The U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued a favorable advisory opinion for a Requestor regarding a vaccine reminder program. In February 2011, the Requestor, a manufacturer of pneumococcal bacteria vaccines for immunization of infants and toddlers, expanded a vaccine reminder program to entities that insure and treat patients covered by federal healthcare programs. Prior to February the reminder program was only to the parents or guardians of children who may have needed one or more doses of the vaccine.
Under the expansion, the Requestor offers the reminder program to entities regardless of the number of children that have been or will be vaccinated. The Requestor also pays for the reminders, either through telephone calls or postcards and there is no other charge to the entities that wish to participate. The reminder postcards or telephone calls do not refer to a specific product and do not recommend a specific avenue for vaccination. They merely suggest that the child’s parent or guardian contact a clinic to determine if a vaccine is required.
The OIG analyzed the program under the beneficiary inducement statute and the anti-kickback statute. The OIG first concluded that the reminder messages to the parents from the Requestor were not inducements since they only inform the parents about the potential need to have a vaccination. Further, the OIG determined that the relationship between the Requestor and the healthcare entities did not violate the anti-kickback statute. Although there is some independent value to the entities from the program, there is a low risk of fraud and abuse because of several factors, including: the arrangement was narrowly tailored and transparent, available to all health insurers and entities regardless of their use of the Requestor’s vaccines and the reminder messages do not recommend a specific vaccine or course of vaccination, thus they still encourage patient’s freedom of choice.
For more information on compliance with anti-kickback statute and other regulations, please visit www.wachler.com or contact a Wachler & Associates attorney at 248-544-0888.