Topic
340B
257 published works
Health Law Diagnosis
Status of 340B Payment Remediation and Manufacturer Litigation
By Robinson+Cole's Health Law Group
Below is an excerpt of an article published in American Health Law Association’s Regulation, Accreditation, and Payment Practice Group on March 21, 2024. The 340B program, as established under Section…
To Be or Not to 340B Blog
340B Developments in 2024 – Litigation and Legislation
By Richard Davis, Brenda Maloney Shafer, Madison Hartman, Michael French
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts. Litigation Update…
Health Law Prof Blog
The 340B Drug Pricing Program: Litigation, Administration, and Reform
Ryan Knox (Harvard-MIT Center for Regulatory Science), Ameet Sarpatwari (Harvard Medical School), The 340B Drug Pricing Program: Litigation, Administration, and Reform, Okla. L. Rev. (forthcoming 2023):The 340B Drug Pricing Program…
Life Sciences Perspectives
Significant 340B Drug Pricing Program Litigation May Impact 340B Scope
By Heath Ingram|William Jackson|Matt Wetzel
Two recent federal court cases signal new significant developments with respect to the 340B Drug Pricing Program. Specifically: (1) new federal district court litigation challenging a recent HRSA Notice involving…
To Be or Not to 340B Blog
District Court Allows for Expanded Interpretation of Eligible Patient in Impactful 340B Program Ruling
By Michael French, Richard Davis, Brenda Maloney Shafer
In a decision likely to send shockwaves through the 340B Program space, the United States District Court of South Carolina recently provided a favorable ruling to 340B-participating covered entities hoping…
Canadian Lawyer Mag
Latham & Watkins names 34 new partners and 48 new counsel
The new partners hail from Asia, the US, Europe, and the Middle East
To Be or Not to 340B Blog
HRSA Notice Provides Clarity on 340B Child Site Registration Requirements
By Richard Davis, Michael French, Madison Hartman, Brenda Maloney Shafer
After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice today confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B…
Health Law Diagnosis
HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics
By Robinson+Cole's Health Law Group
On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver…
Hall Benefits Law Blog
Supreme Court Decision Prompts CMS to Send $9B to 1,600 Hospitals for Medicare Underpayments
By Anne Hall
After a recent U.S. Supreme Court decision found that the U.S. Department of Health and Human Services (HHS) had wrongfully cut prescription drug prices for 349B-covered hospitals between 2018 and…
Health Care Law Today
CMS Proposes Remedy for 340B-Acquired Drug Payment Policy for CY 2018-2022
By Anil Shankar, Stephanie J. Schwartz
Along with its calendar year (CY) 2024 Medicare Outpatient Prospective Payment System (OPPS) proposed rule, the Centers for Medicare & Medicaid Services (CMS) have also published the long-awaited proposal to…