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
On August 25, 2025, the US Department of Health and Human Services Office of Inspector General (OIG) issued a report analyzing Medicare billing for remote patient monitoring (RPM) services. With nearly one million Medicare...more
9/9/2025
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Fraud Abuse and Waste ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
Medicare Fraud ,
OIG ,
Physician Fee Schedule ,
Popular ,
Regulatory Oversight ,
Regulatory Requirements ,
Telehealth
The US Department of Health and Human Services (HHS) announced its intent to begin actively enforcing the information blocking regulations adopted under the 21st Century Cures Act, in a press release on September 3, 2025, and...more
9/8/2025
/ 21st Century Cures Act ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Enforcement ,
Enforcement Actions ,
Health Care Providers ,
Health Information Technologies ,
Information Blocking Rules ,
OIG ,
ONC ,
Regulatory Requirements
On April 23, 2025, the US Court of Appeals for the Fourth Circuit denied PointClickCare Technologies, Inc.’s petition for en banc review in Real Time Medical Systems, LLC v. PointClickCare. A Fourth Circuit panel previously...more
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
On December 17, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more
1/15/2025
/ 21st Century Cures Act ,
Compliance ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Privacy Laws ,
Reproductive Healthcare Issues
On December 16, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more
On October 29, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy (ASTP) released a fact sheet titled “Information Blocking Reminders Related to API Technology.” The fact...more
On September 24, 2024, the Office of Inspector General (OIG) at the US Department of Health and Human Services issued a report recommending additional oversight of remote physiologic monitoring (RPM) services furnished to...more
On August 5, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more
On August 5, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more
On July 1, 2024, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) published a final rule in...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more
6/25/2024
/ Anti-Kickback Statute ,
Appeals ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Dispute Resolution ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Manufacturers ,
No Surprises Act (NSA) ,
OIG ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Telehealth
The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more
4/10/2024
/ Algorithms ,
Artificial Intelligence ,
Certification Requirements ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Information Technologies ,
Healthcare ,
Information Technology ,
ONC ,
Risk Management ,
Technology
On December 13, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) issued the Health Data, Technology, and Interoperability: Certification...more
On October 30, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) released a...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
9/26/2023
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Manufacturers ,
Medical Devices ,
Mental Health ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Agenda ,
Reimbursements ,
Telehealth ,
Telemedicine
Key players across the healthcare industry—including sponsors, contract research organizations (CROs), research sites, regulators and patient advocates—are well aware of the challenges associated with the prompt and effective...more
The US Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a final rule to implement its authority under the 21st Century Cures Act to investigate allegations of information blocking and...more
8/3/2023
/ 21st Century Cures Act ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Final Rules ,
Health Care Providers ,
Health Information Technologies ,
Information Blocking Rules ,
Information Sharing ,
OIG ,
Physicians ,
Risk Mitigation ,
Webinars
On July 3, 2023, the US Department of Health and Human Services Office of Inspector General (OIG) published its long-awaited final rule implementing the 21st Century Cures Act provisions authorizing OIG to investigate claims...more
7/10/2023
/ 21st Century Cures Act ,
Amended Rules ,
Civil Monetary Penalty ,
CMP Law ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Enforcement Actions ,
Health Care Providers ,
Health Information Technologies ,
Information Blocking Rules ,
Information Technology ,
Investigations ,
OIG ,
Proposed Rules ,
Reporting Requirements
On June 27, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule amending OIG’s civil money penalty (CMP) regulations implementing the 21st Century Cures Act...more
7/10/2023
/ 21st Century Cures Act ,
Amended Rules ,
CMP Law ,
Corporate Misconduct ,
Department of Health and Human Services (HHS) ,
Fraud ,
Funding ,
Grants ,
Information Blocking Rules ,
OIG ,
Public Health Service Act
In this session, the panel discussed the opportunities digital health offers currently for behavioral-health care, and what might be around the corner...more