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
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 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
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 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
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
On March 15, 2023, the Centers for Medicare and Medicaid Services (CMS) issued initial program guidance related to implementation of the Medicare Drug Price Negotiation Program. CMS requested public comments on selected...more
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 August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more
10/7/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Antitrust Violations ,
Biotechnology ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Medicare ,
Medicare Shared Savings Program ,
Nurses ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Price Transparency ,
Technology ,
Telehealth ,
TRICARE
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 enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more
9/1/2022
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Inflation Reduction Act (IRA) ,
Long Term Care Facilities ,
Medicare ,
OIG ,
Payment Systems ,
Section 1557 ,
Skilled Nursing Facility
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
The US Department of Justice recently intervened in an qui tam alleging false and fraudulent claims involving the acquisition of physician practice locations by a health system and subsequent management of the health system’s...more
4/19/2022
/ Anti-Kickback Statute ,
Asset Purchase Agreements ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Physicians ,
Professional Services Contract ,
Qui Tam ,
Reimbursements ,
Reversal ,
Section 340B
Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community.
Gain insight into how the industry addresses regulatory and business...more
3/18/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Enforcement Actions ,
Evidence ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Legislative Agendas ,
Life Sciences ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Physicians ,
Regulatory Oversight ,
Scientific Research ,
Stark Law ,
Vaccinations ,
Webinars
[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 April 21, 2020, the Centers for Medicare and Medicaid Services (CMS) issued explanatory guidance on the scope and application of a series of nationwide Section 1135 waivers of the physician self-referral law (Stark Law)...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