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: May 14 – May 20, 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

  • In three separate cases regarding a state law governing contract pharmacy arrangements, plaintiff pharmaceutical companies and plaintiff associations representing drug manufacturers filed joint requests for oral arguments on the motions and cross-motions for summary judgment in all related pending cases.
  • In another case regarding a state law governing contract pharmacy arrangements, intervenor-defendant state primary care association filed a response to plaintiff’s notice of supplemental authority.
  • In a case challenging the 340B Administrative Dispute Resolution (ADR) Rule, the parties filed a joint status report.
  • In a case challenging Arkansas’ Act 1103, the parties filed a joint motion for entry of a stipulated protective order and an electronic discovery order.

Jae Hyun Lee, law clerk in McDermott’s New York office, also contributed to this post. 




This Week in 340B: May 7 – May 13, 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; Other

  • In two related cases regarding a state law governing contract pharmacy arrangements, defendant state attorney general filed addendums to defendant’s notices of supplemental authority.
  • In a third related case regarding a state law governing contract pharmacy arrangements, both defendant state attorney general and plaintiff pharmaceutical companies filed notices of supplemental authority.
  • In a case challenging the New York Department of Health’s 340B Carveout Plan, the court scheduled oral argument.
  • In a case challenging Arkansas’ Act 1103, the parties jointly filed for an agreed scheduling order, which the court granted.



This Week in 340B: April 30 – May 6, 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: Medicare Payment; Contract Pharmacy; Other

  • In the consolidated Medicare payment cut case, the plaintiffs filed a motion for summary judgement.
  • In an appeal before the Ninth Circuit Court of Appeals concerning a qui tam False Claims Act action, the case was released from the mediation program.
  • In an appeal before the Eighth Circuit Court of Appeals challenging Arkansas’ Act 1103, the court denied the plaintiff-appellant’s petition for panel rehearing and rehearing en banc.



This Week in 340B: April 23 – April 29, 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; Other

  • In a case challenging the New York Department of Health’s 340B Carveout plan, the court scheduled oral argument for July 11, 2024.
  • In a case regarding a state law governing contract pharmacy arrangements, defendant state attorney general filed a brief in reply to plaintiff’s opposition to summary judgment.
  • In the same case regarding a state law governing contract pharmacy arrangements, intervenor-defendants filed a reply in support of its motion for summary judgment.



CMS Advises Preparatory Steps for Anticipated PrEP Coverage Transition to Medicare Part B

On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS did not announce any coverage changes in the fact sheet but is providing advance information to avoid any possible disruptions to beneficiaries should the NCD be issued.

We are closely monitoring this issue and will provide further updates regarding the coverage details and additional guidance in the NCD once it is issued.

Under the proposed NCD, PrEP drugs (which may be covered under Medicare Part D and subject to beneficiary cost-sharing obligations) would be transitioned to Medicare Part B, with no beneficiary cost-sharing obligations. CMS also proposes to cover HIV screening tests and counseling visits under Medicare Part B. This would be consistent with most commercial health insurance and Medicaid plans, which, under the Affordable Care Act, must cover PrEP drugs (oral or injectable), laboratory tests and related clinical visits without cost sharing when prescribed by a healthcare provider.

If the proposed change for PrEP drugs occurs, pharmacies will need to be enrolled in Medicare Part B as either a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) supplier (CMS-855S) or as a Part B pharmacy supplier (CMS-855B). Pharmacies not already enrolled should consider doing so in preparation for the final NCD, as Part B coverage will be effective at the time the final NCD is posted. Pharmacies enrolled in Part B with the provider type [...]

Continue Reading




STAY CONNECTED

TOPICS

ARCHIVES

Chambers 2021 Top Ranked
LEgal 500 EMEA top tier firm 2021
Legal 500 USA top tier firm
U.S. News Law Firm of the Year 2022 Health Care Law