Coverage Indications, Limitations, and/or Medical Necessity
Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.
History/Background and/or General Information
This LCD does not address specific wound care procedures described by NCD’s and other items such as:
- Hyperbaric Oxygen (HBO) Therapy (See NCD 20.29)
- Initial physical therapy or occupational therapy evaluations
- Skin Substitutes for Wound Care
- Electrical Stimulation and Electromagnetic Therapy of Specified Wounds (See NCD 270.1)
- Treatment of burns
- Services covered under the DME benefit
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. This definition excludes the following:
- Management of acute wounds, or
- The care of wounds that normally heal by primary intention such as clean, incised traumatic wounds, or
- Surgical wounds that are closed primarily and other postoperative wound care not separately covered during the surgical global period.
Various methods to promote wound healing have been devised over time. A method which is unproven by valid scientific literature would be considered not reasonable and necessary. Wound care involves the evaluation and treatment of a wound, including identifying potential causes of delayed wound healing and the modification of treatment when indicated. Wound evaluations require a plan of care, to include a comprehensive medical evaluation, vascular evaluation, and a metabolic/nutritional evaluation. Functional evaluations by different specialties, and integration of physical therapy may also be of value. Reduction of pressure and/or control of infection have been shown to facilitate healing and may reduce the need for repeated debridement services.
The general discipline of wound care may involve almost any part of the integumentary system. Elements of a previously retired policy particularly focusing on lower extremity care have been incorporated here. Ulcers may develop because of a combination of ischemia, infection, abscess, trauma, prolonged pressure, repetitive stress, edema, and loss of sensation. The management of ulcers includes:
- Overall medical and surgical treatment of the cause and
- Meticulous care of the ulcerated skin and other associated soft tissue with application of medications and dressings, and
- When reasonable and necessary, debridement of the necrotic and devitalized tissue and
- Offloading of the external pressure source(s).
The management of a symptomatic hyperkeratosis may involve medical treatment, paring or cutting, shaving, excision, or destruction. This policy addresses only the paring or cutting approach. These services are coverable and not inclusive of Routine Foot Care when the medical record details the symptoms leading to the need for treatment.
Medicare coverage for wound care on a continuing basis, for a given wound, in a given patient, is contingent upon evidence documented in the patient's medical record that the wound is improving in response to the wound care being provided. Evidence of improvement may include measurable changes in the following:
- Pain and/or tenderness
- Wound dimensions (surface measurements, depth)
- Granulation tissue
- Necrotic tissue/slough
- Tunneling or undermining
Consistent measurement of a wound is essential for the documentation of wound healing and fundamental to good patient care decision making. Wound measurements are consistently reported in terms of length, depth and width, attention to wound volume should be added, when possible. Undermining, tunneling, and the severely contracted patient are acknowledged to compromise both wound measurement and wound healing and should be described in the medical record.
Wound care must be performed in accordance with accepted standards for medical and surgical treatment of wounds. The goal of most chronic wound care should be eventual wound closure with or without grafts, skin replacements, or other surgery (such as amputation, wound excision, etc.). Adjunctive measures include but are not limited to appropriate control of complicating factors such as pressure (e.g., off-loading, padding, and appropriate footwear), infection, vascular insufficiency, metabolic derangement and/or nutritional deficiency. While complete healing of the wound may be the primary objective; a secondary desired objective is that, with appropriate management, a wound may reach a state at which its care may be performed primarily by the patient and/or the patient’s caregiver with periodic physician assessment and supervision.
In appropriate cases, due to severe underlying debility or other factors such as operability, the goal of wound care provided in outpatient settings may be only to prevent progression of the wound and prevention of prolonged hospitalization.
Active wound care procedures involve selective and non-selective debridement techniques and are performed to remove devitalized tissue and promote healing. The provider is required to have direct (one-on-one) patient contact when performing active wound care management.
The appropriate interval and frequency of debridement depends on the individual clinical characteristics of the patient and the extent of the wound.
It is highly recommended that the treatment plan for a patient who requires frequent repeated debridement be reevaluated to ensure that issues including, but not limited to, pressure reduction, nutritional status, vascular insufficiency and infection control have been adequately addressed. Overall, evaluation of the wound should be performed at a regular frequency to determine whether the individualized treatment goals are being met for the patient.
Definition of terms for this policy:
Dressing Changes for Wound Debridement
- Wet dressings: Water and medication may be applied to the skin with dressings (e.g., finely woven cotton or gauze) soaked in solution. Wet compresses, especially with frequent changes, may provide gentle debridement.
- Dry dressings: Used to provide gentle debridement, protect the skin, hold medications against the skin, keep clothing and sheets from rubbing, or keep dirt and air away. Such dressings may also prevent patients from scratching or rubbing the wound.
- Advanced dressings: Used with increasing frequency to provide gentle debridement in the treatment of acute wounds, chronic venous, diabetic and pressure ulcers.
- Dressing changes (removal and subsequent reapplication) alone generally do not require the skills of physicians. They may be performed by physical therapists, occupational therapists, licensed professional nurses, or wound care nurses.
- Medicare would expect that wound care may be necessary for the following types of wounds:
- Surgical wounds that must be left open to heal by secondary intention.
- Infected open wounds induced by trauma or surgery.
- Wounds with biofilm.
- Wounds associated with complicating autoimmune, metabolic, and vascular or pressure factors.
- Open or closed wounds complicated by necrotic tissue and/or eschar.
- Active Wound Care Management
Debridement may be indicated whenever necrotic tissue as well as cellular or proteinaceous debris is present on an open wound in order to keep the wound in an active state of healing. Debridement may also be indicated in cases of abnormal wound healing or repair. The routine application of a topical or local anesthetic does not elevate active wound care management to surgical debridement. Debridement may be categorized as selective or non-selective.
- Wound Care Selective Debridement includes:
- Removal of specific, targeted areas of devitalized or necrotic tissue from a wound along the margin of viable tissue by sharp dissection utilizing scissors, scalpel, curettes, and/or tweezers/forceps. This procedure typically requires no anesthesia and generally has no or minimal associated bleeding.
- Wound Care Non-Selective Debridement may include:
- Mechanical Debridement: This type of debridement is the removal of necrotic tissue by cleansing, or appropriate use of dressings. Removal of debris and dressing changes are not considered a skilled or separate service.
- Enzymatic Debridement: Debridement with topical enzymes is used when the necrotic substances to be removed from a wound are protein, fiber and collagen. The manufacturer’s product insert contains indications, contraindications, precautions, dosage and administration guidelines; it is the clinician’s responsibility to comply with those guidelines.
- Autolytic Debridement: This type of debridement is indicated where manageable amounts of necrotic tissue are present, and there is no infection. Autolytic debridement occurs when the enzymes that are naturally found in wound fluids are sequestered under synthetic dressings.
- Maggot / larvae therapy: Debridement with medical-grade maggots in wounds.
- Wound Care Surgical Debridements
- Conditions that may require surgical debridement of large amounts of skin may include but are not limited to:
- rapidly spreading necrotizing process (sometimes seen with aggressive streptococcal infections),
- severe eczema,
- extensive skin trauma (including large abraded areas with ground-in dirt), or
- autoimmune skin diseases.
- Surgical debridement occurs only if material has been excised and is typically reported for the treatment of a wound to clear and maintain the site free of devitalized tissue including but not limited to necrosis, eschar, slough, infected tissue, biofilm, abnormal granulation tissue, etc., and should be accomplished to the margins of viable tissue.
- These procedures can be very effective but represent extensive debridement. They may be complex in nature and may on occasion require the use of anesthesia.
- Use of Evaluation and Management (E/M) Codes in Conjunction with Surgical Debridements
- 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.
- Negative Pressure Wound Therapy (NPWT)
- See coverage provisions of the Noridian Durable Medical Equipment (DME) LCD L33821
- Low-Frequency, Non-Contact, Non-Thermal Ultrasound
- Low frequency, non-contact, non-thermal ultrasound describes a system that uses continuous low-frequency ultrasonic energy to produce and propel a mist of liquid and deliver continuous low-frequency ultrasound to the wound bed.
- Low-Frequency, Non-Contact, Non-Thermal Ultrasound is considered reasonable and necessary wound therapy and therefore eligible for coverage by Medicare when provided for any of the following clinical conditions:
- Wounds and ulcers which are too painful for sharp or excisional debridement and have failed conventional debridement with documentation supporting the same.
- Wounds and ulcers meeting Medicare coverage for debridement but with documented contraindications to sharp or excisional debridement.
- Wounds and ulcers meeting Medicare coverage for debridement but with documented evidence of no signs of improvement after 30 days of standard wound care.
- Low-frequency, non-contact, non-thermal ultrasound may be provided two to three times per week to be considered reasonable and necessary. The length of individual treatments will vary per wound size.
- Observable, documented improvements in the wound(s) should be evident after six treatments. Improvements include documented reduction in pain, necrotic tissue, or wound size, or improved granulation tissue.
- Application of Paste Boot (Unna Boot) may be of value. Application of a Multi-Layer Compression System may be a useful adjunct to wound care management, particularly with venous ulcerations of the lower extremity.
- Wound care should employ comprehensive wound management including appropriate control of complicating factors such as unrelieved pressure, infection, vascular and/or uncontrolled metabolic derangement, and/or nutritional deficiency in addition to appropriate debridement. Medicare coverage for professional wound care procedures requires that all applicable adjunctive measures are also employed as part of comprehensive wound management. Wound care in the absence of such measures, when they are indicated, is not considered to be medically reasonable and necessary.
- Debridement will be considered not reasonable and necessary for a wound that is clean and free of necrotic tissue/slough.
- Debridements are considered selective or non-selective unless the medical record supports that a surgical excisional debridement was performed.
- Debridements are best provided under an individualized plan of care.
- Wound care may be of a palliative nature. Optimally, the overall goal of care is healing, and it would be neither reasonable nor medically necessary to continue a given type of wound care if evidence of wound improvement leading to healing of the wound as outlined in this LCD cannot be shown. However, if it is determined that the goal of care is not wound healing, which would lead ultimately to wound closure, the patient should be managed following appropriate palliative care standards. Wounds of some Medicare beneficiaries residing in Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs) may not close, heal, or be amenable to self-care in spite of optimal therapy. In those patients where wound closure, healing, or self-care is not a likely outcome, the goals of wound care may include prevention of hospitalization and improvement in quality of life. As such, due to severe underlying debility or other factors, the goal of wound care provided in these settings may be only to prevent progression of the wound by stabilizing the wound by:
- Minimizing the risk of infection and further progression of the wound;
- Managing the multiple issues that cause patient and family suffering; and
- Optimizing the patient’s function and quality of life.
- Complicating circumstances that support additional wound care services as reasonable and necessary must be supported by adequate medical record documentation.
- Autolytic debridement is contraindicated for infected wounds.
- Debridement of extensive eczematous or infected skin is not appropriate for debridement of a localized amount of tissue normally associated with a circumscribed lesion. Examples of this are ulcers, furuncles, and localized skin infections.
- Surgical debridement will be considered not reasonable and necessary when documentation indicates the wound is without devitalized, fibrotic, nonviable tissue, infection, necrosis, foreign matter, or if the wound has pink to red granulated tissue. When utilized, it is expected that the frequency of debridement will decrease over time.
- Wound debridement utilizing a method which is unproven by valid scientific literature would be considered investigational and not reasonable and necessary.
- If a treatment is investigational, under waiver of liability provisions of Medicare law, an Advance Beneficiary Notice must be obtained for the beneficiary.
- When performed in conjunction with another wound care service, the dressing change is considered an integral component of that service and is not a separately covered service.
- A wound that shows no improvement after 30 days may require a new approach, which may include a physician reassessment of underlying infection, off-loading, biofilm, metabolic, nutritional, or vascular problems which may inhibit wound healing.
- Procedures performed for cosmetic reasons or to prepare tissues for cosmetic procedures are statutorily excluded from coverage by Medicare.
- Local infiltration, metacarpal/metatarsal/digital block or topical anesthesia are included in the reimbursement for wound care services and are not separately covered.
- The following procedures are considered part of an E/M service and are not separately covered when an E/M service is performed:
- Removal of necrotic tissue by cleansing and dressing, including wet or dry-to-dry dressing changes,
- Cleansing and dressing small or superficial lesions,
- Removal of coagulated serum from normal skin surrounding an ulcer, and
- Biofilm has been observed in some studies to impact the healing of over 60% of chronic wounds. Some authors rate it immediately behind vascular supply, medical co-morbidities and the need for pressure reduction and offloading as a leading cause of delayed wound healing. Fundamental attention to wound bed preparation, cleaning and debridement are the cornerstones of biofilm management. Routine use of topical or systemic antimicrobials, cleansing and surface tension reducing agents and DNA profiling of the microbiome are all currently under evaluation. The decision making in the management of biofilm is represented within the scope of E&M services. Presently, the topical agents used in the treatment of biofilm are represented within the spectrum of products routinely used in wound care and their use does not constitute a distinct service.
- The following services are considered to be not reasonable and necessary wound debridement services:
- Removal of necrotic tissue by cleansing or dry-to-dry or wet-to-dry dressing.
- Washing bacterial or fungal debris from lesions.
- Removal of secretions and coagulation serum from normal skin surrounding an ulcer.
- Dressing of small or superficial lesions.
- Paring or cutting of corns or non-plantar calluses.
- Incision and drainage of abscess including paronychia, trimming or debridement of mycotic nails, avulsion of nail plates, acne surgery, or destruction of warts.
- Removal of non-tissue integrated fibrin exudates, crusts, or other materials from a wound without removal of tissue does not meet the definition of any debridement code and may not be reported as such.
- Wet-to-dry dressings, jet hydrotherapy, or wound irrigations should be used cautiously as maceration of surrounding tissue may hinder healing.
- Jet therapy and wound irrigation for wound debridement must be performed by skilled personnel in order to be considered reasonable and necessary.
- Medicare expects that with appropriate care:
- Wound volume or surface dimension should decrease, or
- Wounds optimally will demonstrate granulation tissue.
- Debridements of the wound(s) if indicated must be performed judiciously and at appropriate intervals. It is expected that, with appropriate care, and no extenuating medical or surgical complications or setbacks, wound volume or surface dimension should decrease overtime. It is also expected the wound care treatment plan is modified in the event that appropriate healing is not achieved.
- Assurance of sufficient vascular perfusion to support wound healing is a vital part of treatment planning and targeting therapeutic outcomes. Assessment of vascular competence can be made non-invasively using arterial Doppler studies, ankle-brachial index measurement, toe-brachial index measurement, and measurement of transcutaneous oxygen saturation and/or skin perfusion. Assessment can also be made invasively via various direct angiographic technologies. Venous Doppler is of less certain value in the assessment of venous ulcers. The patient’s medical record must identify the testing modality chosen to assess vascular competence, explain that choice in the context of the patient’s medical history, and provide documentation of test results. Where vascular assessment demonstrates an impediment to arterial or venous circulation that is likely to exert a negative impact on wound healing and an expectation that partial or full relief of that impediment will benefit the healing process, the medical record must provide documentation of the intervention performed to reduce the impediment to flow. Its immediate outcome relative to pre-intervention status must be included in the record. If intervention is deferred, the medical record must explain why intervention was not clinically appropriate in the specific patient. It is the expectation of this Contractor that arterial and venous circulation in the extremity be confirmed within two weeks of the initial patient encounter and included in the treatment plan. Once adequacy of vascular supply is established, it is anticipated that these studies need not be repeated unless there is failure to achieve wound healing.
- Similarly, a basic assessment of the patient’s metabolic stability and adequacy of nutritional support should be included in the Plan of Care (treatment plan). Some expected parameters indicating this metabolic stability might be recently documented CBC, BUN/Creatinine (serum), albumin/pre-albumin (serum), glucose and hemoglobin A1C (serum). Patients who are not following the expected progression of wound healing should have a formal nutritional assessment, using a standardized assessment such as the ASPEN criteria.
- To acknowledge the difficulty in assembling this data in varied care settings, Medicare will allow 30 days from the initial patient encounter to organize and enter a comprehensive Plan of Care in the Medical Record. This should be maintained and updated as needed, and available upon request.
- Failure to document any progress in wound healing over an ensuing 30 days should necessitate a revision in the Plan of Care, to include the possibility of alternative treatment approaches, or transition to an alternative care setting, such as a multidisciplinary, and specialized, wound center. It is the expectation of Medicare that patients with chronic wounds may be demonstrating manifestations of underlying chronic illnesses, and that follow-up and coordination of care with other medical practitioners be fully reflected in the chart.
This LCD imposes frequency limitations. For frequency limitations, please refer to the Utilization Guidelines section below.
Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.
Summary of Evidence
A chronic wound is defined as a wound that has failed to progress through normal healing in a timely manner; they generally occur in patients with comorbid conditions, such as diabetes or vascular disease.
Older adults are more likely to have chronic wounds, and to have quality of life affected by such wounds.
Chronic wounds are more challenging to treat and are associated with higher treatment costs, especially in the Medicare population. Chronic wounds include, but are not limited to, diabetic ulcers, vascular ulcers, and pressure ulcers.1-3
Evidence-based clinical guidelines and other published evidence support the following for chronic wound care:4-15
- Removal of necrotic tissue with debridement
- Maintaining moisture balance and selecting the appropriate wound dressing to control excessive moisture or add additional moisture, depending on the wound type
- Infection prevention methods and treatment when needed
- Evaluation and improvement of circulation to the wound area
- Frequent monitoring, evaluation, and measurement of wounds to determine healing progress
- Offloading for diabetic foot ulcers
- Appropriate positioning and support surfaces for pressure ulcers
- Compression for venous leg ulcers.
In large measure, the rate and extent of wound healing parallels the status of a patient’s arterial circulation to the wound site and venous circulation from it. Evidence-based clinical guidelines support noninvasive vascular assessment of the patient and their wound using arterial Doppler studies, ankle-brachial index measurement, toe-brachial index measurement, and measurement of transcutaneous oxygen saturation and/or skin perfusion pressure. Assessment can also be made invasively via various direct angiographic technologies.8,9,12,15-19
Guidelines also support basic nutritional assessment to determine if wound healing progress is being affected by nutritional deficiencies. Patients with wounds not following the expected progression of wound healing should have a formal nutritional assessment, using standardized nutritional evaluation tools, such as the ASPEN criteria.4,6,8,13,14,16,20,21
Debridement is considered first-line treatment for chronic wounds with necrotic tissue. There are several different debridement methods, including surgical, hydrosurgical, mechanical, autolytic, enzymatic, and biologic (i.e., maggot/larval). No one method of debridement has been found to be superior; method choice will depend on several factors, including but not limited to the condition of the wound, amount of necrotic tissue, provider experience, and patient pain tolerance and preference. More than one method of debridement may be required depending on the wound type and progression toward healing.4-9,13,15,16 One mechanical debridement method, wet-to-dry dressings, in which saline-soaked gauze is placed on the wound and then physically ripped off when dry, is no longer considered for standard use because it is nonselective, may damage healing tissue, and is very painful.7
One newer method of debridement, ultrasound (low frequency noncontact or high frequency), is supported by evidence-based guidelines and systematic reviews when indicated; evidence suggests that it may be more comfortable for the patient than surgical debridement.3,5,7-9,22
Biofilm consists of colonies of one or more types of microorganisms that aggregate in a matrix of extracellular polymeric substances they secrete, which facilitates adhesion; these characteristics make them resistant to antimicrobial agents. Medical biofilms can occur in chronic wounds, on indwelling catheters, and on implanted devices. Research suggests that 60% to 78% of chronic wounds contain biofilm.4,23-26 It is thought that chronic wound biofilm forms as a result of skin microenvironment disruption and infection by multiple microbe species. Biofilm should be considered as a cause of delayed healing in any chronic wound that has failed to heal despite optimal treatment interventions and management of underlying medical conditions that may contribute to nonhealing.4,24,25 While there are numerous laboratory and clinical methods for detecting biofilms, none have been unequivocally proven to be effective in the routine clinical setting for diagnosing biofilm as a cause of chronic wound infection and delayed healing.24
In a 2017, an international expert panel on biofilm and chronic wound care issued consensus-based recommendations for identifying and treating biofilm in chronic nonhealing wounds. Key findings and recommendations included the following:25
- Biofilms are present in most chronic wounds, but may not be identified because there are no routine diagnostic tests to identify biofilm in wounds. As a result, treatment may be ineffective and healing may be delayed.
- In the absence of diagnostic tests, clinical signs and symptoms can be used to determine if biofilm is present, and include: resistance to antibiotics or antiseptics, treatment failure despite appropriate antibiotics or antiseptics, delayed healing, excessive moisture and wound exudate, low-level chronic inflammation and erythema, and cycles of recurrent infection/exacerbation.
- Debridement is one of the most important treatment strategies, but does not remove all biofilm and cannot be used alone. Topical antiseptic application in combination with debridement may suppress regrowth of biofilm.
This guideline introduced a step-down/step-up approach for wounds with biofilm consisting of multiple therapies used in combination initially, optimized/personalized therapy based on inflammation and healing status, de-escalated treatment as wound improves, standard wound care, and step-up to advanced therapies (skin grafts, NPWT, growth factors, combination products) if needed.25
Several other evidence-and consensus-based guidelines have also addressed diagnosis and treatment of biofilm in chronic wounds as follows:
- In its 2019 Guideline for Management of Wounds in Patients with Lower-Extremity Venous Disease (LEVD), the Wound, Ostomy and Continence Nurses Society (WOCN) recommended that suspected biofilm be assessed when examining venous ulcers and identifying factors that may impede wound healing. When the presence of biofilm is highly suspected in a venous ulcer (i.e., wound fails to heal despite appropriate wound care and antimicrobial treatment), WOCN recommends determining bacterial bioburden by tissue biopsy or swab and considering debridement.9
- In its 2015 update of guidelines for pressure ulcer evaluation, the Wound Healing Society notes that biofilm contributes to chronic nonhealing wounds and should be suspected when a patient has a poorly healing chronic pressure ulcer. They recommend sharp debridement to control biofilm.4
- The International Working Group on the Diabetic Foot (IWGDF) notes that, while research suggests most chronic wound infections involve biofilm, no clear method has been found to diagnose or treat biofilm-related infections.27
- The American Diabetes Association (ADA) reviewed the evidence on biofilm and diabetic foot ulcers, finding that, as of January 2020, there were no routine diagnostic tests or biomarkers to confirm the presence of biofilm in chronic diabetic foot ulcers. The ADA noted that debridement is one of the most important treatments for removing biofilm, given that the effectiveness of topical antimicrobial agents has not been adequately studied. As of early 2020, high-quality evidence from human clinical trials on topical agents is lacking.23
Analysis of Evidence
(Rationale for Determination)
Wound care must be performed in accordance with accepted standards for medical and surgical treatment of wounds. The body of evidence on wound care is substantial, and there is agreement among professional evidence-based guidelines regarding the steps required for wound care in general. However, published evidence and practice patterns reflect considerable differences among clinicians regarding selection of debridement methods, wound dressings, and other methods of wound care delivery. The appropriate interval and frequency of debridement depends on the individual clinical characteristics of the patient and the extent of the wound. 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. Given the varied nature and diversity of options available to the clinician, this LCD does not impose strictly defined frequency limitations as such on wound care debridements, palliative care wound treatments, and other wound care services.
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 prepay or post pay medical review.