On March 27, the US Department of Health and Human Services (HHS) announced a significant restructuring initiative in accordance with President Trump’s Executive Order, “Implementing the President’s Department of Government...more
3/28/2025
/ Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Employees ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare Reform ,
National Institute of Health (NIH) ,
Regulatory Reform ,
Trump Administration
With 2025 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year....more
In the final days of the Biden Administration, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) to modify the Security Rule under the Health...more
2/10/2025
/ Artificial Intelligence ,
Audits ,
Compliance ,
Cybersecurity ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Emerging Technologies ,
Encryption ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
Notice of Proposed Rulemaking (NOPR) ,
OCR ,
Proposed Rules ,
Risk Management ,
Technology
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute.
Chevron reflected the view...more
7/15/2024
/ Chevron Deference ,
Chevron v NRDC ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Hospitals ,
Judicial Review ,
Loper Bright Enterprises v Raimondo ,
Medicaid ,
Medicare ,
National Marine Fisheries Service ,
Regulatory Agenda ,
Reimbursements ,
Relentless Inc v US Department of Commerce ,
Rulemaking Process ,
SCOTUS
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
6/27/2024
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
HRSA ,
Interstate Commerce ,
Manufacturers ,
Medicaid ,
Pharmaceutical Industry ,
PHRMA ,
Section 340B
Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more
5/15/2024
/ Affordable Care Act ,
Conflicts of Interest ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Federal Rules of Civil Procedure ,
Federal Rules of Evidence ,
Final Rules ,
HRSA ,
Manufacturers ,
Office of Pharmacy Affairs (OPA) ,
Prescription Drugs ,
Section 340B
No personal services are more important than health care. The use of artificial intelligence (AI), involving machines to perform tasks normally requiring human intelligence, is leading to an expansion of the term “personal.”...more
7/11/2023
/ Algorithms ,
American Medical Association ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Fraud Abuse and Waste ,
Healthcare ,
Machine Learning ,
Popular
Telehealth experienced massive growth during the COVID-19 pandemic, due in no small part to various regulatory and reimbursement policies that federal agencies implemented following a declaration by the US Department of...more
6/6/2023
/ CARES Act ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OCR ,
Public Health Emergency ,
Regulatory Agenda ,
Reimbursements ,
SAMHSA ,
Telehealth
With the new year underway, the ArentFox Schiff Health Care team highlights 10 of the most pressing legal issues facing the industry in 2023.
End of the COVID-19 Public Health Emergency. After being in effect for more than...more
2/17/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Healthcare ,
HIPAA Privacy Rule ,
Inflation Reduction Act (IRA) ,
No Surprises Act (NSA) ,
Popular ,
Proposed Rules ,
Public Health Emergency ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Telehealth
On January 23, 2023 the Federal Communications Commission’s (FCC) Consumer and Governmental Affairs Bureau released a Declaratory Ruling addressing a request for clarification submitted by US Department of Health and Human...more
1/31/2023
/ Auto-Dialed Calls ,
Department of Health and Human Services (HHS) ,
Derivatives ,
Facebook Inc v Duguid ,
FCC ,
Federal Contractors ,
FTEU ,
Healthcare ,
SCOTUS ,
Sovereign Immunity ,
TCPA
On July 20, 2022, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert cautioning physicians and other health care practitioners to use “heightened scrutiny” when entering into telemedicine arrangements that...more
8/1/2022
/ Anti-Kickback Statute ,
Bribery ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Durable Medical Equipment ,
Enforcement ,
False Claims Act (FCA) ,
Fraud ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicare Fraud ,
OIG ,
Telehealth ,
Telemedicine
Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions. OIG Advisory Opinion...more
Comments sought regarding the permissibility of messages relating to Medicaid and other health coverage programs.
The FCC is seeking comment on a request for clarification submitted by the Department of Health and Human...more
The US Department of Health and Human Services Office of Inspector General (OIG) recently published a favorable determination, Advisory Opinion 22-06, on behalf of a biopharmaceutical company (the Requestor) regarding the...more
Take note, all providers who received Provider Review Fund (PRF) payments – there are changes in the reporting deadlines and requirements. On June 11, the Department of Health and Human Services announced that it was...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers.
...more
3/3/2021
/ 21st Century Cures Act ,
Anti-Kickback Statute ,
Bonuses ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Commercially Reasonable Efforts ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Fair Market Value ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Profit Sharing ,
Safe Harbors ,
Stark Law ,
Value-Based Care
Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more
2/17/2021
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Digital Health ,
DMEPOS ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Manufacturers ,
Medical Devices ,
OIG ,
Safe Harbors ,
Stark Law ,
Technology ,
Value-Based Care
The Federal government is warning that the threat of cybercrime, and especially ransomware, to US hospitals and healthcare providers has increased.
The Federal government is warning of an “increased and ongoing cybercrime...more
10/29/2020
/ Cyber Crimes ,
Cybersecurity ,
Data Breach ,
Data Collection ,
Department of Health and Human Services (HHS) ,
FBI ,
Health Care Providers ,
Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) ,
Hospitals ,
Personal Information ,
Ransomware
HHS has finalized the CARES Act provider reporting and recoupment rules and they are different from those put forth in the proposed form. Providers should take careful note — the new requirements are significant and...more
On September 17, 2019, the US District Court for the District of Columbia ruled in American Hospital Association, et al. v. Alex Azar, II, et al that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory...more
10/2/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Hospitals ,
Medicaid ,
Medicare ,
Off-Campus Departments ,
Outpatient Prospective Payment System (OPPS) ,
Secretary of HHS ,
Statutory Authority ,
Vacated