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Government Agencies Regulatory Reform Healthcare

A&O Shearman

Italian Medical Device Payback: Italy approves 75% reduction on medical device payback to end disputes

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Background: The Payback Mechanism and Its Impact - Italy’s payback system for medical devices has been a source of significant upheaval in the sector, with both domestic and international companies closely monitoring...more

McDermott Will & Schulte

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

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

Epstein Becker & Green

AI Infrastructure, Ideology, and Exports: Inside the White House’s New AI Orders

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On July 23, 2025, the president signed three AI-related Executive Orders (“E.O.s”) to accompany the recently released White House’s Artificial Intelligence (AI) Action Plan (“AI Action Plan”). These E.O.s seek to add clarity...more

McDermott+

Three key takeaways from the CMS Innovation Center’s new WISeR Model

McDermott+ on

The last week of June was a busy one when it comes to news about prior authorization – a major tool used by health plans and the federal government to manage healthcare utilization. The week started with a commitment from...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

Jackson Lewis P.C.

OFCCP Extends Enforcement Moratorium for VAHBP Providers Until 2027

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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

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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

Spilman Thomas & Battle, PLLC

Certificate of Need in West Virginia – Where We Stand | Spilman Thomas & Battle

Certificate of Need (CON) emerged as a central issue during West Virginia's recent legislative session, with substantial efforts to eliminate the system ultimately falling short. The CON reform has been a longstanding policy...more

Akin Gump Strauss Hauer & Feld LLP

Five FDA Takeaways from the FY26 Budget

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more

Jones Day

Medicare's Innovation Center Charts New Direction: Part 1 - Providers

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The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the first of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding health care...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

Sheppard Mullin Richter & Hampton LLP

Proposed Rule on Medicaid Tax Waivers: CMS Moves to Close a Loophole Shifting Costs to the Federal Government

On May 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule, entitled “Preserving Medicaid Funding for Vulnerable Populations – Closing a Health Care-Related Tax Loophole” to address a...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

Bass, Berry & Sims PLC

CMMI Announces New Strategy

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After months of signaling that a new strategy was in the works, on May 13, 2025, the Centers for Medicare & Medicaid Services (CMS) released a new strategic direction for the CMS Center for Medicare and Medicaid Innovation...more

McGuireWoods Consulting

Senate Health Education Labor and Pensions Committee Releases Report on 340B Program and Recommendations for Change

When Sen. Bill Cassidy became Chairman of the U.S. Senate Health, Education, Labor and Pensions Committee this year, he stated one of his priorities was reforming the 340B Program. On April 24, 2025, he released a majority...more

Epstein Becker & Green

Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast

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Important changes are unfolding in the vaccine space. How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration's federal health...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

Benesch

Dialysis & Nephrology Digest - April 2025

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ESRD ETC among value-based care models being ended early by CMS - This decision to end the ESRD ETC payment model and several others on Dec. 31 aligns with CMS’ goal to focus on models that demonstrate potential for...more

Jones Day

CMS Innovation Center Announces Cost-Saving Restructuring of Value-Based Payment Model Portfolio

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The Center for Medicare and Medicaid Services ("CMS") has announced significant changes to its value-based payment model portfolio projected to save $750 million as part of a shift in the agency's refocused strategy toward...more

Quarles & Brady LLP

Alabama Bill Rewriting Pharmacy Practice Act Clears Senate Hurdle

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As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more

ArentFox Schiff

Mass Layoffs Begin At the FDA

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As a further update to our alert from March 27, the Trump Administration began mass layoffs at US health agencies on April 1....more

Health Care Compliance Association (HCCA)

New NIH Head: Indirect Payments ‘Tips’; Republican Senator Calls Them ‘Grift’

Research universities have had one less worry (at least temporarily) since Judge Angel Kelley of the U.S. District Court for the District of Massachusetts granted a preliminary restraining order prohibiting NIH from imposing...more

McGuireWoods Consulting

New Virginia Legislative Committees Brace For Effects Of Federal Downsizing

On Feb. 4, 2025, Virginia Speaker of the House Don Scott announced the creation of short-term emergency committee to address federal program cuts and layoffs. On March 8, 2025, Senate Finance and Appropriations Chairwoman...more

Stevens & Lee

U.S. HHS Announces Closure of Six Regional Locations of the Office of the General Counsel

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On March 11, 2025, the U.S. Department of Health and Human Services (HHS) announced plans for a “reorganization of the Office of the General Counsel” (OGC) “[a]s part of the department’s ongoing efforts to advance the...more

McDermott Will & Schulte

This Week in 340B: March 11 – 17, 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

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