On November 28, 2017, the Office of Inspector General (OIG) rescinded advisory opinion 06-04, in which it had previously determined that a charity’s (Requestor) proposal to provide assistance to financially needy Medicare beneficiaries did not warrant the imposition of sanctions. The OIG explained that “public interest requires rescission” after finding that Requestor failed to comply with earlier factual certifications that were material to the original advisory opinion.

Under the program, the Requestor provides assistance with premiums and cost-sharing obligations for patients with two specific chronic diseases. Most of the funding for the assistance comes from non-profit organizations, home health agencies, drug manufacturers and service providers that provide services to the patients receiving assistance from Requestor.

In its advisory opinion, the OIG based its conclusion to not impose sanctions on the Requestor on several factors, including: (1) donors cannot link their donations to assistance received by beneficiaries and vice versa, meaning that there is little chance that the donors would influence referrals by Requestor; (2) Requestor awards assistance without regard to any donor’s interests and without regard to a beneficiary’s choice of provider or supplier; (3) Requestor does not provide donors with data that would enable the donors to correlate the amount or frequency of their donations with the use of the donor’s products or services, and similarly, beneficiaries would not receive any information regarding the donors. The OIG modified this advisory opinion in 2015 to align with a May 21, 2014 OIG bulletin regarding patient assistance programs.

The OIG recently determined that the Requestor failed to fully and accurately disclose to the OIG all material and relevant information about its patient assistance program. Specifically, the OIG found that the Requestor provided patient-specific data to the donors so that the donors could correlate the amount and frequency of their donations with the use of their products. Additionally, the OIG found that the Requestor allowed donors to influence the manner in which the Requestor chose the recipients of financial assistance. As with all advisory opinions, the OIG based its conclusions in advisory opinion 06-04 on the Requestor’s certifications presented to it; the OIG does not perform independent investigations of the facts underlying a request for an advisory opinion.

The Requestor did not dispute the OIG’s determination, but instead argued that advisory opinion 06-04 should be further modified so that it could continue with its program, representing that it may cease operations if advisory opinion 06-04 was terminated. The OIG rejected the Requestor’s argument and found that, because Requestor failed to disclose information that contradicted the facts upon which the OIG based advisory opinion 06-04, that advisory opinion must be immediately rescinded, effective from April 20, 2006, the original date of issuance of advisory opinion 06-04.