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
On December 30, 2024, the Massachusetts state legislature passed House Bill 4653 (the Act), which significantly enhances regulatory oversight in the Massachusetts health care market. As signed into law by Governor Maura Healy...more
1/10/2025
/ Compliance ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Infrastructure ,
Investors ,
New Legislation ,
Private Equity ,
Real Estate Transactions ,
REIT ,
State and Local Government ,
State Attorneys General
On October 28, the US Court of Appeals for the Fifth Circuit held that a nonprofit corporation that coordinates health care for privately insured patients does not qualify for tax exemption under Section 501(c)(4) because it...more
11/7/2024
/ 501(c)(3) ,
501(c)(4) ,
Affordable Care Act ,
Appeals ,
Chevron Deference ,
Health Care Providers ,
Insurance Industry ,
IRS ,
Medicare Advantage ,
Nonprofits ,
Tax Court ,
U.S. Treasury
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
The Federal Trade Commission’s (FTC) Final Rule banning noncompete covenants for workers is likely to present particular challenges for employers in the health care industry. Because of the structural and organizational...more
7/9/2024
/ Appeals ,
Employer Liability Issues ,
Employment Contract ,
Employment Litigation ,
Federal Bans ,
Federal Trade Commission (FTC) ,
Final Rules ,
Healthcare ,
Litigation Strategies ,
Non-Compete Agreements ,
Preliminary Injunctions ,
Texas
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
Recent events have caused hospitals and health systems nationwide to contemplate more robust participation in the long term care (LTC) sector, whether through modified ownership, joint venturing, clinical affiliation, or...more
On May 7, the Federal Trade Commission (FTC) published a Final Rule banning noncompete covenants for workers, including employees, independent contractors, and volunteers. The Rule will have practical implications on worker...more
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
Change Healthcare, an affiliate of Optum and UnitedHealth Group, processes more than 15 billion health care transactions annually and touches one of every three patient records. On February 21, Change disconnected its...more
3/15/2024
/ American Medical Association ,
Centers for Medicare & Medicaid Services (CMS) ,
Cyber Attacks ,
Cybersecurity ,
Health Care Providers ,
Healthcare ,
Insurance Industry ,
Medicare Part B ,
Payment Systems ,
Policies and Procedures ,
Popular ,
Prescription Drug Coverage ,
Prescription Drugs ,
Ransomware
As we enter the final quarter of 2023, the ArentFox Schiff Hospitality Industry group has identified several opportunities and challenges that could impact the hospitality industry, including issues related to artificial...more
On September 12, 2023, the Senate Judiciary Subcommittee on Privacy, Technology, and the Law convened a hearing to discuss potential legislation focused on AI models, the third in a series of hearings by the subcommittee...more
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
8/29/2023
/ Advertising ,
Artificial Intelligence ,
Automotive Industry ,
Biometric Information ,
Clean Energy ,
Clinical Trials ,
Confidentiality Policies ,
Cybersecurity ,
Data Protection ,
Data Security ,
Diagnostic Imaging Services ,
Disclosure Requirements ,
Distribution Rules ,
Driverless Cars ,
Energy Sector ,
Enforcement ,
Environmental Social & Governance (ESG) ,
Equal Employment Opportunity Commission (EEOC) ,
Ethics ,
Family Offices ,
Fantasy Sports ,
Fashion Industry ,
Fraud and Abuse ,
Greenwashing ,
Healthcare ,
Hospitality Industry ,
Intellectual Property Protection ,
Labor Regulations ,
Life Sciences ,
Logistics ,
Long-Term Care ,
Machine Learning ,
Medical Devices ,
Medical Research ,
Nonprofits ,
Open Source Software ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Privacy Laws ,
Privately Held Corporations ,
Regulatory Agenda ,
Renewable Energy ,
Retailers ,
Software ,
Sports ,
Sports Betting ,
Technology Sector ,
Vehicle Navigation Systems
In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online...more
8/15/2023
/ Advisory Opinions ,
Algorithms ,
Anti-Kickback Statute ,
Federal Health Care Programs (FHCP) ,
Fees ,
Fraud and Abuse ,
Health Care Providers ,
Health Technology ,
Kickbacks ,
Medicaid ,
Medicare ,
OIG
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
The metaverse is widely regarded as the next frontier in digital commerce, with businesses across all industries spending millions of dollars to acquire a digital presence for positioning as market leaders. While it offers...more
6/14/2022
/ Artificial Intelligence ,
Blockchain ,
Cryptocurrency ,
CVS ,
Data Privacy ,
Digital Assets ,
Digital Marketplace ,
Fraud ,
Healthcare ,
Internet of Things ,
Licenses ,
Metaverse ,
Non-Fungible Tokens (NFTs) ,
Telehealth ,
Trademarks ,
Virtual Reality
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