OIG Issues Two Advisory Opinions Regarding the Provision of Patient Travel and Fertility Subsidies in Connection to Gene Therapy

Although the proposed arrangement may induce patients to receive the treatment and contribute to the company’s opportunity to earn associated fees, thereby implicating the Federal Anti-Kickback Statute, the OIG concluded that the risk of fraud and abuse was sufficiently low based on the following:

1. Due to the limited number of approved treatment centers, travel support removes a barrier to accessing medically necessary care.
2. Since the FDA label requires patients to travel to a treatment center and remain there for several weeks, providing travel support, even for caregivers, is reasonable.
3. Because each drug is provided as a one-time treatment, it is unlikely for patients to be induced to obtain additional services payable by a federal health care program.
4. Other safeguards are in place to mitigate the risk of fraud and abuse, such as the fact that support is not provided for expenses payable by a third-party and the company will not use travel support as a marketing tool.

The OIG also concluded that the proposal falls under the “Promotes Access to Care” exception to the civil monetary penalty provision of the Social Security Act prohibiting inducements to beneficiaries, which allows incentives to be offered to Medicare and Medicaid beneficiaries, if the incentive promotes access to care, rather than providing a reward. Because travel support is unlikely to interfere with clinical decision making, unlikely to increase costs to federal health care programs, and does not raise patient safety or quality of care concerns, the OIG found that this exception applied.