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  • Article

    Appeals Court Enjoins Minnesota Generics Pricing Law

    On June 12, the U.S. Court of Appeals for the Eighth Circuit upheld a federal district court's order that preliminarily enjoined enforcement of Minnesota's law controlling price increases...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    CMS Approves 35 States To Participate In Its Cell And Gene Therapy Model

    On April 25, HHS Secretary Robert F. Kennedy Jr. said that 35 states have agreed to participate in the Center for Medicare & Medicaid Services...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    CMS Finalizes Organ Transplant Access Model

    On November 26, the Centers for Medicare & Medicaid Services (CMS) finalized its Increasing Organ Transplant Access (IOTA) Model, which aims to increase access to kidney transplants...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    CMS Releases New Data And Guidance On Medicaid And CHIP Application Processing

    This overview is excerpted from Manatt on Health, Manatt's subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    Court Strikes Down FDA's Final Rule On Laboratory-Developed Tests

    On March 31, the U.S. District Court for the Eastern District of Texas issued a significant opinion in the case of ACLA et al. v. FDA.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    Examining The Financial Structure And Performance Of Rhode Island's Acute Hospitals And Health Systems

    This study uses publicly available data to examine the financial structure and performance of acute hospitals and health systems in Rhode Island (RI) and compare trends with Connecticut (CT) and Massachusetts (MA).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    Future Of Health: Imperatives For Advancing Data Sharing To Support Digitally Enabled Care

    Traditional brick-and-mortar health care organizations and digital health companies are actively partnering to provide novel, digitally enabled care models to patients.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    Government Shutdown Drags On Amid Little Optimism For Compromise

    Federal fiscal year (FY) 2026 kicked off on October 1 amid a congressional stalemate resulting in a government shutdown.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    HHS Announces Restrictions, New Framework For COVID-19 Vaccines

    On May 20, FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad published an editorial outlining FDA's new approach...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    HHS Partners With Plans To Announce Improvements On Prior Authorizations

    On June 23, HHS Secretary Kennedy and CMS Administrator Dr. Mehmet Oz held a roundtable with health insurance companies to discuss a new pledge to "streamline and improve the prior authorization processes...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    HHS Rescinds Guidance Aimed At Protecting Emergency Abortions, Commits To FDA Review Of Medication Abortion

    On June 3, HHS and the CMS announced the rescission of 2022 guidance directing hospitals and their physicians to provide abortions in emergency scenarios, regardless of conflicting state laws.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    Lykos MDMA Submission Series A

    On December 11, 2023, following positive results from two published Phase 3 studies, MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA)...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    NIH Terminates Grants That No Longer Align With The Administration's Priorities

    Notably, many of these grants had been awarded to Columbia University, which had nearly $400 million in federal grants and contracts canceled by the Administration earlier this month because of alleged inaction over antisemitic events on campus.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    North Carolina Hospitals Sue Medicare Advantage Plans For 340B Underpayments

    Earlier this month, several hospitals affiliated with the University of North Carolina health system filed multiple lawsuits against a group of Medicare Advantage (MA) plans regarding...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    Patient Impact Of The Inflation Reduction Act

    As part of IRA implementation and in advance of calendar year 2025, which is when the implementation of Part D redesign changes accelerate, CMS could take steps to protect beneficiaries by preserving access...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    PBMs Sue Arkansas Over Pharmacy Ownership Prohibition

    On June 9, the Pharmaceutical Care Management Association (PCMA), a national association representing pharmacy benefit managers (PBMs), and Navitas Health Solutions, a PBM, filed a lawsuit...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    Trump Administration Announces U.S.-EU Trade Agreement, Including New Tariff Levels For Pharmaceuticals And Carveout For Generics

    On August 21, the U.S. and the European Union (EU) issued a joint statement announcing a framework on a new trade agreement, including the key terms on pharmaceutical tariffs.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    President Trump Signs EO Directing Government's Response To Sanctuary Jurisdictions

    On April 28, the Trump Administration released an executive order (EO), titled "Protecting American Communities from Criminal Aliens," which explicitly targets "sanctuary" jurisdictions (states and localities)...
    United StatesImmigration
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    Change In Retention Cap For Private Projects In California

    Starting on January 1, 2026, California will enforce a new law that limits retention in private construction contracts to 5%, aligning private projects (where retention is typically 10%) with public works...
    United StatesReal Estate and Construction
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP
  • Article

    Manatt's Artificial Intelligence Package Offering

    To help you build an effective AI compliance program, Manatt has developed a packaged solution. This solution draws on extensive research and the cross-disciplinary knowledge of many Manatt professionals.
    United StatesTechnology
    Manatt, Phelps & Phillips, LLP
    Manatt, Phelps & Phillips, LLP

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