Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug...more
In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more
With just a couple of weeks before election day, the Biden Administration announced on October 21, 2024, that it was issuing proposed rules designed, in part, to require health plans to cover over-the-counter contraception...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
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
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
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
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ...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
On January 30, 2023, the Departments of Health and Human Services, Treasury, and Labor (collectively “the Departments”) issued proposed rules entitled “Coverage of Certain Preventive Services under the Affordable Care Act”...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
On November 29, 2022, the Health Resources and Services Administration (HRSA) issued a proposed rule (Proposed Rule) to revise the alternative dispute resolution (ADR) procedures for disputes arising under the 340B drug...more
On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...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
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
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