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Healthcare Regulatory Reform

Troutman Pepper Locke

Congressional Briefing Highlights Growing Bipartisan Consensus on the Need for Federal Clarity in Hemp-Derived Cannabinoid...

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On July 17, the U.S. House Committee on Agriculture hosted a closed-door roundtable briefing focused on the regulatory gray areas surrounding hemp-derived cannabinoid products. The session, convened in response to ongoing...more

Sheppard Mullin Richter & Hampton LLP

Policy Brief: Aligning Nursing Home Bed Planning with New York’s Certificate of Need Reform Goals

Last month, New York State began a formal review of its Certificate of Need (CON) process for nursing homes, launching a timely conversation about how best to align regulatory oversight with evolving system needs. A new...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Biosimilars Boom: 2025’s Fast Track Approvals Look to Reshape Healthcare

With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close...more

Foley & Lardner LLP

Colorado Medicaid: RAC Program Overhauled with Enhanced Transparency, Greater Provider Protections, and Increased Oversight

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In June 2025, Colorado passed a new law that makes significant changes to the state’s Medicaid Recovery Audit Contractor (RAC) program. Colorado has one of the most aggressive RAC programs in the country that has been rife...more

Quarles & Brady LLP

DOJ and HHS Announce New False Claims Act Working Group

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On July 2, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) announced that they are forming the DOJ-HHS False Claims Act Working Group to further combat healthcare fraud—an...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

Foley & Lardner LLP

The Patent Eligibility Restoration Act and Life Sciences Innovation

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The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more

Jones Day

CMS Updates Kidney Care Choices Model

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The Center for Medicare and Medicaid Innovation ("CMMI") announced sweeping changes to the Kidney Care Choices Model ("KCC Model"), a key set of value-based programs....more

McDermott+

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

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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

Tucker Arensberg, P.C.

New CMS Model Targets Inefficient Medicare Spending Through AI and Clinical Oversight

The Centers for Medicare & Medicaid Services (CMS) has launched the WISeR Model (Wasteful and Inappropriate Service Reduction) to modernize and streamline Medicare’s prior authorization process. ...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

Sheppard Mullin Richter & Hampton LLP

Oregon Prohibits Medical Debt in Credit Reports

On June 23, Oregon enacted SB 605, barring medical-debt information from appearing in consumer credit reports. The measure, which amends the Oregon Unlawful Trade Practices Act, takes effect January 1, 2026....more

McDermott Will & Emery

Oregon considers revisions to expansive corporate practice of medicine law

On June 20, 2025, the Oregon legislature passed House Bill (HB) 3410, which amends portions of the corporate practice of medicine law, Senate Bill (SB) 951, enacted on June 9, 2025. As we previously reported, SB 951 prohibits...more

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

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On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more

Brownstein Hyatt Farber Schreck

Senate Concludes OBBBA Vote-a-Rama

The Senate approved a revised version of the One Big Beautiful Bill Act (OBBBA) (H.R. 1) on July 1, concluding a vote-a-rama that began the morning of June 30 and lasted over 24 hours. Consideration was further delayed after...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

Benesch

AI Reporter - June 2025

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The FDA began integration of generative AI across all its centers, a project that should be completed by the end of June. Newly appointed chief AI officer, Jeremy Walsh, and Office of Strategic Programs at CDER, Sridhar...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

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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

Mintz - Health Care Viewpoints

Oregon Law Restricts Common Management Service Organization – Professional Entity Structure

On June 9, 2025, Oregon Governor Tina Kotek signed into law Oregon Senate Bill 951 (Oregon CPOM Law), further expanding Oregon’s prohibition on the corporate practice of medicine (CPOM) doctrine. The stated purpose of the...more

Brownstein Hyatt Farber Schreck

California Regulators Contemplate Potential State-Level Action on Antitrust

At an upcoming June 26 meeting, The California Law Revision Commission (CLRC) will discuss proposed draft language to introduce state-level merger control provisions into California antitrust law via amendments to the...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

Hogan Lovells

New Oregon CPOM law takes aim at “Friendly PC” arrangements

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On June 9, 2025, Oregon enacted Senate Bill 951, which strengthens Oregon’s existing prohibition on the corporate practice of medicine (CPOM) by limiting the scope of permissible arrangements between professional medical...more

Sheppard Mullin Richter & Hampton LLP

Oregon Targets Corporate Practice of Medicine with Enacted Bill: What SB 951 Means for MSOs, PE-Backed Physician Groups, and...

Overview of SB 951 - Oregon Governor Tina Kotek on Monday, June 9, 2025, signed a first-of-its-kind law that significantly reshapes the state’s regulatory landscape for non-physician investment in medical practices. Senate...more

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