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
Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more
Previously, we discussed how the US Supreme Court’s opinion in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce could create opportunities for private litigants to challenge health...more
On March 20, 2020, President Trump announced the first exercise of the Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of Covid-19, which authorizes the Secretary of Health...more
The COVID-19 emergency presents an unprecedented need to communicate quickly and effectively from a distance. Telehealth and telecommunications applications more broadly are poised to address the potentially crushing demand...more
On May 15, 2019, United States District Judge Amy Totenberg ordered HHS to “immediately cease and desist” from further implementing its April 2019 liver allocation policy pending appellate review in Callahan, et al. v. Azar,...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
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
This week, President Trump will go before Congress for his first State of the Union address. Will it be olive branches or brickbats? The next deadline for a government-funding bill is February 8th, a week from Thursday. Will...more
In contemplating the ways in which physicians may be affected by the possible repeal of the Affordable Care Act (ACA)—and certain features of any legislation that may replace it—a good place to start is with the person...more
A Federal Judge found that the Department of Health and Human Services (DHHS) failed to comply with the Administrative Procedure Act (APA) when it cut hospital inpatient payments by 0.2% as part of its “two-midnight” rule. ...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: Leading Up to the SCOTUS King v. Burwell Decision... House Votes to Repeal the Medical Device Tax... CMS Announces It Will Bolster Transitional Reinsurance Payments... MedPAC Releases June Report to Congress....more
In Armstrong v. Exceptional Child Center, Inc., Case No. 14-15, issued March 31, 2015, the United States Supreme Court ruled that a group of private health care providers could not sue officials in Idaho’s Department of...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