n a July 2, 2025, press release, the U.S. Department of Justice (DOJ) announced a new “DOJ-HHS False Claims Act Working Group” (the Working Group) and identified multiple priority enforcement efforts for the Working Group to...more
7/8/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
OIG ,
Payment Systems ,
Suspensions
Editor’s Note: PYA and Foley & Lardner hosted the 7th Annual “Let’s Talk Compliance” two-day virtual conference on January 23 and 24, 2025. Panelists included Foley attorneys and PYA subject matter experts. The event was...more
3/5/2025
/ Compliance ,
Cybersecurity ,
Data Privacy ,
Department of Government Efficiency (DOGE) ,
Department of Health and Human Services (HHS) ,
Fraud ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Medicaid ,
Medicare ,
OIG ,
Risk Assessment ,
Third-Party
Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more
8/29/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
OIG ,
Telehealth
On June 28, 2024, the Supreme Court rejected the doctrine of Chevron deference in the closely watched case of Loper Bright Enterprises v. Raimondo. In a 6-3 decision, the Court held that Chevron’s rule that courts must defer...more
7/2/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Federal Health Care Programs (FHCP) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
HRSA ,
Loper Bright Enterprises v Raimondo ,
Magnuson-Stevens Act (MSA) ,
Medicaid ,
Medicare ,
National Marine Fisheries Service ,
SCOTUS
Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more
2/2/2024
/ Business Operations ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Exclusions ,
Healthcare Fraud ,
Medicaid ,
Medicare Advantage ,
New Guidance ,
OIG ,
Risk Assessment ,
Self-Disclosure Requirements ,
Telemedicine
In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long...more
11/8/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Audits ,
Civil Monetary Penalty ,
Compliance ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Healthcare Fraud ,
OIG ,
Private Equity ,
Risk Assessment ,
Self-Disclosure Requirements
On July 13, 2023 the Office of Audit Services of the Department of Health & Human Services Office of Inspector General (OIG) released the long-awaited audit (A-02-21-01013) of the Health Resources and Services Administration...more
Session #1: State of the Healthcare Industry Effective Compliance Plans and Enforcement Trends -
In their discussion of compliance program effectiveness and enforcement, attorneys Kolarik and Waltz and Ms. Sumner...more
2/23/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Dispute Resolution ,
Enforcement ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
Mental Health ,
No Surprises Act (NSA) ,
Physician Fee Schedule ,
Public Health Emergency ,
Risk Assessment
As part of the $1.7 million omnibus spending bill that became law December 29, 2022, the Centers for Medicare & Medicaid Services (CMS) extended, through December 31, 2024, the Acute Hospital Care at Home (H@H) initiative...more
One Health Resources and Services Administration program, “COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured,” has been a huge source of...more
4/8/2022
/ American Rescue Plan Act of 2021 ,
CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Families First Coronavirus Response Act (FFCRA) ,
Health Care Providers ,
HRSA ,
OIG ,
Reimbursements ,
U.S. Treasury
On November 8, 2021, the Department of Health & Human Services (HHS) Office of Inspector General (OIG) released a revised and renamed Provider Self-Disclosure Protocol: the OIG “Health Care Fraud Self-Disclosure” protocol...more
Laboratory testing is a key factor in identifying or diagnosing COVID-19 patients, including during the asymptomatic phase, and determining appropriate treatment. With respect to COVID-19, laboratory testing is also critical...more
Federal enforcers typically announce (formally as well as informally) work plans or focus areas for the upcoming year that can provide some guidance as to where providers might anticipate enforcement action and, where they...more
On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released its long-awaited Proposed Rule (Proposed Rule) updating and clarifying the physician...more
10/17/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Medicare ,
Physicians ,
Proposed Regulation ,
Self-Referral ,
Stark Law ,
Value-Based Care
On January 31, 2019, the United States Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) announced a proposed rule, which would eliminate certain drug rebates and encourage direct discounts for...more
2/5/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Regulatory Agenda ,
Safe Harbors
How Oncology Can Benefit from Digital Technology -
Welcome to Foley’s new health care MarketTrends newsletter. Each edition, we will focus on a different aspect of health care and highlight key trends in the industry. In...more
On July 18, 2018, the federal Department of Health and Human Services (HHS) sent a proposed rule to the Office of Management and Budget (OMB) for review and clearance. While the substance of the proposed rule is not yet...more
8/8/2018
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
OMB ,
Out-of-Pocket Expenses ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Request For Information ,
Safe Harbors
The Centers for Medicare and Medicaid Services (CMS) has demonstrated that it will not hesitate to use one of its most crippling administrative enforcement tools—the revocation of Medicare billing privileges—against one of...more
1/25/2017
/ Centers for Medicare & Medicaid Services (CMS) ,
Competitive Bidding ,
Department of Health and Human Services (HHS) ,
Departmental Appeals Board (DAB) ,
Federal Contractors ,
Healthcare Fraud ,
Irreparable Harm ,
Medicare ,
Medicare Billing Privileges ,
Motion to Dismiss ,
Preliminary Injunctions ,
Revocation ,
TRO
As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more
10/12/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
CLFS ,
Clinical Laboratories ,
Comment Period ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Health Insurance ,
Hospitals ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Part B ,
Misrepresentation ,
OIG ,
Omissions ,
PAMA ,
Physicians ,
Proposed Regulation ,
Reporting Requirements
President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. "Precision Medicine"...more
9/21/2015
/ Barack Obama ,
Biotechnology ,
Cancer ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Health Insurance ,
Healthcare ,
Hospitals ,
Innovation ,
Medicare ,
National Institute of Health (NIH) ,
Personalized Medicine ,
Physicians
The Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) has released its Fiscal Year (FY) 2014 Annual Report (Report) on the performance of the Medicaid Fraud Control Units (MFCUs)...more
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) on May 12, 2014 published a proposed rule (Proposed Rule) that would implement the OIG’s expanded authority under the Affordable Care...more
The Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) has released its Fiscal Year (FY) 2013 Annual Report (Report) on the performance of the Medicaid Fraud Control Units (MFCU)...more
On January 9, 2014, the Health Resources and Services Administration (HRSA) posted an update on its current and anticipated 340B drug pricing program (340B) program integrity efforts.1 The update includes a discussion of...more