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
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.
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders...03 January 2017