On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
OIG: PODs “inherently suspect” under anti-kickback statute; Hospitals and ASCs warned of AKS risks to them if they purchase from PODs
Of particular significance, the Special Fraud Alert effectively rebuts the claims of POD promoters that PODs are lawful if they are structured as investment interests where the physician’s return is proportional to the capital invested. OIG reiterates that the test for whether an investment interest violates the AKS is not whether it is a “plain vanilla” investment, but whether the intent underlying the arrangement is to induce or reward referrals, and that such intent may be inferred from the POD’s characteristics. OIG emphasizes this point by observing that because the test for an AKS violation is an intent to use remuneration to induce referrals, “an arrangement may not exhibit any of the suspect characteristics and yet still be . . . unlawful.” See our Health Alert, OIG determines that PODs are ‘inherently suspect’ under the anti-kickback law, for additional information.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017