U.S. Sees 25% Rise in Drug Denials; Sarepta Gene Therapy Deaths; Medicaid Data Access for ICE

Recent data shows a significant 25% increase in prescription drug denials by private insurers in the U.S. from 2016 to 2023. This surge is based on an analysis of over four billion claims and highlights ongoing challenges within the private health insurance system. Rising denials impact patient access and raise concerns about insurer policies and compliance with healthcare coverage obligations.

Sarepta Therapeutics has reported a third patient death this year linked to their experimental gene therapies. A 51-year-old male participant in a limb girdle muscular dystrophy trial died from acute liver failure. Previously, two teenage patients in a Duchenne muscular dystrophy trial succumbed to liver failure, underscoring risks associated with high-cost, novel gene therapy clinical trials and the need for regulatory vigilance.

A new policy grants U.S. Immigration and Customs Enforcement (ICE) officials access to Medicaid recipients' personal data, including addresses and ethnicity, to identify undocumented immigrants. This data sharing raises questions about patient privacy and legal boundaries, with lawmakers and CMS officials debating the appropriateness and legality of such access under healthcare confidentiality regulations.

Private health insurers are proposing notable rate increases for Affordable Care Act (ACA) plans in 2026. These hikes are attributed to rising healthcare costs and federal policy shifts, especially reductions in premium subsidies aimed at assisting individuals with coverage affordability. The anticipated rate changes signal ongoing financial pressures within the ACA marketplace and affect payer strategy and consumer insurance cost burden.



Overall, these developments reflect critical intersections of insurance denials, pharmaceutical innovation risks, governmental data policies, and evolving health coverage economics. Stakeholders across the insurance market and healthcare sectors must monitor regulatory compliance, market adaptations, and patient access to optimize outcomes and mitigate emerging risks.