with ulcer of right lower extremity I87.312 Chronic venous hypertension (idiopathic) with ulcer of left lower extremity I87.313 Chronic venous hypertension (idiopathic) with ulcer of bilateral lower extremity

I87.319 Chronic venous hypertension (idiopathic) with ulcer of unspecified lower

extremity

I87.331 Chronic venous hypertension (idiopathic) with ulcer and inflammation of right

lower extremity

I87.332 Chronic venous hypertension (idiopathic) with ulcer and inflammation of left

lower extremity

I87.333 Chronic venous hypertension (idiopathic) with ulcer and inflammation of

bilateral lower extremity

I87.339 Chronic venous hypertension (idiopathic) with ulcer and inflammation of

unspecified lower extremity

L89.003 Pressure ulcer of unspecified elbow, stage 3 L89.004 Pressure ulcer of unspecified elbow, stage 4 L89.013 Pressure ulcer of right elbow, stage 3 L89.014 Pressure ulcer of right elbow, stage 4 L89.023 Pressure ulcer of left elbow, stage 3 L89.024 Pressure ulcer of left elbow, stage 4




























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L89.103 Pressure ulcer of unspecified part of back, stage 3 L89.104 Pressure ulcer of unspecified part of back, stage 4 L89.113 Pressure ulcer of right upper back, stage 3 L89.114 Pressure ulcer of right upper back, stage 4 L89.123 Pressure ulcer of left upper back, stage 3 L89.124 Pressure ulcer of left upper back, stage 4 L89.133 Pressure ulcer of right lower back, stage 3 L89.134 Pressure ulcer of right lower back, stage 4 L89.143 Pressure ulcer of left lower back, stage 3 L89.144 Pressure ulcer of left lower back, stage 4 L89.153 Pressure ulcer of sacral region, stage 3 L89.154 Pressure ulcer of sacral region, stage 4 L89.203 Pressure ulcer of unspecified hip, stage 3 L89.204 Pressure ulcer of unspecified hip, stage 4 L89.213 Pressure ulcer of right hip, stage 3 L89.214 Pressure ulcer of right hip, stage 4 L89.223 Pressure ulcer of left hip, stage 3 L89.224 Pressure ulcer of left hip, stage 4 L89.303 Pressure ulcer of unspecified buttock, stage 3 L89.304 Pressure ulcer of unspecified buttock, stage 4 L89.313 Pressure ulcer of right buttock, stage 3 L89.314 Pressure ulcer of right buttock, stage 4 L89.323 Pressure ulcer of left buttock, stage 3 L89.324 Pressure ulcer of left buttock, stage 4 L89.43 Pressure ulcer of contiguous site of back, buttock and hip, stage 3 L89.44 Pressure ulcer of contiguous site of back, buttock and hip, stage 4

L89.503 Pressure ulcer of unspecified ankle, stage 3 L89.504 Pressure ulcer of unspecified ankle, stage 4 L89.513 Pressure ulcer of right ankle, stage 3 L89.514 Pressure ulcer of right ankle, stage 4 L89.523 Pressure ulcer of left ankle, stage 3 L89.524 Pressure ulcer of left ankle, stage 4 L89.603 Pressure ulcer of unspecified heel, stage 3 L89.604 Pressure ulcer of unspecified heel, stage 4 L89.613 Pressure ulcer of right heel, stage 3 L89.614 Pressure ulcer of right heel, stage 4 L89.623 Pressure ulcer of left heel, stage 3 L89.624 Pressure ulcer of left heel, stage 4 L89.813 Pressure ulcer of head, stage 3 L89.814 Pressure ulcer of head, stage 4 L89.893 Pressure ulcer of other site, stage 3 L89.894 Pressure ulcer of other site, stage 4 L89.93 Pressure ulcer of unspecified site, stage 3 L89.94 Pressure ulcer of unspecified site, stage 4












































25

HCPCS Level II

Description Comment

E2402 Negative pressure wound therapy electrical pump, stationary or portable

G0456

Negative pressure wound therapy, (e.g., vacuum assisted drainage collection) using a mechanically powered device, not durable medical equipment, including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions for ongoing care, per session; total wounds(s) surface area less than or equal to 50 square centimeters.

Documents

Clinical Policy Title: Negative pressure wound therapy for ... · Clinical Policy Title: Negative pressure wound therapy for chronic ulcers . Clinical Policy Number: 16.03.03. Effective