The Economic Impact of Living Cell Tissue Products in Treating Diabetic Foot Ulcers and Venous Leg Ulcers in Patients with Commercial Insurance: A Retrospective Matched-Cohort Study.

OBJECTIVE: Previous studies demonstrated that costs paid on behalf of Medicare recipients for diabetic foot ulcers and venous leg ulcers treated with cellular and/or tissue-based products (CTPs) varied in part based on the CTP chosen. This study extends previous work to determine how costs vary when paid by commercial insurance carriers. METHODS: A retrospective matched-cohort intent-to-treat design was used to analyze commercial insurance claims data between January 2010 and June 2018. Study participants were matched using Charlson Comorbidity Index, age, sex, type of wound, and geographic location within the US. Patients treated with a bilayered living cell construct (BLCC), dermal skin substitute (DSS), or cryopreserved human skin (CHSA) were included. RESULTS: Wound-related costs and number of CTP applications were significantly lower for CHSA relative to BLCC and DSS at all time intervals (60, 90, and 180 days and 1 year after first application of the CTP). Further, CHSA was associated with significantly fewer amputations at 1 year relative to DSS (14.9% vs 19.7%, P = .03). CONCLUSIONS: There was a statistically significant reduction in cost of treating diabetic foot ulcers (BLCC, DSS, CHSA) and venous leg ulcers (BLCC, CHSA) with CHSA as compared with the other CTPs. These findings are attributed to fewer applications, lower wound care costs, and comparable or reduced incidence of amputation. These commercial insurance data are consistent with prior studies that examined Medicare expenditures.

Physiologic and biochemical rationale for treating COVID-19 patients with hyperbaric oxygen.

The SARS-Cov-2 (COVID-19) pandemic remains a major worldwide public health issue. Initially, improved supportive and anti-inflammatory intervention, often employing known drugs or technologies, provided measurable improvement in management. We have recently seen advances in specific therapeutic interventions and in vaccines. Nevertheless, it will be months before most of the world's population can be vaccinated to achieve herd immunity. In the interim, hyperbaric oxygen (HBO2) treatment offers several potentially beneficial therapeutic effects. Three small published series, one with a propensity-score-matched control group, have demonstrated safety and initial efficacy. Additional anecdotal reports are consistent with these publications. HBO2 delivers oxygen in extreme conditions of hypoxemia and tissue hypoxia, even in the presence of lung pathology. It provides anti-inflammatory and anti-proinflammatory effects likely to ameliorate the overexuberant immune response common to COVID-19. Unlike steroids, it exerts these effects without immune suppression. One study suggests HBO2 may reduce the hypercoagulability seen in COVID patients. Also, hyperbaric oxygen offers a likely successful intervention to address the oxygen debt expected to arise from a prolonged period of hypoxemia and tissue hypoxia. To date, 11 studies designed to investigate the impact of HBO2 on patients infected with SARS-Cov-2 have been posted on clinicaltrials.gov. This paper describes the promising physiologic and biochemical effects of hyperbaric oxygen in COVID-19 and potentially in other disorders with similar pathologic mechanisms.

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.

The Health Economic Impact of Living Cell Tissue Products in the Treatment of Chronic Wounds: A Retrospective Analysis of Medicare Claims Data.

OBJECTIVE: To investigate differences in wound-related costs; product waste; lower-extremity amputations; and number of applications, hospitalizations, and emergency room visits among patients treated with three cellular and/or tissue-based products. METHODS: This retrospective intent-to-treat matched-cohort study analyzed the full Medicare claims dataset from 2011 to 2014. Patients who received either a bilayer cellular construct (BLCC), dermal skin substitute (DSS), or cryopreserved human skin allograft (CHSA) were concurrently matched for Charlson Comorbidity Index, age, sex, and region, resulting in 14,546 study patients. Key variables were reported at 60, 90, and 180 days after the first product application. RESULTS: There were no statistically significant differences in the distribution of Charlson Comorbidity Index, age, sex, and region among cohorts. Wound-related costs and product wastage were lower for CHSA patients relative to both BLCC and DSS patients at all time intervals (P < .05). Patients treated with CHSA received fewer product applications than DSS at 90 and 180 days (P < .05). Amputations were significantly higher among patients treated with DSS than either CHSA or BLCC (P < .0001). CONCLUSIONS: The data demonstrate that wound-related costs, product waste, amputations, and frequency of applications are lower for CHSA than DSS. Wound-related costs and product waste are lower for CHSA compared with BLCC. Further claims analysis and prospective clinical trials could help develop appropriate quality measures and reimbursement models to ensure smarter spending for the growing population of patients with chronic wounds.

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.

The American College of Hyperbaric Medicine consensus statement on physician credentialing for hyperbaric oxygen therapy.

The American College of Hyperbaric Medicine provides this document for hospital credentialing committees as national standards for credentialing hyperbaric physicians. These recommendations represent the consensus opinion of expert leaders in the field of hyperbaric medicine. The principles set forth in this document are intended to serve as a guideline to assist healthcare organizations. This document applies to both hospital-based and nonhospital-affiliated centers.

Hyperbaric oxygen therapy and optic neuritis: case report and literature review.

A history of optic neuritis has long been considered a relative contraindication to hyperbaric oxygen therapy. However, the published medical literature regarding the use of hyperbaric oxygen therapy in patients with previous optic neuritis is very limited, and patients who might benefit from hyperbaric oxygen therapy may be denied its benefit without adequate consideration of the risk-benefit ratio. We present a case report of a patient with a history of optic neuritis who underwent comprehensive ophthalmologic evaluation before and after 40 treatments with hyperbaric oxygen therapy, with no detectable ophthalmologic deficit.