On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more
On December 11, 2024, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a special fraud alert warning about certain marketing schemes that involve questionable payments and...more
12/18/2024
/ Anti-Kickback Statute ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud Alerts ,
Health Care Providers ,
Marketing ,
Medicare Advantage ,
OIG ,
Telemedicine ,
Third-Party
This week, the U.S. Attorney’s Office for the District of Colorado (“USAO”) announced that it entered into a series of interrelated settlement agreements with companies that provide intraoperative neuromonitoring (“IONM”)...more
On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more
9/30/2024
/ Administrative Procedure Act ,
Class Action ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
OCR ,
PHI ,
Proposed Rules ,
Regulatory Requirements ,
Tracking Systems ,
Web Tracking
In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute...more
5/29/2024
/ Anti-Kickback Statute ,
Appeals ,
But For Causation ,
Causation ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Kickbacks ,
OIG ,
Patient Assistance Programs ,
Proximate Cause ,
Regeneron ,
Regulatory Requirements ,
Reimbursements
The U.S. Department of Health and Human Services (“HHS”) has expanded upon its recent Healthcare Sector Cybersecurity Concept Paper (which we covered in a prior blog post), issuing cybersecurity performance goals (“CPGs”) for...more
The U.S. Department of Health and Human Services (HHS) recently issued a strategy paper highlighting key aspects of its plan to revamp cybersecurity requirements in the healthcare industry. Citing a 93% increase in large data...more
12/8/2023
/ Cybersecurity ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Legislative Agendas ,
National Security ,
New Guidance ,
OCR ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements
Last month, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services reaffirmed its longstanding position that an arrangement that “carves out” Federal health care program (FHCP) business is...more
On July 20, 2023, the Federal Trade Commission (“FTC”) and the Office for Civil Rights of the United States Department of Health and Human Services (“OCR”) announced that they had sent a warning letter to about 130 hospital...more
7/25/2023
/ Cyber Threats ,
Data Protection ,
Department of Health and Human Services (HHS) ,
False Endorsements ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
OCR ,
Personally Identifiable Information ,
Telehealth ,
Tracking Systems
In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...more
4/7/2023
/ Anti-Kickback Statute ,
Appeals ,
But For Causation ,
Causation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare ,
OIG ,
Regulatory Standards ,
Remuneration
In recent years, there have been only a handful of corporate integrity agreements (“CIAs”) and integrity agreements (“IAs”) that have included a “conditional exclusion release” of the Office of the Inspector General for the...more
We previously noted that the regulations implementing the No Surprises Act (“NSA”) appeared to be inconsistent with the NSA because they seemed to establish the qualifying payment amount (“QPA”) as the appropriate payment...more
8/31/2022
/ Billing ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Dispute Resolution ,
Health Care Providers ,
Health Insurance ,
Healthcare Facilities ,
Hospitals ,
Interim Final Rules (IFR) ,
No Surprises Act (NSA) ,
U.S. Treasury
On February 24, 2022, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), announced the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH)...more
On January 11, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued, without an opportunity for public notice and comment, a Final Rule, amending its internal process for...more