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Regulatory Agenda Department of Health and Human Services (HHS) Biden Administration

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

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

McDermott+

Regs on the Menu for Rescission Under Budget Reconciliation

McDermott+ on

Over the next several weeks, both the Trump Administration and the 119th Congress will review the “menu” of Biden-era regulations that they may want to rescind or modify. In one of his first orders, President Trump (like...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+

Medicare FFS Regs: Thrills and Chills Under the Trump and Biden Administrations

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Happy Halloween! In the health policy world, there are two things on everyone’s mind this spooky season: the upcoming election and the major calendar year (CY) 2025 Medicare fee-for-service (FFS) final regs that should be...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+

Biden Administration Issues Final Reg on Mental Health Parity Requirements

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Biden Administration Issues Final Reg on Mental Health Parity Requirements McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts....more

McDermott+

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

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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

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

Bradley Arant Boult Cummings LLP

Veep Urges DEA to Reschedule Marijuana “As Quickly as Possible”

In case you missed it, Fat Joe visited the White House late last week to discuss federal marijuana policy. 2024, man. During a roundtable discussion with Mr. Joe (?), Kentucky Gov. Andy Beshear, and several individuals who...more

McDermott Will & Schulte

Biden Administration Proposes New Framework for Exercising March-In Rights on Government-Funded Inventions; Drug Pricing May Be...

Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...more

BakerHostetler

Federal Government Addresses AI Transparency and Safety in Healthcare

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On Oct. 30, President Biden signed an executive order calling for a coordinated government approach to establish new safeguards for AI safety and security in healthcare. In response to the executive order, on Dec. 14 the...more

McDermott Will & Schulte

The Proposed MHPAEA Regulations: A Comment on the Comments

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In our last post, we considered some of the comment letters submitted in response to proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA) issued by the US Departments of Labor, Health and...more

Sheppard Mullin Richter & Hampton LLP

AI’s Executive Order and Its Key Healthcare Implications 

Last week’s historic executive order (EO) on the development and use of artificial intelligence (AI) is teeming with urgency, both in caution and optimism, to keep pace with the technological advancements. The EO addresses...more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

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President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Latham & Watkins LLP

President Biden’s Executive Order on Artificial Intelligence - Initial Analysis of Private Sector Implications

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The Order marks an ambitious effort to stand up a whole-of-government approach to encouraging the benefits and managing the risks of artificial intelligence, with many of its most significant private-sector implications...more

Goodwin

White House Unveils Landmark Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence

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On October 30, 2023, President Biden issued an Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. The EO establishes sweeping directives and priorities for federal...more

Troutman Pepper Locke

HHS Proposes Rescheduling Cannabis to Schedule III – What It Means for the Industry

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It has been widely reported and confirmed publicly that, on August 29, the U.S. Department of Health and Human Services (HHS) sent a letter to the Drug Enforcement Administration (DEA) recommending that cannabis be moved from...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

Perkins Coie

Federal Cannabis Scheduling Decision Expected This Year

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Secretary Xavier Becerra shared during a press conference on June 15 that relevant federal agencies are working to complete their administrative review of cannabis scheduling this year, according to Marijuana Moment....more

Epstein Becker & Green

HHS Proposes Amendments to HIPAA that Protect Reproductive Health Care Information in Wake of Dobbs

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Introduction - Following the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization overturning Roe v. Wade, the federal government, pursuant to President Biden’s Executive Order (the EO) took several steps...more

Polsinelli

HIPAA Notice of Proposed Rulemaking on Reproductive Health Care Privacy

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On April 12, 2023, the Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“Notice” or “NPRM”) to solicit comments on proposed modifications to the HIPAA...more

Robinson+Cole Health Law Diagnosis

HHS Seeks to Strengthen Protections of Confidential Reproductive Health Information with Proposed Changes to HIPAA

On April 12, 2023, the U.S. Department of Health & Human Services (HHS) released a Notice of Proposed Rulemaking (Proposed Rule) that seeks to enhance safeguards of reproductive health care information through changes to the...more

Foley & Lardner LLP

Priorities of the 118th Congress and the Biden Administration

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As the final votes of the 2022 Midterm Elections are counted, Republicans have taken back control of the House of Representatives, while the Democrats will retain control of the Senate. Both chambers will be held by extremely...more

Sheppard Mullin Richter & Hampton LLP

BREAKING NEWS: Biden to Pardon Federal Marijuana Possession Convictions

In a historic move, on October 6, 2022, President Joe Biden announced a three-step program to bring broad changes to federal cannabis policy. As an initial step towards reform, President Biden will pardon all federal...more

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