News & Analysis as of

Department of Health and Human Services (HHS) Enforcement

Sheppard Mullin Richter & Hampton LLP

DOJ False Claims “Working Group” Update

ICYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS) to enforce the False Claims Act...more

Epstein Becker & Green

Texas Judge Strikes Down HIPAA’s Reproductive Health Amendment

Epstein Becker & Green on

Last month, Judge Matthew Kaszmaryk of the U.S. District Court, Northern District of Texas, in Purl v. United Stated Department of Health and Human Services, No. 2:24-cv-00228-Z (N.D. Tex Jun. 18, 2025) struck down nearly all...more

Ropes & Gray LLP

Closeout Requirements During Appeals of Terminations of NIH Research Grants

Ropes & Gray LLP on

On July 7, 2025, the National Institutes of Health (NIH) Office of Policy for Extramural Research issued NOT-OD-25-128, titled “Guidance on Enforcement of Closeout Requirements During the Appeals Process” (the Notice). The...more

Foley & Lardner LLP

DOJ-HHS False Claims Act Working Group: Focus on Medicare Payment Suspensions

Foley & Lardner LLP on

n a July 2, 2025, press release, the U.S. Department of Justice (DOJ) announced a new “DOJ-HHS False Claims Act Working Group” (the Working Group) and identified multiple priority enforcement efforts for the Working Group to...more

Husch Blackwell LLP

DOJ and HHS Launch New False Claims Act Working Group: What The Healthcare Industry Needs to Know

Husch Blackwell LLP on

On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...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

Akin Gump Strauss Hauer & Feld LLP

Eliminating Waste, Fraud, and Abuse in Medicaid (Trump EO Tracker)

This memorandum directs the Secretary of Health and Human Services to take appropriate action to eliminate waste, fraud, and abuse in Medicaid, including by ensuring Medicaid payments rates are not higher than Medicare....more

Health Care Compliance Association (HCCA)

‘I Really Wanted to Stay’: Amid Success, Regrets, OHRP’s Kaneshiro Hopes Agency Will Be Rebuilt

When Jerry Menikoff retired at the end of 2022 after leading the HHS Office for Human Research Protections (OHRP) for 14 years, he left behind an agency limping along with 20 employees, less than half of what it needed. For...more

Mintz

Trump Signs Most-Favored-Nation Executive Order - Potential Impact on Drug Supply Chain

Mintz on

After significant fanfare and anticipation, President Trump issued his “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order) this week. The Executive Order seeks to...more

Health Care Compliance Association (HCCA)

And Then There Were Nine: Disappearing OHRP To Join Enforcement Agency; NIH Cuts Outlined

When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...more

Goodwin

The Impact of Trump’s Executive Order on Eliminating Information Silos

Goodwin on

Hello, everyone. My name is Allan Medina. I am a partner in Goodwin’s Washington, DC, office, with a practice focus on government investigations. I’m here with Liza Craig, who is also a partner in the DC office. We are...more

Health Care Compliance Association (HCCA)

OCR Loses Staff, Faces Move to New ‘Enforcement’ Office; Will HIPAA Focus, Independence Suffer?

Today, the HHS Office for Civil Rights (OCR) stands shoulder-to-shoulder with the likes of the Office of Inspector General and Office of General Counsel, one of just a dozen or so agencies reporting directly to the secretary....more

Dentons

Ep. 52 – Prioritize Hospital Price Transparency Compliance

Dentons on

On February 25, 2025, President Trump signed an Executive Order directing federal agencies to “rapidly implement and enforce” federal healthcare price transparency regulations....more

McCarter & English, LLP

Federal Courts Decide on FCA Claims Actions

There are still several unsettled legal issues regarding the standards applicable to a False Claims Act (FCA) claim, such as the standard to prove causation when an FCA claim is based on a violation of the Anti-Kickback...more

Verrill

Healthcare Costs Demystified: Trump's New Executive Order on Healthcare Price Transparency Explained

Verrill on

President Trump’s Executive Order 14224 reinforces and expands a 2019 Executive Order which aimed to improve healthcare price transparency. On February 25, 2025, President Trump signed a new 2025 Executive Order entitled...more

Akin Gump Strauss Hauer & Feld LLP

Making America Healthy Again By Empowering Patients With Clear, Accurate, and Actionable Healthcare Pricing Information (Trump EO...

The EO announces a policy of the United States to put patients first and ensure they have the necessary information to make well-informed healthcare decisions. The order builds upon Executive Order 13877 (Improving Price and...more

Bass, Berry & Sims PLC

Fourth Circuit Holds that Violation of CIA Can Support Reverse False Claims and Adopts Relaxed Rule 9(b) Presentment Requirement

Bass, Berry & Sims PLC on

On February 3, the U.S. Court of Appeals for the Fourth Circuit reversed a district court’s grant of a motion to dismiss, holding in relevant part that: - Violations of a Corporate Integrity Agreement (CIA) can create an...more

McDermott Will & Schulte

HHS OIG Releases Updated Nursing Facility Compliance Program Guidance: Quality and Safety Lessons

Nursing facilities and skilled nursing facilities that participate in the Medicare and Medicaid programs must comply with certain mandatory compliance program requirements of participation (ROPs). Under the Biden...more

McDermott Will & Schulte

This Week in 340B: January 14 – 20, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Foley Hoag LLP

Health Care Fraud Enforcement in 2025

Foley Hoag LLP on

We kick off our annual Year in Preview series with a comprehensive look at health care fraud enforcement in 2025. This post proceeds in three parts. First, we explore what the second Trump administration might bring, looking...more

ArentFox Schiff

At Long Last, the OIG Issues Its Compliance Program Guidance for Nursing Facilities

ArentFox Schiff on

On November 20, 2024, the US Department of Health and Human Services, Office of Inspector General (OIG) issued its Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (Nursing Facility ICPG)....more

Lowenstein Sandler LLP

In Trump’s Second Term, Healthcare Enforcement May Remain Business as Usual

Compared with other issues, healthcare enforcement during President-elect Donald Trump’s upcoming second term has received little attention. When he takes office again on January 20, should industry actors like pharmaceutical...more

King & Spalding

Texas Sues Federal Government to Protect Medicaid Financing

King & Spalding on

On December 11, 2024, the Texas Health and Human Services Commission filed a complaint in the United States District Court for the Western District of Texas. The complaint seeks to block the enforcement of a May 9, 2014,...more

ArentFox Schiff

HIPAA Reproductive Privacy Rule Takes Effect Amid Legal and Political Uncertainties

ArentFox Schiff on

As of December 23, health care providers, health plans, and health care clearinghouses (covered entities) and their business associates (collectively, regulated entities) must comply with new reproductive health care privacy...more

Foley & Lardner LLP

HIPAA Reproductive Health Care Amendments: Compliance in an Uncertain Enforcement Landscape

Foley & Lardner LLP on

The amendments to the HIPAA Privacy Rule designed to protect reproductive health care information (Amendments) are under legal challenge as the compliance date quickly approaches. As discussed in more detail in our...more

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