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Department of Health and Human Services (HHS) Regulatory Agenda Health Insurance

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

Quarles & Brady LLP on

The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Regulators Pause Mental Health Parity Rules Enforcement

Federal regulators recently indicated they will not enforce parts of the final regulations issued in September 2024 under the Mental Health Parity and Addiction Equity Act (MHPAEA) and may soon propose new rules altogether....more

Ballard Spahr LLP

Mental Health Brake: 2024 MHPAEA Regulations Put on Hold

Ballard Spahr LLP on

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

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

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

Holland & Knight LLP

Holland & Knight Health Dose: February 19, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Holland & Knight LLP

Holland & Knight Health Dose: February 11, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Holland & Knight LLP

Holland & Knight Health Dose: January 21, 2025

Holland & Knight LLP on

Holland & Knight Health Dose Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Holland & Knight LLP

Holland & Knight Health Dose: What to Expect in the 119th Congress – January 16, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ...more

McDermott Will & Schulte

Complying With the ‘Relevant Data’ Requirement Under the Final 2024 Mental Health Parity and Addiction Equity Act: A Proposal for...

McDermott Will & Schulte on

The Mental Health Parity and Addiction Equity Act (MHPAEA) generally requires group health plans and health insurance issuers to ensure that financial requirements (such as copays and deductibles), quantitative treatment...more

Stinson LLP

Trump's First 100 Days: Health Care

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In his first term, President-elect Trump focused on repealing the Affordable Care Act (ACA). He has since shifted away from that approach and indicated plans to improve the ACA and reduce costs....more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | October 2024 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for October 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

McDermott+

Healthcare Preview for the Week of: November 18, 2024

McDermott+ on

The incoming Trump Administration made several decisions and announcements in the first week of the lame duck session, including announcing his nominee for Secretary of the US Department of Health and Human Services (HHS)....more

McDermott+

McDermott+ Check-Up: November 15, 2024

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Congress Returns for Lame Duck Session. The House and Senate returned this week, kicking off the post-election lame duck session. The focus this week was not on legislating, but on organizing for the upcoming 119th Congress,...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | September 2024 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

Verrill

Final Mental Health Parity Rule Spells Compliance Changes

Verrill on

The long-anticipated final rule under the Mental Health Parity and Addiction Equity Act (MHPAEA) was published on September 9, 2024. The MHPAEA prohibits group health plans that provide mental health and substance use...more

McDermott+

Regs Coming Through the End of the Year: Expect the Expected and the Unexpected

McDermott+ on

There could be an all-you-can-eat buffet of regs (and eggs) from now until the end of the year! As you may recall, a July 2024 Regs & Eggs blog post highlighted the spring 2024 “unified agenda” that listed all the regs...more

McDermott+

CMS Issues Guidance to States on Children’s Access to Medicaid Coverage

McDermott+ on

Last week, the Center for Medicaid and CHIP Services within the Centers for Medicare & Medicaid Services (CMS) released what it calls “historic” guidance to states on best practices for adherence to early and periodic...more

McDermott+

Regs, Regs and More Regs: The Biden Administration Releases Spring 2024 Unified Agenda

McDermott+ on

We are in the midst of a storm of regulations that are being released by the Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services (HHS), including the Calendar Year (CY) 2025...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues Final Rule on Medicaid and CHIP Managed Care Access, Finance, and Quality

On April 22, 2024, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule (CMS-2439-F), effective July 9, 2024, aimed at advancing healthcare access,...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

Epstein Becker & Green on

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Akin Gump Strauss Hauer & Feld LLP

What a Difference a Year Makes: IRA’s Drug Pricing Provisions Turn One

This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Proposed Rules Push Mental Health Parity Up Benefit Priority List

Now you know. It could not be any clearer to employers that compliance with the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) will be a—maybe the—top health and welfare benefit priority for federal...more

Nossaman LLP

Understanding the HHS 2023 Proposed Rule

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The Department of Health and Human Services (HHS) released its Notice of Benefit and Payment Parameters for the 2023 Proposed Rule on Wednesday, January 5th 2022. ...more

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