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
In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...more
By letter dated April 13, 2021 (Letter), the Democrat and Republican leadership of the House Committee on Energy and Commerce and its Subcommittee on Health, wrote United States Health and Human Services Secretary, Xavier...more
[co-author: Daniel Weinstein] In response to widespread cash flow issues resulting from the COVID-19 public health emergency, Congress enacted two key pieces of legislation: the CARES Act and the Paycheck Protection...more
The Justice Department and the FBI have quickly acted to focus on fraudsters and hoarders seeking to profit from the public panic in response to the pandemic. DOJ issued a memo to U.S. Attorneys prioritizing investigations...more
In this week’s episode, Mary Beth Johnston, Carolyn Merritt and Leah Richardson discuss the ways in which the Centers for Medicare and Medicaid Services’ (CMS) response to the ongoing COVID-19 outbreak is easing certain...more
On March 30, 2020, the Secretary of the United States Department of Health and Human Services (“HHS”) exercised his authority to waive certain Medicare requirements during an emergency and issued blanket waivers of sanctions...more