News & Analysis as of

New Guidance Department of Health and Human Services (HHS)

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

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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

Holland & Knight LLP

Implementing NIH's New Grant Requirements

Holland & Knight LLP on

The National Institutes of Health (NIH) on April 21, 2025, published a notice (the NIH Notice) updating the civil rights provisions of the NIH Grants Policy Statement and creating new requirements that federally funded...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

Seyfarth Shaw LLP

HHS’ Withdrawal of 2022 Guidance Raises Questions about Coverage for Gender-Affirming Care

Seyfarth Shaw LLP on

In a move with potentially significant implications for entities subject to the Affordable Care Act, the Department of Health and Human Services (HHS) has reversed course and now contends that Section 1557 of the Affordable...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

Health Care Compliance Association (HCCA)

Compliance should promote the hotline

At a recent HCCA event, large digital signs throughout the conference venue displayed a toll-free number and the message, “If you see something, say something.” The message served as a great reminder that healthcare...more

Lathrop GPM

OIG Issues New Nursing Facility Compliance Guidance, Comes on the Heels of Enhanced Medicare Enrollment Requirements for SNFs

Lathrop GPM on

The Office of Inspector General at the U.S. Department of Health and Human Services (OIG) recently followed up on a 2023 commitment to supplement its General Compliance Program Guidance (GCPG) by publishing its first...more

Venable LLP

Event in Review: Major Fraud and Abuse Laws: Anti-Kickback and Self-Referral Prohibitions and False Claims

Venable LLP on

Investment in the healthcare industry requires careful consideration, as it involves numerous distinct areas of the law. Venable's Private Equity Investment in Healthcare webinar series explores the unique issues and timely...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

King & Spalding

HHS Abandons Appeal of AHA’s Lawsuit Challenging HHS Website-Tracking Guidance

King & Spalding on

Last week, HHS filed a motion asking the Fifth Circuit’s permission to voluntarily dismiss its appeal of a District Court order directing HHS to rescind its guidance restricting hospitals’ ability to track online traffic to...more

Jones Day

U.S. District Court Invalidates HHS Guidance Overreading HIPAA's Application to Online Technologies

Jones Day on

On June 20, 2024, a U.S. federal district court held, in a suit brought by Jones Day, that the Department of Health and Human Services ("HHS") had misapplied the Health Insurance Portability and Accountability Act ("HIPAA")...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

Verrill

Don’t Wait – CMS Expects Hospitals to Take Action on Informed Consent for Certain Exams and Procedures

Verrill on

Hospitals should not delay in reviewing and revising their surgical informed consent forms and policies. On April 1, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued new guidance regarding informed consent...more

Holland & Knight LLP

While You Were Sleeping: HHS Releases New Guidance on Sensitive Examinations

Holland & Knight LLP on

"Informed consent" has been described as "a bedrock principle of healthcare in a free society," and if a "patient is denied the ability to exercise or even consider informed consent, the patient's personal liberty suffers."1...more

Epstein Becker & Green

Updated Requirements for Informed Consent: HHS Issues New Guidance on Sensitive Exams

On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”) released new guidance which requires hospitals to obtain informed consent from patients before practitioners, or medical or other students, perform...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

ACA-Required Coverage of Contraceptive Care Remains Agency Focus

Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...more

Gardner Law

Highlights from OIG’s New Compliance Program Guidance

Gardner Law on

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) released an important new compliance resource in November 2023. The HHS OIG’s new General Compliance Program Guidance (GCPG) is intended...more

Health Care Compliance Association (HCCA)

HHS OIG General Compliance Program Guidance: An empowered and independent compliance function

Corporate Compliance & Ethics Week 2023 kicked off with a gift for healthcare and life sciences compliance practitioners by way of the U.S. Department of Health and Human Services (HHS) Office of Inspector General’s (OIG)...more

Mintz

EnforceMintz — DOJ and OIG Guidance Emphasizes the Importance of a Robust and Dynamic Compliance Program

Mintz on

2023 was a busy year across several federal agencies in terms of issuing compliance guidance for corporations, including health care companies. For example, the Department of Justice (DOJ) issued significant compliance...more

Foley & Lardner LLP

“Let’s Talk Compliance”: OIG’s General Compliance Program Guidance: How to Refresh Compliance Programs

Foley & Lardner LLP on

Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more

King & Spalding

OCR Provides Guidance Regarding Patient Visitation Rights

King & Spalding on

On January 25, 2024, HHS Office for Civil Rights (OCR) issued guidance and responses to frequently asked questions regarding nondiscrimination regulations related to patient visitation. Hospitals, long term care facilities,...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2023

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more

McNees Wallace & Nurick LLC

The OIG Releases Updated General Compliance Program Guidance

As 2023 came to a close, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an updated General Compliance Program Guidance (GCPG) manual, which serves as a reference guide for...more

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