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  • Article

    HRSA Issues New Look-Alike Designation Instructions

    On December 18, 2024, the Health Resources and Services Administration (HRSA) issued new instructions to apply for initial designation as a "look-alike" health center.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Feldesman Leifer
    Feldesman Leifer
  • Article

    340B In The New Environment: Opportunity In Uncertainty

    As a new Congress and Administration begin a dizzying series of initiatives, health centers and others participating in the federal 340B drug discount statute understandably crave predictions...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Feldesman Leifer
    Feldesman Leifer
  • Article

    Client Alert: Potential Delays At Payment Management Services "PMS;" Be Prepared

    Today, the Firm learned that there is a new banner on the U.S. Department of Health and Human Services ("HHS") Payment Management Services ("PMS") website announcing...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Feldesman Leifer
    Feldesman Leifer
  • Article

    OMB Issues Update Narrowing Scope Of Federal Program Pause

    The Office of Management and Budget (OMB) has issued an updated Memorandum clarifying the scope of the pause on federal programs...
    United StatesStrategy
    Feldesman Leifer
    Feldesman Leifer
  • Article

    The 340B Program Rebate Bait-And-Switch

    Federally qualified health centers (FQHCs) and other federal grantees participating in the federal 340B drug discount statute face potentially devastating, practical effects on their ability...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Feldesman Leifer
    Feldesman Leifer
  • Article

    HHS Abandons Part 75 And Adopts Federal Grant Regulations At 2 C.F.R. Part 200

    With the October 1, 2024 deadline for implementation of OMB's Uniform Guidance revisions fast approaching, today the Department of Health and Human Services ("HHS")...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Feldesman Leifer
    Feldesman Leifer
  • Article

    OHS Issues Draft Final Rule Adopting Significant Changes To The Head Start Program Performance Standards

    The Office of Head Start issued a draft of the highly anticipated Final Rule Supporting the Head Start Workforce and Consistent Quality Programming on Friday, August 16, 2024.
    United StatesEmployment and HR
    Feldesman Leifer
    Feldesman Leifer
  • Article

    Client Alert: Funding Pause Memo Rescinded

    On Wednesday afternoon, the White House Office of Management and Budget issued a new memorandum—M-25-14...
    United StatesGovernment, Public Sector
    Feldesman Leifer
    Feldesman Leifer
  • Article

    Client Alert: Latest Executive Order May Reverse Longstanding Interpretation Of PRWORA

    Yesterday, the Executive Order titled "Ending Taxpayer Subsidization of Open Borders" may have upended a 1998 interpretation of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA)...
    United StatesGovernment, Public Sector
    Feldesman Leifer
    Feldesman Leifer
  • Article

    After Almost Two Decades, HHS Issues A New Grants Policy Statement For A New Regulatory Landscape

    The Department of Health and Human Services ("HHS") has just released its long-overdue Grants Policy Statement ("GPS") revision, replacing the 2007 version.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Feldesman Leifer
    Feldesman Leifer
  • Article

    Client Alert: Trump Administration Revives Executive Order Targeting Insulin And Epinephrine Pricing At Health Centers

    On April 15, President Trump signed an Executive Order reviving a previous directive to reduce the cost of insulin and injectable epinephrine for low income individuals.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Feldesman Leifer
    Feldesman Leifer
  • Article

    Will HRSA Continue To Stonewall?

    Most government agencies charged with enforcement responsibilities seek to publicize their enforcement efforts and provide transparency into their standards.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Feldesman Leifer
    Feldesman Leifer
  • Article

    Client Alert:Client Alert:DOJ Announces New "Civil Rights Fraud Initiative" Targeting DEI-Related Violations Under The False Claims Act

    On Monday, May 19, the U.S. Department of Justice issued a memorandum announcing the launch of a new "Civil Rights Fraud Initiative," aimed at investigating and pursuing claims under the False Claims Act...
    United StatesCorporate/Commercial Law
    Feldesman Leifer
    Feldesman Leifer
  • Article

    Latest "Most Favored Nation" Executive Order Falls Short On 340B Relief

    On Monday, May 12, the White House issued an Executive Order (EO) aimed at addressing prescription drug prices. The EO opens with a remarkable claim...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Feldesman Leifer
    Feldesman Leifer
  • Article

    Supreme Court Allows Release Of USAID And State Department Foreign Aid

    Yesterday, the U.S. Supreme Court issued a slip opinion in a widely publicized case, Department of State v. AIDS Vaccine Advocacy Coalition, 604 U.S. ___ (2025).
    United StatesLitigation, Mediation & Arbitration
    Feldesman Leifer
    Feldesman Leifer
  • Article

    Client Alert: HRSA Retraction Reverses Previous Statement On Federal Awards

    On Friday, January 31, 2025, the Health Resources and Services Administration (HRSA) sent to all of its grantees, Health Centers, Ryan White programs and others an email stating the following:
    United StatesFood, Drugs, Healthcare, Life Sciences
    Feldesman Leifer
    Feldesman Leifer
  • Article

    Southern California Dental Offices Settle False Claims Act Allegations For Improper PPP Loans

    The government's focused policing of its massive COVID-19 spending—in particular its Paycheck Protection Program (PPP) lending—continues to yield settlements...
    United StatesCriminal Law
    Feldesman Leifer
    Feldesman Leifer
  • Article

    Client Alert: HHS "Pause" In "Grant Announcements" Under Trump Administration, Meaning Unclear

    As Feldesman monitors the Trump Administration's actions, a significant concern is the "pause" on grant announcements by the U.S. Department of Health and Human Services (HHS).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Feldesman Leifer
    Feldesman Leifer
  • Article

    CY 2026 FTCA Redeeming Applications Due June 27, 2025

    On January 7, 2025, the Health Resources and Services Administration (HRSA) published Program Assistance Letter (PAL) 2025-01, Calendar Year 2026 Requirements...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Feldesman Leifer
    Feldesman Leifer
  • Article

    Client Alert: DEI Executive Orders Injunction: What Grantees Need To Know

    As readers may be aware, two Diversity, Equity and Inclusion ("DEI")-related Executive Orders impacting federal contractors and grantees have been challenged in the Federal District Court...
    United StatesGovernment, Public Sector
    Feldesman Leifer
    Feldesman Leifer

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