Key Points -
Courts have routinely observed that Medicare and Medicaid texts are among the most completely impenetrable texts within human experience.
In recent developing case law, more than a half dozen appellate...more
Key Points:
- False Claims Act plaintiff cannot use discovery to satisfy Fed. R. Civ. P. 9(b).
- Payment of fair market value is a dispositive defense in FCA actions alleging a violation of the Anti-Kickback...more
1/28/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Discovery ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
FRCP 9(b) ,
Health Care Providers ,
Medicaid ,
Medicare ,
Qui Tam ,
Relators ,
Rulemaking Process ,
Stark Law ,
Whistleblowers
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
1/8/2020
/ Acquisitions ,
Artificial Intelligence ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
CFIUS ,
Department of Health and Human Services (HHS) ,
Digital Health ,
EU ,
Export Controls ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Innovation ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Mergers ,
Office of Foreign Assets Control (OFAC) ,
Patent-Eligible Subject Matter ,
Pharmaceutical Industry ,
Popular ,
Section 101 ,
USPTO
• How have appellate courts applied the Supreme Court’s ruling in Escobar?
• If the government is aware of the relator’s allegation, but does not undertake any administrative action to address the defendant’s alleged...more
10/11/2017
/ ANSI ,
Centers for Medicare & Medicaid Services (CMS) ,
DCAA ,
Department of Justice (DOJ) ,
Department of the Interior ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Genentech ,
Government Agencies ,
Materiality ,
Medical Devices ,
Qui Tam ,
Relators ,
Side Effects ,
Universal Health Services Inc v United States ex rel Escobar ,
Warning Labels
Key Points:
- Learn the latest case law developments regarding what evidence the government or the relator must establish to prove that the defendant “recklessly” interpreted a statute or regulation in violation of the...more
9/29/2016
/ Ambiguous ,
Centers for Medicare & Medicaid Services (CMS) ,
Evidence ,
False Claims Act (FCA) ,
Health Care Providers ,
Lack of Interpretive Guidance ,
Overpayment ,
Reasonable Interpretations ,
Relators ,
Reverse False Claims ,
Scienter