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
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
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
5/29/2024
/ Advisory Opinions ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Enforcement ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Laboratory Developed Tests ,
Medical Devices ,
Medicare Advantage ,
Medicare Fraud ,
Medicare Part D ,
Non-Compete Agreements ,
Nursing Homes ,
OCR ,
OIG ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
Sentencing ,
Settlement ,
Telemedicine
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2024. We discuss various regulatory developments, including guidance on the use of AI in coverage decisions and texting...more
3/15/2024
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Confidential Information ,
Department of Health and Human Services (HHS) ,
Enforcement ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Hospitals ,
Machine Learning ,
Opioid ,
Patient Confidentiality Breaches ,
Substance Abuse ,
Telehealth ,
Texting
This report reviews notable areas for government enforcement actions during 2023 that were discussed in our monthly Healthcare Regulatory Check-Up reports. In the past year, we saw the relevant federal government enforcement...more
2/29/2024
/ Anti-Kickback Statute ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Stark Law
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more
2/26/2024
/ 1115 Waivers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medicaid ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Prior Authorization ,
Regulatory Agenda ,
Regulatory Reform ,
Self-Referral
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged violations of the False...more
2/1/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Healthcare ,
Legislative Agendas ,
OIG ,
Regulatory Agenda ,
Regulatory Requirements ,
Regulatory Violations
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2023. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new General...more
1/15/2024
/ Ambulatory Surgery Centers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
Enforcement Actions ,
False Claims Act (FCA) ,
Final Rules ,
Fraud and Abuse ,
Healthcare Facilities ,
Healthcare Fraud ,
Healthcare Reform ,
Hospitals ,
No Surprises Act (NSA) ,
Outpatient Prospective Payment System (OPPS) ,
Payment Systems ,
Regulatory Reform ,
Skilled Nursing Facility
On November 29, 2023, the Centers for Medicare & Medicaid Services (CMS) published the 2024 annual update to the designated health services (DHS) Code List. This annual update includes important changes for Medicare providers...more
On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more
12/19/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Digital Health ,
False Claims Act (FCA) ,
Healthcare ,
Incentives ,
Investors ,
Medicare ,
OIG ,
Private Investment Funds ,
REIT ,
Shareholders ,
Transparency
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more
11/30/2023
/ Advisory Opinions ,
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 Facilities ,
Healthcare Fraud ,
Healthcare Reform ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Agenda
On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more
11/16/2023
/ Anti-Kickback Statute ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Fraud ,
OIG ,
Patients ,
Stark Law
In September, the US Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion to a pathology laboratory concerning a proposed services arrangement with referring...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
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA)...more
6/23/2023
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Employer Mandates ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Medicare ,
Nursing Homes ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Public Health Emergency ,
Regulatory Agenda ,
Telehealth ,
Telemedicine ,
Vaccinations
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for April 2023. We discuss several criminal and civil enforcement actions related to the Anti-Kickback Statute (AKS) and the...more
6/8/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Testing ,
False Claims Act (FCA) ,
Fraud ,
Kickbacks ,
Medicaid ,
Medical Debt ,
OIG ,
Self-Disclosure Requirements ,
Settlement ,
Stark Law ,
TRICARE
As a part of the Consolidated Appropriations Act, 2023 (CAA), Congress passed new exceptions to the Physician Self-Referral Law (Stark Law) and the federal Anti-Kickback Statute (AKS) allowing certain healthcare entities to...more
In this session, McDermott Will & Emery Partners Denise Burke, Tony Maida and Monica Wallace discussed top issues and enforcement trends that physician practice management companies (PPMs) and ambulatory surgery centers...more
5/26/2023
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Compensation ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Physicians ,
Professional Conferences ,
Self-Referral Disclosure Protocol ,
Stark Law
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for March 2023. We discuss several criminal and civil enforcement actions that involve Anti-Kickback Statute (AKS) and...more
5/3/2023
/ Coronavirus/COVID-19 ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Durable Medical Equipment ,
Enforcement Actions ,
False Claims Act (FCA) ,
False Statements ,
Florida ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Kickbacks ,
OIG ,
Physicians ,
Remand ,
Settlement ,
Voluntary Disclosure ,
Whistleblowers
After a rare False Claims Act (FCA) trial—especially one premised on violations of the Anti-Kickback Statute (AKS)—a federal jury in Minnesota returned a $43 million verdict against Precision Lens, a distributor of medical...more
3/30/2023
/ Anti-Kickback Statute ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Kickbacks ,
Medical Devices ,
Medicare ,
OIG ,
Physicians ,
Settlement
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between September 21 and October 20, 2022. We review several criminal and civil enforcement actions related to Anti-Kickback Statute...more
11/15/2022
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Reform ,
Medicare Part D ,
OIG ,
Regulatory Agenda