Yesterday, the OIG issued Advisory Opinion No. 11-16 regarding the provision by a pediatric hospital of housing, transportation, meals and other miscellaneous items to patients participating in clinical research protocols. The OIG determined that while the arrangement could potentially generate prohibited remuneration under the anti-kickback statute, the OIG would not impose civil monetary penalties.
The decision noted that the hospital’s provision of these services was not intended to induce referrals of federal health care program business. The purpose behind these services was to enable the patients and families to seek treatment at the hospital. The OIG identified factors that protected the provision of these services from the risk of fraud and abuse:
1. The hospital was a not-for-profit institution which relied primarily on donations, and is reimbursed less than a quarter of its costs from federal health care programs.
2. The nature of the services provided are not likely to induce self referral to the hospital considering that the hospital focuses on treatment for catastrophic diseases of children.
3. The purpose of the services is to enable compliance with the research protocols and allow the hospital to more closely monitor its patients.
4. The lodging facilities are designed for infection control.
5. The provision of meal assistance ensures that the patients and families are able to satisfy basic nutritional requirements.
6. These services are not marketed to prospective patients, their families or referring physicians.
7. There is a substantial public benefit from the specialized care and the research.
As with all of its opinions, the OIG clarifies that the opinion only applies to the requestor of the opinion. If you have questions regarding this advisory opinion please contact Elana Zana.