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
CMS Hears Opposition to Preliminary Decisions on HCPCS Codes at Second of Three Public Meetings
The first of these meetings, held on May 8, 2013, addressed the preliminary decisions regard code requests for drugs, biologicals, and radiopharmaceuticals. In its preliminary decisions, the HCPCS Workgroup proposed granting the majority of coding requests.
The second meeting, held yesterday, addressed supplies and “other” products and services. Presenters supporting a dozen applications spoke at the meeting, opposing CMS’s preliminary decisions. In its preliminary decisions, CMS did not grant a single applicant’s code request. The limited interplay between speakers on behalf of applicants for a code and the HCPCS Workgroup suggests that many of the preliminary decisions issued may be finalized as proposed.
Similarly, CMS’s preliminary decisions regarding Durable Medical Equipment (DME) and Accessories, to be discussed at the third public meeting on June 4, 2013, granted very few of the applicants’ requests. Information about how to attend the final public meeting can be found on the CMS website.
Based on additional information and discussion at the public meetings, CMS may alter preliminary decisions. Final decisions will released be in late October or early November.
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
The Scottish government has announced plans to implement the 28 recommendations proposed in an independent review of access to new end-of-life, orphan and ultra-orphan medicines by patients ...23 December 2016