News & Analysis as of

Regulatory Agenda Rulemaking Process Department of Health and Human Services (HHS)

Dickinson Wright

Breaking: FDA, HHS Seek Public Input on Cutting Rules

Dickinson Wright on

On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced a public Request for Information to “identify and eliminate outdated or unnecessary...more

Hogan Lovells

HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers

Hogan Lovells on

Earlier this week, the Department of Health and Human Services (HHS) published a broad request for information (RFI) seeking input on how to “dramatically deregulate across all areas the Department touches.”1 It specifically...more

Alston & Bird

Trump Administration Changes Seek to Avoid Notice and Comment Hurdles

Alston & Bird on

Our Health Care and Health Care Litigation Groups examine a policy move by the Department of Health and Human Services (HHS) that will allow the department to forgo notice and comment procedures for many of its regulations....more

McDermott+

Price Transparency: A Regulatory Priority

McDermott+ on

The Trump administration is beginning to lay out its regulatory (and deregulatory) priorities, and on February 25, 2025, the administration spotlighted one of those priorities in an executive order on price transparency....more

McDermott+

Regs & Eggs with a Side of DOGE

McDermott+ on

In the health policy world, nothing gets folks like me more “excited” than expecting and then seeing a new healthcare regulation pop up in the Federal Register. While the content of the reg is usually what public stakeholders...more

McCarter & English, LLP

DEA Telemedicine Update

The Drug Enforcement Administration (DEA), in concert with other federal agencies, has taken various steps in the past few months to strengthen a practitioner’s ability to prescribe controlled substances via telemedicine, a...more

Ice Miller

FDA Final Rule for “Healthy” Nutrient Content Claims Effective Date Looms but Rule’s Future Is Uncertain

Ice Miller on

After years of rulemaking with impassioned input from food producers, industry stakeholders, and consumer groups, on December 27, 2024, the Food and Drug Administration (FDA or Agency) published a final rule titled “Food...more

Mintz - Health Care Viewpoints

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more

Troutman Pepper Locke

FDA Withdraws Proposed Bans on Menthol Cigarettes and Flavored Cigars

Troutman Pepper Locke on

In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be...more

Cozen O'Connor

Cozen Currents: Disruption is a Process

Cozen O'Connor on

“President Trump is seen above all else as a disruptor hell-bent on upsetting the established ways of governing. However, even disruption itself has to follow a process in Washington.” — Howard Schweitzer, CEO, Cozen O’Connor...more

Troutman Pepper Locke

HIPAA Security Rule Revamp Is on the Horizon

Troutman Pepper Locke on

On January 6, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published significant proposed amendments (proposed rule) to the Security Rule under the Health Insurance Portability and...more

Quarles & Brady LLP

Fresh From the Oven: OCR-HHS Issues a Notice of Proposed Rulemaking for the HIPAA Security Rule

Quarles & Brady LLP on

‘Tis the season for holiday baking and the elves at the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), have been diligently crafting their own holiday treat. On December 27,...more

ArentFox Schiff

Post-Chevron Health Care Regulations: The Dawn of a New Day

ArentFox Schiff on

On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute. Chevron reflected the view...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

Akin Gump Strauss Hauer & Feld LLP

ONC Steps into AI Regulation by Imposing Requirements for ‘Predictive Decision Support Interventions’; Also Updates Information...

On December 13, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a wide-ranging final rule, Health Data, Technology, and...more

McDermott+

Departments Propose Broader Batching and IDR Process Changes for Surprise Billing Claims

McDermott+ on

On October 27, 2023, the US Departments of Health and Humans Services, Labor and the Treasury (the Departments), along with the Office of Personnel Management, issued a proposed rule titled Independent Dispute Resolution...more

McDermott Will & Emery

HHS, DOL and Treasury Issue a Proposed Rule Increasing Federal IDR Fees

McDermott Will & Emery on

On September 20, 2023, the US Departments of Health and Human Services (HHS), Labor (DOL) and the Treasury (collectively, the departments) issued a proposed rule related to the No Surprises Act’s (NSA’s) federal independent...more

McDermott+

Implementation of the No Surprises Act Is Full of Surprises: What We Do and Don’t Know

McDermott+ on

It’s likely no surprise to anyone who has been following the implementation of the No Surprises Act over the last couple of years that we again find ourselves on an uncertain path. While Regs & Eggs has focused on some of the...more

Hogan Lovells

HHS announces polices related to future rulemaking procedures

Hogan Lovells on

On 24 November 2020, the Department of Health and Human Services (HHS) issued Notices in the Federal Register announcing two new policies related to future rulemaking procedures for all HHS agencies....more

Hogan Lovells

Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

Hogan Lovells on

The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...more

Hogan Lovells

HHS proposes to sunset regulations Issued by FDA, CMS, and other regulatory agencies

Hogan Lovells on

Our team wanted to highlight a proposed rule issued by the U.S. Department of Health and Human Services (HHS) on 4 November 2020 - with only a 30-day comment period - that would establish sunset (expiration) dates for...more

Bricker Graydon LLP

Changes coming to the Stark Law and Anti-Kickback Statute regulations

Bricker Graydon LLP on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued long-awaited proposed changes “to modernize and clarify the...more

Ballard Spahr LLP

Health Care and Price Transparency: The Latest Summary

Ballard Spahr LLP on

Federal executive agencies recently published two rules, one final and one proposed, aimed at publicizing the various costs associated with health care. A final rule, promulgated by the Department of Health and Human Services...more

Polsinelli

Analyzing the Proposed 2019 Stark Reforms

Polsinelli on

The United Stated Department of Health and Human Services (“HHS”) published a notice of proposed rulemaking (NPRM) containing proposed changes to the Physician Self-Referral Law (“Stark Law,” or “Stark”) on October 17, 2019....more

Burr & Forman

Top Three Challenges Health Care Payers and Providers Will Face in 2020

Burr & Forman on

Health care providers operate in one of the most highly regulated industries in terms of compliance and governmental oversight. As a result, providers face a number of regulatory and compliance challenges each year....more

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