News & Analysis as of

Health Insurance Regulatory Reform

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

Ballard Spahr LLP

The OBBBA’s Impact on Employee Benefits and Executive Compensation

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H.R.1—the One Big Beautiful Bill Act (OBBBA)—contains several provisions that directly affect employer-provided benefit programs, primarily health and welfare programs....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

Saul Ewing LLP

Trump’s Megabill: Expanding Choice With Health Savings Accounts

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On July 4, 2025, President Trump signed the reconciliation bill entitled An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14 (“Act”) into law. The changes proposed in the earlier House version of the...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

Quarles & Brady LLP

Indiana Senate Bill 140 Signed into Law Imposing Reforms on Pharmacy Benefit Managers

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Indiana recently enacted significant new legislation that will impact how pharmacy benefit management services are provided in Indiana. Senate Bill 140 (SB 140), signed into law during the 2025 legislative session, imposes...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

McDermott+

First Steps in Implementing the Trump Administration’s Price Transparency Agenda

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Recently, the Trump administration took steps toward implementing one of its major priorities: improving price transparency. As discussed in a previous Regs & Eggs blog post, President Trump signed an executive order (EO) on...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

Arnall Golden Gregory LLP

Health Insurers Under Fire: New Administration Cracks Down on Evasive Pricing Practices

Health insurance regulations are rapidly shifting with unprecedented intensity. Amid growing public outrage over evasive and abusive pricing practices by insurers and years of federal underenforcement, the new administration...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

Ballard Spahr LLP

Mental Health Brake: 2024 MHPAEA Regulations Put on Hold

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A recent court filing offers a reprieve to health plan sponsors in their efforts to comply with final regulations issued last year under the Mental Health Parity and Addiction Equity Act (MHPAEA)....more

Epstein Becker & Green

Federal Regulators Announce Non-Enforcement of the 2024 Rule for Mental Health Parity

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On May 9, 2025, the Departments of Labor, Health and Human Services, and Treasury (collectively, “the Departments”) asked the D.C. federal court to suspend litigation while they consider whether to rescind or modify the 2024...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

Hogan Lovells

French supreme Court, March 20, 2025, Alexion Pharma France: a historic turnaround for the financial regulation of French...

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In a decision of 20 March 2025 (Appeal No. N 22-23.927), the FR supreme Court ruled that the “product clawbacks” negotiated with the Economic Committee for Health Products (‘CEPS’) on the price of pharmaceutical products...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

Polsinelli

Back to Backlog? Polsinelli Shareholders Share Insight on how Terminations of DAB Attorneys and Potential Removal of...

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As the new administration continues its efforts to contract and streamline the federal government, recent developments at the U.S. Department of Health and Human Services (“HHS”) and the Department of Justice (“DOJ”) hint at...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

Wiley Rein LLP

Trump Prioritizes Health Care Pricing Transparency in New Executive Order

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On Tuesday, February 25, 2025, President Trump issued an Executive Order (EO), “Making America Healthy Again By Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information.” The EO aims to improve...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 22 - February 2025

Lawmakers and lobbyists watching the Georgia State Senate on Monday saw a lot of green and red, but it wasn’t exactly Christmas. While some state agencies and contractors stand to see a few extra greenbacks in the Senate...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

Akin Gump Strauss Hauer & Feld LLP

Expanding Access to In Vitro Fertilization (Trump EO Tracker)

This order makes it the policy of the Administration to ensure reliable access to IVF treatment, including by easing unnecessary statutory or regulatory burdens to make IVF treatment more affordable. Within 90 days of the...more

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