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Rulemaking Process Centers for Medicare & Medicaid Services (CMS) Department of Health and Human Services (HHS)

McDermott+

First Steps in Implementing the Trump Administration’s Price Transparency Agenda

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Recently, the Trump administration took steps toward implementing one of its major priorities: improving price transparency. As discussed in a previous Regs & Eggs blog post, President Trump signed an executive order (EO) on...more

Hogan Lovells

White House raises more questions than answers in Executive Order directing Most Favored Nation drug pricing

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On May 12, 2025, the White House issued an Executive Order (EO) entitled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients.” The EO directs the Secretary of Health and Human Services (HHS) to...more

Foley Hoag LLP

HHS Under the Second Trump Administration

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On February 11, 2025, President Trump signed Executive Order (E.O.) 14210, Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative, which instructed the newly formed Department of...more

Arnall Golden Gregory LLP

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

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

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Foley Hoag LLP

Department of Health and Human Services Seeks to Revise Rulemaking Policies

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On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a...more

Epstein Becker & Green

HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking

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

Latham & Watkins LLP

HHS Issues Policy Statement to Expand Use of Rulemaking Without Notice and Comment

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The policy statement aims to bring more rapid action on personnel and management decisions and empowers HHS and each of its offices and subagencies to promulgate or rescind certain rules without a period of notice and comment...more

McDermott+

Price Transparency: A Regulatory Priority

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The Trump administration is beginning to lay out its regulatory (and deregulatory) priorities, and on February 25, 2025, the administration spotlighted one of those priorities in an executive order on price transparency....more

McDermott+

Regs & Eggs with a Side of DOGE

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In the health policy world, nothing gets folks like me more “excited” than expecting and then seeing a new healthcare regulation pop up in the Federal Register. While the content of the reg is usually what public stakeholders...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

ArentFox Schiff

No More Surprise Medical Bills: Providers Score Yet Another Victory as Texas Court Again Vacates Provisions of Biden...

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On August 24, 2023, health care providers in Texas scored yet another victory when a federal court vacated additional portions of the Biden Administration’s rulemaking under the federal No Surprises Act (the Act). This marked...more

Bradley Arant Boult Cummings LLP

Federal Regulators Solicit Comments Regarding Healthcare Point-of-Sale Financing

On July 7, the CFPB, Centers for Medicare & Medicaid Services (CMS), Department of Health & Human Services (HHS), and Department of the Treasury issued a formal request for information regarding forms of consumer-facing...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

Sheppard Mullin Richter & Hampton LLP

CMS Backs Off Price Transparency for Providers and Plans

On August 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued its hospital inpatient prospective payment system (“IPPS”) final rule (“Final Rule”) for fiscal year 2022. In addition to a number of other...more

Sheppard Mullin Richter & Hampton LLP

Permanent Expansion of Medicare Telehealth Services

On December 1, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released the annual Physician Fee Schedule final rule (“Final Rule”) which, among other things, aimed to further President Trump’s October 3, 2019...more

Holland & Knight LLP

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

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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

Foley Hoag LLP

Summary of Trump Administration Drug Pricing and AKS Rulemakings and Implications for Life Sciences Companies and Health Care...

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On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more

Morgan Lewis - Health Law Scan

HHS Regulatory Sprint Crosses the Finish Line: New Stark and Anti-Kickback Rules Forecast Big Changes for Patients and Value-Based...

Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare...more

Hogan Lovells

Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

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The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...more

Hogan Lovells

HHS proposes to sunset regulations Issued by FDA, CMS, and other regulatory agencies

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Our team wanted to highlight a proposed rule issued by the U.S. Department of Health and Human Services (HHS) on 4 November 2020 - with only a 30-day comment period - that would establish sunset (expiration) dates for...more

McDermott Will & Schulte

White House Directs HHS to Model “Most-Favored-Nation” Price Caps for Part B and D Drugs

On September 13, 2020, the White House issued an Executive Order titled “Lowering Drug Prices by Putting America First” (the Executive Order), which directed the Secretary of the US Department of Health and Human Services...more

Seyfarth Shaw LLP

CMS Announces Extension on Publishing Final Rule Governing Physician Self-Referrals in Stark Law

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Health care providers looking for long-awaited answers to new proposed rules changes governing physician self-referral arrangements may have to wait a bit longer. ...more

Bricker Graydon LLP

COVID-19 Update: CMS and ONC delay interoperability rules

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On April 21, 2020, the Department of Health and Human Services (HHS) announced a policy of enforcement discretion regarding compliance with the recently released interoperability final rules. This new policy will afford the...more

K&L Gates LLP

K&L Gates Triage: The Impact of Allina — Potential Limitation on CMS’s Ability to Recoup Overpayments

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In this week’s episode, Adam Cooper discusses the Supreme Court’s decision in Azar v. Allina Health Services, as well as a related memorandum issued in late 2019 by the Centers for Medicare and Medicaid Services (“CMS”) that...more

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