HEALTH & LIFE SCIENCES NEWS

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

By Emily Jane Cook and Reuben Bank on Nov 30, 2023
Posted In 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 on Nov 15, 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 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: October 31 – November 5, 2023

By Emily Jane Cook and Kelsey Reinhardt on Nov 9, 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 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, 340B Covered Entity

A number of 340B covered entities filed suit against HRSA, seeking relief from its requirement that child sites appear on a covered entity’s Medicare cost report and be registered as a child site in OPAIS before the locations can be considered part of the covered entity under the 340B Program.
In a case involving the definition of “patient,” the court issued an order ruling on the parties’ respective motions for summary judgment.
In two separate cases aiming to invalidate the same state law governing contract pharmacy arrangements, each plaintiff filed a motion for summary judgment and the parties in each case filed a joint motion to set the briefing schedule.
A state government agency filed a motion to dismiss a case attempting to invalidate a state law governing contract pharmacy arrangements.
A case alleging that a covered entity was improperly removed from the 340B Program was dismissed with prejudice following confirmation of the covered entity’s continued participation in the program.

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

Top Takeaways | 2023 PPM-ASC Symposium | ASC 2.0 Selected Trends: Bundled Payments, Tech & Anesthesia

By McDermott Will & Emery on Nov 7, 2023
Posted In Digital Health, PPM/ASC

In this session, panelists discussed recent technological, payment and regulatory trends in the ambulatory surgery center (ASC) space, with a focus on implementing and managing bundled payments. The group also explored complex questions raised on structuring and risk, leveraging technology to streamline ASC operations and maximize business outcomes, and structuring anesthesia arrangements for ASCs.

Session panelists included:

Jason Scalise, MD, Chief Growth Officer, HOPCo
Piper Su, Chief Growth Officer, triValence
Tony Maida, Partner, McDermott Will & Emery
Moderator: Ryan Higgins, Partner, McDermott Will & Emery

Top takeaways included:

Bundled Payments

There has been growing interest in expanding the time frame or scope of services included in a bundled payment. Such a shift in focus could help align behaviors and manage the appropriateness of care. But without appropriate real-time data, there are significant challenges in determining the scope and pricing of a bundle.
As the scope of clinical services provided safely in an ASC has continued to expand, there has been a shift from inpatient to outpatient procedures, and driving them to ASCs. The ASC community can play an integral role in determining scope and pricing of bundles.
Bundled payments have had a somewhat spotty reputation in terms of success. One challenge is that the payor may adjust the target annually, leading to cost-cutting and a race to the bottom until there is no opportunity for additional savings. Going forward, bundled payment programs should be developed with an eye toward sustainability, building in inflationary trends, demographic shifts and [...]

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

By Emily Jane Cook and Kelsey Reinhardt on Nov 1, 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 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: 340B Covered Entity, Contract Pharmacy

In a case alleging that a state law governing contract pharmacy arrangements is preempted by federal law, the defendant filed its answer.
The state department of health filed a cross-motion to dismiss the plaintiff’s amended complaint in a case involving New York’s proposed “340B Carveout” plan.

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