HHS Issues Revised ADR Regulations
Today, HHS published revised 340B administrative dispute resolution regulations (ADR Rule) that will replace existing ADR regulations effective June 18. Most notably, the ADR Rule does not include a proposal…
Fighting to Preserve the Benefits of the 340B Program
Today, HHS published revised 340B administrative dispute resolution regulations (ADR Rule) that will replace existing ADR regulations effective June 18. Most notably, the ADR Rule does not include a proposal…
Gilead Expanded Policy Gilead expanded its existing restrictions on contract pharmacy arrangements, effective January 30, 2024, but only for covered entities that dispense 340B drugs through wholly-owned contract pharmacies. Gilead’s…
A growing number of pharmaceutical manufacturers have recently posed restrictions affecting Ryan White Clinics and other Safety Net Providers. RWC-340B has taken action to address these challenges head-on. On…
In response to a rash of reckless decisions by pharmaceutical companies, U.S. Representative Abigail Spanberger is leading a bipartisan effort to protect the 340B Drug Pricing Program and prevent additional…
AbbVie is the 11th Manufacturer to Restrict Access to 340B Prices at Contract Pharmacies By letter dated December 29, 2021, AbbVie announced that, effective February 1, 2022, it will implement…
By letter dated November 22, 2021, drug manufacturer UCB, Inc. notified covered entities that it is “altering its 340B policy” and will no longer honor contract pharmacy arrangements, effective December…
On Friday, November 5, two federal courts issued decisions in four of the lawsuits that drug manufacturers filed against HHS challenging HHS’ May 17 cease-and-desist letters (“May 17 Letters”) notifying…
PRESS STATEMENT: FOR IMMEDIATE RELEASE Contact: Peggy.Tighe@PowersLaw.com RWC-340B Applauds Court’s “Fairest and Most Reasonable” Interpretation of the 340B Drug Pricing Program: Manufacturer Actions Shall Not Undermine the Safety Net…
On Friday, the U.S. District Court for the Southern District of Indiana (the Court) issued a decision supporting HRSA’s statutory interpretation, as reflected in HRSA’s May 17 determination, that Eli…
On October 25, 2021, drug manufacturer Boehringer Ingelheim Pharmaceuticals, Inc. filed a lawsuit in the U.S. District Court for the District of Columbia against HHS, alleging that HHS’s policy on…