News & Analysis as of

Department of Health and Human Services (HHS) Penalties

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

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On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

ArentFox Schiff

Investigations Newsletter: Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS

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Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS - On July 7, Southern District of New York District Judge Colleen McMahon increased a False Claims Act (FCA) judgment from $136...more

Rivkin Radler LLP

DOJ and HHS Announce FCA Working Group

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On July 2, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced the formation of the DOJ-HHS False Claims Act Working Group to strengthen “their ongoing collaboration to advance...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

2025 Enforcement Trends: Risk Analysis Failures at the Center of HHS’s Multimillion-Dollar HIPAA Penalties

In the first five months of 2025, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced it had entered into ten Health Insurance Portability and Accountability Act (HIPAA) resolution...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

Venable LLP

A Federal Court Hands Employers a Win Against ACA Penalties

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A court in Texas has given employers a new weapon in the fight against Affordable Care Act (ACA) penalties. Under the ACA, a large employer can be subject to penalties if it fails to offer coverage to enough of its...more

Health Care Compliance Association (HCCA)

Disclosure of Full Record to Employer Results in $35K Fine, Broad CAP; Echoes of 2017 HIV Case

It’s not immediately obvious why someone would want to disclose a health care test result as part of a job application. But one such request spurred a Pennsylvania entity to provide a lot more than that: it sent her whole...more

Rivkin Radler LLP

Million Dollar Penalty Imposed on Pain Management Practice Following HIPAA Breach

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The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced on December 3 that it imposed a $1.19 million penalty on Gulf Coast Pain Consultants, a pain management practice in Florida, following...more

Lippes Mathias LLP

Hospital Administrators – Is Your Hospital Cyber-Secure?

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On October 2, 2024, New York adopted new regulations requiring general hospitals to implement heightened cybersecurity safeguards. General hospitals, as defined in Article 28 of the NY Public Health Law, generally must begin...more

BakerHostetler

It’s Officially Enforcement Season: OCR Announces First Penalty Under New Risk Analysis Initiative

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On October 31, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) embraced the end of Spooky Season by announcing two more ransomware-related enforcement actions. ...more

Snell & Wilmer

2024 End-of-Year Plan Sponsor “To Do” List (Part 1) Health and Welfare

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We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate SW Benefits Updates. This Part 1 covers year-end health and welfare plan issues. Parts 2,...more

Davis Wright Tremaine LLP

21st Century Cures Act Information Blocking Rule Finally Has Teeth With Respect to Providers

On July 1, 2024, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) published a final rule...more

Clark Hill PLC

Right To Know - June 2024, Vol. 18

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Cyber, Privacy, and Technology Report - Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed....more

Holland & Hart LLP

Avoiding HIPAA Penalties: A Checklist for Covered Entities

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The HIPAA Privacy, Security, and Breach Notification Rules apply to healthcare providers who engage in certain electronic transactions, healthcare clearinghouses, and health plans, including employee group health plans with...more

Mintz - Health Care Viewpoints

HHS Health Care Cybersecurity Performance Goals: Proposed Incentives, Penalties and Compliance Standards

As promised in the U.S. Department of Health and Human Services (HHS) concept paper in December 2023, the agency published voluntary health care and public health cybersecurity performance goals (HPH CPGs) in January 2024 and...more

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

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The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Sheppard Mullin Richter & Hampton LLP

HHS Announces 42 Part 2 Final Rule to Align with HIPAA

The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance...more

Davis Wright Tremaine LLP

Old Rule, New Tricks: HHS Finalizes Most Substantial Changes to Substance Use Disorder Confidentiality Rule in Decades

The long-anticipated final rule addressing substance use disorder (SUD) records at 42 C.F.R. Part 2, commonly referred to as Part 2, is here. The final rule is a joint undertaking by the U.S. Department of Health and Human...more

Foley & Lardner LLP

HIPAA and Part 2 Harmonized: What Health Care Organizations Need to Know

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Substance Use Disorder (SUD) programs and HIPAA-regulated entities seeking to streamline their privacy and security practices and workflows received welcome news from the U.S. Department of Health & Human Services (HHS) last...more

Seyfarth Shaw LLP

Child Labor Law Penalties on the Rise – Employers Face Various Avenues to Increased Exposure

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Seyfarth Synopsis: Child labor laws remain fertile ground for government enforcement as evaluate key issues for 2024. Late last year, the Wage Hour Division released guidance for new processes to assess greater penalties...more

Burr & Forman

Proposed Penalties for Information Blocking Violations

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On October 30, 2023, the Department of Health and Human Services (HHS) released a proposed rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century...more

Harris Beach Murtha PLLC

HHS Office of Inspector General October 2023 Enforcement Activity

The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

Snell & Wilmer

2023 End-of-Year Plan Sponsor “To Do” Lists (Part 1) Health and Welfare

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We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate Employee Benefits Updates. This Part 1 covers year-end health and welfare plan issues....more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Deeper Dive into Other Controversies of the IRA’s Medicare Drug Price Negotiation Program

The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more

Foley & Lardner LLP

Ensuring Child Labor Law Compliance Amid Growing Scrutiny

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In February, the New York Times published an investigative report regarding alleged employment of underage migrants, many from Central America, at U.S. companies. While employment of certain minors is permitted under federal...more

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