News & Analysis as of

Health Care Providers Regulatory Violations

Orrick, Herrington & Sutcliffe LLP

Medical Devices, Cybersecurity & The False Claims Act: What are the Key Takeaways from the Illumina - DOJ Settlement?

Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2024

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Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements related to alleged kickbacks, medically...more

Dentons

DOJ Reports Record False Claims Act Settlements & Judgments in FY 2023

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Fiscal year 2023 saw record recoveries and the highest number of settlements and judgments ever under the Federal False Claims Act. According to a new report released by the United States Department of Justice (“DOJ”), the...more

Robinson+Cole Data Privacy + Security Insider

NYAG Settles with Healthplex for $400,000

On December 8, 2023, New York Attorney General Leticia James penned her approval to an Assurance of Discontinuance with third party dental administrator Healthplex, settling the enforcement action for $400,000 and a litany of...more

Robinson+Cole Health Law Diagnosis

DOJ Announces $3.8 Million Settlement to Resolve Allegations of False Claims Act and Anti-Kickback Statute Violations

On February 9, 2022, the United States Department of Justice (DOJ) announced a $3.8 million settlement with Catholic Medical Center (CMC) of Manchester, New Hampshire. This settlement resolves allegations that CMC violated...more

Jones Day

Fourth Circuit Limits Who Can Act "Knowingly" Under False Claims Act

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Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more

Akerman LLP - Health Law Rx

Hot off the Press! The OIG Revises its Self-Disclosure Protocol for the First Time in Several Years

For the first time since 2013, on November 8, 2021, the Department of Health and Human Services Office of Inspector General (“OIG”) updated its Health Care Fraud Self-Disclosure Protocol (“SDP”). The updated SDP makes several...more

McDermott Will & Schulte

[Webinar] Regulatory Disputes with HHS: When to Negotiate and When to Litigate - March 25th, 12:00 pm - 1:00 pm EST

For healthcare and life sciences companies, regulatory disputes with the U.S. Department of Health and Human Services (HHS) and its operating divisions can present significant economic costs and reputational risks. Efficient...more

Robinson+Cole Data Privacy + Security Insider

Renown Health Pays $75,000 to Settle Right-of-Access Violation Under HIPAA

Renown Health, P.C. (Renown), a non-profit health system in Nevada, settled with the U.S. Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services in a matter resulting from an enforcement action for...more

Bricker Graydon LLP

HHS OCR announces results of most recent round of HIPAA audits

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On December 17, 2020, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued its Industry Report on the HIPAA audits it conducted in 2016 and 2017. OCR found widespread noncompliance with...more

ArentFox Schiff

FDA Proposes to Revise “Intended Use” Regulations (Again) to Clarify that Knowledge Alone Is Not Sufficient to Establish Intent

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Last week FDA published a proposed rule that would revise the agency’s “intended use” regulations to clarify that a manufacturer’s knowledge of off-label use of its drug or device is, by itself, not sufficient to establish a...more

Bricker Graydon LLP

OCR settles five additional cases in HIPAA Right of Access Initiative

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In 2019, the Department of Health and Human Services Office of Civil Rights (OCR) announced the Right of Access Initiative, promising to vigorously enforce the rights of patients to receive copies of their medical records...more

Polsinelli

Georgia Senate Approves HB 987

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On June 24, 2020, the Georgia Senate approved HB 987. The bill provides additional measures of protection for residents of assisted living facilities and personal care homes. The bill had previously passed the Georgia House,...more

McDermott Will & Schulte

Healthcare Enforcement Quarterly Roundup - Q4 2019

In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more

Ballard Spahr LLP

HIPAA 2019 Year in Review: OCR’s Enforcement of HIPAA Security Rule

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Although the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) may yet announce one or two year-end settlements, it appears that 2019 will be known more for the implementation of changes in...more

Ballard Spahr LLP

OCR Hits Health System with $2.2M Fine for HIPAA Violations

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The U.S. Department of Health and Human Services Office of Civil Rights (OCR) imposed $2,154,000 in civil monetary penalties against Jackson Health System in Florida for failing to meet HIPAA privacy and security...more

Akerman LLP - Health Law Rx

Direct Patient Billing Can Create Provider Liability in Florida

To bill or not to bill, that is the question. Or, more appropriately, who to bill and when to bill, that is the question. Providers who bill patients under the circumstances described below may face liability. ...more

Akerman LLP - Health Law Rx

Healthcare Providers Must Remember HIPAA Before Responding to Online Reviews

The latest HIPAA resolution agreement by the U.S. Department of Health and Human Services Office for Civil Rights (OCR) is a reminder that healthcare providers must take the high road when responding to unflattering online...more

Ballard Spahr LLP

OCR Announces $10,000 Settlement for Disclosure of Patients’ PHI through Social Media

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The Office for Civil Rights (OCR) at the Department of Health and Human Services announced it reached a settlement with Elite Dental Associates of Dallas (Elite) to resolve a complaint alleging Elite impermissibly disclosed a...more

Bricker Graydon LLP

Recent Stark Act decision could have significant impact for employed physicians compensated based on personal productivity

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On September 17, 2019, the Third Circuit Court of Appeals issued a decision with potentially far-reaching consequences involving the Stark Act. The case, United States ex rel. Bookwalter v. UPMC, involves allegations that a...more

Bricker Graydon LLP

OCR begins HIPAA right of access enforcement initiative

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Over the past several years, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) has taken various steps to ensure compliance with the right of access by covered entities. The Phase 2 audits...more

Ballard Spahr LLP

HHS Decreases Maximum HIPAA Penalties

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The Department of Health and Human Services has announced that it is lowering the maximum amount it will assess for most types of HIPAA violations. Although the change is couched as an exercise of discretion, HHS states that...more

Miles & Stockbridge P.C.

Department of Health and Human Services: HIPAA Violation Maximum Penalties Update

On Friday, April 26, the Department of Health and Human Services (HHS) issued a notice regarding maximum penalties for HIPAA violations. HHS has now stated that it is exercising its discretion in how it applies the assessment...more

Polsinelli

Historic State AG HIPAA Filing: An Important Case We Are Watching

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In December 2018, twelve state Attorneys General ("AGs") jointly filed suit against Medical Informatics Engineering, Inc. (“MIE”) claiming it violated the Health Insurance Portability and Accountability Act and its related...more

Smith Debnam Narron Drake Saintsing & Myers,...

Second Circuit Holds Flu Shot Reminder Did Not Violate the TCPA

The Second Circuit has affirmed a lower court decision that a flu shot reminder sent by text message by a medical provider did not violate the Telephone Consumer Protection Act (the “TCPA”). The decision is important because...more

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