Regulatory & Legislative Updates

A Once-Daily Epilepsy Pill With No Titration Clears Phase 3

Sonia Reyes
Specialty Medicine, Neurology & CNS Disorders, Regulatory & Legislative Updates | Apr 23, 2026
Azetukalner, a once-daily oral antiseizure agent requiring no titration, reduced focal onset seizures by 53% in phase 3 X-TOLE2, with an NDA filing expected mid-2026

Insurer Claims of Prior Authorization Cutbacks Draw Skepticism From Physicians and Policy Experts

George Padron
Prior Authorization & Appeals, Medicare/Medicaid Updates, Coverage Navigation Strategies, Appeals & Denials Management, Reimbursement Changes, Practice Management, Regulatory & Legislative Updates | Apr 13, 2026
AHIP says insurers eliminated 6.5M prior authorizations for medical services, but critics call the announcement vague and say prescription drugs were excluded.

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.

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

George Padron
Policy & Legislation, Public Health Initiatives, Regulatory & Legislative Updates | Mar 13, 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.

When the Brain Leads, Regulators (Slowly) Follow

Sonia Reyes
Policy & Legislation, Regulatory & Legislative Updates | Feb 26, 2026
Brain-computer interface startups face a regulatory impasse: the FDA requires proof of patient benefit, but the field has yet to agree on how to measure it.