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 Releases Consumer Assistance Programs Final Rule
Pursuant to the Affordable Care Act, all Exchanges must establish a Navigator program. Navigators must facilitate enrollment through the Exchange in Qualified Health Plans and insurance affordability programs, such as Medicaid and CHIP, refer individuals to consumer assistance programs when appropriate, conduct public outreach activities, and provide impartial and culturally appropriate information about health insurance coverage to applicants. Exchanges can also establish non-Navigator assistance programs to help supplement the Navigator program. Certain types of entities, such as insurance companies, are barred from serving as Navigators or non-Navigator assistance personnel. In the proposed rule, HHS authorized a third kind of consumer assistance program- Certified Application Counselors. Certified Application Counselors will provide a more limited scope of enrollment assistance in entities such as community health centers, health care facilities, and social service organizations. Certified Application Counselors are generally subject to less strict conflict of interest and eligibility standards and are not required to provide as broad a range of services as Navigators and non-Navigator assistance personnel.
While the final rule adopted the regulations related to these assistance programs largely as proposed, HHS did alter some aspects of the proposed rule in response to comments it received from the public:
- Instead of requiring the Exchange to certify each Certified Application Counselor, as required in the proposed rule, the final rule provides that each Exchange can designate organizations to certify the counselors;
- The final rule clarified that Certified Application Counselors must complete and achieve a passing score on the certification examination;
- The final rule clarified that all Exchanges must have a Certified Application Counselor program;
- The final rule contains a provision stating that Certified Application Counselors are certified to provide information about the full range of QHPs and must act in the best interest of applicants;
- The final rule clarified that Certified Application Counselors cannot impose any charges for their services.
CMS also released a guidance document on Certified Application Counselors in FFEs and State Partnership Exchanges.
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