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

OBJECTIVE: To identify how cellular and/or tissue-based products (CTPs) relate to value in terms of cost per quality-adjusted life years in wound care with comparisons to treatments in other medical fields. APPROACH: This is a cross-sectional study, cost-effectiveness analysis. Payment limits for each CTP were obtained via HCPCS Q codes and formulated as cost inputs into a cost-utility model published for treatment of Wagner 1 diabetic foot ulcers using dHACA versus standard of care. Additional changes to cap number of CTP applications and adjust for recent inflation were made. The literature was searched for other cost-utility models in other medical fields as comparisons. RESULTS: When the payment limit was ≤$140 per square cm interventions were dominant (less costly, better outcomes) compared to standard of care. When the limit exceeded $430 per square cm 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 in comparison to the results for many other chronic diseases considered to be more serious than chronic wounds. 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 non-cost-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.

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.

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.

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.

Lymphatic function and anatomy in early stages of lipedema.

OBJECTIVE: Lipedema is an inflammatory subcutaneous adipose tissue disease that develops in women and may progress to lipolymphedema, a condition similar to lymphedema, in which lymphatic dysfunction results in irresolvable edema. Because it has been shown that dilated lymphatic vessels, impaired pumping, and dermal backflow are associated with presymptomatic, cancer-acquired lymphedema, this study sought to understand whether these abnormal lymphatic characteristics also characterize early stages of lipedema prior to lipolymphedema development. METHODS: In a pilot study of 20 individuals with Stage I or II lipedema who had not progressed to lipolymphedema, lymphatic vessel anatomy and function in upper and lower extremities were assessed by near-infrared fluorescence lymphatic imaging and compared with that of a control population of similar age and BMI. RESULTS: These studies showed that, although lower extremity lymphatic vessels were dilated and showed intravascular pooling, the propulsion rates significantly exceeded those of control individuals. Upper extremity lymphatics of individuals with lipedema were unremarkable. In contrast to individuals with lymphedema, individuals with Stage I and II lipedema did not exhibit dermal backflow. CONCLUSIONS: These results suggest that, despite the confusion in the diagnoses between lymphedema and lipedema, their etiologies differ, with lipedema associated with lymphatic vessel dilation but not lymphatic dysfunction.

Lymphatic Dissemination and Axillary Web Syndrome in Primary Cutaneous Tuberculosis Secondary to Needlestick Injury.

Cutaneous tuberculosis secondary to skin inoculation of Mycobacterium tuberculosis is uncommon but it can occur in the health care settings. Herein, we report an unusual case of primary cutaneous tuberculosis of the thumb following a needlestick injury. The infection progressed with a necrotic granuloma, lymphatic dysfunction as visualized by near-infrared fluorescence lymphatic imaging, and the development of an axillary web syndrome.

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.

Degradation of lymphatic anatomy and function in early venous insufficiency.

OBJECTIVE: We used near-infrared fluorescence lymphatic imaging in a pilot study to assess the lymphatics in preulcerative (C2-C4) venous insufficiency and determine whether involvement and/or degradation of lymphatic anatomy or function could play a role in the progression of chronic venous insufficiency. We also explored the role of lymphatics in early peripheral arterial disease. METHODS: After informed consent and intradermal injections of indocyanine green for rapid lymphatic uptake, near-infrared fluorescence lymphatic imaging was used to assess the lymphatic anatomic structure and quantify the lymphatic propulsion rates in subjects with early venous insufficiency. The anatomic observations included interstitial backflow, characterized by the abnormal spreading of indocyanine green from the injection site primarily into the surrounding interstitial tissues; dermal backflow, characterized by the retrograde movement of dye-laden lymph from collecting lymphatics into the lymphatic capillaries; and lymphatic vessel segmentation and dilation. RESULTS: Ten subjects with venous insufficiency were enrolled, resulting in two legs with C2 disease, nine legs with C3 disease, eight legs with C4 disease, and one leg with C5 disease. Interstitial and/or dermal backflow were observed in 25%, 33%, and 41% of the injection sites in each limb with C2, C3, and C4 disease, respectively. Distinct vessel segmentation and dilation were observed in limbs with a C3 and higher classification, and dermal backflow proximal to the injection sites was observed in two legs with C4 disease and in the inguinal region of the C5 study subject. The overall average lymph propulsion rates were 1.3 ± 0.4, 1.2 ± 0.7, and 0.8 ± 0.5 contractile events/min for limbs with C2, C3, and C4 disease, respectively. One subject with peripheral arterial disease, who had previously undergone bypass surgery, presented with extensive dermal backflow and lymphatic reflux. CONCLUSIONS: Near-infrared fluorescence lymphatic imaging demonstrated that, compared with normal health subjects, the lymphatic anatomy and contractile function generally degrade with the severity of venous insufficiency. Lymphatic abnormalities mimic those in early cancer-acquired lymphedema subjects, as previously observed by us and others. Additional studies are needed to decipher the relationship, including any causality, between lymphatic dysfunction and peripheral vascular disease and venous insufficiency.

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.

The Development and Treatment of Lymphatic Dysfunction in Cancer Patients and Survivors.

Breast-cancer-acquired lymphedema is routinely diagnosed from the appearance of irreversible swelling that occurs as a result of lymphatic dysfunction. Yet in head and neck cancer survivors, lymphatic dysfunction may not always result in clinically overt swelling, but instead contribute to debilitating functional outcomes. In this review, we describe how cancer metastasis, lymph node dissection, and radiation therapy alter lymphatic function, as visualized by near-infrared fluorescence lymphatic imaging. Using custom gallium arsenide (GaAs)-intensified systems capable of detecting trace amounts of indocyanine green administered repeatedly as lymphatic contrast for longitudinal clinical imaging, we show that lymphatic dysfunction occurs with cancer progression and treatment and is an early, sub-clinical indicator of cancer-acquired lymphedema. We show that early treatment of lymphedema can restore lymphatic function in breast cancer and head and neck cancer patients and survivors. The compilation of these studies provides insights to the critical role that the lymphatics and the immune system play in the etiology of lymphedema and associated co-morbidities.

Wound Center Without Walls: The New Model of Providing Care During the COVID-19 Pandemic.

The COVID-19 pandemic poses a major challenge in delivering care to wound patients. Due to multiple comorbidities, wound patients are at an increased risk for the most extreme complications of COVID-19 and providers must focus on reducing their exposure risk. The Federal, State, and local governments, as well as payers, have urged hospitals and providers to reduce utilization of nonessential health services, but they also have given more flexibility to shift the site of necessary care to lower risk environments. Providers must be prepared for disruption from this pandemic mode of health care for the next 18 months, at minimum. The wound provider must accept the new normal during the pandemic by adapting their care to meet the safety needs of the patient and the public. The Wound Center Without Walls is a strategy to untether wound care from a physical location and aggressively triage and provide care to patients with wounds across the spectrum of the health system utilizing technology and community-centered care.

Assessing lymphatic route of CSF outflow and peripheral lymphatic contractile activity during head-down tilt using near-infrared fluorescence imaging.

Evidence overwhelmingly suggests that the lymphatics play a critical role in the clearance of cerebrospinal fluid (CSF) from the cranial space. Impairment of CSF outflow into the lymphatics is associated with a number of pathological conditions including spaceflight-associated neuro-ocular syndrome (SANS), a problem that limits long-duration spaceflight. We used near-infrared fluorescence lymphatic imaging (NIRFLI) to dynamically visualize the deep lymphatic drainage pathways shared by CSF outflow and disrupted during head-down tilt (HDT), a method used to mimic the cephalad fluid shift that occurs in microgravity. After validating CSF clearance into the lymph nodes of the neck in swine, a pilot study was conducted in human volunteers to evaluate the effect of gravity on the flow of lymph through these deep cervical lymphatics. Injected into the palatine tonsils, ICG was imaged draining into deep jugular lymphatic vessels and subsequent cervical lymph nodes. NIRFLI was performed under HDT, sitting, and supine positions. NIRFLI shows that lymphatic drainage through pathways shared by CSF outflow are dependent upon gravity and are impaired under short-term HDT. In addition, lymphatic contractile rates were evaluated from NIRFLI following intradermal ICG injections of the lower extremities. Lymphatic contractile activity in the legs was slowed in the gravity neutral, supine position, but increased under the influence of gravity regardless of whether its force direction opposed (sitting) or favored (HDT) lymphatic flow toward the heart. These studies evidence the role of a lymphatic contribution in SANS.

The Wound Healing Index for Predicting Venous Leg Ulcer Outcome.

Objective: To develop a venous leg ulcer (VLU) risk stratification system for use in research and clinical practice. Approach: U.S. Wound Registry data were examined retrospectively and assigned an outcome. Bivariate analysis identified significant variables (p < 0.05) that were used to create a multivariable logistic regression model. Ulcers with data for wound area at the first visit before debridement were included in regression analysis, which was based on a 90% development sample. The model was validated on a hold-out 10% data sample. Results: The original dataset included 26,713 VLUs, of which 11,773 ulcers were eligible for preliminary analysis and 10,942 ulcers were eligible for regression analysis. The 90% development model included 9,898 ulcers, of which 7,498 healed (75.8%). The 10% validation sample included 1,044 ulcers, of which 809 healed (77.5%). The following variables significantly predicted healing: number of concurrent wounds of any etiology, wound size, wound age (in days), evidence of bioburden/infection, being nonambulatory, and hospitalization for any reason. Innovation: The VLU Wound Healing Index (WHI) is a comprehensive, validated risk stratification model for predicting VLU healing that incorporates patient- and wound-specific variables. Conclusions: The WHI can identify which VLUs most likely require adjunctive therapies to heal, prioritize referral to venous experts, risk-stratify ulcers to create more generalizable clinical trials and understand the impact of clinical interventions. The Centers for Medicare and Medicaid Services accepts this method for reporting VLU outcome under the Quality Payment Program.

On the Origin of Intraoperative Pressure Injury: An Angiosomal Theory of Pressure Injury Formation.

We review a case of a 22-year-old healthy man who underwent a 5-h maxillofacial surgery while continuously supine with foam pads placed prophylactically over elevated heels. Immediately after surgery, Stage 1 pressure injuries appeared on the left lateral heel and right lateral ankle, despite the absence of local pressure to these areas. Both lesions eventually resolved. Eight months later, a Doppler evaluation was performed of the patient's lower extremities, the peroneal artery and its tributaries were marked, and the intraoperative positioning was simulated to determine if a wedge at the back of the calf could have obstructed blood flow in these vessels. In this position, the feet naturally abducted so that the lateral calcaneal and posterior malleolar arteries became positioned immediately underneath the wedge. We propose a vascular mechanism of pressure injury development, postulating that some heel pressure injuries are not the result of localized pressure but rather angiosomal ischemia, based on the observation that the anatomical pattern of these lesions frequently follow the distribution of a named vessel. We hypothesize that in this case, intraoperative positioning along with permissive hypotension may have occluded arterial or venous flow to the relevant angiosomes, causing an ischemia reperfusion injury to the downstream tissues.

Publicly Reported Wound Healing Rates: The Fantasy and the Reality.

Significance: We compare real-world data from the U.S. Wound Registry (USWR) with randomized controlled trials and publicly reported wound outcomes and develop criteria for honest reporting of wound outcomes, a requirement of the new Quality Payment Program (QPP). Recent Advances: Because no method has existed by which wounds could be stratified according to their likelihood of healing among real-world patients, practitioners have reported fantastically high healing rates. The USWR has developed several risk-stratified wound healing quality measures for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) as part of its Qualified Clinical Data Registry (QCDR). This allows practitioners to report DFU and VLU healing rates in comparison to the likelihood of whether the wound would have healed. Critical Issues: Under the new QPP, practitioners must report at least one practice-relevant outcome measure, and it must be risk adjusted so that clinicians caring for the sickest patients do not appear to have worse outcomes than their peers. The Wound Healing Index is a validated risk-stratification method that can predict whether a DFU or VLU will heal, leveling the playing field for outcome reporting and removing the need to artificially inflate healing rates. Wound care practitioners can report the USWR DFU and VLU risk-stratified outcome measure to satisfy the quality reporting requirements of the QPP. Future Directions: Per the requirements of the QPP, the USWR will begin publicly reporting of risk-stratified healing rates once quality measure data have met the reporting standards of the Centers for Medicare and Medicaid Services. Some basic rules for data censoring are proposed for public reporting of healing rates, and others are needed, which should be decided by consensus among the wound care community.

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.

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.

Qualified Clinical Data Registries: How Wound Care Practitioners Can Make the Most Out of the Merit-Based Incentive Payment System.

Significance: Wound care practitioners have no professional society to promote participation in a Qualified Clinical Data Registry (QCDR), which is essential to thrive under the Merit-Based Incentive Payment System (MIPS), and until recently have lacked relevant quality measures to report. Practitioners can now participate in the nonprofit U.S. Wound Registry (USWR) QCDR for MIPS credit, which can receive data from any certified electronic health record (EHR) and, in so doing, generate data useful for comparative effectiveness research. Recent Advances: For 2018, the Centers for Medicare and Medicaid Services (CMS) has approved 12 wound care and hyperbaric medicine-relevant quality measures and several clinical practice Improvement Activities, which can be reported for MIPS credit through the USWR. Several QCDR measures have met the CMS 3-year reporting criteria to establish national benchmark rates, likely enabling practitioners to achieve higher quality scores than possible with standard MIPS measures. The structured registry data generated have been harnessed to evaluate adherence to evidence-based clinical practice guidelines, understand real-world patient healing rates, and demonstrate the comparative effectiveness of wound therapies. Critical Issues: Wound care practitioners can participate in a QCDR for MIPS credit, which enables them to optimize their MIPS score, particularly if they transmit data directly from their EHR. Utilizing structured data for comparative effectiveness research may help ensure patient access to advanced therapeutics. Future Directions: By 2019, to overcome technological barriers to participation, USWR quality measures will be available as "apps" for EHRs that support the interface required to achieve the next stage of EHR certification as part of the open Application Programming Initiative.

Comparative cost and clinical effectiveness of clostridial collagenase ointment for chronic dermal ulcers.

Chronic dermal ulcers affect approximately 2.4-4.5 million people in the USA and are associated with loss of function, decreased quality of life and significant economic burden. Debridement is a critical component of wound care involving removal of nonviable tissue from chronic wounds to stimulate the granulation and epithelialization process. Clostridial collagenase ointment has been used as a method of wound debridement for more than 50 years and is currently the only enzymatic debriding ointment with US FDA approval. This review discusses the results of recent real-world studies that build upon the evidence demonstrating the clinical effectiveness, cost-effectiveness and safety of clostridial collagenase ointment across wound types and care settings.