HEALTH & LIFE SCIENCES NEWS

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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This Week in 340B: November 12 – 18, 2024

by Emily Jane Cook, Margaret Houtz, Jae Hyun Lee, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Nov 19, 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: ADR Rule; Contract Pharmacy; HRSA; Other

In a case challenging the Health Resources and Services Administration (HRSA’s) policy prohibiting all manufacturer conditions on 340B transactions, the plaintiff filed a first amended complaint for declaratory and injunctive relief.
In a case concerning the Alternative Dispute Resolution (ADR) rule, the parties filed a stipulation of dismissal.
In a contract pharmacy case, the defendants filed a cross motion for partial summary judgment and a motion in opposition to the plaintiff’s motion for summary judgment, and responded to a drug manufacturer’s motion for leave to file an amicus brief.
Two drug manufacturers each filed a complaint against HRSA to challenge HRSA’s decision not to allow their proposed rebate models.
In four cases challenging proposed state laws governing contract pharmacy arrangements in Missouri and Mississippi:
1. MO: In two cases, the court granted proposed intervenors’ motion to intervene and intervenors subsequently filed a motion for dismiss.
2. MS: In two cases, two separate groups of amici filed amicus briefs in [...]
  
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Five Questions With a Life Sciences Lawyer: Michael Ryan

by McDermott Will & Emery | Nov 14, 2024 | Uncategorized

Michael Ryan
Practice Focus Area: Market Access (Diagnostics, Life Sciences)
Office: Washington, DC
Years at Firm: 16

What is your favorite part about practicing life sciences law at McDermott?
Clients come to us with difficult questions that require not just a command of the law, but an in-depth understanding of their business – and in some cases, the technology that makes their business different. Even after more than 16 years, I’m constantly learning something new, and the job is never boring!

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
Diagnostics companies face a lot of challenges, such as IP and fundraising. But in my corner of the world, the biggest problem is the timeline to reimbursement. It can take companies three to five years to get reimbursement from the time they think they’re market ready. The length of this pathway creates many challenges, but also substantial opportunity for those clients who are able to make it through.

What advice would you give to junior lawyers looking to build their practice in your focus area?
Be curious, particularly when it comes to the science underlying a technology. Many lawyers are reluctant to get too “in the weeds,” but it can be a real differentiator when your clients see that you really understand how the technology works and how [...]

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This Week in 340B: November 5 – 11, 2024

by Emily Jane Cook, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Nov 13, 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

In nine cases challenging proposed state laws governing contract pharmacy arrangements in West Virginia, Missouri, Kansas, and the Fifth Circuit Court of Appeals:
1. MO: In one case, the proposed intervenors filed a motion to dismiss. In a second case, plaintiff filed suggestions in support of proposed intervenor’s motion to intervene.
2. KS: Amici filed a motion to file an amicus brief.
3. WV: Defendants in four separate cases filed identical motions to consolidate cases, along with supporting memoranda.
4. Fifth Circuit: Defendants in two separate cases filed reply briefs.

This Week in 340B: October 29 – November 4, 2024

by Emily Jane Cook, Patrick Moore, Deepika Raj and Kelsey Reinhardt | Nov 6, 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; Other

– A healthcare improvement company filed suit against HRSA to challenge HRSA’s policy limiting the circumstances in which covered entities can use their group purchasing arrangements to purchase non-340B drugs.

– A covered entity filed suit against an insurance company alleging that the insurance company failed to reimburse the covered entity for amounts it paid the covered entity using the unlawful Medicare rate of ASP minus 22.5%.

– In a contract pharmacy case, a drug manufacturer filed a motion for leave to file an amicus curiae brief in support of plaintiff’s motion for summary judgment.

– In eleven cases challenging proposed state laws governing contract pharmacy arrangements in Mississippi, West Virginia, Missouri, and Kansas: