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How Will Diabetes Trends Affect Wound Clinics in the Future?

As the increasing prevalence of diabetes leads to more chronic wounds, how will the wound clinic adjust? Wound care specialists and managed care organizations weigh in on this complex and growing problem. 

An estimated 34.2 million Americans have been diagnosed with diabetes as of 2018 and, if current trends continue, diabetes will affect an estimated 1 in 3 Americans by 2050, according to the Centers for Disease Control and Prevention (CDC).1 During their lifetimes, an estimated 1 in 4 patients with diabetes will develop a diabetic foot ulcer (DFU), which is challenging to treat due in large part to the underlying manifestations of diabetes that can cause microvascular disease, lower extremity and neuropathy, increased susceptibility to infection, and impaired cellular function.

The cost of DFUs is high both financially and in terms of morbidity and mortality. Research shows:   

• Nearly 15% of Medicare recipients (8.2 million people) had at least 1 wound or infection. The cost of wound care for Medicare recipients is conservatively estimated at $32 billion.2
• DFUs impose a substantial cost burden on public and private payers with direct costs ranging from $9 billion to $13 billion annually.3
• Wound-related infections are among the most common complications of diabetic ulcers and are a significant risk factor for hospitalizations and amputations.4
• Diabetes is a leading cause of non-traumatic lower extremity amputation; 14% to 24% of patients with diabetes who develop a DFU require amputation.5
• The 5-year mortality rate following a lower limb amputation is reported to be almost 50%.6,7
• Wound duration is the leading independent risk factor for infection and amputation.4

In wounds that don’t respond to standard wound care, advanced therapies and treatment strategies that can accelerate wound healing have the potential to prevent amputations, reduce costs, and save lives.

Physicians who practice wound care and insurers who fund it generally agree that diabetic foot ulcers are the most common, problematic chronic skin wounds, but they aren’t necessarily in agreement about treatment, according to the recent Wound Care Trend Report.8 Prepared from survey responses of from 51 wound care specialists and 40 managed care organization (MCO) executives, the report examines trends in wound care from their two perspectives. The report also reveals areas of common interest and potential collaboration between the two groups to address this serious and growing problem. The report is supported by Smith & Nephew (formerly Osiris Therapeutics, Inc.) and was done in consultation with the Association for the Advancement of Wound Care. Following are some highlights of the findings.

How Prevalent Are DFUs?

Eighty percent of surveyed clinicians said DFUs are “very prevalent” and are the most common type of non-healing chronic ulcer they treat; 78% said DFUs are the most likely type of ulcer to require advanced therapies to achieve wound healing.8

Based on their knowledge of claims data, 76% of managed care medical directors said DFUs were “very prevalent.”8 Relative to all of the services that they manage, MCOs said they spent about 15% of their time on the management of chronic wounds.

Insights on Therapy Choices and Coverage

Wound care specialists emphasize the need for basic “good wound care” as well as access to advanced wound care therapies to achieve optimal patient outcomes. The primary components of good wound care, according to respondents, include controlling edema, blood glucose control, infection management, wound debridement, offloading DFUs, and weekly dressing changes to maintain a moist environment.

Wound care specialists estimate on average 64% of their DFU patients would benefit from advanced therapies.8 They say they rely on personal experience and clinical evidence to make treatment choices. They say cellular- and/or tissue-based products (CTPs) are the most prevalent of advanced therapies for patients with DFUs, and have the best clinical outcomes of all advanced wound care therapy. Respondents report the best clinical outcomes using a combination of CTP with hyperbaric oxygen therapy (HBOT), or a CTP with negative pressure wound therapy (NPWT).

Managed care organizations, on the other hand, say NPWT is most prevalent therapy for DFUs.8 While they view CTPs as promising therapy, MCOs stress the need for clinical studies to demonstrate their efficacy. Prevention of ulcers through diabetes control is an important focus. “We are seeing an increase in the prevalence of diabetes and of diabetes that is poorly controlled leading to diabetic ulcers and other complications of diabetes,” observes Larry Hsu, MD, Medical Director for Blue Cross Blue Shield of Hawaii, a medical advisor for the report. “Treatment of diabetic ulcers needs to be expanded to include diet and a multidisciplinary approach to the management of diabetes,” he says.

MCOs rely mostly on internal review committee evaluation of published clinical trials for developing medical policies for coverage of wound care products. Sixty percent follow Centers for Medicare and Medicaid (CMS) policy. Most MCOs do not cover use of two advanced therapies used concurrently, citing high costs and lack of proof of efficacy.

Identifying and Overcoming Barriers to Treatment

Cost is the leading non-clinical factor providers named in selecting a CTP to treat DFUs.8 For patients, physicians say cost is also the greatest barrier to receiving advanced therapies, whether that be lack of insurance coverage (86%) or patient refusal of treatment due to out-of-pocket expenses (65%).

MCO medical directors, on the other hand, see patient adherence/compliance as the number one barrier to treating patients with advance wound care therapies (63%), followed by lack of clinical evidence (60%) and insurance coverage guidelines (45%).8

“Lack of insurance coverage and high out-of-pocket costs are barriers to care,” says Caroline Fife, MD, Chief Medical Officer at Intellicure Inc., The Woodlands, TX and Executive Director of the U.S. Wound Registry. “As for patient compliance, it is easy to blame the patient,” notes Dr. Fife, who served on the editorial advisory panel for the report. “For patients with venous leg ulcers, I talk with them for 10 minutes on the importance of compression and draw a picture. Patients will say no one explained the need. With offloading, I try to fit it with the patient’s lifestyle. Sticking to a diet is hard for everyone. We need to up our game and communicate better with our patients.”

“Patient compliance is a very big problem,” says Fredrick May, MD, Medical Director of EMI Health in Murray, UT. “It takes a long time for wounds to heal. The wound needs to be kept clean. Patients may not understand the necessity of follow-up care.”

Performance and Merit-based Payment

In the Quality Payment Program developed by CMS, physicians are rewarded according to a Merit-based Incentive Payment System (MIPS) score based on their performance in four treatment- and cost-related categories. Half of survey respondents participated in MIPS in 2017; 52% of wound care specialist respondents expected to participate in MIPS for 2018.8

While both providers and MCOs say the concept of performance and merit-based payment is good, they agree performance is hard to measure.

“MIPS is a great idea, but the quality measures used need to be relevant to wound care,” Thomas Serena, MD, founder and Medical Director of the Serena Group in Hingham, MA, who was also an editorial advisor.

“Some MIPS quality measures are too general and overlap with primary care,” agrees Gary Gibbons, MD, Professor of Surgery at Boston University School of Medicine, and Medical Director of the South Shore Hospital Center for Wound Healing in Weymouth, MA. Dr. Gibbons served on the report’s editorial advisory panel.

Only 13% of MCOs surveyed offered performance-based payment plans in 2017 or 2018.8 Dr. Hsu doesn’t expect to see a significant increase in such plans for wound care.  “It is hard to measure. What exactly is the formula for success?” he says. “Who is going to measure improvement? Over what time period?

“CMS may want to do this for the Medicare population,” Dr. Hsu continues, “but it will be a nightmare for those of us who administer Medicare plans. Additional resources would be needed to manage such programs.”

A Closer Look at Consensus Guidelines

At present, five different societies have published guidelines for DFU treatment, of which 94% of wound care specialists are aware.8 However, the guidelines are not being followed with regard to basic wound care practices, says Dr. Gibbons.

Rather than each group promoting its own guidelines that basically say the same thing, Dr. Gibbons says he would “prefer to see a unified guideline on wound care that we can all practice.”

In contrast, 40% of MCOs said they were aware of published guidelines.8 The potential benefits of such guidelines are uncertain. “Health plans welcome guidelines that are evidence-based and easy to use,” says Dr. Hsu. “If guidelines are overly complicated no one will use them.”

“I don’t think guidelines help,” says Dr. May. “No one has the perfect guideline. Every wound is a little different. Patient compliance is key.”

Future Directions

Wound care specialists offered a wide-ranging and more detailed look ahead at promising trends in the wound care market that will improve outcomes over the next 3 to 5 years compared with MCOs.8 Wound care specialists were more in tune with the science and research on biofilm, DNA testing for bacteria, and advanced dressings. They named advanced skin substitutes or biologics, stem cells, biofilm, and amniotic membranes specialists as the most promising new treatment options and listed better ways of delivering care including prevention, personalized medicine, and evidence-based protocols.

Promising trends in wound control listed by MCOs included better control of diabetes, CTPs and stem cell therapies as well as early detection and monitoring and dedicated wound care centers.

These and other advances are needed to address the growing prevalence of chronic wounds and their costs. More emphasis is needed on promoting basic standard wound care practices in conjunction with advanced wound care therapies. Trials to establish treatment efficacy as well as implementation of quality measures specific to wound care are needed to encourage and support optimal outcomes and the delivery of quality care.

To read a copy of the Wound Care Trend Report, please e-mail kikakua@aol.com.


 

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Peter Sonnenreich, Mary Anne Dunkin, Lou Savant and Natalie Berry
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References

1. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2020.
2. Nussbaum SR, Carter MJ, Fife CE, et al. An economic evaluation of the impact, cost, and Medicare policy implications of chronic nonhealing wounds. Value Health. 2018;21(1):27-32.
3. Rice JB, Desal U, Cummings AK, et al. Burden of diabetic foot ulcers for Medicare and private insurers. Diabetes Care. 2014;37(3):651-658.
4. Lavery LA, Armstrong DG, Wunderlich RP, Mohler MJ, Wendel CS, Lipsky BA. Risk factors for foot infections in individuals with diabetes. Diabetes Care. 2006;29(6):1288-1293.
5. Tresierra-Ayala MA, Rojas AG. Association between peripheral arterial disease and diabetic foot ulcers in patients with diabetes mellitus type 2. Medicina Universitaria. 2017;19(76):123-126.
6. Armstrong DG, Wrobel J, Robbins JM. Guest editorial: are diabetes-related wounds and amputations worse than cancer? Int Wound J. 2007;4(4):286-287.
7. Hoffstad O, Mitra N, Walsh J, Margolis DJ. Diabetes, lower-extremity amputation, and death. Diabetes Care. 2015;38(10):1852-1857.
8. Sonnenreich P, Zoeller J, eds. The Wound Care Report, Volume I, supported by Osiris Therapeutics, Inc., Columbia, MD: 2019.

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