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Department of Health and Human Services (HHS)

Polsinelli

Five Things Every Health Care Provider Should Know About HHS OIG’s 2025 Semiannual Report

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On June 2, 2025, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) published its Semiannual Report to Congress. This report covers the period from October 1, 2024, through March 31, 2025,...more

Epstein Becker & Green

OIG Says Medical Device Company's Proposal to Pay for Exclusion Screening for Customers May Violate the Anti-Kickback Statute

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On June 20, 2025, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued an unfavorable advisory opinion - OIG Advisory Opinion 25-04 (“AO 25-04”)....more

Latham & Watkins LLP

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

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President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

Stevens & Lee

HIPAA Final Rule on Reproductive Health Care Privacy Struck Down

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In June 2024, the U.S. Department of Health & Human Services’ Office for Civil Rights (HHS) issued a Final Rule modifying the HIPAA Privacy Rule to enhance reproductive health care privacy affecting all HIPAA covered entities...more

Epstein Becker & Green

Agencies’ Listening Sessions to Focus on Lowering Drug Prices Through Competition

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The Federal Trade Commission (FTC) and the Antitrust Division of the U.S. Department of Justice (DOJ), along with the U.S. Department of Commerce and the U.S. Department of Health and Human Services (collectively, “the...more

Holland & Knight LLP

FDA Announces "National Priority Voucher" Program to Accelerate Reviews of New Drugs

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The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced on June 17, 2025, the creation of a new initiative called the "Commissioner's National Priority Voucher" (CNPV)...more

Foley Hoag LLP

CMS Rescinds Post-Dobbs EMTALA Guidance, Raising New Questions for Emergency Departments

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I. Key Takeaways - Federal enforcement under the Emergency Medical Treatment and Labor Act (EMTALA) may be changing after the Centers for Medicare & Medicaid Services (CMS) rescinded guidance issued under the Biden...more

Bass, Berry & Sims PLC

Court Vacates HIPAA 2024 Final Rule Related to Reproductive Health Care Privacy

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On June 18, 2025, the U.S. District Court for the Northern District of Texas issued an opinion that vacates the 2024 final rule that enhanced privacy protections for protected health information (PHI) related to reproductive...more

Morgan Lewis

On the Basis of Sex: HHS Rescinds Prior Section 1557 Guidance Interpreting Sex-Based Discrimination

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The US Department of Health and Human Services (HHS) has rescinded several pieces of informal guidance, including its 2021 interpretation of Section 1557 of the Affordable Care Act (Section 1557), in response to executive...more

Dorsey & Whitney LLP

HIPAA’s 2024 Reproductive Health Rule is Vacated Nationwide - One Year After Going Into Effect

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On June 18, 2025, a Texas court issued a ruling that vacated, on a nationwide basis, the HIPAA Privacy Rule to Support Reproductive Health Care Privacy (the “Reproductive Health Rule”), just one year after the rule went into...more

Pullman & Comley - Labor, Employment and...

Federal Court Decision Reshapes ACA Enforcement by HHS and IRS

The recent federal district court decision in Faulk Company, Inc. v. Xavier Becerra, et al., No. 24-cv-00609-P (N.D. Tex. 2025) significantly alters the primary mechanism used by the U.S. Department of Health and Human...more

Holland & Knight LLP

HIPAA's Reproductive Health Rule Is Vacated Nationally

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The U.S. District Court for the Northern District of Texas on June 18, 2025, issued an order vacating the HIPAA Privacy Rule to Support Reproductive Health Care Privacy, published on April 26, 2024, which amended the Health...more

DLA Piper

OIG Issues Favorable Advisory Opinion on Telehealth Marketplace MSO-PC Arrangement

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The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion under the federal Anti-Kickback Statute (AKS), wading into the world of not only telehealth but also...more

Woods Rogers

Supreme Court’s Skrmetti Decision Redefines Legal Landscape for Gender-Affirming Care for Youth

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On Wednesday, June 18, 2025, the Supreme Court of the United States issued a landmark 6-3 decision in United States v. Skrmetti, directly addressing the constitutionality of state laws banning gender-affirming care for...more

Robinson+Cole Health Law Diagnosis

OIG Green Lights MSO Model Arrangement for Telehealth Platforms in New Advisory Opinion

On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03 (the Advisory Opinion), in which OIG approved of a proposed arrangement under which a management...more

Holland & Knight LLP

Holland & Knight Health Dose: June 17, 2025

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The U.S. Senate is in session for three days this week while the U.S. House of Representatives is in recess all week. Both chambers will return for a week before breaking for the July 4 recess. Negotiations on the...more

McDermott+

Health Information Technology Policy Under the Trump Administration

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Patient engagement. Information blocking. Interoperability. These buzz words are flying around the health information technology (HIT) world as the Trump administration starts to make its mark on the HIT policy landscape....more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - June 2025 #2

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Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more

Health Care Compliance Association (HCCA)

From $5,000 to $800,000: Days Apart, OCR Security Settlements Show Puzzling Math

A single incident that may have started as a personal vendetta or an extortion threat seven years ago has cost a Florida health care system $800,000, and comes on the heels of an unrelated breach suffered by a different...more

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

McGuireWoods Consulting

Trump’s Health Care Budget Cuts: Part Three

The President’s Budget Request Impact on Programs for the Disabled and Older Americans Act Programs - This is part three of a series on health care budget cuts....more

Ropes & Gray LLP

With Implementation Deadline Looming, ORI Releases Sample Research Misconduct Policies and Procedures

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On June 4, 2025, the U.S. Department of Health and Human Services Office of Research Integrity (“ORI”) published a Sample Policies and Procedures for Addressing Allegations of Research Misconduct (“Sample Policy”) to align...more

Paul Hastings LLP

Recent Investigations by the Texas Attorney General Piggyback on Federal ‘Make America Healthy Again’ Initiatives

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Texas Attorney General Ken Paxton recently announced that his office is investigating some of the country’s most ubiquitous home brands — including Colgate-Palmolive, Proctor & Gamble, and General Mills — for allegedly...more

Husch Blackwell LLP

False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?

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Host Jonathan Porter welcomes to the show Husch Blackwell partner Brian Flood to discuss how newly appointed personnel in the Trump administration could impact False Claims Act (FCA) enforcement for the remainder of 2025 and...more

McDermott+

McDermott+ Check-Up: June 13, 2025

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THIS WEEK’S DOSE - - Reconciliation Moves Forward. Senate committees continue to release their reconciliation provisions. - NIH Director Testifies on FY 2026 Budget. National Institutes of Health (NIH) Director Bhattacharya...more

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