News & Analysis as of

Public Comment Medicaid Department of Health and Human Services (HHS)

Holland & Knight LLP

Holland & Knight Health Dose: May 6, 2025

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Reconciliation markups in the U.S. House of Representatives Committee on Energy and Commerce, as well as the House Committee on Ways and Means, were expected to be held this week but have been postponed until next week at the...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

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: March 5, 2024

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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

Foley Hoag LLP

CMS Releases Request for Information on Medicare Advantage Data

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On January 30, 2024, CMS published in the Federal Register an RFI to seek input from the public regarding increased public releases of MA data to improve transparency in the program. CMS stated responses to this RFI may be...more

Faegre Drinker Biddle & Reath LLP

FCC Seeks Comment on HHS/CMS Request for Certainty About Communications Critical to Federal and State Health Insurance Programs...

Reacting quickly to a joint request by the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) (collectively, the Health Agencies) last Thursday, the FCC released a Public...more

Jones Day

Certain Pharmaceutical Discounts No Longer Safe Under the "Safe Harbors"?

Jones Day on

The proposed rule evidences the HHS' and the Administration's continued interest in reducing federal spending for pharmaceutical products. On February 6, 2019, the Department of Health and Human Services ("HHS") published...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

Skadden, Arps, Slate, Meagher & Flom LLP

Sweeping Changes Proposed to Safe Harbors for Drug Discounts to Health Plans

The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more

Bass, Berry & Sims PLC

OIG Proposed Rule Seeks to Address Drug Pricing Concerns – But Will It?

In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more

Holland & Knight LLP

Administration Proposes Changes to the Drug Rebate Program

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On Jan. 31, 2019, the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) issued a long-awaited proposed rule that would, if finalized, remove the existing legal "safe harbor" that protects...more

Baker Donelson

HHS Proposes Removing Anti-Kickback Safe Harbor Protection for PBM Rebates, Proposes Two New Safe Harbors

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On January 31, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued for public display a proposed regulation that would subject certain pharmaceutical manufacturer rebates paid to...more

King & Spalding

HHS Proposes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

King & Spalding on

The Proposed Rule Would Make Clear that the Anti-Kickback Statute’s Discount Safe Harbor Does Not Protect Manufacturer Rebates to PBMs or Payors, But Would Create New Safe Harbors for Rebates Passed Through to the...more

Holland & Knight LLP

Healthcare Law Update: September 2018

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Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

Mintz - Health Care Viewpoints

President Trump Delivers Much Anticipated Drug Pricing Speech

On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs....more

BakerHostetler

HHS Reopens Comment Period for Proposed Rule on 340B Drug Program

BakerHostetler on

The U.S. Department of Health and Human Services (HHS) is reopening the comment period for the proposed rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” HHS released...more

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