Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
This Week in Washington: 118th Congress begins, House finally chooses Speaker...more
This Week in Washington: House Passes FDA User Fee Reauthorization Package...more
We are back again with another 340B post. The 340B program has recently been a regular feature on the blog in the context of ongoing litigation discussed here and here. Today, we wanted to provide readers the details of an...more
The 340B Program’s Growing Scope - The 340B program has grown significantly in scope. According to the Health Resources and Services Administration (HRSA), as of January 1, 2018, the 340B program included 12,823 providers...more
This week in Washington: The House and Senate will be in recess the week of Feb. 17 in observation of Presidents Day....more
On January 27, the Government Accountability Office (GAO) published a report concluding that the US Department of Health and Human Services (HHS) has provided limited oversight of the 340B and Medicaid Drug Rebate Programs,...more
Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more
Less than two weeks into the new year, the federal government has released two new publications addressing concerns related to 340B Program oversight by both state and federal agencies. After a relatively quiet 2019, 340B...more
In this issue, Polsinelli’s 340B and Reimbursement teams provide an update on the most recent developments in the ongoing 340B /Part B Payment litigation and also highlight recent Government Accountability Office (“GAO”)...more
It seems like every week, there are multiple new developments in the 340B program. While it has just been a few weeks since my last 340B blog post, since that time we have had another Senate hearing, a new GAO Report, a new...more
HOUSE OKs DOZENS OF OPIOID-RELATED BILLS; MORE VOTES SCHEDULED - The House last week approved 38 bills that lawmakers hope will stem the opioid epidemic, and it scheduled votes this week on at least a dozen more....more
I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed...more
On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015. A...more
I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more