• OIG Approves Charitable Assistance for Patients' Share of Costs for Advanced Diagnostic Tests
  • June 24, 2009 | Author: Steven A. Eisenberg
  • Law Firm: Baker & Hostetler LLP - Cleveland Office
  • Under Advisory Opinion 09-04, issued May 11, 2009, the Office of Inspector General (OIG) approved a charitable program that provides cost-sharing financial assistance to HIV-positive and colorectal cancer patients for certain advanced diagnostic tests. The tests assist physicians in accurately prescribing appropriate drug therapies. Donors to the program are comprised of individuals, corporations and foundations, including manufacturers of drug products, pharmacies and suppliers of the types of services used by patients receiving assistance through the program. Donors are not permitted to earmark funds for specific patients, providers, practitioners, services, tests or products, nor are they provided with any specific patient or testing information, and patients are not informed of the identity of donors (though a list of donations is publicly available upon request in accordance with IRS regulations). Further, the charity does not make any referrals or recommendations for physicians, services, tests or products, and patients have complete freedom of choice. To qualify for assistance, patients must meet objective financial need criteria.

    The OIG first determined that the donations do not serve as grounds for the imposition of civil monetary penalties or run afoul of the anti-kickback statute because (1) no donor or affiliate directly or indirectly controls the charity or the donated funds; (2) assistance to patients is independent of the donors; (3) the charity does not consider which product, provider, practitioner, service or supplier is used in awarding assistance; (4) assistance is awarded consistently based on an objective, verifiable, uniform financial need criteria; and (5) the charity provides donors with no data allowing them to correlate their donations with the use of their products or services. The OIG then determined that the patient assistance likewise did not trigger civil monetary penalties or implicate the anti-kickback statute because (1) the assistance was provided to patients on a first-come, first-served basis to the extent funding was available; (2) eligibility is based solely on financial need; (3) the patient’s freedom of choice to direct his or her own healthcare was not restricted; and (4) the charity’s mission served as a significant incentive for it to monitor utilization to minimize expenditures.

    In approving this program, the OIG followed long-standing OIG guidance allowing industry stakeholders to effectively contribute to the healthcare safety net for financially needy beneficiaries by donating to independent, bona fide charitable assistance programs. The OIG concludes that, if properly structured, such donations raise few, if any, concerns about improper beneficiary inducements.