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Health Care Triage: Genesis Healthcare and the 340B Program Patient Definition

In this episode, Andrew Ruskin, Leah Richardson, and Victoria Hamscho analyze the U.S. Court of Appeals for the Fourth Circuit’s recent decision in Genesis Healthcare v. Becerra. They discuss its potential impact on the...more

HHS Opens Provider Relief Fund Reporting Portal With New Guidance on Reporting Requirements

On 1 July 2021, the Department of Health and Human Services (HHS) opened the Provider Relief Fund Reporting Portal for funding recipients to start submitting information in accordance with the Post-Payment Notice of Reporting...more

COVID-19: Biden Administration Issues First Major Update to Provider Relief Fund Requirements: Reporting Portal Opens 1 July 2021

On Friday, 11 June, the Department of Health and Human Services (HHS) released long-awaited updates to its reporting requirements for recipients of Provider Relief Fund (PRF) payments. HHS’s updated Post-Payment Notice of...more

Hospitals Ask Supreme Court to Reverse Site-Neutral, 340B Payment Rulings

How far can an agency go to allow agency-developed policy objectives to supersede concerns about faithful adherence to the law? Similarly, how much should health systems and others regulated by Medicare be concerned about...more

CMS Issues Most Favored Nation Model Interim Final Rule: What to Expect Next

On November 20, the Centers for Medicare & Medicaid Services (CMS) issued the Most Favored Nation (MFN) Model interim final rule (MFN Rule), implementing President Trump’s proposal to align drug prices in the United States...more

340B Update: HRSA Moves Forward with 340B ADR Rule as Covered Entities Challenge Contract Pharmacy Actions

In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug...more

K&L Gates Triage: Eye on Election 2020: California v. Texas and the Future of the Affordable Care Act

In this episode, Rebecca Schaefer and Victoria Hamscho provide an update on next month’s Supreme Court oral arguments in California v. Texas, a case in which the Court will be reviewing the constitutionality of key parts of...more

340B Update: Congress and the Administration Respond to Drug Manufacturers' 340B Contract Pharmacy Actions

In recent weeks, several drug manufacturers have taken actions that impact covered entities participating in the 340B Drug Pricing Program (340B Program) and their contract pharmacies....more

K&L Gates Triage: Recent Developments in the 340B Drug Pricing Program

In this episode, Richard Church, Andrew Ruskin, and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent actions by drug manufacturers to limit contract pharmacy access to 340B...more

K&L Gates Triage: 340B Update - Hospitals Request Eligibility Flexibilities Amid COVID-19 Pandemic

In this episode, Richard Church and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent COVID-19 guidance by the Health Resources and Services Administration and hospital requests...more

340B Update: CMS Issues Updated Acquisition Cost Data Survey

On February 7, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a notice relating to the agency’s intention to survey hospitals about their acquisition costs for specified covered outpatient drugs (“SCODs”)...more

K&L Gates Triage: 340B Update: CMS Issues Guidance for Avoiding Duplicate Discounts in Medicaid

In this episode, Macy Flinchum and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent guidance by the Centers for Medicare and Medicaid Services on best practices for states to...more

K&L Gates Triage: Looking Ahead to 2020: Developing Issues in Pharmacy Law and the 340B Drug Pricing Program

In this episode, Ryan Severson and Victoria Hamscho discuss recent developments in pharmaceutical pricing and the 340B Drug Pricing Program heading into 2020, including reimbursement cuts for 340B drugs under the Outpatient...more

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