WILL ‘GUIDELINES’ PROTECT YOU AGAINST MALPRACTICE RISK?
In order to win in a medical malpractice case against a physician, a plaintiff must prove that the physician owed the patient a duty, that the physician breached the duty, and that the physician’s breach in duty caused the patient to suffer damages. A key aspect in a vast majority of malpractice litigation involves whether a physician breached a duty to a patient, which plaintiff attorneys call negligence.
There are many ways in which litigants can demonstrate what a physician’s duties were (the “standard of care”) and whether the physician lived up to those duties.
What’s the Standard of Care?
Expert witness testimony is the most common method by which malpractice litigants try to prove whether the standard of care was met. An expert reviews a patient’s medical records and then, on the basis of the expert’s knowledge and experience, the expert renders an opinion regarding the appropriateness of the patient’s medical care.
Adherence to guidelines is another method by which litigants may attempt to prove whether a physician met the standard of care. Guidelines are generally not admissible as evidence in medical malpractice litigation without an expert’s testimony that the guidelines apply to the issues in the case. For example, in Shell v. St. Francis Medical Center Inc (48613-CA, La. App. 2 Cir., 2013),[1] the Louisiana Court of Appeals held that guidelines regarding treatment of a spider bite were insufficient to establish the standard of care for managing an abscess and were also insufficient to show how alleged deficiencies in treatment may have caused the patient’s injuries, stating, “this is not a case where medical expert testimony was not needed.”
Similarly, in Laskowski v. US Dept of Veteran’s Affairs (918 F. Supp.2d 301 (2013)),[2] the federal court focused on expert testimony about applicability of institutional guidelines before ruling that the standard of care required clinicians treating post-traumatic stress disorder to be familiar with treatment guidelines and only to deviate from them for compelling reasons.
Although guidelines may help guide diagnosis and treatment of disease, their use is not limited to clinical purposes. Guidelines may also be used by insurance companies to approve or deny payment. The nuances in the underlying purpose of guidelines highlight the importance of examining the intent of guidelines before offering them as evidence in a medical malpractice case.
HOW DO PAYMENT GUIDELINES AFFECT A MALPRACTICE CASE?
Insurance companies, including Medicare and Medicaid, routinely create medical treatment guidelines that are payment oriented. For example, Medicare guidelines require a 3-day hospital admission before Medicare will cover the costs of rehabilitative services. Commercial insurance guidelines often require preapproval before insurance companies will pay for certain procedures. If you order an MRI without obtaining preauthorization, the patient may be forced to pay for the test—if the test is performed at all.
While it’s unlikely that such payment guidelines would be used as evidence of wrongdoing in a malpractice trial, other payment-related guidelines can be relevant to medical malpractice cases. If a clinician fails to document two aspects of a patient’s past social and family history, a high-complexity visit cannot be billed under Medicare’s payment guidelines.
 |
In most cases, failing to document a patient’s past family history would be unlikely to increase risk during a medical malpractice case. However, an expert could easily testify that a failure to inquire about a family history of heart disease would have caused a physician to underestimate a chest pain patient’s risk of having a heart attack.
Plaintiff attorneys may also try to inappropriately use payment guidelines as proof of medical negligence. Consider, for example, the list of “never events” initially created by the National Quality Forum and later adopted by the Centers for Medicare & Medicaid Services (CMS). The most recent iteration of these “never events” includes serious injuries to mothers or neonates during low-risk labor and delivery, any injuries due to patient falls, development of stage 3 or 4 decubitus ulcers, and perioperative deaths in low-risk patients.[3] Prior iterations of the list classifiedClostridium difficile infections and postoperative deep venous thromboses as “never events.” While some of the events on the list, such as wrong-site surgeries, should legitimately never occur, under Section 5001(c) of the Deficit Reduction Act, the stated purpose of the list was to reduce healthcare expenditures under the Social Security Act.
During malpractice litigation, a plaintiff attorney could try to assert that violation of payment guidelines constitutes proof of improper care, thereby using payment guidelines to increase a practitioner’s malpractice risk. For example, a plaintiff’s attorney might allege that because perioperative patient deaths are considered a “never event” by CMS, perioperative patient deaths should “never” occur and a patient’s death after surgery therefore constitutes per se negligence. Should this type of argument be raised, defendants and their attorneys should be quick to point out that payment guidelines were created for entirely different purposes than clinical practice guidelines and that payment guidelines were never intended to create a clinical standard of care.
What About Clinical Practice Guidelines?
There are more than 2500 guidelines related to diseases and thousands more guidelines related to treatment of diseases, according to a review of the National Guideline Clearinghouse.[4] Clinical practice guidelines may be used by either party in a medical malpractice lawsuit.
Plaintiffs may try to demonstrate that a physician was negligent for failing to follow a clinical practice guideline, while defendants may use adherence to guidelines as evidence that the standard of care was met. Unfortunately, in some cases, clinical practice guidelines are not based on the strongest evidence, and in other cases, medical technology tends to advance rapidly, potentially making some guidelines inapplicable or even harmful to patients.
It is therefore important to use clinical practice guidelines as outlines of general care that may change based on current medical research, and not as stringent datasets that necessarily define the standard of care. Examples of several types of clinical guidelines and how they may affect a physician’s medical malpractice risk are discussed below.
CHOOSING WISELY CAN BOTH HELP AND HARM
The Choosing Wisely® initiative is one example of clinical practice guidelines that have the potential to both help and harm physicians accused of medical malpractice. The Choosing Wisely campaign was created by the ABIM Foundation to challenge medical specialty organizations to create a list of tests or procedures that can be used to “spark discussion” between patients and physicians regarding the utility of the tests.
In determining whether Choosing Wisely guidelines will protect physicians from a medical malpractice lawsuit, the basis for the guidelines and the research behind the guidelines need to be considered. Some Choosing Wisely guidelines are straightforward and appropriate. For example, the American Academy of Orthopaedic Surgeons recommends that patients with osteoarthritis of the knee stop taking glucosamine and chondroitin. There is simply no reliable evidence that these supplements improve symptoms in patients with osteoarthritis of the knee.
However, many other Choosing Wisely guidelines subject practitioners to a low but significant risk of missing serious diseases if the guidelines are followed. Consider, for example, the American College of Physicians (ACP) recommendation to avoid imaging in patients with nonspecific low back pain. This recommendation was based on a joint clinical practice guideline from the ACP and the American Pain Society that had only moderate-quality evidence.
While a vast majority of patients with nonspecific back pain will have no serious cause for their symptoms, about 130,000 of the 19 million outpatient visits for back pain each year will have symptoms caused by cancer; about 1900 back pain visits will be due to a spinal infection, and about 7600 back pain visits will be caused by cauda equina syndrome. Many of the patients with each of these dangerous conditions will present with “nonspecific” back pain; a recommendation not to perform imaging that goes against a physician’s clinical judgment under such circumstances could prove catastrophic to patients.
Similarly, the American College of Radiology’s Choosing Wisely recommendation not to perform CT scanning on patients with low pretest probability of pulmonary embolism will result in missing between 0.1% and 4.8% of pulmonary emboli. Up to one third of patients with missed pulmonary emboli will die from their condition.
On one hand it may provide some protection from malpractice risk if a defendant physician is able to show that the utility of a test was questioned under the Choosing Wisely initiative. However, when a diagnosis is missed because a physician chose to follow a Choosing Wisely guideline, there are multiple arguments that a plaintiff’s expert could use to counter the defendant physician’s assertions.
Perhaps the patient’s symptoms did not fit entirely within the guideline’s vague parameters (eg, the back pain was not “uncomplicated” or the patient was not “low-risk” for pulmonary embolism). Perhaps the guideline itself was based on less than adequate evidence or on studies that have since been disproven. Or perhaps the expert could show that the intent of Choosing Wisely guidelines was to encourage discussion between physicians and patients rather than to completely recommend against testing.
The disclaimers contained in Choosing Wisely guidelines, such as “use of this report is at your own risk” and “the ABIM Foundation … [is] not liable for any loss, injury, or other damage related to your use of this report,” also seem to show the ABIM Foundation’s acknowledgement that the guidelines in its own initiative will not insulate practitioners from liability when a diagnosis is missed.
Choosing Wisely guidelines could also increase malpractice risk for physicians under certain circumstances. Suppose, for example, that a patient has an anaphylactic reaction to intravenous contrast during a CT scan and suffers an adverse outcome. A Choosing Wisely guideline advising against performing a CT scan for the patient’s symptoms or diagnoses could provide a compelling argument that it was negligent to perform the test which caused the patient’s adverse outcome.
HOW INTENTLY SHOULD YOU FOLLOW PROFESSIONAL ASSOCIATION GUIDELINES?
As with Choosing Wisely recommendations, guidelines promulgated by professional medical associations can be a valuable source of information for medical treatment decisions. Such guidelines are often researched and vetted by experts before being published, and compliance with professional association guidelines can be used during a malpractice case to show that a physician’s treatment was within the standard of care.
However, just as with other types of guidelines, failing to comply with a guideline’s recommended courses of action may infer that a physician negligently managed a patient’s condition. Before deciding to rely on guidelines from professional medical associations, it is wise to review the studies and evidence supporting those recommendations. In some instances, even “strong” guidelines have been based on inappropriate data which, in turn, needlessly increases a physician’s potential medical malpractice risk.
Consider the 2013 guidelines for use of intravenous thrombolytics in the management of acute ischemic stroke, developed in a collaboration between the American Academy of Neurology and the American College of Emergency Physicians (ACEP).[5]
These guidelines gave the highest “Level A” recommendation for administering intravenous thrombolytics in patients suffering from an acute ischemic stroke, meaning that the guidelines represented “Generally accepted principles for patient management that reflect a high degree of clinical certainty (i.e., based on strength of evidence Class I or overwhelming evidence from strength of evidence Class II studies that directly address all of the issues).”
However, of 12 high-quality trials regarding thrombolytic use in stroke, two studies showed patient benefit, six studies showed no benefit, and four studies showed increased patient harm (including increased rates of mortality and intracranial bleeding).[6] A public outcry by emergency physicians after the publication of the thrombolytic guidelines caused the ACEP Board to open the guidelines for comment on ACEP’s website, but the results of the comments were never made public and the policy was never rescinded. A poll of readers in Emergency Physicians Monthly showed that 88% of respondents believed that ACEP’s thrombolytic guidelines needed to either be rescinded or revised to reflect the current standards of care.[7][Disclosure: Dr Sullivan is a senior editor atEmergency Physicians Monthly.] In addition, after the guidelines were published, an article in theBritish Medical Journal noted that several of the guideline authors failed to disclose their associations with the manufacturer of the thrombolytic being used in the guidelines.[8]
Despite a strong “Level A” recommendation from several professional organizations, these stroke guidelines showed potential harm to patients and continue to be questioned by most practicing physicians.
THE VALIDITY OF CMS QUALITY INDICATORS
CMS has created a Hospital Compare website wherein consumers can review how well hospitals have met certain quality guidelines chosen by CMS. Again, although many of these guidelines are based on sound medical practice, other CMS guidelines have the potential to increase a physician’s medical malpractice risk.
For example, in November 2005, a study of 45,852 patients in the COMMIT trial[9] showed that subacute administration of metoprolol in patients with acute myocardial infarction decreased subsequent reinfarction and ventricular fibrillation. However, the same study showed that early metoprolol administration in acute myocardial infarction significantly increased the incidence of cardiogenic shock.
Despite these findings, CMS continued ranking hospitals lower on its Hospital Compare website when hospitals did not follow CMS guidelines to provide beta-blockers on arrival to patients suffering from acute myocardial infarctions. Clinicians were then put in the unenviable position of either prescribing a medication during a timeframe that was proven to cause patients to have worse outcomes or to have their hospitals labeled as providing inferior care if they refused to follow CMS guidelines in prescribing the medication.
Fortunately, CMS retired this quality guideline. However, CMS continues to create additional quality guidelines that also may have negative clinical consequences. For example, the CMS guideline that all pneumonia patients have blood cultures performed before receiving an initial dose of antibiotics may delay administration of antibiotics, significantly increases the cost of care, and seldom has an effect on a patient’s outcome. Negative cultures do not exclude a bacterial pneumonia, while positive cultures infrequently change treatment. In addition, CMS Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) guidelines such as those suggesting that a patient’s pain should “always” be well controlled will probably only aggravate the current opiate abuse epidemic while subjecting physicians to allegations of low-quality care when a patient’s subjective expectations are not met.
Although clinical practice guidelines generally provide a good summary on evaluation and treatment of medical conditions that can decrease a practitioner’s liability when followed, not all clinical practice guidelines are appropriate. The potential conflict between clinical practice guidelines or “quality measures” and generally accepted medical care underscores the need to review the research and studies supporting the guidelines, and to compare the guidelines with current literature when deciding whether the guidelines constitute appropriate medical practice— for purposes of both clinical care and malpractice litigation.
SAFE HARBORS ARE MEANT TO PROTECT
Safe harbors are legislative guidelines created to protect practitioners from lawsuits. The theory behind safe harbors is that physicians often order low-yield testing to avoid being sued for either missing an uncommon diagnosis or for missing an uncommon presentation of a more common diagnosis.
If a medical guideline used in a safe harbor recommends certain medical care and the physician follows that guideline, the safe harbor statute would prevent the physician from being sued if a bad outcome occurs. Presumably, safe harbors decrease the amount of “defensive medicine” currently being practiced while at the same time standardizing management of patients.
In the past, several states have created pilot projects to determine whether adherence to statutory practice guidelines would have any effect on medical malpractice cases. One of the first such projects was Maine’s Medical Liability Demonstration Project (Me. Rev. Stat. Ann. Title 24 2971-2979 [repealed]).[10] In this program, medical advisory committees created practice guidelines applicable to four specialties. Anesthesia guidelines included preoperative lab testing, proper documentation, and intraoperative monitoring. Emergency medicine guidelines highlighted when to obtain cervical spine x-rays in trauma patients and the procedure used to transfer patients to other hospitals. Obstetrical guidelines included when to perform cesarean sections with failure to progress, and how to manage intrapartum fetal distress. Radiologic guidelines addressed screening mammography and antepartum ultrasounds.
If a physician chose to participate in the program and was later sued for medical care relating to the guidelines, the physician would be able to use the adherence to the guidelines as an affirmative defense in a medical malpractice case, essentially making the physician immune from liability. The Maine project continued for nearly 10 years but was eventually repealed after a review of the data from the project showed no medical malpractice cases in which the affirmative defense was used, and showed that there was no significant effect on malpractice costs or on the number of malpractice cases filed in the state.
The number of malpractice payments per year in Maine was unfortunately low, making it difficult to determine whether low sample size may have had an effect on the results. However, National Practitioner Databank data show that the number of medical malpractice payments in Maine increased from 35 per year during the 10 years that the project was in effect to 43 per year in the 10 years after the project was discontinued, a 23% increase.
The appeal of using statutory guidelines as a safe harbor is that, for purposes of a medical malpractice action, it is difficult for an expert witness to allege that the physician was negligent if the physician adhered to the statutory guidelines. Without an allegation of negligence, the physician is protected from legal liability because negligence is a prerequisite for a medical malpractice action. However, the adverse impact of using statutory guidelines as a standard of care is that failure to include one minor aspect of a long safe harbor checklist may cause the physician to lose immunity under the statute. If physicians become more concerned with checking statutory requirements than with providing a reasoned patient evaluation, it may raise a concern as to whether “checkbox” medicine is truly in the best interest of the patients.
In addition, any medical treatment that deviates from the statutory guidelines may create an inference that the physician’s actions fell outside the standard of care. The Maine Medical Liability Demonstration Project specifically considered this issue by prohibiting plaintiffs from using a practitioner’s deviation from the guidelines as evidence during litigation.
THE LATEST DEVELOPMENTS
Congress is currently poised to revisit safe harbors with the Saving Lives, Saving Costs Act (H.R. 4106) sponsored by Representative Andy Barr from Kentucky.[11] Under the Act, professional organizations would submit clinical practice guidelines to the Secretary of Health and Human Services who then selects guidelines to be used under the Act and publishes the guidelines online. If an eligible physician alleges that a patient’s care adhered to an applicable clinical guideline under the Act, the physician may transfer a state malpractice action into federal court, where the case will be reviewed by a three-physician independent medical review panel.
Favorable findings of the review panel can be used as a basis to dismiss a claim against the physician. If a plaintiff pursues a case against a physician after a review panel finds in the physician’s favor and the physician subsequently wins the case, the plaintiff may be forced to pay for the physician’s costs and attorney’s fees.
Summary
Guidelines are created for many purposes. The intent of a guideline significantly affects whether the guideline will protect a physician against medical malpractice risk. Guidelines relating to payment issues should not be used for clinical or medicolegal purposes without strong clinical research supporting their conclusions. While clinical practice guidelines may be useful for both clinical and medicolegal purposes, the recommendations should be compared with current medical literature to determine whether the guidelines constitute appropriate medical care.
Statutory guidelines and safe harbors significantly reduce a practitioner’s malpractice risk and also provide a strong deterrent to frivolous lawsuits. However, the decreased risk must be weighed against the inference of negligence that occurs if a statutory guideline is not followed, and against the potential transition of medical practice from a healing art to an exercise in checking all of the appropriate boxes to avoid liability.
The most judicious use of guidelines is to treat them as general outlines subject to change as our knowledge of medicine evolves, rather than as strict directives of medical diagnosis and management.