HEALTH & LIFE SCIENCES NEWS

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

By Emily Jane Cook, Ming Chuang and Kelsey Reinhardt on Feb 21, 2023
Posted In 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: February 7 – 13, 2023

By Emily Jane Cook, Reuben Bank and Kelsey Reinhardt on Feb 14, 2023
Posted In 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.

This Week in 340B: January 31 – February 6, 2023

By Emily Jane Cook, Reuben Bank and Kelsey Reinhardt on Feb 6, 2023
Posted In 340B, Uncategorized

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

By Emily Jane Cook and Anisa Mohanty on Feb 2, 2023
Posted In 340B

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

By Emily Jane Cook on Jan 31, 2023
Posted In 340B

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.