US Department of Justice (DOJ) and the US Department of Health and Human Services re-launched their joint False Claims Act Working Group, signaling a heightened focus on artificial intelligence (AI)-enabled billing, Medicare...more
12/2/2025
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Corporate Practice of Medicine ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare Advantage ,
Private Equity ,
Risk Management
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for October 2025, which was relatively quiet due to the federal government shutdown....more
11/21/2025
/ Affordable Care Act ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Education ,
Department of Health and Human Services (HHS) ,
DMEPOS ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Physician Fee Schedule ,
Popular ,
Public Service Loan Forgiveness program (PSLF program) ,
Section 1557 ,
Weight-Loss Products
This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2025, including an update on the Centers for Medicare & Medicaid Services (CMS) Rural Health Transformation...more
11/10/2025
/ Advertising ,
Ambulatory Surgery Centers ,
Anti-Kickback Statute ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Digital Health ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Healthcare ,
Mental Health ,
OIG ,
Prescription Drugs ,
Prior Authorization ,
Rural Health Care Program ,
Rural Health Care Providers
The Advanced Medical Technology Association (AdvaMed) announced its updated Code of Ethics on Interactions with US Health Care Professionals on October 6, 2025. The medical technology industry has relied on the AdvaMed code...more
11/3/2025
/ Anti-Kickback Statute ,
Compliance ,
Cybersecurity ,
Data Management ,
Data Privacy ,
Data Protection ,
Digital Health ,
Ethics ,
Health Care Providers ,
Medical Devices ,
Popular ,
Regulatory Requirements ,
Transparency
Since its enactment in 2018, the Eliminating Kickbacks in Recovery Act (EKRA) has remained one of the greater compliance mysteries facing the healthcare industry. The statute’s odd language and structure raises more...more
10/27/2025
/ Anti-Kickback Statute ,
Appeals ,
Appellate Courts ,
Compliance ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Healthcare Facilities ,
Healthcare Fraud ,
Popular ,
Statutory Interpretation
On August 11, 2025, New Jersey Lieutenant Governor Tahesha Way, acting for Governor Phil Murphy, signed into law two bills, A3973/S3952 and A3974/S3955 (collectively, the 2025 amendment), that modify New Jersey’s existing...more
10/14/2025
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Criminal Prosecution ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Enforcement ,
Enforcement Authority ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
New Amendments ,
New Legislation ,
Patient Referrals ,
State and Local Government ,
State Legislatures
This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for August 2025, including the formation of a joint Healthcare Advisory Committee between the US Department of Health and...more
10/6/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Executive Orders ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Gender Dysphoria ,
Healthcare Fraud ,
OIG ,
Pharmaceutical Industry ,
Transgender
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 ,
Popular ,
Proposed Rules ,
Qui Tam ,
Telehealth
The US Department of Justice (DOJ) and the US Department of Health and Human Services (HHS) recently announced the relaunch of the DOJ-HHS False Claims Act Working Group, intended to “strengthen[] [the agencies’] ongoing...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more
7/28/2025
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
DMEPOS ,
EMTALA ,
Enforcement Actions ,
Enforcement Priorities ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Reform ,
Medical Devices ,
OIG
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2025, including the rollout of a new Centers for Medicare & Medicaid Services (CMS) strategy to expand and enhance Medicare...more
7/1/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Stark Law
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA) and other Medicare programs....more
5/28/2025
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Durable Medical Equipment ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Government Agencies ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Medicare ,
Medicare Advantage ,
New Legislation ,
OIG ,
Physicians ,
Regulatory Agenda ,
Technology ,
Telehealth ,
Telemedicine
This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features:
- Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more
4/28/2025
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Government Agencies ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Notice Requirements ,
OIG ,
Overpayment ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Requirements
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2025, including long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability Act...more
4/1/2025
/ Anti-Kickback Statute ,
Controlled Substances ,
Criminal Prosecution ,
Executive Orders ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Hospitals ,
OIG ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Freeze ,
Telehealth ,
Telemedicine ,
Trump Administration
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more
3/3/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Executive Orders ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
HMOs ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Private Equity ,
Regulatory Agenda ,
Technology Sector ,
Telehealth ,
Telemedicine ,
Trump Administration ,
Whistleblowers
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for December 2024. We discuss several civil and criminal enforcement actions pertaining to healthcare fraud and abuse authorities,...more
1/27/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Medicaid ,
Medicare ,
OIG ,
Regulatory Reform ,
Stark Law
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 Centers for Medicare and Medicaid Services (CMS) finalized material changes to the overpayment rules for Medicare Parts A, B, C, and D effective January 1, 2025. These changes create new ambiguity and practical challenges...more
12/20/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Medicare Part A ,
Medicare Part B ,
Medicare Part C ,
Medicare Part D ,
Physician Fee Schedule ,
Regulatory Agenda ,
Voluntary Overpayment Rule
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for October 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more
11/21/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Criminal Convictions ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Regulatory Agenda
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more
10/25/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Employer Liability Issues ,
False Claims Act (FCA) ,
Health and Welfare Plans ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
OIG ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Stark Law
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for August 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more
10/7/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
OIG ,
Regulatory Agenda ,
Stark Law
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
9/6/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Information Blocking Rules ,
Medicare ,
OIG ,
Proposed Regulation ,
Regulatory Agenda ,
Telehealth
In response to comments on the 2022 proposed changes to the overpayments regulation, the Centers for Medicare & Medicaid Services (CMS) proposed additional changes to the overpayment rule to clarify that the obligation to...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
8/1/2024
/ AIDS ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
HIV ,
Hospitals ,
Medicare ,
Medicare Part B ,
MIPS ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Agenda ,
Stark Law
At the end of the 2024 term, the executive branch struck out when the US Supreme Court issued three separate decisions along ideological lines that have the potential to materially weaken the enforcement authority of federal...more