Policy & Legislation

FDA Clears Daraxonrasib Expanded Access for Pretreated Metastatic Pancreatic Cancer

George Padron
Oncology Care, Healthcare Headlines, Policy & Legislation, Reimbursement Changes | May 1, 2026
FDA approved expanded access to the RAS inhibitor daraxonrasib for patients with previously treated metastatic pancreatic cancer just two days after Revolution Medicines requested it.

Medicare's AI-Driven Prior Authorization Pilot Draws Physician Backlash and a Federal Lawsuit

Sonia Reyes
Prior Authorization & Appeals, State & Federal Regulations, Medicare/Medicaid Updates, Healthcare Headlines, Policy & Legislation, Reimbursement Changes, Practice Management, Regulatory & Legislative Updates | Apr 10, 2026
Three months into Medicare's WISeR prior auth pilot, physicians report widespread claim denials, and the EFF has sued CMS for transparency on AI vendor practices.

First Brain-Penetrating Enzyme Therapy Wins FDA Approval for Hunter Syndrome

Sonia Reyes
Precision Medicine, Specialty Medicine, Policy & Legislation | Apr 4, 2026
Denali's Avlayah wins accelerated FDA approval as the first brain-penetrating enzyme replacement therapy for Hunter syndrome's cognitive decline.

Why a National Health Data Blueprint Should Matter to Every Payer

George Padron
AI & Critical Decision Support, Policy & Legislation | Mar 28, 2026
A National Academy of Medicine discussion paper outlines a national digital health infrastructure framework aligned with CMS goals for interoperability and AI integration.

White-Label Medical Groups Draw Regulatory Scrutiny in GLP-1 Telehealth Crackdown

George Padron
Healthcare Headlines, Policy & Legislation, Telehealth & Virtual Care, Obesity & Metabolic Health | Mar 18, 2026
A STAT News investigation finds that four medical groups are linked to 30% of FDA-warned GLP-1 telehealth companies, raising legal and patient safety concerns for payers.