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Medicaid › Rebates › Department of Health and Human Services (HHS)

Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with... more +
Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with children.  less -
Goodwin

Federal Court Affirms HRSA Authority to Preapprove 340B Rebate Models but Urges HRSA to Reconsider Rejection of Rebate Model

Goodwin on

In a May 15, 2025, opinion, Judge Dabney Friedrich of the US District Court for the District of Columbia denied drugmakers’ motions for summary judgment against the US Department of Health and Human Services and the Health...more

Mintz - Health Care Viewpoints

Stakeholders Raise 340B Concerns in Medicaid Drug Rebate Program Final Rule; CMS, With Hands Tied, Shrugs

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On September 26, 2024, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing changes to the Medicaid Drug Rebate Program (MDRP). While not the focus of the agency’s rulemaking, stakeholders...more

Harris Beach Murtha PLLC

OIG Enforcement Summary: August 16, 2022 – August 31, 2022

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The following is a summary of the federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are...more

Sheppard Mullin Richter & Hampton LLP

Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates and Creates Two New Safe Harbors for...

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On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more

Akin Gump Strauss Hauer & Feld LLP

Battle Lines Drawn with Release of Speaker’s Drug Pricing Plan

Akin Gump Strauss Hauer & Feld LLP on

[co-authors: Sean Feely, Senior Public Policy Specialist and Julie E. Nolan, Senior Policy Advisor] • On September 19, Speaker Pelosi released a drug pricing plan that includes proposals for Medicare direct price...more

Foley & Lardner LLP

Drug Pricing: White House Announces Withdrawal of Proposed Changes to Anti-Kickback Safe Harbors

Foley & Lardner LLP on

On July 11, 2019, the Trump administration announced it would withdraw a proposed rule that would eliminate the Anti-Kickback Statute (AKS) safe harbor that protected rebates made from pharmaceutical manufacturers to pharmacy...more

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. GRASSLEY CONFIRMS DELAY ON DRUG BILL WHILE ANOTHER COMMITTEE PLANS VOTES - Senate Finance Committee Chairman...more

King & Spalding

Congress Acts to Eliminate MDRP Misclassification

King & Spalding on

President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more

Husch Blackwell LLP

HHS Targets PBMs But May Exceed Its Legal Authority In Proposed Rule Eliminating AKS Protection For Drug Rebates

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The Trump Administration’s latest effort to limit the power of pharmacy benefit managers (“PBMs”) is marred by economic uncertainty and looming legal scrutiny. The Office of Inspector General (“OIG”) within the Department of...more

Verrill

OIG Proposes Revisions to Anti-Kickback Safe Harbor Regulations Affecting Prescription Drug Rebates

Verrill on

Recently, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) in the Federal Register to amend the federal anti-kickback statute safe harbor...more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

Sheppard Mullin Richter & Hampton LLP on

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

K&L Gates LLP

HHS Issues Proposed Rule to Remove Safe Harbor for Drug Rebates

K&L Gates LLP on

On January 31, 2019, the U.S. Department of Health & Human Services (“HHS”) issued a long-awaited proposed rule (the “Proposed Rule”) which, if finalized, would modify the discount safe harbor under the federal Anti-Kickback...more

Epstein Becker & Green

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

Epstein Becker & Green on

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more

Dorsey & Whitney LLP

Drug Rebates Threatened Under Proposed Anti-kickback Rule

Dorsey & Whitney LLP on

The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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?

Bass, Berry & Sims PLC on

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

Holland & Knight LLP on

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

Baker Donelson on

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

Patrick Malone & Associates P.C. | DC Injury...

Will Rx drug costs fall if U.S. puts squeeze on middlemen and curbs rebates?

Patrick Malone & Associates P.C. | DC Injury... on

The Trump Administration has put out its latest prescription to try to slash out-of-control prescription drug prices: Officials want to call medication “rebates” what they say they’ve really become — “kickbacks” — and crack...more

Baker Donelson

OIG May 2018 Work Plan Update

Baker Donelson on

The OIG added seven new items to its Work Plan in the May 2018 update. Among the issues addressed are emergency preparedness, the impact of generics on Medicaid drug rebates, reviews of claims for Part B outpatient cardiac...more

Holland & Knight LLP

White House Unveils Proposal on Drug Pricing

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On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

Holland & Knight LLP

Recent Congressional Actions Bring Drug Pricing Debate Back Into National Spotlight

Holland & Knight LLP on

In late October, Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) introduced the Medicare Drug Price Negotiation Act of 2017 (S. 2011; H.R. 4138), which would allow the Department of Health and Human Services (HHS)...more

Mintz - Health Care Viewpoints

The Four Things That Surprised Us in the EpiPen False Claims Settlement

Mintz - Health Care Viewpoints on

On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug...more

Mintz - Health Care Viewpoints

The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?

Mintz - Health Care Viewpoints on

The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by...more

Foley & Lardner LLP

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

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Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

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