SVU

The Growing Flap Over Preliminary Interpretations
By Bill Sarraille, J.D, Arent, Fox Law Firm, Washington, DC

The practice of technologists providing preliminary interpretations has come under attack as potentially involving "fraud and abuse." A commonplace and pervasive practice, preliminary interpretations have become the source of allegations that are leading to the filing of actions under the Federal Civil False Claims Act. A review of the issues surrounding preliminary interpretations shows how a well-accepted clinical practice can have completely unforeseen legal and regulatory implications.

By virtually all accounts, the practice of a technologist providing preliminary interpretations to the interpreting physician, the treating physician or both is so common as to constitute the standard of practice for technologists in the United States. The American Registry of Diagnostic Medical Sonographers, working in concert with the Society of Vascular Technology and other groups, has, through different surveys, demonstrated that technologists and sonographers provide preliminary interpretations between 65 and 85 percent of the time.

To understand how this accepted practice has suddenly become a hot "fraud and abuse" issue, we need to review the critical points of the Federal Civil False Claims Act. Under that statute, which has a criminal law corollary provision, it is a civil offense for "any person" to "knowingly" file a false claim with the United States (including any federally-funded health care program) or to "cause" a false claim to be filed. Where a violation of the False Claims Act occurs, the defendant is obligated to pay up to three times the actual damages, plus as much as $10,000 per claim in penalties. Under the "whistleblower" provision of the False Claims Act, any person may file a False Claims Act case on behalf of the United States and may receive as much as 30 percent of any resulting recovery. With this kind of powerful financial incentive, the number of health care-related whistleblower cases increased by 1,200 percent in one recent five year period.

In the vast majority of cases where a preliminary interpretation is produced (either orally or in writing), the interpreting physician will review either still or video films and dictate a separate interpretation from the preliminary interpretation generated by the technologist. In cases such as these, there is no potential for False Claims Act liability.

However, in at least some cases, the use of preliminary interpretations by some physicians appears to deviate from this kind of conservative approach. In some cases, the interpreting physician may, as a routine matter, simply sign a preliminary written report generated by a technologist, with or without ever reviewing the underlying video or still films for the study. In other cases, the interpreting physician may simply redictate the preliminary interpretation supplied by the technologist without any changes. Again, this may be done with the benefit of the physician's review of still or video films or without benefit of such a review. In these cases, the practice of providing preliminary interpretations can raise issues under the False Claims Act.

Here's how. When an ultrasound service is provided, two charges are generated to the Medicare program or other applicable federally-funded health care program. One is for the technical component of the service, and the other is for the professional component of the service, which is for the interpretation of the ultrasound study. If a Medicare carrier or other payor comes to believe that a professional component service has been billed, but no interpretation was actually performed by the physician, the carrier or payor will conclude that a false claim has been filed.

There is little guidance from Medicare as to what constitutes an "interpretation." However, the Medicare program has stated that physician services are those that do not involve "the interposition" of other persons. Based on this, the Medicare program appears to be increasingly taking the position that physician interpretations that are "dependent" on preliminary interpretations involving technologists are not a physician service. The reasoning seems to be that the "interposition" of the technologist is not permissible, since the act of "interpreting" a study constitutes, in the eyes of the Medicare program, the practice of medicine.

Clearly, it is difficult to imagine a strong defense where a physician "interpretation" has been billed for, but the physician has not actually reviewed the underlying stills or video. There have been a number of cases in which physicians who submitted hundreds or even thousands of interpretation services to Medicare and other payors could not even explain the meaning or importance of particular values contained on "their" interpretations. In such a case, the government would likely be able to argue with force that a false claim was knowingly submitted.

The more difficult situation to assess is when the evidence indicates that the interpreting physician did, in fact, review either stills or video, but that the physician either signed a report drafted by a technologist or redictated the technologist's report without any changes whatsoever. The issue becomes more difficult when the physician essentially never deviates from the technologist's preliminary reports in his or her interpretations.

On the one hand, a strong argument can be made that there is not anything improper or inappropriate in situations such as this. If the physician has reviewed either stills or video, a physician interpretation has occurred. By reviewing the stills or video, there is arguably no "interposition" of another person between the physician and the study being interpreted. Even if a physician reviews and signs a draft report prepared by a technologist in a case such as this, the physician is necessarily making the draft report his or her "own" by reviewing it. To the extent that a physician rarely deviates from a draft report, that fact may only suggest that the preliminary report is being prepared in a competent fashion.

With all this said, however, we have to understand that a contrary argument can be made. A suspicious or skeptical person reviewing this kind of fact patten might conclude that, where few or no changes are ever made to preliminary reports by the interpreting physician, the "preliminary" report is effectively the "real" interpretation. Accordingly, the argument might be made that a physician interpretation did not occur and may not be billed.

This is not a hypothetical issue. There have been a number of cases that have rested on allegations just like these. Several cases raising these issues are pending even as this article is written. In the face of this kind of information, the temptation for some technologists who provide preliminary reports that may not, in fact, be "preliminary" is to try and convince themselves that they need not be concerned. As one technologist told me recently, "I'm not submitting a false claim, after all, right?"

Well, it just is not that simple. The Federal Civil False Claims Act makes it a violation of law for any person, not only to "submit" false claims, but to "cause" a false claim to be submitted. If a technologist contributes to a series of actions that lead to the submission of false claims, then the technologist himself or herself could have liability under the False Claims Act. Fortunately, as a practical matter, technologists are rarely pursued under a False Claims Act theory, but that does not in any way negate the legal and ethical obligation of technologists to ensure that their actions are appropriate in all respects.

So, the question that I am asked is how can this risk be managed appropriately? In many ways, I am not the right person to answer this question, simply because I am not a clinician. Ultimately, what is appropriate and what is not appropriate is dictated by how clinicians would delineate the scope of practice of a physician and the scope of practice of a technologist.

I can offer some suggestions about how to decrease the likelihood that a preliminary report will be viewed as something inappropriate by laymen, like the government attorneys and agents who have used the Federal False Claims Act so effectively. The first two observations are so obvious that hardly anyone would disagree with them. Interpreting physicians must, in every case, review either stills or the video. Further, because whistleblowers have a powerful financial incentive to trust or misread the facts, interpreting physician reviews of stills or video must be documented. For stills, the best way to do that is to have the interpreting physician sign and date the stills and to maintain those stills in the medical record. For video, interpreting physicians should document their review of a video in a log book.

Next, I believe it is important for preliminary reports to be called reports and not interpretations. Further, report language should be organized differently on a form than the final physician interpretation. I would also recommend limiting preliminary reports to phrases, as opposed to complete sentences, so that an interpreting physician is forced to dictate his or her own interpretation.

Preliminary interpretations are an important and evolving issue. It should be an issue that is widely and thoughtfully debated within the ultrasound community.

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