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Regulatory Requirements Department of Health and Human Services (HHS) New Guidance

Alston & Bird

Health Care Week in Review | CMS Announces Oversight Initiative to Increase Medicaid and CHIP Citizenship Enforcement; HHS...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Cozen O'Connor

FDA Encourages Food Manufacturers to Phase Out FD&C Red No. 3 Ahead of 2027 Deadline

Cozen O'Connor on

On July 14, 2025, the Food and Drug Administration (FDA) issued new guidance encouraging food manufacturers to phase out FD&C Red No. 3 ahead of the previous 2027 deadline and “as soon as is practicably possible.” Recall...more

McDermott Will & Schulte

HRSA issues 340B rebate model pilot program guidance, requests comments

The Health Resources and Services Administration (HRSA) issued a notice announcing the application process for the 340B rebate model pilot program and requesting public comment. The notice sets the parameters of 340B rebate...more

Amundsen Davis LLC

Federal Public Benefits and Immigration Status: What HHS’s Guidance Means for Mental Health Providers

Amundsen Davis LLC on

Mental health services are often partially funded with federal money, whether through grants or federal health care plans. Recently, the Department of Health and Human Services (“HHS”) updated its guidance clarifying how...more

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

Baker Donelson on

In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

Morgan Lewis on

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

Rivkin Radler LLP

Quality of Care Considerations in OIG’s Nursing Facility Compliance Guidance

Rivkin Radler LLP on

In November 2024, the U.S. Department of Health and Human Services’ Office of the Inspector General (“OIG”) published the long-awaited Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (“Nursing...more

McDermott+

Breaking Down the New No Surprises Act FAQs Post-TMA III

McDermott+ on

On January 14, 2025, the US Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), jointly issued Part 69 of a series of...more

Epstein Becker & Green

The NIH IDC – Where Are We Now

Epstein Becker & Green on

On February 7, the National Institutes of Health (“NIH”) issued a Notice (NOT-OD-25-068) entitled “Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates” (the “Notice”), though which NIH announced...more

Moore & Van Allen PLLC

New OCR Guidance on Tracking Technologies

Moore & Van Allen PLLC on

On March 18, 2024, the Office for Civil Rights ("OCR") at the U.S. Department of Health and Human Services ("HHS") published updated guidance on the use of online tracking technologies by HIPAA covered entities and business...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

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