On December 14, 2007, the Department of Health and Human Services' Office of Inspector General (OIG) released OIG Advisory Opinion No. 07-16 (Advisory Opinion).
In the Advisory Opinion, a home health agency (Agency) inquired whether providing prospective orthopedic patients with free educational videos with instructions for postoperative home based convalescence (Arrangement) would constitute grounds for sanctions under the civil monetary penalty (CMP) provision prohibiting beneficiary inducements or violate the Federal anti-kickback statute and result in related sanctions.
Based on the facts presented, the OIG concluded that the Arrangement would not constitute grounds for the imposition of CMPs, and while the Arrangement could potentially generate prohibited remuneration under the Federal anti-kickback statute (if the requisite intent were present), the OIG concluded that it would not impose related sanctions.
According to the Advisory Opinion, the Agency provides home health care for postoperative total knee and hip joint replacement patients who are beneficiaries of Federal health care programs (e.g., Medicare and Medicaid programs). Orthopedic surgeons refer patients to the Agency for post-surgical care when the surgeon's office schedules the patients' operation. The surgeons have no financial or employment interest in the Agency and receive no remuneration in connection with the referrals.
The Agency follows up each referral with an initial telephone call. During the call, a patient is reminded of his or her right to opt for a different home health agency (HHA). At that time, preparations are also made to send the patient educational videos prior to surgery. The videos inform patients about the restrictions and physical limitations that post-surgical total joint replacement patients typically encounter during home based convalescence and advise patients on various issues (e.g., optimal furniture placement and sleeping and bathing arrangements).
However, the videos do not render medical advice or diagnoses. Instead, the videos advise patients to consult their individual doctors and physical therapists about the various issues addressed. Further, the Agency does not charge patients for the videos and they become the patients' to keep on receipt. The Agency reports that the videos have essentially no resale value and that patients are not required to view the videos in order to receive home health care services.
During the videos, viewers are invited to consider whether they may desire or need personal attendance during convalescence. At certain points in the videos, different individuals (identified as former patients) also speak about their own home convalescence. The videos do not contain substantive promotional claims. However, throughout the videos, small, transparent letters write out the Agency's name in the lower right hand corner of the screen.
In the Advisory Opinion, the OIG first considered whether the Arrangement would constitute grounds for imposing CMPs. In doing so, the OIG considered whether the videos are something of value to a patient that a provider knows, or should know, is likely to influence a patient's selection of a particular provider.
In considering whether the videos are something of value, the OIG examined whether the Agency's free educational videos constitute remuneration to a patient, and whether their value is more than nominal. The OIG also pointed out that it has previously taken the position that "incentives that are only nominal in value are not prohibited" and that the OIG has interpreted "nominal value to be no more than $10 per item, or $50 in the aggregate on an annual basis."
After examining the facts presented, the OIG concluded that a prospective patient is not likely to believe that he or she has received an item worth more than $10. In fact, the OIG noted that similar information is available on the Internet and from other public sources without charge. Nevertheless, the OIG found that it was not presented with firm evidence that the videos are worth no more than $10 (i.e., nominal value) to a prospective patient.
Since the OIG lacked conclusive evidence as to the value of the videos, the OIG proceeded to the next question in the CMP analysis. That is, whether the free educational videos are likely to influence a patient to select the Agency as a provider for postoperative items and services payable by Federal health care programs. The OIG concluded that the free videos were not likely to influence a patient's selection for a combination of reasons, including:
- patients do not receive the videos until after being referred to the Agency;
- it is probable that a surgeon's implicit endorsement of the Agency substantially informs the patient's choice;
- the videos' content is applicable to surgical patients regardless of which HHA a patient chooses, and that similar content is widely available without charge from other sources; and
- no individually personalized safety or health care recommendations accompany the videos.
Because the videos are unlikely to influence patient selection, the OIG did not consider whether the Agency knows, or should know, that the Arrangement is likely to influence patients' selection of a HHA.
However, the OIG did distinguish the Arrangement from offers by HHAs to provide free in-person and telephone preoperative home safety assessments for patients scheduled to undergo orthopedic surgery. The OIG considers such preoperative assessments to be more concerning than the free educational videos because such assessments are personalized, often performed by a physical therapist during a home visit or telephone call, typically give the impression that the assessment is a valuable service, and initiate a personal relationship between the patient and physical therapist. In fact, the OIG believes that such in-person and telephone assessments are likely to influence a patient's selection of a particular HHA as a service provider. See OIG Advisory Opinion No. 06-01.
Finally, for the reasons set forth above, the OIG concluded that the Arrangement is unlikely to be a vehicle to pay unlawful kickbacks to patients and, therefore, the OIG indicated that it would not impose sanctions on the Agency in connection with the Federal anti-kickback statute.