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Rulemaking Process › Public Comment › Department of Health and Human Services (HHS)

Arnall Golden Gregory LLP

U.S. Department of Health and Human Services Rescinds "Richardson Waiver" Policy

Arnall Golden Gregory LLP on

On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...more

Epstein Becker & Green

HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking

Epstein Becker & Green on

On March 3, 2025, the Secretary of Health and Human Services published a policy statement in the Federal Register that reverses a policy adopted over 50 years ago that was intended to expand public participation in the...more

Holland & Knight LLP

HHS Releases Four Major Rules to Lower Drug Prices, Amend Anti-Kickback and Stark Laws

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) issued four major rules on Nov. 20, 2020, which was the final day for the Trump Administration to issue a rule with a 60-day implementation period for it to take effect...more

Akin Gump Strauss Hauer & Feld LLP

HHS Proposes to Rein In Its Use of Regulatory “Dark Matter”

Akin Gump Strauss Hauer & Feld LLP on

- HHS is overhauling its process for developing interpretive guidance documents under a new Proposed Rule. - HHS proposes to no longer use “guidance documents” to establish broadly applicable legal obligations on the...more

Mintz - Health Care Viewpoints

Administration Finally Releases Proposed Drug Importation Policies for Stakeholder and Public Comments

Mintz - Health Care Viewpoints on

At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...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

Robinson+Cole Health Law Diagnosis

Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to...

Robinson+Cole Health Law Diagnosis on

On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more

Polsinelli

HHS Office for Civil Rights Proposes Changes to Section 1557 Rules: What Health Care Providers Need to Know

Polsinelli on

On May 24, 2019, the Department of Health and Human Services (“HHS”) announced its proposed changes to the regulations issued under Section 1557 of the Affordable Act Care (“ACA”). Section 1557 is the primary...more

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