Topic
340B
257 published works
To Be or Not to 340B Blog
Breaking Down the Proposed Omnibus Guidance – Covered Entity Eligibility, Registration & Termination
By Alyce Katayama, Elizabeth Gebarski
As promised, the blog will be taking an in-depth look at discrete topics included in the proposed 340B Drug Pricing Program Omnibus Guidance ("Guidance"), which was published August 28, 2015.…
Health Law Update
340B Guidance: Eight Key Points Covered Entities Should Consider
By Lee H. Rosebush, Dena Kessler, Nita Garg, Lindsay Holmes
On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus…
Triage Health Law
HRSA “Drops” its Latest 340B Omnibus Guidance – Don’t Stop Believin’ in Drug Discounts
On August 27, the Health Resources and Services Administration (“HRSA”) released its long-awaited proposed guidance for covered entities – a class of providers that includes qualifying hospitals and clinics –…
Health Industry Washington Watch
340B Drug Pricing Program Omnibus Guidance Notice Published by HRSA
On August 28, 2015, the Health Services Resources Administration (HRSA) published long-awaited 340B Drug Pricing Program Omnibus Guidance. Although many aspects of the notice reiterate previous HRSA guidance, several elements…
Life Sciences Legal Update
340B Drug Pricing Program Omnibus Guidance Notice Published by Health Services Resources Administration
By Lisa Baird
On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate…
To Be or Not to 340B Blog
The Proposed 340B Drug Pricing Program Omnibus Guidelines Have Landed
By Alyce Katayama, Elizabeth Gebarski
It is official: The Health Resources and Services Administration ("HRSA") has published the long-awaited "Mega Guidance." The Proposed 340B Drug Pricing Program Omnibus Guidelines ("Guidelines") were published in the Federal Register…
Health Care and Life Sciences
HRSA Issues Proposed “Omnibus Guidance”
By Alan J. Arville, Selena M. Brady, Constance A. Wilkinson, Lesley R. Yeung
The Health Resources and Services Administration ("HRSA") issued a notice proposing guidance under the 340B Drug Pricing Program. The proposed Omnibus Guidance was issued in pre-publication format and is available…
Capital Thinking
Republicans Consider Obamacare Repeal; CMS Releases Proposed Update to Physician Fee Schedule; Obama Nominates Slavitt to Lead CMS; GAO Releases Report on 340B Drug Pricing Program
Legislative Activity Republicans Consider Obamacare Repeal Through Reconciliation Some GOP lawmakers continue to advocate for an Affordable Care Act repeal via the budget reconciliation process. Others, however, have been questioning…
Health Industry Washington Watch
GAO Report Examines Hospital Financial Incentives to Prescribe 340B Drugs to Medicare Beneficiaries
The Government Accountability Office (GAO) has issued a report examining financial and other characteristics of hospitals that participate in the 340B Drug Pricing Program, focusing on disproportionate share hospitals (DSH)…
Health Law Update
Proposed 340B Rule Would Impose Penalties for Overcharging, Plus Other Charges
By Lee H. Rosebush, Dena Kessler
A recently-released proposed rule would impose civil monetary penalties on drug manufacturers that intentionally overcharge healthcare providers for medications purchased under the 340B Discount Drug Program. The proposed rule, if…