Patient Assistance Programs

News & Analysis as of

Drug Companies and Charitable Patient Foundations

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

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

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

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

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

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

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

OIG Tightens Requirements of Prior Favorable Advisory Opinion on Charity Patient Assistance Program for Cancer Drugs

On December 7, 2015, OIG posted a modification adding additional strictures to a prior favorable Advisory Opinion (No. 07-11) regarding a charity’s operation of a patient assistance program (PAP) to provide financial...more

Why Industry Drug-Assistance Programs Are a Sham

You probably heard about the recent price hike for a drug critical to AIDS patients when the manufacturer sold it to an evil hedge fund manager who promptly marked it up 5,000%. This prompted Los Angeles Times columnist...more

OIG Will Not Impose Sanctions on Entities for Program That Provides Free Drugs to Patients Experiencing Delayed Insurance...

On August 5, 2015, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG) issued Advisory Opinion No. 15-11 (the “Opinion”) in response to a request by pharmaceutical manufacturers that...more

OIG Approves Charitable Organization's Patient Assistance Program

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

Locke Lord QuickStudy: Recent Health Care Updates

On January 29, the Centers for Medicare & Medicaid Services (CMS) announced its plan to propose changes to the Electronic Health Record Incentive Program (EHR Incentive Program). According to CMS, the rule will address...more

New OIG guidance issued on independent charity patient assistance programs

On May 21, 2014, the Office of Inspector General (“OIG”) issued a Supplemental Special Advisory Bulletin (“Bulletin”) on independent charity patient assistance programs (“PAPs”). The Bulletin, which supplements the 2005...more

OIG Supplemental Special Advisory Bulletin Raises New Concerns About Independent Charity Patient Assistance Programs

In an effort to address new concerns about the independence of charity patient assistance programs (PAPs), the Office of Inspector General (OIG) released its Supplemental Special Advisory Bulletin: Independent Charity Patient...more

OIG Supplemental Advisory Bulletin on Patient Assistance Programs Leaves Open Questions for High-Cost Breakthrough Drugs in...

On May 21, 2014, the Office of the Inspector General ("OIG") of the Department of Health and Human Services issued a Supplemental Special Advisory Bulletin ("Supplemental Bulletin") addressing the risks that Independent...more

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

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

"HHS OIG Issues New Guidance on Patient Assistance Programs"

On May 21, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a special advisory bulletin addressing independent charity patient assistance programs (PAPs) for federal health care...more

HHS OIG Issues Supplemental Special Advisory Bulletin on Patient Assistance Programs

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

A Continued Examination of Charitable Patient Assistance Programs Part Eight in a Series: What Products Say About Charitable PAPs

In today’s challenging health care environment, Charitable Patient Assistance Programs (Charitable PAPs) have emerged to meet the needs of the nearly 30 million Americans that are underinsured and have difficulty paying...more

A Continued Examination of Charitable Patient Assistance Programs - Part Seven in a Series: Charitable PAPs: Donations and...

In today’s challenging health care environment, Charitable Patient Assistance Programs (Charitable PAPs) have emerged to meet the needs of the nearly 30 million Americans that are underinsured and have difficulty paying...more

Ruminations on Observation

On July 29, 2013, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) released a memorandum report finding that Medicare paid more on average for short inpatient stays than for...more

A Continued Examination of Charitable Patient Assistance Programs Part Five in a Series: How Charitable PAPs Organize Disease...

In today’s challenging health care environment, Charitable Patient Assistance Programs (Charitable PAPs) have emerged to meet the needs of the nearly 30 million Americans that are underinsured and have difficulty paying...more

A Continued Examination of Charitable Patient Assistance Programs Part Four in a Series: Staying True to the Definition of an...

In today’s challenging health care environment, Charitable Patient Assistance Programs (Charitable PAPs) have emerged to meet the needs of the nearly 30 million Americans that are underinsured and have difficulty paying...more

Examining Charitable Patient Assistance Programs Part Three in a Series: Using Third Parties to Evaluate Charitable PAPs

In today’s challenging health care environment, Charitable Patient Assistance Programs (Charitable PAPs) have emerged to meet the needs of the nearly 30 million Americans that are underinsured and have difficulty paying...more

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