Proposed LCD - Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041)

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for skin substitutes for the treatment of diabetic foot ulcers and venous leg ulcers. 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 skin substitutes for the treatment of diabetic foot ulcers and venous leg ulcers 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 may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 15, Section 50.4.1 Approved Use of DrugCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 17, Section 40 Discarded Drugs and BiologicalsCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Code of Federal Regulations (CFR) References:CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 Human cells, tissues, and cellular and tissue-based productsCoverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationThis LCD addresses the medically reasonable and necessary threshold for coverage of skin replacement surgery for application of skin substitute grafts for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).Application of skin substitute grafts for wound care indications other than for DFU or VLU are not addressed by this LCD. Use of skin substitute grafts must meet the medically reasonable and necessary threshold for coverage and these devices must be used in accordance with their approved United States (U.S.) Food and Drug Administration (FDA) intended use.Chronic wounds of the lower extremities, including venous stasis ulcers, DFUs and pressure sores, are a major public health problem. While lower extremity ulcers have numerous causes such as burns, trauma, mixed venous-arterial disease, immobility, and vasculitis, nutritional or other neuropathy, over 90% of the lesions in the U.S. are related to venous stasis disease and diabetic neuropathy.1-3Generally, depending on the purpose of the product and how it functions, skin substitutes are regulated by the FDA premarket approval (PMA) process, FDA 510(k) premarket notification process, or the FDA regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). Although skin substitutes have attributes of both biologicals and devices, the current position is that these products are best characterized as surgical supplies or devices because of their required surgical application and their similarity to other surgical supplies. It has been noted that there are instances in which certain products might have a wound healing indication but may not necessarily meet the definition of skin substitutes. Therefore, FDA classification and indication alone does not determine if a product meets the definition of skin substitute and/or meets the medically reasonable and necessary threshold for coverage.Amniotic/chorionic-based products are HCT/Ps as defined in 21 CFR 1271.3(d) and must meet criteria in 21 CFR 1271 and 361 of the Public Health Service Act (PHS Act). The HCT/Ps not regulated under 361 are regulated as drugs as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)]. In order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product's intended use.4-6Standard treatment of lower extremity ulcers (e.g., DFUs and/or VLUs) may include mechanical offloading, infection control, mechanical compression, limb elevation, debridement of necrotic tissue, management of systemic disease and medications, nutrition assessment, tissue perfusion and oxygenation, and counseling on the risk of continued tobacco use. In addition, maintenance of a moist wound environment through appropriate dressings facilitates development of healthy granulation tissue and epithelialization and thus may potentiate complete healing at a wound site. Dressings are an integral part of wound management by not only maintaining a moist environment but by stopping contamination and absorbing exudate.7-12Despite advancements in various synthetic occlusive dressings some ulcers fail to heal. The development of skin substitutes has been employed as an adjunct to established wound care methods to increase the chances of healing.1,13Chronic wounds and frequently recurring wounds related to DFUs and VLUs are a challenge to treat effectively. Chronic wounds may be unresponsive to initial therapy or persist despite additional care. A wound that has not healed within one to three months may be considered chronic and the application of a skin substitute graft, an advanced treatment modality, may be considered medically reasonable and necessary for certain patients.1-3Patients receiving skin replacement surgery with a skin substitute graft should be under the care of a physician/non-physician practitioner (NPP) for the treatment of their systemic disease process (e.g., diabetes mellitus, chronic venous insufficiency, and/or peripheral vascular disease). It is imperative that their systemic disease be monitored/treated in order to ensure adequate healing of the wound site.3,9It is the expectation that a specific skin substitute graft product will be used for the episode of skin replacement surgery for wound care (defined as 12 weeks from the first application of a skin substitute graft) assuming its use is not in conflict with the FDA assessments (e.g., indications, contraindications, how supplied and directions for use, etc.) and/or the American Association of Tissue Banks (AATB) approved use and assuming there is one related wound. Repeat application of a skin substitute graft within the 12-week episode of skin replacement surgery for wound care may be appropriate per the package insert based on wound re-assessment and must be supported in the medical record documentation for that encounter. Additional applications of a skin substitute product beyond the 12-week episode of skin replacement wound care are not expected if the wound has responded to the skin replacement surgery with epithelialization and other progression. This LCD does not endorse particular products for separate payment. The medical record documentation must support the medical necessity for skin replacement surgery and that the product is being used within its approved FDA indications.Covered IndicationsIf the patient meets all of the criteria as outlined in this LCD, application of a skin substitute graft for lower extremity DFU or VLU is considered medically reasonable and necessary for the following:The presence of a chronic, non-infected DFU having failed to respond to documented conservative wound care measures (outlined below) for greater than four weeks with documented compliance.7The presence of a chronic, non-infected VLU having failed to respond to documented conservative wound care measures (outlined below) for greater than four weeks with documented compliance.10For purposes of this LCD, conservative wound care measures include, but are not limited to2,7-12:Comprehensive patient assessment (history, exam, Ankle-Brachial Index [ABI]) and diagnostic tests as indicated) and implemented treatment plan.For patients with a DFU - assessment of Type 1 vs. Type 2 diabetes and management history with attention to certain comorbidities (e.g., vascular disease, neuropathy, osteomyelitis), review of current blood glucose levels/hemoglobin A1c (HbA1c), diet and nutritional status, activity level, physical exam that includes assessment of skin and wound, ABI, and check of off-loading device or assessment of appropriate footwear.3For patients with a VLU - assessment of clinical history (prior ulcers, thrombosis risks), physical exam (edema, skin changes), ABI, diagnostic testing to verify superficial or deep venous reflux, perforator incompetence, and chronic (or acute) venous thrombosis. In this regard, venous duplex ultrasound is recommended to confirm the Clinical class, Etiology, Anatomy, and Pathophysiology (CEAP) classification and categorize the patients chronic venous disorder to guide the analysis of management alternatives. The Venous Clinical Severity Score (VCSS) is used to assess changes in response to therapy.An implemented treatment plan demonstrating all of the following:Debridement as appropriate.Some form of offloading for DFUs and some form of compression for VLUs.Infection control.Management of exudate - maintenance of a moist environment (moist saline gauze, other classic dressings, bioactive dressing, etc.).Patient is a nonsmoker or has refrained from smoking for at least 6 weeks prior to planned skin replacement surgery or has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation.The skin substitute graft is applied to an ulcer that has failed to respond to documented conservative wound care measures. Failed response is defined as an ulcer that has increased in size or depth, or no change in baseline size or depth, or no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closing). Documentation of response requires measurements of the initial ulcer, measurements at the completion of at least four weeks of conservative wound care measures, and measurements immediately prior to placement of the skin substitute graft for a DFU. For VLUs, conservative wound care measures must continue for no less than four weeks and include on-going compression therapy.7,10,13The medical record documentation specifically addresses the circumstances regarding why the wound has failed to respond to standard wound care treatment of greater than four weeks and references the specific interventions that have failed based on the prior wound evaluation. The record must include an updated medication history, review of pertinent medical problems that may have arisen since the previous wound evaluation, and explanation of the planned skin replacement surgery with choice of skin substitute graft product. The procedure risks and complications must also be reviewed and documented.7,10,13-14Skin substitute grafts utilized per the approved FDA intended use.The patient is under the care of a qualified physician/NPP for their underlying chronic condition.3,9LimitationsThe following are considered not medically reasonable and necessary1-3,9-10:Greater than two applications of a specific skin substitute graft product within the episode of skin replacement surgery for wound care (defined as 12 weeks from the first application of a skin substitute graft).The expectation is treatment will consist of the fewest repeat applications and amount of product to heal the wound. It is expected that products are used per the labeling. It is not expected that every ulcer, in every patient will require the maximum number of applications listed on the product label. This utilization pattern may be subject to focused medical review.Switching skin substitute graft products in a 12-week episode of skin replacement surgery for wound care. Exceptions should be rare and may be considered on appeal when the medical necessity of the change is clearly documented in the medical record.Application of a skin substitute graft product beyond 12-weeks.Repeat applications of skin substitute grafts when a previous application was unsuccessful. Unsuccessful treatment is defined as increase in size or depth of an ulcer, or no change in baseline size or depth and no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closing).Application of skin substitute grafts in patients with inadequate control of underlying conditions or exacerbating factors, or other contraindications (e.g., uncontrolled diabetes, active infection, active Charcot arthropathy of the ulcer extremity, active vasculitis).Use of surgical preparation services (for example, debridement), in conjunction with routine, simple and/or repeat skin replacement surgery with a skin substitute graft.Excessive wastage (discarded amount).The skin substitute graft must be used in an efficient manner utilizing the smallest package size available for purchase from the manufacturer that could provide the appropriate amount for the patient.All liquid skin substitute products for wound care.15Refer to the CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 for Human-derived products regulated as human cells, tissues, or cellular or tissue-based product (HCT/P) for additional limitations.Provider QualificationsServices provided within the LCD coverage indications will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the providers professional licensure; and when all procedures are performed by appropriately trained providers in the appropriate setting.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, 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.General InformationAssociated InformationPlease refer to the related Draft Local Coverage Article: Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117) for documentation requirements, utilization parameters and all coding information as applicable.Sources of Information