In 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) provided useful insights to the healthcare industry regarding how it approaches various fraud and abuse issues in an...more
2/7/2025
/ Anti-Kickback Statute ,
Billing ,
Compliance ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare ,
Healthcare Fraud ,
Medicare ,
Medicare Advantage ,
OIG ,
Risk Management ,
Settlement ,
Stark Law ,
Telehealth
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more
2/1/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Information Technologies ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Information Blocking Rules ,
Litigation Strategies ,
New Guidance ,
OIG ,
Regulatory Agenda ,
Telehealth
On November 6, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released the most up-to-date, comprehensive, and practical general compliance guidance in decades. The new...more
12/7/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Investment ,
New Guidance ,
OCR ,
OIG ,
Private Equity
On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more
11/6/2023
/ Audits ,
Comment Period ,
Covered Entities ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Patients ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On October 26, the Health Resources and Services Administration (HRSA) issued a notice clarifying the registration requirements for offsite hospital outpatient facilities under the 340B drug pricing program. The Notice, which...more
On August 18, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-05, finding that an entity’s proposal to facilitate referring surgeons’ ownership of turnkey...more
Nearly 25 years ago, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) created a regulatory safe harbor to the federal Anti-Kickback Statute (AKS) for physician investment in...more
On June 15, the U.S. Supreme Court issued a unanimous decision finding Medicare payment cuts to hospitals participating in the 340B drug pricing program illegal. The decision in favor of 340B hospitals is the culmination of a...more
On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more
1/13/2022
/ Administrative Procedure Act ,
Appeals ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement ,
HRSA ,
Manufacturers ,
OIG ,
Pharmacies ,
Section 340B