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Anti-Kickback Statute › Charitable Organizations

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 -
King & Spalding

OIG Issues Advisory Opinion on Arrangement for Charitable Organization to Buy and Forgive Patient Debt from Providers

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On July 24, 2020, OIG issued an Advisory Opinion (AO), AO 20-04, regarding whether an arrangement where a charitable organization purchases or receives donations of unpaid medical debt from health care providers, and then...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on

On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

The Volkov Law Group

Two Charitable Foundations Pay $6 Million for Anti-Kickback Violations

The Volkov Law Group on

Two charitable foundations that helped patients pay for drug co-payments settled anti-kickback charges for $6 million.  The Patient Access Network Foundation (PANF) agreed to pay $4 million and Good Days agreed to pay $2...more

Baker Donelson

OIG Approves Charitable Pediatric Clinic's Cost-Sharing Waivers in Advisory Opinion 19-01

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On January 9, in its first Advisory Opinion of 2019 (OIG Advisory Opinion 19-01), the U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable opinion regarding an arrangement...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion Allows Charitable Pediatric Clinic to Provide Routine Cost-Sharing Waivers

Robinson+Cole Health Law Diagnosis on

On January 14, 2019, the Health and Human Services Office of Inspector General (OIG) published a favorable Advisory Opinion allowing a charitable pediatric clinic (Clinic) to routinely waive cost-sharing amounts for patients...more

King & Spalding

OIG Rescinds Advisory Opinion Regarding a Patient Assistance Charity Program

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For the first time in history, OIG rescinded an advisory opinion that had previously protected a patient assistance charity from anti-kickback statute (AKS) liability. In its letter to the charity, OIG stated that it based...more

Hogan Lovells

A Path Forward: Corporate Integrity Agreement Sheds Light on Manufacturer Interactions With Independent Charitable Foundations

Hogan Lovells on

Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent charitable foundations that assist...more

The Volkov Law Group

Drug Companies and Charitable Patient Foundations

The Volkov Law Group on

Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more

Baker Donelson

OIG Approves Charitable Program Providing Financial Assistance for MRIs in Advisory Opinion 15-14

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On November 13, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-14. The Arrangement at issue is a charitable program designed to assist financially needy...more

Baker Donelson

OIG Approves Another Patient Assistance Program in Advisory Opinion 15-16

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On December 28, 2015, the Office of Inspector General (OIG) approved another patient assistance program in Advisory Opinion 15-16. The OIG analyzed contributions to a private charitable organization under the anti-kickback...more

Baker Donelson

Charity's Patient Assistance Program Passes OIG Muster in Advisory Opinion 15-17

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On December 28, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued OIG Advisory Opinion 15-17, approving a charity’s proposal to unveil a new patient assistance program dedicated to...more

King & Spalding

OIG Authorizes Arrangement to Pay for MRI Services

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On November 20, 2015, OIG issued a favorable advisory opinion, Advisory Opinion No. 15-14, regarding a charitable organization’s arrangement to pay for magnetic resonance imaging (MRI) services for patients afflicted with a...more

Cooley LLP

HHS OIG Issues Supplemental Special Advisory Bulletin on Patient Assistance Programs

Cooley LLP on

On May 21, 2014, the United States Department of Health & Human Services Office of Inspector General (“HHS OIG”) issued a fifteen page Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs...more

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