Food, Drugs, Healthcare, Life Sciences

The Fifth Circuit's en banc ruling on the No Surprises Act challenges federal agencies' methodology for calculating provider reimbursement rates, specifically addressing the controversial inclusion of "ghost rates" and exclusion of bonus payments in determining the qualifying payment amount. This landmark decision will reshape how insurers calculate reimbursement rates for out-of-network claims and significantly impact negotiations between healthcare providers and insurance companies.

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage.

Artificial Intelligence (“AI”) is increasingly moving beyond clinical decision support and into the administrative functions that directly impact healthcare reimbursement.