METHODS: The study employed mixed quantitative-qualitative primary research methodology to solicit aggregate insights. Forced-choice surveys were distributed to medical directors (n=10) representing national and regional plans, including 1 integrated delivery network. Following collection of survey data, individual interviews were conducted with each responder, centered on structured narratives where directors assessed prospective access and coverage of hypothetical BDD devices with profiles based on existing BDD-assigned products.

RESULTS: Consensus payer decision-maker feedback indicates that potentially relaxed Medicare coverage standards will not drive corresponding reduced clinical evidence requirements for commercial payers; as a result, excluding Medicare advantage patients, commercial plan beneficiaries are unlikely to see increased access to BDD products without manufacturer investment in compelling efficacy and safety data from rigorous studies. Particularly for invasive therapies, most surveyed payers suggest that long-term outcomes and comparative trials may still be needed to obtain favorable coverage and reimbursement for innovative technologies. In contrast, financially sensitive payers, such as IDNs, may also accept health economic data, including preliminary evidence, offering an opportunity to further expand early access to BDD therapies before more mature data is available.