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
News Briefs - Lawmakers Boosting Investigation of P.E. Role in Healthcare - Influential U.S. Senators are the latest to launch investigations into private equity's increasing role in owning and operating everything from...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
News Briefs - Appeals Court Rules Drug Firms Can Limit 340B Discounted Drugs - An appeals court has upheld a lower court ruling on 340B that sided with drug manufacturers. At issue is whether pharmaceutical companies can...more
News Briefs - Medicare Proposal Would Require Hospitals to Report Emissions - Hospitals for the first time could be asked to report their greenhouse gas emissions to the federal health department. A new Medicare proposal to...more
ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...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
As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and...more
In June of 2022, the Supreme Court of the United States unanimously held in American Hospital Association v. Becerra that the United States Department of Health and Human Services (“HHS”) and the Centers for Medicare and...more
The Centers for Medicare & Medicaid Services (CMS) finalized its Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payment rates on Nov. 2 for calendar year (CY) 2024. The Final Rule...more
The 340B Drug Pricing Program has been making headlines. Two recent developments are difficult to square with one another. First, the Health Resources and Services Administration (HRSA), the federal agency that administers...more
After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B...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
On October 26, the Health Resources and Services Administration (HRSA) issued a notice clarifying the registration requirements for offsite hospital outpatient facilities under the 340B drug pricing program. The Notice, which...more
Sharpen your pencils and locate your reading glasses: the final Medicare payment regulations for calendar year (CY) 2024 will be released within the next week. In the last Regs & Eggs blog post, I discussed a major issue...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. ...more
This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
News Briefs - Hospitals Report Major Drug Shortages, Many Rationing Care - As drug shortages near record levels in the United States, a new survey shows how widespread -- and serious -- the effects are. About 99 percent of...more
On Friday, July 7, The Centers for Medicare & Medicaid Services (CMS) published its proposed rule to remedy payment rates the Supreme Court held invalid in a ruling last summer. A key component of the remedy is maintaining...more
News Briefs - SCOTUS Affirmative Action Ruling May Impact Healthcare Sector - Doctors are concerned that a Supreme Court ruling issued June 29 will have far-reaching effects not only on the diversity of doctors and other care...more
On July 7, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to implement a remedy in response to last year’s Supreme Court decision finding the Medicare Part B payment policy for hospitals in the 340B...more
On July 7, 2023, the Centers for Medicare and Medicaid Services (CMS) released the proposed rule, Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased for Calendar Years 2018–2022, to...more
Throughout 2022, the 340B Drug Program (340B) and participating hospital systems experienced myriad new developments. From continued disputes with drug manufacturers to a landmark U.S. Supreme Court ruling, 340B made...more
The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2022, released the calendar year (CY) 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule...more