The Supreme Court of the United States issued its highly anticipated ruling in a pair of cases challenging the long-standing Chevron doctrine on June 28, 2024. Foreshadowed by decisions in recent years slighting Chevron, it...more
8/29/2024
/ Administrative Procedure Act ,
Affordable Care Act ,
Birth Control ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Government Agencies ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Judicial Authority ,
Loper Bright Enterprises v Raimondo ,
Non-Compete Agreements ,
Public Health Service Act ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
Baker Donelson recently published Anticipating SCOTUS Ruling on Chevron Deference – What to Know and Five Ways to Prepare explaining the United States Supreme Court's upcoming ruling which is expected to impact the regulatory...more
6/26/2024
/ Administrative Agencies ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Chevron v NRDC ,
Department of Health and Human Services (HHS) ,
Disability Benefits ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Health Care Providers ,
Long-Term Care ,
Medicaid ,
Medicare ,
Regulatory Authority ,
Reimbursements ,
SCOTUS ,
Social Security Act ,
Statutory Authority ,
Statutory Interpretation
According to President Biden's recently published column, the Administration's proposed rule, published on September 6, 2023, mandating that nursing homes begin to staff facilities so that registered nurses (RNs) and nurse...more
On July 26, 2022, the United States Court of Appeals for the Eighth Circuit held that "resulting from" under the 2010 amendment to the Anti-Kickback Statute (AKS)1 requires the government to prove that "but-for" the illegal...more
On July 20, 2022, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), released a Special Fraud Alert (the Alert) regarding fraudulent arrangements between practitioners and telemedicine...more
The Department of Justice (DOJ) has made numerous recent public statements reflecting increased priorities for enforcement, especially in the health care industry. The DOJ has a variety of tools at its disposal to enforce...more
1/31/2022
/ Anti-Kickback Statute ,
Audits ,
Civil Investigation Demand ,
Cooperation ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Enforcement Priorities ,
False Claims Act (FCA) ,
Government Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Physicians ,
Voluntary Disclosure
The recent federal court opinion issued in United States ex rel. Integra Med Analytics, LLC v. Baylor Scott & White Health, et al, illustrates the continued importance of examining the plausibility of allegations made in qui...more
9/27/2019
/ Business Profits ,
Centers for Medicare & Medicaid Services (CMS) ,
Coding ,
Defense Strategies ,
Dismissal With Prejudice ,
False Billing ,
False Claims Act (FCA) ,
Federal Pleading Requirements ,
FRCP 8(a) ,
FRCP 9(b) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Motion to Dismiss ,
Physicians ,
Qui Tam ,
Relators
The U.S. Department of Justice (DOJ) kicked off the new year by issuing two internal memoranda that are directly relevant to actions brought under the False Claims Act. The January 2018 memoranda offer valuable insight into...more
The U.S. Department of Justice (DOJ) kicked off the new year with two new resolutions to help clarify some enforcement and litigations policies, both of which are directly relevant to claims brought under the False Claims...more
A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more
6/16/2017
/ Anti-Corruption ,
AstraZeneca ,
Bribery ,
Bureau of Industry and Security (BIS) ,
Civil Monetary Penalty ,
Compliance ,
Corporate Misconduct ,
Cuba ,
Department of Justice (DOJ) ,
Economic Sanctions ,
Enforcement Actions ,
Export Administration Regulations (EAR) ,
Export Controls ,
Foreign Corrupt Practices Act (FCPA) ,
GlaxoSmithKline ,
Health Care Providers ,
Imports ,
Iran ,
Medical Devices ,
Novartis ,
Office of Foreign Assets Control (OFAC) ,
Open General Export Licences (OGELs) ,
Pharmaceutical Industry ,
Public Officials ,
Research and Development ,
Securities and Exchange Commission (SEC) ,
Settlement ,
Sudan ,
Teva Pharmaceuticals
As a wave of devastating ransomware-based attacks spread across the globe last week, it became abundantly clear that the medical industry at large was ill-prepared for the threat despite years of warnings. The virus hit...more