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# OIG Refining Patient Assistance Program Rules: Attorney
- URL: https://www.fdaweb.com/oig-refining-patient-assistance-program-rules-attorney/
- Published: 2016-02-24T12:00:00.000Z
- Updated: 2026-09-15T02:38:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134875

> Attorney **Chelsea Rutherford** (McDermott Will & Emery) says that the HHS Inspector General has been issuing advisory opinions that revise its approach to patient assistance programs (PAPs) that provide financial assistance or free prescription drugs to low-income individuals. “While none of these opinions or modifications are dramatically new on their face,” she says in an online blog [post](http://www.lexology.com/library/detail.aspx?g=c994279f-2b94-4425-b262-01446f042784&ref=fdaweb.com), “together they provide valuable insight into the types of facts that can mitigate the OIG’s general concerns with tailored disease funds.”  
>  
> Historically, Rutherford explains, the OIG has been more comfortable with true charitable programs that are not drug-specific and that reflect other characteristics demonstrating a broad patient focus, rather than those reflecting a drug or pharmaceutical manufacturer focus.  
>  
> Because of a trend of some independent charity PAPs establishing or operating specific disease funds that limit assistance to a subset of available products, the OIG in 2014 articulated a concern with such PAPs and said it would view them as having a higher baseline risk of abuse when their assistance was limited to only a subset of available FDA-approved products for treatment of the disease.  
>  
> New opinions and modifications in 2015, Rutherford writes, are consistent with the standard but add nuanced factors and exceptions that appear to show a more refined stance on specific disease funds.  
>  
> “While the OIG continues to reiterate the potential risks posed by disease funds that are tailored to specific symptoms, severity of symptoms, method of drug administration, stages of a disease, or types of drug treatment,” she concludes, “its recent opinions and modifications illustrate several exceptions to this general position.”