News & Analysis as of

Office of the Inspector General Charitable Organizations

Health Care Compliance Association (HCCA)

Rob DeConti on the Latest Guidance and Insights from the OIG at HHS

In this podcast Rob DeConti, Assistant Inspector General for Legal Affairs within the office of counsel to the Inspector General at HHS, was good enough to share a tremendous amount of insight into what the OIG is seeing,...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 28. News Briefs: August 2020

Report on Medicare Compliance 29, no. 28 (August 3, 2020) - The HHS Office of Inspector General (OIG) has given the green light to a plan by a charitable organization to “purchase or receive donations of unpaid medical...more

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

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

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

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

Skadden, Arps, Slate, Meagher & Flom LLP

Health Care Investigation Trends: Corporate Integrity Agreements No Longer a Given

2017 was slightly above average for new corporate integrity agreements (CIAs), with 46 entered into by the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and companies and individuals...more

Holland & Knight LLP

OIG Issues Letter Declining to Impose Administrative Sanctions for Provision of Certain Free Drugs

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On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...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

Robinson+Cole Health Law Diagnosis

OIG Rescinds Advisory Opinion Due to Requestor’s Failure to Disclose Information

On November 28, 2017, the Office of Inspector General (OIG) rescinded advisory opinion 06-04, in which it had previously determined that a charity’s (Requestor) proposal to provide assistance to financially needy Medicare...more

Holland & Knight LLP

OIG Rescinds Advisory Opinion

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The Department of Health and Human Services Office of Inspector General (the OIG), on November 28, 2017, issued a Rescission Letter terminating Advisory Opinion Number 06-04 (Advisory Opinion 06-04). In Advisory Opinion...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

Baker Donelson

OIG Approves Charitable Organization's Patient Assistance Program

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On May 28, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving a charitable organization’s proposal to provide financial assistance to individuals with...more

Baker Donelson

OIG Approves Nonprofit Foundation's Proposed Copayment Assistance Program

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On January 5, 2015, the OIG posted a favorable advisory opinion, OIG Advisory Opinion 14-11, regarding a 501(c)(3) charitable foundation’s (Foundation) proposal to establish a patient assistance program that would provide...more

Benesch

Supplemental Special Advisory Bulletin Clarifies OIG Positions on Independent Charity Patient Assistance Programs

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Introduction - The OIG has released a Supplemental Special Advisory Bulletin that “reiterates and amplifies” previous OIG Special Advisory Bulletin guidance from 2005. Pharmaceutical manufacturers and Patient...more

Cooley LLP

HHS OIG Issues Supplemental Special Advisory Bulletin on Patient Assistance Programs

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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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