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
On April 20, 2023, the United States Department of Health and Human Services Office of the Inspector General (HHS OIG) released a new toolkit designed to help analyze telehealth claims to assess federal healthcare program...more
The US Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion (AO) 23-03, analyzing a proposed arrangement in which a company that manufactures an at-home colon cancer...more
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community.
Join us for insightful discussion about the latest regulatory and reimbursement developments....more
2/1/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Diagnostic Tests ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Laboratory Developed Tests ,
Legislative Agendas ,
Medicare Administrative Contractors (MAC) ,
Prior Authorization ,
Regulatory Agenda ,
Reimbursements
On July 20, 2022, the US Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert (Alert) concerning the fraud and abuse risks associated with healthcare practitioners entering...more
1/4/2023
/ Controlled Substances ,
Criminal Investigations ,
Department of Health and Human Services (HHS) ,
Fraud ,
Health Care Providers ,
Medicaid ,
Medicare ,
OIG ,
Prescription Drugs ,
Telehealth ,
Telemarketing ,
Telemedicine
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between October 21 and November 18, 2022, including recent enforcement activity, new litigation associated with the Office of...more
12/9/2022
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Violations ,
Healthcare ,
Healthcare Fraud ,
OIG ,
Regulatory Agenda ,
Settlement
On September 2, 2022, the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a data brief analyzing telehealth services covered by Medicare and related program integrity risks. OIG...more