News & Analysis as of

Administrative Procedure Act Proposed Rules Department of Health and Human Services (HHS)

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

Hogan Lovells on

The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

Maynard Nexsen

HHS Abandons Public Comment Practices Under the Richardson Waiver

Maynard Nexsen on

On March 3, 2025, the Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., officially announced the rescission of the Richardson Waiver, a policy in place since 1971 that required public...more

Stotler Hayes Group, LLC

Status of Nursing Home Staffing Standards Announced by Biden Administration and Orders Announced by Trump Administration

Attorneys General from 20 states asked a federal judge to grant a temporary injunction halting implementation of changes to new rules affecting minimum nursing home staffing requirements announced by the Centers for Medicare...more

Proskauer - Health Care Law Brief

Shortly After its Online Tracking Technologies Bulletin is Declared Unlawful, HHS-OCR Stands Down, Withdraws Appeal

On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more

King & Spalding

CMS Proposes 200% Fee Hike to No Surprises Act IDR Fees

King & Spalding on

On September 20, 2023, the Departments of Health and Human Services, Labor, and the Treasury (the Departments) announced the Federal Independent Dispute Resolution (IDR) Process Administrative Fee and Certified IDR Entity Fee...more

Sheppard Mullin Richter & Hampton LLP

Executive Order on Promoting Competition in the American Economy: The Biden Administration Considers Drug Pricing Strategies While...

On August 10, 2021, the Centers for Medicare and Medicaid (“CMS”) published a proposed rule (“Proposed Rule”) to rescind the Most Favored Nation Model (“MFN Model”) interim final rule that was published on November 26, 2020...more

Polsinelli

CY 2020 OPPS Proposed Rule – HHS Seeks Comments on 340B Payment Reductions and Remedies

Polsinelli on

This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...more

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more

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