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
OPM Releases Final Rule on the Affordable Care Act’s Multi-State Plan Program
The Affordable Care Act directs OPM to contract with private health insurance issuers to offer at least two multi-state health plans (MSPs) in the Exchange for each state. In the final rule, OPM clarifies that MSPs must comply with federal requirements regarding availability of plans in both the individual and SHOP exchanges, but with OPM discretion to phase in this participation to ensure that network capacity is sufficient. On the same basis, MSPs must comply with state SHOP requirements, including states that have combined the individual and small group market.
The final rule makes clear that MSPs are governed by State and Federal laws and regulations that apply to qualified health plans (QHPs), and that MSPs must comply with state laws relating to their benchmark, including a requirement that QHPs may not alter or modify the benchmark benefits. However, OPM will not require MSPs to comply with a state’s active purchaser exchange requirements or competitive bidding, as authority to select MSPs resides with OPM under federal law.
Open enrollment in MSPs begins October 1, 2013 in at least 31 marketplaces for the coverage year beginning in 2014. By 2017, MSPs will be available to consumers in all states and in D.C.
OPM also released a fact sheet summarizing the rule.
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