OIG Gives Green Light to Patient Assistance Program

A non-profit charitable organization’s proposal to provide assistance in the form of partial or full coverage of copayments for certain financially needy patients with Crohn’s disease or ulcerative colitis received a favorable advisory opinion by the Office of Inspector General (OIG) of the Department of Health and Human Services (DHHS).

In OIG Advisory Opinion 14-11, the OIG looked at two aspects of the proposal in relationship to the Anti-Kickback Statute and the Civil Monetary Penalties for beneficiary inducement:  (1) The charitable organization’s donors’ (e.g., industry stakeholders such as drug companies or providers) contributions to the program and (2) the charitable organization’s assistance to Federal health program beneficiaries (e.g., Medicare and Medicaid).

The OIG determined that neither of these financial relationships would pose more than a minimal risk to Federal health programs because of the following safeguards:

  1. Donors would have no control, direct or indirect, over the program
  2. Before applying for assistance all patients would have already selected their physician and would have a treatment regimen in place.
  3. Donors would not receive any data that would correlate the amount or frequency of donations to amount or frequency of its drugs/services.
  4. Even though donors could earmark funds for a certain disease (e.g., Crohn’s vs. ulcerative colitis) the diseases may be treated with a broad range of treatments and drug regimens which cannot be earmarked.
  5. Determination of a patient’s qualification will be based on financial need on a first-come first-served basis. Financial need will be determined by a uniform verifiable basis.


The OIG further noted that its conclusion was consistent with its November 2005 Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees and its May 2014 Supplemental Special Advisory Bulletin on Independent Charity Patient Assistance Programs.

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