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Department of Health and Human Services (HHS) Civil Monetary Penalty

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

King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

King & Spalding on

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

Saul Ewing LLP

OCR Imposes $200,000 Civil Money Penalty Against HIPAA-Covered Entity

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On March 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a civil money penalty (“CMP”) of $200,000 against Oregon Health & Science University (“OHSU”) for failing to...more

Health Care Compliance Association (HCCA)

We’ll Take the Fine: OCR’s ‘Unwarranted,’ Costly Demands Prompted Hospital’s $538K Payment

The saga that led Children’s Hospital Colorado to accept a fine of more than $500,000 imposed by the HHS Office for Civil Rights (OCR) began on July 11, 2017, when a physician’s email account containing details on 3,300...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Private Equity Throws FCA Enforcement Off-Kilter

Over the last 15 years, private equity (“PE”) firms have invested hundreds of billions of dollars in the healthcare sector, infiltrating every corner of the industry from emergency rooms and labs to billing providers and...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Genetic Testing

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more

Mintz - Health Care Viewpoints

EnforceMintz —Could the Supreme Court’s Decision in Jarkesy Mean the End to HHS Civil Monetary Penalty Authorities as We Know...

Last June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy, which holds that the Seventh Amendment entitles a defendant to a jury trial when the Securities and Exchange Commission (SEC)...more

Saul Ewing LLP

Two CMPs and One Settlement Close Out 2024 HIPAA Enforcement

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December 2024 was an active month for the U.S. Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR"). OCR announced (i) a $1.19 million civil monetary penalty ("CMP") against Gulf Coast Pain...more

Jackson Lewis P.C.

Florida Healthcare Provider Faces $1.19M HIPAA Penalty Following Independent Contractor Breach

Jackson Lewis P.C. on

A healthcare provider delivering pain management services in Florida and other states faces a $1.19 million civil monetary penalty from the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR)....more

Saul Ewing LLP

A “Scary” OCR CMP Imposed Upon a Solo Dental Practice

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On October 21, 2024, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a civil monetary penalty (“CMP”) of $70,000 against a solo dental practice that provides family dental...more

Saul Ewing LLP

Medical Practice Ordered to Pay HIPAA Civil Monetary Penalty Following Acquisition

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In October 2024, the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced the imposition of a civil monetary payment against Providence Medical Institute (“PMI”), a large medical...more

Gardner Law

OIG’s Perspective on Discount and Refund Programs

Gardner Law on

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more

Burr & Forman

Federal Agency Deference Eliminated, Now What?

Burr & Forman on

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

ArentFox Schiff

The 340B ‘Saga’ Continues: As More States Pass 340B Contract Pharmacy Laws, More Lawsuits Follow

ArentFox Schiff on

In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...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

Keating Muething & Klekamp PLL

Benefits Monthly Minute - August 2024

The August Monthly Minute highlights new IRS guidance addressing student loan matching programs, HHS’s increases to civil monetary penalties and Form 5330 paper filing updates....more

Saul Ewing LLP

OCR Imposes $115,200 CMP Against HIPAA-Covered Entity

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On August 1, 2024, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a civil monetary penalty of $115,200 against American Medical Response (“AMR”) based on a complaint that...more

Arnall Golden Gregory LLP

OCR Announces Latest in Right of Access Enforcement Actions With Imposition of Civil Monetary Penalty

On August 1, 2024, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced the imposition of a civil monetary penalty (“CMP”) of $115,200 collected against American Medical Response...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

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

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

Venable LLP

Federal Efforts to Incentivize States to Promulgate False Claims Statutes

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The federal False Claims Act (FCA) is widely regarded as a powerful tool to punish fraud against the federal government. Since 1986, the federal government has recovered more than $75 billion from FCA settlements and...more

Hendershot Cowart P.C.

Doctors: Don’t Fall Victim To Telemedicine Fraud Schemes

Hendershot Cowart P.C. on

Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...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

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

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