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Department of Health and Human Services (HHS) Healthcare Regulatory Requirements

Bass, Berry & Sims PLC

Compliance Deadlines for New Section 1557 Nondiscrimination Rules Approaching, Includes Application to Medicare Part B Recipients

Bass, Berry & Sims PLC on

In April 2024, the Department of Health and Human Services (HHS) finalized revised regulations implementing Section 1557 of the Patient Protection and Affordable Care Act (ACA). The new, final Section 1557 regulations (2024...more

Health Care Compliance Association (HCCA)

New ORI Misconduct Rule Offers ‘Thoughtful’ Revisions in Wake of Highly Criticized NPRM

Now that the HHS Office for Research Integrity (ORI) has published its final rule revising 2005 regulations governing misconduct, compliance officials could be engaging in three activities simultaneously: checking to see if...more

Proskauer - Health Care Law Brief

Shortly After its Online Tracking Technologies Bulletin is Declared Unlawful, HHS-OCR Stands Down, Withdraws Appeal

On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more

McDermott+

Biden Administration Issues Final Reg on Mental Health Parity Requirements

McDermott+ on

Biden Administration Issues Final Reg on Mental Health Parity Requirements McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts....more

Baker Donelson

Information Blocking: Disincentives Established for Health Care Providers

Baker Donelson on

The United States Department of Health and Human Services (HHS) has now established disincentives for certain health care providers if found by the Office of Inspector General (OIG) to have committed information blocking...more

McDermott+

HHS Institutes Information Blocking Disincentives for Healthcare Providers

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The long-awaited final reg is upon us! The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released a final regulation earlier this week...more

McDermott Will & Emery

Federal Court Invalidates Key Part of HHS OCR Bulletin Regarding Application of HIPAA to Online Tracking Technologies

McDermott Will & Emery on

In a consequential decision for Health Insurance Portability and Accountability Act (HIPAA)-regulated entities, on June 20, 2024, the US District Court for the Northern District of Texas ruled in American Hospital Association...more

Manatt, Phelps & Phillips, LLP

Preparing for the Future of Health Care Antitrust Scrutiny

Now, more than ever, health care organizations are facing complex antitrust issues as their mergers/acquisitions, hiring, contracting, and private funding are being scrutinized by the federal and state governments.  Proper...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

Woods Rogers

HHS Updates Its Guidance on Online Tracking Technologies – Controversy Remains

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The U.S. Department of Health and Human Services, Office of Civil Rights (OCR) recently updated its controversial, year-old guidance document on the use of online tracking technologies by healthcare providers and other...more

Quarles & Brady LLP

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

Quarles & Brady LLP on

In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more

Mayer Brown

Private Equity in Healthcare: Increased Scrutiny from FTC, DOJ, and HHS

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Private equity acquisitions in healthcare will likely face increased scrutiny from multiple federal departments, as well as from state antitrust enforcement officials....more

McDermott Will & Emery

Ensuring Nondiscrimination in Patient Visitations

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Reflecting on lessons learned and complaints received during the COVID-19 pandemic, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released detailed frequently asked questions (FAQs)...more

Shutts & Bowen LLP

New Guidelines Anticipated Following HHS’s Health Cybersecurity Concept Paper

Shutts & Bowen LLP on

Updates to the Health Insurance Portability and Accountability Act Security Rule (“HIPAA Security Rule”) are planned for Spring 2024. New guidance from The Department of Health and Human Services (“HHS”) via a recently...more

Fenwick & West LLP

New Federal Requirements for AI and IT System Implementation in Healthcare

Fenwick & West LLP on

On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | December 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged violations of the False...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Jones Day

HHS Announces Upcoming Federal Strategies to Enhance Cybersecurity for Health Care and Public Health Sectors

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The Department of Health and Human Services ("HHS") has released a concept paper outlining its new cybersecurity strategies for the health care sector, identifying cybersecurity priorities, potential future regulations and...more

Akerman LLP - Health Law Rx

OCR Will Focus on You if You Don’t Focus on Cybersecurity

With a couple of “firsts,” the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is signaling that it is cracking down on healthcare organizations that fail to identify and address cybersecurity...more

Proskauer - Health Care Law Brief

HHS Publishes Roadmap of New Strategy for Cybersecurity in the Healthcare Sector

The U.S. Department of Health and Human Services (HHS) recently issued a strategy paper highlighting key aspects of its plan to revamp cybersecurity requirements in the healthcare industry. Citing a 93% increase in large data...more

Nelson Mullins Riley & Scarborough LLP

OIG Issues General Compliance Program Guidance

On November 6, 2023, the Department of Health and Human Services Office of Inspector General (OIG) issued General Compliance Program Guidance (GCPG) via publication on its website, which can be accessed by this link. The...more

Davis Wright Tremaine LLP

HHS Proposes Information Blocking Disincentives for Health Care Providers

While health care providers have been required to comply with the 21st Century Cures Act Information Blocking Rule (the Rule) since April 5, 2021, as of yet there is no enforcement mechanism in place with respect to the Rule...more

McDermott+

McDermottPlus Check-Up: October 6, 2023

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THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more

Butler Snow LLP

Health Care Due Diligence: An Ounce of Prevention is Worth a Pound of Cure

Butler Snow LLP on

Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...more

Epstein Becker & Green

HHS Recommends Re-Classification of Marijuana as a Schedule III Controlled Substance – A Bellwether for the Future of...

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On August 30, an official at the United States Department of Health and Human Services (HHS) released one of the most significant announcements made at the federal level concerning marijuana reclassification. In a letter...more

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