On August 28, 2015, the Health Resources and Services Administration (HRSA) and the Department of Health and Human Services (HHS) issued the long-awaited omnibus guidance regarding administration of the 340B Drug Pricing Program (340B Program). The most significant effect of
State and Federal Tasmanian Members of Parliament have stepped up the pressure on the Federal Government to allow production of industrial hemp for human consumption.
In Australia, the National Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) includes
A home health provider may offer free “introductory visits” to new patients without fear of implicating the Anti-Kickback Statute or Civil Monetary Penalties law, so long as those patients have already chosen it as their home health provider, OIG said
Germany is currently undergoing substantial legislative changes in the healthcare sector. While the current Government had announced these reforms already in its coalition agreement 2013, it is only now beginning to act on them. Although not part of an overall
The OIG released an advisory opinion stating that it would not impose administrative sanctions against two drug manufacturers or their affiliated pharmacy for offering a free 30-day supply of an antineoplastic drug to patients who experience a delay in the
Kim Kardashian’s recent Instagram post yielded 466,000 “likes” and one FDA Warning Letter. In her social media post, also posted on Facebook, Kardashian discussed the drug DICLEGIS and the positive effect she claims it has had on her morning
Please consider submitting your organization’s compliance practices for recognition at this year’s Healthcare Best Compliance Practices Forum. The Health Ethics Trust’s Best Practices process assigns evaluation of submitted practices to independent panels of compliance professionals.
Quality metrics are utilized throughout the pharmaceutical industry to monitor quality control systems and processes and to drive continuous improvement efforts in drug development and manufacturing. The U.S. Food and Drug Administration, through a recently-published draft guidance and its
On August 7, New York Federal Judge Paul A. Engelmayer granted Amarin Pharma Inc. (Amarin) a preliminary injunction “to ensure its ability to engage in truthful and non-misleading speech free from the threat of a misbranding action” by the Food
In the first decision interpreting the 60-day overpayment rule of the False Claims Act (”FCA”), Judge Edgardo Ramos of the Southern District of New York held that an overpayment has been “identified” for purposes of starting the 60-day overpayment refund