Trends in Medicare Costs of Hyperbaric Oxygen Therapy, 2013 through 2022.

Objective: To analyze Hyperbaric Oxygen Therapy Registry (HBOTR) data to estimate the Medicare costs of hyperbaric oxygen therapy (HBO2) based on standard treatment protocols and the annual mean number of treatments per patient reported by the registry. Methods: We performed a secondary analysis of deidentified data for all payers from 53 centers registered in the HBOTR from 2013 to 2022. We estimated the mean annual per-patient costs of HBO2 based on Medicare (outpatient facility + physician) reimbursement fees adjusted to 2022 inflation using the Medicare Economic Index. Costs were calculated for the annual average number of treatments patients received each year and for a standard 40-treatment series. We estimated the 2022 costs of standard treatment protocols for HBO2 indications treated in the outpatient setting. Results: Generally, all costs decreased from 2013 to 2022. The facility cost per patient per 40 HBO2 treatments decreased by 10.7% from $21,568.58 in 2013 to $19,488.00 in 2022. The physician cost per patient per 40 treatments substantially decreased by -37.8%, from $5,993.16 to $4,346.40. The total cost per patient per 40 treatments decreased by 15.6% from $27,561.74 to $23,834.40. In 2022, a single HBO2 session cost $595.86. For different indications, estimated costs ranged from $2,383.4-$8,342.04 for crush injuries to $17,875.80-$35,751.60 for diabetic foot ulcers and delayed radiation injuries. Conclusions: This real-world analysis of registry data demonstrates that the actual cost of HBO2 is not nearly as costly as the literature has insinuated, and the per-patient cost to Medicare is decreasing, largely due to decreased physician costs.

Angiosomal Vascular Occlusions, Deep-Tissue Pressure Injuries, and Competing Theories: A Case Report.

ABSTRACT: Compression of the soft tissue between a support surface and a bony prominence has long been the accepted primary mechanism of pressure injury (PrI) formation, with the belief that said compression leads to capillary occlusion, ischemia, and tissue necrosis. This explanation presupposes an "outside-in" pathophysiologic process of tissue damage originating at the local capillary level. Despite advances in prevention protocols, there remains a stubbornly consistent incidence of severe PrIs including deep-tissue injuries, the latter usually evolving into stage 4 PrIs with exposed bone or tendon. This article presents just such a perioperative case with the aim of providing further evidence that these more severe PrIs may result from ischemic insults of a named vessel within specific vascular territories (labeled as angiosomes). Pressure is indeed a factor in the formation of severe PrIs, but these authors postulate that the occlusion occurred at the level of a named artery proximal to the lesion. This vascular event was likely attributable to low mean arterial pressure. The authors suggest that the terminology proposed three decades ago to call both deep-tissue injuries and stage 4 PrIs "vascular occlusion pressure injuries" should be the topic of further research and expert consensus.

Development and psychometric evaluation of the U.S. English Wound-QoL questionnaire to assess health-related quality of life in people with chronic wounds.

People with chronic wounds perceive an impaired health-related quality of life (HRQoL). For the assessment of HRQoL, valid instruments are needed. Therefore, the Wound-QoL questionnaire was originally developed and psychometrically validated for use in Germany. As the Wound-QoL is to be used in numerous countries, international versions are required. Therefore, this study aimed to psychometrically validate the U.S. English Wound-QoL version. Upon translation into U.S. English, psychometric testing was performed based on cross-sectional data deriving from the U.S. Wound Registry. Besides descriptive statistics, internal consistency and concurrent validity were tested. In addition, a graded response model was used. The sample consisted of 599 people with chronic wounds of different etiologies. Participants were between 18 and 95 years old, mean age was 63.7 (SD = 15.9) years. Gender was distributed almost equally, with 47.4% female patients. High internal consistency, low floor and ceiling effects of the subscales could be largely confirmed. The internal consistency of the global score was excellent, with α > .9. Concurrent validity between the Wound-QoL and pain, the surface area of the largest wound, total surface area, and total number of active wounds could be confirmed. In contrast, item response theory (IRT) analyses could not fully confirm the factorial model underlying the Wound-QoL subscales. Furthermore, the items regarding smell and discharge and the items on problems with hitting the wound against something, climbing stairs and feeling dependent on help from others showed a low item information in their belonging dimensions. In conclusion, the newly validated Wound-QoL is available for HRQoL measurement in people with chronic wounds in the United States. It showed good psychometric properties, demonstrating its reliability and validity. Therefore, the instrument may be used to assess HRQoL in clinical practice. However, IRT analyses showed that the instrument may benefit from future refinement.

An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds.

OBJECTIVE: The aim of this study was to determine the cost of chronic wound care for Medicare beneficiaries in aggregate, by wound type and by setting. METHODS: This retrospective analysis of the Medicare 5% Limited Data Set for calendar year 2014 included beneficiaries who experienced episodes of care for one or more of the following: arterial ulcers, chronic ulcers, diabetic foot ulcers, diabetic infections, pressure ulcers, skin disorders, skin infections, surgical wounds, surgical infections, traumatic wounds, venous ulcers, or venous infections. The main outcomes were the prevalence of each wound type, Medicare expenditure for each wound type and aggregate, and expenditure by type of service. RESULTS: Nearly 15% of Medicare beneficiaries (8.2 million) had at least one type of wound or infection (not pneumonia). Surgical infections were the largest prevalence category (4.0%), followed by diabetic infections (3.4%). Total Medicare spending estimates for all wound types ranged from $28.1 to $96.8 billion. Including infection costs, the most expensive estimates were for surgical wounds ($11.7, $13.1, and $38.3 billion), followed by diabetic foot ulcers ($6.2, $6.9, and $18.7 billion,). The highest cost estimates in regard to site of service were for hospital outpatients ($9.9-$35.8 billion), followed by hospital inpatients ($5.0-$24.3 billion). CONCLUSIONS: Medicare expenditures related to wound care are far greater than previously recognized, with care occurring largely in outpatient settings. The data could be used to develop more appropriate quality measures and reimbursement models, which are needed for better health outcomes and smarter spending for this growing population.

The Hyperbaric Oxygen Therapy Registry: Driving quality and demonstrating compliance.

OBJECTIVE: To provide an update on the status of provider participation in the US Wound Registry (USWR) and its specialty registry the Hyperbaric Oxygen Therapy Registry (HBOTR), which provide much-needed national benchmarking and quality measurement services for hyperbaric medicine. METHODS: Providers can meet many requirements of the Merit-Based Incentive Payment System (MIPS) and simultaneously participate in the HBOTR by transmitting Continuity of Care Documents (CCDs) directly from their certified electronic health record (EHR) or by reporting hyperbaric quality measures, the specifications for which are available free of charge for download from the registry website as electronic clinical quality measures for installation into any certified EHR. Computerized systems parse the structured data transmitted to the USWR. Patients undergoing hyperbaric oxygen (HBO2) therapy are allocated to the HBOTR and stored in that specialty registry database. The data can be queried for benchmarking, quality reporting, public policy, or specialized data projects. RESULTS: Since January 2012, 917,758 clinic visits have captured the data of 199,158 patients in the USWR, 3,697 of whom underwent HBO2 therapy. Among 27,404 patients with 62,843 diabetic foot ulcers (DFUs) captured, 9,908 DFUs (15.7%) were treated with HBO2 therapy. Between January 2016 and September 2018, the benchmark rate for the 1,000 DFUs treated with HBO2 was 7.3%, with an average of 28 treatments per patient. There are 2,100 providers who report data to the USWR by transmitting CCDs from their EHR and 688 who submit quality measure data, 300 (43.6%) of whom transmit HBO2 quality data.

Harnessing electronic healthcare data for wound care research: Standards for reporting observational registry data obtained directly from electronic health records.

The United States Food and Drug Administration will consider the expansion of coverage indications for some drugs and devices based on real-world data. Real-world data accrual in patient registries has historically been via manual data entry from the medical chart at a time distant from patient care, which is fraught with systematic error. The efficient automated transmission of data directly from electronic health records is replacing this labor-intensive paradigm. However, real-world data collection is unfamiliar. The potential sources of bias arising from the source of data and data accrual, documentation, and aggregation have not been well defined. Furthermore, the technological aspects of data acquisition and transmission are less transparent. We explore opportunities for harnessing direct-from-electronic health record registry reporting and propose the ABCs of Registries (Analysis of Bias Criteria of Registries), which are an evaluation framework for publications to minimize potential bias of real-world data obtained directly from an electronic health record method. These standards are based on a point-of-care data documentation process using a common definitional framework and data dictionaries. By way of example, we describe a wound registry obtained directly from electronic health records. This qualified clinical data registry minimizes bias by ensuring complete and accurate point-of-care data capture, standardizes usual care linked to quality reporting, and prevents post-hoc vetting of outcomes. The resulting data are of high quality and integrity and can be used for comparative effectiveness research in wound care. In this way, the effort needed to succeed with the Quality Payment Program is leveraged to obtain the real-world data needed for comparative effectiveness research.

A new approach to clinical research: Integrating clinical care, quality reporting, and research using a wound care network-based learning healthcare system.

The disparity between ideal evidence from randomized controlled trials and real-world evidence in medical research has prompted the United States Food and Drug Administration to consider the use of real-world data to better understand safety and effectiveness of new devices for a broader patient population and to prioritize real-world data in regulatory decision making. As the healthcare system transitions from volume- to value-based care, there is a growing need to harness the power of real-world data to change the paradigm for wound care clinical research and enable more generalizable clinical trials. This paper describes the implementation of a network-based learning healthcare system by a for-profit consortium of wound care clinics that integrates wound care management, quality improvement, and comparative effectiveness research, by harnessing structured real-world data within a purpose-built electronic health record at the point of care. Centers participating in the consortium submit their clinical data and quality measures to a qualified clinical data registry for wound care, enabling benchmarking of their data across this national network. The common definitional framework of the purpose-built electronic health record and the 21 wound-specific quality measures help to standardize the potential sources of bias in real-world data, making the consortium data useful for comparative effectiveness research. This consortium can transform wound care clinical research and raise the standards of care, while helping physicians achieve success with the Merit-Based Incentive Payment System.

Skin and Wound Care in Lymphedema Patients: A Taxonomy, Primer, and Literature Review.

BACKGROUND: Lymphedema is a condition of localized protein-rich swelling from damaged or malfunctioning lymphatics. Because the immune system is compromised, there is a high risk of infection. Infection in patients with lymphedema may present in a variety of ways. OBJECTIVE: The goals of this review were to standardize the terminology of skin breakdown in the context of lymphedema, synthesize the available information to create best practice recommendations in support of the American Lymphedema Framework Project update to its Best Practices document, and create recommendations for further research. DATA SOURCES: Publications on skin care and wounds were retrieved, summarized, and evaluated by a team of investigators and clinical experts. STUDY SELECTION AND DATA EXTRACTION: Terms for lymphedema-associated skin breakdown were compiled and paired with photographs of commonly noted skin changes among patients with lymphedema. A list of standard dermatological terms was created. A more extensive literature search was then conducted by all authors. DATA SYNTHESIS: Skin disorders associated with lymphedema have been classified into 5 categories. Descriptions, photographs, and recommendations for treatment are presented. CONCLUSIONS: Skin care is an important defense against infection. Because of the lack of research, a consensus of thought and content leaders' opinion should guide the best practices for wound care in lymphedema.

Treating pressure ulcers with clostridial collagenase ointment: Results from the US Wound Registry.

We assessed the clinical effectiveness of clostridial collagenase ointment (CCO) as an adjunct to selective debridement compared with selective debridement alone for the management of stage IV pressure ulcers (PU) in the hospital outpatient department setting. Outcome data were derived from retrospective de-identified electronic medical records from 2007 to 2013 using the US Wound Registry. A propensity score method was used to adjust for selection bias and to test for treatment effect between PU treated with CCO plus selective debridement vs. selective debridement alone. A total of 337 CCO and 336 non-CCO stage IV PU were identified. The proportion of wounds closed at any time (e.g., at 1 or 2 years) was two times greater for stage IV PU treated with CCO compared with those not treated with CCO. Kaplan-Meier analysis showed that time to wound closure at 1 year was significantly faster for PU treated with CCO vs. PU not treated with CCO. Among those with five or more CCO applications or selective debridement treatments, significantly more CCO-treated PU were closed at 1 or 2 years than non-CCO-treated PU. CCO as an adjunct to selective debridement improved clinical outcomes and provided faster rates of closure of stage IV PU relative to selective debridement alone.

Lymphatic abnormalities are associated with RASA1 gene mutations in mouse and man.

Mutations in gene RASA1 have been historically associated with capillary malformation-arteriovenous malformation, but sporadic reports of lymphatic involvement have yet to be investigated in detail. To investigate the impact of RASA1 mutations in the lymphatic system, we performed investigational near-infrared fluorescence lymphatic imaging and confirmatory radiographic lymphangiography in a Parkes-Weber syndrome (PKWS) patient with suspected RASA1 mutations and correlated the lymphatic abnormalities against that imaged in an inducible Rasa1 knockout mouse. Whole-exome sequencing (WES) analysis and validation by Sanger sequencing of DNA from the patient and unaffected biological parents enabled us to identify an early-frameshift deletion in RASA1 that was shared with the father, who possessed a capillary stain but otherwise no overt disease phenotype. Abnormal lymphatic vasculature was imaged in both affected and unaffected legs of the PKWS subject that transported injected indocyanine green dye to the inguinal lymph node and drained atypically into the abdomen and into dermal lymphocele-like vesicles on the groin. Dermal lymphatic hyperplasia and dilated vessels were observed in Rasa1-deficient mice, with subsequent development of chylous ascites. WES analyses did not identify potential gene modifiers that could explain the variability of penetrance between father and son. Nonetheless, we conclude that the RASA1 mutation is responsible for the aberrant lymphatic architecture and functional abnormalities, as visualized in the PKWS subject and in the animal model. Our unique method to combine investigatory near-infrared fluorescence lymphatic imaging and WES for accurate phenoptyping and unbiased genotyping allows the study of molecular mechanisms of lymphatic involvement of hemovascular disorders.

Rapid analysis of hyperbaric oxygen therapy registry data for reimbursement purposes: Technical communication.

OBJECTIVE: To explain how Hyperbaric Oxygen Therapy Registry (HBOTR) data of the US Wound Registry (USWR) helped establish a fair analysis of the physician work of hyperbaric chamber supervision for reimbursement purposes. METHODS: We queried HBOTR data from January 1, 2013, to December 31, 2013, on patient comorbidities and medications as well as the number of hyperbaric oxygen (HBO2) therapy treatments supervised per physician per day from all hyperbaric facilities participating in the USWR that had been using the electronic medical record (EHR) for more than six months and had passed data completeness checks. RESULTS: Among 11,240 patients at the 87 facilities included, the mean number of comorbidities and medications was 10 and 12, respectively. The mean number of HBO2 treatments supervised per physician per day was 3.7 at monoplace facilities and 5.4 at multiplace facilities. Following analysis of these data by the RUC, the reimbursement rate of chamber supervision was decreased to $112.06. CONCLUSIONS: Patients undergoing HBO2 therapy generally suffer from multiple, serious comorbidities and require multiple medications, which increase the risk of HBO2 and necessitate the presence of a properly trained hyperbaric physician. The lack of engagement by hyperbaric physicians in registry reporting may result in lack of adequate data being available to counter future challenges to reimbursement.

A predictive model for pressure ulcer outcome: the Wound Healing Index.

PURPOSE: The purpose of this learning activity is to provide information regarding the creation of a risk-stratification system to predict the likelihood of the healing of body and heel pressure ulcers (PrUs). TARGET AUDIENCE: This continuing education activity is intended for physicians and nurses with an interest in skin and wound care. OBJECTIVES: After participating in this educational activity, the participant should be better able to:1. Explain the need for a PrU risk stratification tool.2. Describe the purpose and methodology of the study.3. Delineate the results of the study and development of the Wound Healing Index. OBJECTIVE: : To create a validated system to predict the healing likelihood of patients with body and heel pressure ulcers (PrUs), incorporating only patient- and wound-specific variables. DESIGN: The US Wound Registry data were examined retrospectively and assigned a clear outcome (healed, amputated, and so on). Significant variables were identified with bivariate analyses. Multivariable logistic regression models were created based on significant factors (P < .05) and tested on a 10% randomly selected hold-out sample. SETTING: Fifty-six wound clinics in 24 states PATIENTS: : A total of 7973 body PrUs and 2350 heel PrUs were eligible for analysis. INTERVENTION: Not applicable MAIN OUTCOME MEASURE: : Healed PrU MAIN RESULTS:: Because of missing data elements, the logistic regression development model included 6640 body PrUs, of which 4300 healed (64.8%), and the 10% validation sample included 709 PrUs, of which 477 healed (67.3%). For heel PrUs, the logistic regression development model included 1909 heel PrUs, of which 1240 healed (65.0%), and the 10% validation sample included 203 PrUs, of which 133 healed (65.5%). Variables significantly predicting healing were PrU size, PrU age, number of concurrent wounds of any etiology, PrU Stage III or IV, evidence of bioburden/infection, patient age, being nonambulatory, having renal transplant, paralysis, malnutrition, and/or patient hospitalization for any reason. CONCLUSIONS: Body and heel PrU Wound Healing Indices are comprehensive, user-friendly, and validated predictive models for likelihood of body and heel PrU healing. They can risk-stratify patients in clinical research trials, stratify patient data for quality reporting and benchmarking activities, and identify patients most likely to require advanced therapeutics to achieve healing.

Diabetic foot ulcer off-loading: The gap between evidence and practice. Data from the US Wound Registry.

OBJECTIVE: To evaluate the practice of off-loading diabetic foot ulcers (DFUs) using real-world data from a large wound registry to better identify and understand the gap between evidence and practice. DESIGN: Retrospective, deidentified data were extracted from the US Wound Registry based on patient/wound characteristics, procedures performed, and at which clinic the DFU was treated. SETTING: 96 clinics (23 from the United States and Puerto Rico) PATIENTS: : 11,784 patients; 25,114 DFUs MAIN OUTCOME MEASURES: : Healed/not healed, amputated, percent off-loading, percent use of total contact casting (TCC), infection rate MAIN RESULTS: : Off-loading was documented in only 2.2% of 221,192 visits from January 2, 2007, to January 6, 2013. The most common off-loading option was the postoperative shoe (36.8%) and TCC (16.0%). There were significantly more amputations within 1 year for non-TCC-treated DFUs compared with TCC-treated DFUs (5.2% vs 2.2%; P = .001). The proportion of healed wounds was slightly higher for TCC-treated DFUs versus non-TCC-treated DFUs (39.4% vs 37.2%). Infection rates were significantly higher for non-TCC-treated DFUs compared with TCC-treated DFUs (2.6 vs 1.6; P = 2.1 × 10). Only 59 clinics used TCC (61%); 57% of those clinics used traditional TCC, followed by TCC-EZ (36%). Among clinics using any type of TCC, 96.3% of the DFUs that did not receive TCC were "TCC-eligible" ulcers. Among clinics using "traditional" TCC systems, 1.4% of DFUs were treated with TCC, whereas clinics using TCC-EZ provided TCC to 6.2% of DFUs. CONCLUSION: Total contact casting is vastly underutilized in DFU wound care settings, suggesting that there is a gap in practice for adequate off-loading. New, easier-to-apply TCC kits, such as the TCC-EZ, may increase the frequency with which this ideal form of adequate off-loading is utilized.

Counting the Cost of Cellular and/or Tissue-Based Products in Diabetic Foot Ulcers: Is There a Justifiable Price Limit per Square Centimeter?

Objective: To identify how cellular and/or tissue-based products (CTPs) relate to value in terms of cost per quality-adjusted life years (QALYs) in wound care in comparison with treatments in other medical fields. Approach: This is a cross-sectional study and a cost-effectiveness analysis. Payment limits for each CTP were obtained via the Healthcare Common Procedure Coding System Q codes and formulated as cost inputs into a cost-utility model published for treatment of Wagner 1 diabetic foot ulcers using dehydrated human amnion and chorion allograft versus standard of care (SOC). Additional changes to cap the number of CTP applications and adjustments for recent inflation were made. The literature was searched for other cost-utility models in other diabetes-related diseases as a comparison. Results: When the payment limit was ≤$140 per square centimeter, interventions were dominant (less costly, better outcomes) compared with SOC. When the limit exceeded $430 per square centimeter, the cost-effectiveness threshold of $100,000/QALY was exceeded. Newer Q codes are generally much more expensive and likely to not be cost-effective, similar to the results for many other chronic diabetes-related diseases . Innovation: This study presents decision makers with tools, by which they can determine as to whether a given CTP is likely to be cost-effective for patients. Conclusion: Over a third of all CTPs will very likely result in noncost-effective interventions. This number is likely to be higher when wounds are larger or used in other wound types where they are less efficacious. The recent trend in much higher costs for CTPs is worrisome.

Development of a wound healing index for patients with chronic wounds.

Randomized controlled trials in wound care generalize poorly because they exclude patients with significant comorbid conditions. Research using real-world wound care patients is hindered by lack of validated methods to stratify patients according to severity of underlying illnesses. We developed a comprehensive stratification system for patients with wounds that predicts healing likelihood. Complete medical record data on 50,967 wounds from the United States Wound Registry were assigned a clear outcome (healed, amputated, etc.). Factors known to be associated with healing were evaluated using logistic regression models. Significant variables (p < 0.05) were determined and subsequently tested on a holdout sample of data. A different model predicted healing for each wound type. Some variables predicted significantly in nearly all models: wound size, wound age, number of wounds, evidence of bioburden, tissue type exposed (Wagner grade or stage), being nonambulatory, and requiring hospitalization during the course of care. Variables significant in some models included renal failure, renal transplant, malnutrition, autoimmune disease, and cardiovascular disease. All models validated well when applied to the holdout sample. The "Wound Healing Index" can validly predict likelihood of wound healing among real-world patients and can facilitate comparative effectiveness research to identify patients needing advanced therapeutics.

The Impact of Underlying Conditions on Quality-of-Life Measurement Among Patients with Chronic Wounds, as Measured by Utility Values: A Review with an Additional Study.

Significance: Quality of life (QoL) is important to patients with chronic wounds and is rarely formally evaluated. Understanding what comorbidities most affect the individual versus their wounds could be a key metric. Recent Advances: The last 20 years have seen substantial advances in QoL instruments and conversion of patient data to a single value known as the health utilities index (HUI). We review these advances, along with wound-related QoL, and analyze real-world comorbidities challenging wound care. Critical Issues: To understand the impact of underlying comorbidities in a real-world patient population, we examined a convenience sample of 382 patients seen at a hospital-based outpatient wound center. This quality reporting study falls outside the regulations that govern human subject research. Comorbid conditions were used to calculate HUIs using a variety of literature-reported approaches, while Wound-Quality-of-Life (W-QoL) questionnaire data were collected from patients during their first visit. The mean number of conditions per patient was 8; 229 patients (59.9%) had utility values for comorbidities/conditions, which were worse/lower than their wounds' values. Sixty-three (16.5%) patients had depression and/or anxiety, 64 (16.8%) had morbid obesity, and 204 (53.4%) had gait and mobility disorders, all of which could have affected W-QoL scoring. The mean minimum utility value (0.5) was within 0.05 units of an average of 13 studies reporting health utilities from wound care populations using the EuroQol 5 Dimension instrument. Future Directions: The comorbidity associated with the lowest utility value is what might most influence the QoL of patients with chronic wounds. This finding needs further investigation.

Imaging peripheral lymphatic dysfunction in chronic conditions.

The lymphatics play important roles in chronic diseases/conditions that comprise the bulk of healthcare worldwide. Yet the ability to routinely image and diagnose lymphatic dysfunction, using commonly available clinical imaging modalities, has been lacking and as a result, the development of effective treatment strategies suffers. Nearly two decades ago, investigational near-infrared fluorescence lymphatic imaging and ICG lymphography were developed as routine diagnostic for clinically evaluating, quantifying, and treating lymphatic dysfunction in cancer-related and primary lymphedema, chronic venous disease, and more recently, autoimmune and neurodegenerative disorders. In this review, we provide an overview of what these non-invasive technologies have taught us about lymphatic (dys) function and anatomy in human studies and in corollary animal studies of human disease. We summarize by commenting on new impactful clinical frontiers in lymphatic science that remain to be facilitated by imaging.

Chronic wound prevalence and the associated cost of treatment in Medicare beneficiaries: changes between 2014 and 2019.

OBJECTIVE: To determine the cost of wound care and prevalence of chronic wounds for Medicare beneficiaries in the aggregate, by wound type, and by setting between the years 2014 and 2019. METHODS: This retrospective analysis of Medicare claims data included beneficiaries who experienced episodes of care for diabetic foot ulcers and infections; arterial ulcers; skin disorders and infections; surgical wounds and infections; traumatic wounds; venous ulcers and infections; unspecified chronic ulcers; and others. The 2014 data were based on a Medicare 5% Limited Data Set whereas for 2019 the data used were for all fee-for-service Medicare beneficiaries. Three methods were used to generate expenditure estimates: (a) a low (Medicare provider payments when the wound was a primary diagnosis, excluding any kind of deductible); (b) mid (primary plus secondary diagnosis with weighted attribution); and (c) high (primary or secondary diagnosis). The main outcomes were the prevalence of each wound type, Medicare expenditure for each wound type and aggregate, and expenditure by type of service. RESULTS: Over the 5-year period the number of Medicare beneficiaries with a wound increased from 8.2 million to 10.5 million. Wound prevalence increased by 13% from 14.5% to 16.4%. Over the 5-year period, the Medicare beneficiaries with the largest increase in chronic wound prevalence were those aged <65 years (males: 12.5% to 16.3%; females: 13.4% to 17.5%). The largest changes in terms of wound prevalence were increases in arterial ulcers (0.4% to 0.8%), skin disorders (2.6% to 5.3%), and decreases in traumatic wounds (2.7% to 1.6%). Expenditures decreased regardless of the three methods used with a reduction of $29.7 billion to $22.5 billion for the most conservative method. Except for venous ulcers in which costs per Medicare beneficiary increased from $1206 to $1803, cost per wound decreased with surgical wounds remaining the most expensive to treat (2014: $3566; 2019: $2504), and the largest decrease for arterial ulcers ($9651 to $1322). Hospital outpatient fees saw the largest reduction ($10.5 billion to $2.5 billion) although home health agency expenditures decreased from $1.6 billion to $1.1 billion. Physician offices saw an increase from $3.0 billion to $4.1 billion and durable medical equipment increased from $0.3 billion to $0.7 billion. CONCLUSIONS: It appears that chronic wound care expenditures have shifted to the physician's office from the hospital-based outpatient department. Given that the prevalence of chronic wounds is increasing, especially among the disabled under 65, it will be important to know whether these shifts have positively or negatively affected outcomes.

HighlightsIn 2014 chronic wounds impacted 14.5% of Medicare beneficiaries but this increased to 16.3% by 2019. The group of Medicare beneficiaries most affected in terms of chronic wound prevalence over the 5-year period were those aged <65 years (males: 12.5% to 16.3%; females: 13.4% to 17.5%). The largest changes in terms of prevalence were increases in arterial ulcers (0.4% to 0.8%), skin disorders (2.6% to 5.3%), and traumatic wounds (2.7% to 1.6%)Over the 5-year period, regardless of the method used, there was a decrease in chronic wound-related costs ($29.7 billion in 2014 to $22.5 billion in 2019 for the most conservative method: Medicare provider payments when the wound was a primary diagnosis, excluding any kind of deductible). Surgical complications still represent the largest wound category of costs with a small decrease from 2014 to 2019 of $6.1 billion to $5.9 billion. Based on the most conservative method, there was a very large cost reduction observed for outpatients from $10.5 billion to $2.5 billion with a correspondingly smaller decrease for inpatients of $5.3 billion to $4.2 billion, but an increase from $3.0 billion to $4.1 billion for physician offices. In addition, while durable medical equipment increased from $0.3 billion to $0.7 billion, home health agency expenditures decreased from $1.6 billion to $1.1 billion.Our data suggest that while most of the cost remains in the subacute setting it has shifted to the physician's office from the hospital-based outpatient department. Given the increasing prevalence of chronic wounds, especially among the disabled under 65, it will be important to know whether these shifts have positively or negatively affected outcomes.

Consensus principles for wound care research obtained using a Delphi process.

Too many wound care research studies are poorly designed, badly executed, and missing crucial data. The objective of this study is to create a series of principles for all stakeholders involved in clinical or comparative effectiveness research in wound healing. The Delphi approach was used to reach consensus, using a web-based survey for survey participants and face-to-face conferences for expert panel members. Expert panel (11 members) and 115 wound care researchers (respondents) drawn from 15 different organizations. Principles were rated for validity using 5-point Likert scales and comments. A 66% response rate was achieved in the first Delphi round from the 173 invited survey participants. The response rate for the second Delphi round was 46%. The most common wound care researcher profile was age 46-55 years, a wound care clinic setting, and >10 years' wound care research and clinical experience. Of the initial 17 principles created by the panel, only four principles were not endorsed in Delphi round 1 with another four not requiring revision. Of the 14 principles assessed by respondents in the second Delphi round, only one principle was not endorsed and it was revised; four other principles also needed revision based on the use of specific words or contextual use. Of the 19 final principles, three included detailed numbered lists. With the wide variation in design, conduct, and reporting of wound care research studies, it is hoped that these principles will improve the standard and practice of care in this field.