340B Archives - HEALTH & LIFE SCIENCES NEWS

This Week in 340B: January 31 – February 7, 2024

by Emily Jane Cook, Bryan Frederick and Patrick Moore | Feb 9, 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, a subscription product from McDermott+Consulting.

Issues at Stake: Contract Pharmacy; Other

In a qui tam False Claims Act action alleging that defendants failed to charge accurate ceiling prices to 340B Covered Entities, the plaintiff-relator submitted a memorandum in opposition to the defendants’ renewed request for judicial notice and an omnibus opposition to defendants’ motion to dismiss the first amended complaint.
In a case regarding a state law governing contract pharmacy arrangements, the oral argument for defendant’s motion to dismiss was set for March 5, 2024.
In a separate case regarding a state law governing contract pharmacy arrangements, the court denied plaintiff’s motion to file a second amended complaint, ordered the clerk to close the case, and issued a judgment in favor of Defendant pharmaceutical companies.

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: August 30 – September 6, 2023

by Emily Jane Cook and Kelsey Reinhardt | Sep 8, 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:

The trade association appellant in a contract pharmacy case notified the court that the government appellee began enforcement of a state law that is the subject of their pending litigation.
The State of New York filed an antitrust case against a large retail pharmacy chain.

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

This Week in 340B: March 21 – 27, 2023

by Emily Jane Cook, Reuben Bank, Ming Chuang and Kelsey Reinhardt | Mar 28, 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.

Issue at Stake: 340B Covered Entity

The plaintiff in one case involving covered entities and the prime vendor program has filed an opposition to the defendant’s motion to dismiss the case.

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

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

by Emily Jane Cook, Reuben Bank, Ming Chuang and Kelsey Reinhardt | Mar 22, 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.

Issue at Stake: 340B Covered Entity

A new case was filed against the New York State Department of Health arguing that the “340B Carveout” is unconstitutional and would limit 340B Covered Entities’ opportunities to realize 340B savings on drugs dispensed to Medicaid managed care enrollees.

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

This Week in 340B: February 21 – 27, 2023

by Emily Jane Cook, Ming Chuang and Kelsey Reinhardt | Feb 27, 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
Where Things Stand:

In one contract pharmacy case, the plaintiff-appellant filed its opening brief arguing that Section 340B and the Federal Food, Drug, and Cosmetic Act preempt an Arkansas state law regulating manufacturers’ delivery of 340B-discounted drugs.
The district court judge in a state law case involving a 340B covered entity plaintiff has discharged its show cause order.
The district court judge in a contract pharmacy case has granted the parties’ joint motion to stay further proceedings in the matter pending HHS’ ongoing rulemaking proceeding relating to the 340B administrative dispute resolution rule.
In three contract pharmacy cases that were decided in January, HHS filed an Unopposed Motion for a 30-Day Extension of Time to File a Petition for Rehearing En Banc.

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

This Week in 340B: February 7 – 13, 2023

by Emily Jane Cook, Reuben Bank and Kelsey Reinhardt | Feb 14, 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; HRSA Audit Process; Medicare Payment Cuts
Where Things Stand:

In one contract pharmacy case, the court ordered a stay pending the D.C. Circuit Court’s ultimate decision in Novartis Pharmaceuticals Corp. v. Johnson and United Therapeutics Corp. v. Johnson.
The 340B Covered Entity plaintiff in one case asked that the court take specific discovery actions with respect to its challenge of the definition of “patient.”
Six Medicare payment cut cases were ordered stayed until May 19, 2023, pending a decision in AHA v. Becerra regarding remedies.
In three Medicare payment cut cases, the district court judge has signaled her inclination to transfer the cases to the judge handling most other Medicare payment cut cases, and has asked for the parties to enter any objections to a transfer.

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

340B in 2021: What Covered Entities and Their Partners Need to Know Now

by McDermott Will & Emery | Mar 31, 2021 | Hospitals & Health Systems, Life Sciences

Since March 2010, increased growth in the 340B Program has been accompanied by increased scrutiny from state and federal governments and conflicts between various 340B Program stakeholders. A transition in U.S. Department of Health & Human Services (HHS) and Health Resources & Services Administration (HRSA) leadership may lead to changes in 340B Program policy, but the ongoing conflicts, particularly around contract pharmacies, will not likely be resolved quickly.

In this webinar, we discussed the current issues affecting 340B Program stakeholders, the tools (and their limitations) that may be employed by stakeholders and government agencies to resolve those issues, and what covered entities can expect in future developments affecting the 340B Program.

Covered entities will likely be unable to resolve contract pharmacy issues quickly through either the current litigation or the ADR panels. While there are a number of pending cases related to the 340B Program, litigation can be inherently slow process. The Administrative Dispute Resolution (ADR) Final Rule that was published in December 2020 was recently enjoined and additional injunctions may follow. While HHS appears to be moving forward with operationalizing the ADR process, the ADR Panel members who would hear the disputes remain under review by the Biden Administration. If and when the ADR panels are finally implemented, decisions of those panels may be litigated too.
Covered entities should review and monitor their state Medicaid program’s billing requirements for 340B drugs. State Medicaid programs must have a mechanism to identify 340B drugs when required to exclude them from [...]

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