On February 22, 2008, the Department of Health and Human Services' Office of Inspector General (OIG) posted OIG Advisory Opinion No. 08-05 (Advisory Opinion).
In the Advisory Opinion, a company that develops, manufacturers and markets pharmaceuticals (Company) for a number of diseases and conditions, including 4 disease states (Disease States), inquired about a proposal to place electronic kiosks, which offer patients free Disease State screening questionnaires, in physicians' offices (Proposed Arrangement).
Specifically, the Company inquired whether the Proposed Arrangement would violate the Federal anti-kickback statute or the prohibition against beneficiary inducements and result in the imposition of related sanctions. Based on the facts presented, the OIG concluded that the Proposed Arrangement would not violate the Federal anti-kickback statute or the prohibition against beneficiary inducements.
Under the Proposed Arrangement, the Company would place freestanding kiosks, which offer interactive questionnaires about the Disease States, in the waiting rooms of physicians. Use of the kiosks would be voluntary. The kiosks would generate a printout containing the screening questions and the patient's responses. The printouts would not provide any conclusions regarding whether a patient has a particular condition or requires a particular therapy, but would advise patients to talk to their physician about the screening results. According to the Company, the kiosks would help patients determine whether they should discuss symptoms of the Disease States with a physician.
Furthermore, the Company would offer to place the kiosks in the writing room of physicians whom the Company expects would treat a large number of patients with the Disease States, including Federal health care program beneficiaries. However, the physicians would not be required to prescribe the Company's drugs in return for the kiosks. The physicians would also neither pay the Company,
nor receive payment from the Company, for hosting the kiosks. The physicians could have the kiosks removed at any time.
Moreover, the questionnaires would not mention the Company's drug
products or contain any advertisements or incentives for using the
kiosks. However, the kiosks would carry a
small image of the Company's logo with wording similar to "brought to
you by [Company]" and a footer on the printouts that would display the
Company's logo and a copyright notice. The Company would obtain the aggregate data from the kiosks,
but no individual identifying data.
The OIG examined the Proposed Arrangement under 2 possible kickback scenarios. However, after examining both scenarios, the OIG found that the Proposed Arrangement would not generate prohibited remuneration under the Federal anti-kickback statute.
First, the OIG considered whether there would be a potential kickback from the Company to the patient users of the kiosks to induce them to self-refer to the Company's drugs. Since the kiosks would only provide a printout reprising the questionnaire and each patient's answers and not offer incentives for using the kiosks, the OIG found that the Proposed Arrangement would not provide anything of value to the patients and not implicate the Federal anti-kickback statute. However, the OIG noted that its conclusion would most likely be different if the kiosks were used to communicate offers of remuneration to patients (e.g., coupons, gifts or services).
Second, the OIG considered whether there would be a potential kickback from the Company to the participating physicians to induce them to prescribe the Company's drugs. However, the OIG found that the kiosks would "amount to little more than high-tech interactive brochures" and have no independent value to the physicians. The OIG pointed out that the kiosks would remain the property of the Company, physicians would not receive any space rental, utilities fees or other compensation, and found that the kiosks would not influence prospective patients to select a particular physician.
For the same reasons that the Proposed Arrangement would not generate prohibited remuneration under the Federal anti-kickback statute, the OIG concluded that the Proposed Arrangement would not violate the prohibition against beneficiary inducements.