On November 15, 2011, the OIG released Advisory Opinion 11-16. In this new advisory opinion, the OIG reviewed a non-profit Hospital’s domiciliary services program that provides transportation, lodging, and meal assistance to certain patients and their family members. The OIG issued a favorable opinion of the arrangement and concluded that (i) the Arrangement does not constitute grounds for the imposition of civil monetary penalties; and (ii) while the Arrangement could potentially generate prohibited remuneration under the Anti-Kickback Statute, the OIG will not impose administrative sanctions.
The Hospital is an internationally known, not-for-profit institution dedicated to finding cures for catastrophic diseases in children through research and treatment. The Hospital offers unique and cutting-edge research and therapy options. The highly complex nature of many of the clinical and translational trials that it designs and conducts requires greater patient participation, and more time at the Hospital’s campus, than the clinical trials conducted by most cooperative groups or single institutions.
For these reasons, many of the patients who seek treatment at the Hospital must travel or temporarily relocate to the Hospital’s metropolitan area. In order to ease the burdens associated with participation in its programs, the Hospital offers an extensive domiciliary services program that provides transportation, lodging, and meal assistance for patients and their families depending on criteria such as anticipated length of stay and distance from the Hospital. The Domiciliary Services Program is not advertised or marketed to prospective patients, their families, or referring physicians. Patients generally are informed of the availability of Domiciliary Services only after they have been accepted to the Hospital.
The provision of the services in the Domiciliary Services Program could potentially create risk under the Federal Anti-kickback Statute. However, the OIG concludes that it will not seek enforcement as a result of several significant factors in the arrangement, which are –
- The Hospital is a not-for-profit institution that is reimbursed for less than a quarter of the costs it expends to care for the Federal health care program beneficiaries it treats. Most of the remaining costs for care not reimbursed by the Federal health care programs, and all of the costs of providing the Domiciliary Services, are funded by philanthropic sources.
- The unique nature of the services makes it unlikely that the Domiciliary Services will induce patients to self-refer to the Hospital’s facilities for unnecessary services. The Hospital focuses on the treatment and cure of catastrophic diseases in children; such services typically are not susceptible to overutilization. Furthermore, the fact that the vast majority of the Hospital’s patients are on clinical research protocols not offered elsewhere makes it unlikely that the provision of Domiciliary Services would cause a patient to seek services at the Hospital at the expense of another facility.
- The Domiciliary Services help ensure that the Hospital’s patients can take advantage of, and remain compliant with, the research and treatment protocols.
- Many of the Hospital’s patients have compromised immune systems and, therefore, have special hygiene needs. The lodging facilities have been designed with infection control in mind, and offer a clean, safe environment that promotes healing.
- The Hospital’s provision of meal assistance ensures that its patients and their families are able to satisfy their basic nutritional requirements. Its provision of miscellaneous items and services such as child restraint devices, developmental items, and special events, allows its patients and their families to focus on their treatment regimens and to celebrate treatment milestones. The meal assistance and the miscellaneous items and services are small in value compared to the other Domiciliary Services and the care itself, are not advertised, and are funded exclusively by philanthropic sources.
- The Domiciliary Services are not advertised or marketed to prospective patients, their families, or referring physicians, and patients generally are informed of the availability of the Domiciliary Services only after they have been accepted for treatment,. As a result, the Domiciliary Services are unlikely to serve as an inducement to select the Hospital
- None of the costs of the items and services provided under the Domiciliary Services Program are claimed or have their costs shifted—either directly or indirectly—to the Federal health care programs or other third party payors.
To see the full Advisory Opinion, click here —-> OIG Advisory Opinion 11-16