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
CMS Releases New List of Potential NCD Topics
The list of Potential NCD Topics is noteworthy for a number of reasons. Although the title of the document is “Potential NCD Topics,” CMS explains that it could review the topics through claims analysis, literature reviews, or NCDs. In fact, CMS explicitly states that an NCD is not appropriate for certain items on the list. It therefore may be more appropriate to consider the items on the list as areas of interest or concern to CMS. While stakeholders should be prepared to see the items addressed through a variety of mechanisms, including potentially audits or other investigations, it also is worth noting that CMS did not develop NCDs for or otherwise review many of the items on the list of Potential NCD Topics that it released in 2008 and which is replaced by this new document.
The new list of Potential NCD Topics includes such items and services as power wheelchairs, abdominal computed tomography (CT), colorectal cancer screening, genetic testing, and proton beam therapy, among others. CMS identified three items of the list as internally generated including intraaortic balloon pumps and percutaneous ventricular assist devices, lap-band surgery for obesity, and kyphoplasty. Both kyphoplasty and proton beam therapy also were on the 2008 list of Potential NCD Topics.
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