In the context of Medicare Advantage (“MA”) reform initiatives, we previously addressed the Centers for Medicare & Medicaid Services’ (“CMS”) December 27, 2022 proposal to amend its regulations set forth at 42 C.F.R. §...more
8/6/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Final Rules ,
Healthcare Fraud ,
Investigations ,
Medicare Advantage ,
Medicare Part D ,
Overpayment ,
Physician Fee Schedule ,
Proposed Rules ,
Regulatory Reform ,
Reporting Requirements ,
Voluntary Disclosure
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
On June 16, 2023, the Supreme Court (the “Court”) in United States ex rel. Polansky v. Executive Health Resources affirmed the federal government’s power to dismiss a False Claims Act (“FCA”) action brought under the qui tam...more
7/19/2023
/ Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
Fraud and Abuse ,
FRCP 41 ,
Healthcare ,
Motion To Intervene ,
Qui Tam ,
Regulatory Authority ,
Relators ,
SCOTUS ,
United States ex rel Polansky v Executive Health Resources Inc ,
Whistleblowers
In a unanimous opinion, the United States Supreme Court (“Court”) recently held that the False Claims Act’s (“FCA”) scienter requirement refers to a defendant’s knowledge and subjective beliefs, rather than what a...more
We previously wrote about the United States Department of Justice’s (“DOJ”) Civil Cyber-Fraud Initiative (“CCFI”), which “aims to hold accountable entities or individuals that put U.S. information or systems at risk by...more
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
On Friday, March 31, 2023, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2024 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (Rate Announcement). This Rate...more
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
Last fall, the United States Department of Justice (“DOJ”) launched its Civil Cyber-Fraud Initiative (“CCFI”) as part of its effort to “combat new and emerging cyber threats to the security of sensitive information and...more
7/21/2022
/ Audits ,
Cybersecurity ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
DFARS ,
False Claims Act (FCA) ,
Federal Acquisition Regulations (FAR) ,
Fraud ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Settlement Agreements ,
US State Departments
This past week, the Supreme Court of the United States (Supreme Court) denied UnitedHealthcare Insurance Company’s (UnitedHealthcare) petition for a writ of certiorari (Petition) challenging, in part, the Centers for Medicare...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