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
HHS: Qualified Health Plans are Not “Federal Health Care Programs”
The Department of Health and Human Services does not consider QHPs, other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act to be federal health care programs. This includes the State-based and Federally-facilitated Marketplaces; the cost-sharing reductions and advance payments of the premium tax credit; Navigators for the Federally-facilitated Marketplaces and other federally funded consumer assistance programs; consumer-oriented and operated health insurance plans; and the risk adjustment, reinsurance, and risk corridor programs.
Among other things, this clarification seemingly clears the way for pharmaceutical manufacturers to make copay coupons available to patients who purchase insurance through the Marketplaces, as well as for other forms of patient assistance and support that would be problematic if QHPs were considered federal health care programs.
The letter also explains that HHS is taking measures to “protect consumers and ensure robust oversight of these critical Affordable Care Act programs” through other provisions in the law and regulations issued by the department. HHS also will continue to work closely with the Office of the Inspector General, the Department of Justice, the Federal Trade Commission, and state departments of insurance to exercise these authorities effectively and coordinate oversight of ACA programs.
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