News & Analysis as of

Department of Health and Human Services (HHS) Reporting Requirements

Lathrop GPM

Administration Issues Cross-Agency Guidance Targeting Health Care Pricing and Focusing on Hospitals and Health Plans

Lathrop GPM on

On May 22, 2025, the U.S. Department of Health and Human Services, Department of Treasury and Department of Labor (the “Agencies”) announced new steps intended to “strengthen healthcare price transparency.” ...more

Epstein Becker & Green

The Final Rule on Research Misconduct Regulations: What Institutions Need to Know as Implementation Looms

Epstein Becker & Green on

When the current federal administration took office, it issued a memorandum requiring, among other things, that federal agencies delay the issuance of new or proposed rules to the Office of the Federal Register until further...more

Holland & Knight LLP

New York Budget Omits Changes to State's "Disclosure of Material Transactions" Law

Holland & Knight LLP on

In a prior blog post, we summarized proposed legislation included in New York Gov. Kathy Hochul's state fiscal year (FY) 2025-2026 budget that would have subjected "material transactions" to additional disclosure and...more

Akin Gump Strauss Hauer & Feld LLP

Improving the Safety and Security of Biological Research (Trump EO Tracker)

This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen...more

Rivkin Radler LLP

OIG Audit of MACs Finds Deficiencies

Rivkin Radler LLP on

The 12 regional Medicare Administrative Contractors (MACs) were recently audited by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG). Each of the MAC jurisdictions was found by the OIG to...more

Sheppard Mullin Richter & Hampton LLP

New York State Releases Much Anticipated Guidance on Reporting Requirements for Material Healthcare Transactions as Budget...

On August 1, 2023, the New York State’s Department of Health (the “DOH”) began implementation of Public Health Law Article 45-A, the State’s new statutory requirement for advance notice and public disclosure of certain...more

Nelson Mullins Riley & Scarborough LLP

Senate Bill 316: An Overview for North Carolina Hospitals

Earlier this week, Senate Bill 316 (the “Bill”) was filed in the North Carolina state legislature. The Bill covers a large swathe of healthcare-related issues, and the additional regulatory elements of the Bill would likely...more

Foley & Lardner LLP

Colorado: Proposed Expanded Medical Care Transaction Oversight - What Providers and Investors Need to Know

Foley & Lardner LLP on

On March 5, 2025, two Senators and one Representative introduced SB 25-198 (the Bill), designed to enhance transparency in transactions involving health care entities. The Bill seeks to impose notification and reporting...more

BakerHostetler

Trump Signs Price Transparency Executive Order

BakerHostetler on

On Tuesday, Feb. 25, President Donald Trump signed an executive order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the Executive Order)....more

Epstein Becker & Green

A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule

Epstein Becker & Green on

Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase 1 expectations under FDA’s Laboratory Developed Tests Final Rule (the “LDT Final...more

Bricker Graydon LLP

What Goes Around Comes Around: White House Signals Increased Transparency in Coverage Enforcement

Bricker Graydon LLP on

On February 25, 2025, the White House issued a new executive order aimed at implementing many of the Administration's previously issued directives to health plans. ...more

Stevens & Lee

Urgent Care Centers Must Now Comply With Pennsylvania Newborn Safe Haven Law

Stevens & Lee on

Pennsylvania’s Safe Haven Law, also known as the Newborn Protection Act (the Act), allows parents to surrender their infants at hospitals, EMS providers and police stations without criminal liability, but for a few...more

Akin Gump Strauss Hauer & Feld LLP

Making America Healthy Again By Empowering Patients With Clear, Accurate, and Actionable Healthcare Pricing Information (Trump EO...

The EO announces a policy of the United States to put patients first and ensure they have the necessary information to make well-informed healthcare decisions. The order builds upon Executive Order 13877 (Improving Price and...more

McDermott Will & Emery

Human Trafficking Monitoring for Telehealth Providers

Telehealth providers are uniquely positioned to monitor for human trafficking when interacting with patients. Survivor records indicate that health services are among the most common points of access to help trafficked...more

McDermott Will & Emery

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more

Bradley Arant Boult Cummings LLP

HHS’s Proposed Security Rule Updates Could Require Group Health Plan Document Changes and New Plan Sponsor Security Practices

Proposed regulations may require employers to invest additional resources to safeguard group health plan participants’ protected health information. In this installment of our blog series on the U.S. Department of Health...more

McCarter & English, LLP

New Jersey Regulatory Update Part I - January 2025

Below is Part I of our New Jersey Regulatory Update focusing on regulations that were finalized in 2024 by various New Jersey agencies that impact healthcare. The final regulations range from additional transparency...more

Verrill

The Gag Clause Quandary for Self-Insured Group Health Plans—New FAQ Guidance

Verrill on

The Departments of Labor, Health and Human Services, and the Treasury, with the Office of Personnel Management (the “Departments”) jointly released FAQs About Consolidated Appropriations Act, 2021 Implementation Part 69...more

Bass, Berry & Sims PLC

Athira Pharma Inc. Agrees to Settle False Claims Act Allegations

Bass, Berry & Sims PLC on

On January 6, the Department of Justice (DOJ) announced that Athira Pharma Inc., a Washington-based biopharmaceutical company, agreed to pay over $4 million to settle allegations it violated the False Claims Act (FCA). The...more

Kilpatrick

Recent Changes in Appropriations Legislation May Have Given "Baby False Claims Act" New Teeth

Kilpatrick on

On December 23, 2024, President Biden signed into law H.R. 5009 - “Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025.” (2025 NDAA). First passed in 1961, the NDAA is a...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

PilieroMazza PLLC

Weekly Update for Government Contractors and Commercial Businesses – December 2024

PilieroMazza PLLC on

Corporate Transparency Act, Part 4: Reporting Requirements Temporarily Suspended - As you may have been following, PilieroMazza previously reported on the requirements of the Corporate Transparency Act (CTA) and the...more

Gardner Law

LDT Compliance: Countdown to May 2025

Gardner Law on

We previously reported on the FDA’s laboratory-developed test (LDT) rule published on May 6, 2024, which classifies LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This shift marks the end...more

Holland & Knight LLP

NY Department of Health Bolsters Hospital Cybersecurity Regulations

Holland & Knight LLP on

New York hospitals have less than a year to dust off their Health Insurance Portability and Accountability Act (HIPAA) compliance programs and update them to comply with more stringent and detailed state regulations. Last...more

Lippes Mathias LLP

Hospital Administrators – Is Your Hospital Cyber-Secure?

Lippes Mathias LLP on

On October 2, 2024, New York adopted new regulations requiring general hospitals to implement heightened cybersecurity safeguards. General hospitals, as defined in Article 28 of the NY Public Health Law, generally must begin...more

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