HEALTH & LIFE SCIENCES NEWS

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

by Emily Jane Cook, Matthew David, Margaret Houtz, Jae Hyun Lee, Deepika Raj, Kelsey Reinhardt and Nadine Tejadilla | Mar 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: Rebate Model; Contract Pharmacy; Other

In three appealed cases challenging a proposed Louisiana law governing contract pharmacy arrangements, the appellee filed a motion to consolidate.
In a case challenging the US Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA’s) decision to prevent drug manufacturers from unilaterally implementing rebate models, defendants filed a cross motion for summary judgment and opposition to the plaintiff’s motion for summary judgment.
In a case challenging HRSA’s policy limiting the circumstances in which covered entities can use their group purchasing arrangements to purchase non-340B drugs, the plaintiff filed a motion for summary judgment.
In three cases challenging a proposed state law governing contract pharmacy arrangements in Missouri, defendants and intervenors in each case filed answers to amended complaints.
In four cases against HRSA alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
- In three cases, the defendants filed a cross motion for summary judgment and opposition to the [...]
  
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Unclaimed Property Laws and the Health Industry: Square Peg, Round Hole

by Stephen P. Kranz, Diann Smith, Eric Carstens and Vanessa S. Torres | Mar 18, 2025 | Uncategorized

Likely due to the tremendous number of healthcare mergers, acquisitions, and private equity deals that have been taking place, the industry has recently been the target of multistate unclaimed property audits. This increased scrutiny has highlighted many of the complexities and tensions that exist in this space. At almost every stage of the process, healthcare industry holders are pressured by state unclaimed property auditors and administrators to fit a square peg in a round hole – something both they and their advocates should continue to vigorously push back against.

Determining whether any “property” exists to report in the first instance can be a daunting task in an industry where multiple parties are involved in a single patient transaction that is documented by complex business arrangements between sophisticated parties, which are updated and accounted for on a rolling basis. Unclaimed property audits are conducted in a vacuum of one single holder and use standard document requests that were developed to apply to all businesses, creating unrealistic record retention and management expectations that almost never neatly align with healthcare industry laws or practices.

Making matters worse, unclaimed property auditors and voluntary disclosure agreement (VDA) administrators frequently do not have a detailed understanding of the complex healthcare privacy, billing, and payment practices, yet these practices materially impact how providers manage unclaimed property and when they report it. Getting them up to speed on these laws, practices, and procedures can be very time-consuming. For example, providers or their advisors may need to explain to [...]

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This Week in 340B: March 4 – 10, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Margaret Houtz, Jae Hyun Lee, Kelsey Reinhardt and Nadine Tejadilla | Mar 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: Contract Pharmacy; HRSA Audit Process; Medicare Payment; Rebate Model

In a case appealing a decision on a state contract pharmacy law, two amicus briefs were filed in support of the defendant-appellant state.
In one Health Resources and Services Administration (HRSA) audit process case, the court granted motion to withdraw the plaintiff’s motion for preliminary injunction.
In a case challenging a Medicare Advantage plan’s response to 340B payment cuts, defendants’ motion to compel the production of a damages spreadsheet was granted in part and denied in part.
In six cases against HRSA alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
- In five such cases, the court granted intervenor’s motion to intervene and a group of amici filed an amicus brief in support of the defendant.
- In one such case, intervenors filed a notice of supplemental authority to which the plaintiff filed a response and a group of amici filed an amicus brief in support of the defendant.

This Week in 340B: February 25 – March 3, 2025

by Emily Jane Cook, Reuben Bank, Matthew David, Margaret Houtz, Jae Hyun Lee, Deepika Raj, Kelsey Reinhardt and Nadine Tejadilla | Mar 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: Antitrust; Contract Pharmacy; HRSA Audit Process; Rebate Model

In an antitrust class action case, the court granted the defendant’s motion to dismiss.
In an appealed case challenging a proposed state law governing contract pharmacy arrangements, a group of amici filed an amicus brief in support of appellees.
In an appealed case challenging a proposed state law governing contract pharmacy arrangements, defendants-appellants filed an opening brief.
In a Freedom of Information Act (FOIA) case, the plaintiff filed a reply in support of its motion to strike the government’s motion for summary judgment.
In one one Health Resources and Services Administration (HRSA) audit process case, the plaintiff filed a supplemental brief in support of the plaintiff’s motion for preliminary injunction.
A group of 340B covered entities filed a complaint against a group of commercial payors, alleging that the payors were in breach of their contracts by failing to pay the proper amounts for 340B-acquired drugs.
In three cases challenging a proposed state law governing contract [...]

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Five Questions With a Health Lawyer: Stacey L. Callaghan

by McDermott Will & Emery | Feb 28, 2025 | Uncategorized

Stacey L. Callaghan
Practice Focus Area: Health and Life Sciences, Innovative Care Delivery
Office: Chicago
Years at Firm: 5

What is your favorite part about practicing healthcare law at McDermott?
My favorite part about practicing healthcare law here at McDermott is the phenomenal team. There are thought leaders in every sub-specialty you can imagine, and the people I work with everyday are genuinely kind, good people. I have worked at other firms with a shorter bench; the ease with which we are able to navigate incredibly complex issues here is special. I also love that the firm and practice group encourage us to develop areas about which we are passionate. Because of this, I’ve been fortunate to become the co-chair of our Women’s Digital Health Initiative.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
The biggest opportunity and the greatest challenge are both the fact that healthcare law is changing so rapidly, especially in the innovative care delivery space following the COVID-19 pandemic. There is more opportunity than ever before for healthcare companies and other stakeholders to be creative with their partnerships and their use of technology, but healthcare laws and regulations are still catching up to the innovation in many cases.

What advice would you give to junior lawyers looking to build their practice in your focus area?
I would [...]

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