United States: Healthcare

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
DOJ Fraud Division And HHS-OIG Announce Policy To Coordinate On Voluntary Self-Disclosures In Healthcare Fraud Matters
The Department of Justice's National Fraud Enforcement Division and HHS Office of Inspector General have announced a coordinated policy that streamlines voluntary self-disclosures of healthcare fraud. Companies can now disclose potential criminal conduct to a single point of contact and receive benefits under both DOJ's Corporate Enforcement Policy and HHS-OIG's Self-Disclosure Protocol, eliminating the need for multiple simultaneous disclosures.
United States Criminal
GP
Goodwin Procter LLP
Article
FDA Submits Interim Peptide Compounding Policy For White House Review: What Pharmacies Should Know
FDA has submitted an interim access policy for peptide compounding to the Office of Management and Budget for review, marking a potential shift in federal enforcement. While the submission signals regulatory progress, the policy's scope, covered substances, and operational requirements remain undisclosed, leaving compounding pharmacies to navigate uncertainty about which peptides will qualify and under what conditions they may be prepared.
United States Healthcare
BI
Buchanan Ingersoll & Rooney PC
Article
Vermont Restricts Private Equity Control Of Clinical Decision Making And Introduces Ownership Reporting For Health Care Facilities And MSOs
Vermont's Act 133 imposes new restrictions on private equity and hedge fund involvement in health care facilities, limiting investor control over clinical decisions while requiring detailed ownership disclosures to state regulators. The law creates significant compliance obligations for investors and operators, including an initial reporting deadline of March 1, 2027, and ongoing disclosure requirements for ownership changes.
United States Commercial
HL
Hogan Lovells Cadwalader
Article
Hospital Mergers And In-House Pharmacies: Licensing, Payor Contracting And Operational Issues That Cannot Wait Until Closing
Hospital mergers require careful attention to pharmacy operations, which involve separate licenses, registrations, payor contracts and accreditation requirements that don't automatically transfer with the hospital. Overlooking pharmacy integration as a distinct transaction workstream can interrupt network participation, delay reimbursement and disrupt patients' access to medications, making early planning essential for regulatory compliance and operational continuity.
United States Healthcare
BI
Buchanan Ingersoll & Rooney PC
Article
Under New Management? Not So Fast: Federal CPOM Bill Targets MSO Structures, ‘friendly Physician’ Model
Federal legislation introduced in Congress would establish nationwide restrictions on corporate ownership of medical practices, prohibit management service organizations from controlling physician practices, and void most noncompete agreements for healthcare workers. The bill targets private equity and corporate involvement in healthcare delivery through mandatory divestiture requirements and treble-damages enforcement.
United States Healthcare
SR
McDermott Will & Schulte
Article
Benesch Healthcare Dialysis & Nephrology Digest No. 79
Benesch Healthcare Partner Jason Greis recently joined the BackTable Vascular & Interventional Podcast to discuss the growing scrutiny surrounding Medicare audits and what physicians and medical practices should know. During the conversation, he examined common audit triggers, the increasing use of artificial intelligence in audit activities, compliance and documentation best practices, and strategies for responding to audits and navigating the appeals process.
United States Healthcare
B
Benesch Friedlander Coplan & Aronoff LLP
Article
The Race For Clinical Trials: Can The FDA’s New Pilot Program Stop The U.S. From Falling Behind?
The United States has lost approximately 10% of its global share of Phase 1 clinical trials since 2015, with China now accounting for 39% of all global trials by 2024. The FDA's new Expedited IND Pilot Program introduces Qualified Research Institutions and rolling submissions to help sponsors reach first-in-human dosing faster domestically. For life sciences companies whose financing depends on rapid trial initiation, this program could fundamentally reshape development strategy and restore U.S. competitive
United States Healthcare
FH
Foley Hoag LLP
Article
Intellectual Property Strategy In An Era Of Foreign Clinical Trials
Biotech companies conducting early-stage biologics trials outside the United States face complex intellectual property challenges that can significantly impact their ability to secure U.S. market exclusivity. Foreign clinical trial registrations, contractor disclosures, and misaligned regulatory timelines create prior-art risks and patent forfeiture scenarios that many companies fail to anticipate. This analysis examines how strategic patent filing coordination with foreign Phase I development can preserve
United States IP
FH
Foley Hoag LLP
Article
PBM Policy And Legislative Update — Fall 2026
Mintz's Managed Care, PBMs & Pharmacies practice examines critical federal and state developments impacting pharmacy benefit managers and the prescription drug supply chain from mid-February through June 2026. This comprehensive quarterly update analyzes legislative activity, regulatory changes, enforcement actions, and emerging market trends affecting PBMs, health plans, pharmacies, manufacturers, and industry stakeholders navigating an evolving regulatory landscape.
United States Healthcare
M
Mintz
Article
Mental Health Parity Under The Trump Administration: Where DOL Is Headed And What Congress Is Doing About It
On September 8, 2026, the U.S. Department of Labor's Employee Benefits Security Administration (EBSA) issued Field Assistance Bulletin No. 2026-03 (Bulletin 2026-03), narrowing near-term enforcement of the Mental Health Parity and Addiction Equity Act (MHPAEA) to three priority areas and confirming nonenforcement of the 2024 Final Rule's newer provisions pending litigation. The administration has also stopped defending that rule in court and promised a substantially revised proposal by December 31, 2026.
United States Employment
M
Mintz
Article
Seals And Sale Bans: California's New Non-UPF Certification And Age Limits On Dietary Supplements & OTC Diet Products
California continues to lead the way in regulating foods and dietary supplements sold within its borders. Two recent developments are worth highlighting: the nation’s first statewide “Non-Ultraprocessed” food certification program, and a second-of-its-kind law restricting sales of certain dietary supplements and over-the-counter products to individuals under 18. Below, we break down both measures and what they may mean for food and supplement companies doing business in the state.
United States Healthcare
AG
Akin Gump Strauss Hauer & Feld LLP
Article
Henry Ford Health Sues CVS Over Improper Diversion Of 340B Savings
Henry Ford Health has filed a federal lawsuit against CVS Health and its affiliates, alleging the improper diversion of over $29 million in savings from the federal 340B Drug Pricing Program through manipulated reimbursements for specialty drugs. The healthcare system claims CVS used back-end pricing mechanisms to retain funds that should have been remitted under their pharmacy services agreements, with similar allegations emerging from other major health systems across the country.
United States Healthcare
HB
Hall Benefits Law
Article
FDA Opens Applications For New Pilot To Shorten Drug Approval Times: What Sponsors Need To Know
The FDA has launched a new Expedited IND Pilot Program under Operation TrialBlazer, introducing Qualified Research Institutions and rolling submission platforms to accelerate the path from preclinical work to first-in-human trials. With applications due October 30 and only 8-10 sponsor-QRI pairs to be selected, this initiative aims to reduce the current two-year timeline for FIH trial initiation while maintaining existing safety standards.
United States Healthcare
SM
Sheppard, Mullin, Richter & Hampton LLP
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