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 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.
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