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
The Menopause Market Is Becoming Mainstream: What Employers, Providers, And Investors Need To Know Now
The menopause care market is projected to reach tens of billions of dollars by 2030, driven by expanding state coverage mandates and employer benefits. As this frontier in health law and investment accelerates, stakeholders must navigate complex compliance issues spanning telehealth regulations, controlled substances, data privacy, advertising claims, and billing practices across varying state jurisdictions.
United States Healthcare
KM
Katten Muchin Rosenman LLP
Article
Trump’s Proposed Tariffs On Generic Pharmaceuticals
The Trump Administration has proposed escalating tariffs on imported generic pharmaceuticals, starting at 0% in August 2026 and rising to 200% by 2029, aiming to reshape U.S. pharmaceutical manufacturing and reduce dependence on foreign suppliers. With India supplying a significant portion of America's generic drugs and 91% of U.S. prescriptions being generics, the policy could dramatically impact drug costs, supply chains, and international trade relationships. This trade policy shift reflects the Administ
Worldwide International
TT
Torres Trade Law, PLLC
Article
DOL Proposes Electronic Disclosure Safe Harbor For Health Plan Documents
The US Department of Labor has proposed a new electronic disclosure safe harbor specifically for ERISA-covered group health plans, potentially transforming how plan administrators deliver required disclosures to participants. This proposed framework would mirror the 2020 retirement plan e-disclosure safe harbor by enabling default electronic delivery through a notice-and-access model, moving away from the outdated 2002 consent-based standard. The DOL projects this change could raise electronic delivery rate
United States Employment
MB
Mayer Brown
Article
Building The Next Generation Of Behavioral Health Platforms
The behavioral health sector faces a critical gap between patient need and treatment access, with only half of the 61.5 million US adults experiencing mental illness receiving care. As regulatory changes reshape reimbursement models and investors increasingly favor specialized, high-quality providers, organizations are pursuing platform-building strategies focused on integrated care delivery, operational excellence, and measurable clinical outcomes to capture growth opportunities across autism services, sub
United States Healthcare
SR
McDermott Will & Schulte
Article
CMS Turns Up The Heat With Sweeping New Enrollment Enforcement Tools In HH PPS Proposed Rule
The Centers for Medicare & Medicaid Services has proposed sweeping changes to Medicare enrollment regulations that would dramatically expand its authority to deny and revoke provider enrollments. These proposals introduce retroactive revocation powers, extended reapplication bars, and new grounds for enforcement actions that could fundamentally reshape program integrity oversight and increase compliance risks for healthcare providers, suppliers, and their investors.
United States Healthcare
SR
McDermott Will & Schulte
Article
Recent FCA Enforcement Illustrates DOJ’s Focus On Wound Care
The U.S. Department of Justice has intensified False Claims Act enforcement in the wound care industry, targeting allegedly medically unnecessary skin substitutes, improper billing practices, and kickback arrangements. With billion-dollar settlements and a record-breaking $6.8 billion in FCA recoveries for fiscal year 2025, federal scrutiny of manufacturers, distributors, and healthcare providers continues to escalate. How are recent Medicare reimbursement changes and regulatory concerns reshaping complianc
United States Government
GP
Goodwin Procter LLP
Article
HHS-OIG Raises The Stakes For Medicaid Fraud Enforcement: New Scrutiny Of State MFCUs Signals Broader Enforcement Shift
The U.S. Department of Health and Human Services Office of Inspector General has denied recertification of New York's Medicaid Fraud Control Unit, suspending its federal funding and signaling a dramatic shift in federal oversight of state Medicaid fraud enforcement. This decision, following similar action against Hawaii and conditional recertifications for eight other states, transforms the annual recertification process from a routine compliance check into a substantive performance evaluation tool that scr
United States Government
AP
Arnold & Porter
Article
TEFCA Expansion Signals Heightened Federal Scrutiny Of Health Information Sharing
Federal regulators are dramatically expanding health information exchange through TEFCA while simultaneously ramping up enforcement against information blocking practices. With over 1 billion health records now flowing through the network and a new federal auditor in place, healthcare organizations face heightened scrutiny and potential penalties reaching $1 million per violation. How should providers prepare for this new era of interoperability oversight?
United States Healthcare
BS
Bond, Schoeneck & King PLLC
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