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Recent Developments to the 340B Drug Pricing Program

In this episode Victoria Hamscho, Andrew Ruskin, and Leah Richardson provide an update on key developments to the 340B Program. They discuss the effects of the Supreme Court’s decision earlier this year overturning 340B...more

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

340B Update: Supreme Court Accepts Certiorari in 340B Payment Reduction Case

On 2 July 2021, the Supreme Court announced that it has accepted the American Hospital Association’s (AHA) petition for certiorari in American Hospital Association v. Becerra. At issue is the Centers for Medicare and Medicaid...more

340B Update: Federal Court Halts 340B Administrative Dispute Resolution Rule

Safety net providers participating in the 340B Drug Pricing Program (340B Program) continue to grapple with drug manufacturers imposing restrictions on 340B contract pharmacy arrangements. In response to these actions, the...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

HRSA Publishes Long-Awaited (and Long-Overdue) 340B Program Alternative Dispute Resolution Process Final Rule

On Thursday, 10 December 2020, the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) issued a pre-publication copy of the long-awaited 340B Drug Pricing Program Alternative...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

340B Update: Ryan White Clinics Sue in Response to Contract Pharmacy Actions as Congress Requests Information on Ways to Improve...

Covered entities participating in the 340B Drug Pricing Program (340B Program) continue to grapple with drug manufacturers’ actions to limit contract pharmacy access to 340B pricing....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: Rutledge v. Pharmaceutical Care Management Association

In this episode of Triage, Leah D’Aurora Richardson and Victoria Hamscho discuss next month’s Supreme Court oral arguments in Rutledge v. Pharmaceutical Care Management Association, including its potential impact on nearly...more

340B Update: Appeals Court Upholds 340B Payment Reduction Under the OPPS as CMS Proposes Further Reductions for CY 2021

On 31 July 2020, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) upheld the U.S. Department of Health and Human Services’ (HHS) decision to allow the Centers for Medicare and Medicaid Services...more

President Trump Signs Drug Pricing Executive Orders Reinforcing the Administration's Priorities

On July 24, 2020, President Trump issued four executive orders aimed at lowering drug prices. The executive orders direct the Secretary of the Department of Health and Human Services (HHS) to: Increase access to insulin and...more

340B Update: HRSA Indicates it Lacks Authority to Enforce 340B Program Guidance

The Health Resources and Services Administration (HRSA) recently indicated that it lacks authority to enforce 340B Drug Pricing Program (340B Program) guidance in response to Eli Lilly and Co.’s notice to 340B covered...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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