The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a...more
STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION -
FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more
2/11/2022
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
Nursing Homes ,
Pharmaceutical Industry ,
Pharmacies ,
Qui Tam ,
Telehealth
The Office of Inspector General for the U.S. Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Requestor) to provide financial...more
2/3/2020
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
CMP Law ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
REMS ,
Travel Expenses
The Department of Justice (DOJ) recently announced that it has agreed to a $21.36 million settlement with compounding pharmacy Diabetic Care Rx LLC d/b/a Patient Care America (PCA), private equity firm Riordan, Lewis & Haden...more
9/23/2019
/ Amended Complaints ,
Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Drug Compounding ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Fraud and Abuse ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Portfolio Companies ,
Private Equity Firms ,
TRICARE
Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) to loan a...more
2/7/2019
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Civil Monetary Penalty ,
Digital Health ,
Health Care Providers ,
Low-Income Issues ,
Manufacturers ,
Medical Devices ,
New Guidance ,
OIG ,
Patient Assistance Programs ,
Patient Safety ,
Pharmaceutical Industry ,
Smartphones
The Protecting Access to Medicare Act of 2014 (HR 4302), signed by President Obama yesterday, contains a number of provisions that are important to clinical laboratories, and they include...more
GlaxoSmithKline (“GSK” or the “Company”) announced yesterday that it will stop paying health care professionals to promote its drug products and will no longer tie the compensation of its worldwide sales force to individual...more
Originally published in the Health Care Fraud Report, 17 HFRA 219, on 03/06/2013.
The final rule (the ‘‘Final Rule’’) implementing the Physician Payments Sunshine Act (‘‘Sunshine Act’’), published in the Federal...more
The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more
2/5/2013
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Continuing Medical Education ,
Data Collection ,
Enforcement ,
GPOs ,
Medicaid ,
Medical Devices ,
Medical Supplies ,
Payment Records ,
Pharmaceutical Industry ,
Physicians ,
Reporting Requirements ,
Sunshine Act
The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more