Viewpoint: 2014 Changes to Reimbursement for Cellular and Tissue-Based Wound Care Products Protection Status
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by Thomas E. Serena MD, FACS, FACHM, FAPWCA

Resting peacefully by the fire, eggnog in hand, wearied from stringing lights and eleventh-hour shopping, I settled in for the evening. My eyes lazily perused the laptop screen when the news bulletin shattered my serenity. The Centers for Medicare Services (CMS) had sabotaged the evidenced-based pyramid in the field of wound care. Our fragile edifice of evidence crumbled under the weight of the "Black OPPS." Sequestered beneath a mountain of digital output, which took hours to dig through, lay a new categorization of the most commonly used advanced wound care modalities: Cellular and Tissue-Based Products (CTPs), formerly called "skin substitutes."

Impact of the CTP Product Categories on Wound Care

This furtive government operation had separated all of the CTPs into two categories–high cost and low cost–seemingly completely ignoring the evidence supporting the use of these products. I stared aghast: living cellular tissues, which had undergone the FDA's rigorous PMA approval process, were pigeon-holed alongside products that have little or no evidence for efficacy or effectiveness and had been cleared through the back-door 510K process. Worse still, the reimbursement levels assigned to these cellular constructs will rapidly price them out of the marketplace altogether. In the low cost category, I found evidence-based scaffold CTPs placed there simply because they were manufactured in such a fashion that their overall price was less than $32/cm2. Why hadn't the low-cost manufacturers the foresight to produce small expensive products with no clinical evidence supporting their use in chronic wounds? The following message rang loud and clear to me that December evening: "Don't spend your money on gathering evidence for your product because the Black OPPs may come in the middle of the night, cut your reimbursement, and lump you in with a piece of unproven animal hide."

The tree is back in the basement and the dust has settled. The government has already begun to punish those who enjoyed the holidays rather than we people on the sidewalk who rushed about at the last minute updating our superbills. Now I am asked, what do we do in light of these recent changes? Fortunately, there were products that were not visited by the angel of death this past holiday. These tissues have clinical evidence supporting their use and adequate reimbursement to keep the business of wound care going for at least another year. If you would like a copy of the SerenaGroup™ 2014 policies on CTPs please feel free to e-mail me at

About The Author
Dr. Thomas Serena has published more than 75 peer-reviewed papers and has made in excess of 200 presentations worldwide. He has been elected to the Board of Directors of both The Wound Healing Society and the American College of Hyperbaric Medicine (ACHM), the leading academic society in the field of Hyperbaric Medicine. In 2013 Dr. Serena was elected vice president of the American Professional Wound Care Association (APWCA). Dr. Serena has opened and operates Wound Care and hyperbaric oxygen treatment clinics across the United States.

The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.

Cellular and Tissue-based Products Roundtable

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