News & Analysis as of

Department of Health and Human Services (HHS) Rulemaking Process Health Care Providers

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

Shipman & Goodwin LLP on

On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon...

Maynard Nexsen on

This week on the podcast, Lynnsey and Lauren are joined by their colleague, Maynard Nexsen healthcare attorney Shannon Lipham, who helps healthcare providers and practices navigate complex federal and state 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

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

Troutman Pepper Locke

HIPAA Security Rule Revamp Is on the Horizon

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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

Davis Wright Tremaine LLP

March 2024 UDAAP Bulletin

Editor's Note The following document provides a monthly roundup summarizing enforcement actions, guidance, rulemakings, and other public statements from the Consumer Financial Protection Bureau, the Federal Trade Commission,...more

ArentFox Schiff

No More Surprise Medical Bills: Providers Score Yet Another Victory as Texas Court Again Vacates Provisions of Biden...

ArentFox Schiff on

On August 24, 2023, health care providers in Texas scored yet another victory when a federal court vacated additional portions of the Biden Administration’s rulemaking under the federal No Surprises Act (the Act). This marked...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

ArentFox Schiff

No More Surprise Medical Bills: In Another Victory for Providers, Texas Court Vacates Administrative Fee and Batching Provisions...

ArentFox Schiff on

On August 3, 2023, health care providers in Texas scored yet another victory when a federal court vacated additional portions of the Biden Administration’s rules governing fee collection and claim batching under the federal...more

McDermott Will & Schulte

Teleprescribing of Controlled Substances Temporarily Extended Beyond PHE – What’s Next?

The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the...more

ArentFox Schiff

No More Surprise Medical Bills: Providers Continue to Pursue Additional Challenges to Government Rulemaking Under No Surprises Act

ArentFox Schiff on

In parallel cases, health care providers are continuing to challenge rulemaking by the US Departments of Treasury, Labor, and Health and Human Services (the Departments) under the No Surprises Act (the Act). Having already...more

Sheppard Mullin Richter & Hampton LLP

Key Healthcare Provisions of the Consolidated Appropriations Act, 2023

Introduction On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (the “Act”). The Act provides for nearly $1.7 trillion in funding across a range of domestic initiatives, including certain...more

McDermott Will & Schulte

NSA Update: HHS Indefinitely Delays Co-Provider, Co-Facility Requirements for Good Faith Estimates

McDermott Will & Schulte on

On December 2, 2022, the US Department of Health and Human Services (HHS) issued an FAQ announcing that it will not enforce the requirement for convening providers and convening facilities to include expected charges for...more

ArentFox Schiff

No More Surprise Medical Bills: Providers Again Challenge No Surprises Act Rulemaking

ArentFox Schiff on

In late September 2022, health care providers in Texas sued the Departments of Treasury, Labor, and Health and Human Services (collectively, the Departments) over a recently issued final rule implementing the federal No...more

ArentFox Schiff

Texas Court Vacates Arbitration Provisions of Biden Administration Surprise Billing Rule

ArentFox Schiff on

On February 23, 2022, in what is being heralded as a significant victory for health care providers, a federal court in Texas vacated portions of the Biden Administration’s rules governing the arbitration procedures to resolve...more

Sheppard Mullin Richter & Hampton LLP

CMS Backs Off Price Transparency for Providers and Plans

On August 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued its hospital inpatient prospective payment system (“IPPS”) final rule (“Final Rule”) for fiscal year 2022. In addition to a number of other...more

Bass, Berry & Sims PLC

First Installment of Surprise Billing Regulations Released

On July 1, the Department of Health and Human Services (HHS), Department of Labor, and Department of the Treasury (Departments) jointly issued interim final rules (IFR) implementing certain aspects of the No Surprises Act...more

Bricker Graydon LLP

First rules implementing surprise medical billing law issued

Bricker Graydon LLP on

On July 1, 2021, the U.S. Departments of Labor, Treasury, and Health and Human Services (HHS) issued the first rules implementing the No Surprises Act, which prohibits health care providers from billing patients more than...more

McDermott Will & Schulte

[Webinar] Healthcare Anti-Discrimination Litigation: What Payors Need to Know - May 13th, 1:00 pm - 2:00 pm ET

As we continue our three-part webinar series, McDermott’s litigation and healthcare lawyers will focus on how payors can actively prepare for possible enforcement and litigation stemming from recent and potential changes to...more

Sheppard Mullin Richter & Hampton LLP

Permanent Expansion of Medicare Telehealth Services

On December 1, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released the annual Physician Fee Schedule final rule (“Final Rule”) which, among other things, aimed to further President Trump’s October 3, 2019...more

Holland & Knight LLP

HHS Releases Four Major Rules to Lower Drug Prices, Amend Anti-Kickback and Stark Laws

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) issued four major rules on Nov. 20, 2020, which was the final day for the Trump Administration to issue a rule with a 60-day implementation period for it to take effect...more

Foley Hoag LLP

Summary of Trump Administration Drug Pricing and AKS Rulemakings and Implications for Life Sciences Companies and Health Care...

Foley Hoag LLP on

On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...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

Morgan Lewis - Health Law Scan

HHS Regulatory Sprint Crosses the Finish Line: New Stark and Anti-Kickback Rules Forecast Big Changes for Patients and Value-Based...

Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare...more

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