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: January 17 – 23, 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 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; Definition of Patient
Where Things Stand:

• A District Court in one case related to the 340B definition of “patient” granted the parties’ Joint Motion to Seal the Certified Administrative Record.
• One case was ordered stayed in consideration of the opinion in AHA v. Becerra, and the parties were instructed to file a joint status report by February 9, 2023.

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




This Week in 340B: January 9 – 16, 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 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; ADR Rule; Definition of Patient
  • Where Things Stand:
    • A District Court issued an opinion in AHA v. Becerra remanding the issue of remedies in the Medicare 340B payment cuts to HHS and declining to vacate the payment rule.
    • Seven cases will remain stayed pending a decision in AHA v. Becerra regarding remedies for the now-vacated 340B Medicare payment cuts.
    • Parties in one case challenging the ADR Rule, which is currently stayed, moved for the dismissal of the action without prejudice.
    • Plaintiffs in one case related to the 340B definition of “patient” filed a Joint Motion to Seal the Certified Administrative Record.

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




This Week in 340B Litigation: January 2 – 9, 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 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 in Developments Last Week: Medicare Payment; HRSA Audit Process
  • Where Things Stand:
    • A Confidentiality Order issued in one case, ordering that certain administrative record and discovery material may be treated as confidential and setting forth the terms and procedure for designating such documents as confidential.
    • Five cases will remain stayed pending a decision in AHA v. Becerra on remedies for the now-vacated 340B Medicare payment cuts. The Court also ordered that the parties in these cases file a Joint Status Report on or before April 10, 2023.
    • Parties in three cases filed a Joint Status Report in their respective courts, requesting that their cases remain stayed pending a remedies decision in AHA v. Becerra.

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.




Doctor-Patient Relationships and Medical Marijuana: Where Are We Now?

On December 2, 2022, President Joseph Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (Cannabis Research Act), which provides a mechanism for industry and academia to access and research cannabis, including marijuana and other cannabis-derived products without violating the Controlled Substances Act (CSA). The Cannabis Research Act creates a pathway for researchers to register with the US Department of Justice to legally conduct scientific research on such products subject to certain requirements. The act also creates a system to allow drug manufacturers to legally produce products approved by the US Food and Drug Administration (FDA) that contain cannabidiol (CBD) or marijuana for commercial sale. Of particular significance for healthcare providers, the Cannabis Research Act also includes a doctor-patient relationship provision that permits state-licensed physicians to discuss the “currently known potential harms and benefits of marijuana and its derivatives, including cannabidiol, which may be derived from marijuana or other cannabis products such as hemp, as a treatment.”

The full provision is provided below:

  • SEC. 301. DOCTOR-PATIENT RELATIONSHIP.
    It shall not be a violation of the Controlled Substances Act (21 U.S.C. 801 et seq.) for a State-licensed physician to discuss—(1) the currently known potential harms and benefits of marijuana derivatives, including cannabidiol, as a treatment with the legal guardian of the patient of the physician if the patient is a child; or (2) the currently known potential harms and benefits of marijuana and marijuana derivatives, including cannabidiol, as a treatment with the patient or the legal guardian of [...]

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Investing in Global Healthcare and Life Sciences

Today’s global healthcare marketplace is marked by unprecedented transformation. This presents both challenges and opportunity to today’s market participants. We know how important it is to structure cross-border investments and transactions to account for complex and ever-shifting regulations.

Within this dynamic environment, McDermott’s health lawyers wield a deep knowledge of how healthcare services, medical technology and pharmaceuticals are delivered around the world, and how the laws that affect those entities and that help drive action are creating the market of tomorrow.

We’re passionate about our role in shaping the alliances that will lead to next-generation digital health technologies, new pharmaceuticals and superior healthcare delivery.

If you’re doing something that’s never been done before, or looking to do something better than it’s ever been done before, we’re here to help. Together, we’re pushing boundaries and knocking down barriers to usher in a new age of healthcare.

Bringing this experience and commercial focus together we are proud to present the International Guide to Investing in Healthcare and Life Sciences.

For each jurisdiction you’ll discover:

  • The impact of COVID-19 on the provision of healthcare and life sciences
  • Ownership or equivalent restrictions in relation to the provision of healthcare services
  • Reimbursement of public or national healthcare services and award of contracts
  • Drug approvals and reimbursement
  • Devices certification and reimbursement
  • Regulation of AI and software as a medical device
  • Telemedicine and teleconsultation
  • Anti-kickback rules and incentives to doctors
  • Merger and foreign investment control
  • Forthcoming and anticipated changes in healthcare and life [...]

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