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 Finalizes Rule Seeking Information Regarding Essential Health Benefits
Data to Help Define the EHB: Starting in 2014, the EHB must be covered by all non-grandfathered health plans in the individual and small group market, Medicaid benchmark and benchmark-equivalent plans, and Basic Health Plans, where applicable. In December 2011, CMS released a bulletin detailing the agency’s intention to allow states to define EHB using a benchmark plan selected by each state. CMS also released a set of Frequently Asked Questions regarding the approach outlined in the EHB bulletin in February 2012. While much about the EHB still remains unclear, this final rule provides some additional information regarding the process for defining the EHB package.
Specifically, the final rule creates a data collection requirement to “support the definition of essential health benefits.” As such, the final rule would require the issuers of the three largest health insurance products in each state to submit the following data to the agency by September 4, 2012:
- Administrative data necessary to identify the relevant health plan;
- All health benefits in the plan;
- Treatment limitations;
- Drug coverage; and
Accreditation of QHPs: Also starting in 2014, health plan must be certified as QHPs in order to be offered through a health insurance exchange. The final rule outlines a two-phase approach for accrediting entities as QHPs. Recognizing the time constraints imposed by upcoming deadlines regarding the establishment of health insurance exchanges, the agency will use the National Committee for Quality Assurance and URAC to accredit QHPs during the first phase. For phase two, the agency plans to develop its own accreditation process through future rulemaking.
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