The US Department of Justice, along with several state attorneys general, has issued subpoenas and civil investigative demands to hospitals, physicians, telehealth companies, and pharmaceutical manufacturers engaged in...more
11/5/2025
/ Civil Investigation Demand ,
Department of Justice (DOJ) ,
Gender Discrimination ,
Gender Expression ,
Gender Identity ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Privacy Rule ,
Hospitals ,
LGBTQ ,
Patient Privacy Rights ,
PHI ,
Shield Laws ,
State Attorneys General ,
State Privacy Laws ,
Subpoenas ,
Telehealth ,
Transgender
California Governor Gavin Newsom recently signed two new bills into law that formalize restrictions on medical and dental practice management platforms operated by private equity groups and hedge funds and increase the...more
10/28/2025
/ California ,
Corporate Practice of Dentistry ,
Corporate Practice of Medicine ,
Corporate Sales Transactions ,
Dental Practice ,
Dentists ,
Health Care Providers ,
Healthcare ,
Hedge Funds ,
Merger Controls ,
New Legislation ,
Non-Compete Agreements ,
Premerger Notifications ,
Private Equity Firms ,
Regulatory Oversight ,
Regulatory Reform ,
Reporting Requirements
The White House issued a memorandum on September 9, 2025 directing the secretary of the US Department of Health and Human Services (HHS) and the commissioner of the US Food and Drug Administration (FDA) to significantly...more
9/16/2025
/ Advertising ,
Department of Health and Human Services (HHS) ,
Digital Media ,
Enforcement Priorities ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Influencers ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Rulemaking Process ,
Social Media ,
Trump Administration
Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while maintaining a measured,...more
The risks associated with the growth of AI in the healthcare and life sciences industries, as well as recent federal and state activity and enforcement actions, emphasize the importance of understanding and implementing a...more
The Centers for Medicare & Medicaid Services (CMS) recently announced the launch of the Wasteful and Inappropriate Services Reduction (WISeR) Model, a six-year model under the CMS Innovation Center aimed at reducing...more
The 340B Drug Pricing Program (the Program) has long been a cornerstone for healthcare providers seeking to deliver affordable care to underserved communities. However, as the regulatory and compliance landscape evolves,...more
As part of a broader resurgence in pharmaceutical pricing reform and manufacturing policies in 2025, President Donald Trump and bipartisan congressional leaders have introduced contemporaneous proposals to lower prescription...more
Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding requirements for device...more
Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a perennial focus of stakeholders...more
On May 10, 2024, the Centers for Medicare and Medicaid Services (CMS) published its Final Rule to implement minimum staffing standards for long-term care (LTC) facilities in the United States. However, as discussed in our...more
The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security...more
4/24/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicare ,
National Security ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Prescription Drugs ,
Supply Chain
Through the issuance of Inauguration Day executive orders, the Trump Administration signaled its apparent intent to tackle drug pricing reforms over the next four years. However, Biden-era policies are likely to limit a...more
This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug products by allowing the approval of a nonprescription drug product with an “Additional Condition...more
The Centers for Medicare & Medicaid Services issued its long-anticipated final rule clarifying the 60-day overpayment refund obligation (the 60-Day Rule) first established in a 2016 regulation for Medicare Part A and B...more
In response to rising prescription costs and overall state-level healthcare spending, numerous states, including Maryland and Oregon, have established prescription drug affordability review boards (PDABs) to review certain...more