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: October 31 – November 5, 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 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.




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This Week in 340B: October 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 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.




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HRSA Issues Notice Confirming 340B Registration Requirement

On October 26, the Health Resources and Services Administration (HRSA) published a Federal Register notice addressing the use of 340B drugs at off-campus hospital outpatient locations that have not yet appeared on a filed Medicare cost report. These locations are known as “unregistered child sites.”

In the notice, HRSA maintains that its prior policy allowing the use of 340B drugs at unregistered child sites was intended only to be a waiver during the COVID-19 public health emergency (PHE) and that the waiver is no longer needed. HRSA further explains that the waiver created challenges in its ability to oversee the integrity of the 340B program.

HRSA states in the notice that some covered entities believed that the use of 340B drugs at unregistered child sites was a permanent policy change. HRSA is providing two compliance options for covered entities that used 340B drugs at unregistered child sites after the end of the PHE:

  1. For off-site outpatient locations that have appeared on a filed Medicare cost report with associated outpatient costs and charges, but have not yet registered in the Office of Pharmacy Affairs Information System (OPAIS), HRSA will allow registration in January 2024.
  2. For off-site outpatient locations that began using 340B drugs prior to the publication of the notice, but have not yet appeared on a filed Medicare cost report with associated outpatient costs and charges, HRSA will allow their continued use of 340B drugs if the covered entities provide the following information to HRSA within [...]

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This Week in 340B: October 13 – 17, 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 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 involving the definition of “patient,” amici filed a reply brief in support of HHS.
  • The court issued a briefing and hearing schedule in a qui tam action.
  • In a case alleging that a covered entity was improperly removed from the 340B Program, the parties filed a motion to postpone briefing schedules and indicated that they anticipate settling.
  • A drug manufacturer filed a complaint to invalidate a state law governing contract pharmacy arrangements.

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




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This Week in 340B: October 4 – 12, 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 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

  • In a case involving a 340B covered entity’s termination from the 340B program, the court granted the covered entity’s temporary restraining order.
  • In a case involving the definition of “patient,” HHS filed its reply brief in support of its cross-motion for summary judgment, and an amicus curiae brief was filed.

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




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This Week in 340B: September 27 – October 3, 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 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

  • The Ninth Circuit granted the prime vendor program appellee’s request for an extension to file its appellee brief.
  • A 340B Covered Entity filed suit against HHS, alleging it was improperly removed from the 340B Program.
  • Defendants in a qui tam action filed a Motion to Dismiss, which will be heard by the District Court for the Central District of California in December 2023.
  • The plaintiff in a case aiming to invalidate a state law governing contract pharmacy arrangements filed a First Amended Complaint.

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




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This Week in 340B: September 20 – 26, 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 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

  • The prime vendor program appellee in a Ninth Circuit case requested an extension to file its appellee brief.
  • In a case involving anti-trust and tort claims, the court denied the plaintiff’s Motion for a Temporary Restraining Order and Preliminary Injunction.
  • In a case involving the definition of “patient,” a national 340B advocacy organization filed an Amicus Brief.
  • A drug manufacturer filed a complaint to invalidate a state law governing contract pharmacy arrangements.

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




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This Week in 340B: September 12 – 19, 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 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

  • A medical group filed an antitrust case in Pennsylvania federal court against a 340B covered entity.
  • In a case involving the definition of “patient”, the covered entity filed a reply brief.
  • The covered entity appellant in a Ninth Circuit case filed its opening brief against the prime vendor program appellee.

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




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This Week in 340B: September 6 – 11, 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 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

  • The government appellee in a contract pharmacy case filed a response to the trade association appellant’s Rule 28(j) letter.
  • The government defendant filed an answer in a state contract pharmacy case.

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




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This Week in 340B: August 30 – September 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 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.




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