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Healthcare Civil Monetary Penalty

Burr & Forman

Federal Agency Deference Eliminated, Now What?

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On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

Foley & Lardner LLP

Health Care Enforcement: “Tea Leaves” in the 2024 National Health Care Fraud Summer Takedown

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Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 4, August 2024

Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more

Foley & Lardner LLP

Health Care Investing: Washington’s Continued Assault Reflected in “Corporate Crimes Against Healthcare Act of 2024”

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On June 11, Senators Elizabeth Warren (D-Mass) and Edward Markey (D-Mass) introduced a bill titled “The Corporate Crimes Against Healthcare Act of 2024.” The proposed Act would criminalize acts of senior executives who...more

Hinch Newman LLP

Whoa! U.S. Lawsuit Against Telehealth Providers and Executives Should Turn Heads

Hinch Newman LLP on

On June 10, 2024, the U.S. Justice Department announced that together with the Federal Trade Commission, it filed an amended complaint against telehealth company Cerebral Inc., Cerebral’s founder and former Chief Executive...more

Gardner Law

CMS Audits on the Horizon: Prepare for Increased CMS Audits Under the Sunshine Act

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Historically, the Centers for Medicare and Medicaid Services (“CMS”) has not aggressively pursued enforcement activity under the Sunshine Act. However, this may change in 2024. Late last year, CMS updated its Open Payments...more

Health Care Compliance Association (HCCA)

Privacy Briefs: May 2024

Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more

Cozen O'Connor

Indiana AG Sues Apria Healthcare for Data Breach(ing HIPAA Duties)

Cozen O'Connor on

Indiana AG Todd Rokita sued home healthcare equipment and services provider Apria Healthcare, LLC for allegedly failing to investigate and inform consumers regarding data breaches beginning in 2019 in violation of state data...more

Health Care Compliance Association (HCCA)

In Biggest Stark-Based FCA Settlement Ever, Indiana Hospital Pays $345M, Has Unusual CIA

Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more

Bass, Berry & Sims PLC

District Court Finds that $487 Million False Claims Act Judgment Violates Eighth Amendment

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On February 8, the U.S. District Court for the District of Minnesota ruled that a $487 million False Claims Act (FCA) damages award entered last year against Precision Lens and its co-founder violated the Eighth Amendment’s...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2023

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more

Skadden, Arps, Slate, Meagher & Flom LLP

FTC Enforcement Trends in Consumer Protection Under the Biden Administration

The Federal Trade Commission (FTC or the Commission) has continued aggressive regulation in the consumer protection space under the Biden administration. This persistent approach has occurred even in the face of recent...more

Bass, Berry & Sims PLC

Déjà vu? OIG Reiterates Concerns about Providing Free Items or Services to Federal Healthcare Program Beneficiaries

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On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more

Davis Wright Tremaine LLP

California's New Employment Laws: Get Ready for 2024

Governor Newsom signed into law a plethora of bills that significantly expand the rights of employees in California, although notably vetoing a bill that would have prohibited caste discrimination. Most of the new laws take...more

Troutman Pepper

CMS Publishes Final Rule on Civil Monetary Penalties for Section 111 Reporting

Troutman Pepper on

The Centers for Medicare and Medicaid Services (CMS) published the final rule outlining how civil monetary penalties will be calculated and imposed when Responsible Reporting Entities (RRE) fail to meet their Medicare...more

Quarles & Brady LLP

Million Dollar Maybe: Enforcement of Cures Act Information Blocking Prohibitions Begins

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As of September 1, 2023, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) can officially begin enforcement against Certified Health Information Technology (“HIT”) developers, health...more

King & Spalding

OIG Publishes the Spring 2023 Semiannual Report to Congress

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OIG released its Semiannual Report to Congress (the Report) which summarizes the agency’s activities from October 1, 2022, through March 31, 2023 (the Reporting Period). Among other accomplishments, the Report highlights...more

Gardner Law

Healthcare Enforcement in a Post-Pandemic World

Gardner Law on

After a year-over-year reduction in drug, device, and biologic Warning Letters from 2012 through 2019, Warning Letters spiked to pre-2014 levels in 2020 during the pandemic. This was due in large part to a significant number...more

Sheppard Mullin Richter & Hampton LLP

CMS Releases CY2024 Final Rule for PACE Organizations

On April 12, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released a final rule updating key regulations pertaining to Programs of All-Inclusive Care for the Elderly (“PACE”) (the “Final Rule”). Overall, these...more

Perkins Coie

FTC Claims Sharing User Health Data With Advertising Platforms Is a “Security Breach”

Perkins Coie on

For the first time, the Federal Trade Commission has brought an enforcement action under its 2009 Health Breach Notification Rule (HBNR). The case was brought against a digital health company, GoodRx Holdings, Inc., for...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 22, Number 11. MD Anderson Won Against OCR, But Agency’s Response—Including on Fines—Keeps...

Report on Patient Privacy Volume 22, Number 11. (November 2022) Nearly five years passed from the time the University of Texas MD Anderson Cancer Center reported to the HHS Office for Civil Rights (OCR) that three...more

Nelson Mullins Riley & Scarborough LLP

Comparison of Three Federal Fraud and Abuse Laws

In the post-COVID era, health care fraud and abuse issues will be aggressively and swiftly enforced by the government. The legal framework and regulations in the health care space can be intimidating. Below is a comparison of...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 22-19: OIG Warns That Proposed Drug Cost Subsidization Arrangement May Warrant Sanctions

On October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the...more

Foley & Lardner LLP

FTC Imposes Civil Penalty for Faulty “Messenger Model” Contracting

Foley & Lardner LLP on

On September 30, the Federal Trade Commission (FTC) filed a complaint and proposed judgment in U.S. District Court for the District of Columbia against San Juan IPA, Inc. (San Juan) for allegedly operating an unlawful...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 22-16: OIG Declines to Impose Sanctions for Arrangement Involving Provision of Gift Cards to Patients for...

On August 19, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-16 (Advisory Opinion) in which it declined to impose sanctions for an arrangement under which the requestor provides gift cards to...more

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