In 2024 alone, over 676 private equity firms and related investors acquired healthcare companies or related assets. The growing influence of private equity in the healthcare industry has not gone unnoticed on either of the...more
5/6/2025
/ Acquisitions ,
Antitrust Provisions ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Hospitals ,
Mergers ,
Popular ,
Private Equity ,
Proposed Legislation ,
Regulatory Requirements ,
State and Local Government ,
State Attorneys General
In its first advisory opinion of the year, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) assessed a pharmaceutical manufacturer’s free product program and found that, although the...more
President Donald Trump has signed more than 60 executive orders since taking office, including Executive Order 14173, titled “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” (EO 14173 or the Executive...more
After years of FDA discussion and failed congressional efforts to assert greater oversight of laboratory developed tests (LDTs), FDA has proposed a rule that would require many LDTs to comply with FDA’s requirements for in...more
As we take stock of the Supreme Court’s 2023 term, two landmark decisions shift our understanding of scienter and government intervention as it relates to the False Claims Act (“FCA”), 31 U.S.C. § 3729. First, on June 1,...more
9/15/2023
/ Department of Justice (DOJ) ,
Drug Pricing ,
False Claims Act (FCA) ,
Foreign Corrupt Practices Act (FCPA) ,
Healthcare ,
Medicaid ,
Medicare ,
Prescription Drugs ,
Qui Tam ,
Reasonable Interpretations ,
Scienter ,
SCOTUS ,
United States ex rel Polansky v Executive Health Resources Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
While mergers and acquisitions, and attendant financings may not be at a blistering pace globally, the prognosis for deal activity in the healthcare sector remains healthy, in particular as the consolidation of providers, the...more
6/15/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Investment ,
Life Sciences ,
Medical Technology Companies ,
Medicare ,
Non-Compete Agreements ,
OIG ,
Prescription Drugs ,
Restrictive Covenants ,
Vertical Mergers
Ten years in the making, and full implementation is finally coming. In about a year—beginning on November 27, 2023—prescription drug manufacturers and their supply chain partners will be required to fully trace and verify...more