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Anti-Kickback Statute › Drug Pricing › Office of the Inspector General

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +
The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -
McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

King & Spalding

OIG Issues Favorable Opinion Regarding a Program to Provide Patients with Free Access to a Pharmaceutical Product

King & Spalding on

On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more

MoFo Life Sciences

Supreme Court Denies Review Of Cost Sharing Assistance Program

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The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible...more

Sheppard Mullin Richter & Hampton LLP

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

Sheppard Mullin Richter & Hampton LLP on

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

Sheppard Mullin Richter & Hampton LLP

OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies

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On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part...more

ArentFox Schiff

Investigations Newsletter: OIG Warns That Proposed Drug Discounts May Warrant Sanctions

ArentFox Schiff on

OIG Warns That Proposed Drug Discounts May Warrant Sanctions - On October 5, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued an advisory opinion assessing a proposal that involved...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | August 2022 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January - April 2022 Recap

McDermott Will & Schulte on

This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more

Snell & Wilmer

HHS Office of Inspector General Issues Important Update to Self-Disclosure Protocol

Snell & Wilmer on

For the first time since 2013, on November 8, 2021, the Health and Human Services Office of Inspector General (“HHS-OIG” or “OIG”) made a number of significant updates to its Health Care Fraud Self-Disclosure Protocol...more

Goodwin

Judge Dismisses Pfizer’s Lawsuit Over HHS Limits on Drug Copay Assistance

Goodwin on

In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...more

King & Spalding

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

King & Spalding on

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

Sheppard Mullin Richter & Hampton LLP

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

Sheppard Mullin Richter & Hampton LLP on

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

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

Baker Donelson on

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

Butler Snow LLP

CMS and OIG Release Stark and AKS Final Rules to Support Reforms for Coordinated, Value-Based Care

Butler Snow LLP on

On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of the Inspector General (“OIG”) released their highly-anticipated final rules to modernize and...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

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

Bass, Berry & Sims PLC

CMS and OIG Release Changes to the Stark, Anti-Kickback and Patient Inducement Laws to Fuel Innovation, Ease Regulatory Burdens,...

Bass, Berry & Sims PLC on

On November 20, in a coordinated effort, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) released final rules to modernize regulations implementing the federal physician-self...more

McDermott Will & Schulte

OIG Finalizes Revisions to Safe Harbor Protection for Drug Rebates and Establishes New Safe Harbors for Point-of-Sale Price...

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On November 20, 2020, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule as part of ongoing administration drug pricing reform efforts and in conjunction with 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

King & Spalding

New Risks, New Rewards, New Exposure

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Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

McGuireWoods Consulting

Washington Healthcare Update - December 2019 #1

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This Week in Washington: The House and Senate are back from Thanksgiving recess. Congress is expected to be in session until or about Dec. 20....more

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