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Settlement Compliance Department of Health and Human Services (HHS)

Health Care Compliance Association (HCCA)

From $5,000 to $800,000: Days Apart, OCR Security Settlements Show Puzzling Math

A single incident that may have started as a personal vendetta or an extortion threat seven years ago has cost a Florida health care system $800,000, and comes on the heels of an unrelated breach suffered by a different...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Hidden Dangers Lurking in Corporate Integrity Agreements

When I litigated False Claims Act (FCA) cases at the U.S. Department of Justice (DOJ), it was common practice for settlements to require Corporate Integrity Agreements (CIAs) setting forth ongoing duties and responsibilities...more

Health Care Compliance Association (HCCA)

Delayed Action on Misconduct Costs Firm $4M; FCA Whistleblower Flagged Earlier Application

Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more

Mintz - Health Care Viewpoints

EnforceMintz — Additional Health Care Provider Joins the OIG’s “Heightened Scrutiny” List in 2024

The HHS Office of Inspector General (OIG), in connection with its enforcement responsibilities, must exclude a party from the federal health care programs if the party is found to have violated certain federal laws. This type...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

Davis Wright Tremaine LLP

Whether Naughty or Nice, Compliance Deadline for HIPAA Reproductive Care Privacy Is Coming to Town

We just want to provide a friendly reminder that, before key staff depart for the holidays, HIPAA covered entities and business associates should finalize their compliance with the 2024 HIPAA amendments related to...more

King & Spalding

HIPAA Reproductive Healthcare Privacy – Recent Settlement Related to Privacy Rule Violation and Reminder of December 2024 Privacy...

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Last week, HHS Office of Civil Rights (OCR) announced a settlement with a Pennsylvania provider (the Provider) concerning an alleged violation of the HIPAA Privacy Rule. Specifically, the Provider impermissibly disclosed a...more

ArentFox Schiff

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

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Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

Saul Ewing LLP

No “Trick”: Plastic Surgery Practice Agrees to Pay a $500,000 HIPAA Settlement Following Ransomware Attack

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On October 31, 2024, the U.S. Department of Health and Human Services (“HHS”), Office of Civil Rights (“OCR”) announced a $500,000 settlement with Plastic Surgery Associates of South Dakota (“PSA”) concerning potential...more

Health Care Compliance Association (HCCA)

2nd Settlement Triggered by 2017 Ransomware Attack Costs WA Practice $100K; ‘Not a Breach’

Let’s review for a moment. It’s not a HIPAA violation to be a victim of ransomware. It’s not a HIPAA violation to pay a ransom. It’s up to the covered entity (CE) to determine if a security or privacy incident is a...more

Gardner Law

Kickbacks and Consequences: Lessons from the Innovasis Settlement

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On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more

Saul Ewing LLP

HIPAA Security Rule Settlement Results in $950,000 Payment by a Mid-Atlantic Health System

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On July 1, 2024, the U.S. Department of Health and Human Services (“HHS”) Office For Civil Rights (“OCR”) announced a $950,000 settlement with Heritage Valley Health System (“Heritage Valley”) and a three-year Corrective...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: March 2024

The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) are among a handful of groups “urging the Biden administration to rescind a policy proposal that would threaten the American...more

Health Care Compliance Association (HCCA)

News Briefs: January 8, 2024

H. Lee Moffitt Cancer Center & Research Institute Hospital Inc. in Tampa, Florida, has agreed to pay $19.564 million to settle false claims allegations over claims submitted to federal health care programs for items and...more

Saul Ewing LLP

NYC Hospital Agrees to Pay $4.75 Million as Part of a HIPAA Settlement

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On February 6, 2024, the HHS Office for Civil Rights (“OCR”) announced a settlement with Montefiore Medical Center (“MMC”) for alleged HIPAA Security Rule violations and MMC agreed to pay $4.75 million and enter into a...more

Health Care Compliance Association (HCCA)

Hospital Settles CMP Case Over Free APPs; 'Bona Fide' Use Shouldn't Inspire Fear, Lawyer Says

In a case that may hit a raw compliance nerve, Ascension Macomb Oakland Hospital in Michigan has agreed to pay $100,000 in a settlement with the HHS Office of Inspector General (OIG) over free services provided to certain...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

Health Care Compliance Association (HCCA)

Privacy Briefs: October 2023

Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...more

WilmerHale

HHS OCR Settles with iHealth Solutions Over Alleged HIPAA Violations

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On June 28, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement (resolution agreement and corrective action plan) with iHealth Solutions (also known as Advantum Health)...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | April 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for April 2023. We discuss several criminal and civil enforcement actions related to the Anti-Kickback Statute (AKS) and the...more

Health Care Compliance Association (HCCA)

Settlement Involves 'Dark Overlord' Hack, Tip by Breach-Tracking Journalist

Report on Patient Privacy 20, no. 10 (October 2020) - September was quite the month for enforcement actions by the HHS Office for Civil Rights (OCR). The agency announced eight settlements totaling more than $10 million....more

Arnall Golden Gregory LLP

Playing Catch Up? HHS OCR Announces Eight New HIPAA Settlements in September

In a flurry of recent activity, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has announced eight resolution agreements since September 15, 2020. These resolution agreements settle...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 30. News Briefs: August 2020

Report on Medicare Compliance 29, no. 30 (August 24, 2020) - A federal court on Aug. 17 blocked HHS from enforcing its revised definition of sex discrimination in Sec. 1557, which prohibits discrimination on the basis of...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 25. News Briefs: July 2020

Report on Medicare Compliance 29, no. 25 (July 13, 2020)  -  Ophthalmic Consultants PA in Sarasota, Florida, agreed to pay $4.8 million to settle false claims allegations that it billed Medicare and other federal payers...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 20. News Briefs: June 2020

Report on Medicare Compliance 29, no. 20 (June 1, 2020) - The HHS Office of Inspector General (OIG) has unveiled its “OIG Strategic Plan: Oversight of COVID-19 Response and Recovery.” Its goals are protecting people, funds...more

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