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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

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

Federal Courts Block Implementation of Most Favored Nation Drug Pricing Rule

On 23 December 2020, Judge Catherine Blake of the U.S. District Court for the District of Maryland granted the Pharmaceutical Research and Manufacturers of America (PhRMA) a 14-day nationwide temporary restraining order,...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

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

Trump Administration Issues Flurry of Last Minute Healthcare Regulations: What Will the Incoming Administration Do Next?

On 20 November 2020, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General finalized several rules from President Trump’s health care agenda...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

COVID-19 Policy Update: House Passes Coronavirus Response

On March 14, the House of Representatives passed the Families First Coronavirus Response Act (H.R. 6201), as amended, in a 363-40 vote; the House subsequently passed an amended version of the measure on March 16 containing...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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