This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2024. We discuss several US Department of Justice (DOJ) enforcement actions involving the False Claims Act (FCA) and the...more
1/3/2025
/ Acute Facilities ,
Anti-Kickback Statute ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Legislative Agendas ,
Medicare Payment Reform ,
OIG ,
Pharmaceutical Industry ,
Price Transparency ,
Regulatory Agenda ,
Regulatory Reform ,
Stark Law
The 2024 election results will create significant tailwinds for Republican legislative and regulatory priorities in US Congress, federal agencies, and state houses across the country. This On the Subject considers the outlook...more
12/6/2024
/ Biosimilars ,
Corporate Governance ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Pharmaceutical Industry ,
Presidential Elections ,
Regulatory Agenda ,
Stakeholder Engagement ,
Transparency ,
Trump Administration ,
Vaccinations
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more
4/24/2024
/ Anti-Kickback Statute ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
OIG ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform ,
Stark Law
On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a “patient” under the 340B Program Statute. The...more
11/17/2023
/ Covered Entities ,
Enforcement Actions ,
Genesis HealthCare ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Litigation Strategies ,
MDRP ,
Patients ,
Rulemaking Process ,
Section 340B
On July 26, 2023, two days after the Centers for Medicare and Medicaid Services (CMS) issued its second largest civil monetary penalty for noncompliance with the hospital price transparency rule, CMS hosted a webinar...more
On November 2, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it will implement increased penalties for hospitals that do not comply with the Hospital Price Transparency Rule, effective January 1,...more
In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more
2/7/2020
/ Administrative Procedure Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Compounding ,
Drug Distribution ,
Enforcement Actions ,
Enforcement Guidance ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare Fraud ,
Healthcare Reform ,
Kickbacks ,
Medicare ,
Opioid ,
Overpayment ,
Pain Management ,
Pharmacies ,
Prescription Drugs ,
Private Equity ,
Regulatory Violations ,
Rulemaking Process ,
Settlement Negotiations ,
Stark Law