Dobson | DaVanzo attended the Wound Care Evidence Summit from May 19th - May 20th 2022, organized by the Alliance of Wound Care Stakeholders.
The summit convened a multi-disciplinary group of wound care stakeholders including payers, federal regulators such as the FDA, researchers, clinicians, and manufacturers to collaboratively discuss the challenges in wound care research, clinical care, and coverage. Specifically, stakeholder discussions focused on understanding the quantity and type of evidence payers need to make a coverage determination for wound care products and services, and how that evidence fulfills the requirements of federal regulators concerning safety and efficacy.
During the two-day meeting, attendees reflected on the drawbacks of evidence from clinical trials that are often designed with stringent inclusion criteria - limiting the generalizability of these studies to the actual patients with wound seen in a clinical practice in a hospital or a clinic. Panelists and attendees also discussed the opportunities for using Real World Evidence (RWE) obtained from Real World Data (RWD), including Electronic Health Records (EHRs), administrative claims, registries, and patient-generated data, to support Federal regulatory approvals and payer coverage decisions.
Over the next few weeks, Dobson | DaVanzo will prepare and publish conference proceedings that will include key lessons learned as well as actionable next steps that wound care stakeholders can take to address the challenges discussed.
Dobson | DaVanzo has extensive experience applying rigorous statistical and econometric methodologies to Medicare FFS Claims to infer causal relationships between interventions (such as drugs or services) and outcomes. For instance, in a recently published journal article, we used a two-stage inverse probability treatment weighting model to compare the outcomes for Medicare patients with diabetic foot ulcer(s) (DFU) receiving cryopreserved placental membrane containing viable cells (vCPM) to other Cellular- and Tissue-Based Products (CTPs).
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