In our May 2024 Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to include in vitro diagnostic products (IVDs), even those manufactured in a...more
4/24/2025
/ Administrative Procedure Act ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Hospitals ,
Judicial Authority ,
Laboratory Developed Tests ,
Loper Bright Enterprises v Raimondo ,
Medical Devices ,
Regulatory Authority ,
Statutory Interpretation ,
Vacated
The Department of Justice Antitrust Division (DOJ), the Federal Trade Commission (FTC), and the Department of Health and Human Services (HHS) (together the Agencies) launched a cross-government agency request for information...more
2/13/2025
/ Acquisitions ,
Antitrust Division ,
Competition ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Health Insurance ,
Healthcare ,
Hospitals ,
Mergers ,
Private Equity
The Centers for Medicare & Medicaid Services (CMS) has adopted an age-friendly quality hospital measure in its most recent final rule addressing prospective payment systems, policy changes, and quality program requirements...more
Every year, the New Jersey legislature passes statutes that impact healthcare beyond rate increases under the Medicaid program. Last year was no different, and the discussion below highlights some of those statutes, such as...more
6/6/2024
/ Acute Facilities ,
Centers for Medicare & Medicaid Services (CMS) ,
Cost-Sharing ,
Drug Pricing ,
False Claims Act (FCA) ,
Healthcare ,
Hospitals ,
Licensees ,
Medical License ,
Mental Health ,
New Jersey ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Supply Chain ,
Telehealth
The U.S. Food and Drug Administration (FDA) published a final rule amending its regulations to include in vitro diagnostic products (IVDs) as devices, even those manufactured in a laboratory, and issuing policy to phase out...more
Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more
5/10/2024
/ Child Care ,
Dental Practice ,
Department of Health and Human Services (HHS) ,
Disabilities ,
Financial Transactions ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Hospitals ,
Inpatient Rehab Facilities ,
Long Term Care Facilities ,
Medicaid ,
New Jersey ,
Pharmaceutical Industry ,
Pharmacist ,
Recordkeeping Requirements ,
Regulatory Standards ,
State Health Departments ,
Transparency
New guidance released by the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) on April 1, 2024, clarified that hospitals will not be eligible for Medicare or Medicaid...more
4/11/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Conditions of Participation (CoP) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Healthcare ,
Hospitals ,
Informed Consent ,
Medical Examinations ,
Nurses ,
Pharmaceutical Industry ,
Physicians ,
Teaching Hospitals ,
Vaccinations