News & Analysis as of

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

Hogan Lovells

FDA Announces Plans for Post-Market Chemical Review Program

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The U.S. Food and Drug Administration (FDA) recently announced plans to update its post-market food chemical review program. In its announcement, FDA explained that its forthcoming plans will take a proactive approach to...more

Mintz - Health Care Viewpoints

CMS’s ACA Marketplace Integrity and Affordability Proposed Rule – What it may mean for Health Plans

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies...more

McDermott+

To Comment or Not to Comment: Looking at the Biden Administration’s HIPAA Cybersecurity Proposed Reg

McDermott+ on

One of the Biden Administration’s last healthcare regs was a proposed rule that, if finalized, would make significant changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule to...more

BakerHostetler

FDA Advances Proposal To Lower Nicotine in Cigarettes

BakerHostetler on

In the final days of the Biden administration, the Food and Drug Administration (FDA) has taken a significant step toward reducing nicotine levels in cigarettes by submitting a proposed rule to the Office of Management and...more

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

Fisher Phillips

White House Takes Aim at Inefficient Business Practices Through “Time Is Money” Initiative: 5 Things Employers Should Do

Fisher Phillips on

The Biden Administration wants to crack down on corporate practices that it believes waste consumers’ time and money through excessive paperwork, long wait times, and other aggravations – and you’ll want to take note so you...more

Moore & Van Allen PLLC

The AI Executive Order: What’s Happened and What’s Coming Up… 

Last week, the White House issued an update on President Biden’s October 30, 2023 Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (the “AI EO” or “EO”). The update detailed...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

ArentFox Schiff

No More Surprise Medical Bills: Biden Administration Issues New Surprise Billing Rulemaking Proposing Batching and Procedural...

ArentFox Schiff on

*This is the 12th article in a series analyzing the No Surprises Act and its implementation. To view the entire series, click here. A link to the proposed rule is here.  As background, Congress passed the Act to prevent...more

Goodwin

LDT Proposed Rule Remains Under OIRA Review

Goodwin on

Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President (“OIRA”) has held stakeholder meetings regarding a proposed rule which, if enacted,...more

ArentFox Schiff

Mental Health Parity Act: Biden Administration Issues Long-Awaited Rulemaking Cracking Down on Treatment Limitations

ArentFox Schiff on

On July 25, 2023, the US Departments of Labor (DOL), Treasury (DOT), and Health and Human Services (HHS) (the Departments) released a much-anticipated interim final rule to ensure that group health plans comply with the...more

Epstein Becker & Green

HHS Proposes Amendments to HIPAA that Protect Reproductive Health Care Information in Wake of Dobbs

Epstein Becker & Green on

Introduction - Following the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization overturning Roe v. Wade, the federal government, pursuant to President Biden’s Executive Order (the EO) took several steps...more

McDermott Will & Emery

OCR Issues Proposed Rule to Modify HIPAA Privacy Rule to Include Explicit Protections for Reproductive Healthcare

McDermott Will & Emery on

On April 12, 2023, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking detailing its proposal to modify the HIPAA Privacy Rule (Proposed Rule). The...more

Polsinelli

HIPAA Notice of Proposed Rulemaking on Reproductive Health Care Privacy

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On April 12, 2023, the Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“Notice” or “NPRM”) to solicit comments on proposed modifications to the HIPAA...more

Robinson+Cole Health Law Diagnosis

HHS Seeks to Strengthen Protections of Confidential Reproductive Health Information with Proposed Changes to HIPAA

On April 12, 2023, the U.S. Department of Health & Human Services (HHS) released a Notice of Proposed Rulemaking (Proposed Rule) that seeks to enhance safeguards of reproductive health care information through changes to the...more

Snell & Wilmer

Proposed Rules Expand Access to Contraceptive Care as a Preventive Service

Snell & Wilmer on

On January 30, 2023, the Departments of Health and Human Services, Treasury, and Labor (collectively “the Departments”) issued proposed rules entitled “Coverage of Certain Preventive Services under the Affordable Care Act”...more

Stevens & Lee

Biden Administration Proposes New Religious Conscience Rule for Health Workers

Stevens & Lee on

On December 29, 2022, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) proposed the rule, “Safeguarding the Rights of Conscience as Protected by Federal Statutes” (the “Proposed Rule”)....more

Sheppard Mullin Richter & Hampton LLP

Proposed Rule Leverages Section 1557 for Healthcare Equity

On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable...more

Foley Hoag LLP

Biden Administration Proposes Significant Revisions to Trump-Era Nondiscrimination Regulations

Foley Hoag LLP on

On July 25, 2022, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a long-awaited proposed rule on Section 1557 of the Affordable Care Act (ACA), the nondiscrimination protections...more

Sheppard Mullin Richter & Hampton LLP

The Biden Administration’s and HHS’s Plan to Advance Health Care Equity

President Biden issued Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (Executive Order) on inauguration day in 2021, signalizing the Administration’s...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #1

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Sheppard Mullin Richter & Hampton LLP

Back to the Future: 2023 Payment Rule Would Revert Nondiscrimination and Guaranteed Availability Provisions to Pre-Trump Forms,...

Today HHS published the Notice of Benefit and Payment Parameters for 2023 proposed rule in the Federal Register. The annual rulemaking details changes to qualified health plans (“QHPs”), QHP issuers, and the ACA’s exchanges...more

ArentFox Schiff

Biden’s HHS Seeks to Undo Trump Era Regulations

ArentFox Schiff on

Proposed Rules Seek to Repeal Multiple Trump Era Regulations That Received Prior Industry Scrutiny - The United States Department of Health and Human Services (HHS) – still within its first full year under the direction...more

Health Care Compliance Association (HCCA)

Kim Brandt on the Latest Washington Healthcare News

Kim Brandt, partner at Tarplin, Downs & Young has long provided the healthcare community with her expertise in all things Washington, having spent substantial time at CMS, the OIG at HHS and on Capitol Hill. She’ll be...more

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