An Office of Inspector General (OIG) Advisory Opinion, OIG Advisory Opinion No. 09-06, was released addressing the issue of whether or not “expanding an existing program that provides free oral nutritional supplements to malnourished end-stage renal disease patients who are on dialysis” would violate the civil monetary penalty provision or the anti-kickback statute.
The Requestor (the individual(s) requesting the opinion) operates dialysis facilities serving patients with end-stage renal disease (ESRD). Many of these patients, as a result of their ESRD, suffer from malnutrition. When ESRD patients consume oral nutritional supplements, it has shown improved health including “decreased risks of hospitalization, infection, and mortality.” Unfortunately, according to Requestor, many of these patients will not take the supplements on their own, even if the physician recommends it, because they do not taste good. The Requestor currently conducts a small-scale program that provides a three-month supply of the nutritional supplements per year per patient. The Requestor wants to expand this program on a larger scale taking into account the following considerations:
– The patient would only be eligible for the program if s/he met certain requirements set by the Requestor;
– The Requestor would only provide the nutritional supplements upon the patient’s physician’s request , when medically necessary;
– The Requestor would deliver the dose to the patient with certain conditions including taking the dose at dialysis facility and consuming the dose within a certain time frame of the dialysis treatment;
– Once the patient is ineligible, the nutritional supplements would no longer be provided to the patient;
– There would be not advertising of the nutritional supplements to anyone; and – Nobody would claim the cost of the nutritional supplements on the Federal health care program cost report in any way.
In its analysis, the OIG was “particularly concerned that dialysis facilities might induce beneficiaries to obtain Federally payable items and services by offering them the [nutritional] [s]upplements when they are not, in fact, part of a targeted, properly structured, and clinically appropriate treatment modality.” Noting the reasons why Congress restricted giveaways related to Medicare and Medicaid, the OIG concluded that the program “poses a low risk of fraud and abuse.” Furthermore, the OIG mentions that the risk of abuse is “effectively minimize[d]” due to the aforementioned considerations.
As the OIG notes, the program could raise remuneration issues under the anti-kickback statute; however because of the aforementioned considerations and safeguards, the OIG concluded that the program would not result in the OIG imposing sanctions for violating the civil monetary penalty provision or the anti-kickback statute.
For more information, please call Abby Pendleton, Esq., Robert Iwrey, Esq., Adrienne Dresevic, Esq., Carey F. Kalmowitz, Esq. or Jessica L. Gustafson, Esq. at (248) 996-8510 or visit The HLP website.