The OIG found that the arrangement potentially implicates the Federal Anti-Kickback Statute and the civil monetary penalty law that prohibits inducements to beneficiaries because the company’s donations to the foundation and the foundation’s grants to patients’ families constitute prohibited remuneration. However, the OIG determined that the risk of fraud and abuse is low due to several mitigating factors, including:

• The arrangement is unlikely to lead to overutilization or inappropriately increase costs to federal health care programs because families must have a therapy plan in place before applying for a grant.

• Grant funding is unlikely to incentivize a provider to recommend unnecessary therapy because the grants are paid directly to families rather than providers.

• The arrangement is unlikely to lead to inappropriate steering or unfair competition because the company’s donations to the foundation are unrestricted and independent of any patient referrals or provider selection.

• The Foundation awards grants based on financial need, not on a family’s choice of provider, and families remain eligible for grants even if they switch providers.

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