The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more
11/28/2023
/ Comment Period ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Scientific Evidence ,
Scientific Research
The U.S. Supreme Court clarified the standard for a defendant's state of mind in False Claims Act ("FCA") cases, holding that a defendant acts "knowingly"—which the FCA defines also to include deliberate ignorance and...more
The Situation: The U.S. Department of Justice ("DOJ") published its annual report regarding False Claims Act ("FCA") recoveries for fiscal year 2020 (ending September 2020) and announced its priorities for 2021.
The...more
3/12/2021
/ Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
EHR ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Medicare Part C ,
Opioid ,
Prescription Drugs
The proposed rule evidences the HHS' and the Administration's continued interest in reducing federal spending for pharmaceutical products.
On February 6, 2019, the Department of Health and Human Services ("HHS") published...more
3/6/2019
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Safe Harbors
The Situation: In Spay v. CVS Caremark Corp., the Third Circuit became the latest court of appeals to hold that, in False Claims Act litigation, scienter can be lacking when the government has knowledge of "the facts...more
11/28/2017
/ Acquiescence ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
False Statements ,
Government Knowledge Defense ,
Material Misstatements ,
Materiality ,
Medicare Part D ,
Prescription Drugs ,
Scienter ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar