Pmd36 Analysis of Safety Adverse Reporting Events of Essure Medical Device: The End Road of Essure

Abstract

data submitted for FDA approval, was reviewed along with target patient distribution, coverage status, and commentary from Medicare and the top 20 commercial insurers (by number of covered lives). Results: Eight FDA-approved interventions with BDD status were identified across 7 broad therapeutic indicationsemphysema, diabetic retinopathy, iris defects, type 1 diabetes, and chronic heart failure therapies; and traumatic brain injury and solid tumor cancer diagnostics. Of these devices, 3 were widely non-covered, 4 had limited coverage, and 1 had insufficient data for analysis among commercial insurers; in contrast, Medicare and its regional contractors explicitly covered 1 of these devices, with no formal policy for the remaining devices. Non-coverage rationale stated by health plan policies was primarily insufficiently compelling evidence of clinical efficacy. A prospective analysis of these products, assuming retroactive coverage aligned with H.R. 5333 (116 th Congress; 2019-2020 or similar legislation, determined that during a 3-year effective period, market access would increase by 55% or more, driven primarily by the distribution of Medicare beneficiaries across target patient populations. Conclusions: Breakthrough Device Designation, while potentially valuable to expedite U.S. regulatory clearance, does not directly correlate with coverage by payer stakeholders. While pending legislative efforts may offer guaranteed, temporary Medicare coverage, innovators must pair these initiatives with additional, payerresonant clinical evidence to secure widespread market access.