As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
1/26/2024
/ Acquisitions ,
Amgen v Sanofi ,
Antitrust Division ,
Artificial Intelligence ,
Biden Administration ,
Biosimilars ,
Chevron Deference ,
Clawbacks ,
Clinical Trials ,
Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Data Preservation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
EU ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigations ,
Life Sciences ,
Mergers ,
Mobile Devices ,
OPDP ,
Pharmaceutical Industry ,
Pilot Programs ,
Privacy Laws ,
Proposed Rules ,
Risk Management ,
Section 340B ,
Self-Disclosure Requirements ,
Voluntary Disclosure
In a highly anticipated opinion in the AseraCare case, issued on September 9, 2019, the Eleventh Circuit Court of Appeals affirmed the district court’s holding that “a clinical judgment of terminal illness warranting hospice...more
9/12/2019
/ Defense Strategies ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospice ,
Medical Necessity ,
Motion for Summary Judgment ,
Physicians ,
Qui Tam ,
Relators ,
Remand ,
Sua Sponte
On July 31, 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed a lower court’s decision to grant summary judgment to hospital operator HCA and dismiss relator Thomas Bingham’s allegations. Bingham v. HCA (S.D....more
8/19/2019
/ Anti-Kickback Statute ,
Discovery ,
False Claims Act (FCA) ,
Federal Pleading Requirements ,
Health Care Providers ,
Healthcare Fraud ,
Motion To Strike ,
Physician Compensation Arrangements ,
Relators ,
Rule 9(b) ,
Stark Law
Federal prosecutors announced yesterday the Government’s settlement with electronic health records (“EHR”) vendor Greenway Health, LLC (“Greenway”) of False Claims Act (“FCA”) allegations for a payment of $57.25 million and...more
In a key case being watched by the industry, Judge Collyer of the United States District Court for the District of Columbia issued an opinion today granting UnitedHealthcare’s Motion for Summary Judgment in UnitedHealthcare...more
In 2010, the Affordable Care Act (“ACA”) enacted new rules governing overpayments made by the Medicare and Medicaid programs. Under these rules, providers have 60 days from the date that the overpayment has been identified to...more
7/14/2016
/ 60-Day Rule ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Health Care Providers ,
Medicaid ,
Medicare ,
Medicare Part A ,
Medicare Part B ,
Overpayment ,
Overpayment Recovery Time Limits ,
Universal Health Services Inc v United States ex rel Escobar
On June 16, 2016, the Supreme Court issued its opinion (“Op.”) in Universal Health Services v. U.S. ex rel. Escobar (“Escobar”), a case testing the viability and scope of the implied certification theory of False Claims Act...more
6/20/2016
/ Conditions of Payment ,
Failure To Disclose ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Pleading Requirements ,
Fraud ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Mental Health ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar ,
Unlicensed Medical Providers