I just got this letter by email from a physician emphasizing (in addition to the ethical issues) the need for clinical studies of Cellular Tissue Products / Skin Substitutes on pressure ulcers. Thoughts anyone?
–Caroline
Dear Dr. Fife,
I am writing to express a growing concern I have recently encountered in my wound care practice. In the last two weeks alone, I have evaluated two patients — aged 95 and 98 — both enrolled in hospice care, who were receiving amnion graft applications from mobile wound care companies.
While I am a strong supporter of the hospital-at-home model and innovative approaches to patient care, I am deeply troubled by the use of costly biologic products like amnion grafts in patients at the end of life. From both a clinical and ethical standpoint, it is difficult to justify such expensive interventions without clear indications or alignment with the principles of standard wound management, especially in hospice settings where the focus should be comfort and quality of life. This practice not only raises concerns about medical appropriateness, but also about the broader impact on our healthcare system. I have seen the comments by others on your blog that the fundamental problem is the payment system which enables this behavior, but surely the real problem is that some clinicians chose to abuse and overuse of high-cost products for financial gain. This behavior threatens to drain the Medicare Trust Fund — a resource that is vital for future generations, including our own as we age.
I would also appreciate it if you could share any data or guidelines you may have regarding the use of skin substitutes, particularly amnion products, in pressure ulcer management and especially for hospice patients. Reliable evidence would be critical as we work to protect both patient well-being and the sustainability of our healthcare system. I look forward to hearing your thoughts and discussing potential strategies to ensure wound care practices remain patient-centered, appropriate, and sustainable.
[Name withheld on request]
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.
This is a very concerning report, Caroline, so thank you for forwarding it to your contacts.
Something is really wrong with our medical system. Medicare is going bankrupt while doctors recommend tests & procedures which may actually be unnecessary. Doctors & hospitals seem most concerned about potential lawsuits. Have you noticed the fabulous additions & renovations to our local hospitals after the C0VlD debacle? –And expensive billboards? Where is that funding coming from? Let’ really milk the system!!
As a new AP-CWOCN provider, I was beyond happiness when I was recruited by a wound management company to work in various outpatient wound care settings in 2015. My entire career, as an RN, culminated in my being able to specialize in wound and ostomy care as an APRN. The experience of working for a wound management company eventually culminated in my expulsion from the wound and Ostomy specialty I loved, and excelled, in.
I eventually became employed by a teaching facility, where my primary patient census was Medicaid patients. No hyperbarics and no skin substitutes. What I learned was wounds heal without all those bells and whistles, even amongst the sickest and poorest patients with just following the simplest, and most basic of, wound care interventions along with attention to arterial, venous, and lymphatic circulation issues. My observations were confirmed when I attended the “Care of the Neuropathic Foot” provided by the US Public Health Service’s National Hansen’s Program in Baton Rouge. Commissioned Officers of this international program travel to the remotest parts of the world with only the most basic wound care supplies, and are able to heal some of the worst wounds. Imagine the conference attendees’ surprise when the public health officers shared they used plain gauze on wounds, before applying total contact casts to promote wound healing. And, yes, members of their outreach team included orthotists to ensure foot wounds did not recur, once healed.
One of the most horrific events I witnessed during my orientation at the wound management company remains vivid in my memory: a young ventilator-dependent paraplegic man was surgically debrided during my preceptor’s initial consult visit. The patient was emaciated and clearly within days of death. When the LTACH’s wound care team turned the patient to his side, his entire skeleton was visible as one large imprinted Stage 3 pressure injury from his scapulas to his heels, including thigh and calf bony structures. There was zero slough or necrotic tissue, miraculously. Only 100% red tissue. A muscle layer surgical debridement was performed, shoulder blades to heels.
I saw this pattern repeatedly in the LTACH’s I rounded at. I was bombarded with one question, by the LTACH case managers, during my initial consults on patients admitted into the LTACHs, “When are you going to surgically debride, and what level are you going to debride to.” One day, I asked what the big deal was about on whether or not I did a surgical debridement. The case manager told me that my surgical debridements increased the LTACH’s DRG, by a minimum of $10,000. When I replied I did not feel comfortable with the facility making admission decisions, upon my doing a surgical debridement, within days, the Vice President of the LTACH chain flew thousands of miles to “supposedly” meet the NPs working for the wound management company. When my lucky number was called to meet the vice president, I requested my collaborating physician be there to ensure nothing I said was misconstrued. I was informed the vice president cancelled his “meet and greet” with me because I was so defensive.
I worked for that wound management company for approximately 1.5 years. For nearly 8 subsequent years, I was federally-mandated to remain silent about my experiences. My “seal of silence” has been lifted and I will one day be able to fully share what I experienced as a passionate, compassionate, and highly competent AP-CWOCN who became ensnared within one of the most heinous of healthcare experiences of my 30+ years as both an RN, and APRN.
To the guilty party, who may be reading this, I will share this: anyone can heal a typical wound, as long as the circulatory (venous and arterial) systems have been addressed by vascular. Then, biofilm can be addressed by compressing the lymphatics to improve immune function in the lower extremities. Then, a competent “wound care specialist” is required to ask one final question: is the wound healable, non-healable, maintenance, or palliative? I learned that the international wound care industry generates $64 billion per year. The application of skin substitutes and HBOT oftentimes fails to consider this $64 billion question. Revenue-generating interventions are treating all wounds as healable, when clearly they are not.
With regard to pressure ulcers on sacral areas, no one regards the vascular component underlying that area of the human anatomy. Magically, the aorta, internal and external iliac arterial systems are totally ignored, while their distant relatives—the legs gain all the attention of vascular and “wound care specialists.”
Wound care is about revenue. It has become a fungating wound within the national, and international, wound care industry and is a symptom of greed, corruption, and organized crime.
The original author of this blog demonstrates the validity of this perception.
Well said! Sadly, it seems there are more providers entering wound care not as a calling and simply for financial gain. Recently, I was told by an NP who spent 25 years in pain management that was now starting a mobile wound clinic because the money was insane, and the application of CTPs were so simply that “a monkey could do this”.
I think I hear the death knell tolling for a lot of wound care clinics