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
Medicare Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Final Rule
The final rule includes several modifications to the quality reporting programs for hospital outpatient departments and ASCs. These include procedural requirements relating to the use of measures, and, for ASCs, a methodology for applying a 2% payment reduction when the quality program’s reporting requirements are not met. No new measures will be implemented for either quality program.
CMS will reimburse hospitals for the acquisition and pharmacy overhead costs of separately payable drugs and biologicals at the statutory default of average sales price (ASP) plus 6 percent, the same rate that applies to drugs with pass-through status.
CMS also will use the geometric mean costs of services within an Ambulatory Payment Classification group to determine the relative payment weights of services, rather than the median costs that the agency has used since the inception of the OPPS.
The OPSS and ASC final rule under the Medicare program (CMS-1589-FC) is scheduled for publication in the Federal Register on November 15, 2012.
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