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Regulatory Requirements Healthcare Regulatory Reform

McDermott Will & Emery

A need for speed: FDA piloting voucher program to expedite drug review

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On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more

Foley & Lardner LLP

FDA: Commissioner’s National Priority Voucher Program Aims to Streamline Some Drug Reviews

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Share on Twitter Share by Email Share Back to top The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of...more

BakerHostetler

HHS Issues a Request for Information on Deregulation and Innovation: Considerations for Legal and Compliance Teams

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On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...more

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

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In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

McDermott+

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

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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

Jackson Lewis P.C.

OFCCP Extends Enforcement Moratorium for VAHBP Providers Until 2027

Jackson Lewis P.C. on

In a move the Agency reported is designed to maintain healthcare access for active and retired service members and their families, the Office of Federal Contract Compliance Programs (OFCCP) has announced a two-year extension...more

Knobbe Martens

Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth

Knobbe Martens on

The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...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

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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

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

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

Hendershot Cowart P.C.

Texas HB 3749: What IV Hydration Clinic Owners Need to Know

Hendershot Cowart P.C. on

Texas House Bill 3749 (HB 3749), known as "Jenifer's Law," has undergone dramatic revisions since its introduction. What began as a bill that could have shuttered many IV hydration clinics has transformed into legislation...more

Stikeman Elliott LLP

Ontario’s More Convenient Care Act, 2025: A New Strategy for the Healthcare Sector

Stikeman Elliott LLP on

On May 5, 2025, the Ontario government introduced Bill 11, the proposed More Convenient Care Act, 2025 (“MCCA”), a legislative initiative aimed at supporting the province’s long-term healthcare goals for first reading. Bill...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

Seyfarth Shaw LLP

Parity in Peril? Plan Sponsors Breathe Easier As Trump Administration Hits Pause on Enforcement of Mental Health Parity Final Rule

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On May 15, 2025 the Departments of Labor, Health and Human Services, and Treasury (the “Departments”) announced they will temporarily not enforce their new standards published under the mental health parity Final Rule last...more

Sheppard Mullin Richter & Hampton LLP

Reflections on the FDLI 2025 Annual Conference – Differing Tones, Shared Goals

From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of...more

McDermott Will & Emery

Colorado Fails to Amend Groundbreaking AI Law: What Happened and What’s Next

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On May 5, 2025, the Colorado Senate rejected an attempt by state lawmakers to amend Colorado’s landmark artificial intelligence (AI) law, known as Senate Bill (SB) 205. Colorado State Senator Robert Rodriguez and State...more

Jackson Lewis P.C.

Colorado Legislature Fails to Amend Recent Artificial Intelligence Act

Jackson Lewis P.C. on

In 2024, Colorado passed the first comprehensive state-level law in the U.S. regulating the use of artificial intelligence, the Artificial Intelligence Act (the Act). It imposed strict requirements on developers and users of...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

Sheppard Mullin Richter & Hampton LLP

CMS Proposes Medicare Payment Policies for Hospital Inpatient Services for Federal Fiscal Year 2026

The Centers for Medicare & Medicaid Services (CMS) recently published the fiscal year (“FY”) 2026 proposed rule for Hospital Inpatient Prospective Payment Systems (IPPS) (the “Proposed Rule”). Comments to the Proposed Rule...more

Epstein Becker & Green

Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®

On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs). The court’s judgment...more

King & Spalding

Executive Order Continues Focuses on Anticompetitive Regulations

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On April 9, 2025, President Trump issued an executive order, titled “Reducing Anti-Competitive Regulatory Barriers” (the EO), directing federal agencies to identify and rescind or modify anticompetitive regulations. The EO...more

Quarles & Brady LLP

Arkansas Law Prohibits Pharmacy Benefit Managers from Obtaining or Holding Pharmacy Permits

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On April 16, 2025, Arkansas House Bill 1150 (the “Bill”) was signed by Governor Huckabee Sanders. The Bill will have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country....more

McDermott+

FY 2026 Proposed Rules Are Out! Overview of the IPPS Proposed Rule

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Last Friday, the Centers for Medicare & Medicaid Services (CMS) officially launched the health policy community into reg season, releasing in one fell swoop all the fiscal year (FY) 2026 Medicare proposed regulations for...more

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