HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
340B
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This Week in 340B: January 31 – February 6, 2023

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
Where Things Stand:

  • 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.
  • In one contract pharmacy case, the parties requested a stay pending the D.C. Circuit Court’s ultimate decision in Novartis Pharmaceuticals Corp. v. Johnson and United Therapeutics Corp. v. Johnson.
  • The drug manufacturer party in a contract pharmacy-related antitrust case filed a letter with the court to advise it of the Third Circuit Court of Appeals’ recent decision in Sanofi Aventis v. HHS and ask that it reach the same decision.
  • In the contract pharmacy-related antitrust case, the drug manufacturer parties filed a notice of supplemental authority with the court citing the Third Circuit Court of Appeals’ recent decision in Sanofi Aventis v. HHS in support of their motion opposing the plaintiff’s motion to amended their complaint.

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




340B Covered Entities May See Access Changes to Contrast Media, Radiopharmaceuticals and Other Products

340B covered entities may experience expanded access to contrast media, radiopharmaceuticals and other products at 340B prices in the coming months. Buried in the over 1,600 pages of the Consolidated Appropriations Act, 2023 is a new law requiring the US Food and Drug Administration (FDA) to treat all contrast media, radiopharmaceuticals and over-the-counter (OTC) monograph drugs as “drugs.” As a result, certain products—notably some contrast media—that were previously classified as “devices” by the FDA will now be considered “drugs.”

This means that some products that were not previously available at 340B prices may now be. Specifically, products that were excluded from the 340B definition of “covered outpatient drug” because they did not go through the FDA drug approval process may eventually obtain drug approval and therefore qualify for 340B pricing. Further, going forward, new contrast media, radiopharmaceuticals and OTC monograph drugs will also be considered “drugs” and may meet the definition of “covered outpatient drug” for 340B pricing purposes. We expect the FDA to release guidance on the implementation of this new law. In the interim, there could be challenges in obtaining some of the products previously marketed as “devices.”

340B covered entities should review their current purchasing process for contrast media, radiopharmaceuticals and OTC monograph drugs that are not available through 340B accounts to determine which products may soon have 340B prices available. Additionally, 340B covered entities should review their policies and procedures and make any updates that may be necessary because of this new law and note [...]

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Court Rules in Favor of Manufacturers in 340B Contract Pharmacy Case

Earlier today, the US Court of Appeals for the Third Circuit issued a much-anticipated decision in one of the 340B contract pharmacy cases. The decision is a win for drug manufacturers who have sought to restrict access to 340B prices on drugs dispensed through contract pharmacy arrangements.

The Court found that the 340B statute does not require delivery of 340B drugs to an unlimited number of contract pharmacies because (1) the text of the statute is silent about delivery, (2) structural clues confirm that the statute does not require unlimited delivery, and (3) neither drafting history nor legislative purpose compels a different result.

Additionally, the Court found that the 340B Administrative Dispute Resolution Rule that was published in December 2020 is lawful. The US Department of Health and Human Services has since published a new proposed rule that would replace the December 2020 one.

This is the first of three decisions in 340B contract pharmacy appeals cases. The remaining two are expected at any time. We are continuing to track more than 40 cases in courts across the country related to a wide range of 340B program issues. Our summaries are compiled in the 340B Litigation Tracker, a subscription product from McDermott+Consulting.




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

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

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

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

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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