News & Analysis as of

New Guidance Department of Health and Human Services (HHS) Final Rules

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

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

Verrill

Gag Clauses – New Guidance and Litigation Will Inform Compliance

Verrill on

Certain provisions of the Transparency in Coverage Final Regulations and the Consolidated Appropriation Act, 2021 (“CAA”) require group health plans and/or their vendors to report information to federal agencies. On December...more

King & Spalding

HHS Proposes Repeal of Two Trump Administration Rules on Guidance, Enforcement, and Adjudication Procedures

King & Spalding on

On October 20, 2021, HHS published in the Federal Register a proposal to repeal two final rules issued during the Trump administration. The final rules up for repeal are the “Department of Health and Human Services Good...more

Sheppard Mullin Richter & Hampton LLP

Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings

Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more

Pillsbury Winthrop Shaw Pittman LLP

GAO Report on Section 3610 Reimbursement

While GAO does not make any recommendations in its report, it provides a useful overview of the federal government’s implementation of Section 3610. Agencies made relatively little use of their Section 3610 authority...more

Verrill

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

Verrill on

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more

Buchalter

OIG Finalizes New and Expanded Anti-Kickback Safe Harbors, Issues Guidance Regarding Nominal Gifts

Buchalter on

In an uncertain health care environment following the presidential election, the Department of Health & Human Services Office of Inspector General (“OIG”) finalized a new rule expanding existing safe harbors to the federal...more

Proskauer Rose LLP

The ERISA Litigation Newsletter - September 2015

Proskauer Rose LLP on

Editor's Overview - It has been a little more than one year since the U.S. Supreme Court altered the legal landscape for litigating ERISA breach of fiduciary duty claims relating to the investment in employer stock...more

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