Victor R Cotton, MD, JD, is President of Law and Medicine, Hershey, Pennsylvania.
Douglas H Kirkpatrick, MD, is Past President of the American College of Obstetricians and Gynecologists and practices in Denver, Colorado.
Failure to recommend genetic testing could put doctors at risk
It has been more than a decade since the last malpractice crisis and, as the insurance market has stabilized, healthcare providers have benefited from stable-to- falling premiums. This same pattern of calm-after-the-storm was seen with the malpractice crises of the 1970s and 1980s, and on both occasions the respite was short-lived.
Although we do not know when the next crisis will appear or what form it will take, the millions of patients who meet criteria for cancer-related, genetic testing but who have not been tested represent an area of potentially overwhelming exposure.
The two main concerns are BRCA mutations and Lynch Syndrome. Approximately 1 in 400 persons carries a pathogenic, BRCA mutation. Affected women have a 50-70% lifetime risk of breast cancer and a 15% to 64% lifetime risk of ovarian cancer. Lynch Syndrome (hereditary non-polyposis colon cancer) is even more common, affecting 1 in 350 patients. These individuals face a 70% lifetime risk of colon cancer, along with elevated risks of endometrial, gastrointestinal and genitourinary cancers. For most of these patients, their genetic mutation and associated cancer risk is their most important healthcare issue.
Based on a population of 320 million people, there are nearly two million carriers of these mutations in the United States. For an average-sized primary care practice of 2,400 patients, this equates to six patients with BRCA mutations and seven patients with Lynch Syndrome.
Unfortunately, despite the presence of screening recommendations from multiple scientific entities and the increased awareness created by the actress Angelina Jolie’s revelation that she carried a BRCA mutation, the vast majority of these patients have not been tested and fewer than 5% have been identified. This is not only a public health concern, it is a medical-legal powder keg.
Because it takes time for lawsuits to progress through the legal system, published opinions related to genetic testing are just starting to appear. A Connecticut case, Downs v. Trias, involved a 48-year-old mother who met criteria for BRCA analysis. Unfortunately, her physician failed to appreciate this and the patient went untested. She subsequently developed ovarian cancer, was found to be BRCA positive and sued her physician, alleging that timely genetic testing would have allowed her to undergo prophylactic surgery and thereby avoid ovarian cancer. At trial, the jury awarded her $4 million, an amount that was upheld on appeal.
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This type of lawsuit is problematic in several ways. First, because genetic testing of at-risk individuals is currently recommended by multiple organizations (e.g., USPSTF, ACOG, ASCO and ACS), it is difficult to defend a physician who does otherwise, especially given the severity of the potential consequences.
Second, because these cases usually involve serious injury or premature death from a preventable cancer, they are expensive to settle. Finally, because the mutations are relatively common, the overall cost quickly becomes unmanageable.
Assuming there are two million carriers of pathogenic BRCA and Lynch Syndrome mutations in the United States, it is likely that, without intervention, at least one million of them will eventually develop cancer. Although most of these one million patients are not presently aware that they carry a pathogenic mutation, they will almost certainly learn so once they are diagnosed with cancer.
At that point, the only question is: How many of them will piece the puzzle together and file a lawsuit. If we assume that the number is just 5% and conservatively estimate an average indemnity payment of $2 million for each case, the potential liability is $100 billion (50,000 lawsuits times $2 million per lawsuit).
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For comparison, the total annual premium collected by the malpractice insurance industry in the United States is just $15 billion, and most of that money is already allocated to other cases.
Fortunately, clinicians can avert this potential crisis with the most basic of clinical tools-obtaining a family cancer history with attention to the criteria in the accompanying tables. To facilitate the process, most of the information can be gathered by physician extenders or provided directly by the patient using an electronic interface to the medical record.
Because there is significant overlap between the cancers caused by the various genetic mutations, most at-risk patients are best served by undergoing a “panel test,” which simplifies the process for the physician and identifies twice as many pathogenic mutations as single-gene testing for BRCA or Lynch Syndrome.
The Affordable Care Act requires insurers to provide coverage for both BRCA and Lynch Syndrome testing at no cost to the patient. And in most cases, the added cost to the patient for a full panel test is nominal. Patients who test positive for a pathogenic mutation can be referred for further evaluation while those who test negative can be provided with the appropriate reassurances.
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While the genesis of the next malpractice crisis is difficult to predict, the millions of patients who meet criteria for genetic testing but who have not been tested represent a level of financial exposure that could overwhelm the insurance industry. Fortunately, most of this exposure is within the control of primary care physicians.