News & Analysis as of

Rulemaking Process Secretary of HHS

Venable LLP

Exploring the Future of GRAS: HHS’s Recent Directive and Its Potential Impact on the Food Industry

Venable LLP on

On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS Secretary Robert F. Kennedy has directed the Food and Drug Administration (FDA or Agency) “to take steps to explore potential...more

ArentFox Schiff

Drug Importation Lawsuit Stays Alive, For Now

ArentFox Schiff on

In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the...more

McDermott Will & Emery

White House Directs HHS to Model “Most-Favored-Nation” Price Caps for Part B and D Drugs

McDermott Will & Emery on

On September 13, 2020, the White House issued an Executive Order titled “Lowering Drug Prices by Putting America First” (the Executive Order), which directed the Secretary of the US Department of Health and Human Services...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2020

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

Mintz - Health Care Viewpoints

Trump Administration Releases Series of Executive Orders on Drug Pricing

The Trump Administration issued a series of Executive Orders (“EOs” or “Orders”) Friday afternoon related to drug pricing. Several of the EOs seek to restart stalled or withdrawn policy initiatives previously announced by the...more

Mintz - Health Care Viewpoints

Administration Finally Releases Proposed Drug Importation Policies for Stakeholder and Public Comments

At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more

Hogan Lovells

HHS tackles barriers to value-based care: Part 1 – new protections for value-based arrangements under Stark and the AKS and other...

Hogan Lovells on

Nearly a decade after the Affordable Care Act signaled a transition of the U.S. health care system to value-based care, the Department of Health and Human Services (HHS) published on October 9 two long-awaited proposed rules...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Mintz - Health Care Viewpoints

Recent Executive Order Makes the Road to Increased Healthcare Transparency Unclear

Last week, President Trump signed an “Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First.” The order, which “seeks to enhance the ability of patients to choose the...more

McDermott Will & Emery

Executive Order on Hospital Price Transparency May Prompt Disclosure of Negotiated Prices

McDermott Will & Emery on

President Trump has issued an Executive Order instructing several federal agencies to begin rulemaking processes intended to increase the transparency of hospital pricing. Among other measures, the Executive Order directs the...more

Proskauer - Employee Benefits & Executive...

Executive Order Seeks to Improve Consumer-Driven Healthcare

On June 24, 2019, the President issued his Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First. The Executive Order directs regulators to take action to improve healthcare...more

King & Spalding

CMS Publishes Clarification of FY 2004 Outlier Fixed-Loss Threshold As Required by Two Recent Federal Court Rulings

King & Spalding on

On January 22, 2016, CMS published an explanation of its FY 2004 outlier fixed-loss threshold rulemaking. The explanation was required by two 2015 federal court orders in cases brought by hospitals challenging the outlier...more

Baker Donelson

Challenges to Medicare's Outlier Payment Rules - the Secretary Largely Prevails

Baker Donelson on

As we reported in an earlier Payment Matters article, the United States Court of Appeals for the District of Columbia Circuit handed hospitals a partial victory on May 19, 2015, in their challenge to Medicare outlier payments...more

Baker Donelson

Uncertainty Continues for Two-Midnight Rule's Payment Reduction

Baker Donelson on

In Shands Jacksonville v. Burwell [PDF], No. CV 14-1477, 2015 WL 5579653, (D.D.C. Sept. 21, 2015), the United States District Court for the District of Columbia gave the Secretary of the Department of Health and Human...more

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