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Abrupt CMS decision sets dangerous policymaking precedent for healthcare coverage

Imagine being told you have a condition with a higher mortality rate than many cancers, something that leads to amputation, impacts your quality of life, impairs your mobility, and negatively affects your family and caregivers. Now, imagine that a safe and effective therapy which has been used for years is no longer covered by Medicare. This is precisely what’s happening with medical-grade honey dressings and patients with chronic wounds.

The Centers for Medicare and Medicaid Services (CMS) recently unilaterally decided to alter its long-standing reimbursement policy for advanced surgical wound dressings, limiting access to care for millions of patients suffering from chronic wounds. Clinicians like us across the country are questioning how this sudden policy reversal was made when so much evidence exists to support both the clinical outcomes and the cost effectiveness of medical-grade, honey-impregnated dressings for chronic wounds due to diabetes, vascular disease, pressure, and burns.

{mosads}There are 100,000 amputations in the United States annually, performed mostly on those with diabetes and largely in the Medicare or veteran population. The studies show that, in this population, 84% of amputations are preceded by a wound that has become complicated by delayed healing, infection, or gangrene. 

It’s not just the 1.4 million people with diabetes living with chronic wounds. There are 600,000 people with venous leg ulcers, in addition to those with wounds from burns, accidents, or arterial disease.

If not properly treated, these wounds also have devastating outcomes including infection, hospitalization, gangrene, amputation, and death. The social, psychological and economic impact is immeasurable for those patients dealing with chronic wounds who are trying to live a normal, active life.

Wounds are a complex condition to treat, and as any clinician will attest, there is no “one-size-fits-all” treatment. Since each patient is unique, healing protocols require that we maintain access to diverse treatments.

As providers who specialize in complex wound care, we treat patients every day with advanced dressings. Medical-grade, honey-impregnated dressings have been shown to be cost effective, well tolerated by patients and supported by solid evidence-based research that demonstrates their clinical ability to clean wounds, prevent infections, and speed up healing. 

As a result of the CMS action, 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.

What’s also surprising is that the CMS decision to remove coverage for these products runs counter to federal government policies including those enacted in the Affordable Care Act (ACA) and the Obama Administration’s recent executive order on overuse of antibiotics.

The ACA provides that preferred treatments are those that abide by the high standards of evidence-based medicine to increase the quality of care and improve outcomes. Consistent with this, when considering coverage changes, 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 however, CMS contractors completely disregarded this accepted protocol, and recently announced that a coverage change had been made, immediately impacting patient treatment without input from practicing clinicians.

The recent interagency plan issued by the White House to fight drug-resistant bacteria by curbing antibiotic use at hospitals makes clear that we must do all we can to stop the overuse of antibiotics. Chronic wounds are too often treated with topical antibiotics, despite clinical data that these drugs do not effectively address active infections and instead give rise to dangerous resistant bacteria. Chronic wounds have dead and dying tissue which harbors bacteria. Honey-impregnated dressings aid the removal of this necrotic tissue without the use of topical antibiotics. Thus, the CMS decision to stop coverage of honey-impregnated products is in direct conflict with the White House plan.

Removing coverage of honey-impregnated dressings from Medicare is a dangerous path for policymakers to take, eliminating a cost-effective, evidence-based treatment option. We urge Congress to consider the implications this decision is having on patients everywhere and the ramifications of the precedent set by CMS’ decision-making process CMS must reconsider its position by reinstating coverage for these products immediately. Each day that passes places more patients with chronic wounds in danger.

Desmond Bell, DPM, CWS, Co-founder of the “Save A Leg, Save A Life” Foundation, and private practice, First Coast Cardiovascular Institute, Jacksonville, Florida*

Robert J. Snyder, DPM, MSc, CWS, Professor, Barry University School of Podiatric Medicine, Miami Shores, Florida; immediate past president, Association for the Advancement of Wound Care*

Lee C Rogers, DPM, 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 in Los Angeles, California*

*The opinions contained in this Op-Ed are exclusively those of the authors and may not represent the opinions of their affiliations.


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