Topic
340B
257 published works
To Be or Not to 340B Blog
Controversy Continues to Swirl Around the 340B Program
Although the 340B program accounts for only two percent of over $300 billion in annual drug purchases in the US, there continues to be a lot of ink spilled over…
To Be or Not to 340B Blog
The Mega Rule is Dead! Long Live the Interpretive Guidance Documents!
HRSA/OPA announced the withdrawal of the so-called mega rule last November. This major piece of legislative rulemaking had been over four years in the works. The rule had spent the…
Health Care and Life Sciences
HRSA Withdraws 340B “Mega-Reg;” Plans to Issue Guidance in 2015
By Selena M. Brady, Constance A. Wilkinson, Alan J. Arville
On November 13, 2014, the Health Resources and Services Administration ("HRSA") announced its plans to abandon the much anticipated "mega-reg" amid questions concerning HRSA's rule-making authority. The "mega-reg" was expected to…
Health Law Update
HRSA Withdraws Proposed “Mega Rule” for 340B Drug Pricing Program
The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), has withdrawn a proposed omnibus rule, referred to as the “mega…
Inside Government Contracts
Department of Health and Human Services Announces It Will Issue 340B Guidance and Targeted Rules in Place of Omnibus 340B Rule
On November 13, 2014, the Health Resources and Services Administration (“HRSA”) withdrew a proposed rule (known as the “340B mega-reg”) intended to establish comprehensive 340B Drug Pricing Program requirements for…
Triage Health Law
Update: 340B Mega Rule Halted
In a recent blog post, we urged providers to ready themselves for publication of the 340B mega rule. The Health Resources and Services Administration (HRSA), however, has halted publication of…
Health Industry Washington Watch
HRSA Withdraws Pending 340B Rule, Plans New 2015 Rulemaking
The Health Resources and Services Administration (HRSA) has officially withdrawn from Office of Management and Budget review a long-awaited proposed rule to establish comprehensive requirements for entities and manufacturers participating…
Triage Health Law
A Breakdown of Recent 340B Program Changes
In a recent article, Eugenia Pierson, a Principal in Squire Patton Boggs Public Policy Health Care Practice, urged providers to prepare for HRSA’s promulgation of the 340B mega rule. In…
Inside Government Contracts
PhRMA Filed Suit Today Seeking to Invalidate the 340B Orphan Drug Exclusion Interpretative Rule
By Jennifer Plitsch, Covington Team
Today, Pharmaceutical Research and Manufacturers of America (“PhRMA”) filed a suit seeking to invalidate the 340B Orphan Drug Exclusion Interpretative Rule. The same Health Resources and Services Administration (“HRSA”) policy in the "interpretive…
Nebraska Debt & Bankruptcy Blog
What happens at the bankruptcy court hearing?
By Sam Turco