As of mid-2025, private equity (PE) investors remain intensely interested in health care services and technology companies despite higher borrowing costs, heightened regulatory scrutiny, and an increasingly complex state...more
Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
President Trump’s Executive Order (EO) 14187, “Protecting Children from Chemical and Surgical Mutilation,” represents a significant shift in federal policy regarding gender-affirming care (GAC) for minors....more
4/17/2025
/ Constitutional Challenges ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Funding ,
Gender Identity ,
Hospitals ,
Medicaid ,
Medicare ,
Minors ,
Popular ,
Preliminary Injunctions ,
Trump Administration
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more
On March 3, the US Department of Health and Human Services (HHS) published a change in policy that could result in fewer opportunities for stakeholders and members of the public to weigh in on HHS regulatory action related to...more
On January 8, Massachusetts Governor Maura Healy signed into law “An Act Relative To Pharmaceutical Access, Costs And Transparency.” The Act will have a profound impact on all parties involved in setting and applying drug...more
2/28/2025
/ Cost-Sharing ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
Insurance Industry ,
Medicaid ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Regulatory Requirements ,
Reporting Requirements ,
State and Local Government
Gender-affirming care (GAC) is a model of care encompassing medical, surgical, mental health, and non-medical services to support transgender and nonbinary individuals in affirming their gender identity. Advocates argue that...more