News & Analysis as of

Department of Health and Human Services (HHS) Patients Prescription Drugs

McDermott Will & Schulte

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

McDermott Will & Schulte

HRSA Filings in Genesis Shed Light on Definition of “Patient” for 340B Covered Entities

A recent case before the US Court of Appeals for the Fourth Circuit addressed the issue of which persons qualify as “patients” of a 340B program participating entity (covered entity). Court-ordered filings in ongoing...more

Robinson+Cole Health Law Diagnosis

Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to...

On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...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

Akin Gump Strauss Hauer & Feld LLP

Congress Makes Key Changes to Medicare Physician Payment Programs as Part of Short-Term Government Funding Bill

• Congress amended current law to prevent CMS from applying the “MIPS” payment adjustment to separately billed items like drugs and biologics, which will drastically reduce the total amount of payment adjustments to clinical...more

Holland & Knight LLP

OIG Issues Letter Declining to Impose Administrative Sanctions for Provision of Certain Free Drugs

Holland & Knight LLP on

On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...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

Baker Donelson

Drastic Changes in "Patient" Definition as HHS Releases the Long-Awaited Proposed 340B Omnibus Guidance

Baker Donelson on

After years of fits and starts, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) has finally released its proposed omnibus guidance for the 340B Drug Discount...more

Cooley LLP

Blog: HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 2015

Cooley LLP on

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the...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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