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 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
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 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 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
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
9/1/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare ,
OIG ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Physicians ,
Proposed Regulation ,
Regulatory Agenda ,
Reimbursements ,
Settlement