On June 27, 2014, the D.C. Circuit vacated the U.S. District Court for the District of Columbia’s hotly-debated opinion in United States ex rel. Barko v. Halliburton Co., making it clear that internal investigation...more
As of August 1, 2013, pharmaceutical companies and medical device manufacturers are required to report to the federal government payments made to physicians under the Physician Payment Sunshine Act (PPSA). ...more
8/23/2013
Criminal justice practitioners understand that ‘‘joint and several liability’’ stands for the common proposition that each co-conspirator should be equally responsible for all provable losses the conspiracy caused. Put...more
Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013.
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for...more
3/22/2013
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Disclosure Requirements ,
Healthcare ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Reporting Requirements ,
Sunshine Act
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more
2/13/2013
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Common Ownership ,
Covered Recipients ,
GPOs ,
Medicaid ,
Medical Devices ,
Medical Supplies ,
Medicare ,
Payment Records ,
Penalties ,
Pharmaceutical Industry ,
Reporting Requirements ,
Sunshine Act
On November 29, 2012, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a report raising concerns about the Centers for Medicare and Medicaid Services’ (CMS) oversight of the...more
On December 3, 2012, in United States v. Caronia, a three-judge panel of the Second Circuit reversed a drug salesperson’s conviction for conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor...more