Topic
340B
257 published works
To Be or Not to 340B Blog
Site Neutral Payments Put 340B Child Sites in Jeopardy
By Alyce Katayama, Elizabeth Gebarski
Just when you thought you understood all the threats facing the 340B Drug Pricing Program ("340B Program"), along comes the Bipartisan Budget Act of 2015 ("BBA 2015). BBA 2015 changes…
Health Law Update
Rosebush and Holmes Author Article on Contract Pharmacies and 340B Compliance in Journal of Health Care Compliance
Partner Lee Rosebush and Associate Lindsay Holmes authored an article published in the November-December 2015 issue of the Journal of Health Care Compliance. The article, “340B Compliance Issues: Contracting with Contract Pharmacies,” analyzes the compliance…
Health Industry Washington Watch
OIG Examines Medicare Part B Payments for 340B Purchased Drugs
A new OIG report reviews Medicare Part B spending on drugs purchased by eligible health care providers through the 340B drug discount program. The OIG describes the report as “an…
Delaware Bankruptcy Update
Affirmative Insurance Holdings, Inc. Files for Bankruptcy – 341 and Formation Meetings Scheduled
On October 14, 2015, Affirmative Insurance Holdings, Inc. and 7 affiliates filed for relief under chapter 11 of the Bankruptcy Code. The cases are jointly administered under Case Number 15-12136 and…
Health Law Update
D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule
By Lee H. Rosebush, Lindsay Holmes
Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging…
Health Care and Life Sciences
U.S. District Court Vacates HRSA’s Interpretative Rule on Orphan Drugs
By Alan J. Arville, Selena M. Brady, Constance A. Wilkinson
On Wednesday, October 14, 2015, the U.S. District Court for the District of Columbia (the "Court"), Judge Rudolph Contreras, vacated the Health Resources and Services Administration's ("HRSA") interpretive rule on…
Health Care and Life Sciences
340B Program and Mega-Guidance Webinar
Constance Wilkinson, Member of Epstein Becker Green, will co-present on a webinar on "340B Program and the Proposed Mega-Guidance" on October 22, 2015, from 2:00 - 3:00 p.m. ET. With…
To Be or Not to 340B Blog
PhRMA 2-0 in The Orphan Drug Wars
By Alyce Katayama, Elizabeth Gebarski
U.S. Federal District Court Judge for the District of Columbia, Rudolph Contreras, ruled Wednesday, October 14, 2015 that manufacturers need not offer 340B discounts for orphan drugs sold to a specified…
Capital Thinking
House To Vote On ACA Repeal Provisions; HHS Projects 2016 ACA Marketplace Enrollment; HRSA’s 340B Orphan Drug Policy Struck Down Again
Legislative Activity House To Vote On ACA Repeal Provisions House Majority Leader Kevin McCarthy (R-CA) has included two health-related bills on this week’s floor schedule. On Wednesday, the House is…
To Be or Not to 340B Blog
Breaking Down the Proposed Omnibus Guidance – Child Sites
By Alyce Katayama, Elizabeth Gebarski
It is coming down to the wire - comments are due on the 340B Drug Pricing Program Omnibus Guidance (“Guidance”) in about two weeks! On October 28, 2015 the comment…