Important Radiology Advisory Opinion
On April 30th, the Office of Inspector General for the Department of Health & Human Services issued a new advisory opinion that has important implications for radiologists and operators of freestanding diagnostic imaging centers.

In this advisory opinion, several requestors submitted a request for guidance regarding a proposal by several imaging providers to offer free insurance pre-authorization services to patients and physicians.  The requestors (the "Imaging Providers") were (1) a not-for-profit hospital corporation and (2) a not-for-profit organization operating free-standing outpatient diagnostic imaging centers and urgent care centers, including the employment of physicians to work at the clinics and centers.   Interestingly, the OIG expressed no opinion regarding a distinction of the diagnostic imaging provider being for-profit vs not-for-profit in its analysis.  The ultimate conclusion of the OIG in this advisory opinion was that while the Proposed Arrangement could potentially generate prohibited remuneration under the anti-kickback statute, the OIG would not impose administrative sanctions on the requestors in connection with the Proposed Arrangement.

FACT SCENARIO:

Under the Proposed Arrangement, the Imaging Providers would institute a program to obtain any required pre-authorization from insurers for subject diagnostic imaging services provided at the Imaging Providers in the following manner. The Imaging Providers would establish a call center to receive calls from patients and the offices of referring physicians to request pre-authorization services. The call center’s services would be free and made available on an equal basis to all patients and referring physicians using the Imaging Providers without regard to any physician’s overall volume or value of expected or past referrals.

The call center would collect from physician offices and/or patients, and submit to insurers, documentation of medical necessity, and otherwise assist referring physicians and patients in assessing the sufficiency of such documentation. Call center personnel would identify themselves to insurers as representatives of the Imaging Providers and would disclose to insurers the nature of the program. The Imaging Providers would follow any rules, directions or requirements imposed by insurers. Requestors would provide each physician with a copy of all the information the call center submits to insurers to obtain pre-authorization for that physician’s patients, and it would make such documentation available to the Secretary of Health and Human Services upon request.  The opinion acknowledges that many insurance companies have different approval and pre-authorization process and different companies place this obligation on the referring physician, while others impose this obligation on the diagnostic imaging provider.

ANALYSIS:
The OIG begins its analysis by repeating, "The OIG’s position on the provision of free or below-market goods or services to actual or potential referral sources is longstanding and clear: such arrangements are suspect and may violate the anti-kickback statute, depending on the circumstances."   However, the OIG has often distinguished between a provider that offers free items and services that are integrally related to that provider’s services, and those that are not.  Based upon a long list of reasons explained, primarily focused upon safeguards inherent in such a process, the OIG indicated it would not impose administrative sanctions under the for arising under the anti-kickback statute on Requestors in connection with the Proposed Arrangement.  Among the issues deemed important in the OIG's analysis are the following:

1)  It believes the risk of fraud and abuse in such situations are low (based upon the facts described in the Advisory Opinion), but did describe other situations that could be problematic.   The situation would seem to be unlikely to be used as a system to reward referrals if applied uniformly, regardless of the volume or value of a referring physician's referrals.

2)  Certain safeguards in place to avoid abusive situations.

3)  The call center should operate transparently, as opposed to situations where a referral seeker wishes to place a staff member in a referring physician's office to help with pre-authorizations (which should be discouraged).

4)   Importantly, the Imaging Providers/Requestors have an significant business interest in making certain that the services they are providing do in fact get appropriately "pre-authorized" as required by various insurance plans.

The issue of pre-authorization services being provided by diagnostic imaging providers has long been debated in the radiology community.  This advisory opinion should be helpful is assisting providers in making legal and business judgments about these services.


As follows is a link to the Advisory Opinion text itself.   It is important to remember that Advisory Officials cannot be officially relied on as advice to the entire health care community and are binding only between the requestor of the advisory opinion and the OIG.  Nevertheless, the analysis offered by the OIG in this advisory opinion explains some of the rationale that might be considered relevant to analysis of any similar situations.  Facts and circumstances are important to any such analysis, as indicated in the attached.

http://www.oig.hhs.gov/fraud/docs/advisoryopinions/2010/AdvOpn10-04.pdf


Article authored by Dan Peters, J.D. of Husch Blackwell Sanders.