Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
With the reconciliation package signed into law, the U.S. House of Representatives is in recess and will return on July 14, 2025. In the interim, the U.S. Senate will focus on the appropriations bills for fiscal year (FY)...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Last week, the US Department of Health and Human Services (HHS) announced that it will undergo a major restructuring and plans to eliminate 10,000 employees on top of 10,000 HHS employees who have already departed (20,000...more
On March 5, 2025, the Center for Clinical Standards and Quality (CCSQ) within the Centers for Medicare & Medicaid Services (CMS) released a Quality & Safety Special Alert Memo for hospitals related to President Trump’s...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Congress Votes on CR, Health-Related Legislation. After reaching a deal over the weekend, both chambers passed a CR to avoid a government shutdown and fund the federal government through December 20, 2024. This tees up a push...more
House Education & the Workforce Health, Employment, Labor, and Pensions Subcommittee Holds Hearing on ERISA’s 50th Anniversary. Members and witnesses assessed how the Employee Retirement Income Security Act of 1974 (ERISA)...more
On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more
A Quiet Healthcare Week on Capitol Hill. Congress was largely in recess this week, although the Senate returned briefly to complete consideration of a long-awaited foreign aid bill. Both chambers will return to session the...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more
The U.S. is experiencing a maternal health crisis: it has one of the highest maternal mortality rates among high-income nations; increasing rates of complications from pregnancy or childbirth; and persistent disparities in...more
Just over one year ago, I wrote about the Department of Health and Human Service’s (“HHS”) $105 million award to support 1,333 federally qualified health centers (“Health Centers”) across the United States improve the quality...more
The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more
The Trump Administration released on May 23, 2017, its full Fiscal Year (FY) 2018 budget request, titled "A New Foundation for American Greatness." President Donald Trump's request builds off of the administration's March 16...more
Eric Zimmerman, along with McDermott+Consulting Vice Presidents Adaeze Enekwechi and Piper Su, wrote this +Insights publication detailing the possible effects of the Trump Administration's 2018 budget on health programs and...more
This is the 54th in a series of WorkCite articles concerning the Patient Protection and Affordable Care Act and its companion statute, the Health Care and Education Reconciliation Act of 2010 (referred to collectively as the...more
In This Issue: - Top News ..The Congressional Agenda is Light as the Focus Shifts to the Midyear Elections ..Physician Supervision Requirement for Small and Rural Hospitals ..CMS Offers Hospitals...more
In This Issue: - Judge Rules Against 340B Drug Authority - FDA Approves Skin Infection Drug - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more