News & Analysis as of

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

MoFo Life Sciences

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

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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

Maynard Nexsen

HHS Abandons Public Comment Practices Under the Richardson Waiver

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On March 3, 2025, the Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., officially announced the rescission of the Richardson Waiver, a policy in place since 1971 that required public...more

Holland & Knight LLP

Holland & Knight Health Dose: September 12, 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

McDermott+

McDermottPlus Check-Up: September 8, 2023

McDermott+ on

CONGRESS - House Republicans Release Healthcare Package. On September 6, House Republicans unveiled the Lower Costs, More Transparency Act, a draft package of healthcare transparency provisions, pharmacy benefit manager...more

Mintz - Health Care Viewpoints

Pharmacy Benefit Managers are on the Federal Government’s Radar: Senate, House, and Agency Proposals Seek to Increase PBM...

Bipartisan legislative activity related to pharmacy benefit manager (PBM) oversight is at an all-time high in both the House and Senate. As we noted last week, several bills that address PBM activities are moving through the...more

Husch Blackwell LLP

CMS Releases CY 2023 OPPS and ASC Proposed Rule

Husch Blackwell LLP on

The Centers for Medicare and Medicaid Services (CMS) issued the calendar year (CY) 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule on July 15, 2022. The Proposed...more

Mintz - Health Care Viewpoints

Health Plan Transparency Rule: Comment Period Ends This Week

In November 2019, the U.S. Department of Health and Human Services, along with the U.S. Department of Treasury and the U.S. Department of Labor, (collectively, the Departments) released a proposed rule requiring group health...more

King & Spalding

CMS Finalizes Rule to Require Hospitals to Disclose Negotiated Rates

King & Spalding on

The Department of Health and Human Services (HHS), and the Trump Administration as a whole, has placed a particular focus on the promotion of price transparency as a tool to control the costs of healthcare. In June, the...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Employers May Need to Provide Cost Data Under Proposed ACA Rules

Employer-sponsored health plans and health insurers may be required to post online - and to provide participants upon request - a range of pricing and cost-sharing information beginning in 2021. Proposed Affordable Care...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

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

Wilson Sonsini Goodrich & Rosati

HHS Proposes New Rule Requiring Drug TV Advertisements to Include the Drug's Retail Price

Prescription drug pricing in the U.S. has received significant and widespread attention lately from the media, consumers, and the government. For example, the Washington Post ran an article that examines the sometimes opaque...more

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