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This Week in 340B: November 13 – 27, 2023

by Emily Jane Cook, Reuben Bank, Bryan Frederick and Patrick Moore | Nov 30, 2023 | 340B

We’re back from the Thanksgiving holiday with two weeks of summaries 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.

Issues at Stake: ADR Rule; Contract Pharmacy; Medicare Payment; Other

In a federal antitrust action, the parties filed a joint stipulation of dismissal.
In an appeal concerning obligations of the 340B Prime Vendor, the 340B Prime Vendor submitted its Appellee Brief.
In a case challenging the 340B Administrative Dispute Resolution (ADR) Rule, the parties filed a Joint Status Report.
In response to the final rule published on November 2, 2023 detailing a remedy for underpayment in light of the Supreme Court’s decision in AHA v. Becerra, stay orders were issued in three of the pending Medicare payment cut cases for 100 days to allow for implementation of the final rule. The parties anticipate that the cases would be dismissed after the payments are made.
In a case regarding a state law governing contract pharmacy arrangements, the state government agency filed a response in opposition to the defendant’s motion to dismiss.
In a separate case regarding a state law governing contract pharmacy arrangements, the state government agency filed its answer to the plaintiff’s first amended complaint.
In a separate case regarding a state law governing contract [...]

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This Week in 340B: November 6 – 12, 2023

by Emily Jane Cook, Reuben Bank and Kelsey Reinhardt | Nov 15, 2023 | 340B

This weekly series provides brief summaries 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.

Issues at Stake: Contract Pharmacy, Medicare Payment

In response to the final rule published on November 2, 2023 detailing a remedy for underpayment in light of the Supreme Court’s decision in AHA v. Becerra, the parties in 11 of the pending Medicare Payment Cut cases requested that the cases be further stayed by 100 days to allow for implementation of the final rule. The parties anticipate that the cases would be dismissed after the payments are made. Stay Orders were issued in six of the cases.
In a qui tam action against a group of drug manufacturers, the plaintiffs filed an amended complaint.
A case attempting to invalidate an Arkansas state law governing contract pharmacy arrangements was transferred to a judge who is presiding over a case with similar allegations.
In two separate cases attempting to invalidate the same Louisiana state law governing contract pharmacy arrangements, a non-profit comprised of community health centers filed a Motion to Intervene and an Answer in Intervention to the plaintiff’s complaint.

Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the
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This Week in 340B: July 25 – August 1, 2023

by Emily Jane Cook, Reuben Bank, Ming Chuang and Kelsey Reinhardt | Aug 3, 2023 | 340B

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.

Issues at Stake: Medicare Payment, Contract Pharmacy

On July 28, 2023, HRSA filed a Motion for Summary Judgment and Response in Opposition to Summary Judgment in a case involving the definition of “patient”.
The court in a Medicare payment case ordered the case to stay.
A national association representing drug manufacturers filed a complaint to invalidate a state law governing contract pharmacy arrangements.
The appeal court mediator scheduled mediation sessions separately with the parties for the month of August in a case involving a covered entity against a prime vendor program.

Get more details on these 340B cases with the 340B Litigation Tracker, a subscription product from McDermott+Consulting.

This Week in 340B: February 14 – 20, 2023

by Emily Jane Cook, Ming Chuang and Kelsey Reinhardt | Feb 21, 2023 | 340B

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.

Issues at Stake: Medicare Payment Cuts; Other
Where Things Stand:

The district court judge in a state law case has ordered the 340B covered entity plaintiff to show cause explaining why this action should not be dismissed for lack of prosecution.
Three Medicare payment cut cases have been reassigned to the district court judge handling most other Medicare payment cut cases.

Get more details on these 340B cases with the 340B Litigation Tracker, a subscription product from McDermott+Consulting.

This Week in 340B: January 24 – 30, 2023

by Emily Jane Cook and Reuben Bank | Jan 30, 2023 | 340B

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.

Issues at Stake: Contract Pharmacy; ADR Rule; Medicare Payment
Where Things Stand:

• An opinion was issued in one of the three federal Appeals Court cases addressing contract pharmacy restrictions. The Court found that HHS could not require drug manufacturers to provide 340B pricing on drugs shipped to an unlimited number of contract pharmacies. The Court also upheld the December 2020 Administrative Dispute Resolution Rule.
• The parties in two stayed cases filed joint status reports in light of the decision in AHA v. Becerra. The government requested that the cases remain stayed pending HHS’s decision on a remedy for past underpayment, while the hospitals asked for the stay to be lifted.

Get more details on these 340B cases with the 340B Litigation Tracker, a subscription product from McDermott+Consulting.

This Week in 340B: January 17 – 23, 2023

by Emily Jane Cook and Reuben Bank | Jan 26, 2023 | 340B

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.

Issues at Stake: Medicare Payment; Definition of Patient
Where Things Stand:

• A District Court in one case related to the 340B definition of “patient” granted the parties’ Joint Motion to Seal the Certified Administrative Record.
• One case was ordered stayed in consideration of the opinion in AHA v. Becerra, and the parties were instructed to file a joint status report by February 9, 2023.

Get more details on these 340B cases with the 340B Litigation Tracker, a subscription product from McDermott+Consulting.

This Week in 340B: January 9 – 16, 2023

by Emily Jane Cook and Reuben Bank | Jan 18, 2023 | 340B

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.

Issues at Stake: Medicare Payment; ADR Rule; Definition of Patient
Where Things Stand:
- A District Court issued an opinion in AHA v. Becerra remanding the issue of remedies in the Medicare 340B payment cuts to HHS and declining to vacate the payment rule.
- Seven cases will remain stayed pending a decision in AHA v. Becerra regarding remedies for the now-vacated 340B Medicare payment cuts.
- Parties in one case challenging the ADR Rule, which is currently stayed, moved for the dismissal of the action without prejudice.
- Plaintiffs in one case related to the 340B definition of “patient” filed a Joint Motion to Seal the Certified Administrative Record.

Get more details on these 340B cases with the 340B Litigation Tracker, a subscription product from McDermott+Consulting.

This Week in 340B Litigation: January 2 – 9, 2023

by Emily Jane Cook and Kelsey Reinhardt | Jan 12, 2023 | 340B

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.

Issues at Stake in Developments Last Week: Medicare Payment; HRSA Audit Process
Where Things Stand:
- A Confidentiality Order issued in one case, ordering that certain administrative record and discovery material may be treated as confidential and setting forth the terms and procedure for designating such documents as confidential.
- Five cases will remain stayed pending a decision in AHA v. Becerra on remedies for the now-vacated 340B Medicare payment cuts. The Court also ordered that the parties in these cases file a Joint Status Report on or before April 10, 2023.
- Parties in three cases filed a Joint Status Report in their respective courts, requesting that their cases remain stayed pending a remedies decision in AHA v. Becerra.

Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the 340B Litigation Tracker, a subscription product from McDermott+Consulting.

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