Abrupt CMS Decision May Threaten Hundreds of Thousands of Wound Care Patients With Potential Limb Loss

A safe and effective therapy for persons with a chronic wound — a condition with a higher mortality rate than many cancers that can lead to amputation, impact quality of life, impair mobility, and negatively affect family and caregivers — is no longer covered by Medicare. 

The Centers for Medicare and Medicaid Services (CMS) recently and unilaterally decided to alter its long-standing Medicare Part B reimbursement policy for advanced surgical wound dressings. This means millions of patients suffering from chronic wounds who use a product at home without the assistance of home care will have limited access to care. The CMS has begun to apply a nonclinical metric to surgical dressing coding and coverage. In a recent ruling, dressings impregnated with >50% (by weight) honey were no longer covered. In addition, in the preliminary HCPCS coding decisions issued in May 2015, a noncovered code was assigned to a silver product that should have been assigned to a composite dressing code; part of the CMS reasoning related to the weight of the silver contained in the dressing. Is this just the beginning of the CMS using nonclinical metrics to review multicomponent dressings? 

Clinicians like us across the country are questioning how this sudden policy reversal was determined. Wounds are a complex condition to treat; each patient is unique, and healing protocols require we maintain access to diverse treatments. Chronic wounds, if not properly treated, have devastating outcomes, including infection, hospitalization, gangrene, amputation, and death. The social, psychological, and economic impact is immeasurable for patients dealing with chronic wounds who are trying to live a normal, active life. Use of medical grade honey-impregnated dressings, for example, is supported by a great deal of evidence regarding both the clinical outcomes and the cost effectiveness of its use for chronic wounds due to diabetes, vascular disease, pressure, and burns.

When considering coverage changes, the CMS typically allows clinicians and other stakeholders to provide commentary that speaks to the clinical value and cost-effectiveness of respective treatments. In this case, CMS contractors completely disregarded this accepted protocol and announced the coverage change, effective immediately, impacting Medicare Part B patient treatment without input from practicing clinicians.

Removing coverage of medical grade, honey-impregnated dressings from Medicare is a dangerous path for policymakers to take. It eliminates a cost-effective, evidence-based treatment option. As a result of the CMS action, Medicare Part B patients will be forced to move to less effective treatment options and, in our opinion, may experience delays in healing, worse outcomes, and increased cost.

Wound care specialists must act. We need to share our concern over the lack of our engagement in the process and the limits now placed on proven treatment options. We urge our fellow clinicians to contact your legislators and voice your concern about the access to care issue created by this coverage change. You can locate your local legislator at: www.opencongress.org/people/zipcodelookup.

Each day that passes places more patients with chronic wounds in danger. Please act now.

Dr. Bell is co-founder of the Save a Leg, Save a Life Foundation and in private practice, First Coast Cardiovascular Institute, Jacksonville, FL. Dr. Snyder is a Professor, Barry University School of Podiatric Medicine, Miami Shores, FL; and Immediate Past President, Association for Advancement of Wound Care. Dr. Rogers is former chair of the Foot Care Council for the American Diabetes Association; and Executive Medical Director for the Amputation Prevention Center at Sherman Oaks Hospital, Los Angeles, CA.

The opinions contained in this letter are exclusively those of the authors and may not represent the opinions of their affiliations. This article was not subject to the Wounds peer-review process.