HEALTH & LIFE SCIENCES NEWS

This Week in 340B: January 28 – February 3, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Jae Hyun Lee, Patrick Moore and Kelsey Reinhardt | Feb 5, 2025 | 340B

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 summary of relevant updates from the prior week in this industry-shaping body of litigation. Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the 340B Litigation Tracker.

Issues at Stake: HRSA Audit Process; Contract Pharmacy; Rebate Model; Other

In one Health Resources and Services Administration (HRSA) audit process case, the plaintiff filed a brief in opposition to the government’s motion to dismiss.
In a Freedom of Information Act (FOIA) case, the government filed a motion for summary judgment.
In a breach of contract claim filed by a 340B covered entity against several related party Medicare Advantage plans, defendants’ filed an amended answer and defenses to plaintiff’s second amended complaint, and plaintiff filed a response in opposition to defendants’ motion to compel plaintiff’s claims spreadsheet.
In several cases challenging HRSA’s policy prohibiting all manufacturer conditions on 340B transactions, the court granted the parties’ joint motion for a stipulated protective order.
In a case challenging a proposed state law governing contract pharmacy arrangements in West Virginia, the court granted plaintiff’s third motion for an extension of time to respond to defendants’ motion to consolidate.
In a case challenging HRSA’s policy prohibiting manufacturer rebate models, three [...]

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Five Questions With a Health Lawyer: Andrea Zazulia

by McDermott Will & Emery | Jan 31, 2025 | Uncategorized

Andrea Zazulia
Practice Focus Area: Healthcare Transactions and M&A
Office: Miami
Years at Firm: 5+

What is your favorite part about practicing healthcare law at McDermott?
I am grateful to be part of a health and life sciences team that is truly world-class. Our group is intentional about collaboration and innovation. Having a bench of thought leaders in every niche of healthcare is an invaluable resource for providing comprehensive and cohesive counsel to our clients, and for training and career growth. I also think our overlap between healthcare regulatory and transactional knowledge is unmatched and allows us to provide practical guidance to clients, whether they are trying to get deals done or build and run their businesses.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
The effective implementation of artificial intelligence and the security and use of protected health information are undoubtedly going to be among the biggest drivers of success and failure in the health industry over the next five to ten years. There is incredible potential for improvement in efficiency and quality of care, but as we have seen, there is also significant risk. The health services sector (e.g., physician and dental offices, hospitals) could particularly benefit from leveraging this technology to lower costs and improve patient outcomes. However, implementation will require a thoughtful and measured approach [...]

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This Week in 340B: January 21 – 27, 2025

by Emily Jane Cook, Reuben Bank and Matthew David | Jan 29, 2025 | 340B

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 summary of relevant updates from the prior week in this industry-shaping body of litigation. Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the 340B Litigation Tracker.

Issues at Stake: HRSA Audit Process; Other

In a suit by a 340B covered entity against the Health Resources and Services Administration (HRSA), HRSA filed a response to show cause and a response to motion for a temporary restraining order (TRO) and preliminary injunction, and the covered entity filed a motion to enforce administrative stay.
In two HRSA audit process cases, the government filed reply briefs in further support of the government’s motion to dismiss.

This Week in 340B: January 14 – 20, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Jan 22, 2025 | 340B

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 summary of relevant updates from the prior week in this industry-shaping body of litigation. Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the 340B Litigation Tracker.

Issues at Stake: HRSA Audit Process; Contract Pharmacy; Rebate Model; Other

In one Health Resources and Services Administration (HRSA) audit process case, the government filed a motion to dismiss.
In two HRSA audit process cases, the government filed reply briefs in further support of the government’s motion to dismiss.
A drug manufacturer filed suit against HRSA to challenge HRSA’s disapproval of its proposed rebate model.
A 340B covered entity filed suit against HRSA, alleging that HRSA prevented it from accessing the 340B Program.
A 340B covered entity filed suit against HRSA to challenge HRSA’s determination that certain clinics were not eligible for the 340B Program, and, in the same case, the court issued an administrative stay.
In three cases challenging proposed state laws governing contract pharmacy arrangements in Missouri and West Virginia:
- MO: Defendants and intervenors separately filed reply suggestions in support of the motion to dismiss.
- WV: Plaintiffs in two separate cases filed oppositions to defendants’ motions to consolidate

This Week in 340B: January 7 – 13, 2025

by Emily Jane Cook, Matthew David and Jae Hyun Lee | Jan 15, 2025 | 340B

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 summary of relevant updates from the prior week in this industry-shaping body of litigation. Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the 340B Litigation Tracker.

Issues at Stake: Contract Pharmacy; Other

In two appealed cases challenging a proposed Louisiana law governing contract pharmacy arrangements, the appellants filed their opening brief.
In a breach of contract case related to the Medicare 340B cuts, the court terminated the action without prejudice.