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 Limits Reporting Requirements for Plans that Meet Medical Loss Ratio Standard
In December 2011, CMS published an interim final rule and a final rule with comment that established notice requirements applicable to health insurance issuers who owed rebates for failure to meet the applicable MLR standard, and addressed the treatment of mini-med and expatriate policies with regards to MLR requirements. At that time, CMS invited comments regarding (a) whether insurers who met or exceeded the MLR standard in a given year should be required to provide notice to policyholders and stakeholders, and (b) whether issuers should be required to include in their notices information about the issuer’s MLR from the previous year.
After reviewing submitted comments, CMS released amendments to the regulations that:
- Creates a “simple straightforward notice requirement” for health insurers that meet or exceed the MLR standards set in PPACA;
- Only requires the above notice be sent for the 2011 reporting year; and
- Does not require issuers to provide information on the prior year MLR in their notice.
The rule notes that information about a specific insurer’s past years MLR will be available on the HHS website.
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