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 Seeks Comments on Qualified Health Plan Certification Requirements and Exchange Enrollment Forms
- Qualified Health Plan (QHP) Certification. In order to offer health insurance through an exchange, a health plan must meet certain standards—including standards related to network adequacy, essential health benefits, and actuarial value--in order to be certified as a QHP. Exchanges are responsible for collecting data to verify that plans meet the requirements of a QHP—a threshold requirement to being offered through an exchange. CMS seeks comments on its initial guidance regarding this data collection requirement.
- SHOP Application Form for Employees. As required by Section 1311 of PPACA, CMS has developed a single, streamlined form that can be used by employees of small employers to enroll in QHPs offered in the small group market, as well as employees seeking coverage through a Small Business Health Option Program (SHOP) exchange. CMS seeks comments with respect to this form.
- SHOP Application Form for Employers. Also, as required by Section 1311, CMS has created a single, streamlined form for small business employers who wish to provide coverage to their employees through a SHOP exchange. Employers will be required to provide the information in CMS’s form upon initial application to the SHOP exchange and at subsequent information collections. The proposed form would be required of all employers who wish to apply for coverage a SHOP exchange. CMS seeks comments with respect to this form.
- Enrollment Form for Exchange and Insurance Affordability Programs. As required by Section 1413 of PPACA, CMS has developed a single, streamlined form that states may use to have individuals apply for coverage through the Exchange and “Insurance Affordability Programs,” defined to include Medicaid, CHIP, the Basic Health Program, and federal premium and cost-sharing assistance. States may opt to use their own form, as long as that form meets standards outlined by HHS. CMS seeks comments with respect to this form.
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