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Regulatory Requirements Healthcare Healthcare Reform

McDermott+

Site neutrality is on the menu in the CY 2026 Medicare Outpatient Prospective Payment System proposed rule

McDermott+ on

Last week, the Centers for Medicare & Medicaid Services (CMS) issued two major regs: the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) proposed rule and the CY 2026 Outpatient Prospective Payment System (OPPS)...more

Sheppard Mullin Richter & Hampton LLP

Pulse Check: How is Your California Practice Leveraging “103 NPs” – and Preparing for the Arrival of “104 NPs” in 2026?

Nearly three years ago, the passage of California Bill AB 890, effective January 1, 2023, set in motion a future pathway for qualified nurse practitioners (“NPs”) to practice independently under a new category of licensure....more

McDermott+

CMS releases CY 2026 Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System proposed rule

McDermott+ on

On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule [CMS-1834-P],...more

Woods Rogers

Federal Court Strikes Down HIPAA Reproductive Health Privacy Rule Lifting Compliance Requirements for Regulated Entities

Woods Rogers on

In a sweeping decision published in June, a federal court in Texas struck down most of the HIPAA Rule to Support Reproductive Health Care Privacy (Reproductive Health Rule) enacted in 2024 under the Biden administration to...more

King & Spalding

CMS Escalates Aggressive Rates Cut in Home Health Prospective Payment System Proposed Rule for CY 2026

King & Spalding on

On June 30, 2025, CMS issued its annual Home Health Prospective Payment System Proposed Rule for Calendar Year (CY) 2026 (the Proposed Rule). The Proposed Rule continues the agency’s policy of using provisions of the...more

Stevens & Lee

Pennsylvania to Join Three Interstate Health Care Licensure Compacts

Stevens & Lee on

Pennsylvania Governor Josh Shapiro recently announced that, effective July 7, 2025, Pennsylvania will commence full participation in three interstate health care licensure compacts: the Interstate Medical Licensure Compact,...more

DLA Piper

A Growing State of Oversight: How States are Continuing to Reshape (and restrict) Healthcare Transactions and Private Equity...

DLA Piper on

State governments are increasingly introducing new laws regulating healthcare transactions in an effort to thwart the level of influence that private equity firms and other corporate investors have on healthcare providers. To...more

McDermott+

Health Plans’ Commitment to Prior Authorization Improvements: What’s New Versus What’s Already Required

McDermott+ on

Health plan members of AHIP and the Blue Cross and Blue Shield Association made news earlier this week when they announced a series of steps that a broad swath of health insurers will take to improve the prior authorization...more

Clark Hill PLC

Texas enacts sweeping changes to noncompete agreements for healthcare providers

Clark Hill PLC on

On June 20, Gov. Greg Abbott signed into law significant amendments to the Texas Business and Commerce Code, as contained in Senate Bill 1318, that will substantially restrict noncompete agreements for physicians and other...more

Skadden, Arps, Slate, Meagher & Flom LLP

The European Health Data Space – What EU Health Care Providers and Data Holders Need To Know

- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more

McDermott Will & Emery

Partnering with Legal at the Critical AI/Healthcare Crossroads

McDermott Will & Emery on

The intersection of AI and healthcare is outpacing the development of laws and regulations governing the technology. Even in the early days of AI transformation, this is creating uncertainty for healthcare organizations....more

Clark Hill PLC

Beyond HIPAA: How state laws are reshaping health data compliance

Clark Hill PLC on

We are in an era where smartphones track sleep patterns, fitness apps monitor heart rates, and online searches reveal sensitive medical inquiries. As a result, the notion of “health data” has expanded dramatically. This...more

Sheppard Mullin Richter & Hampton LLP

Understanding the Federal Reconciliation Bill’s Implications for MCO Tax Structure

New York’s Medicaid financing strategy—particularly its use of a managed care organization (MCO) tax—has come under renewed federal scrutiny amid recent legislative proposals and regulatory developments. The federal...more

McDermott+

Health Information Technology Policy Under the Trump Administration

McDermott+ on

Patient engagement. Information blocking. Interoperability. These buzz words are flying around the health information technology (HIT) world as the Trump administration starts to make its mark on the HIT policy landscape....more

A&O Shearman

Council position on EU pharma package adopted

A&O Shearman on

On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more

Bass, Berry & Sims PLC

New Tennessee Law Eases Physician Employment Restrictions for Certain Hospitals

Bass, Berry & Sims PLC on

On May 21, Governor Bill Lee signed House Bill 979 (HB 979) into law.  Notably, provisions of this law aim to address physician shortages and improve access to specialized medical care in rural and underserved areas in...more

McDermott Will & Emery

GLP-1 Update: Court Backs FDA in Tirzepatide Compounding Case

McDermott Will & Emery on

On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more

Pullman & Comley - Connecticut Health Law

Three Bills Affecting Health Care Transactions That Will Not Be Signed into Law This Year

Members of the health care community may recall that the 2025 legislative session of the Connecticut General Assembly started out with Governor Lamont signing into law an emergency certificate of need (CON) process for...more

Sheppard Mullin Richter & Hampton LLP

The One Big Beautiful Bill Act’s Proposed Moratorium on State AI Legislation: What Healthcare Organizations Should Know

Congress is weighing a sweeping proposal that could significantly reshape how artificial intelligence (AI) is regulated across the United States. At the end of May, the United States House of Representatives passed, by a vote...more

McDermott Will & Emery

CMS Requires Hospitals to Publish More Pricing Information, Signals Focus on Enforcement

McDermott Will & Emery on

On May 22, 2025, the Centers for Medicare & Medicaid Services (CMS) released new guidance for compliance with the hospital price transparency rule and published a request for information (RFI) seeking ways to bolster hospital...more

McDermott Will & Emery

CMS Requests Hospitals Submit Gender-Affirming Care Data

McDermott Will & Emery on

On May 28, 2025, the Centers for Medicare & Medicaid Services (CMS) sent a letter to “select hospitals” that provide gender-affirming care services, requesting information about how those hospitals adhere to quality standards...more

McDermott Will & Emery

McDermott HealthEx 2025: McKinsey Key Takeaways

McDermott Will & Emery on

McDermott HealthEx convened more than 1,300 of the most influential leaders in healthcare and life sciences. The event emphasized creativity, transformation, and growth, with sessions dedicated to innovation, AI-powered...more

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

A&O Shearman

The future of the robotics metaverse in the healthcare sector

A&O Shearman on

On 26 February 2025, the European Economic and Social Committee (EESC) adopted an opinion addressing the integration of robotics and the metaverse in healthcare. This forward-looking document outlines the opportunities and...more

J.S. Held

Beyond Safety & Effectiveness: Business Reasons to Prioritize Human Factors in Medical Device Design

J.S. Held on

To err is human. We have short attention spans and get distracted easily. We have unreliable memories and forget. We have a limited ability to process information, and we overgeneralize rules-of-thumb to the wrong situations....more

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