HEALTH & LIFE SCIENCES NEWS

This Week in 340B: February 11 – 17, 2025

by Emily Jane Cook, Matthew David, Margaret Houtz, Jae Hyun Lee, Patrick Moore, Deepika Raj, Kelsey Reinhardt and Nadine Tejadilla | Feb 19, 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; Medicare Payment; Rebate Model

In a case challenging a proposed state law governing contract pharmacy arrangements in Missouri, the court granted in part and denied in part defendant’s and intervenor’s separate motions to dismiss.
In a breach of contract claim filed by a 340B covered entity against several related party Medicare Advantage plans, defendants filed a reply in support of their motion to compel plaintiff’s claims spreadsheets.
In five cases against the Health Resources and Services Administration (HRSA) alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
1. Five amicus briefs were filed in support of the drug manufacturer.
2. In four such cases, drug manufacturers filed a joint position statement on consolidation.
3. In one such case, a drug manufacturer filed a notice of opposition to consolidation and memorandum in opposition to intervenors.
4. In one such case, the government filed a position statement in support of consolidation.

This Week in 340B: February 4 – 10, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Margaret Houtz, Jae Hyun Lee, Patrick Moore, Kelsey Reinhardt and Nadine Tejadilla | Feb 12, 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; Rebate Model; Other

In a case brought by a 340B covered entity against the Health Resources and Services Administration (HRSA) alleging that HRSA prevented the covered entity from accessing the 340B Program, the covered entity filed a notice of voluntary dismissal.
In a case challenging HRSA’s policy prohibiting all manufacturer conditions on 340B transactions, plaintiffs filed a motion for summary judgment.
In a Freedom of Information Act (FOIA) case, the plaintiff filed a motion to strike HRSA’s motion for summary judgment.
In one HRSA audit process case, the plaintiff filed a brief in opposition to a drug manufacturer’s motion for leave to file as amicus curiae.
In four HRSA audit process cases, the parties filed joint stipulations that the government will provide to the plaintiffs thirty days’ written notice before termination of the plaintiffs from the 340B Program.
In five cases against HRSA alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
- In two cases, each [...]
  
  Continue Reading

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 [...]

Continue Reading

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 [...]

Continue Reading

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.