Accountable Care Organizations Prove They are Here to Stay
One of the key missions of the Affordable Care Act is to slow the rising cost of health care. The Obama administration…
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November 2015
2016 Physician Fee Schedule: Includes Changes on Self-Referral Rules,…
Earlier this year, we wrote about the proposed Medicare Physician Fee Schedule. In the proposed rule, CMS sought comment…
HHS OIG Enforcement Actions on the Horizon Utilizing Open Payments, Advises…
Pharmaceutical and device companies can expect federal agencies to begin pursuing enforcement actions against companies…
2016 Data Collection and Submittal Changes under the Open Payments System
A representative of the Open Payments Team at CMS, hosted a Webinar on Thursday, October 29, 2015 about Open Payments…
Court Strikes Down HRSA’s 340B Orphan Drug Policy, Again
In October, a federal court struck down a Health Resources and Services Administration 340B orphan drug policy (the…
Both Houses of Congress Investigating Prescription Drug Prices
There have been numerous media reports referencing dramatic drug price increases after the acquisition or merger of…
Off-label Marketing is “Dead,” Diversion Cases on the Rise
"Off-label marketing is dead so-to-speak. There's been a death knell of that."
That news was delivered by Charlene…
HHS OIG Issues 2016 Work Plan
The Department of Health and Human Services Office of Inspector General recently released its 2016 Work Plan. OIG's…
Amarin Update – The Case of Many Cases
There are currently two cases working their way through the legal system relating to Amarin and their quest for exclusivity and…
Pacira Update: A Settlement in the Works?
As we have previously written, the FDA has recently removed the Pacira warning letter from their website, which set off a…