Wound and Ulcer Care

Jurisdiction: JE Part B. States: California, Hawaii, Nevada, American Samoa, Guam, Northern Mariana Islands. Type: Active LCD

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 and ulcers 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, progressing through normal phases of the healing cycle, or The care of wounds that normally heal by primary intention such as clean, incised traumatic wounds that have approximated edges. 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 should lead to a plan of care, to include a comprehensive medical evaluation, vascular assessment , 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, venous and arterial insufficiency, 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 healing is being maintained in response to the wound care being provided. 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. Undermining and tunneling are reported by location according to numbers on a clock, oriented so that the patient’s head is at 12 o’clock and feet are at 6 o’clock. Undermining is measured by inserting a cotton swab under intact skin at the wound’s edge at the point of longest extension under the skin. Tunneling is measured by inserting a swab into the deepest channel. Infection is reported by describing wound exudate – amount, turbidity, color, and odor – and signs of infection (cellulitis) in the tissue surrounding the wound. Necrosis is the ultimate loss of tissue vitality. The presence of devitalized tissue impedes healing. Ongoing wound care may include debridement to promote healing. The patient’s clinical status and the characteristics of the wound will determine the appropriate method of debridement, its frequency, and the interval between treatments. Please see “Covered Indications” for more information on debridement methods. Wound care must be performed in accordance with accepted standards for medical and surgical treatment of wounds. The goal of most acute wound or chronic ulcer care should be eventual wound closure with or without grafts, cellular or tissue products, or other surgery (such as amputation, wound excision, etc.). Standard wound care 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. Frequent debridement suggests a need to reassess and reexamine the treatment plan to ensure that clinicians are addressing all facets of care. 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 in the treatment of acute wounds, chronic venous, diabetic and pressure ulcers. May be used to provide gentle debridement, moisture control, prevent bacterial overgrowth, for thermal insulation and for physical protection. Dressing changes (removal and subsequent reapplication) alone generally do not require the skills of physicians. They may be performed by physical therapists, occupational therapists, or wound care nurses. Covered Indications 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. 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, curette, 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 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 where the normal process of healing has not progressed as expected at 30 days. Low-frequency, non-contact, non-thermal ultrasound is considered reasonable and necessary when provided two to three times per week. 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, as is the use of Total Contact Casting. Application of a Multi-Layer Compression System may be a useful component of wound care management, particularly with venous ulcerations of the lower extremity. Limitations 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 has not progressed as expected 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 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. Jet hydrotherapy, or wound irrigations should be used cautiously as maceration of surrounding tissue may hinder healing. Wet-to-dry dressing are noted to have limitations and should be used with discretion. 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. Regarding assessment of venous ulcers, venous Doppler is of less certain value. It is primarily efficacious in the evaluation of venous thrombosis. Duplex investigation, which is a combination of B-mode echography and Doppler sonography, is a preferred technique in evaluating venous leg ulcers. A commonly used, but invasive alternative is venography. 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 30 days 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, or newer assessment tools such as the MEAL scale more applicable to the outpatient status. 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. Areas which are rural or underserved may benefit from evolving applications of telehealth to add expertise to the development of the Care Plan, or revision thereof, should the patient prove refractory. Failure to document expected healing after 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.