News & Analysis as of

Patients Medicare Pharmaceutical Industry

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

King & Spalding

OIG Issues a Favorable Advisory Opinion to a Pharmaceutical Manufacturer Regarding Free Transportation, Lodging and Support for...

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On December 31, 2024, OIG posted Advisory Opinion No. 24-13, a favorable advisory opinion allowing a pharmaceutical manufacturer (the Requestor) to offer free transportation, lodging, and other support to eligible patients...more

McDermott Will & Schulte

This Week in 340B: November 2023

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Quarles & Brady LLP

HRSA Notice Provides Clarity on 340B Child Site Registration Requirements

Quarles & Brady LLP on

After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B...more

McDermott Will & Schulte

This Week in 340B: September 2023 #3

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Schulte

This Week in 340B: July 2023 #4

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

McDermott Will & Schulte

This Week in 340B: February 2023

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

Sheppard Mullin Richter & Hampton LLP

Day 1 Notes from the 41st Annual J.P. Morgan Healthcare Conference

I was struck on the first day of the 41st Annual J.P. Morgan Healthcare Conference by Sanjay Doddamani (CEO of UpStream Healthcare) saying that “Health is a state of independence.” A simple statement, but a very profound and...more

Sheppard Mullin Richter & Hampton LLP

Day 1 Notes at the 2020 J.P. Morgan Healthcare Conference

If I printed a tee shirt for the 2020 J.P. Morgan Healthcare Conference, what would it say? In past years, it would have been “Big Data,” Analytics, Artificial Intelligence, ACA, Risk, Medicare Advantage or Quality. This...more

Holland & Knight LLP

Healthcare Law Update: May 2018

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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

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

Sheppard Mullin Richter & Hampton LLP

Temporal Proximity Is Not Enough: Third Circuit Nixes FCA/Anti-Kickback Suit For Failure To Link Alleged Scheme to Claims

On January 19, 2018, the United States Court of Appeals for the Third Circuit affirmed a district court’s ruling granting summary judgment to a specialty pharmacy that was accused of violating the Anti-Kickback Statute and...more

Holland & Knight LLP

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

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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

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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

McDermott Will & Schulte

21st Century Cures: A Closer Look

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

Mintz - Health Care Viewpoints

The Proposed 340B Guidance:  Who is the Biggest Loser?

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more

Robinson & Cole LLP

Health Law Pulse - October 2015

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The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

King & Spalding

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

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On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...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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