News & Analysis as of

Hospitals Covered Entities

Manatt, Phelps & Phillips, LLP

340B Hospitals Sue HRSA for Authorizing Audits of 340B Records

On July 24, two hospitals that participate in the Section 340B drug discount program—Oregon Health & Science University and Maine General Medical Center—filed separate lawsuits against the Health Resources and Services...more

Holland & Knight LLP

New Requirements for Research Security Programs Raise the Stakes for Compliance

Holland & Knight LLP on

The National Security Presidential Memorandum-33 (NSPM-33), issued in January 2021, directed federal agencies that fund research and development (R&D) projects to require certain "Covered Institutions" to certify that the...more

BakerHostetler

Northern District of Texas Flashes the ‘Blue Lights’ on OCR’s Pixel Guidance

BakerHostetler on

On June 20, 2024, the Northern District of Texas issued its final order in American Hospital Association, et al. v. Becerra, et al. (AHA), granting the plaintiffs’ (the American Hospital Association, two Texas health systems...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

Dorsey & Whitney LLP

Indiana Notification of Health Care Transactions Law Takes Effect

Dorsey & Whitney LLP on

On July 1, 2024, Indiana’s new health care transactions notification law takes effect. The law is designed to increase government oversight of mergers and acquisitions involving health care entities....more

Goodwin

State Healthcare Transaction Notification Laws - Vermont

Goodwin on

Key Takeaways - ..Requires parties to provide notice to the Vermont Attorney General (“VT AG”) for transactions involving Vermont hospitals that are acquiring medical practices. ..The parties must provide 90 days...more

Goodwin

State Healthcare Transaction Notification Laws - Rhode Island

Goodwin on

Key Takeaways - ..Parties must obtain approval from the Rhode Island Attorney General (“RI AG”) and Department of Health (“DOH”) for certain transactions involving Rhode Island hospitals. ..Under the statute, the RI...more

Goodwin

State Healthcare Transaction Notification Laws - New York

Goodwin on

Key Takeaways - ..Requires parties to provide notice to the New York Department of Health (“NYDOH”) of certain transactions involving “health care entities”. ..The parties must provide 30 days notice before closing to...more

Goodwin

State Healthcare Transaction Notification Laws - Illinois

Goodwin on

Key Takeaways - ..Requires parties to provide notice to the Illinois Attorney General (“IL AG”) for transactions involving certain health care facilities and provider organization group practices. ..The parties must...more

Ward and Smith, P.A.

Navigating the National Practitioner Data Bank: A Guide for Healthcare Professionals (NPDB or Data Bank).

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Few aspects of the healthcare regulatory apparatus evoke more confusion and dread for healthcare practitioners than the National Practitioner Data Bank (NPDB or Data Bank).  Being reported to the Data Bank is often regarded...more

McDermott Will & Emery

This Week in 340B: May 28 – June 3, 2024

Find this week’s updates on 340B litigation 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

Goodwin

Indiana Enacts Broad Notification Requirements for Healthcare Transactions with a Clear Focus on Private Equity

Goodwin on

Earlier this year, Indiana joined a growing number of states by enacting a new notification requirement for certain healthcare transactions. Indiana Senate Bill Number 9 (SB 9), effective July 1, 2024, is likely to require...more

BakerHostetler

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

BakerHostetler on

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

Cornerstone Research

5 Questions with Sayeh Nikpay: The 340B Drug Pricing Program

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A periodic feature by Cornerstone Research, in which our affiliated experts, senior advisors, and professionals, talk about their research and findings. We interview Professor Sayeh Nikpay of the School of Public Health,...more

Dorsey & Whitney LLP

HIPAA on the Horizon in the New Year: Important Lessons from an Active 2023 and Regulatory Initiatives to Watch for in 2024

Dorsey & Whitney LLP on

2023 marked 20 years since the first compliance deadline under the Health Insurance Portability and Accountability Act’s (“HIPAA”) privacy rule. Despite the two decades of experience with HIPAA, compliance continues to remain...more

King & Spalding

Medicare Advantage Payors Have Not Redressed 340B Underpayments

King & Spalding on

CMS recently published its remedy in response to the Supreme Court’s decision that CMS’s 340B outpatient drug payment policy violated the Medicare statute. Many hospitals that are 340B covered entities will now receive tens...more

Holland & Knight LLP

The 340B Drug Pricing Paradox

Holland & Knight LLP on

The 340B Drug Pricing Program has been making headlines. Two recent developments are difficult to square with one another. First, the Health Resources and Services Administration (HRSA), the federal agency that administers...more

Holland & Knight LLP

Lawsuit Seeks to Block OCR HIPAA Guidance on Online Tracking Tools

Holland & Knight LLP on

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

McDermott Will & Emery

HRSA Issues Notice Confirming 340B Registration Requirement

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On October 26, the Health Resources and Services Administration (HRSA) published a Federal Register notice addressing the use of 340B drugs at off-campus hospital outpatient locations that have not yet appeared on a filed...more

McDermott Will & Emery

This Week in 340B: September 2023 #3

McDermott Will & Emery on

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

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

Goodwin

340B Drug Pricing Program Reform Considerations

Goodwin on

The 340B Drug Pricing Program is a government program, administered by the Health Resources and Services Administration (HRSA), that allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy...more

Sheppard Mullin Richter & Hampton LLP

Important Deadline Approaches for California Healthcare Employers to Apply for Worker Retention Payments

On June 30, 2022, Governor Gavin Newsom signed legislation to stabilize and promote the retention of California’s healthcare workforce in response to the COVID-19 pandemic. This response included the allocation of $1.3...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)

[Webinar] How to Talk to Your Pharmacist about 340B - July 11th, 12:00 pm - 1:30 pm CDT

Learning Objectives - Describe the basic structure of a 340B program implementation at a hospital or grant-funded clinic - Illustrate the permissible and impermissible uses of 340B-priced drugs - Explain the roles of...more

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