News & Analysis as of

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

Arnall Golden Gregory LLP

U.S. Department of Health and Human Services Rescinds "Richardson Waiver" Policy

On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...more

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Foley Hoag LLP

Department of Health and Human Services Seeks to Revise Rulemaking Policies

Foley Hoag LLP on

On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a...more

Epstein Becker & Green

HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking

On March 3, 2025, the Secretary of Health and Human Services published a policy statement in the Federal Register that reverses a policy adopted over 50 years ago that was intended to expand public participation in the...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

Holland & Knight LLP

HHS Publishes Notice About Policy on Adhering to Text of Administrative Procedure Act

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) on Feb. 28, 2025, issued a policy statement limiting the circumstances under which HHS agencies must publish proposed rules for public comment before the rules are...more

Latham & Watkins LLP

HHS Issues Policy Statement to Expand Use of Rulemaking Without Notice and Comment

Latham & Watkins LLP on

The policy statement aims to bring more rapid action on personnel and management decisions and empowers HHS and each of its offices and subagencies to promulgate or rescind certain rules without a period of notice and comment...more

Troutman Pepper Locke

Federal Appellate Court Agrees that FDA Cannot Regulate “Premium Cigars”

Troutman Pepper Locke on

Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium...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

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

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

K&L Gates LLP

K&L Gates Triage: The Impact of Allina — Potential Limitation on CMS’s Ability to Recoup Overpayments

K&L Gates LLP on

In this week’s episode, Adam Cooper discusses the Supreme Court’s decision in Azar v. Allina Health Services, as well as a related memorandum issued in late 2019 by the Centers for Medicare and Medicaid Services (“CMS”) that...more

McDermott Will & Emery

New Guidance on Medicare Payment Rule Enforcement

McDermott Will & Emery on

A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more

Polsinelli

CMS Outlines New Standard for Challenging Medicare Payment Denials, Echoing Brand Memo on Force of Sub-Regulatory Guidance

Polsinelli on

On October 31, 2019, the Office of General Counsel for the U.S. Department of Health and Human Services (HHS) issued an important memo from Kelly M. Cleary, CMS Chief Legal Officer, and Brenna E. Jenny, Deputy General...more

Polsinelli

CY 2020 OPPS Proposed Rule – HHS Seeks Comments on 340B Payment Reductions and Remedies

Polsinelli on

This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...more

Brownstein Hyatt Farber Schreck

Medicare Rulemaking After Azar v. Allina Health Services

The Medicare Program, established in 1965, initially seemed simple: provide health care for senior citizens by paying hospitals and doctors directly for the care the seniors required. Initially, there were two parts to...more

King & Spalding

Supreme Court Delivers Victory to Providers in Allina DSH Part C Case in a Decision with Broad Implications

King & Spalding on

In a major win for providers that serve a disproportionate share of indigent patients, the Supreme Court today upheld the D.C. Circuit’s earlier decision invalidating CMS’s policy to treat beneficiaries enrolled in Part C...more

Mintz - Health Care Viewpoints

Update on Azar v. Allina Health Services: Supreme Court Hears Oral Argument on When CMS Must Use Formal Rulemaking

On January 15, 2019, the Supreme Court heard oral arguments in Azar v. Allina Health Services, a prominent case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive...more

Mintz - Health Care Viewpoints

Supreme Court to Decide Critical Case on When CMS Must Use Formal Rulemaking when Instructing Medicare Contractors

On January 15, 2019, the U.S. Supreme Court will hear arguments in a hotly-contested case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive legal standard” and thus...more

Baker Donelson

Supreme Court Grants Review in Allina Health Services Case

Baker Donelson on

Is the Department of Health and Human Services (HHS or the government) required to engage in notice and comment rulemaking when it changes a requirement that has an important impact on hospitals' reimbursement? As we reported...more

McDermott Will & Emery

Guidance on Guidance: DOJ Limits Use of Agency Guidance Documents in Civil Enforcement Cases

McDermott Will & Emery on

In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions,...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

Baker Donelson

Uncertainty Continues for Two-Midnight Rule's Payment Reduction

Baker Donelson on

In Shands Jacksonville v. Burwell [PDF], No. CV 14-1477, 2015 WL 5579653, (D.D.C. Sept. 21, 2015), the United States District Court for the District of Columbia gave the Secretary of the Department of Health and Human...more

25 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide