Medicare OPPS Advisory Panel To Meet August 19-20, 2019

The U.S. Food and Drug Administration has released a discussion paper outlining its initial framework for regulating generative AI-enabled medical devices, proposing a two-axis risk assessment approach and a novel competency-based premarket evaluation system. With public comments due by October 19, 2026, this represents a critical opportunity for device manufacturers and stakeholders to shape the regulatory landscape for this transformative technology.

On Friday, California Office of Health Care Affordability (“OHCA”) published proposed final regulations that implement a 2026 law that significantly expanded OHCA’s review authority over health care transactions involving private equity (“PE”) groups, hedge funds, and management services organizations (“MSOs”). Stakeholders involved in California health care transactions should re-assess whether their ongoing or contemplated transactions are implicated by these regulations, because newly covered transactions will need to comply with the 90-day advance notice requirement established in the original OHCA regulations.

The FDA, in collaboration with federal partners, held a landmark public hearing on September 14, 2026, to gather input on the future therapeutic use of psychedelic drugs, drawing over 18,000 registered attendees. This hearing represents one of the earliest implementations of Executive Order 14401, which directs federal agencies to expedite research, review, and approval of psychedelic drugs for serious mental health conditions.

Over the past year, industry has had a front row seat as the Food and Drug Administration (“FDA” or the “Agency”) decides just how much leeway it wants to afford the manufacture, marketing, and sale of peptide products, and just where it wants to draw the line. Despite the recent decision of FDA’s Pharmacy Compounding Advisory Committee (“PCAC”) to recommend a number of peptides for inclusion on the 503A bulks list process — a move that represents a potentially more permissive stance toward peptide regulation, at least in terms of what can and cannot be compounded under 503A...

On November 17, 2022, FDA posted warning letters to 7 companies for selling different dietary supplements with claims that caused the products to be "drugs" in violation..

The healthcare mergers and acquisitions (M&A) market began 2025 with a slower start than expected given the easing headwinds and building momentum at the end of last year...

For those that have been awaiting the federal government’s issuance of the final rules modifying the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security regulations...

ONn February 3, 2026, Congress enacted the Consolidated Appropriations Act, 2026, marking a watershed moment in the regulation of pharmacy benefit managers (PBMs).

On September 15, 2026, a dozen independent pharmacies in Arkansas filed a lawsuit against Express Scripts Inc. (ESI), a pharmacy benefit manager (PBM), alleging that it reimbursed the pharmacies...

The Centers for Medicare & Medicaid Services has launched a groundbreaking 10-year Accountable Care Organization program that promises unprecedented benchmark stability and financial flexibility for healthcare providers. With applications due by May 17, 2026, the Long-term Enhanced ACO Design (LEAD) Model introduces innovative payment mechanisms, specialist integration pathways, and enhanced support for high-needs populations that could fundamentally reshape value-based care delivery through 2036.