The Health Resources and Services Administration (HRSA) has adopted its proposal to delay the effective date of its final rule revising the calculation of the 340B “ceiling price” that may be charged to covered entities and related civil money penalties.  As previously reported, while implementation of the January 5, 2017 rule was already delayed until...… Continue Reading
Tom Price is out as Secretary of the U.S. Department of Health and Human Services (“HHS”).  Mr. Price announced his resignation on September 29th as he faced more questions and increasing scrutiny over his use of taxpayer-funded private planes.  While Mr. Price’s departure from HHS will impact some aspects of the Trump Administration’s health care... Continue Reading…

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 9, 2017.  This week’s preview discusses many topics, including the Trump administration’s roll back of the ACA’s mandate that employers cover birth control coverage. It also discusses Congess’ work on health extenders, CHIP, and the community health centers program, among other things. The...

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Background The U.S. District Court for the Central District of California recently dismissed a complaint-in-intervention filed by the U.S. Department of Justice (DOJ) in U.S. ex rel. Swoben v. Secure Horizons.  As previously reported, in this significant test case, DOJ filed its complaint on May 1, 2017, as to the UnitedHealth Group parties (collectively, UnitedHealth),... Continue Reading…
Telemedicine rules in the District of Columbia underwent a second round of revisions as the District of Columbia Department of Health issued a new set of proposed rules . The newly-revised proposed telemedicine rules, issued in July, replace the Department’s first draft of telemedicine regulations issued in early 2016, and incorporate comments submitted by a number...… Continue reading this entry
The Patented Medicine Prices Review Board (PMPRB) has issued an excessive-pricing order against Alexion Pharmaceuticals Inc. (Alexion) in respect of SOLIRIS (eculizumab) based on the application of a Lowest International Price Comparison (LIPC) test. In public reasons issued September 27, 2017, the PMPRB ordered Alexion to (i) repay excess revenues to the Crown from the...… Continue reading
Nine Days and Counting – The Fate of CHIP Remains Uncertain Amid Congressional Deadlock While congressional Republicans spent much of September pushing for passage of the Graham-Cassidy “repeal and replace” bill, other time-sensitive legislative tasks were left to languish, including a September 30 deadline to reauthorize funding for the Children’s Health Insurance Program (“CHIP”) that has since come and gone. The failure to timely reauthorize the program has put … Continue Reading
The Trump Administration has formally withdrawn a number of pending Department of Health and Human Services (HHS) proposals that never reached the final rule stage. This includes:  a controversial Part Medicare B drug payment innovation model; a proposal to protect same sex marriages in certain Medicare and Medicaid facilities (predating a related Supreme Court decision);...… Continue Reading