On 15 November 2016, the European Commission (“the Commission”) opened its second report on Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12...08 December 2016
CMS Issues New Notice on Its National Coverage Determination Process
Perhaps the most novel aspect of the notice is a new "expedited administrative process" to remove certain NCDs, which would leave coverage determinations on the topic to the discretion of Medicare contractors. This process would impact NCDs that have not been reviewed for at least 10 years, and CMS would assess the continued need to have a national coverage policy on the topic. Under the process, CMS will publish a list of the NCDs it proposes to remove and accept public comments on the proposals before making a final decision.
This issuance by CMS is a notice that will be effective as of the date it is published in the Federal Register, which is expected to be August 7, 2013. CMS has not solicited comments on the provisions contained in the notice.
On 26 September 2016, a new EU-US collaboration between the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) was announced. This new collaboration is ...06 October 2016
As reported here, earlier this month the U.S. Drug Enforcement Administration (DEA) issued a decision declining to transfer marijuana out of Schedule I. As marijuana remains a Schedule I...07 September 2016