News & Analysis as of

Settlement Dept. of Health and Human Services

The Four Things That Surprised Us in the EpiPen False Claims Settlement

On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug...more

Electronic Health Records Vendor Agrees to $155 Million Settlement to Resolve FCA Allegations, Required to Make Free Upgrades to...

by King & Spalding on

On May 31, 2017, the DOJ announced a $155 million settlement with eClinicalWorks (ECW), one of the nation’s largest electronic health records (EHR) vendors, to resolve a False Claims Act lawsuit brought by a whistleblower. ...more

Memorial Hermann’s Use of Patient Name in Press Release Leads to $2.4 Million HIPAA Settlement

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced another large HIPAA-related settlement last week with Memorial Hermann Health System (Memorial Hermann), the largest not-for-profit...more

Settlement Highlights Need for HIPAA-Covered Entities to Have Business Associate Agreements in Place with PHI Vendors

by Dickinson Wright on

The Department of Health and Human Services’ Office for Civil Rights (ORC) announced an agreement to settle possible Health Insurance Portability and Accountability Act (HIPAA) violations with The Center for Children’s...more

Another HIPAA Settlement: Stolen Laptop Costs $2.5 Million Plus Encryption Requirement

by Perkins Coie on

The U.S. Department of Health and Human Services (HHS) recently announced yet another HIPAA privacy and security settlement involving Protected Health Information (PHI) on a stolen laptop. Although this might be seen as just...more

$2.5 Million Settlement Reached as HIPAA Crackdown Continues on Unsecured Portable Devices

by Jones Day on

A recent settlement of $2.5 million for alleged violations of the Health Insurance Portability and Accountability Act ("HIPAA") continues a trend of government enforcement targeting health care providers and vendors that fail...more

Gone Phishin’: Hack Leads to HIPAA Settlement

Earlier this week, the HHS Office for Civil Rights (“OCR”) announced a $400,000 settlement with Metro Community Provider Network (“MCPN”) related to a 2012 HIPAA breach caused by a phishing scam. The phishing scam, carried...more

Mobile Health App Developers Under Fire for Misleading Claims and Irresponsible Privacy Practices

by Dechert LLP on

Mobile health apps are becoming more and more popular as a tool for consumers in maintaining healthy lifestyles. However, there is a growing concern that the health-related benefits are being over-stated by mobile health app...more

Recent HIPAA Privacy and Security Settlements and Lessons Learned

by Perkins Coie on

Although the fate of the Affordable Care Act remains undecided, enforcement of the HIPAA privacy and security regulations by the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services is ongoing,...more

Excluded Party Cases Dominate OIG Published Self Disclosure Settlements

by Ruder Ware on

In 2013, the HHS Office of Inspector General issued revised protocols outlining the process through which health care providers are able to self-disclose and resolve potential liability under the OIG’s civil monetary penalty...more

Fraud and Abuse Investigations Should be Taken Very Seriously

by Burr & Forman on

According to the United States Government, fraud and abuse recovery has an excellent return for each investment dollar spent. According to the Health Care Fraud and Abuse Control (HCFAC) Program Report,released by the...more

HHS Reaches $2.2 Million Settlement With Life Insurance Company For Impermissible Disclosure Of ePHI

by King & Spalding on

On January 18, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS OCR”) announced that it had agreed to a $2.2 million settlement with MAPFRE Life Assurance Company of Puerto Rico (“MAPFRE Life”),...more

Failure to Timely Notify Results in Enforcement Action and Significant Settlement

by Wilson Elser on

For the first time, on January 9, 2017, the Department of Health and Human Services, Office for Civil Rights (HHS/OCR) settled a HIPAA enforcement action based on the untimely reporting of a breach of unsecured protected...more

It Ain't Over 'Till It's Over – First Circuit Rejects Settlement Agreements Between Providers and Intermediary and Upholds Cost...

by Baker Ober Health Law on

On October 27, 2016, a three-judge panel for the United States Court of Appeals for the First Circuit issued an opinion concluding that a Medicare fiscal intermediary (Intermediary) does not have the authority to enter into a...more

The Federal Government Holds Individuals Responsible for Involvement in Corporate Healthcare Fraud and Abuse

by Sherman & Howard L.L.C. on

In September 2016, three corporate officers in two healthcare fraud and abuse cases settled allegations that they were personally liable for violations of federal fraud and abuse laws. These settlements come one year after...more

Oncology Practice Agrees to Pay $5.3 Million to Settle Copayment Waiver Case

by King & Spalding on

A New York State hematology-oncology medical practice (the Practice), has agreed to pay $5.3 million to resolve allegations that, over an approximate five-year period, it provided kickbacks to patients in the form of waived...more

Failure Under the HIPAA Security Rule Costs $2.14 Million

by Sherman & Howard L.L.C. on

On October 18, 2016, the Department of Health and Human Services, Office of Civil Rights (“OCR”) announced a $2.14 million settlement with St. Joseph Health (“St. Joseph”), a non-profit integrated Catholic healthcare delivery...more

Five Things to Know About the Mylan EpiPen “Settlement” – What It Is and What It Isn’t

Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate...more

One Year Later: The Yates Memo, False Claims Act and Director & Executive Liability

by McDermott Will & Emery on

On September 19 and 27, 2016, the US Department of Justice announced two False Claims Act settlements that required corporate executives to make substantial monetary payments to resolve their liability. How will director and...more

Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

HIPAA Security Rule Compliance for Providers & Business Associates in Three Easy Steps

by Buchalter on

On August 4, 2016, the Office for Civil Rights (“OCR”) of the U.S. Health & Human Services Department (“HHS”) announced a $5.55 million HIPAA settlement with Advocate Health Care Network (“Advocate”), the largest...more

$2.75 Million OCR Settlement Underscores the Importance of Risk Management and Analysis

by BakerHostetler on

How the theft of a single password-protected laptop turned into an enterprise-wide review of an organization’s data protection practices. Following the announcement of a recent settlement between the U.S. Department of...more

It’s Not the Olympics, but OCR Sets New HIPAA Settlement Records

by Davis Wright Tremaine LLP on

Athletes at the Rio Olympics aren’t the only ones setting records this year. Hoping to send a “strong message” about the importance of safeguarding electronic protected health information (PHI) and conducting mandated risk...more

Blog: Advocate Data Breaches Result in Largest HIPAA Settlement To Date

by Cooley LLP on

On August 8th, 2016, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued the largest Health Insurance Portability and Accountability Act (HIPAA) settlement to date with Advocate Health...more

Largest Health & Human Services HIPAA Settlement Wake-Up Call for Covered Entities to Evaluate and Mitigate Risks

On Thursday, August 4, 2016, the U.S. Department of Health & Human Services, Office of Civil Rights (OCR) announced the largest settlement ever with a single entity for multiple potential Health Insurance Portability and...more

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