Recently, the National Institutes of Health (“NIH”) extended the effective date of its policy on the use of the single Institutional Review Board (“IRB” or “sIRB” if a single IRB) to January 25, 2018. NIH created the sIRB policy to establish the expectation that a sIRB be used in the ethical review of multi-site, domestic, … Continue Reading
Health policy in the US is a problem in search of a solution and, despite a current pause in actions, reform efforts will continue this year. The Squire Patton Boggs policy team has put together an excellent article recapping recent events regarding the actions torepeal and replace the Affordable Care Act (ACA) and the decision … Continue Reading
On December 13, 2016, President Barack Obama signed H.R. 34, the 21st Century Cures Act (the Act), into law. This sweeping healthcare law addresses the discovery, development and delivery of new drugs and medical treatments; it also includes substantial mental health reforms and assorted Medicare- and Medicaid-related provisions. The law is a product of the … Continue Reading
Today, CMS submitted to the Federal Register (for publication on April 27th) its annual notice of proposed IPPS rates and policy changes for federal fiscal year (“FY”) 2017. Today’s notice contains a proposal to eliminate permanently the .2% payment reduction that CMS had implemented in FY 2014 to offset a projected net increase in IPPS … Continue Reading
Last legislative session, the Ohio General Assembly passed a measure in House Bill 52 requiring health care cost transparency for non-emergency services. The new measure requires that most medical service providers provide in writing, prior to a service being rendered, “a good-faith estimate” of (1) the amount the provider will charge the patient’s health … Continue Reading
On August 31, 2015, the Environmental Protection Agency (“EPA”) Administrator signed the proposed Management Standards for Hazardous Waste Pharmaceuticals rule outlining management and disposal standards for hazardous waste pharmaceuticals that are generated specifically by healthcare facilities. Additionally, this rule “clarif[ies] the regulation of the reverse distribution mechanism used by healthcare facilities for the management of … Continue Reading
The results of this year’s mid-term election, while historic, also raise considerable uncertainty regarding future legislative action. What legislative initiatives can we expect to see from the Republican controlled Congress? Will President Obama and Congress work together or will Republican control of both houses result in continued gridlock? What will happen to the ACA? To help answer … Continue Reading
