News & Analysis as of

Proposed Rules Comment Period Department of Health and Human Services (HHS)

Troutman Pepper Locke

FDA Withdraws Proposed Bans on Menthol Cigarettes and Flavored Cigars

Troutman Pepper Locke on

In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be...more

Goodwin

DEA Proposes Three-Tiered Special Registration System for Prescribing and Dispensing of Controlled Substances

Goodwin on

On January 15, 2025, the Department of Health and Human Services (HHS) and Drug Enforcement Administration (DEA) issued a series of rules relating to the telemedicine prescribing of controlled substances, including a proposed...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

Vorys, Sater, Seymour and Pease LLP

Proposed Update to the HIPAA Security Rule

In early January, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a Notice of Proposed Rulemaking. The Proposed Rule would modify the Security Standards for the Protection of...more

Fisher Phillips

PEOs Need to Prepare for Increased Cybersecurity Requirements Thanks to Proposed HIPAA Security Rule Revisions

Fisher Phillips on

With the HIPAA Security Rule set to undergo a massive overhaul to boost cybersecurity protections, PEOs need to take note. After all, as stewards of worksite employee and client company data – and as sponsors of group health...more

Fisher Phillips

Proposed Updates to HIPAA Security Rule Would Require Entities to Adopt Enhanced Cybersecurity Measures

Fisher Phillips on

The HIPAA Security Rule may soon undergo a big overhaul that would better defend healthcare data from cybersecurity threats – and require much more from covered entities when it comes to establishing and maintaining defenses....more

Foley Hoag LLP - Security, Privacy and the...

HHS Office for Civil Rights Proposes Measures to Strengthen Cybersecurity in Health Care Under HIPAA

The Department of Health and Human Services (HHS) has proposed significant modifications to the HIPAA Security Rule and the HITECH Act in an attempt to strengthen cybersecurity protections for electronic protected health...more

Bass, Berry & Sims PLC

HHS Proposed Rule Seeks to Align Health IT Procurement Standards to Leverage Interoperable Data

Bass, Berry & Sims PLC on

On August 9, the Department of Health and Human Services (HHS) published a proposed rule that seeks to amend and update the Health and Human Services Acquisition Regulation (HHSAR) to align health IT procurement requirements....more

Sheppard Mullin Richter & Hampton LLP

Comment Period for the No Surprises Act Proposed Rule, “Federal Independent Dispute Resolution (IDR) Operations,” Will Reopen

On January 17, 2024, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the “Departments”) and the Office of Personnel Management issued a notice that they will reopen the period for...more

Troutman Pepper Locke

New Proposed Rules to Combat Health Information Blocking

Troutman Pepper Locke on

The U.S. Department of Health and Human Services (HHS) has just unveiled a proposed rule designed to penalize health care providers engaging in information blocking. Information blocking is a practice where health care...more

McDermott Will & Emery

HHS, DOL and Treasury Issue a Proposed Rule Increasing Federal IDR Fees

McDermott Will & Emery on

On September 20, 2023, the US Departments of Health and Human Services (HHS), Labor (DOL) and the Treasury (collectively, the departments) issued a proposed rule related to the No Surprises Act’s (NSA’s) federal independent...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

Bricker Graydon LLP

340B Update: Proposed Rule on Drug Acquisition Cost Cuts Suggests Lump Sum Repayment

Bricker Graydon LLP on

The Department of Health and Human Services has published a proposed rule to address short payments on drug acquisition costs for 340B hospitals from 2018 to September 2022. On June 15, 2022, the Supreme Court unanimously...more

Groom Law Group, Chartered

Tri-Agencies Issue Proposed Rule on Short-Term, Limited-Duration Insurance, Excepted Benefits, and Level-Funded Plans

On July 7, the Departments of Labor, Treasury, and Health and Human Services (the “Tri-Agencies”) published a long-anticipated proposed rule (“Proposed Rule”) that...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

Akerman LLP - Health Law Rx

OCR’s Proposed Rule Finds Fertile Ground for Enhanced Reproductive Privacy Protection

The Department of Health and Human Services Office for Civil Rights (OCR) issued a proposed rule on April 17, 2023, to amend provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to strengthen...more

Holland & Knight LLP

HHS Proposes HIPAA Changes to Protect Reproductive Health Information

Holland & Knight LLP on

The U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) published a Notice of Proposed Rule Making (Proposed Rule) on April 12, 2023, proposing amendments to the Health Insurance Portability and...more

Polsinelli

HIPAA Notice of Proposed Rulemaking on Reproductive Health Care Privacy

Polsinelli on

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

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Health Insurance Market Reforms for 2024

On December 21, 2022, the Department of Health and Human Services (“HHS”) issued a proposed rule aimed at advancing health equity and mitigating health disparities while minimizing administrative burden...more

Bass, Berry & Sims PLC

CMS Proposed Rule Addresses Multiple Aspects of Medicare Advantage Program for 2024, Including an Overpayment Rule Update

Bass, Berry & Sims PLC on

On December 14, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that contemplates several changes to, and clarifications of, guidance for the Medicare Advantage (MA) program in coverage year 2024....more

McDermott Will & Emery

HHS Goes Back to the Drawing Board on the 340B ADR Process

McDermott Will & Emery on

Citing “policy and operational challenges” with the current 340B Administrative Dispute Resolution (ADR) Process, the US Department of Health and Human Services (HHS) has issued a new Proposed Rule to modify the current ADR...more

Robinson+Cole Health Law Diagnosis

HHS Proposes Rule to Align Part 2 Records and HIPAA

On November 28, 2022, the Department of Health and Human Services (HHS) issued a proposed rule to modify the confidentiality protections of Substance Use Disorder (SUD) patient treatment records under 42 CFR Part 2 (Part 2)...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

Bricker Graydon LLP

First rules implementing surprise medical billing law issued

Bricker Graydon LLP on

On July 1, 2021, the U.S. Departments of Labor, Treasury, and Health and Human Services (HHS) issued the first rules implementing the No Surprises Act, which prohibits health care providers from billing patients more than...more

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