Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
News Briefs - Statistics Show Upward Trend in Healthcare Data Breaches - Healthcare data breach statistics clearly show there has been an upward trend in data breaches over the past 14 years, with 2021 seeing more data...more
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more
Welcome to our second issue of The Health Record - our healthcare law insights e-newsletter! SCOTUS Agrees to Review Medicare DSH Payments Case - “The suit, Advocate Christ Medical Center v. Becerra, was originally filed in...more
A periodic feature by Cornerstone Research, in which our affiliated experts, senior advisors, and professionals, talk about their research and findings. We interview Professor Sayeh Nikpay of the School of Public Health,...more
On October 26, the Health Resources and Services Administration (HRSA) published a Federal Register notice addressing the use of 340B drugs at off-campus hospital outpatient locations that have not yet appeared on a filed...more
Report on Medicare Compliance Volume 32, no 25 (July 2023) The former chief hospital executive of Bayonne Medical Center (BMC) in New Jersey has filed a False Claims Act (FCA) lawsuit alleging the hospital and two others...more
On January 10, 2020, the U.S. Government Accountability Office (GAO) issued a report claiming that the Health Resources and Services Administration (HRSA) does not use adequate controls to confirm the eligibility of private...more
Tips on preserving the provider-based status for existing clinics. The Bipartisan Budget Act of 2015 (H.R. 1314) was signed into law on Monday, November 2. Notwithstanding significant concerns raised by the hospital...more
On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals. The...more
On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more
We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more
The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more
On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more
On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more
Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more
Safety-net providers, manufacturers, members of Congress, and other stakeholders have been tracking the status of the Health Resources and Services Administration’s (“HRSA”) draft 340B Omnibus Guidance closely as it promises...more
Last week, new bi-partisan legislation was introduced to increase the number of graduate medical education (GME) slots over the next five years at teaching hospitals and academic medical centers. If passed, the Resident...more
In This Issue: - Top News ..Congress Passes Omnibus Spending Package ..HRSA Cancels Plan for 340B ‘Mega Reg’; Congress Weighs Options ..Supreme Court to Hear Challenge to ACA Subsidies ...more
In This Issue: - Top News ..The Congressional Agenda is Light as the Focus Shifts to the Midyear Elections ..Physician Supervision Requirement for Small and Rural Hospitals ..CMS Offers Hospitals...more
On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more
In This Issue: - Judge Rules Against 340B Drug Authority - FDA Approves Skin Infection Drug - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more
340B “Mega-Reg” Under Review by OMB – The Health Resources and Service Administration (HRSA), Office of Pharmacy Affairs sent the long-awaited 340B Proposed Rule to the Office of Budget and Management Affairs (OMB) last week...more
The U.S. Department of Health and Human Services last week clarified when hospitals are allowed to buy socalled orphan drugs at sharply discounted prices, but it left open questions for drug manufacturers about the risk of...more