News & Analysis as of

Patients Drug Pricing Department of Health and Human Services (HHS)

McDermott Will & Emery

New EO Targets Prescription Drug Costs – and Drug Manufacturers, Hospitals, and Health Centers

On April 15, 2025, President Trump signed an executive order (EO) aimed at addressing the cost of prescription drugs. This EO, titled “Lowering Drug Prices by Once Again Putting Americans First,” outlines specific directives...more

Butler Snow LLP

CMS and OIG Release Stark and AKS Final Rules to Support Reforms for Coordinated, Value-Based Care

Butler Snow LLP on

On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of the Inspector General (“OIG”) released their highly-anticipated final rules to modernize and...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration Drug Pricing Blueprint: Overview and Analysis

• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted. • Many of the more dramatic proposals would require federal rulemaking or...more

K&L Gates LLP

K&L Gates Triage: Pharmacy Gag Clauses & Clawbacks

K&L Gates LLP on

Pharmacy Benefit Managers (PBMs) are increasingly utilizing gag clauses in pharmacy contracts as a means of prohibiting pharmacies from telling customers that paying for drugs out of pocket would cost them less than if they...more

Holland & Knight LLP

Administration Releases Blueprint to Lower Drug Prices, Reduce Out-of-Pocket Costs

Holland & Knight LLP on

• "American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs" outlines actions that the Administration proposes to lower prescription drug prices. • The plan includes...more

Holland & Knight LLP

Recent Congressional Actions Bring Drug Pricing Debate Back Into National Spotlight

Holland & Knight LLP on

In late October, Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) introduced the Medicare Drug Price Negotiation Act of 2017 (S. 2011; H.R. 4138), which would allow the Department of Health and Human Services (HHS)...more

Baker Donelson

340B Drug Pricing Program: The Withdrawal of Mega Guidance and the Future of Patient Definition

Baker Donelson on

In the wake of a recent directive issued by the Trump administration to halt pending regulations and guidance while the new leadership conducts its own review, the Department of Health and Human Services, on January 30, 2017,...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

Foley & Lardner LLP on

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

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