News & Analysis as of

Proposed Rules HRSA

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

Baker Donelson on

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

Jackson Lewis P.C.

Health Plan Coverage Mandate for Over-the-Counter Contraception Proposed by Biden Administration

Jackson Lewis P.C. on

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

McGuireWoods Consulting

Washington Healthcare Update - June 2024

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

McGuireWoods Consulting

Washington Healthcare Update - May 2024 #4

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

McGuireWoods Consulting

Washington Healthcare Update - May 2024 #2

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

McDermott Will & Emery

HHS Issues 340B Administrative Dispute Resolution Final Rule

McDermott Will & Emery on

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

McGuireWoods Consulting

Washington Healthcare Update March 2024 #2

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 LLP

Holland & Knight Health Dose: October 31, 2023

Holland & Knight LLP on

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

Jones Day

Congress Authorizes Competitive Multivendor Contracts in U.S. Organ Transplant System

Jones Day on

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

McGuireWoods Consulting

Washington Healthcare Update - May 2023

This Week in Washington: Debt Limit fight continues; Disagreements arise during Senate HELP Committee mark-up of PBM and Generic Drug Competition Bills...more

Snell & Wilmer

Proposed Rules Expand Access to Contraceptive Care as a Preventive Service

Snell & Wilmer on

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

McGuireWoods Consulting

Washington Healthcare Update - January 2023

This Week in Washington: 118th Congress begins, House finally chooses Speaker...more

McGuireWoods Consulting

Washington Healthcare Update - December 2022 #2

McGuireWoods Consulting on

This Week in Washington: All Efforts Are on Funding the Government Through the Rest of the Fiscal Year...more

King & Spalding

HRSA Proposes Changes to ADR Procedures for 340B Disputes

King & Spalding on

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

Foley Hoag LLP

HRSA Proposes to Overhaul 340B Dispute Process

Foley Hoag LLP on

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

McGuireWoods Consulting

Washington Healthcare Update - June 2022 #2

This Week in Washington: Supreme Court Rules in Favor of 340B Hospitals, FDA Approves COVID-19 Vaccines for Children Under Five...more

McGuireWoods Consulting

Washington Healthcare Update - June 2022

This Week in Washington: House Passes FDA User Fee Reauthorization Package...more

McGuireWoods Consulting

Washington Healthcare Update - May 2022 #2

This Week in Washington: Senate Fails to Advance Bill Protecting Abortion Rights After Supreme Court Draft Opinion Leak...more

McGuireWoods Consulting

Washington Healthcare Update - April 2022 #3

This Week in Washington: White House Releases National Drug Control Strategy...more

McGuireWoods Consulting

Washington Healthcare Update - April 2022 #2

This Week in Washington: COVID-19 Public Health Emergency Extended for 90 More Days...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #3

Alston & Bird on

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

McGuireWoods Consulting

Washington Healthcare Update - March 2022 #2

This Week in Washington: Congress Passes Appropriations to Fund Government Through Fiscal Year 2023...more

McGuireWoods Consulting

Washington Healthcare Update - February 2022

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

McGuireWoods Consulting

Washington Healthcare Update - January 2022 #4

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

McGuireWoods Consulting

Washington Healthcare Update - January 2022 #3

This Week in Washington: President Biden and Speaker Pelosi Open to Moving Pieces of the Build Back Better Act....more

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