News & Analysis as of

Compliance Department of Health and Human Services (HHS) Trump Administration

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check July 2025

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In the early days of the second Trump Administration, several federal funding agencies announced caps to indirect cost (“IDC”) rates for federally funded research awards. In many cases, these caps would substantially reduce...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

White & Case LLP on

On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...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

Health Care Compliance Association (HCCA)

Former OCR Director Fontes Rainer Reflects On ‘Imperfect’ RSP Law, Urges Final Security Reg

In October, the HHS Office for Civil Rights (OCR) fined Providence Medical Institute (PMI) $240,000, an amount that reflected a 20% discount for having “recognized security practices” (RSPs) in place. But many more covered...more

Bass, Berry & Sims PLC

Healthcare Regulatory & Compliance Summit 2025 Recap

Health Policy Fireside Chat: What to Expect from the New Administration - Bill Mathias, Member at Bass, Berry & Sims, engaged in a fireside chat with Colin Roskey, Principal at FHP Strategies, former Deputy Assistant...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

McDermott+

Trump Administration Executive Order Tracker

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Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Saul Ewing LLP

Trump on Transparency: Making America Healthy Again Through Executive Order 14221; How Plan Sponsors Can Respond

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One mandate under the PPACA required health care providers, non-grandfathered health insurance issuers and self-insured group health plans to provide consumers with access to information about the cost of services before they...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

Health Care Compliance Association (HCCA)

‘Waking Up With Panic Attacks’: NIH 15% Plan Caps Tumultuous Weeks Under New Administration

If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more

Robinson+Cole Health Law Diagnosis

Trump Administration Issues Executive Order Prioritizing Hospital Price Transparency Enforcement

On February 25, 2025, President Donald Trump issued an Executive Order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the 2025 Order). The...more

Snell & Wilmer

Healthcare Price Transparency Executive Order Mandates Enforcement

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On Tuesday, February 25, 2025, President Trump signed an Executive Order aimed at promoting healthcare price transparency (the 2025 Executive Order).1 The 2025 Executive Order mandates that certain federal departments must...more

Sheppard Mullin Richter & Hampton LLP

Updated: The Future of Gender-Affirming Care – New Legal and Regulatory Considerations for Hospitals Providing These Services

As legal and policy developments continue to evolve, hospitals and health care professionals that provide gender-affirming care face new uncertainties regarding federal funding, compliance, and patient access. While these...more

McDermott Will & Emery

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

McDermott Will & Emery on

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

Davis Wright Tremaine LLP

HIPAA Security Rule Resolves To Hit the Gym and Bulk Up

For more than 20 years, the HIPAA Security Rule has been virtually unchanged other than extending its scope beyond covered entities to also include business associates. During that time, technology has changed, cybersecurity...more

Brownstein Hyatt Farber Schreck

Bipartisan AI Task Force Report Sets the Stage for Health Care AI Action in 2025

The House Task Force on Artificial Intelligence (AI) released a comprehensive 253-page report providing a roadmap for Congress as it develops policies to regulate and optimize the use of this rapidly advancing technology. The...more

Health Care Compliance Association (HCCA)

[Event] Virtual 2020 New York Regional Conference - May 8th, New York, NY

Regional Virtual Healthcare Compliance Conference Overview - Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your...more

Hogan Lovells

Why Healthcare and Life Sciences Companies Need to Step Up Their Compliance Efforts in Advance of a U.S. Government Investigation

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In this hoganlovells.com interview, Hogan Lovells partner Gejaa Gobena discusses how the perception of compliance, remediation, and self-disclosure has evolved in the eyes of government prosecutors from how they factor at...more

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