This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2025, including the results of the US Department of Justice’s (DOJ) 2025 National Health Care Fraud Takedown, DOJ...more
8/29/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
HCPCS ,
Healthcare ,
Healthcare Fraud ,
Inpatient Prospective Payment System (IPPS) ,
Kickbacks ,
Long Term Care Facilities ,
Medicare ,
OIG ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Proposed Rules ,
Qui Tam ,
Telehealth
On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more
6/13/2025
/ Appeals ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Judicial Authority ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Supply Shortages
On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more
On January 21, 2025, the Washington state legislature introduced Senate Bill (SB) 5387, aiming to codify a restrictive state prohibition on the corporate practice of healthcare, commonly referred to as a corporate practice of...more
3/3/2025
/ Compliance ,
Corporate Practice of Medicine ,
Enforcement Actions ,
Health Care Providers ,
Healthcare ,
Legislative Agendas ,
New Legislation ,
Regulatory Agenda ,
Regulatory Requirements ,
State Legislatures ,
Telemedicine ,
Washington
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
2/27/2025
/ Appeals ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Litigation Strategies ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Requirements ,
Section 340B
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
2/13/2025
/ Audits ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
FOIA ,
Health Care Providers ,
Healthcare ,
HRSA ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Section 340B
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
2/5/2025
/ Class Action ,
Enforcement Actions ,
FOIA ,
Health Care Providers ,
Healthcare ,
HRSA ,
Medicare ,
Medicare Advantage ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Requirements ,
Section 340B