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
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more
8/8/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Department of Health and Human Services (HHS) ,
Disproportionate Share Adjustments ,
Dobbs v. Jackson Women’s Health Organization ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Long Term Care Facilities ,
Medicare ,
Nursing Homes ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Roe v Wade ,
Skilled Nursing Facility
This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more
5/27/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Co-payments ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
False Claims Act (FCA) ,
Health Care Providers ,
Manufacturers ,
Medicaid Drug Rebate Program ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Stark Law
This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more
5/26/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Nursing Home Reform Act (FNHRA) ,
Global Code of Ethics ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
OIG ,
Regulatory Agenda
On September 24, 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a request for information (RFI) to advance its guidance modernization initiative. The RFI seeks industry...more
12/9/2021
/ Advisory Opinions ,
Audits ,
Comment Period ,
Compliance ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Fraud Alerts ,
List of Excluded Individuals/Entities (LEIE) ,
OIG ,
Regulatory Oversight ,
Request For Information ,
Resource Management
On November 8, 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued an update to the Health Care Fraud Self-Disclosure Protocol (SDP). This update revises and renames the...more
In keeping with — and in response to — HHS-OIG’s November 2020 Special Fraud Alert on industry speaker programs, the Pharmaceutical Research and Manufacturers of America has updated its Code on Interactions with Health Care...more
Stay current on the healthcare enforcement issues impacting your business’ compliance strategies. In this installment of the Healthcare Enforcement Roundup, we address:
• Key areas of enforcement scrutiny in 2021,...more
4/2/2021
/ 1135 Waivers ,
Biden Administration ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Enforcement Guidance ,
Executive Orders ,
False Claims Act (FCA) ,
Healthcare Fraud ,
OIG ,
Private Equity ,
Regulatory Oversight ,
Revocation ,
Telehealth ,
Telemedicine
On November 20, 2020, the US Department of Health and Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and...more
11/25/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Final Rules ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Safe Harbors ,
Stark Law ,
Telehealth
On November 20, 2020, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule as part of ongoing administration drug pricing reform efforts and in conjunction with the...more
In its November 16, 2020, Special Fraud Alert, the HHS Office of Inspector General drew attention to potential fraud and abuse risks of speaker programs hosted by pharmaceutical companies and medical device manufacturers....more
11/18/2020
/ AdvaMed ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Care Providers ,
Healthcare Fraud ,
Inspector General ,
Manufacturing Facilities ,
Medical Devices ,
New Guidance ,
OIG ,
Pharmaceutical Industry ,
PHRMA ,
Risk Factors ,
Speaker Programs
The US Department of Justice and the US Department of Health and Human Services Office of Inspector General recently announced a significant healthcare fraud takedown involving $4.5 billion in allegedly false and fraudulent...more
[co-authors: Mara McDermott and Katie Waldo, McDermott+Consultants]
This report from McDermott Will & Emery and McDermott+Consulting provides a detailed analysis of the latest Provider Relief Fund (PRF) distributions,...more
9/14/2020
/ Children's Health Insurance Program (CHIP) ,
Dental Practice ,
Department of Health and Human Services (HHS) ,
Fund Distribution ,
Health Care Providers ,
Hospitals ,
Indian Health Service (IHS) ,
Medicaid ,
Medicare ,
Nursing Homes ,
Provider Relief Fund ,
Rural Health Care Providers ,
Skilled Nursing Facility
On May 26, 2020 the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published its Oversight of COVID-19 Response and Recovery Strategic Plan, identifying the agency’s four primary objectives...more
On April 21, 2020, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a proposed rule that would amend its civil money penalty (CMP) regulations to address a 21st Century Cures Act...more
This On the Subject was updated on April 7, 2020, to address the Department of Health and Human Services Office of Inspector General’s (OIG’s) April 3, 2020, Policy Statement and its potential impact as well.
The Centers...more
The US Department of Health and Human Services, Office of Inspector General has created an information portal and established a process to provide guidance on the application of the Anti-Kickback Statute and Beneficiary...more
Hospitals and health systems are facing consumer demand for innovation, the need to expand and enhance streams of revenue and the push for improved quality, all while navigating changing regulations, federal enforcement,...more
2/6/2020
/ Antitrust Litigation ,
Centers for Medicare & Medicaid Services (CMS) ,
CMIA ,
Cyber Attacks ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Medicare ,
No-Poaching ,
OCR ,
Popular ,
Ransomware