RESEARCH AND REGISTRIES FOR HBOT PLENARY HBO AND DFU PLENARY
RESEARCH AND REGISTRIES FOR HYPERBARIC OXYGEN THERAPY PLENARY
8:00 AM - 10:00 AM
Caroline Fife, MD
"The Hyperbaric Oxygen Therapy Registry and the role of a Qualified Clinical Data Registry in protecting reimbursement"
The field of hyperbaric oxygen therapy and hyperbaric practitioners are under unprecedented scrutiny, with a resulting 50% decrease in HBO2 utilization nationally. Most practitioners are now subject to The Merit Based Incentive Payment System (MIPS), which requires the submission of quality measures. Qualified Clinical Data Registries (QCDRs) can develop specialty-specific quality measures and transmit data to CMS on behalf of clinicians, increasing the opportunity for bonus payments.
The HBOTR, through the USWR, offers specialty registry participation as part of MIPS. Registry participation is possible via automated transmission of Continuity of Care Documents (CCDs) which can enable national benchmarking of many key parameters and can address patient selection bias for other types of registry participation by providing a “denominator” for patients/conditions treated. QCDRs manage identified data and can link to the Medicare data warehouse, facilitating HBO2 cost effectiveness research. Patient-reported questionnaires can be enshrined as quality measures, enabling practitioners to realize a small reimbursement benefit for performing them. Provider scores on specialty-specific quality measures are publicly available via the USWR website linked to “Physician Compare,” a welcome alternative to star ratings derived only from standard (and irrelevant) MIPS measures. Hyperbaric Centers may also benefit from quality measure reporting. The HBOTR leverages current mandatory reporting quality requirements and available electronic health record technology to automate registry participation, an important consideration given the lack of funding for HBO2 research.
The HBOTR has already saved physician payment from a substantial reduction and can be harnessed for clinical research. Since January 2012, data on 27,404 patients has been captured. Among the 62,843 DFUs with data, 9,908 DFUs (15.7%) were treated with HBO2 therapy, although in 2017, the benchmark rate for HBOT 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 measure data.
Jay Buckey, MD
"The hyperbaric medicine registry at Dartmouth"
The value of hyperbaric oxygen is being questioned even for well-established UHMS-approved indications. Although every hyperbaric center treats cases for established indications, the outcomes are not gathered together at a central site, analyzed, and published. As a result, outcome data for hyperbaric oxygen are limited and hard to find. An outcomes registry collects outcomes data from multiple sites consistently, which could allow for more powerful analyses, and more widely accessible results. This talk will describe the outcomes-focused hyperbaric registry currently in use at Dartmouth, and how it could be used to advance the field of hyperbaric medicine.
Judy Rees, MD, PhD
"The role of registries in medicine"
The goal of a disease or treatment registry is to document important data systematically from a sample of patients and use it to make inferences to a larger population. This presentation will consider how registries can be used, some of the pitfalls awaiting the unsuspecting registry researcher; and approaches that will give the best chance of success.
HBO AND DFU PLENARY
4:00 PM - 5:00 PM
Dirk Ubbink, MD
"The effectiveness and costs of hyperbaric oxygen therapy for diabetic ischemic ulcers: results of the DAMOCLES multicenter trial"
This trial was conducted in 9 hyperbaric centers and 25 referring hospitals to find out whether additional HBOT would benefit patients with diabetes and ischemic leg ulcers. We randomized 120 diabetic patients with an ischemic wound to standard care without (SC) or with HBOT (SC+HBOT). Primary outcomes were limb salvage and wound healing, amputation-free survival (AFS), and direct and indirect medical costs.
Limb salvage was achieved in 47 patients in the SC group vs. 53 patients in the SC+HBOT group. After 12 months, 28 index wounds were healed in the SC group vs. 30 in the SC+HBOT group. AFS was achieved in 41 patients in the SC group and 49 patients in the SC+HBOT group. In the SC+HBOT group 21 patients (35%) were unable to complete the HBOT-protocol as planned. Those who did had significantly fewer major amputations and higher AFS. Overall costs were slightly higher in the SC+HBOT-group.
Michael Strauss, MD
"The Long Beach Wound Score as a Validated Tool for Comparative Effectiveness Research of Wounds and Objectifying the Indications for Hyperbaric Oxygen"
The Long Beach Wound Score (LBWS) is a validated wound scoring system that is user-friendly, intuitively obvious and applicable for all wounds - not just diabetic foot ulcers. Five assessments, each graded from 2-points (best possible) to 0-points using objective criteria to grade each, are summated to generate 0 to 10-point scores.
The scores then quantify three wound categories; "Healthy" 7.5 to 10 points, "Problem" 3.5 to 7 points and "End-stage" 0 to 3 points. The assessments include 1) Appearance of the wound base, 2) Size--including undermining, 3) Depth--to wound base or bottom of a tract, 4) Infection and 5) Perfusion.
For wounds in the "Healthy" category only simple wound care and, occasionally, biologics are needed for management. Deep infection, deformity, and/or ischemia are invariable present in the "Problem" wound category. These require debridements and antibiotics plus revascularization and/or hyperbaric oxygen (HBO2). Juxta-wound transcutaneous oxygen measurements in room air and with HBO2 objectify when this modality is indicated for wound management. Wounds in the "End-stage" category require amputation or revascularization if salvage is indicated. The decision for amputation versus salvage in a "Transition" zone (LBWS in the 2.5 to 4 point range) require information about the patients' wellness and goals, both quantified by 0 to 10 scores as intuitively obvious and easy to use as the LBWS.
With 24 billion dollars a year being spent in the USA for management of chronic wounds, comparative effectiveness research (CER) is needed to evaluate the effectiveness, cost benefits, and convenience of wound care. The essential consideration for CER is using a wound scoring system that objectifies the evaluation so "like can be compared with like." The LBWS is the reliable (similar scores by two or more observers) and validated tool that meets this requirement. With the LBWS the UHMS has the potential to establish a registry, document the effectiveness of interventions and become the "go to" source for payers to justify authorizations for wound management including HBO2 treatments.