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

This Week in 340B: July 9 – 15, 2024

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; Medicare Payment

  • In the consolidated Medicare payment cut case, the government filed a reply in support of its cross motion to dismiss.
  • In a case challenging proposed state laws governing contract pharmacy arrangements, an amicus brief was filed in support of defendant’s opposition to plaintiff’s motion for a preliminary injunction.
  • The defendants in four separate cases, all of which challenged a state law concerning contract pharmacy arrangements, filed motions to consolidate their respective cases.
  • In a case challenging a state law governing contract pharmacy arrangements, advocacy groups representing 340B Covered Entities filed an amicus brief in support of defendants’ motion to dismiss and in opposition to plaintiffs motion for a preliminary injunction.
  • In a case challenging a state law governing contract pharmacy arrangements, the plaintiff filed a memorandum opposing the defendants’ motion to dismiss.
  • In a case challenging a state law governing contract pharmacy arrangements, the plaintiff filed an amended complaint.
  • In a breach of contract claim [...]

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Loper Bright and the 340B Statute

In its Loper Bright decision last week, the Supreme Court of the United States likely opened opportunities for further legal challenges to the Health Resources and Services Administration’s (HRSA’s) interpretation and application of the 340B statute. Going forward, we expect that much of the 340B statute will be subject to interpretation by federal courts.

HRSA’s historic policies that are not the “best” interpretation of the statutory language may not survive legal challenges. Where HRSA retains the authority to regulate the 340B program, it will be required to demonstrate that it is acting based on “reasoned decision-making.”

Examples of what the application of the new Loper Bright standard might look like in practice, as applied to provisions in the 340B statute:

  • Definition of “Patient”: The 340B statute does not define “patient.” The 340B statute states in relevant part that “a covered entity shall not resell or otherwise transfer the drug to a person who is not a patient of the entity.” Under Loper Bright, a court will likely decide, without deference to HRSA, who qualifies as a patient. A court is not required to defer to HRSA’s statutory interpretation.
  • Requirements for Registration of DSH Hospital Child Sites Prior to Use of 340B Drugs: The 340B statute defines disproportionate share hospital (DSH) hospital covered entities as “a subsection (d) hospital (as defined in section 1886(d)(1)(B) of the Social Security Act) that [meets certain additional requirements set forth in the statute related to ownership, DSH percentage and GPO purchasing].” The 340B statute [...]

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This Week in 340B: July 2 – 8, 2024

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; Medicare Payment

  • A drug manufacturer filed a challenge to a state law governing contract pharmacy arrangements.
  • In a case challenging a state law governing contract pharmacy arrangements, the state attorney general filed a motion to dismiss.
  • In a case challenging a state law governing contract pharmacy arrangements, four amici filed a brief in support of defendant’s opposition to plaintiff’s motion for preliminary injunction.
  • In a breach of contract claim filed by a 340B Covered Entity against several related party Medicare Advantage plans, the 340B Covered Entity filed its opposition to the Medicare Advantage Plans’ motion to dismiss its first amended complaint.
  • In a case challenging a state law governing contract pharmacy arrangements, the court denied the plaintiff’s motion for a preliminary injunction and the plaintiff appealed.
  • In another case challenging a state law governing contract pharmacy arrangements, the plaintiff appealed the court’s prior denial of its motion for preliminary injunction.



This Week in 340B: June 28 – July 1, 2024

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

  • Two drug manufacturers filed three separate complaints against two state attorneys general to challenge state laws governing contract pharmacy arrangements.
  • In four separate cases challenging state laws governing contract pharmacy arrangements:
      • A defendant state attorney general filed a motion to dismiss. In the same case, four proposed amici filed a brief of amici curiae in support of defendant’s opposition to plaintiff’s motion for a preliminary injunction.
      • A separate defendant state attorney general filed a response in opposition to plaintiff’s motion for preliminary injunction.
      • A court denied the plaintiff’s motion for preliminary injunction.
      • Four proposed amici filed a brief of amici curiae in support of a separate defendant state attorney general’s opposition to plaintiff’s motion for a preliminary injunction.



CMS Issues FAQs to Aid Pharmacies in Preparing for Medicare Part B Coverage of PrEP Medications

As we previously advised, the Centers for Medicare & Medicaid Services (CMS) is preparing to issue a national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV under Medicare Part B. In response to questions from stakeholders, CMS released FAQs on June 25, 2024, to guide pharmacies through certain enrollment and billing intricacies.

Specifically, pharmacies are instructed that no new Medicare enrollment is needed if pharmacies are already enrolled in Medicare as a Part B pharmacy or a durable medical equipment, prosthetic, orthotics and supplies (DMEPOS) supplier. However, if the pharmacy is not currently enrolled in Medicare, they should consider enrolling as a Part B pharmacy rather than a DMEPOS supplier so that they are not subject to the supplier standards, accreditation and surety bond requirements.

CMS also provides pharmacies with appropriate ICD-10 CM diagnosis codes and J-codes to include with claims and instructs pharmacies that the date the drug is picked up or mailed should be entered as the date of service. Finally, recognizing that some pharmacies will fill orders for injectable PrEP to be administered by qualified practitioners, pharmacies may include a claim for the supplying fee along with a claim for the drug where appropriate. CMS anticipates that the final NCD will be posted and effective in late September 2024. The NCD is expected to be similar to the proposed NCD published on July 12, 2023.




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