On May 21, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced a significant expansion of its auditing efforts with respect to Medicare Advantage (“MA”) plans....more
The U.S. Supreme Court has issued a significant ruling affecting hospitals that serve low-income Medicare beneficiaries, narrowing the interpretation of the Disproportionate Share Hospital (“DSH”) payment formula. In...more
5/23/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Government Agencies ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Hospitals ,
Medicaid ,
Medicare ,
Reimbursements ,
SCOTUS ,
Statutory Interpretation ,
Supplemental Security Income (SSI)
In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the Food and Drug Administration’s (“FDA”) 2024 final rule that sought to bring...more
4/16/2025
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Clinical Laboratories ,
Food and Drug Administration (FDA) ,
Judicial Review ,
Laboratory Developed Tests ,
Loper Bright Enterprises v Raimondo ,
Medical Devices ,
Regulatory Authority ,
Statutory Interpretation
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
The First Circuit has issued its long-anticipated opinion in United States v. Regeneron Pharmaceuticals, Inc., clarifying the standard for establishing False Claims Act (“FCA”) liability based on Anti-Kickback Statute (“AKS”)...more
The standard for an “identified overpayment” under Medicare Parts A–D now aligns with section 1128J(d)(4)(A) of the Social Security Act, which incorporates by reference the Federal False Claim Act’s (the “FCA”) “knowledge”...more
1/28/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Final Rules ,
Medicare ,
Medicare Advantage ,
Overpayment ,
Reporting Requirements ,
Risk Management
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
The health care industry is anxiously awaiting the First Circuit’s ruling on the standard of causation for actions brought under the False Claims Act (FCA) predicated on a federal Anti-Kickback Statute (AKS) violation. The...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 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
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
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
On February 6, 2023, a judge for the United States District Court for the Eastern District of Texas (“Texas District Court”) ruled in favor of the Texas Medical Association (“TMA”) and against the United States Departments of...more
After multiple extensions over the past three years, on Monday, January 30, 2023, President Biden announced that the COVID-19 national emergency and public health emergency (“PHE”) will officially end on May 11, 2023....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
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