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Enforcement Actions Proposed Rules Department of Health and Human Services (HHS)

Vedder Price

Trump Administration Issues Executive Order Aimed At Lowering Prescription Drug Pricing

Vedder Price on

On May 12, 2025, President Donald J. Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” This executive order aims to lower the cost of prescription drugs...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Bass, Berry & Sims PLC

HHS Proposes Rule to Establish Disincentives for Healthcare Providers That Engage in Information Blocking

Bass, Berry & Sims PLC on

In 2020, when the U.S. Department of Health and Human Services (HHS) published its Final Rule to implement the information blocking prohibitions of the 21st Century Cures Act, HHS left healthcare providers wondering what...more

McDermott Will & Emery

Special Report - A Million Reasons to Share: OIG’s Final Rule on Information Blocking Enforcement

McDermott Will & Emery on

On July 3, 2023, the US Department of Health and Human Services Office of Inspector General (OIG) published its long-awaited final rule implementing the 21st Century Cures Act provisions authorizing OIG to investigate claims...more

McDermott+

McDermottPlus Check-Up: April 28, 2023

McDermott+ on

Congress was in session, and it was a busy healthcare week at the committee level, with six hearings focused specifically on health issues. On the House floor, Republicans passed the Limit, Save, Grow Act—a bill that raises...more

ArentFox Schiff

Biden’s HHS Seeks to Undo Trump Era Regulations

ArentFox Schiff on

Proposed Rules Seek to Repeal Multiple Trump Era Regulations That Received Prior Industry Scrutiny - The United States Department of Health and Human Services (HHS) – still within its first full year under the direction...more

Baker Donelson

Proposed HHS Rule Would Further Solidify Limitations on Enforcement of Agency Guidance Documents

Baker Donelson on

Consistent with President Trump's actions seeking to rein in the use of sub-regulatory guidance in government enforcement actions, the U.S. Department of Health and Human Services (HHS) issued a notice of proposed rulemaking...more

Sheppard Mullin Richter & Hampton LLP

Information Blocking And The Right To Access Initiative: Why Patients Struggle to Obtain their Medical Records and what the Office...

Access to healthcare information (or lack thereof) has always been touted as one of the key factors/necessities to realizing the promise of technology in the delivery of healthcare. Despite various legislative, judicial,...more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

McDermott Will & Emery

2018 Digital Health Data Developments – Navigating Change in 2019

Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott’s 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights...more

Holland & Knight LLP

Healthcare Law Update: September 2018

Holland & Knight LLP on

Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

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