News & Analysis as of

Transparency Final Rules Department of Health and Human Services (HHS)

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

MoFo Life Sciences

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

MoFo Life Sciences on

On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more

Akin Gump Strauss Hauer & Feld LLP

Is Self-Affirming GRAS Off the Menu?

United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...more

BakerHostetler

What’s Hot in Healthcare: Digital Health Regulatory Update

BakerHostetler on

As the summer winds down, regulatory updates related to digital health services certainly do not appear to be showing any signs of cooling off. It has been a busy summer, and below we have summarized several key updates for...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues Final Rule on Medicaid and CHIP Managed Care Access, Finance, and Quality

On April 22, 2024, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule (CMS-2439-F), effective July 9, 2024, aimed at advancing healthcare access,...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

Mintz - Health Care Viewpoints

HHS, ONC HTI-1 Final Rule Introduces New Transparency Requirements for Artificial Intelligence in Certified Health IT

The Department of Health and Human Services (HHS) was tasked with coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on the Safe, Secure, and Trustworthy...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

Davis Wright Tremaine LLP

Ownership Transparency: The New Normal in Healthcare?

On November 17, 2023, the U.S. Department of Health and Human Services ("HHS") Centers for Medicare and Medicaid Services ("CMS") published a final rule (the "Final Rule") requiring Medicare skilled nursing facilities...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

Verrill

Gag Clauses – New Guidance and Litigation Will Inform Compliance

Verrill on

Certain provisions of the Transparency in Coverage Final Regulations and the Consolidated Appropriation Act, 2021 (“CAA”) require group health plans and/or their vendors to report information to federal agencies. On December...more

Mintz - Employment Viewpoints

HHS, Treasury and Labor Issue More Guidance on the No Surprises Act

Title I of Division BB of the Consolidated Appropriations Act, 2021 (the “Act”), and interim final rules issued by the Departments of Health and Human Services, Treasury and Labor (the “Departments”) in July 2021 (see our...more

Rivkin Radler LLP

Transparency in Coverage Final Rule Took Effect on July 1

Rivkin Radler LLP on

The Centers for Medicare & Medicaid Services’ Transparency in Coverage Final Rule took effect on July 1, following a six-month delay in implementation to allow payers to come into compliance....more

Williams Mullen

Health Plan Transparency Requirements are Effective Now

Williams Mullen on

The Consolidated Appropriations Act, 2021 (“CAA” or the “Act”) includes several transparency requirements for health plans. Some of these requirements are already in effect for plan years beginning on or after January 1,...more

Bradley Arant Boult Cummings LLP

July 1 Deadline for Health Plan Website Disclosures

The Departments of Labor, Health and Human Services and the Treasury recently issued FAQs About Affordable Care Act Implementation Part 53 (FAQ), which provides additional guidance for non-grandfathered group health plans and...more

Verrill

You Are Here: A Mall Directory for Healthcare Transparency Requirements

Verrill on

The old adage “you can’t get where you’re going unless you know where you are” has never seemed more true than when applied to the current mélange of healthcare transparency guidance. Fortunately, a fading relic from...more

Goodwin

HHS, Labor, and Treasury Departments Defer Enforcement of Transparency in Coverage and No Surprises Act Requirements

Goodwin on

The No Surprises Act and Transparency in Coverage final rules go into effect January 1, 2022. Implemented as Titles I and II of Division BB of the Consolidated Appropriations Act, these rules are intended to protect patients...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

Maynard Nexsen

Transparency in Pricing Trend Continues with New Federal Rule that Applies to Health Plans

Maynard Nexsen on

On October 29, 2020, the Department of Health and Human Services (HHS), the Department of Treasury, and the Department of Labor issued a new “transparency in coverage” final rule that is focused on insurance companies and...more

Sheppard Mullin Richter & Hampton LLP

Trump Administration Finalizes The Transparency in Coverage Rule

On October 29, 2020, the Department of Health and Human Services (“HHS”), the Department of Labor, and the Department of the Treasury (collectively, the “Departments”) released the Transparency in Coverage Final Rules (the...more

McDermott Will & Emery

Agencies Issue Final Employer Healthcare Price Transparency Rule

McDermott Will & Emery on

On October 29, 2020, the US Departments of Health and Human Services, Labor and Treasury (collectively, the Departments) issued the Transparency in Coverage final rule (the Rule), along with a fact sheet, setting forth...more

King & Spalding

Transparency in Coverage Final Rule Requires Insurance Disclosure to Consumers

King & Spalding on

On October 29, 2020, HHS, the Department of Labor, and the Department of Treasury (the Departments) jointly issued a final rule requiring health plans to disclose price and cost-sharing information to participants,...more

Faegre Drinker Biddle & Reath LLP

Health Plan Transparency Final Rule Requires New Health Plan Disclosures

On October 29, 2020, the Department of Health and Human Services (HHS), Department of the Treasury (Treasury) and Department of Labor (DOL) issued the final rule on transparency in health plan coverage. The final rule imposes...more

Foley & Lardner LLP

Federal Departments Release Transparency in Coverage Final Rule

Foley & Lardner LLP on

On October 29, 2020 the United States Departments of Health and Human Services, Labor and Treasury (the Departments) issued a final rule entitled Transparency in Coverage (the Rule). The Rule continues on the Trump...more

Bass, Berry & Sims PLC

Trump Administration Proposes Transparency Rule for Group Health Plans and Insurers

Bass, Berry & Sims PLC on

On November 15, 2019, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury (collectively, the Departments), unveiled a proposed rule (scheduled to be published on November...more

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