The Trump administration has been vocal in its criticism of the Affordable Care Act (ACA), and already has worked with the Republican-controlled Congress to begin rolling back key provisions of the legislation.
Tag Archives: Affordable Care Act
340B Program: HRSA Releases Final Rule on Orphan Drug Exclusion
HRSA released its final rule on the orphan drug exclusion this morning. The final rule is set to be published in the Federal Register tomorrow, July 23, 2013. The effective date of the final rule is October 1, 2013 and HRSA expressly states that the final rule applies prospectively only. The Affordable Care Act (ACA) added
Sample Reporting Under Section 6004 of the Affordable Care Act
We’ve received a number of questions lately about the status of the sample reporting requirements under Section 6004 of the Affordable Care Act (ACA) of 2010. Section 6004 requires that manufacturers and authorized distributors submit certain information about drug sample distribution to FDA: (1) the identity and quantity of drug samples requested; (2) the identity
Review of issues for 2013
The following is a summary of some of the key issues Congress and the Administration will be debating in 2013. Please contact us with any questions. We are happy to provide further analysis as well as insight into other areas of interest. Agriculture: Tom Vilsack is expected to stay on as Secretary of Agriculture. The
Breaking decisions from the Supreme Court: Term in review
On Tuesday afternoon, three of Hogan Lovells’ Appellate practice partners will provide an analysis of some of the key decisions that will impact businesses as the Supreme Court concludes its current term. Neal Katyal, former Acting Solicitor General of the United States and Appellate practice Co-Director, Cate Stetson, Co-Director of our Appellate practice; and Chris