Caroline Fife, M.D., medical director of the CHI St. Luke’s–Wound Care Clinic at The Woodlands, Texas, is passionate about advancing care for chronic wounds, improving the reporting of wound care data and developing wound care-related quality measures.
How did you decide to make wound care your specialty?
I didn’t set out to do this at all! I’m board-certified in hyperbaric medicine, and I did a hyperbaric and environmental medicine fellowship at Duke. I came to Houston because of the offshore diving industry and neutral buoyancy laboratory at NASA. I had an exciting career taking care of divers in the Gulf of Mexico and helping those involved in getting a space shuttle built.
Because I was running the hyperbaric chamber at the Texas Medical Center, doctors began to send me patients with wounds. I went to my chairman to complain that somebody should start a wound center, and he told me that I had to do it. So, in 1990 I started a venous leg ulcer clinic using only a handout that Dr. Claude Burton at Duke had given me when I visited his clinic. Within just a few months, it was so busy, I couldn’t see all the patients. There was no one else in the Texas Medical Center providing wound care.
How do chronic wounds affect people?
Chronic wounds impact people both emotionally and psychologically, in a way that other chronic problems do not. These patients are in pain. They’re up all night. Many patients have dealt with these problems and suffered for years. Wounds can prevent people from leaving their house, going to church or spending time with grandchildren. The average patient comes to a wound center for almost eight months, and they never have just one wound. Some of these people have many illnesses they are dealing with, but we do our best to treat their wounds and hopefully make that part of their lives better.
How do you define and diagnose an infection within a wound? Walk us through the operational perspective when assessing a patient with a chronic wound and determining their plan of care.
Diagnosing infection is a moving target. To get a precise diagnosis, we do a biopsy of tissue and look at the number of bacteria per unit of tissue. We sometimes also do assays that analyze the DNA of these heavily colonized wounds to analyze all of the bacteria that make up the biofilm. It is not uncommon to have 10 or 15 bacteria identified by DNA assay.
There are no hard and fast guidelines. It’s a complicated decision tree that’s based on how vulnerable the patient is, the type and quantity of bacteria present, the needs of the wound and whether it is getting better or worse, the presence or absence of systemic symptoms, whether healing is our goal or comfort, and even the financial realities. When making decisions about treatment protocol, I ask for a lot of input from the nurses. The nurses have more insight into these patients’ daily lives and practical issues that might affect their treatment.
For example, a wound could be colonized with bacteria, yet not rise to the level of an infection, which we usually define as the patient’s body deciding to go to war with the bacteria (and vice versa). However, when a wound is heavily colonized, the current thinking is that the bacteria inhibit healing because the bacteria utilize the resources that the body needs to grow tissue.
Because these bacteria are making a mess, we would prefer to kick them out so that the cells can get back to work. But we’re always trying to decide how aggressive to be with colonizing bacteria. If someone has a fever and red streaks coming from the wound, we would all agree it’s infected and is going to need either IV or oral antibiotics. But there’s a gradation; we first have to decide how sick the patient is. We might have to put them in the hospital for IV antibiotics because we just can’t get ahead of it. If the patient isn’t necessarily sick, but their wound is colonized heavily with bacteria, we might use oral or topical antibiotics. If we think we can beat it with topical agents, we have to decide if we’re going to use antimicrobial dressings, which wound cleansers can best help without hurting and how often they need to be applied.
How do these practical variables inform your decision-making on certain dressings?
We consider practical questions such as: What other medications are these patients on? How frequently do their dressings need to be changed? Who is going to help them with their treatment at home? Are there any limitations in terms of insurance, or do we need to provide a recipe for a very inexpensive cleanser they can make at home?
We try to match treatment with what is practical for the individual patient. It wouldn’t be possible to create an algorithm that could do what we do as we plan and negotiate at the bedside what makes the most sense for a particular patient. We sometimes learn in these examinations that the patient has the dressing on backward, or that the dressing has slipped out of place. I listen to patients when they say the dressing isn’t working for them. I want to make sure everybody is on board with the treatment.
What are some best practices that focus on antimicrobials?
The antimicrobial products used to help either kill or suppress bacterial growth in chronic wounds usually contain silver or iodine preparations, though some products with honey may also be considered to be part of that category. There are no large prospective trials evaluating the antimicrobial effect of honey dressings, but they perform well in clinical practice and patients like them.
Silver is the most popular antimicrobial, but it’s also the more expensive option. The Food & Drug Administration (FDA) is afraid that patients may be developing a resistance to silver, even though there is no practical and reimbursable test for it.
The topic of antimicrobial dressings is a controversial one. These dressings are expensive, but CMS doesn’t put antimicrobials in a separate category for reimbursement purposes. It may be hard to justify their high cost if we are not sure we can demonstrate a specific benefit. Can we show that they decrease pain, decrease odor, prevent maceration, reduce drainage volume, decrease nonviable tissue in the wound bed or reduce the risk of clinical infection? Those seem to me to be better endpoints than healing since most dressings are only used for a few days at a time.
I’m watching a new category that may be the next big thing for antimicrobials: antibiofilm agents. These agents are not drugs or dressings, so as a result, they are not covered by CMS. They don’t actually kill bacteria, but they reduce the bacteria’s ability to adhere to the wound bed. In some cases, the patient’s response to these products has been spectacular. At between $70 and $250 dollars per tube, however, they are cost prohibitive, and the patients must purchase them out of pocket. Even if the manufacturers produce them in single-use packets, the reimbursement rate for an outpatient clinic visit is probably too low to cover it. That may not be true in settings where patients are under a capitated rate, and if the antibiofilm agent allows them to be discharged sooner.
How do you handle supply costs and the negotiation of physician preference items?
At our clinic at The Woodlands, we all strive to be cost-conscious. However, the reality is we’re never putting just one product on a wound—there could be a seaweed-based dressing impregnated with silver, an absorbing foam to control draining and a compression wrap to control swelling and hold it all in place. We have to think about the total cost we can pay for dressing supplies and still keep the clinic afloat.
Recently our supply prices got out of control. Our clinical manager, Sherrill White-Wolfe, and I gathered everyone together and said we have to contain or lower costs while maintaining quality. We asked everyone to come up with the products they couldn’t live without and which ones they could bend on. We set the standard in the very beginning that we will only do what is in the best interest of the patients.
We put a price list in front of our clinicians, which was enlightening to all of us. It made a huge difference to our doctors and nurses who thought they had to have certain products. Once they saw that the price was so much higher than an equivalent, they couldn’t justify paying that much more for what was essentially the same product. Even though I might have a preference toward a certain supplier’s product, there might not be enough of a difference in the elements between the two to justify paying four times as much for essentially the same thing.
It didn’t feel like finger pointing; it was really a conversation where we tried to find a way to move forward together. We went around the table and said, “Every clinician can have one product they don’t think they can manage good patient care without.” The most surprising thing was that once everyone got their “favorite thing,” they were then willing to compromise and negotiate on the others.
How has the industry changed since you first started treating wound care patients?
One of the biggest negative changes has to do with what I call “fantasy healing rates.” In part because of the way we were doing clinical trials, people got used to the idea that “all wounds heal.” So, many companies that run wound centers have their contracts tied to healing rates. In fact, our clinical manager is under a lot of pressure to report healing rates as a metric of how well our program performs.
But what people forget is that if a wound isn’t healing, there’s usually a good reason why. Our body’s system of healing wounds normally works perfectly, but when it doesn’t, it’s because there’s something horribly wrong. Our job is to figure out what’s wrong and fix it. A chronic wound is a symptom of another disease or condition, such as diabetes or malnutrition, etc. It’s not really that a patient just has a diabetic foot or vein ulcer, it’s that they have congestive heart failure that’s poorly controlled and have fluid shifts where their legs suddenly swell. Or they’re malnourished because they have chronic diarrhea and can’t hang on to their proteins.
It’s not just about what dressing we’re going to use, but how we are going to do something about all of their medical problems. Even if we were to fix that one wound, it would come back if there are underlying issues.
We report honest healing rates to CMS using risk stratification, which levels the playing field by reporting healing rates in relation to the predicted likelihood of healing, so that doctors taking care of the sickest patients don’t look like they have worse outcomes. CMS approved our risk stratified pressure ulcer healing measure for physician reporting as part of MIPS in 2019.
Why are chronic wounds so expensive to treat? What kind of healthcare payment model would be needed to cover costs?
Since so many patients have wounds as a symptom of underlying medical conditions, most of the expense is not during brief hospitalizations. The expense is going to be the months and maybe years of nursing home services, home nursing services or outpatient therapy. DRGs (diagnostic-related groups) have controlled the cost of inpatient hospitalization, but outpatient costs continue to soar. Since wounds can take months to heal and require very expensive therapies, Medicare’s cost of caring for them is a staggering $96 billion per year.
If you look across the board at most wound centers, at least 50 percent of patients with chronic wounds are Medicare beneficiaries. Many of these patients have limited incomes and may not have secondary insurance. I am worried, for example, that the high-cost “skin substitutes” commonly used in wound care are almost off limits to Medicare patients without secondary insurance. And there are other barriers to access. I spent 23 years in a medical center and the average patient there struggled to pay the daily $12 parking fee. Many seniors can’t afford the nutritional supplements that I recommend and yet the simplest and most important thing that I correct every day are nutritional deficiencies.
If we are going to spend $96 billion a year caring for patients with wounds, someone is going to have to be focused on reducing those costs. Medicare is leaning toward episode-based payments for some treatments like “skin substitutes.” Private insurance companies thought they could be more efficient with care and save money, but they didn’t realize how much wound care for these patients was actually going to cost. I believe the situation could improve drastically if we came up with a different approach to allocating what is actually covered. While the concept of linking payment with outcome is supposedly the focus of Medicare’s Quality Payment Program (QPP), it doesn’t have any wound care measures. That’s why the U.S. Wound Registry (USWR) had to create some. Unfortunately, for a host of reasons, only a handful of wound care practitioners report wound care quality measures, even though I can prove that doing so improves patient outcomes.
What is one of your biggest challenges?
The coordination of care is one of our biggest challenges. One way to solve that is through wound care coordinators, similar to transplant coordinators. Transplant coordinators deal with patients that have a lot of complicated diseases that require multiple medicines. They’re committed to making sure those patients are taken care of at every stage. I think it’s a great model for wound care because our patients, on average, have up to 10 major comorbid conditions and take 12 medications. We can’t manage them nearly as well without the help of a coordinator.
We also need a better reporting system so we have the analytics to determine which products or techniques work best on patients. The USWR is perhaps the largest repository of detailed, structured data on patients with wounds, but many electronic health record (EHR) vendors have blocked the transmission of data to the USWR. We hope to have a “SMART App” available for the Epic EHR in 2019 that will facilitate the reporting of wound care quality measures from hospitals with that system.
Dr. Fife shares additional thoughts on wound care on her blog.
Caroline Fife, M.D., is medical director of the CHI St. Luke’s–Wound Care Clinic at The Woodlands, Texas, and a professor of geriatrics at the Baylor College of Medicine in Houston, Texas. She is the chief medical officer of Intellicure, a Texas-based health information technology company that provides a specialty specific electronic health record to wound and hyperbaric centers across the U.S. Fife is the executive director of the U.S. Wound Registry, a nonprofit organization recognized by CMS as a Qualified Clinical Data Registry (QCDR) for MIPS reporting and the development of quality measures for wound care physicians.
Fife received her bachelor’s and master’s degrees from Texas A&M University College of Medicine. After a residency in family medicine at the University of Texas, Southwestern, she completed a fellowship in undersea and hyperbaric medicine at Duke University, then joined the University of Texas Health Science Center, Houston, where she served on the faculty for 23 years. She is board-certified in undersea and hyperbaric medicine through the American Board of Preventive Medicine and has been a certified wound specialist since 1998. She has served on the boards of the American Academy of Wound Management, the Association for the Advancement of Wound Care and the American Professional Wound Care Association. She initiated the Memorial Hermann Center for Wound Healing, which is affiliated with the University of Texas, Houston, in 1990, and the Memorial Hermann Center for Lymphedema Therapy in 1998. She is currently the co-chair of the Alliance of Wound Care Stakeholders.