News & Analysis as of

Final Rules Biden Administration Department of Health and Human Services (HHS)

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+

Healthcare Preview for the Week of: January 13, 2025

McDermott+ on

During the Biden Administration’s final week, congressional Republicans are moving full steam ahead with Senate confirmation hearings for Trump-nominated officials and with ongoing budget reconciliation discussions....more

Ropes & Gray LLP

Biden Administration Finalizes Its Last Changes To Health Data Interoperability and Information Blocking Regulations

Ropes & Gray LLP on

In December 2024, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (“ASTP/ONC”) within the U.S. Department of Health and Human Services (“HHS”) published two...more

Holland & Knight LLP

OCR Shores Up Access to Healthcare with Nondiscrimination Protections

Holland & Knight LLP on

Access to quality healthcare services has long been a priority of the U.S. Department of Health and Human Services (HHS), and through its Office for Civil Rights (OCR) this agency has, since at least 2001, sought to provide...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

Holland & Knight LLP

Holland & Knight Health Dose: September 10, 2024

Holland & Knight LLP on

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+

Biden Administration Issues Final Reg on Mental Health Parity Requirements

McDermott+ on

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

Seyfarth Shaw LLP

HHS Issues New Affordable Care Act Section 1557 Nondiscrimination Regulations

Seyfarth Shaw LLP on

Seyfarth Synopsis: New regulations effective August 6, 2024 restore and expand scope of civil rights protections under Section 1557 of the Affordable Care Act....more

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

King & Spalding

Biden Administration Streamlines CHIP and Medicaid Enrollment, Expands Protections for Covered Population

King & Spalding on

Last week, the Biden-Harris administration (the Administration) announced a new rule simplifying the process for enrolling in Medicaid, the Children’s Health Insurance Program (CHIP), and the Basic Health Program (BHP)....more

Fenwick & West LLP

New Federal Requirements for AI and IT System Implementation in Healthcare

Fenwick & West LLP on

On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more

BakerHostetler

Federal Government Addresses AI Transparency and Safety in Healthcare

BakerHostetler on

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

Holland & Knight LLP

CMS Issues Final Rule on Ownership Transparency

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) announced on Nov. 17, 2023, a final rule requiring skilled nursing facilities (SNFs) to publicly disclose additional ownership and management information. The rule was...more

McDermott+

McDermottPlus Check-Up: November 3, 2023

McDermott+ on

CONGRESS - House Ways & Means Chair Smith, House Energy & Commerce Chair Rodgers and Senate Finance Ranking Member Crapo Call for Withdrawal of Nurse Staffing Mandate. Rep. Smith (R-MO), Rep. Rodgers (R-WA) and Sen. Crapo...more

Holland & Knight LLP

Holland & Knight Health Dose: October 17, 2023

Holland & Knight LLP on

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

ArentFox Schiff

No More Surprise Medical Bills: Biden Administration Issues New Rule Governing Arbitration Fees and Takes First Step to Restarting...

ArentFox Schiff on

On September 21, 2023, the US Departments of Treasury (DOT), Labor (DOL), and Health and Human Services (HHS) (the Departments) issued new rulemaking governing the administrative fee required to access the arbitration process...more

ArentFox Schiff

No More Surprise Medical Bills: Third ‘No Surprises Act’ Rule Issued; Focus On QPA Rolled Back, but Claims Backlog Persists

ArentFox Schiff on

On August 19, 2022, the US Departments of Health and Human Services, Labor, and Treasury, as well as the Office of Personnel Management, released a highly-anticipated final rule clarifying the procedures and considerations...more

McGuireWoods LLP

HHS Draws Curtain on the Healthcare Regulatory SUNSET Final Rule

McGuireWoods LLP on

On May 27, 2022, the U.S. Department of Health and Human Services (HHS) announced it was withdrawing the Securing Updated Necessary Statutory Evaluations Timely final rule (SUNSET final rule), which was originally set to take...more

Sheppard Mullin Richter & Hampton LLP

2023 Payment Rule’s Nondiscrimination Provisions and Anticipation of New Section 1557 Rules

On January 5, 2022, we discussed the Notice of Benefit and Payment Parameters for 2023 proposed rule released by the Centers for Medicare & Medicaid Services (CMS). On April 28, 2022, CMS issued the NBPP 2023 Final Rule. CMS...more

King & Spalding

HHS Proposes Repeal of Two Trump Administration Rules on Guidance, Enforcement, and Adjudication Procedures

King & Spalding on

On October 20, 2021, HHS published in the Federal Register a proposal to repeal two final rules issued during the Trump administration. The final rules up for repeal are the “Department of Health and Human Services Good...more

McGuireWoods Consulting

Washington Healthcare Update - September 2021 #3

Upcoming Hearings/Markups - September 27 - House Rules Committee Meeting: to discuss H.R. 3110 — PUMP for Nursing Mothers Act, H.R. 3992 — Protect Older Job Applicants (POJA) Act and H.R. 2119 — Family Violence Prevention...more

McGuireWoods Consulting

Washington Healthcare Update - September 2021

This week in Washington: Reconciliation markups begin. Congress  - Upcoming Hearings/Markups - House - • Need for Continuing Resolution to Fund the Government...more

McGuireWoods Consulting

Washington Healthcare Update - August 2021 #3

This week in Washington: Senate passes infrastructure bill; Senate passes budget resolution with reconciliation instructions; Congress enters recess with House members to return Aug. 23....more

King & Spalding

Implementation of Final Rule Excluding PBM Rebates from Discount Safe Harbor Delayed Until 2023

King & Spalding on

Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...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

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