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Healthcare Regulatory Reform Health Insurance

Jones Day

Congress Expands Orphan Drug Exemptions From Medicare Price Negotiations

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The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....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+

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

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

Arnall Golden Gregory LLP

Locked Out: How a Federal Moratorium on AI Regulation Could Reshape Healthcare Oversight

On May 22, 2025, the U.S. House of Representatives passed the “One Big Beautiful Bill Act” (H.R. 1) by a vote of 215-214, which includes a significant provision imposing a 10-year moratorium on state and local regulation of...more

McDermott Will & Schulte

Enforcement of Mental Health Parity Regulations Suspended: Takeaways for Plan Sponsors and Health Insurance Issuers

In January 2025, The ERISA Industry Committee (ERIC) filed a complaint against the US Departments of Labor, Health and Human Services, and the Treasury (the departments) seeking to invalidate the 2024 final regulations under...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

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

Jones Day

Executive Orders and Policy Updates

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Since President Trump's inauguration, the Trump administration has issued a number of executive orders and policy actions with potential impacts for the life sciences industry. Notable actions include rescinding Biden-era...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 24 - February 2025

With one week to go until Crossover Day, lawmakers and lobbyists are already feeling the exhaustion and exasperation captured in the face of James Oglethorpe’s bust on the North Steps. As committees convene constantly to...more

Alston & Bird

Health Care Week in Review | The House of Representatives Approved a Budget Resolution and President Trump Signed an EO on...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McDermott Will & Schulte

Trump Administration May Expand Access to IVF Services

On February 18, 2025, US President Donald Trump signed an executive order directing his administration to develop policy recommendations within 90 days to increase access to in vitro fertilization (IVF) services and to reduce...more

Mintz - Health Care Viewpoints

PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team...more

Akin Gump Strauss Hauer & Feld LLP

Protecting Children from Chemical and Surgical Mutilation (Trump EO Tracker)

Summary - The Executive Order announces that the United States "will not fund, sponsor, promote, assist, or support the so-called ‘transition’ of a child from one sex to another and will rigorously enforce all laws that...more

Fennemore

Regulatory Landscape of Insurance Claims Denial Practices and Suggestions for a Path Forward to a Sustainable Healthcare Future

Fennemore on

In the wake of the December 4, 2024 fatal shooting of UnitedHealthcare’s CEO Brian Thompson, questions were raised about insurance claim denial practices. Several news outlets noted that UnitedHealth Group’s profits have been...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | December 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for December 2024. We discuss several civil and criminal enforcement actions pertaining to healthcare fraud and abuse authorities,...more

Cozen O'Connor

Pennsylvania Perspective for Thursday, January 9, 2025

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New Legislative Session Begins- Pennsylvania lawmakers began the 2025-26 legislative session this week, with Rep. Joanna McClinton (D-Philadelphia) reelected as House Speaker, securing the position with bipartisan support...more

DLA Piper

New York issues extensive new pharmacy benefit manager regulations

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On November 27, 2024, the New York State Department of Financial Services (DFS) will be releasing new regulations governing pharmacy benefit managers (PBMs). Beginning with legislation in 2021, New York has been active in...more

Epstein Becker & Green

Affordable Care Act Overpayments in the CY 2025 Medicare Physician Fee Schedule Proposed Rule: Implications for False Claims

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Stakeholders are continuing to analyze the implications of the mammoth proposed rule on “Medicare and Medicaid Programs: [Calendar Year (CY)] 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B...more

Fenwick & West LLP

The Shifting Regulatory Landscape for Level-Funded Plans: An Alternative for Group Health Insurance

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In the constantly changing health insurance landscape, level-funded health plans are steadily gaining ground as a viable middle approach between fully insured health plan and self-funded health plans—arguably offering...more

Cornerstone Research

5 Questions with Erin Trish: Surprise Billing in Healthcare

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5 Questions is a periodic feature produced by Cornerstone Research, which asks our professionals, senior advisors, or affiliated experts to answer five questions. We interview Professor Erin Trish, of the Schaeffer Center...more

Polsinelli

Third Party Administrator & Pharmacy Benefit Manager 2023 Newsletter: TPA & PBM Licensing And Compliance Developments

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Florida OIR Issues Informational Memorandum OIR-23-04M to PBMs - On July 19, 2023, the Florida Office of Insurance Regulation (“OIR”) issued Informational Memorandum OIR-23-04M (“Memorandum”) to Pharmacy Benefit Managers...more

Polsinelli

CMS Proposes Changes to Medicare Provider Enrollment Rules

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The Centers for Medicare & Medicaid Services (“CMS”) published proposed changes to the Medicare Provider Enrollment requirements in the 2024 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”). If finalized,...more

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