News & Analysis as of

Covered Entities Department of Health and Human Services (HHS) Hospitals

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

Health Care Compliance Association (HCCA)

HHS Abandons Appeal in Public Website Pixel Case, But CEs and BAs Should Expect Continued Scrutiny

The HHS Office for Civil Rights (OCR) has abandoned its appeal of a federal judge’s ruling overturning OCR’s guidance prohibiting covered entities (CEs) and business associates (BAs) from using the web-tracking technologies...more

Clark Hill PLC

HHS Bulletin on Online Tracking Technologies Declared Unlawful: What Covered Entities and Business Associates Need to Know About...

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Online tracking technologies are used by healthcare and hospital systems throughout the United States to analyze their website traffic, personalize content, and provide relevant information to website visitors, some of whom...more

BakerHostetler

Lipstick on a Pig: OCR’s Cosmetic Revisions to Guidance on Tracking Technology in Healthcare Fail to Address Fundamental Issues

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When the U.S. Department of Health and Human Services, Office for Civil Rights (HHS OCR) issued its guidance on “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates” on Dec. 1, 2022 Original...more

Holland & Knight LLP

Lawsuit Seeks to Block OCR HIPAA Guidance on Online Tracking Tools

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Hospitals care about patient privacy, but they also have to connect with the public. In the real world, people mostly connect online. Having a fully functional online presence often requires help from third parties. ...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

BakerHostetler

HHS Proposes Rule Strengthening Section 1557 Protections Against Nondiscrimination in Health Activities

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​​​​​​​On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the...more

Health Care Compliance Association (HCCA)

2022 Outlook: More Dangerous Ransomware Coupled With Inadequate Security Practices

Report on Patient Privacy 22, no. 1 (January, 2022) - As the COVID-19 pandemic enters its third year, real “security fatigue” with pandemic-related issues will combine with cybercriminals’ increasingly sophisticated...more

Faegre Drinker Biddle & Reath LLP

Fifth Circuit Decision Motivates Covered Entities to Appeal Unreasonable Enforcement Outcomes

The United States Court of Appeals for the Fifth Circuit (the “Court”) vacated a $4,348,000 civil monetary penalty (“CMP”) imposed by the U.S. Department of Health and Human Services’ Office for Civil Rights (“HHS-OCR”) in...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 30, Number 2. News Briefs: January 2021 #2

Report on Medicare Compliance 30, no. 2 (January 18, 2021) - Recovery audit contractors (RACs) may soon be auditing positron emission tomography (PET) for initial treatment strategy in oncologic conditions for compliance...more

K&L Gates LLP

K&L Gates Triage: 340B Update - Hospitals Request Eligibility Flexibilities Amid COVID-19 Pandemic

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In this episode, Richard Church and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent COVID-19 guidance by the Health Resources and Services Administration and hospital requests...more

Foley Hoag LLP - Medicaid and the Law

CMS Issues Guidance to States on 340B Duplicate Discounts

Late last year, we noted that the Massachusetts Medicaid program had proposed regulations to address issues related to the prohibition on duplicate discounts in the 340B program. The Massachusetts solution was relatively...more

McDermott Will & Emery

2020 Starts Off with Two Government Publications Critical of 340B Program Oversight

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Less than two weeks into the new year, the federal government has released two new publications addressing concerns related to 340B Program oversight by both state and federal agencies. After a relatively quiet 2019, 340B...more

King & Spalding

OCR Imposes $2.15 Million Penalty Against Hospital System for Alleged HIPAA Violations

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On October 23, 2019, the Office for Civil Rights (OCR) at HHS announced the imposition of a $2,154,000 civil monetary penalty against a Florida hospital system (Hospital System) for alleged violations of the HIPAA Security...more

Baker Donelson

OIG's List of Excluded Individuals/Entities – What Employers Need to Know

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OIG maintains a list of all currently excluded individuals and entities called the "List of Excluded Individuals/Entities," or LEIE. Covered entities that hire – or continue to employ or work with – an individual or entity on...more

Sheppard Mullin Richter & Hampton LLP

Company’s Vendor Suffers Breach, No Business Associate Agreement, $500K OCR Settlement

A Florida staffing agency which provides physicians to hospitals and nursing homes, has agreed to a $500,000 settlement with the U.S. Department of Health and Human Services, Office for Civil Rights. The settlement comes...more

Verrill

No More Waiting: 340B Drug Pricing Program Pharma Oversight and Enforcement Rule To Be Effective January 1, 2019

Verrill on

The U.S. Department of Health and Human Services (“HHS”) recently published a final rule on the 340B Drug Pricing Program (“340B Program”), moving the effective date for changes to the program up to January 1, 2019. Making...more

Baker Donelson

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities

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Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more

Harris Beach Murtha PLLC

Another HIPAA Breach, Another 6-Figure HIPAA Settlement

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A Colorado Hospital reached an $111,400 settlement with the Office for Civil Rights (“OCR”) for failing to terminate a former employee’s access to electronic protected health information. OCR’s investigation uncovered that...more

Bricker Graydon LLP

Lights, camera, HIPAA! HHS announces settlement related to “Boston Med”

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On September 20, 2018, the U.S. Department of Health and Human Services (HHS) announced that it reached settlements with three hospitals for compromising the privacy of patients’ protected health information (PHI) by...more

Foley & Lardner LLP

Court Rules Against 340B Hospitals, Allows Medicare Reimbursement Cuts to Go Forward

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On Friday, December 29, 2017, the U.S. District Court for the District of Columbia dealt a blow to hospitals participating in the 340B Drug Pricing Program. By participating in the 340B program, eligible public and...more

Robinson+Cole Data Privacy + Security Insider

HHS Issues Limited Waiver of HIPAA Sanctions Post-Hurricane Harvey

The U.S. Department of Health and Human Services (HHS) has used its authority to waive certain provisions of HIPAA in response to Hurricane Harvey. HHS previously declared a public health emergency in Texas and Louisiana...more

McDermott Will & Emery

Final Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

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The US Department of Health and Human Services and the Health Resources and Services Administration recently issued final rules related to the 340B Drug Pricing Program that impose fines on drug manufacturers that overcharge...more

Patterson Belknap Webb & Tyler LLP

HSS Issues New Guidance on Ransomware Attacks Against HIPAA-Covered Entities

Ransomware attacks at hospitals and other healthcare facilities have dramatically increased over the last several years, putting healthcare providers in the uncomfortable position of having to consider paying thousands of...more

Foley & Lardner LLP

Ransomware Reporting Requirements & New HHS Guidance

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Ransomware is malicious software that denies access to data, usually by encrypting the data with a private encryption key that is only provided once a ransom is paid. Sometimes the ransomware will actually destroy, steal, or...more

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