News & Analysis as of

New Guidance Healthcare

Stevens & Lee

NY Department of Health Provides Guidance Regarding Material Transactions Law

Stevens & Lee on

Under the Material Transactions Law, certain health care entities involved in a transaction that increases gross, in-state revenue to at least $25 million must provide written notice of the transaction to the New York State...more

Pullman & Comley, LLC

IRS Announces HSA and HDHP Dollar Limits for 2026

Pullman & Comley, LLC on

The IRS has announced the 2026 cost-of-living adjustments to the applicable dollar limits for health savings accounts (HSAs), high-deductible health plans (HDHPs), and excepted benefit health reimbursement arrangements...more

Epstein Becker & Green

Attorney General Issues Guidance to U.S. Department of Justice Regarding Transgender Healthcare for Children

On April 22, 2025, U.S. Attorney General Pam Bondi issued a memorandum entitled “Preventing the Mutilation of American Children” (“the AG Memorandum”)....more

McDermott Will & Emery

CMS Updates SNF Attachment Guidance Ahead of May 1 Enrollment Deadline

McDermott Will & Emery on

Skilled nursing facilities (SNFs) historically have been required to disclose ownership and managerial control information as part of their Medicare enrollment. However, these requirements were significantly expanded to...more

Proskauer - Health Care Law Brief

DOH Issues Guidance on New York’s Material Health Care Transaction Law

Nearly two years ago, and as previously discussed in a Proskauer alert, New York enacted Public Health Law Article 45-A (the “Material Transactions Law”), which requires reporting of certain material health care transactions....more

Jones Day

Blurring the Line Between the Dry and Wet Lab: Joint Inventorship in AI-Assisted Life Science Inventions

Jones Day on

In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more

Rivkin Radler LLP

NYS Reinforces Its Scrutiny Over Healthcare Transactions

Rivkin Radler LLP on

We recently discussed increasing state regulation of healthcare mergers and acquisitions in the face of the current Administration’s clear policy of federal deregulation. We noted that 15 states had implemented oversight laws...more

King & Spalding

NY Department of Health Issues Clarifying FAQs on Healthcare Transaction Notice Law

King & Spalding on

Earlier this month, the New York State Department of Health (DOH) released its first formal guidance under Public Health Law (PHL) Article 45-A, the state’s recently enacted healthcare transaction notice law. Issued in the...more

Holland & Knight LLP

New York State Department of Health Issues Long-Awaited Guidance on Material Transactions Law

Holland & Knight LLP on

The New York State Department of Health (DOH) has published a set of Frequently Asked Questions (FAQs) to provide guidance on the "Disclosure of Material Transactions" law that took effect on Aug. 1, 2023. Pursuant to Article...more

Sheppard Mullin Richter & Hampton LLP

New Ohio Transparency Pricing Rules for Hospitals Comes with Limits to Targeted Advertising

Starting April 3, Ohio hospitals will have to navigate new requirements under House Bill 173. This law mandates greater transparency in healthcare pricing. It also includes rules for selling or targeted advertising related to...more

Arnall Golden Gregory LLP

AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Andrew Tsui, AGG Healthcare Litigation partner, to explore the intricacies of reimbursement in the U.S....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

Goodwin

2024 Year in Review: Cards, Payments, and Consumer Banking

Goodwin on

We expect continued scrutiny by regulators on fees, including enforcement actions and rulemakings, with the caveat that the new administration could shift federal priorities away from this fee crackdown....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

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Emery on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

McDermott Will & Emery

End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists

On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...more

Akin Gump Strauss Hauer & Feld LLP

FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more

McCarter & English Blog: Government Contracts...

Antitrust Corporate Compliance Programs: Late 2024 Changes Mean Companies Should Revisit Their Programs Early in 2025

The US Department of Justice Antitrust Division (DOJ or Division) recently released a revised Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations (Guidance). The Guidance reflects how the Division...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

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

Jones Day on

As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Quarles & Brady LLP

FDA Releases Declaratory Order Regarding Tirzepatide Shortage

Quarles & Brady LLP on

The FDA released a Declaratory Order on December 19th re-evaluating and essentially re-instituting its previous position on the tirzepatide shortage, declaring the shortage resolved. As a bit of history, on October 2, 2024...more

Harris Beach Murtha PLLC

New York Issues Guidance on Prenatal Leave Law

Harris Beach Murtha PLLC on

As expected, New York’s Department of Labor (DOL) has issued FAQ guidance for employers on the state’s new Paid Prenatal Leave Law, which goes into effect on Jan. 1, 2025. While the guidance answers some questions, others...more

Proskauer - Law and the Workplace

New York Releases Guidance on Paid Prenatal Leave Law Taking Effect January 1, 2025

The New York State Department of Labor (NYDOL) has issued informal guidance regarding the Paid Prenatal Leave benefit that will be available to New York employees beginning January 1, 2025.  The guidance includes general...more

King & Spalding

OIG Issues Nursing Facility Compliance Guidance

King & Spalding on

On November 20, 2024, OIG released new compliance program guidelines for nursing facilities titled, “Nursing Facility Industry Segment-Specific Compliance Program Guidance” (the Nursing Facility ICPG or the Guidance). The...more

Holland & Hart LLP

OCR Provides Guidance to the Healthcare Industry to Combat Ransomware Attacks

Holland & Hart LLP on

In the spirit of National Cybersecurity Awareness Month, the Office of Civil Rights (“OCR”) released a new video on October 17, 2024, to promote awareness on ransomware trends in the healthcare industry and how HIPAA subject...more

164 Results
 / 
View per page
Page: of 7

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide