The Office of Inspector General (OIG) would not impose sanctions related to a proposed arrangement that would allow a charitable organization to provide financial assistance to cover cost-sharing obligations associated with outpatient drug treatment for financially needy Medicare or Medicaid patients and was reliant upon donor funds, because it was designed with sufficient safeguards.
The patient assistance program would focus primarily on increasing access to high-cost, medically necessary drug treatment options that were often skipped by patients who could not afford to pay. All prospective assistance recipients would be required to complete an application on a first-come, first-served basis, to the extent funding was available. Grants would be awarded pursuant to assessment of the applicants’ individual financial needs based on national standards of indigence. The organization would provide financial assistance for so long as the participating patient continued to meet the program’s eligibility criteria. The patient assistance program would be governed by an independent board of directors, which would handle all policy-making functions, such as the determination of patient eligibility requirements.
The proposed design and administration of the patient assistance program interposed an independent, bona fide charitable organization between donors and patients in a manner that effectively insulated beneficiary decision-making from information attributing the funding of the benefit to any donor. It was unlikely that donor contributions would influence any patient’s selection of a particular provider, supplier, product, or insurance plan. The patient assistance program also did not take into account (1) the identity of provider, practitioner, supplier of items or services, or drug or other product the applicant may use; (2) the identity of referring person or organization; or (3) the amount of contributions made by a donor whose services or products were used or may be used by the applicant.
OIG Advisory Opinion, No. 08-17, Oct. 21, 2008, Health Care Compliance Reporter, ¶500,197
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