K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more
Earlier today, Governor Cooper and Dr. Cohen, Secretary of Health and Human Services, held a press conference to provide an update on the State’s COVID-19 response. First, Governor Cooper issued a series of new Executive...more
In Washington: The House passed a one-week funding extension (HR 8900) to give lawmakers more time to finalize a fiscal 2021 spending package and coronavirus relief. The vote was 343-67. The measure (HR 8900) now goes to...more
In Washington: The Center for Disease Control and Prevention (CDC) is finalizing new guidelines to shorten its recommended coronavirus quarantine period from 14 days to between 7 and 10 days. The agency hopes more people...more
In Washington: President Donald Trump and first lady Melania Trump have tested positive for the coronavirus, the White House physician announced late Thursday. The President tweeted at 12:54 a.m. Friday: “Tonight, @FLOTUS...more
In Washington - President Trump announced a plan Monday to deploy 150 million rapid tests to states and vulnerable communities. This comes one month after the administration initially announced the purchase. During a Rose...more
As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more
Governor Roy Cooper announced July 14, 2020 safety measures to allow in-person academic instruction to resume this fall. The Governor announced that, of the three options the state was considering, Plan B would be the...more
In Washington - The divide between Democrats and Republicans continues as talks today have still resulted in no deal on a new coronavirus stimulus package. House Speaker Nancy Pelosi (D-CA), Senate Minority Leader Chuck...more
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health Care policy news and legislation. *Please note that we...more
Congress returned from its spring recess with a host of issues to address—trade, Trump administration nominations and opioid legislation sitting atop the priority list. Given the ongoing data scandal at Facebook, privacy...more
Opioid Funding Overview - In 2016, through the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act, Congress authorized roughly $1.4 billion in spending to combat the opioid crisis....more
With the FY2017 reconciliation instructions behind us, we look ahead to what is left in store for health care between now and the end of the calendar year. While Secretary Price’s departure was expected, what he leaves behind...more
On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more
The U.S. Congress, based on its members’ legally required financial disclosures, fares far better than most. Senators and representatives are worth a net $1 million on average. But is it seemly for so many of our crucial...more
Republicans jammed through their health policy guru in the middle of the night, and they and their new HHS Secretary are still trying to figure out what to do with the Affordable Care Act, aka Obamacare. Insurance markets are...more
President-elect Trump and congressional Republicans have promised to “repeal and replace” the Affordable Care Act (ACA), but there is deep division regarding which provisions will be rescinded and around the details of the...more
On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more
This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more
This Week: Congress Agrees on Budget Framework... FDA Launches Global Unique Device Identification Database (GUDID)... POTUS Nominates DeSalvo to Serve as Assistant Secretary for Health....more
Secretary Burwell continues to settle in to her new position as the Department of Health and Human Services (HHS), this week making a number of management changes at the department; CMS released the long awaited proposed rule...more
Congress held several hearings last week ranging from Sylvia Burwell’s nomination for Secretary of the Department of Health and Human Services (HHS), to Medicare payment oversight, to post-acute care in Medicare. The Centers...more