As previously discussed, health care reform established a new Patient-Centered Outcomes Research Institute (“PCORI”) to study patient-centered outcomes, funded by a Patient-Centered Outcomes Research (“PCOR”) fee. This fee must be reported on Form 720 annually for seven years, beginning with the plan …
DOJ and GSK Enter Into Record-Setting $3 Billion Settlement, Expansive CIA
July 2, 2012 Leave a Comment
The Department of Justice today announced the largest-ever health care fraud settlement and largest-ever payment by a drug company. Global pharmaceutical giant GlaxoSmithKline LLC (GSK) agreed to pay $3 billion to resolve criminal and civil liability in connection with its drug sale and promotion practices, …
Calculating the Patient-Centered Outcomes Research Fee
May 24, 2012 Leave a Comment
Last month, Treasury released proposed regulations regarding fees for Patient-Centered Outcomes Research (PCOR) and the Patient-Centered Outcomes Research Institute (PCORI). As you may recall, the Affordable Care Act established a new Institute to study patient-centered outcomes, funded by a PCOR fee. This fee …
OIG Issues Report on Pharma Compliance Roundtable
March 28, 2012 Leave a Comment
On March 26, the Office of Inspector General (OIG) issued a paper entitled: Report From February 23, 2012, Pharmaceutical Compliance Conference (Report). The Report summarized discussions at a roundtable discussion convened by OIG for the 23 pharmaceutical industry manufacturers currently operating under a …
CMS Releases Proposed Rule on PPACA’s 60-Day Report and Repay Requirement
February 15, 2012 Leave a Comment
Yesterday CMS released a proposed rule implementing Section 6402 of PPACA (the Proposed Rule), which requires Medicare and Medicaid overpayments to be reported and repaid with 60 days. Section 6402 provides that the knowing concealment or avoidance of a repayment obligation gives rise to potential civil False …
Where Is The CIA? – Recent Pharmaceutical and Hospital False Claims Act Settlements Raise The Question Of Whether A Presumption Against Corporate Integrity Agreements Exists For Certain Categories of Conduct
February 14, 2012 Leave a Comment
New Drug Pricing Settlement In the most recent of a long line of False Claims Act (FCA) whistleblower settlements involving allegations of shenanigans with government price reporting metrics, late last week Dava Pharmaceuticals, Inc. agreed to pay the United States $11 million to settle claims that it misreported …