News & Analysis as of

Administrative Procedure Act Enforcement Actions Department of Health and Human Services (HHS)

Wilson Sonsini Goodrich & Rosati

Texas District Court Vacates 2024 HIPAA Rule Designed to Enhance Reproductive Healthcare Privacy, Effective Nationwide

On June 18, 2025, the United States District Court for the Northern District of Texas vacated most of the rules designed to enhance reproductive healthcare privacy promulgated by the U.S. Department of Health and Human...more

Saul Ewing LLP

Federal District Court Issues Opinion Vacating HHS Rule Protecting Reproductive Health Information

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On June 18, 2025, U.S. District Judge Matthew Kacsmaryk of the Northern District of Texas (the “District Court”) vacated a 2024 final rule issued by the U.S. Department of Health and Human Services (“HHS”) under the Biden...more

Warner Norcross + Judd

Federal Court Vacates HIPAA Rule on Reproductive Health Care Privacy

Warner Norcross + Judd on

Last year, the federal Office for Civil Rights (OCR) modified the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to strengthen protections for reproductive health care information (the “2024 Rule”)....more

McGuireWoods LLP

Fourth Circuit Upholds OIG Advisory Opinion Process

McGuireWoods LLP on

On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services,...more

Troutman Pepper Locke

Federal Appellate Court Agrees that FDA Cannot Regulate “Premium Cigars”

Troutman Pepper Locke on

Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium...more

Mintz - Health Care Viewpoints

EnforceMintz —Could the Supreme Court’s Decision in Jarkesy Mean the End to HHS Civil Monetary Penalty Authorities as We Know...

Last June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy, which holds that the Seventh Amendment entitles a defendant to a jury trial when the Securities and Exchange Commission (SEC)...more

BakerHostetler

DSIR Deeper Dive: Tracking the Crackdown on Tracking/Pixel Technologies: Web Litigation and Regulatory Landscape - Part 2

BakerHostetler on

In the first part of this blog post, we looked into the OCR and FTC’s focus on third-party tracking technologies. We also reviewed the AHA Lawsuit and its impact for the use of tracking technologies. In this blog post, we...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

Foley & Lardner LLP

Court Sides with Drug Manufacturers in Ongoing 340B Litigation

Foley & Lardner LLP on

Over the last year, covered entities participating in the 340B Drug Pricing Program (340B Program) have anxiously monitored a flurry of litigation that could determine the scope of the 340B Program. The litigation and related...more

Sheppard Mullin Richter & Hampton LLP

Secret Rules and Hidden Penalties: Biden Executive Order Takes Aim at the Trump Administration’s Efforts to Limit HHS’s Use of...

Executive Orders and the Biden Administration’s promises to postpone or withdraw certain last-minute, so-called “midnight rules” promulgated by the Trump Administration are currently grabbing everyone’s attention, especially...more

Rivkin Radler LLP

HHS Rule Blocks Enforcement Actions Based Solely On Guidance

Rivkin Radler LLP on

On January 12, the U.S. Department of Health and Human Services (HHS) released a final rule on “Transparency and Fairness in Civil Administrative Enforcement Actions.” The rule, which was effective immediately, states that...more

Sheppard Mullin Richter & Hampton LLP

Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the...

On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a...more

K&L Gates LLP

K&L Gates Triage: The Impact of Allina — Potential Limitation on CMS’s Ability to Recoup Overpayments

K&L Gates LLP on

In this week’s episode, Adam Cooper discusses the Supreme Court’s decision in Azar v. Allina Health Services, as well as a related memorandum issued in late 2019 by the Centers for Medicare and Medicaid Services (“CMS”) that...more

McDermott Will & Schulte

New Guidance on Medicare Payment Rule Enforcement

A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more

McDermott Will & Schulte

Guidance on Guidance: DOJ Limits Use of Agency Guidance Documents in Civil Enforcement Cases

In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions,...more

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