News & Analysis as of

Department of Health and Human Services (HHS) Healthcare Administrative Procedure Act

Proskauer - Health Care Law Brief

Shortly After its Online Tracking Technologies Bulletin is Declared Unlawful, HHS-OCR Stands Down, Withdraws Appeal

On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more

Burr & Forman

Federal Agency Deference Eliminated, Now What?

Burr & Forman on

On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

Baker Donelson

60 Days After Loper: Health Care Impact of Chevron Deference's End

Baker Donelson on

The Supreme Court of the United States issued its highly anticipated ruling in a pair of cases challenging the long-standing Chevron doctrine on June 28, 2024. Foreshadowed by decisions in recent years slighting Chevron, it...more

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Bass, Berry & Sims PLC

Healthcare Private Equity: What to Expect for the Rest of 2024

Bass, Berry & Sims PLC on

Although the U.S. healthcare industry has weathered the storm over the past couple of years, we may be reaching calmer waters in the coming months. Dry powder held by U.S. private equity investors has reached an all-time...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Husch Blackwell LLP

The Overturning of Chevron Deference: Implications for AI in Medical Research

Husch Blackwell LLP on

In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more

McCarter & English, LLP

No Doubt, ‘Chevron’ Is Out; How Will This Impact Healthcare?

Through its recent decision in Loper Bright Enterprises v. Raimondo, No. 22-451 (S. Ct. June 28, 2024), the US Supreme Court overturned the landmark decision in Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc.,...more

Bradley Arant Boult Cummings LLP

The Overturn of Chevron: A New Design for Healthcare Law

On June 28, 2024, SCOTUS overturned the long-standing Chevron doctrine in its decision Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce. The Court’s ruling will have a significant impact on...more

Schwabe, Williamson & Wyatt PC

Chevron’s End Means Uncertainty and Opportunity for the Healthcare Industry

“Chevron is overruled.” The U.S. Supreme Court’s June 28 decision in Loper Bright Enterprises v. Raimondo and its companion case, Relentless v. Department of Commerce, will have enormous effects on the healthcare sector....more

Akin Gump Strauss Hauer & Feld LLP

Chevron Runs Out of Gas: The Bumpy Road Ahead for Health Regulations After Loper Bright

On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more

Warner Norcross + Judd

HHS Recommends DEA Reschedule Marijuana from Schedule I to Schedule III – Now What?

Warner Norcross + Judd on

A year ago today on October 6, 2022, President Joe Biden asked the U.S. Secretary of Health and Human Services (HHS) and the U.S. Attorney General to initiate an administrative process to review how marijuana is scheduled...more

Akerman LLP - Health Law Rx

THE NO SURPRISES ACT: Hoping for an End to the Surprises

By looking at the events that have transpired since the Consolidated Appropriations Act, 2021, which includes the No Surprises Act (the Act), was signed into law, it is clear that the Departments of Health and Human Services,...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

Manatt, Phelps & Phillips, LLP

NSA Update: IDR Process Suspended After TX District Court Invalidates Batching and Fee Increases

Last week, after several slow news months for the No Surprises Act (NSA), a Texas district court issued its most recent decision in a series of cases brought by the Texas Medical Association and other health care providers...more

King & Spalding

Federal District Court Grants Injunction Barring CMS from Implementing New Policy on Medicaid Funding Designed to Prevent...

King & Spalding on

On June 30, 2023, the United States District Court for the Eastern District of Texas (the Court) granted the State of Texas’ preliminary injunction motion, enjoining CMS from implementing and enforcing its Informational...more

Sheppard Mullin Richter & Hampton LLP

Secret Rules and Hidden Penalties: Biden Executive Order Takes Aim at the Trump Administration’s Efforts to Limit HHS’s Use of...

Executive Orders and the Biden Administration’s promises to postpone or withdraw certain last-minute, so-called “midnight rules” promulgated by the Trump Administration are currently grabbing everyone’s attention, especially...more

King & Spalding

District Court Orders HHS to Immediately Cease New Liver Transplant Allocation Policy

King & Spalding on

On May 15, 2019, United States District Judge Amy Totenberg ordered HHS to “immediately cease and desist” from further implementing its April 2019 liver allocation policy pending appellate review in Callahan, et al. v. Azar,...more

Littler

WPI Insider Briefing: New President, New Congress, New Direction in Workplace Policy

Littler on

President Donald J. Trump was sworn into office on January 20, 2017, ushering in a new balance of power in Washington and what is expected to be a dramatically different era of workplace policy. On his first day in office,...more

K&L Gates LLP

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

K&L Gates LLP on

In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

Mintz - Health Care Viewpoints

“Two-Midnight” Rule Needs Tweaking, Says Federal Judge

A Federal Judge found that the Department of Health and Human Services (DHHS) failed to comply with the Administrative Procedure Act (APA) when it cut hospital inpatient payments by 0.2% as part of its “two-midnight” rule. ...more

Epstein Becker & Green

D.C. Circuit Requires Greater Disclosure of Changes in Medicare Regulations

Epstein Becker & Green on

The rulemaking process often accommodates a variety of interests, including the preference of regulatory agencies to maintain some flexibility and the rights of interested parties to participate in the regulatory process. On...more

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