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Federal Circuit Interprets BPCIA Provision on Notice of Commercial…
In early July 2016, a three-judge panel of the Federal Circuit Court of Appeals issued a unanimous decision in Amgen v. Apotex…
What You Don’t Know About AMP Can Hurt You – Part 2 This is Not Your…
As part of a series on the Average Manufacturer Price (AMP), this month’s article explores the of AMP from the beginning of the…
HHS Issues Proposed Rule on Medicare Appeal Backlog
The United States Department of Health and Human Services (HHS) issued a proposed rule intended to address the significant backlog…
Transparency Across the Pond – A Look at Efforts in Germany and the UK
On June 30, 2016, transparency efforts around the world released numbers on financial interactions between industry and…
Caveat User, Caveat Emptor – Issues from the Soft Under Belly of The…
While the goals of Open Payments and transparency are arguably good public policy, the usefulness of Open Payments depends…
OIG Report on Postal Service Compound Drug Costs
The Department of Labor (DOL) Office of Workers’ Compensation Program (OWCP) administers the Federal Employees’ Compensation Act…
European Conference Vetting Systems “Leaks” Into America
We have known for awhile that the European Federation of Pharmaceutical Industries and Associations (EFPIA) tracks and assesses…
‘Tis the Season – 2015 Open Payments Highlights and Risk…
On June 30th, 2016 CMS published the third year of Open Payments data. With more than two full years of transaction level spend…
The More Industry Changes, Stark Law Stays the Same
The Stark Law has become increasingly convoluted over the years due to complicated regulations, restrictions on historically…
Bristol-Myers Squibb Settles with California Insurance Commissioner
In July 2016, California Insurance Commissioner Dave Jones reached a $30 million settlement with pharmaceutical company…