'Defensive' ordering of procedures, tests can increase your legal risks
Patients might be harmed and sue
If physicians order diagnostic tests or procedures believing that "defensive" medicine will protect them legally, they might find themselves named in a malpractice suit as a result, warns Kathryn Wire, JD, MBA, president and principal consultant at Kathryn Wire Risk Strategies, a St. Louis, MO, firm specializing in healthcare risk management and former director of risk and claims for two St. Louis health systems.
"There is no such thing as a benign medical procedure," says Wire. "I had a patient death from post-biopsy sepsis at a hospital where I was working last year. It happens." Any invasive process carries the risk of infection, radiology procedures radiate the patient, contrast material poses the risk of a reaction, and all medications have some risk, she adds.
"If a side effect or complication occurs as the result of an unnecessary procedure or test, the 'unavoidable' defense is lost," Wire says. "The negligence is the ordering of unnecessary care knowing that it involved risk, and the damages are the side effect or other injury."
Long-term epidemiological studies are beginning to suggest increased risks of cancer due to use of CT scans, many of which are unnecessary, she notes. "Unless there is a complication, the plain professional liability risk is minimal," Wire says. "But if a complication occurs, the physician will have exposure for ordering an unnecessary test or procedure."
Larry Burnett, RN, MS, managing director of Chicago-based Huron Healthcare, says, "We are likely to see physicians pay more attention to identifying and addressing over-utilization, as part of a comprehensive risk management strategy."
There is emerging recognition that unnecessary tests are not only wasteful, but also can lead to unnecessary risk of harm to patients, he explains. "Examples could include bleeding, infection, embolic stroke and death from unnecessary cardiac catheterization, and allergic reactions or kidney failure from intravenous contrast given for imaging procedures," he says.
Scott Martin, JD, a partner with Husch Blackwell in Kansas City, MO, has represented many providers against allegations that they did not order sufficient testing. "The rationale for not performing additional tests ranges from medical necessity, to test availability, to the inherent risks associated with the test," he explains.
Wire says that she is unfamiliar with any cases in which the ordering of an arguably unnecessary test formed the basis of a claim, "but that factor has been a significant consideration in my decision to settle cases in which the plaintiffs had other allegations."
Duty to evaluate results
Once the test results are received, the physician generally has a separate duty to evaluate and respond to the information, notes Martin. One of his partners recently defended a case involving a biopsy of the pancreas that was interpreted as strongly suggestive but not positive for cancer, which alleged that the subsequent surgery was not necessary because the patient did not have cancer.
"This led to a very extensive Whipple surgery where no cancer was found. The patient sued for postop complications," says Martin. "The plaintiff argued that additional biopsy specimens should have been obtained."
The defense showed that a false positive biopsy interpretation occurs about 10% of the time, without negligence, and doing additional biopsies was not the standard of care, reports Martin. A defense jury verdict was affirmed by Missouri Court of Appeals.1
Radiology studies might reveal patient conditions that might not have been considered by the ordering physician. "In the event that any suspicious or abnormal finding is not reported, that could result in a claim," says Martin. "Unfortunately, plaintiff's experts have the ability to retrospectively review these studies while usually knowing the outcome."
Physicians should carefully explain all aspects of a diagnostic test before obtaining the patient's written consent and should highlight the fact that the patient has a right to refuse the test, advises Elizabeth E. Trende, JD, an attorney at Squire Sanders in Columbus, OH.
The federal government has heightened its scrutiny of billing patterns in recent months to address fraud in the healthcare system, and physicians who order diagnostic tests in excess of statistical norms can expect to be scrutinized, no matter how well-intentioned their efforts, adds Trende. "Become a good keeper of evidence," she recommends. "The reasoning behind your test order may be perfectly rational in your mind, and with the patient's best interests at heart. But you can't enter your good heart before a court of law."
Make every effort to thoroughly document your rationale for each test at the time it is ordered, says Trende. "If you think your position might be reinforced through the opinion of another physician in your group practice, get it in writing," she advises. (See related story, below, on what puts physicians at risk for anti-fraud violations.)
- Kaplan, et al. v. Johnson et al., Case No. WD74369. Missouri Court of Appeals, Western District, 2011.
For more information on liability risks of "defensive" medicine, contact:
- Brian Bewley, JD, Partner, Husch Blackwell, Kansas City, MO. Phone: (816) 983-8261. Fax: (816) 983-8080. Email: Brian.Bewley@huschblackwell.com.
- Zack Buck, JD, Visiting Assistant Professor, Seton Hall University School of Law, Newark, NJ. Phone: (973) 642-8088. Email: email@example.com.
- Scott Martin, JD, Partner, Husch Blackwell, Kansas City, MO. Phone: (816) 283-4678. Email: Scott.Martin@huschblackwell.com.
- Elizabeth E. Trende, JD, Associate, Squire Sanders, Columbus, OH. Phone: (614) 365-2700. Fax: (614) 365-2499. Email: Elizabeth.Trende@squiresanders.com.
- Kathryn Wire, JD, MBA, Kathryn Wire Risk Strategies, St. Louis, MO. Phone: (314) 540-4910. Email: firstname.lastname@example.org.
Are you over-ordering? Anti-fraud violations possible
Over-ordering scans or tests, or even "over-treating" generally, can subject physicians and other providers to major liability through the False Claims Act and other anti-fraud statutes, warns Zack Buck, JD, a visiting assistant professor at Seton Hall University School of Law in Newark, NJ.
"The 'kyphoplasty initiative,' in which the government has settled with 40 hospitals over the last three years, is one example of the government going after hospitals who have allegedly administered medically unnecessary procedures," he adds. (For more information on the settlements, go to http://1.usa.gov/wPZBSx.)
With the ever-growing costs of federal healthcare programs, the government has recently increased its anti-fraud efforts quite substantially under the Obama administration, and it will continue to do so, he says.
"If physicians are administering unnecessary tests, they can trigger False Claims Act liability, which is a severe, blunt statute with mandatory statutory penalties, if they are billing the federal government through Medicaid or Medicare for those unnecessary tests," says Buck.
If diagnostic tests are reimbursable under Medicare and Medicaid, and if the government believes that the tests were not medically necessary, the government can pursue civil and criminal legal actions against the physicians that ordered the tests, says Brian Bewley, JD, a partner at Husch Blackwell in Kansas City, MO.
On the civil side, the government's main enforcement mechanisms are the False Claims Act and the Office of Inspector General's Civil Monetary Penalties Law, he notes.1,2 Under both, the government can pursue a civil lawsuit against a physician who submitted claims for services that were not medically necessary.
"This could include claims for diagnostic tests," says Bewley. "If the government is successful, the consequences from a monetary perspective are pretty serious, including up to treble damages and even exclusion from participating in Medicare or Medicaid."
On the criminal side, the government can prosecute an individual for the same conduct by alleging healthcare fraud, which could mean jail time, says Bewley.
The government is increasingly relying on data mining to ferret out cases of over-treatment and/or fraud, adds Buck. "Some cases of over-treatment directly and clearly harm individuals," he says. "But any time a provider subjects a patient to an unnecessary procedure, the patient isn't getting care that meets the standard."