Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
President Trump’s Executive Order (EO) 14187, “Protecting Children from Chemical and Surgical Mutilation,” represents a significant shift in federal policy regarding gender-affirming care (GAC) for minors....more
4/17/2025
/ Constitutional Challenges ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Funding ,
Gender Identity ,
Hospitals ,
Medicaid ,
Medicare ,
Minors ,
Popular ,
Preliminary Injunctions ,
Trump Administration
Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more
2/27/2025
/ Compliance ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Pharmaceutical Industry ,
Pharmacies ,
Popular ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Requirements ,
Telehealth
As of December 23, health care providers, health plans, and health care clearinghouses (covered entities) and their business associates (collectively, regulated entities) must comply with new reproductive health care privacy...more
12/20/2024
/ Administrative Procedure Act ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Loper Bright Enterprises v Raimondo ,
OCR ,
PHI ,
Popular ,
Reproductive Healthcare Issues ,
SCOTUS ,
Statutory Interpretation ,
Texas ,
Trump Administration
On June 20, a federal district court in Texas ruled that the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) exceeded its authority under the Health Insurance Portability and Accountability Act...more
8/22/2024
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Violations ,
OCR ,
Personally Identifiable Information ,
PHI ,
Popular ,
Serious Health Conditions ,
Tracking Systems
Who will notify the potentially millions of individuals whose information might have been jeopardized by the massive cyberattack on Change Healthcare? Since the affiliate of UnitedHealth Group (UHG) first reported the...more
6/19/2024
/ Breach Notification Rule ,
Compliance ,
Cyber Attacks ,
Department of Health and Human Services (HHS) ,
Guidance Update ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Breach ,
HIPAA Privacy Rule ,
HIPAA Security Rule ,
Investigations ,
OCR ,
PHI ,
Popular
On April 26, the US Department of Health and Human Services Office for Civil Rights (OCR) published a Final Rule that adds protections under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule...more
5/29/2024
/ Attestation Requirements ,
Compliance ,
Covered Entities ,
Data Collection ,
Disclosure Requirements ,
Dobbs v. Jackson Women’s Health Organization ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Privacy Rule ,
Investigations ,
Notice Requirements ,
OCR ,
PHI ,
Popular ,
Privacy Laws ,
Reproductive Healthcare Issues ,
SCOTUS
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
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