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
As we previously advised, the Centers for Medicare & Medicaid Services (CMS) is preparing to issue a national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV under...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 Physician Practice Management (PPM) and ASC Symposium 2024 is the destination event for PPM and ASC industry leaders and health industry investors. Join us as we deliver actionable insights on the state of the market and...more
5/3/2024
/ Ambulatory Surgery Centers ,
Artificial Intelligence ,
Business Development ,
Business Opportunities ,
Continuing Legal Education ,
Events ,
Exit Strategies ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Investment Banks ,
Investment Opportunities ,
Investors ,
Joint Venture ,
Medicare ,
Mental Health ,
Partnerships ,
Physicians ,
Prior Authorization ,
Privacy Laws ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Reimbursements ,
Risk Management ,
Substance Abuse ,
Telehealth ,
Value-Based Care
On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS...more
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
The US Centers for Medicare & Medicaid Services (CMS) finalized important changes to the Medicare enrollment regulations applicable to hospices and home health agencies (HHAs), including increasing the level of screening that...more
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
The US Centers for Medicare & Medicaid Services (CMS) finalized important changes to the Medicare provider and supplier enrollment regulations, including adding marriage and family therapists (MFTs) and mental health...more
On November 17, 2023, the US Department of Health and Human Services (HHS) published a final rule requiring nursing facilities participating in Medicaid and skilled nursing facilities participating in Medicare to disclose...more
12/11/2023
/ Business Ownership ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Investment ,
Investors ,
Mortgage REITS ,
Private Equity ,
Skilled Nursing Facility
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
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
McDermott’s Healthcare Litigation, Compliance and Investigations Forum is back when you need it the most.
Heightened regulatory scrutiny and enforcement activity pose legal, financial and reputational risks for healthcare...more
10/10/2023
/ Administrative Procedure Act ,
Anti-Kickback Statute ,
Antitrust Provisions ,
Attorney-Client Privilege ,
Chief Compliance Officers ,
Compliance ,
Continuing Legal Education ,
Enforcement Actions ,
Events ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Facilities ,
Investigations ,
Life Sciences ,
Physicians ,
Regulatory Requirements ,
Restrictive Covenants
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
Following an implementation delay during the COVID-19 public health emergency (PHE), on August 1, 2023, the Centers for Medicare and Medicaid Services (CMS) initiated Medicare hospital claims edits that will return certain...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more
7/31/2023
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Emerging Technologies ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Fraud ,
Medicare ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Securities and Exchange Commission (SEC) ,
Telehealth ,
Telemedicine
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
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
On April 20, 2023, the US Department of Health and Human Services (HHS) made ownership data of all Medicare-certified hospices and home health agencies publicly available for the first time. This move is consistent with the...more
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
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