Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
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
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
This Week in Washington: Senate Finance Committee Chairman sends letters concerning healthcare cybersecurity measures; House Energy and Commerce Committee Oversight and Investigations Subcommittee holds hearing on 340B...more
This Week in Washington: Senate Finance Committee releases draft proposal outline concerning GME program; Senate HELP Committee marks up seven healthcare bills; NIH issues first-of-its-kind policy proposal to promote equal...more
On April 18, 2024, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a new Final Rule for its oft-criticized 340B Administrative Dispute Resolution (ADR)...more
Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more
This Week in Washington: House Ways and Means Committee marks up telehealth legislation; CMS extends state Medicaid unwinding flexibilities; Senate HELP Committee ranking member releases white paper outlining possible NIH...more
In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more
On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more
On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative dispute resolution (ADR) process...more
On April 4, 2024, a final rule published on February 2, 2024 (the Final Rule) went into effect that concerns medication for the treatment of opioid use disorder. The Final Rule, published by the Substance Abuse and Mental...more
This Week in Washington: Congress passes six appropriations bills including skinny health package; House Ways and Means Committee reports bill to block CMS nursing home minimum staffing levels requirement; HHS requests...more
This Week in Washington: Debt Limit fight continues; Disagreements arise during Senate HELP Committee mark-up of PBM and Generic Drug Competition Bills...more
This Week in Washington: 118th Congress begins, House finally chooses Speaker...more
This Week in Washington: All Efforts Are on Funding the Government Through the Rest of the Fiscal Year...more
This Week in Washington: Supreme Court Rules in Favor of 340B Hospitals, FDA Approves COVID-19 Vaccines for Children Under Five...more
This Week in Washington: House Passes FDA User Fee Reauthorization Package...more
This Week in Washington: Senate Fails to Advance Bill Protecting Abortion Rights After Supreme Court Draft Opinion Leak...more
This Week in Washington: White House Releases National Drug Control Strategy...more
This Week in Washington: COVID-19 Public Health Emergency Extended for 90 More Days...more
This Week in Washington: Congress Passes Appropriations to Fund Government Through Fiscal Year 2023...more
Upcoming Hearings/Markups - February 8 - Senate Health, Education, Labor and Pensions Committee Hearing: “Lessons Learned from COVID-19: Highlighting Innovations, Maximizing Inclusive Practices and Overcoming Barriers to...more
This Week in Washington: Senate HELP Committee Chair Patty Murray and Ranking Member Richard Burr Release Discussion Draft of Bipartisan Pandemic and Public Health Response Bill....more
This Week in Washington: President Biden and Speaker Pelosi Open to Moving Pieces of the Build Back Better Act....more