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Healthcare Reform Regulatory Agenda Regulatory Requirements

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

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 & Schulte

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

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

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

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

Washington Enacts “Mini-HSR” Law, Expanding State-Level Premerger Filing Requirements

Bass, Berry & Sims PLC on

On April 4, Washington became the first state to adopt the Uniform Premerger Notification Act (Act) when Washington Governor Jay Inslee signed the bill into law. The new statute imposes state-level premerger filing...more

Health Care Compliance Association (HCCA)

Advancing shared accountability to reduce regulatory burden, promote well-being

Introduction: A different perspective - Within the compliance profession, Cecilia Fellouse has noted, “Under the weight of incessant regulatory demands, individuals and teams often fall prey to compliance fatigue. This...more

Bradley Arant Boult Cummings LLP

Alabama CON Report - April 2025

I. II. Certificate of Need Program - A. AL2024-025, 211-213 Ana Drive Operations, LLC d/b/a Hilltop at Glenwood II, Lauderdale County, AL: Proposes to convert sixteen (16) existing assisted living facility (ALF) beds into...more

Maynard Nexsen

NAIC Spring Meeting Update Part Two

Maynard Nexsen on

As discussed in last week’s article, along with almost 3,000 regulators and insurance industry leaders, the Maynard Nexsen Insurance Regulatory team of attorneys attended the National Association of Insurance Commissioners...more

McDermott+

Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off

McDermott+ on

Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off - It’s March, which means one thing for sports fans: the madness of the NCAA men’s and women’s basketball tournaments. However, to folks in the...more

Holland & Knight LLP

Holland & Knight Health Dose: March 25, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Mintz - Health Care Viewpoints

CMS’s ACA Marketplace Integrity and Affordability Proposed Rule – What it may mean for Health Plans

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies...more

Holland & Knight LLP

Holland & Knight Health Dose: March 19, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott+

Sound of Silence? What the CMS Innovation Center’s Announcement Does and Doesn’t Say

McDermott+ on

The Centers for Medicare & Medicaid Services (CMS) Innovation Center made headlines last week by announcing that it would end eight models early. The Innovation Center put out a fact sheet explaining its rationale behind...more

McDermott+

Coding Update - CPT Editorial Panel Meeting: What’s on the Agenda and Why It Matters

McDermott+ on

The American Medical Association (AMA) CPT®1 Editorial Panel will meet in Brooklyn, New York, from May 1 to 3, 2025. The meeting agenda includes proposals to create new current procedural terminology (CPT) codes and to revise...more

McDermott+

Trump Administration Executive Order Tracker

McDermott+ on

Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Holland & Knight LLP

Holland & Knight Health Dose: March 4, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott Will & Schulte

This Week in 340B: February 18 – 24, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Holland & Knight LLP

Holland & Knight Health Dose: February 25, 2025

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Holland & Knight Health Dose Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Quarles & Brady LLP

Alabama Bill Proposes Rewrite of Pharmacy Practice Act

Quarles & Brady LLP on

The future direction of the Alabama Board of Pharmacy (“the Board”) hangs in the balance following recent legislation that, if passed, would revise many portions of the state Pharmacy Practice Act. House Bill 123, sponsored...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The Future of the Medicare Drug Price Negotiation Program

The Centers for Medicare and Medicaid Services (CMS) and pharmaceutical drug manufacturers are gearing up for the second round of negotiations as part of the Medicare Drug Price Negotiation Program (the Negotiation Program),...more

Holland & Knight LLP

Holland & Knight Health Dose: February 11, 2025

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott Will & Schulte

Trending in Telehealth: January 6 – 27, 2025

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

McDermott Will & Schulte

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

Holland & Knight LLP

Holland & Knight Health Dose: January 29, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

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