The latest advisory opinion published by the U.S. Department of Health and Human Services Office of the Inspector General (HHS OIG) approves one pharmaceutical manufacturer’s travel and lodging support program, but manufacturers should refrain from viewing this opinion as opening the door for similar programs in other contexts. Despite its continued concern that such support could lead to inappropriate utilization and increased federal program costs, the OIG was swayed by the particular facts and circumstances of this request, which focused on a one-time, potentially curative treatment with concomitant life-threatening or fatal reactions in certain patients. This opinion suggests that, subject to certain controls and limitations, similarly situated manufacturers may consider providing travel and lodging support for similar products, but the OIG continues to view such arrangements generally with skepticism except in certain limited situations.
>The product at issue in this advisory opinion is a personalized medicine made from the patient’s own cells and is a one-time, potentially curative treatment for two indications: (1) a refractory or recurrent disease generally affecting children and young adults; and (2) a relapsed or refractory disease generally affecting adults. The product contains a black box warning of certain life-threatening or fatal reactions including an unspecified syndrome and certain neurological toxicities. In response to these risks, the approved U.S. Food and Drug Administration (FDA) labeling for the product requires physicians to monitor patients for signs or symptoms of the syndrome for at least four weeks after infusion, and instructs patients to remain within proximity of the administering facility during this time. The product’s Risk Evaluation and Mitigation Strategy (REMS) program limits the administration of the product to certain certified physicians who accept responsibility for implementing necessary safety protocols.
The Requestor’s proposed arrangement offers travel and lodging support in order (1) to ensure that patients receive care in compliance with these FDA requirements, and (2) to promote access to patients who may otherwise find the financial costs associated with four or more weeks’ post-infusion travel and lodging to be overly burdensome. The proposed arrangement offers assistance with travel, lodging, meals, and certain out-of-pocket costs incurred by the patient and two caregivers (for the pediatric indication) and the patient and one caregiver (for the adult indication) incurred during and after the patient’s infusion (excluding initial patient consultations, required leukapheresis appointments, or follow-up visits). Eligible patients are those who have been prescribed the product for an FDA-approved indication, have a household income below 600% of the Federal Poverty Level (FPL), live more than 100 miles (or two hours driving distance) from the nearest treatment center accepting patients, and have no insurance for non-emergency medical travel. Patients also are excluded if they can obtain assistance from the treatment center directly.
The OIG has long expressed concerns with such travel and lodging support programs offered by pharmaceutical manufacturers based on the concern that manufacturers could use such support to steer patients to their drugs over competing, potentially more cost effective, treatment options. Moreover, under limited distribution networks, the OIG is concerned that manufacturers could use the offer of travel and lodging support for patients to drive patient volume in return for providers’ agreement to promote or exclusively prescribe the manufacturer’s product.
Despite these concerns, the OIG concluded that although the arrangement implicated the Anti-Kickback Statute (AKS) and the Beneficiary Inducements Civil Monetary Penalty (CMP), it would not impose sanctions on the Requestor for several reasons. First, the OIG emphasized the importance of the financial support to increase access to care for financially needy patients and those living in rural areas, who may not otherwise be able to afford travel to one of the limited number of certified treatment centers or afford lodging and related expenses for the post-infusion monitoring period. The OIG also expressed concern that, without support, patients may decline to remain within proximity for the post-infusion monitoring period, as required by the label, thus increasing the risk that potential life-threatening or fatal reactions could take place without appropriately trained medical personnel available to respond. The OIG concluded that the program will help providers comply with the product’s label and REMS requirements for ongoing monitoring within proximity to the treatment center.
The OIG also favorably cited certain program controls and limitations, including:
- the product’s refractory indication and the limited patient eligibility for those prescribed the treatment consistent with the product’s label;
- uniform eligibility for centers to become REMS certified, with no requirement to prescribe the product exclusively;
- patient eligibility restrictions that limit the program to patients who live certain distances from the treatment center (at least 100 miles for travel support or 300 miles for air travel support) and who are ineligible for lodging assistance from the treatment center or private insurance;
- the provision of travel and lodging only to the nearest treatment center accepting patients; and,
- the company does not advertise the program.
For these reasons, the OIG concluded that although the proposed arrangement implicates the AKS and the Beneficiary Inducements CMP, the OIG would not impose sanctions. Although the OIG found the particular facts and circumstances associated with this innovative treatment to be persuasive, the advisory opinion expresses OIG’s continued concerns about such programs in other situations, and the opinion should not be read to permit manufacturer support of such travel and lodging programs generally.
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