HEALTH & LIFE SCIENCES NEWS

Five Questions With a Health Lawyer: Jim Owens

by McDermott Will & Emery | Dec 19, 2024 | Uncategorized

Jim Owens
Practice Focus Area: Healthcare
Office: Los Angeles
Years at Firm: 8+

What is your favorite part about practicing healthcare law at McDermott?
The lawyers and other professionals here, first and foremost. We have an amazingly talented team with a wealth of experience advising sophisticated clients in all segments of the healthcare industry. The substantive law depth and breadth, market knowledge, and geographic scope of our healthcare practice is impressive and makes us the best in the business. It is truly the “A team,” and it enables me to bring together the full spectrum of healthcare law advisers to provide a one-stop-shop of high-quality services for our clients. I also enjoy working with our smart and successful clients who value our work and who treat us as members of their team.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
My practice is focused primarily on representing health systems and hospitals. Some of the biggest challenges facing our clients are diminishing margins caused by declining reimbursement and rising costs, physician and nursing shortages in the face of an aging population, and increased regulatory hurdles to many types of healthcare transactions. Some of the biggest opportunities include innovative partnerships among providers for specific types of services, and innovations in digital health and artificial intelligence in [...]

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This Week in 340B: December 10 – 16, 2024

by Emily Jane Cook, Reuben Bank, Margaret Houtz, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Dec 18, 2024 | 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; HRSA Audit Process; Other

A drug manufacturer filed suit against the Health Resources and Services Administration (HRSA) to challenge HRSA’s determination that its proposed rebate model violates the 340B statute.
In two HRSA audit process cases, HRSA filed a motion to dismiss for a lack of subject-matter jurisdiction and failure to state a claim.
In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, defendants filed a notice of non-opposition, and the court granted plaintiff’s motion for leave to file a second amended complaint and motion to file the second amended complaint under seal.
In an appealed qui tam action alleging that various drug manufacturers failed to charge accurate ceiling prices to 340B Covered Entities, the appellant filed a reply brief.
In four consolidated Kansas contract pharmacy cases, the parties filed a joint stipulation of dismissal without prejudice.
In eight cases challenging a proposed state law governing contract pharmacy arrangements in West Virginia, [...]

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This Week in 340B: December 3 – 9, 2024

by Emily Jane Cook, Reuben Bank, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Dec 11, 2024 | 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; Other

In a Freedom of Information Act (FOIA) case, the Health Resources and Services Administration (HRSA) filed a reply in support of its cross-motion for partial summary judgment.
In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, the 340B Covered Entity filed a motion for leave to file its second amended complaint and the court ordered that the related party Medicare Advantage plans show cause why the motion for leave should not be granted.
In one HRSA audit process case, the plaintiff filed a motion for stay of agency action and preliminary injunction.
In two HRSA audit process cases, HRSA filed a motion to dismiss for a lack of subject-matter jurisdiction and failure to state a claim.
In a case challenging HRSA’s policy prohibiting all manufacturer conditions on 340B transactions, the court approved the parties’ motion for leave to file an amended complaint.
In four cases challenging a proposed [...]

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This Week in 340B: November 19 – December 2, 2024

by Emily Jane Cook, Reuben Bank, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Dec 4, 2024 | 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; Other

In four Health Resources and Services Administration (HRSA) audit process cases, the plaintiffs filed motions for a temporary restraining order.
In four HRSA audit process cases, the courts approved a joint motion to withdraw the plaintiff’s previously-flied motion for a temporary restraining order.
In a Freedom of Information Act (FOIA) case, the drug manufacturer plaintiff filed a reply in support of its motion for summary judgment and opposition to defendants’ motion for partial summary judgment.
A drug manufacturer filed suit against HRSA to challenge HRSA’s disapproval of its proposed rebate model.
In eight cases challenging proposed state laws governing contract pharmacy arrangements in West Virginia and Missouri:
- WV: The court in four separate cases granted the parties’ joint motions and stipulations to delay proceedings for fourteen days to allow related courts to decide pending preliminary injunction motions in similar cases.
- MO: In two cases, the plaintiff filed suggestion in opposition to intervenor’s motion to [...]
  
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California Ballot Proposition 34 Targets Spending by Certain 340B Covered Entities

by Emily Jane Cook and Patrick Moore | Nov 20, 2024 | 340B

Proposition 34 requires certain California healthcare providers to spend at least 98% of their net drug sale revenue on direct patient care. The measure targets certain providers who benefit from a federal drug discount program known as the 340B Program.

The 340B Program allows qualifying safety net healthcare providers who serve a disproportionate share of low-income and uninsured patients to purchase outpatient drugs at a significant discount. The intent of the 340B Program is to allow providers that participate in the program to offer more comprehensive services to patients and their communities.

The 340B Program does not dictate how eligible providers use revenue generated from sales of the discounted drugs. Proposition 34 imposes such restrictions.

Who Does It Affect?

Not all providers who participate in the 340B Program are affected by Proposition 34. It only applies to 340B providers that:

Spend more than $100 million on non-direct-care expenses.
Own and operate apartment buildings.
Have accumulated at least 500 severe health and safety violations in the past decade.

Currently, the AIDS Healthcare Foundation (AHF) is believed to be the only organization that meets these criteria.

Background and Controversy

Proposition 34 is one of the first state-level efforts to restrict use of savings generated from participation in the 340B Program. Opponents of Proposition 34 believe that it was on the ballot largely due to political and housing interest groups’ opposition to the president of AHF and certain spending by AHF under his leadership. AHF has become a significant player in [...]

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