340B Drug Pricing Program Compliance
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ... ...more
On February 28, 2023, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would change how Medicare disproportionate share hospital (DSH) payments are calculated with respect to the counting of...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
This Week: Happy New Year! The 116th Congress begins and healthcare issues are part of the "buzz" of day one. Part of the government is still closed. ...more
As the Trump Administration moves forward with proposed policy changes to address high drug prices, a common theme is emerging: a number of the proposals have the potential to reduce Medicare reimbursement to hospitals and...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
On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the final rule implementing the prescription drug rebate provisions enacted as part of the health care reform law, the Affordable Care Act...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
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
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
In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more
The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more