Wound Care

Italicized font -represents CMS national NCD language/wording copied directly from CMS Manuals or CMS Transmittals. Contractors are prohibited from changing national NCD language/wording.

Title XVIII of the Social Security Act; Section 1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Title XVIII of the Social Security Act section 1862 (a)(1)(A). This section excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. A service must be reasonable and necessary, which includes services which are safe and effective, furnished in the appropriate setting and ordered and/or furnished by qualified personnel.

Title XVIII of the Social Security Act section 1862 (a) (1) (D). This section states that no Medicare payment may be made under part A or part B for any expenses incurred for items or services that are investigational or experimental.

CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Sections
100 - Surgical Dressings. Splints, Casts, and Other Devices Used for Reductions of Fractures and
Dislocations
220 – Coverage of Outpatient Rehabilitation Therapy Services (Physical Therapy, Occupational
Therapy, and Speech-Language Pathology Services, Under Medical Insurance and
230 – Practice of Physical Therapy, Occupational Therapy, and Speech-Language Pathology.

CMS IOM Publication 100-03 Medicare Coverage Determinations (NCD) Manual, Chapter 1, Part One, Section 20.29: Hyperbaric Oxygen Therapy (Section C, Topical Application of Oxygen).

CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 270 – Wound Treatment
270.1 Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds
270.2 Noncontact Normothermic Wound Therapy (NNWT)
270.3 Blood Derived Products for Chronic Non-Healing Wounds
270.6 Infrared Therapy Devices

MLM SE17027 Clarification of Billing and Payment Policies for Negative Pressure Wound Therapy (NPWT) Using a Disposable Device

CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 - Reasonable and Necessary Provisions in an LCD.

42 Code of Federal Regulations (CFR) § 410.20 - Physicians' services

This Local Coverage Determination (LCD) offers coverage indications and guidelines for wound care involving debridement, electrical stimulation and electromagnetic therapy, negative pressure wound therapy, low frequency non-contact non-thermal ultrasound (MIST Therapy), and topical oxygen therapy (TOT).

For the purposes of this LCD, wound care is defined as care of wounds that are refractory to healing or have complicated healing cycles either because of the nature of the wound itself or because of complicating metabolic and/or physiological factors.

Active wound care procedures are performed to remove necrotic tissue and/or devitalized tissue to promote healing. Providers are responsible to determine medical necessity and use the appropriate current CPT/HCPCS code for service provided. Please consult the current AMA CPT book for the complete code description of the procedures being performed to submit claims.

This LCD supplements but does not replace, modify, or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for additional wound care. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify, or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations, and rules for Medicare payment for additional wound care sessions and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies are provided in CMS National Coverage Policy section.

This policy does not address metabolically active human skin equivalent/substitute dressings, burns, skin cancer or hyperbaric oxygen therapy.

Debridement

Debridement is defined as the removal of foreign material and/or devitalized or contaminated tissue from or adjacent to a traumatic or infected wound until surrounding healthy tissue is exposed. This LCD applies to debridement of localized areas such as wounds and ulcers. The mere removal of secretions, cleansing of a wound, does not represent a debridement service.

At least ONE of the following conditions must be present and documented:

• Pressure Injury, Stage II, III or IV,
• Venous insufficiency ulcers,
• Arterial insufficiency ulcers including diabetic lower extremity ulcers,
• Dehiscenced wounds,
• Wounds with exposed hardware or bone,
• Neuropathic ulcers,
• Neuroischaemic ulcers,
• Diabetic Foot Ulcer(s)
• Complications of surgically created or traumatic wound where accelerated granulation therapy is necessary which cannot be achieved by other available topical wound treatment.

Should deep tissue pressure injury or Stage II injury progress to Unstageable, Stage III or Stage IV requiring debridement then documentation supporting this must be included in the medical record

Goals of Debridement:
Remove devitalized tissue
Decrease risk of infection
Promote wound healing
Prevent further complications

Debridement may be categorized as selective or non-selective:

Selective debridement refers to the removal of specific, targeted areas of devitalized or necrotic tissue from a wound along the margin of viable tissue. Occasional bleeding and pain may occur. The routine application of a topical or local anesthetic does not elevate active wound care management to surgical debridement. Selective debridement includes selective removal of necrotic tissue by sharp dissection including scissors, scalpel, and forceps; and selective removal of necrotic tissue by high-pressure water jet. Selective debridement should only be done under the specific order of a physician.

Wound Care Non-Selective Debridement includes:

• Surgical debridement is excision or wide resection of all necrotic or devitalized tissue, possibly including excision of the viable wound margin. This is usually carried out in the operating room by a surgeon. Anesthesia is usually required. It is frequently used for deep tissue infection, drainage of abscess or involved tendon sheath, or debridement of bone.
• Sharp debridement is the removal of necrotic or foreign material just above the level of viable tissue and is performed in an office setting or at the patient’s bedside with or without the use of local anesthesia. Sharp debridement is less aggressive than surgical debridement but has the advantage of rapidly improving the healing conditions in the ulcer. These typically are the services of recurrent, superficial, or repeated wound care.
• Enzymatic Debridement is debridement with topical enzymes used when the necrotic substances to be removed from a wound are protein, fiber, and collagen. The manufacturers’ product insert contains indications, contraindications, precautions, dosage, and administration guidelines.
• Wet to moist dressing: This type of dressing is used to keep the wound moist. This type of dressing is used to remove drainage and necrotic tissue from wounds.

Debridement of the wound(s), if indicated, must be performed judiciously and at appropriate intervals. Medicare expects that with appropriate care and no extenuating medical or surgical complications or setbacks, wound volume or surface dimensions should decrease over time or wounds optimally will demonstrate granulation tissue. Wounds that fail to demonstrate measurable reduction in size at 2 to 4 weeks despite appropriate therapy are unlikely to heal. There is also literature to support that a reduction of less than 40% for venous and less than 50% diabetic ulcers at 4 weeks is an overall predictor of outcome for healing.

Medicare expects the wound care treatment plan to be modified in the event that appropriate healing is not achieved. Debridement should be performed by a health care professional acting within the scope of his/her legal authority.

Evidence of improvement includes measurable changes (decreases) of some of the following:

Drainage (color, amount, consistency)
Inflammation
Swelling
Pain
Wound dimensions (diameter, depth, tunneling)
Necrotic tissue/slough

Use of Evaluation and Management (E/M) Codes in Conjunction with Debridement(s)

Patients who have chronic wounds may frequently have underlying medical problems that require concomitant management in order to bring about wound closure. In addition, patients may require education, other services, and coordination of care both in the preoperative and postoperative phases of the debridement procedure. An E/M service provided and documented on the same day as a debridement service may be covered by Medicare only when the documentation clearly establishes the service as a "separately identifiable service" that was reasonable and necessary, as well as distinct, from the debridement service(s) provided.

Biophysical Agents

Biophysical agents or modalities such as electrical stimulation; induced electrical stimulation;
negative pressure wound therapy; hyperbaric oxygen; and non-contact, non-thermal ultrasound all add some form of energy to the wound bed to help drive the healing process forward, especially in the compromised tissues of patients who tend to get pressure ulcers.

Electrical Stimulation and Electromagnetic Therapy

Please refer to: CMS Publication 100-03, Medicare National Coverage Determination (NCD) Manual, Chapter 1-Part 4, § 270.1 Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds.

Negative Pressure Wound Therapy

Negative Pressure Wound Therapy (NPWT), utilizing either durable or disposable medical equipment, involves the application of controlled or intermittent negative pressure to a properly dressed wound cavity. Suction (negative pressure) is applied under airtight wound dressings to promote the healing of open wounds resistant to prior treatments. Coverage of traditional NPWT (tNPWT) device/unit/type, or supplies is under DME and providers should consult their DME LCD for specific coverage, parameters, and guidelines.

Low Frequency, Non-contact, Non-thermal Ultrasound (MIST Therapy)

Low frequency, non-contact, non-thermal ultrasound is a system that uses continuous low frequency ultrasonic energy to atomize a liquid and deliver continuous low frequency ultrasound to the wound bed. This modality is often referred to as “MIST Therapy”.

There should be documented improvements in the wound(s) evident after six MIST treatments.
Improvements include documented reduction in pain, necrotic tissue, or wound size or improved granulation tissue. Continuing MIST treatments for wounds demonstrating no improvement after six treatments is considered not reasonable and necessary. No more than 18 services of low frequency, non-contact, non-thermal ultrasound (MIST Therapy) within a six-week period will be considered reasonable and necessary. Also, Low Frequency, Non-Contact, Non-Thermal Ultrasound treatments would be separately billable if other active wound management and/or wound debridement is not performed.

Topical Oxygen Therapy

Refer to Change Request (CR) 10220, Hyperbaric Oxygen (HBO) Therapy (Section C, Topical Application of Oxygen.

Despite many recent advances in wound care, the challenge of managing chronic wounds remains
complicated by the lack of agreement on clearly defined comprehensive wound care principles and consistently accepted analytical scientific methods to evaluate outcomes.

Negative Pressure Wound Therapy (NPWT)
There is moderate evidence in the peer-reviewed published literature to indicate that NPWT using a powered device approved by the U.S. Food and Drug Administration (FDA) is effective for a specific subgroup of patients who have failed a comprehensive, conventional wound therapy program that includes all reasonable, well-established alternative medical treatments. There is also moderate evidence to support the use of this therapy as an alternative to surgery. There is insufficient evidence to support the routine use of NPWT.

Although NPWT appears effective and its superiority to conventional techniques has been demonstrated, there are still some critical concerns concerning its efficacy. Because its mechanisms of action remain partly unclear and because there are still some gaps between evidence-based data and the excellent clinical results, further prospective, randomized, ideally blinded studies are needed.¹

Low Frequency, Non-contact, Non-thermal Ultrasound (MIST Therapy)
A 2011 meta-analysis, three randomized-control trials. 444 patients with various chronic wounds.
It found 85% wound-area reduction in a mean of 7 weeks, wound-volume reduction of 80% at a mean of 12 weeks, and 42% complete wound closure at 12 weeks. By comparison, a meta-analysis of standard-of-care treatment found only 24% complete wound closure at 12 weeks.
Thus, Noncontact, Low Frequency Ultrasound (NLFU) achieves almost twice the healing of the standard treatment.2

Topical Oxygen Therapy (TOT)
Because of the difficulties in obtaining reliable wound measurements, wound closure is an important and measurable goal, and we agree with the FDA that complete wound closure is the most objective and clinically meaningful endpoint. Studies were weighted stronger when randomized and with controls, and when study end-points or patient selection did not change during the study. The review of the literature that was conducted for TOT is summarized below.

Azimian’s paper was a sample of 100 hospitalized adult patients were recruited to this single blinded multi-center study and were randomly assigned to an intervention or control group. Patients in the intervention group received transdermal wound oxygen therapy (TWOT). TWOT consisted of the direct application of humidified high-pressure oxygen via disposable catheter, at a rate of 10 liters per minute, to the wound site for 20 minutes, three times a day for 12 days. The authors concluded that transdermal wound oxygen therapy could effectively promote the healing of pressure wounds on the sacral and ischial areas of the body. However, due to the relatively small study sample, they recommended larger studies be pursued.

Blackman’s paper describes a controlled, single site study of a prospective comparison of the healing rates of chronic diabetic foot ulcers (DFUs) treated with either topical wound oxygen therapy (TWO₂) or advanced moist wound therapy (AMWT). Only 28 patients were included in the trial. The authors concluded that the wounds of study patients treated with TWO₂ were significantly more likely to heal and in a shorter period than those treated with AMWT, and that well designed randomized controlled trials to confirm the efficacy of TWO2 were needed.

The goal of this prospective, randomized study, reported by Driver was to evaluate the efficacy of the use of transdermal continuous oxygen therapy (TCOT) in patients with nonhealing diabetic foot wounds by following wound healing and biological markers of tissue response. Eligible patients were randomized either to the intervention group (n = 9) or control group (n=8) by a block randomization scheme. TCOT provided a continuous delivery of 99.8% pure oxygen by cannula at a rate of 3 mL/hour directly to the wound site. The manufacturer of the TCOT device supported this study. The authors concluded that the clinical efficacy of TCOT was established, as there was a significant difference in percent volume reduction in wound size for the TCOT group compared to the control group. No wounds completely healed during the study.

Niederauer 2015 reports a planned interim analysis of a randomized, balanced, double blind, sham controlled, parallel group clinical trial performed to evaluate use of a device providing the continuous diffusion of oxygen (CDO) to diabetic foot ulcers (DFU) compared to treatment of the ulcers with standard moist wound therapy (MWT).

The full sample size of the study is anticipated to be 84 subjects. With this report of the results of the first 50% of subjects who completed a twelve-week course of treatment (n=42). The primary outcome of the investigation is complete wound closure defined as complete reepithelization with no drainage. Those in the sham group received no oxygen to the wound but did receive standard of care MWT. Patients were followed for twelve weeks or until wound closure, whichever came first. Dressing change frequency depended on rate of exudate and varied from 2-12 times per week.

Upon analysis of the data, the investigators excluded any subject that had fast wound healing between the screening and visit number one.
As the study progressed, the authors found it necessary to have regular conference calls with investigators to provide emphasis on the proper principles of moist wound therapy, and the number of dressing changes.
Any subject who withdrew from the study, for any reason, was excluded from the statistical analysis. This study reported on the first 42 subjects (active group: n = 21; sham group, n= 21) to complete the study per protocol. The authors reported that they found no significant and beneficial treatment effect in the active arm of the study.

However, in a series of subsequent analyses, the authors found that among subjects with wound size of at least 1.5 cm² and who experienced wound closure and excluding subjects who experienced fast closure between Screen and Visit 1 (Active n=9; Sham n=3), the average number of days to closure was significantly lower among the active group than the sham group. However, stratification was then used and at the median randomization date, wound closure was found to be significantly increased in those individuals in the active group seen after the median randomization date. The authors concluded that this interim analysis suggested improved healing with CDO versus MWT for slower to close, larger chronic wounds.

Niederauer (2017) followed up on the interim report (2015) that was published in Wound Medicine; with the protocol being amended to change the minimum baseline wound size and run-in rate of wound closure inclusion/exclusion criteria. Subjects that failed these criteria were removed from the study. Sixty-six of 146 subjects were now dropped or excluded from the study after randomization. The authors stated that the results of this study suggest that CDO over a wound leads to significantly higher rates of closure and faster time to closure compared to similarly treated patients receiving standard therapy provided along with a sham device.

In a paper by Tawfick, a parallel group observational comparative study was used to examine the safety and efficacy of topical wound oxygen (TWO₂) versus conventional compression dressings in the management of refractory nonhealing venous ulcers. Here patient preference determined group allocation. The ulcer healing time among wounds treated with TWO₂ was shorter regardless of the duration or size of the ulcer. During the twelve-month follow up, none of the 37 healed TWO₂ ulcers showed signs of reoccurrence, while five of the thirteen healed ulcers by compression did. The authors concluded that TWO₂ produced superior outcomes to compression therapy in the treatment of refractory venous ulcers by achieving shorter healing times and reducing recurrence rates. They also noted that a randomized controlled trial was underway to study the benefits of TWO₂.

Yu’s paper reports a pilot randomized controlled trial to compare a continuous topical oxygen delivery system to standard best practice in patients with nonhealing DFUs. Patients were randomized into either a group which received topical oxygen as well as standard of care (SOC) (n=10) or into a nonplacebo control group which received standard of care alone (n = 10). The study was performed for eight weeks. One subject in the continuous topical oxygen group dropped out; and the results of one subject in the control group were discarded as an outlier, due to the large size of the wound. (n=18 total). The authors concluded that though this study was underpowered, it demonstrated that topical oxygen applied continuously to a chronic wound can have a great effect on healing.

Level of Evidence
Quality –Moderate
Strength – Limited
Weight – Limited

Documentation
The medical record must clearly show that the criteria under Coverage Indications, Limitations, and /or Medical Necessity have been met. The medical record must include a certified plan of care containing a treatment plan with goals, physician follow-up, the expected frequency and duration of the skilled treatment, and the potential to heal. With continuation of a treatment plan, there needs to be ongoing evidence of the effectiveness of the plan, including diminishing area and depth of the ulceration, resolution of surrounding erythema and /or wound exudates, decreasing symptomatology, and overall assessment of wound status (such as stable, improved, worsening, etc.) documented. Appropriate modification of treatment plan, when necessitated by failure of wounds to improve, must be demonstrated. The record must document complicating factors for wound healing as well as measures taken to control complicating factors when debridement is part of the plan. Medical records must be made available to Medicare upon request.

The patient’s medical record must contain clearly documented evidence of the progress of the wound’s response to treatment at each visit. This documentation must include, at a minimum:

• Current wound volume (surface dimensions and depth).
• Presence (and extent of) or absence of obvious signs of infection.
• Presence (and extent of) or absence of necrotic, devitalized or non-viable tissue or other material in the wound that is expected to inhibit healing or promote adjacent tissue breakdown.

When debridement is reported, the debridement procedure notes should demonstrate tissue removal (i.e., skin, full or partial thickness; subcutaneous tissue; muscle and/or bone), the method used to debride (i.e., hydrostatic, sharp, abrasion, etc.) and the character of the wound (including dimensions, description of necrotic material present, before and after debridement; and after debridement the description of tissue removed (including amount in sq. cm, degree of epithelialization, etc.). Procedure notes should also include the severity of tissue destruction, undermining or tunneling, necrosis, infection or evidence of reduced circulation.

When performing debridement of a single wound, report depth using the deepest level of tissue removed. In multiple wounds, sum the surface area of those wounds that are at the same depth, but do not combine sums from different depths. See current CPT Book for coding guidance.

Active debridement must be performed under a treatment plan as any other therapy service outlining specific goals, duration, frequency, modalities, an anticipated endpoint, and other pertinent factors as they may apply. Departure from this plan must be documented.

Documentation for debridement exceeding Utilization Guidelines must include a complete description of the wound, progress towards healing, complications that have delayed healing and a projected number of additional treatments necessary.

Appropriate evaluation and management of contributory medical conditions or other factors affecting the course of wound healing (such as nutritional status or other predisposing conditions) should be addressed in the record at intervals consistent with the nature of the condition or factor.

Photographic documentation of wounds immediately before and after debridement is recommended for prolonged or repetitive debridement services and maybe requested by this contractor for payment of claims.

When wound care is provided by the Therapist, for both in and outpatient wound care, the medical record is required to have the following documentation:

• Practitioner’s order(s) for therapy/wound care services and signed plan of treatment (also known as a plan of care) detailing treatment modalities for therapy/wound care services must be established as soon as possible or within 30 days.
• Initial evaluation of therapy/wound care services.
• Wound characteristics such as diameter, depth, color, presence of exudates or necrotic.
• Previous wound care services administered including date and modalities of treatment.
• Every 10 days progress notes to include current wound status, measurements (including size and depth), and the treatment provided.
• Description of instrument used for selective or sharp debridement (i.e. forceps, scalpel, scissors, tweezers, high-pressure water jet, etc.).
• Certification/recertification for therapy/wound care services.
• Actual minutes provided to support each timed service/HCPCS provided.

Note on documentation of goals:

Goals should be specific, measurable, attainable, relevant and time bound. Regarding documentation related to goals, it’s expected that the provider will state what the wound should look like when the documented goal is reached. Progress needs to be documented towards these goals and show that goals not being met are being addressed. If goals are not being met and the plan of care is not adjusted or modified to reflect any issues it may be denied.

Utilization Guidelines
Prolonged, repetitive debridement services require adequate documentation of complicating circumstances that reasonably necessitated additional services. The record must clearly document the failure of wounds to improve to support the medical necessity for removal of muscle and/or bone for complicated management of wounds.

Coverage of traditional Negative Pressure Wound Therapy (tNPWT) device/unit/type, or supplies is covered under the Durable Medical Equipment benefit (Social Security Act §1861(s)(6)), and providers should consult their DME LCD for specific coverage, parameters, and guidelines.

The beneficiaries who undergo treatment utilizing negative pressure wound therapy, only when medical necessity continues to be met and there is documented evidence of clear benefit from the NPWT treatment already provided.

The number of debridements and NPWT for a wound within the context of a palliative treatment plan (i.e., when wounds are not expected to heal or when patients are in an end-of-life situation) would be expected to be of a limited frequency and duration consistent with that of palliative care.

The extent and number of services provided should be medically necessary and reasonable based on the documented medical evaluation of the patient's condition, diagnosis, and plan.
Only when medical necessity continues to be met and there is documented evidence of clear benefit from the services provided, should services be continued. When services are performed in excess of anticipated peer norms based on data analysis, the services may be subject to medical review.

Summary of Evidence from Comment Period (09/26/2019 – 11/10/2019):

Overall conclusions:

Included in this LCD are the revisions to add debridement for stage 2 pressure injuries, diabetic foot ulcers (DFU) and chronic non-pressure ulcers with severity limited to breakdown of the skin when biofilm or devitalization is present. It is clear, and never under reconsideration, that a standard treatment of wounds includes debridement of devitalized tissue including necrotic, infected, slough, debris and tissue with abnormal granulation. Prior to the reconsideration, debridement was limited to stage 3 and 4 pressure ulcerations. The reconsideration requested the addition of stage 2, DFU (listed in addition to neuroischemic ulceration) and non-pressure wounds with limited skin breakdown.

Although literature directly discussing stage 2 pressure injury and the value of debridement may be limited, we accept the premise but the National Pressure Ulcer Advisory Panel stating “there is strong informed clinical consensus to support the role of debridement in wound bed preparation, despite the ethically understandable lack of randomized controlled trials directly comparing debridement to no debridement in human subjects.” There is ample evidence demonstrating debridement of ulcers with biofilm or devitalized tissue, regardless of the stage. It is therefore reasonable and medically necessary, and considered the medically accepted standard of care, to treat with debridement. Biofilms and devitalized tissue can be found both on the surface and in deeper wounds. Accepting the premise that wounds with biofilms and devitalized tissue require debridement it is then accepted that Stage 2 pressure injury and non-pressure wounds with limited skin breakdown may require debridement for proper wound healing.

It has been and continues to be accepted that DFU require debridement as part of standard wound healing practices. Prior to this reconsideration request, DFU were categorized as part of neuroischemic ulcerations understanding the mechanism of most diabetic wounds arise from a vascular or neurologic etiology. The request in the reconsideration was to specifically add DFU for coverage. The reviewed literature and comments support evidence for diabetic foot wounds with an etiology other than neurological or ischemic injury. Such other causes include deformity, limited ankle range of motion, high plantar foot pressures, minor trauma, previous ulceration or amputation and visual impairment. Evidence has shown that debridement of diabetic foot ulcers enhances the healing process when combined with standard wound care for a diabetic foot ulcer. Accepting that not all DFU are neuroischemic and continuing to accept that debridement is an important part of the wound treatment, the LCD has been changed to specifically identify DFU for coverage independent of neurological and ischemic injuries.

Analysis of Evidence

(Rationale for Determination)

Analysis of Evidence included in the above Summary of Evidence from Comment Period (09/26/2019 – 11/10/2019).

Summary of Evidence for Reconsideration (01/17/2019):

Khanolkar MP, Bain SC, Stephens JW. The diabetic foot. QJM: An International Journal of Medicine. 2008;101(9) 9:685–695. https://doi.org/10.1093/qjmed/hcn027. The article discusses epidemiology, pathogenesis, assessment, and management of the “Diabetic Foot”. The article states, “Regular foot care includes debridement of calluses as this has been shown to reduce peak plantar pressure by 26%.” The debridement discussion focuses on the types of debridement but does not expand into the types of wounds that should be debrided and when a diabetic wound should be debrided. The authors only mentions regular debridement of calluses, which are not classified as wounds.

Johani K, Malone M, Jensen S, Gosbell I, Dickson H, Hu H, Vickery K. Microscopy visualisation confirms multispecies biofilms are ubiquitous in diabetic foot ulcers. Int Wound J. 2017;6:1160-1169. https://onlinelibrary.wiley.com/doi/pdf/10.1111/iwj.12777. Epub Jun 23, 2017. The article studied tissue specimens taken from 65 subjects with diabetic foot ulcers (DFU) to see if the presence of biofilms in chronic wounds contribute to delay in wound healing. A secondary objective was to study the results of microscopic wound observations to determine if clinical cues are useful in detecting wound biofilm. The article lists various factors (neuropathy, peripheral vascular disease, trauma and infection) that can cause diabetic foot complications along with management. This included the general management of “diabetic foot” (correct foot care, smoking cessation etc.) to more advanced interventions (debridement, prophylactic foot surgery etc.). In summary, this study reviews biofilms and their relationship to diabetic foot ulcers. Debridement is mentioned only once in the context of poor healing post debridement and may be the presence of biofilms. This study does not directly address the requested additions in the reconsideration request.

Schultz GS, Sibbald RG, Falanga V, Ayello EA, Dowsett C, Harding K, Romanelli M., Stacey MC, Teot L, Vanscheidt W.Wound bed preparation: a systematic approach to wound management. Wound Repair Regen.2003;Suppl 1:S1-28. An article discussing the molecular events and key elements of wound bed management in acute and chronic wound healing.

The article addresses the benefits of debridement in the healing process but does not address the type of wounds such as those requested in the reconsideration. Allogenic bilayered tissue is discussed in regards to diabetic foot ulcer treatment but there is no mention of debridement and its role in healing. There is a discussion on the role of human recombinant PDGF and its role in the healing of pressure ulcers. There is no mention of the stage of pressure ulcer or debridement.

Medicare National Coverage Determinations Manual 270.1: Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/ncd103c1_Part4.pdf

Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. 2014; Cambridge Media: Osborne Park, Australia. A summary of evidence based recommendations and guidelines for prevention and treatment of pressure ulcers.

The article discusses debridement of devitalized tissue within the wound bed or edge of pressure ulcers when appropriate to the individual’s condition and consistent with overall goals of care. It is noted the strength of evidence is grade C. Grade C means, the recommendation is supported by indirect evidence (e.g., studies in healthy humans, humans with other types of chronic wounds, animal models) and/or expert opinion). The authors also note that caution should be taken when debriding tissue with inadequate perfusion to the wound. The review suggests diabetic ulcers would be high risk given poor circulation. The article notes Surgical/sharp debridement is recommended in the presence of extensive necrosis, advancing cellulitis, crepitus, fluctuance, and/or sepsis secondary to ulcer-related infection. This description is not consistent with a stage II pressure ulceration. The only mention of debridement in regards to the stage of ulcer (referring only to stage III/IV and not stage II) is Refer individuals with Category/Stage III or IV pressure ulcers with undermining, tunneling/sinus tracts,and/or extensive necrotic tissue that cannot be easily removed by other debridement methods for surgical evaluation as appropriate to the individual’s condition and goals of care.

Steed DL, Donohoe D, Webster MW, Lindley L. Effect of extensive debridement and treatment on the healing of diabetic foot ulcers. Diabetic Ulcer Study Group. J Am Coll Surg. 1996;183(1):61-64. One hundred and eighteen patients participated in a randomized, prospective, double-blind, multicenter study to analyze the effect of extensive debridement and treatment on the healing of Diabetic Foot Ulcers. The treatment also included topically applied recombinant human platelet derived growth factor or placebo to treat patients with chronic nonischemic diabetic ulcers. ALL study participants underwent sharp debridement of the ulcer bed.

Results: use of rhPDGF had better healing than placebo. All patients had debridement at assessment and as needed during the treatment phase of study. The percentage of debridement was the same between groups. The authors state more debridement (regardless of group) led to better healing. The authors do not describe criteria for debriding. The authors provide no cut off of “intermediate vs high debridement,” and there was no statistics to show clinically significant difference. They note that the influence of debridement was evaluated by reviewing clinic notes at the time of follow up which is a very subjective and non-objective evaluation tool. Conclusions are drawn looking at one chart illustration without statistical analysis. This study’s primary purpose was to evaluate the effect of rhPDGF on wound healing. The additional effects of frequent debridement were not appropriately analyzed.

Sage RA, Webster JK, Fisher SG. Outpatient care and morbidity reduction in diabetic foot ulcers associated with chronic pressure callus. J Am Podiatr Med Assoc. 2001; 91(6):275-279. A retrospective review of 233 cases of diabetic foot ulceration preceded by minor trauma to determine if aggressive outpatient care was effective in decreasing hospitalization and surgery in these patients. This article makes the case for debridement of keratotic and pressure lesions such as focal pressure keratosis in PREVENTION of wounds. The article is not relevant to the request as it does not address treatment of DM ulcer, stage II wounds (discusses prevention) and NON-pressure wounds with limited skin breakdown.

Saap LJ, Falanga V. Debridement performance index and its correlation with complete closure of diabetic foot ulcers. Wound Repair Regen. 2002;10(6):354-359. The article is written to address the current issue of there being an established way to judge the appropriate extent of debridement and its performance. The use of the Debridement Performance Index was used as an independent predictor of wound closure. The methods included evaluation of digital photographs from 143 patients. The study was a controlled, randomized pivotal clinical trial. The study compared “standard therapy” (twice daily moist saline gauze dressings and off-loading) vs. the use of a bilayered graft. All ulcers were defined as full thickness neuropathic ulcers. The frequency and need for debridement was not defined. The study reviews the effectiveness of debridement using the debridement performance index (DPI). The better the DPI score the better results in regards to wound closure. This study does not address the issue defined in the reconsideration request. The study evaluates the benefit of the DPI index. The study does not account for how standard treatment or biofilm grafting effected the results. The study includes “neuropathic ulcers” which are currently included in the LCD coverage criteria.

Ndip A, Jude EB. Emerging evidence for neuroischemic diabetic foot ulcers: model of care and how to adapt practice. Int J Low Ext Wounds. 2009;82-94. A study discussing the importance of conducting a vascular review in patients with ischemic/neuroischemic ulcers utilizing a multidisciplinary foot care team. The article repeatedly discussed neuroischemic foot ulcers and does not address specifically diabetic foot ulcer as the etiology compared to other causes of neuroischemic ulceration. Debridement is mentioned in the context of general treatments for neuroischemic ulcers. Does not address the request.

Analysis of Evidence

(Rationale for Determination)

Overall conclusions:

Diabetic foot ulcerations:

1. No study was presented to show clear evidence that debridement improves ulcer healing. One study suggests high frequency debridement improves ulcer healing. There was no data analysis to support this finding and show statistical significance. One study evaluates the DPI and indirectly measures the effect of debridement on DFUs. It is noted however that all ulcers debrided were classified as “neuropathic ulcers.”
2. Studies repeatedly describe pressure keratosis (callus) debridement to prevent diabetic ulcer. The provider request is for diabetic and non-pressure ulcer.

Stage II ulcer

1. No study was submitted that specifically addresses stage II debridement. No study discussed outcomes of debridement in any stage. Studies presented referred to class C evidence in support of debridement and debridements MAY decrease the time to healing.

Non-pressure limited to breakdown of skin:

1. No studies presented addressing debridement for this. Frequent discussion of treatment of PRESSURE keratosis to PREVENT ulcers.

My Recommendation: No change to current LCD coverage guidelines.

Level of Evidence

Quality – The overall quality of evidence is average. There is mix of review studies and randomized trials. Although most studies address the topic of the article adequately, none of the articles directly addresses the specific requests of the reconsideration.

Strength – The strength of the evidence is poor. No study directly provided evidence to support debridement of stage II foot ulcerations. Stage III and IV were addressed and are already included in the current LCD. Treatment and prevention of diabetic foot ulcerations were reviewed in several articles but the mention of debridement was focused on neuropathic ulceration, which are already included in the current LCD article.

Weight – No weight is given to the articles provided. The articles do not address the reconsideration request in such a way to justify the addition of stage II pressure ulcers and diabetic foot ulcers, with associated requested codes, to the LCD.

N/A

Bibliography from Comment Period (09/26/2019 – 11/10/2019):

American Physical Therapy Association (APTA): Minimum required skills of physical therapist graduates at entry-level. BOD G11-05-20-49. https://www.apta.org/contentassets/d778a3ac22b04e9d9352257c5c1011e2/minreqskillsptgrad.pdf Accessed March 22, 2023.

Armstrong DG, de Asia RJ. Management of diabetic foot ulcers. Edits:JF, Mills JL, Nathan DM, eds. UpToDate.

Attinger CE, Bulan EJ. Debridement: The key initial first step in wound healing. Foot Ankle Clin N Am. 2001; 6:627- 660.

Cuddigan J, NDNQI: Getting the numbers - pressure injuries across the U.S., in NPUAP 2017 Biennial Conference Pressure Injury: Advancing the Vision. 2017; National Pressure Ulcer Advisory Panel: New Orleans, LA.

Edsberg LE, et al., Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs. 2016;43(6):585-597.

Game FL, Apelqvist J, Attinger C, et al. for the International Working Group on the Diabetic Foot (IWGDF). IWGDF Guidance on use of interventions to enhance the healing of chronic ulcers of the foot in diabetes. International Working Group on the Diabetic Foot. 2015.

Gupta S, Andersen C, Black J, et al. Management of chronic wounds: Diagnosis, preparation, treatment, and follow-up. Wounds. 2017; 29(9 Suppl):S19-S36.

Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: A practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg 2016; 63(2S): 3S-21S.

International Working Group on the Diabetic Foot (IWGDF) Guidance on use of interventions to enhance the healing of chronic ulcers of the foot in diabetes. International Working Group on the Diabetic Foot. 2015.

International Best Practice Guidelines: Best Practice Guidelines: Wound Management in Diabetic Foot Ulcers. Wounds International, 2013.

Lavery LA, Davis KE, Berriman SJ, et al. WHS guidelines update: Diabetic foot ulcer treatment guidelines. Wound Repair Regen. 2016; 24:112-126.

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. Clinical Infectious Diseases. 2012; 54:132-173.

National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Australia; 2014.

National Pressure Ulcer Advisory Panel. National Pressure Ulcer Advisory Panel (NPUAP) announces a change in terminology from pressure ulcer to pressure injury and updates the stages of pressure injury. 2016 June 14.

National Pressure Ulcer Advisory Panel. NPUAP Position statement on staging - 2017 clarifications. 2017 Jan 24.

Ndip A, Ebah L, Mbako A. Neuropathic diabetic foot ulcer – evidence-to-practice. Int J Gen Med. 2012.

Püllen R, Popp R, Volkers P, Füsgen I. Prospective randomized double-blind study of the wound-debriding effects of collagenase and fibrinolysin/deoxyribonuclease in pressure ulcers. Age Ageing. 2002;31(2):126-130. doi:10.1093/ageing/31.2.126.

Schultz G, Bjarnsholt T, James G et al. Consensus guidelines for the identification and treatment of biofilms in chronic nonhealing wounds. Wound Repair Regen. 2017;25(5):744-757. doi:10.1111/wrr.12590.

Steed DL, Attinger C, Colaizzi T, et al. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006; 15:680-692.

Wilcox J, Carter M, Covington S. Frequency of debridements and time to heal. JAMA Dermatol.
2013;149(9):1050-1058. doi:10.1001/jamadermatol.2013.4960.

Wolcott RD, Kennedy JP, Dowd SE. Regular debridement is the main tool for maintaining a healthy wound bed in most chronic wounds. J Wound Care 2009;18(2):54-56.

Wounds International. International Best Practice Guidelines: Wound Management in Diabetic Foot Ulcers. Wounds International. 2013.

Bibliography for Reconsideration (01/17/2019): 

Johani K, Malone M, Jensen S, Gosbell I, Dickson H, Hu H, Vickery K. Microscopy visualisation confirms multispecies biofilms are ubiquitous in diabetic foot ulcers. Int Wound J. 2017;6:1160-1169. https://onlinelibrary.wiley.com/doi/pdf/10.1111/iwj.12777. Epub Jun 23, 2017.

Khanolkar MP, Bain SC, Stephens JW. The diabetic foot. QJM: Int J Med. 2008;101(9) 9:685–695. https://doi.org/10.1093/qjmed/hcn027

Medicare National Coverage Determinations Manual 270.1: Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/ncd103c1_Part4.pdf

Ndip A, Jude EB. Emerging evidence for neuroischemic diabetic foot ulcers: model of care and how to adapt practice. Int J Low Ext Wounds. 2009;82-94.

Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan PacificPressure Injury Alliance. 2014; Cambridge Media: Osborne Park, Australia.

Saap LJ, Falanga V. Debridement performance index and its correlation with complete closure of diabetic foot ulcers. Wound Repair Regen. 2002;10(6):354-9.

Sage RA, Webster JK, Fisher SG. Outpatient care and morbidity reduction in diabetic foot ulcers associated with chronic pressure callus. J Am Podiatr Med Assoc. 2001; 91(6):275-9.

Schultz GS, Sibbald RG, Falanga V, Ayello EA, Dowsett C, Harding K, Romanelli M., Stacey MC, Teot L, Vanscheidt W.Wound bed preparation: a systematic approach to wound management. Wound Repair Regen.2003;Suppl 1:S1-28.

Steed DL, Donohoe D, Webster MW, Lindley L. Effect of extensive debridement and treatment on the healing of diabetic foot ulcers. Diabetic Ulcer Study Group. J Am Coll Surg. 1996;183(1):61-4.

Original Bibliography:

Agency for Healthcare Research and Quality (AHRQ). Pressure ulcer treatment strategies: comparative effectiveness. Effective Health Care Program. 2013 May; 90:1-24.

Agency for Healthcare Research and Quality (AHRQ). Negative pressure wound therapy devices. Technology Assessment Program 2009 May;1-59.

Alumia A, Improving outcomes with noncontact low-frequency ultrasound.
Wound Care Advisor. 2013 Sept./Oct.; 2(5):17-202.
http://woundcareadvisor.com/wp-content/uploads/2013/09/BP_IMPROVE_S-O13.pdf

Azimian J, Nayeri ND, Pourkhaleghi E, Ansari M. Transdermal Wound Oxygen Therapy on Pressure Ulcer Healing: A single-blind multi-center randomized controlled trial. Iran Red Crescent Med J. 2015; 17(11): e20211. doi:10.5812/ircmj.20211. PMID: 26734476.

Baharestani MM., Berger T M, Bolton LL, et al. Association for the Advancement of Wound Care Guideline of Pressure Ulcer Guidelines. Agency for Healthcare Research and Quality. National Clearinghouse Website. 2010 Oct 1.

Bell, A.L., Cavorsi, J. Noncontact ultrasound therapy for adjunctive treatment of nonhealing wounds: A retrospective analysis. Phys Ther. 2008 Dec; 88(12):1517-1524.

Blackman E, Moore C, Hyatt J, Railton R, Frye C. Topical wound oxygen therapy in the treatment of severe diabetic foot ulcers: A prospective controlled study. Ostomy Wound Manage. 2010; 56(6): 24-31. PMID: 20567051.

Burke TJ. The effect of monochromatic infrared energy on sensation in subjects with diabetic peripheral neuropathy: a double-blind, placebo-controlled study. Diabetes Care. 2006 May; 29(5):1186. A response to Clifft et al. Accessed 11/03/2015.

Cole PS, Quisberg J, Melin MM. Adjuvant use of acoustic pressure wound therapy for treatment of chronic wounds. J Wound Ostomy Continence Nurs. 2009 Mar/Apr; 36(2):171-177.

Department of Health and Human Services. Negative Pressure Wound Therapy Technologies For Chronic Wound Care in the Home Setting – Technology Assessment Program. 2014; (Project ID: WNDT0913) Rockville, Maryland.

¹Division of Plastic Surgery and Reconstructive Surgery, Medical University Graz, et al Negative pressure therapy: theory and practice. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:72-7. doi: 10.1002/dmrr.2243.

²Driver VR, Yao M, Miller CJ. Noncontract low-frequency ultrasound therapy in the treatment of chronic wounds: A meta-analysis. Wound Repair Regen. 2011 Jun; 19(4): 475-480.

Driver VR, Yao M, Kantarci A, Gu G. Park N, Hasturk H. A Prospective, Randomized Clinical Study Evaluating the Effect of Transdermal Continuous Oxygen Therapy on Biological Processes and Foot Ulcer Healing in Persons with Diabetes Mellitus. Ostomy Wound Manage. 2013; 59(11): 19-26. PMID: 24201169.

Escandon J, Vivas,AC, Perez R, Kirsner R, Davis S. A prospective pilot study of ultrasound therapy effectiveness in refractory venous leg ulcers. Int Wound J. 2012 Oct; 9(5):570-578.

Flanagan M. Wound measurement: can it help us to monitor progression to healing? J Wound Care. 2003; 12(5):189–194.

Fonder MA, Lazarus GS, Cowan DA, Aronson-Cook B, Kohli AR, Mamelak AJ.
Treating the chronic wound: A practical approach to the care of nonhealing wounds and wound care dressings. J of Am Acad Dermatol. 2008,Feb; 58(2):185-206.

Gray, M., Black, J.M., Baharestani, M.M., Bliss, D.Z., Colwell, J.C., Goldberg, M., et al.
Moisture-Associated Skin Damage: Overview and Pathology. J Wound Ostomy Continence Nurs. 2011;38(3):233-241. Wound Care Literature Review 2011

Haan J, Lucich, S. A retrospective analysis of acoustic pressure wound therapy:
effects on the healing progression of chronic wounds. J Am Col Certif Wound Spec.2009; 1:28-34.

Honaker JS, Forston MR, Davis EA, Wiesner MM., Morgan JA. Effects of noncontact low-frequency ultrasound on healing of suspected deep tissue injury: a retrospective analysis. Int Wound J. 2013 Feb; 10(1):65-72.

Hurd T, Trueman P, Rossington A. Use of a portable, single-use negative pressure wound therapy device in home care patients with low to moderately exuding wounds: a case series. Ostomy Wound Manage. 2014 Mar; 60(3):1943-2720.

International Consolidated Venous Ulcer Guideline (ICVUG) 2015
(Update of AAWC Venous Ulcer Guideline, 2005 and 2010) Retrieved from: https://aawconline

Krokowicz L, Borejsza-Wysocki M, Mackiewicz J, Iqbal A, Drews M.
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Negative Pressure Wound Therapy. 2014 Jan; 1(1):27-321.

Niederauer MQ, Michalek JE, Armstrong DG. Interim results for a prospective, randomized, double-blind multicenter study comparing continuous diffusion of oxygen therapy to standard moist wound therapy in the treatment of diabetic foot ulcers. Wound Med. 2015; 8:19–23. http://dx.doi.org/10.1016/j.wndm.2015.03.005.

Niederauer M, Michalek J, Armstrong D. A prospective, randomized, double-blind multicenter study comparing continuous diffusion of oxygen therapy to sham therapy in the treatment of diabetic foot ulcers. J Diabetes Sci Technol. 2017; 1-9.

Photography in Wound Documentation: Fact Sheet from Wound Ostomy and Continence Nurses Society January 2, 2012.

U.S. Food & Drug Administration, UPDATE on Serious Complications Associated with Negative Pressure Wound Therapy Systems: FDA Safety Communication. Date issued: February 24, 2011.

Sheehan P, Jones P, Caswlli A, Giurini and J. Veves. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Diabetes Care. 2003 Jun; 26(6):1879-1882. https://doi.org/10.2337/diacare.26.6.1879.

Synder RJ, Cardinal M, Dauphinée DM, Stavpsky J. A post-hoc analysis of reduction in diabetic foot ulcer size at 4 weeks as a predictor of healing by 12 weeks. Ostomy Wound Manage. 2010 Mar 1; 56(3):44-50.

Steed D L, Attinger C, Colaizzi T, Crossland M, Franz M, Harkless L, Johnson A, Moosa H, Robson M, Serena T, Sheehan P, Veves A, Wiersma-Bryant L. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen 2006; 14:680–692. doi:10.1111/j.1524-475X.2006. 00176.x

Tawfick WA, Sultan S. Does Topical Wound Oxygen (TWO2Offer an Improved Outcome Over Conventional Compression Dressings (CCD) in the Management of Refractory Venous Ulcers (RVU)? A Parallel Observational Comparative Study. Eur J Vasc Endovasc Surg. 2009 Jul; 38(1):125-32. doi: 10.1016/j.ejvs.2009.03.027. Epub 2009 May 22. PMID: 19464933.

The Management of Diabetic Foot: A Clinical Practice Guideline by the Society for Vascular Surgery in Collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg 2016; special supplement published February 2016.

Yu J, Lu S, McLaren A, Perry JA, Cross KM. Topical oxygen therapy results in complete wound healing in diabetic foot ulcers. Wound Repair Regen. 2016. doi: 10.1111/wrr.12490. PMID: 27733020.

• Debridement
• Electrical Stimulation
• Electrical Therapy
• MIST
• Wound