News & Analysis as of

Patients Covered Entities

Health Care Compliance Association (HCCA)

OCR: Rule Halts Disclosures Under ‘Presumption of Lawfulness,’ Shares Model Attestation Form

Attestations are at the heart of permissible disclosures under the HHS Office for Civil Rights’ (OCR) new reproductive health privacy rule—and OCR wants covered entities (CEs) and business associates (BA) to use them now. The...more

Proskauer - Health Care Law Brief

New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive...

On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act...more

Health Care Compliance Association (HCCA)

‘I Will Not Rest’; ‘I Am All In’: Remarkable Breach Hearing Sees Pledges by UHG CEO, Sen. Wyden

United Healthcare Group (UHG) CEO Andrew Witty was in a board meeting on Feb. 21 when officials interrupted with the news that Change Healthcare—a clearinghouse UHG subsidiary Optum had purchased for $1.3 billion in October...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

Epstein Becker & Green

In Genesis Case, South Carolina District Court Scraps HRSA Interpretation of “Patient” Under 340B Statute

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On November 3, 2023, the United States District Court for the District of South Carolina issued its decision in the long-running dispute between Genesis Health Care Inc., a federally qualified health center and 340B-covered...more

McDermott Will & Emery

What Makes a Patient a “Patient”? Court Rejects Restrictive 340B Definition

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On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a “patient” under the 340B Program Statute. The...more

Bass, Berry & Sims PLC

Court Guts 340B Program “Patient” Definition, Opening Door to More 340B Use

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On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more

McDermott Will & Emery

This Week in 340B: September 2023 #3

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This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Holland & Knight LLP

New Legislation Shakes Up the Florida Healthcare Landscape

Holland & Knight LLP on

The 2023 Florida legislative session came to a close on May 5, 2023. The Legislature was very active and passed approximately 200 bills, including several that will impact the healthcare regulatory landscape. Once approved by...more

McDermott Will & Emery

This Week in 340B: February 2023

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This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

K&L Gates LLP

Health Care Triage: Genesis Healthcare and the 340B Program Patient Definition

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In this episode, Andrew Ruskin, Leah Richardson, and Victoria Hamscho analyze the U.S. Court of Appeals for the Fourth Circuit’s recent decision in Genesis Healthcare v. Becerra. They discuss its potential impact on the...more

McDermott Will & Emery

HRSA Filings in Genesis Shed Light on Definition of “Patient” for 340B Covered Entities

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A recent case before the US Court of Appeals for the Fourth Circuit addressed the issue of which persons qualify as “patients” of a 340B program participating entity (covered entity). Court-ordered filings in ongoing...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

Bass, Berry & Sims PLC

Perfection Not Required: Fifth Circuit Vacates HHS OCR $4.3 Million Penalty for Potential Data Breach Case

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On January 14, the Fifth Circuit vacated the University of Texas M.D. Anderson Cancer Center’s (M.D. Anderson) $4.3 million fine for HIPAA violations arising from its loss of more than 35,000 individuals’ protected health...more

Butler Snow LLP

Privacy Versus Pandemic: Must HIPAA Yield to a Public Health Emergency?

Butler Snow LLP on

The worldwide COVID-19 pandemic visited on America in the past several months has quickly reinvigorated the foundational and important debate concerning where, in a free society, individual autonomy ends (or should end) and...more

McDermott Will & Emery

OCR Issues New HIPAA Guidance for Covered Entities Contacting Recovered COVID-19 Patients for Plasma Donations

McDermott Will & Emery on

The United States Department of Health and Human Services Office for Civil Rights (OCR) recently issued updated guidance on contacting former COVID-19 patients about blood plasma donation in light of the privacy protections...more

Baker Donelson

Protecting LTC Residents' PHI: Eight Tips for Avoiding a Data Breach

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Organizations that meet the definition of "covered entity" under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (HIPAA) must be diligent to maintain the privacy and security...more

Baker Donelson

340B Drug Pricing Program: The Withdrawal of Mega Guidance and the Future of Patient Definition

Baker Donelson on

In the wake of a recent directive issued by the Trump administration to halt pending regulations and guidance while the new leadership conducts its own review, the Department of Health and Human Services, on January 30, 2017,...more

Pullman & Comley, LLC

Alert: Proposed 340B Drug Pricing Program Omnibus Guidance - Defines "Eligible Patient"

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On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published the proposed 340B Drug Pricing Program Omnibus Guidance (“Omnibus Guidance”) which is intended to clarify for covered entities, such as...more

Mintz - Health Care Viewpoints

The Proposed 340B Guidance:  Who is the Biggest Loser?

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more

Robinson & Cole LLP

Health Law Pulse - October 2015

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The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

King & Spalding

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

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On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

Baker Donelson

Drastic Changes in "Patient" Definition as HHS Releases the Long-Awaited Proposed 340B Omnibus Guidance

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After years of fits and starts, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) has finally released its proposed omnibus guidance for the 340B Drug Discount...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

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The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

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