Issued June 1, 2011, and posted June 8, 2011
Written by Julie Kass; reviewed by Heather Deixler*
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) has issued favorable Advisory Opinion 11-07, concerning an arrangement where the manufacturer of pneumococcal bacteria vaccines for immunization of infants and toddlers (Requestor) could expand a vaccine reminder program to include entities that insure and treat patients covered by a fee-for-service federal healthcare program. OIG found that the arrangement would not subject the Requestor to the imposition of civil money penalties or administrative sanctions under either the Anti-Kickback Statute (AKS) or the civil money penalty for inducement of beneficiaries.
The Requestor introduced a pneumococcal vaccine in 2001, and then expanded the vaccine for additional strains in February 2010. The original and expanded vaccines are administered in four doses to children under the age of fifteen months. In addition, children ages fifteen months to five years who previously received four doses of the original vaccine should receive a supplemental dose of the expanded vaccine. In order to ensure that children receive all of the appropriate doses of vaccine, the Requestor sponsors a vaccine reminder program (Program). Under the Program, the Requestor either arranges for: (1) the delivery of postcards, or (2) telephone reminders to the parents or guardians of children who may be in need of one or more doses of the vaccine. Until February 2011, the Requestor had limited participation in the Program to members and patients who were not covered by a fee-for-service federal healthcare program. In February 2011, the Requestor expanded the Program to include all health insurers and healthcare entities, including those that treat patients covered by a fee-for-service healthcare program.
There are two ways in which the Program works: the reminders can either be provided by an external third party or by the Requestor itself. The Requestor offers this Program to all healthcare insurers and healthcare entities without regard to the number of children who have been or will be vaccinated. Under the Program, the telephone calls and postcard reminders are paid for by the Requestor, and there is no charge to the health insurance or healthcare entities that wish to participate. Participating entities, however, must be able to filter and transfer information to either the Requestor or its third-party contractor in order to ensure that individuals who want to opt out will not be contacted as part of the Program. For entities that do not have the necessary data filtering programs, only the postcard service is available. The Requestor sends the postcards to the healthcare entity and the healthcare entity, sends it to its own patients. Postcards that are sent by the Requestor or its contractor can be personalized with the healthcare entity's corporate logo or other corporate branding.
The reminder postcards or telephone calls do not mention any specific product. They do not recommend any specific course of vaccination. The postcards merely state that the patient's family should contact their doctor or clinic to determine if a follow-up vaccine is required.
Both the postcards and the telephone calls include statements that the Requestor has provided financial support for the communication and that no patient-specific information is provided to the Requestor. The Requestor stated that these vaccine reminder programs improve adherence to immunization schedules.
OIG analyzed the arrangement under both the beneficiary inducement statute and the AKS. OIG questioned whether the Program provides something of benefit to the parents and guardians of the children who receive the vaccine reminders. OIG concluded that the reminder messages are not remuneration to the recipient parents and guardians under either statute. OIG stated that the reminder messages only inform parents about the potential need to have a vaccination. There are no incentives offered as part of the reminder program, and they do not provide any actual or expected economic benefit. Accordingly, neither AKS nor the beneficiary inducement statutes were implicated by the Program.
With respect to the relationship between the Requestor and the healthcare entities, OIG analyzed the AKS. OIG analyzed whether the Program has value to the healthcare entities, and determined that the services do have independent value to those entities because were it not for the Program, the healthcare entities might otherwise need to use its time and resources to provide the reminders themselves. In addition, there is potential for additional benefit to physicians if patients are encouraged to come in for an appointment for which the physician will be reimbursed. Notwithstanding the above, OIG believed that the Program presented sufficiently low risk of fraud and abuse and therefore, would not impose administrative sanctions on the Requestor based on the following factors:
The arrangement is narrowly tailored and operates transparently. OIG stated that the Program messages are only sent to parents of children who have begun, but who have not completed their pneumococcal vaccines in accordance with the recommended dosage. In addition, the reminder notices include a disclosure that the Requestor provides financial support for the Program. Further, the Requestor does not have an opportunity to influence referrals because the messages are only provided to recipients who have already been prescribed, and have at least received one dose of the vaccine.
OIG was comforted that the Program is available to all health insurers and healthcare entities regardless of the overall volume or value of their expected past, or anticipated referrals of the Requestor's vaccines.
The Requestor certified that the administration of the vaccine is the standard of care and is universally recommended. Thus, there is no specific inducement for a physician to administer a vaccine that would have otherwise not been administered absent the Program.
OIG does not believe that the Program would result in unfair competition or a decrease in patient freedom of choice because the reminder messages do not recommend a specific vaccine or course of vaccination.
OIG found that the Program would increase the quality of healthcare in that insurers and healthcare entities are reminding parents of patients that their children should conclude their course of vaccinations.
Based on all of these factors, OIG felt that there was no need to impose administrative sanctions on this Program.
*The Fraud and Abuse Practice Group Leadership would like to thank Advisory Opinion Task Force Members Julie Kass, Esquire (Ober Kaler, Baltimore, MD), and Heather Diexler, Esquire (Morgan Lewis & Bockius LLP, San Francisco, CA), for respectively drafting and reviewing this summary.