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Safe Harbors Medicare Part D

Williams Mullen

Annual Employee Benefits Compliance Checklists - Plan Administrators

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Plan administrators should review the following actions to be taken before the end of 2024 and focus on what to expect for 2025. The following checklist addresses plan amendments, notices, and other considerations for...more

Sheppard Mullin Richter & Hampton LLP

Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS

Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting...more

ArentFox Schiff

Arent Fox's Stark & Anti-Kickback Statute Final Rules Analysis

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Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more

King & Spalding

Implementation of Final Rule Excluding PBM Rebates from Discount Safe Harbor Delayed Until 2023

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Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more

Arnall Golden Gregory LLP

Pharmaceutical Companies Beware: New Final Rule Changes Existing Anti-Kickback Statute Discount Safe Harbor Provisions

In November 2020, the Department of Health and Human Services (HHS) finalized a regulation aimed at lowering prescription drug prices and out-of-pocket spending for prescription drugs by excluding rebates on prescription...more

Patterson Belknap Webb & Tyler LLP

Does HHS’s Elimination of the Safe Harbor for Manufacturer Rebates Leave Manufacturers with Increased Antitrust Risk?

On November 20, 2020, the U.S. Department of Health & Human Services (HHS) finalized a rule to take effect in 2022, which eliminates the safe harbor under the federal anti-kickback statute for manufacturer rebates to Medicare...more

White & Case LLP

Trump Administration’s Eleventh-Hour Drug Pricing Regulations Face an Uncertain Path Forward

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The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more

K&L Gates LLP

OIG Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts...

K&L Gates LLP on

On 20 November 2020, the United States Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released its final rule on drug rebates entitled “Removal Of Safe Harbor Protection For Rebates...more

Baker Donelson

HHS/OIG Finalizes Rule Stripping PBM Rebates of Safe Harbor Protection

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On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by...more

ArentFox Schiff

Discount Safe Harbor Final Rule Released: OIG Seeks to Adopt Major Changes

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Final Rule largely tracks prior proposal to make significant changes to the Discount Safe Harbor and other regulatory safe harbors to the Federal Anti-Kickback Statute. The Department of Health and Human Services Office of...more

Hogan Lovells

Trump Administration revives rebate safe harbor rule in late effort to reform drug pricing

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On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more

Seyfarth Shaw LLP

President Trump Orders HHS to Rescind Discount Safe Harbor for PBMs, but Questions Remain

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Prescription drug prices are one of the biggest drivers of rising health care costs. To address this issue, the Trump administration issued its Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to...more

ArentFox Schiff

White House Issues Executive Orders Addressing Drug Pricing

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The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.” A fourth Executive Order tying...more

Dorsey & Whitney LLP

Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration

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As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more

Holland & Knight LLP

New Medicare Part D Demonstration to Address Proposed Changes to Anti-Kickback Safe Harbors

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• The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D demonstration to address the potential implementation of a recent proposed rule that would exclude from anti-kickback safe harbor...more

Wilson Sonsini Goodrich & Rosati

HHS Releases Proposed Rule That Could Significantly Impact Drug Manufacturers, PBMs, and Other Stakeholders

The pharmaceutical industry invests billions in research and development. And as a result, the pharmaceutical industry has brought—and continues to bring—beneficial, life-saving, life-prolonging, life-enhancing, and...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

Gray Reed

Proposed Revisions To The Anti-Kickback Regulatory Discount Safe Harbor: What Does This Mean For The Drug Industry And For Your...

Gray Reed on

Continuing the Trump administration’s efforts to lower drug prices and reduce patient out-of-pocket costs, on February 6,2019, the U.S. Department of Health and Human Services Office of Inspector General (“HHS”) released a...more

Arnall Golden Gregory LLP

HHS Proposes Anti-Kickback Safe Harbor Revisions that Would Impact Drug Manufacturer Rebates to Health Plans, MCOs, and Pharmacy...

On January 31, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) proposed a new rule that would amend the safe harbor regulations under the Federal anti-kickback statute (42 U.S.C....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

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

Hogan Lovells

Trump administration proposes ambitious AKS rewrite on drug rebates, but needs answers to big questions

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In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more

Robinson+Cole Health Law Diagnosis

HHS Proposes to Amend AKS Safe Harbors to Exclude PBM Rebates and Incentivize Consumer Drug Discounts

On February 6, 2019, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a proposed rule (Proposed Rule) that would amend the safe harbor regulations 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...

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

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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

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