Clinical Psychiatry News is pleased to announce the addition of two new Editorial Advisory Board members.

Pooja Lakshmin, MD, is a board-certified psychiatrist specializing in women’s mental health and perinatal psychiatry, and a clinical assistant professor of psychiatry at the George Washington University, Washington. She maintains a private practice in Washington and is a clinical supervisor in the university’s Five Trimesters Perinatal Psychiatry Clinic. She is passionate about empowering women through psychoeducation and advocacy. She takes an integrative approach to psychiatry and frequently writes about topics related to women’s mental health, maternal mental health, and self-care.

Steven Starks, MD, a geriatric psychiatrist, is a congressional fellow at the Health and Aging Policy Fellows Program in Washington. Dr. Starks, a representative to American Psychiatric Association assembly for the APA Caucus of Black Psychiatrists, is keenly interested in understanding the cultural and social effects of geriatric mental health conditions on the lives of patients and families. Previously, Dr. Starks served as an assistant professor in the Baylor College of Medicine Menninger department of psychiatry and behavioral sciences, and in the department of neurology, Houston. He also was a faculty member at Baylor’s Alzheimer’s Disease and Memory Disorder Center.

Clinical Psychiatry News is pleased to announce the addition of two new Editorial Advisory Board members.

Pooja Lakshmin, MD, is a board-certified psychiatrist specializing in women’s mental health and perinatal psychiatry, and a clinical assistant professor of psychiatry at the George Washington University, Washington. She maintains a private practice in Washington and is a clinical supervisor in the university’s Five Trimesters Perinatal Psychiatry Clinic. She is passionate about empowering women through psychoeducation and advocacy. She takes an integrative approach to psychiatry and frequently writes about topics related to women’s mental health, maternal mental health, and self-care.

Steven Starks, MD, a geriatric psychiatrist, is a congressional fellow at the Health and Aging Policy Fellows Program in Washington. Dr. Starks, a representative to American Psychiatric Association assembly for the APA Caucus of Black Psychiatrists, is keenly interested in understanding the cultural and social effects of geriatric mental health conditions on the lives of patients and families. Previously, Dr. Starks served as an assistant professor in the Baylor College of Medicine Menninger department of psychiatry and behavioral sciences, and in the department of neurology, Houston. He also was a faculty member at Baylor’s Alzheimer’s Disease and Memory Disorder Center.

Clinical Psychiatry News is pleased to announce the addition of two new Editorial Advisory Board members.

Pooja Lakshmin, MD, is a board-certified psychiatrist specializing in women’s mental health and perinatal psychiatry, and a clinical assistant professor of psychiatry at the George Washington University, Washington. She maintains a private practice in Washington and is a clinical supervisor in the university’s Five Trimesters Perinatal Psychiatry Clinic. She is passionate about empowering women through psychoeducation and advocacy. She takes an integrative approach to psychiatry and frequently writes about topics related to women’s mental health, maternal mental health, and self-care.

Steven Starks, MD, a geriatric psychiatrist, is a congressional fellow at the Health and Aging Policy Fellows Program in Washington. Dr. Starks, a representative to American Psychiatric Association assembly for the APA Caucus of Black Psychiatrists, is keenly interested in understanding the cultural and social effects of geriatric mental health conditions on the lives of patients and families. Previously, Dr. Starks served as an assistant professor in the Baylor College of Medicine Menninger department of psychiatry and behavioral sciences, and in the department of neurology, Houston. He also was a faculty member at Baylor’s Alzheimer’s Disease and Memory Disorder Center.

A 39-year-old woman presented to an Arkansas cardiologist on February 12, 2010, with complaints of chest pain. The physician conducted an ankle-brachial index (ABI) test to measure the blood pressure in her lower extremity and interpreted it as less than 0.9%. He then ordered an echocardiogram to gauge the patient’s ejection fraction and interpreted the reading at 25%. Both measurements were below the normal average, which prompted the cardiologist to diagnose peripheral vascular disease and congestive heart failure.

The patient was eventually prescribed a course of cardiac medication and monitored over the ensuing months. On April 15, the cardiologist conducted a nuclear stress test; the computer-generated measurement of her ejection fraction was 50%, which the physician adjusted to 42%. In May, the patient underwent cardiac catheterization, which showed no lesions or blockages in the vessels. In the following months, the patient’s medication dosages were increased. On September 27, the cardiologist conducted another echocardiogram, which he read as 30%, and reaffirmed his diagnosis of congestive heart failure.

The physician continued to monitor the patient. On November 11, after being diagnosed with congestive heart failure, the patient was admitted to the hospital, where the cardiologist implanted an automated implantable cardioverter defibrillator (AICD).

On May 18, 2011, while running with her 2 daughters and a friend, the patient suddenly collapsed and experienced electrical currents coursing through her body (5 times). She was driven to a hospital, where it was determined that she did not go into cardiac arrest (which she suspected) but rather her defibrillator malfunctioned. The defibrillator was recalibrated to a higher setting, and she experienced no further issues.

In the ensuing years, the patient continued to follow up with her cardiologist. She eventually filed a lawsuit claiming that he had misdiagnosed congestive heart failure and unnecessarily implanted the AICD. Her experts in cardiology and cardiac electrophysiology testified that the defendant’s readings of the February 2010 ABI and echocardiogram results were incorrect; the ABIs were in fact .128 and .138 and the ejection fractions were 50% to 55% percent—in both instances, normal results. Furthermore, the September 2010 echocardiogram and another taken in February 2011, which showed little change from the first echocardiogram, were also normal, according to the experts.

The experts also opined that American College of Cardiology/American Heart Association guidelines state that a patient’s ejection fraction has to be less than 35% before a defibrillator is placed. Both experts concluded that the plaintiff did not have congestive heart failure and was therefore not a candidate for an AICD. The cardiac electrophysiology expert stated that to be a candidate, a patient must have an enlarged left ventricle—which plaintiff did not have. Moreover, none of the plaintiff’s physical findings were ever consistent with congestive heart failure: She did not have fluid in her lungs, as examinations always revealed clear lungs without congestion; there was no distention in her jugular veins; she did not experience sleep apnea; she did not lose consciousness; and she only experienced fatigue with exertion. The cardiology expert further faulted the defendant for failing to adjust the patient’s medication dosages to optimize her cardiac repair.

The defense maintained that the defendant’s treatment of the patient met the standard of care. According to the defense, the defendant’s judgment and interpretation of the patient’s ABI and echocardiogram results were medically sound and the defibrillator was necessary.

Continue to: VERDICT

VERDICT

After a 4-day trial and 3 hours of deliberation, the jury found that the defendant was liable and his actions were a factual cause of injury to plaintiff, who was awarded $1.75 million in damages.

COMMENTARY

In this case, the defendant cardiologist placed an AICD (also known as an implantable cardioverter defibrillator, or ICD). There was no allegation that the placement itself was negligent; rather, the claimed negligence was the decision to place it. But the plaintiff’s damages arise from the device’s malfunction—not the cardiologist’s decision to place it.

This case brings up an interesting issue of causation. As most of us know, medical malpractice plaintiffs must show (1) duty, (2) breach, (3) causation, and (4) harm. In law, there are 2 ways to think of causation: “but for” causation and “proximate” causation.

So-called “but for” causation is based on whether any causal relationship exists between an action and an outcome. For example, a drunk driver veers off the highway, through the breakdown lane, and strikes a tree, catching his car on fire. One minute later, a driver in the high-speed lane is captivated by the flaming vehicle, rubbernecks, fails to pay attention to traffic, and rear-ends the vehicle in front of him—injuring the driver of that car. Using “but for” causation, the drunk driver striking the tree “caused” the accident. If that had never happened, the second driver would never have been distracted, and if the driver wasn’t distracted, the second accident would not have occurred.

By contrast, “proximate” causation entails the immediate cause, which is foreseeable. Black’s Law defines proximate cause as “The result of a direct action and cause of loss to property that sets in motion a chain of events that is unbroken and causes damage, injury and destruction with no other interference” (emphasis added).¹ Using a proximate causation analysis, the second driver’s negligent failure to pay attention to the road would be the proximate cause of the second crash.

Continue to: Generally, causation analysis...

Generally, causation analysis is limited to proximate cause on the basis that harm is reasonably foreseeable. A famous example is the case of Palsgraf v. Long Island Railroad.²

Mrs. Palsgraf was standing on a train platform. A man carrying an ordinary-looking package rushed to board a moving train, with help from 2 railroad employees (1 in the car and 1 on the platform). As the ­employees pushed and pulled the man aboard, the package fell onto the tracks. Unbeknownst to everyone but the package’s owner, it contained fireworks—which exploded when the rear wheels of the train ran over the package. The explosion caused a large standing scale to fall over and land on Mrs. Palsgraf, injuring her. This is what law professors live for.

Mrs. Palsgraf sued the railroad, arguing that if the employees had not negligently pushed and pulled the man, the package would not have fallen and would not have exploded, and the scale never would have fallen on her. Mrs. Palsgraf won her trial and won her first appeal. In a famous decision by a famous judge, the win was overturned on the basis that Mrs. Palsgraf’s injuries “were not a reasonably foreseeable consequence of any possible negligence by the railroad.” This case set a foundation of American law regarding reasonable foreseeability, both in terms of identifiable plaintiffs and expected danger.

What does a railroad accident have to do with medical malpractice? In the case described here, we had an arguably negligent medical decision to place the defibrillator. Then we had a malfunction of the device, which caused the plaintiff injury. Was it reasonably foreseeable that the device would malfunction and cause harm—and should the physician be on the hook for that?

Unlike the unforeseeable risk of knocking a simple package to the ground—which unexpectedly turned out to contain fireworks—the risk of device malfunction would be foreseeable. Why? Beyond the usual surgical risks of bleeding and infection, an ICD’s leads can dislodge, the device can fail, and devices can shock inappropriately (with younger patients at increased risk for inappropriate shocks).^3,4 These risks are known, and it is highly likely the defendant cardiologist disclosed them on the consent form he asked the plaintiff to sign. The defense could not credibly argue that device malfunction was an unforeseeable risk. The malpractice here was the decision to place the ICD—and because placement wasn’t warranted in this patient, neither were the risks.

Continue to: This brings us to...

This brings us to the first malpractice trap: If you practice in a setting where a procedure is routinely offered, and that treatment has a billable cost, be cautious. Your decision-making can be made to appear driven by a profit motive. The lay public (including jurors) is suspicious of profit motive in medicine—a concept most clinicians find alien and repugnant.

Back in 2009, while outlining his rationale for the Affordable Care Act, President Obama made several statements that earned him swift rebuke from physician groups; I include them here not to incite political rants but to demonstrate the keen suspicion the public has for profit motives in clinical decision-making. On one occasion, he said, “Right now, doctors a lot of times are forced to make decisions based on the fee payment schedule. ... The doctor may look at the reimbursement system and say to himself, ‘You know what? I make a lot more money if I take this kid’s tonsils out.’”⁵ In another statement, while acknowledging that primary care providers offering preventive diabetes care make “a pittance,” Obama added, “But if that same [patient] ends up getting their foot amputated, that’s $30,000, $40,000, $50,000 immediately the surgeon is reimbursed.”⁶

For most clinicians, the idea of deciding on a course of treatment because it will be lucrative is an alien concept. Good clinicians base treatment on the accepted medical standard, and cost factors are a distant consideration if one at all.

However, if your practice involves a procedure or intervention that is a particularly lucrative billable event, do your part to play mental “devil’s advocate” and ensure that patients are genuinely in need of the treatment.

In some rare, bad (and usually highly publicized) cases, a procedure will be overused in a patently fraudulent way, which we all recognize is unethical and illegal. However, in other instances, a procedure may be overused because it is familiar and available. We’ve all heard the adage, “If all you have is a hammer, everything looks like a nail.” This “cute” expression holds some truth about the risk for cognitive bias based on the over-reliance on a familiar remedy.⁷ This particularly involves specialty practices that perform certain procedures frequently.

Continue to: In this case...

In this case, the plaintiff’s nuclear stress test showed an ejection fraction of 50%, which the defendant decreased to 42%. That is substantially different than the first ejection fraction of 25% and the second of 30% in a 39-year-old patient without any clinical signs of congestive heart failure. Did the defendant’s ability to offer an ICD color his appraisal of the patient’s cardiac function?

In closing arguments to the jury, the plaintiff’s attorney probably argued “this defendant behaved as if every human heart could be improved with a battery and wires.” Examine your practice to be sure you aren’t seeing nails where they don’t exist—because tomorrow, they will be the nails in the coffin of your career.

One thing missing from this case summary—but available via court records—is that the plaintiff claimed she had wanted a second opinion but was told she couldn’t have one: “I wanted a second opinion. And when I called [the defendant’s] office and asked ‘Could I have a second opinion,’ his nurse answered the phone and said that if I did get a second opinion, then I couldn’t come back.”⁸

There are a few aspects to discuss here, one of which is the second malpractice trap: viewing second opinions as an enemy. Most clinicians realize they are actually your friend. However, some providers are threatened by second opinions. It is as if they roll out of bed in the morning and consult the mirror to ask, “Who is the top cardiologist of them all?” and need the validation of that voice saying, “You, Dr. Smith—why of course, you!”

To that I say, forget the mirror, you egotistical so-and-so. Snow White will help protect you, your career, and most importantly, your patient. Allow the second opinion. In fact, integrate an expectation of the them into your practice style, to disarm any feelings of awkwardness, confrontation, or defensiveness. Think of the benefits: If Snow White validates your opinion, you have much stronger case that a course of treatment was indicated. Conversely, if Snow White arrives at a different opinion, she may have seen something you did not, and/or it may also relieve pressure from the patient to take an action with which you were only borderline comfortable.

Continue to: In cases I've worked on...

In cases I’ve worked on, I’ve seen some excellent surgeons who require a second opinion as a precondition to operating. This is particularly helpful when patient expectations are uncertain or there is a track record of unsuccessful interventions (eg, chronic back pain with multiple failed surgeries). Furthermore, a second opinion shows diligence, humility, and concern for the patient. It also gives you backup. As Top Gun taught us, there is no need to be a “maverick” when you can have a wingman.

As far as the alleged comment by the cardiologist’s nurse: We don’t know for certain if this actually happened—but if it did, it was unwarranted and foolish. Any jury would hear this and conclude the defendant (1) was an ass, (2) had something to hide, or (3) was guarding a profit source. Any way you slice it, this is bad for the patient and ultimately bad for the defendant. Make room in your practice for second opinions.

There was a legal fight regarding the admissibility of what the nurse had said. The defense filed a motion to prevent the plaintiff from telling the jury about the nurse’s statement, on the basis that the nurse’s statement was inadmissible hearsay. The court denied the motion, ruling that the cardiologist’s nurse was his agent and her words could be properly brought before the jury. The court found that the plaintiff relied on that statement in determining whether to have the ICD placed or obtain a second opinion.

This raises an interesting malpractice awareness point: If you are sued for malpractice, anything you had said to a patient, the patient’s family, or your coworkers will be admissible in court as a “party admission,” classified as either nonhearsay or a hearsay exception (assuming the statement was not made as part of a bona fide peer review, in which case it will likely be subject to peer review privilege). As seen in this case, this also applies to people acting as agents on your behalf. Be cautious of what you say and how you say it—and what your practice’s representatives are saying as well.

Interestingly, the jury found for the plaintiff in the amount of $1.75 million, but they declined to award punitive damages, which are designed to punish defendants rather than compensate the plaintiff. In Arkansas, the standard for punitive damages is tough; the plaintiff must “prove by clear and convincing evidence that the defendant knew or ought to have known, that their conduct would naturally and probably result in injury or damage and that they continued the conduct with malice or in reckless disregard of the consequences from which malice may be inferred.”⁹ A similar standard exists in most states. Because there were no punitive damages, we can infer the jury did not think the defendant implanted the ICD (for profit) knowing it wasn’t indicated.

Continue to: IN SUMMARY

IN SUMMARY

Consider foreseeable risks of practice interventions; be sure your practice is not on “autopilot,” recommending a common procedure or intervention too frequently. Don’t be threatened by second opinions; welcome them. And watch your words—­as they say on every police procedural you’ve ever watched, they can be used against you.

A 39-year-old woman presented to an Arkansas cardiologist on February 12, 2010, with complaints of chest pain. The physician conducted an ankle-brachial index (ABI) test to measure the blood pressure in her lower extremity and interpreted it as less than 0.9%. He then ordered an echocardiogram to gauge the patient’s ejection fraction and interpreted the reading at 25%. Both measurements were below the normal average, which prompted the cardiologist to diagnose peripheral vascular disease and congestive heart failure.

The patient was eventually prescribed a course of cardiac medication and monitored over the ensuing months. On April 15, the cardiologist conducted a nuclear stress test; the computer-generated measurement of her ejection fraction was 50%, which the physician adjusted to 42%. In May, the patient underwent cardiac catheterization, which showed no lesions or blockages in the vessels. In the following months, the patient’s medication dosages were increased. On September 27, the cardiologist conducted another echocardiogram, which he read as 30%, and reaffirmed his diagnosis of congestive heart failure.

The physician continued to monitor the patient. On November 11, after being diagnosed with congestive heart failure, the patient was admitted to the hospital, where the cardiologist implanted an automated implantable cardioverter defibrillator (AICD).

On May 18, 2011, while running with her 2 daughters and a friend, the patient suddenly collapsed and experienced electrical currents coursing through her body (5 times). She was driven to a hospital, where it was determined that she did not go into cardiac arrest (which she suspected) but rather her defibrillator malfunctioned. The defibrillator was recalibrated to a higher setting, and she experienced no further issues.

In the ensuing years, the patient continued to follow up with her cardiologist. She eventually filed a lawsuit claiming that he had misdiagnosed congestive heart failure and unnecessarily implanted the AICD. Her experts in cardiology and cardiac electrophysiology testified that the defendant’s readings of the February 2010 ABI and echocardiogram results were incorrect; the ABIs were in fact .128 and .138 and the ejection fractions were 50% to 55% percent—in both instances, normal results. Furthermore, the September 2010 echocardiogram and another taken in February 2011, which showed little change from the first echocardiogram, were also normal, according to the experts.

The experts also opined that American College of Cardiology/American Heart Association guidelines state that a patient’s ejection fraction has to be less than 35% before a defibrillator is placed. Both experts concluded that the plaintiff did not have congestive heart failure and was therefore not a candidate for an AICD. The cardiac electrophysiology expert stated that to be a candidate, a patient must have an enlarged left ventricle—which plaintiff did not have. Moreover, none of the plaintiff’s physical findings were ever consistent with congestive heart failure: She did not have fluid in her lungs, as examinations always revealed clear lungs without congestion; there was no distention in her jugular veins; she did not experience sleep apnea; she did not lose consciousness; and she only experienced fatigue with exertion. The cardiology expert further faulted the defendant for failing to adjust the patient’s medication dosages to optimize her cardiac repair.

The defense maintained that the defendant’s treatment of the patient met the standard of care. According to the defense, the defendant’s judgment and interpretation of the patient’s ABI and echocardiogram results were medically sound and the defibrillator was necessary.

Continue to: VERDICT

VERDICT

After a 4-day trial and 3 hours of deliberation, the jury found that the defendant was liable and his actions were a factual cause of injury to plaintiff, who was awarded $1.75 million in damages.

COMMENTARY

In this case, the defendant cardiologist placed an AICD (also known as an implantable cardioverter defibrillator, or ICD). There was no allegation that the placement itself was negligent; rather, the claimed negligence was the decision to place it. But the plaintiff’s damages arise from the device’s malfunction—not the cardiologist’s decision to place it.

This case brings up an interesting issue of causation. As most of us know, medical malpractice plaintiffs must show (1) duty, (2) breach, (3) causation, and (4) harm. In law, there are 2 ways to think of causation: “but for” causation and “proximate” causation.

So-called “but for” causation is based on whether any causal relationship exists between an action and an outcome. For example, a drunk driver veers off the highway, through the breakdown lane, and strikes a tree, catching his car on fire. One minute later, a driver in the high-speed lane is captivated by the flaming vehicle, rubbernecks, fails to pay attention to traffic, and rear-ends the vehicle in front of him—injuring the driver of that car. Using “but for” causation, the drunk driver striking the tree “caused” the accident. If that had never happened, the second driver would never have been distracted, and if the driver wasn’t distracted, the second accident would not have occurred.

By contrast, “proximate” causation entails the immediate cause, which is foreseeable. Black’s Law defines proximate cause as “The result of a direct action and cause of loss to property that sets in motion a chain of events that is unbroken and causes damage, injury and destruction with no other interference” (emphasis added).¹ Using a proximate causation analysis, the second driver’s negligent failure to pay attention to the road would be the proximate cause of the second crash.

Continue to: Generally, causation analysis...

Generally, causation analysis is limited to proximate cause on the basis that harm is reasonably foreseeable. A famous example is the case of Palsgraf v. Long Island Railroad.²

Mrs. Palsgraf was standing on a train platform. A man carrying an ordinary-looking package rushed to board a moving train, with help from 2 railroad employees (1 in the car and 1 on the platform). As the ­employees pushed and pulled the man aboard, the package fell onto the tracks. Unbeknownst to everyone but the package’s owner, it contained fireworks—which exploded when the rear wheels of the train ran over the package. The explosion caused a large standing scale to fall over and land on Mrs. Palsgraf, injuring her. This is what law professors live for.

Mrs. Palsgraf sued the railroad, arguing that if the employees had not negligently pushed and pulled the man, the package would not have fallen and would not have exploded, and the scale never would have fallen on her. Mrs. Palsgraf won her trial and won her first appeal. In a famous decision by a famous judge, the win was overturned on the basis that Mrs. Palsgraf’s injuries “were not a reasonably foreseeable consequence of any possible negligence by the railroad.” This case set a foundation of American law regarding reasonable foreseeability, both in terms of identifiable plaintiffs and expected danger.

What does a railroad accident have to do with medical malpractice? In the case described here, we had an arguably negligent medical decision to place the defibrillator. Then we had a malfunction of the device, which caused the plaintiff injury. Was it reasonably foreseeable that the device would malfunction and cause harm—and should the physician be on the hook for that?

Unlike the unforeseeable risk of knocking a simple package to the ground—which unexpectedly turned out to contain fireworks—the risk of device malfunction would be foreseeable. Why? Beyond the usual surgical risks of bleeding and infection, an ICD’s leads can dislodge, the device can fail, and devices can shock inappropriately (with younger patients at increased risk for inappropriate shocks).^3,4 These risks are known, and it is highly likely the defendant cardiologist disclosed them on the consent form he asked the plaintiff to sign. The defense could not credibly argue that device malfunction was an unforeseeable risk. The malpractice here was the decision to place the ICD—and because placement wasn’t warranted in this patient, neither were the risks.

Continue to: This brings us to...

This brings us to the first malpractice trap: If you practice in a setting where a procedure is routinely offered, and that treatment has a billable cost, be cautious. Your decision-making can be made to appear driven by a profit motive. The lay public (including jurors) is suspicious of profit motive in medicine—a concept most clinicians find alien and repugnant.

Back in 2009, while outlining his rationale for the Affordable Care Act, President Obama made several statements that earned him swift rebuke from physician groups; I include them here not to incite political rants but to demonstrate the keen suspicion the public has for profit motives in clinical decision-making. On one occasion, he said, “Right now, doctors a lot of times are forced to make decisions based on the fee payment schedule. ... The doctor may look at the reimbursement system and say to himself, ‘You know what? I make a lot more money if I take this kid’s tonsils out.’”⁵ In another statement, while acknowledging that primary care providers offering preventive diabetes care make “a pittance,” Obama added, “But if that same [patient] ends up getting their foot amputated, that’s $30,000, $40,000, $50,000 immediately the surgeon is reimbursed.”⁶

For most clinicians, the idea of deciding on a course of treatment because it will be lucrative is an alien concept. Good clinicians base treatment on the accepted medical standard, and cost factors are a distant consideration if one at all.

However, if your practice involves a procedure or intervention that is a particularly lucrative billable event, do your part to play mental “devil’s advocate” and ensure that patients are genuinely in need of the treatment.

In some rare, bad (and usually highly publicized) cases, a procedure will be overused in a patently fraudulent way, which we all recognize is unethical and illegal. However, in other instances, a procedure may be overused because it is familiar and available. We’ve all heard the adage, “If all you have is a hammer, everything looks like a nail.” This “cute” expression holds some truth about the risk for cognitive bias based on the over-reliance on a familiar remedy.⁷ This particularly involves specialty practices that perform certain procedures frequently.

Continue to: In this case...

In this case, the plaintiff’s nuclear stress test showed an ejection fraction of 50%, which the defendant decreased to 42%. That is substantially different than the first ejection fraction of 25% and the second of 30% in a 39-year-old patient without any clinical signs of congestive heart failure. Did the defendant’s ability to offer an ICD color his appraisal of the patient’s cardiac function?

In closing arguments to the jury, the plaintiff’s attorney probably argued “this defendant behaved as if every human heart could be improved with a battery and wires.” Examine your practice to be sure you aren’t seeing nails where they don’t exist—because tomorrow, they will be the nails in the coffin of your career.

One thing missing from this case summary—but available via court records—is that the plaintiff claimed she had wanted a second opinion but was told she couldn’t have one: “I wanted a second opinion. And when I called [the defendant’s] office and asked ‘Could I have a second opinion,’ his nurse answered the phone and said that if I did get a second opinion, then I couldn’t come back.”⁸

There are a few aspects to discuss here, one of which is the second malpractice trap: viewing second opinions as an enemy. Most clinicians realize they are actually your friend. However, some providers are threatened by second opinions. It is as if they roll out of bed in the morning and consult the mirror to ask, “Who is the top cardiologist of them all?” and need the validation of that voice saying, “You, Dr. Smith—why of course, you!”

To that I say, forget the mirror, you egotistical so-and-so. Snow White will help protect you, your career, and most importantly, your patient. Allow the second opinion. In fact, integrate an expectation of the them into your practice style, to disarm any feelings of awkwardness, confrontation, or defensiveness. Think of the benefits: If Snow White validates your opinion, you have much stronger case that a course of treatment was indicated. Conversely, if Snow White arrives at a different opinion, she may have seen something you did not, and/or it may also relieve pressure from the patient to take an action with which you were only borderline comfortable.

Continue to: In cases I've worked on...

In cases I’ve worked on, I’ve seen some excellent surgeons who require a second opinion as a precondition to operating. This is particularly helpful when patient expectations are uncertain or there is a track record of unsuccessful interventions (eg, chronic back pain with multiple failed surgeries). Furthermore, a second opinion shows diligence, humility, and concern for the patient. It also gives you backup. As Top Gun taught us, there is no need to be a “maverick” when you can have a wingman.

As far as the alleged comment by the cardiologist’s nurse: We don’t know for certain if this actually happened—but if it did, it was unwarranted and foolish. Any jury would hear this and conclude the defendant (1) was an ass, (2) had something to hide, or (3) was guarding a profit source. Any way you slice it, this is bad for the patient and ultimately bad for the defendant. Make room in your practice for second opinions.

There was a legal fight regarding the admissibility of what the nurse had said. The defense filed a motion to prevent the plaintiff from telling the jury about the nurse’s statement, on the basis that the nurse’s statement was inadmissible hearsay. The court denied the motion, ruling that the cardiologist’s nurse was his agent and her words could be properly brought before the jury. The court found that the plaintiff relied on that statement in determining whether to have the ICD placed or obtain a second opinion.

This raises an interesting malpractice awareness point: If you are sued for malpractice, anything you had said to a patient, the patient’s family, or your coworkers will be admissible in court as a “party admission,” classified as either nonhearsay or a hearsay exception (assuming the statement was not made as part of a bona fide peer review, in which case it will likely be subject to peer review privilege). As seen in this case, this also applies to people acting as agents on your behalf. Be cautious of what you say and how you say it—and what your practice’s representatives are saying as well.

Interestingly, the jury found for the plaintiff in the amount of $1.75 million, but they declined to award punitive damages, which are designed to punish defendants rather than compensate the plaintiff. In Arkansas, the standard for punitive damages is tough; the plaintiff must “prove by clear and convincing evidence that the defendant knew or ought to have known, that their conduct would naturally and probably result in injury or damage and that they continued the conduct with malice or in reckless disregard of the consequences from which malice may be inferred.”⁹ A similar standard exists in most states. Because there were no punitive damages, we can infer the jury did not think the defendant implanted the ICD (for profit) knowing it wasn’t indicated.

Continue to: IN SUMMARY

IN SUMMARY

Consider foreseeable risks of practice interventions; be sure your practice is not on “autopilot,” recommending a common procedure or intervention too frequently. Don’t be threatened by second opinions; welcome them. And watch your words—­as they say on every police procedural you’ve ever watched, they can be used against you.

A 39-year-old woman presented to an Arkansas cardiologist on February 12, 2010, with complaints of chest pain. The physician conducted an ankle-brachial index (ABI) test to measure the blood pressure in her lower extremity and interpreted it as less than 0.9%. He then ordered an echocardiogram to gauge the patient’s ejection fraction and interpreted the reading at 25%. Both measurements were below the normal average, which prompted the cardiologist to diagnose peripheral vascular disease and congestive heart failure.

The patient was eventually prescribed a course of cardiac medication and monitored over the ensuing months. On April 15, the cardiologist conducted a nuclear stress test; the computer-generated measurement of her ejection fraction was 50%, which the physician adjusted to 42%. In May, the patient underwent cardiac catheterization, which showed no lesions or blockages in the vessels. In the following months, the patient’s medication dosages were increased. On September 27, the cardiologist conducted another echocardiogram, which he read as 30%, and reaffirmed his diagnosis of congestive heart failure.

The physician continued to monitor the patient. On November 11, after being diagnosed with congestive heart failure, the patient was admitted to the hospital, where the cardiologist implanted an automated implantable cardioverter defibrillator (AICD).

On May 18, 2011, while running with her 2 daughters and a friend, the patient suddenly collapsed and experienced electrical currents coursing through her body (5 times). She was driven to a hospital, where it was determined that she did not go into cardiac arrest (which she suspected) but rather her defibrillator malfunctioned. The defibrillator was recalibrated to a higher setting, and she experienced no further issues.

In the ensuing years, the patient continued to follow up with her cardiologist. She eventually filed a lawsuit claiming that he had misdiagnosed congestive heart failure and unnecessarily implanted the AICD. Her experts in cardiology and cardiac electrophysiology testified that the defendant’s readings of the February 2010 ABI and echocardiogram results were incorrect; the ABIs were in fact .128 and .138 and the ejection fractions were 50% to 55% percent—in both instances, normal results. Furthermore, the September 2010 echocardiogram and another taken in February 2011, which showed little change from the first echocardiogram, were also normal, according to the experts.

The experts also opined that American College of Cardiology/American Heart Association guidelines state that a patient’s ejection fraction has to be less than 35% before a defibrillator is placed. Both experts concluded that the plaintiff did not have congestive heart failure and was therefore not a candidate for an AICD. The cardiac electrophysiology expert stated that to be a candidate, a patient must have an enlarged left ventricle—which plaintiff did not have. Moreover, none of the plaintiff’s physical findings were ever consistent with congestive heart failure: She did not have fluid in her lungs, as examinations always revealed clear lungs without congestion; there was no distention in her jugular veins; she did not experience sleep apnea; she did not lose consciousness; and she only experienced fatigue with exertion. The cardiology expert further faulted the defendant for failing to adjust the patient’s medication dosages to optimize her cardiac repair.

The defense maintained that the defendant’s treatment of the patient met the standard of care. According to the defense, the defendant’s judgment and interpretation of the patient’s ABI and echocardiogram results were medically sound and the defibrillator was necessary.

Continue to: VERDICT

VERDICT

After a 4-day trial and 3 hours of deliberation, the jury found that the defendant was liable and his actions were a factual cause of injury to plaintiff, who was awarded $1.75 million in damages.

COMMENTARY

In this case, the defendant cardiologist placed an AICD (also known as an implantable cardioverter defibrillator, or ICD). There was no allegation that the placement itself was negligent; rather, the claimed negligence was the decision to place it. But the plaintiff’s damages arise from the device’s malfunction—not the cardiologist’s decision to place it.

This case brings up an interesting issue of causation. As most of us know, medical malpractice plaintiffs must show (1) duty, (2) breach, (3) causation, and (4) harm. In law, there are 2 ways to think of causation: “but for” causation and “proximate” causation.

So-called “but for” causation is based on whether any causal relationship exists between an action and an outcome. For example, a drunk driver veers off the highway, through the breakdown lane, and strikes a tree, catching his car on fire. One minute later, a driver in the high-speed lane is captivated by the flaming vehicle, rubbernecks, fails to pay attention to traffic, and rear-ends the vehicle in front of him—injuring the driver of that car. Using “but for” causation, the drunk driver striking the tree “caused” the accident. If that had never happened, the second driver would never have been distracted, and if the driver wasn’t distracted, the second accident would not have occurred.

By contrast, “proximate” causation entails the immediate cause, which is foreseeable. Black’s Law defines proximate cause as “The result of a direct action and cause of loss to property that sets in motion a chain of events that is unbroken and causes damage, injury and destruction with no other interference” (emphasis added).¹ Using a proximate causation analysis, the second driver’s negligent failure to pay attention to the road would be the proximate cause of the second crash.

Continue to: Generally, causation analysis...

Generally, causation analysis is limited to proximate cause on the basis that harm is reasonably foreseeable. A famous example is the case of Palsgraf v. Long Island Railroad.²

Mrs. Palsgraf was standing on a train platform. A man carrying an ordinary-looking package rushed to board a moving train, with help from 2 railroad employees (1 in the car and 1 on the platform). As the ­employees pushed and pulled the man aboard, the package fell onto the tracks. Unbeknownst to everyone but the package’s owner, it contained fireworks—which exploded when the rear wheels of the train ran over the package. The explosion caused a large standing scale to fall over and land on Mrs. Palsgraf, injuring her. This is what law professors live for.

Mrs. Palsgraf sued the railroad, arguing that if the employees had not negligently pushed and pulled the man, the package would not have fallen and would not have exploded, and the scale never would have fallen on her. Mrs. Palsgraf won her trial and won her first appeal. In a famous decision by a famous judge, the win was overturned on the basis that Mrs. Palsgraf’s injuries “were not a reasonably foreseeable consequence of any possible negligence by the railroad.” This case set a foundation of American law regarding reasonable foreseeability, both in terms of identifiable plaintiffs and expected danger.

What does a railroad accident have to do with medical malpractice? In the case described here, we had an arguably negligent medical decision to place the defibrillator. Then we had a malfunction of the device, which caused the plaintiff injury. Was it reasonably foreseeable that the device would malfunction and cause harm—and should the physician be on the hook for that?

Unlike the unforeseeable risk of knocking a simple package to the ground—which unexpectedly turned out to contain fireworks—the risk of device malfunction would be foreseeable. Why? Beyond the usual surgical risks of bleeding and infection, an ICD’s leads can dislodge, the device can fail, and devices can shock inappropriately (with younger patients at increased risk for inappropriate shocks).^3,4 These risks are known, and it is highly likely the defendant cardiologist disclosed them on the consent form he asked the plaintiff to sign. The defense could not credibly argue that device malfunction was an unforeseeable risk. The malpractice here was the decision to place the ICD—and because placement wasn’t warranted in this patient, neither were the risks.

Continue to: This brings us to...

This brings us to the first malpractice trap: If you practice in a setting where a procedure is routinely offered, and that treatment has a billable cost, be cautious. Your decision-making can be made to appear driven by a profit motive. The lay public (including jurors) is suspicious of profit motive in medicine—a concept most clinicians find alien and repugnant.

Back in 2009, while outlining his rationale for the Affordable Care Act, President Obama made several statements that earned him swift rebuke from physician groups; I include them here not to incite political rants but to demonstrate the keen suspicion the public has for profit motives in clinical decision-making. On one occasion, he said, “Right now, doctors a lot of times are forced to make decisions based on the fee payment schedule. ... The doctor may look at the reimbursement system and say to himself, ‘You know what? I make a lot more money if I take this kid’s tonsils out.’”⁵ In another statement, while acknowledging that primary care providers offering preventive diabetes care make “a pittance,” Obama added, “But if that same [patient] ends up getting their foot amputated, that’s $30,000, $40,000, $50,000 immediately the surgeon is reimbursed.”⁶

For most clinicians, the idea of deciding on a course of treatment because it will be lucrative is an alien concept. Good clinicians base treatment on the accepted medical standard, and cost factors are a distant consideration if one at all.

However, if your practice involves a procedure or intervention that is a particularly lucrative billable event, do your part to play mental “devil’s advocate” and ensure that patients are genuinely in need of the treatment.

In some rare, bad (and usually highly publicized) cases, a procedure will be overused in a patently fraudulent way, which we all recognize is unethical and illegal. However, in other instances, a procedure may be overused because it is familiar and available. We’ve all heard the adage, “If all you have is a hammer, everything looks like a nail.” This “cute” expression holds some truth about the risk for cognitive bias based on the over-reliance on a familiar remedy.⁷ This particularly involves specialty practices that perform certain procedures frequently.

Continue to: In this case...

In this case, the plaintiff’s nuclear stress test showed an ejection fraction of 50%, which the defendant decreased to 42%. That is substantially different than the first ejection fraction of 25% and the second of 30% in a 39-year-old patient without any clinical signs of congestive heart failure. Did the defendant’s ability to offer an ICD color his appraisal of the patient’s cardiac function?

In closing arguments to the jury, the plaintiff’s attorney probably argued “this defendant behaved as if every human heart could be improved with a battery and wires.” Examine your practice to be sure you aren’t seeing nails where they don’t exist—because tomorrow, they will be the nails in the coffin of your career.

One thing missing from this case summary—but available via court records—is that the plaintiff claimed she had wanted a second opinion but was told she couldn’t have one: “I wanted a second opinion. And when I called [the defendant’s] office and asked ‘Could I have a second opinion,’ his nurse answered the phone and said that if I did get a second opinion, then I couldn’t come back.”⁸

There are a few aspects to discuss here, one of which is the second malpractice trap: viewing second opinions as an enemy. Most clinicians realize they are actually your friend. However, some providers are threatened by second opinions. It is as if they roll out of bed in the morning and consult the mirror to ask, “Who is the top cardiologist of them all?” and need the validation of that voice saying, “You, Dr. Smith—why of course, you!”

To that I say, forget the mirror, you egotistical so-and-so. Snow White will help protect you, your career, and most importantly, your patient. Allow the second opinion. In fact, integrate an expectation of the them into your practice style, to disarm any feelings of awkwardness, confrontation, or defensiveness. Think of the benefits: If Snow White validates your opinion, you have much stronger case that a course of treatment was indicated. Conversely, if Snow White arrives at a different opinion, she may have seen something you did not, and/or it may also relieve pressure from the patient to take an action with which you were only borderline comfortable.

Continue to: In cases I've worked on...

In cases I’ve worked on, I’ve seen some excellent surgeons who require a second opinion as a precondition to operating. This is particularly helpful when patient expectations are uncertain or there is a track record of unsuccessful interventions (eg, chronic back pain with multiple failed surgeries). Furthermore, a second opinion shows diligence, humility, and concern for the patient. It also gives you backup. As Top Gun taught us, there is no need to be a “maverick” when you can have a wingman.

As far as the alleged comment by the cardiologist’s nurse: We don’t know for certain if this actually happened—but if it did, it was unwarranted and foolish. Any jury would hear this and conclude the defendant (1) was an ass, (2) had something to hide, or (3) was guarding a profit source. Any way you slice it, this is bad for the patient and ultimately bad for the defendant. Make room in your practice for second opinions.

There was a legal fight regarding the admissibility of what the nurse had said. The defense filed a motion to prevent the plaintiff from telling the jury about the nurse’s statement, on the basis that the nurse’s statement was inadmissible hearsay. The court denied the motion, ruling that the cardiologist’s nurse was his agent and her words could be properly brought before the jury. The court found that the plaintiff relied on that statement in determining whether to have the ICD placed or obtain a second opinion.

This raises an interesting malpractice awareness point: If you are sued for malpractice, anything you had said to a patient, the patient’s family, or your coworkers will be admissible in court as a “party admission,” classified as either nonhearsay or a hearsay exception (assuming the statement was not made as part of a bona fide peer review, in which case it will likely be subject to peer review privilege). As seen in this case, this also applies to people acting as agents on your behalf. Be cautious of what you say and how you say it—and what your practice’s representatives are saying as well.

Interestingly, the jury found for the plaintiff in the amount of $1.75 million, but they declined to award punitive damages, which are designed to punish defendants rather than compensate the plaintiff. In Arkansas, the standard for punitive damages is tough; the plaintiff must “prove by clear and convincing evidence that the defendant knew or ought to have known, that their conduct would naturally and probably result in injury or damage and that they continued the conduct with malice or in reckless disregard of the consequences from which malice may be inferred.”⁹ A similar standard exists in most states. Because there were no punitive damages, we can infer the jury did not think the defendant implanted the ICD (for profit) knowing it wasn’t indicated.

Continue to: IN SUMMARY

IN SUMMARY

Consider foreseeable risks of practice interventions; be sure your practice is not on “autopilot,” recommending a common procedure or intervention too frequently. Don’t be threatened by second opinions; welcome them. And watch your words—­as they say on every police procedural you’ve ever watched, they can be used against you.

Patients at very high risk of adverse cardiovascular outcomes derive substantial benefit from proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition, according to results of two analyses from the ODYSSEY OUTCOMES trial.

In one prespecified analysis, the PCSK9 inhibitor alirocumab was linked to improved cardiovascular outcomes in patients with prior coronary artery bypass grafting (CABG), while in the other, researchers wrote that alirocumab showed a “large absolute benefit” in patients with polyvascular disease, which they defined as the presence of concomitant peripheral artery disease, cerebrovascular disease, or both.

These reports on alirocumab outcomes in patients with prior CABG and polyvascular disease appear in the Journal of the American College of Cardiology.

Prior CABG and polyvascular disease were both associated with markedly elevated risks of major adverse coronary events (MACE) and death, investigators wrote in the reports.

The ODYSSEY OUTCOMES trial included 18,924 patients with recent acute coronary syndrome (ACS) and high atherogenic lipoproteins despite intensive statin treatment. The primary outcome was MACE, comprising a composite of coronary heart disease death, nonfatal MI, ischemic stroke, or unstable angina requiring hospitalization. During a median 2.8 years of follow-up, this outcome occurred in 9.5% of the overall population randomized to alirocumab and 11.1% of those on placebo, for a statistically significant and clinically meaningful 15% relative risk reduction.

Polyvascular disease

In the trial population, 1,405 patients had polyvascular disease in at least two beds, including a coronary artery, plus either peripheral artery or cerebrovascular, while 149 had polyvascular disease in all three beds. The remainder, including 17,370 patients, were classified as having monovascular disease.

The incidences of MACE for placebo-treated patients with monovascular disease, two-bed polyvascular disease, and three-bed polyvascular disease were 10.0%, 22.2%, and 39.7%, respectively. Alirocumab treatment resulted in an absolute risk reduction for MACE of 1.4%, 1.9%, and 13.0%, for those respective groups (P = .0006).

Similarly, the incidence of the secondary endpoint of death for placebo-treated patients was 3.5%, 10.0%, and 21.8%, and the ARR with alirocumab was 0.4%, 1.3%, and 16.2% (P = .002), according to their reported data.

These results suggest that patients with polyvascular disease are an “easily identifiable subgroup” of ACS patients with a high absolute risk of MACE and death, according to the investigators, led by J. Wouter Jukema, MD, PhD, of Leiden (the Netherlands) University Medical Center.

“The large absolute benefit of PCSK9 inhibition with alirocumab, when added to high-intensity statin therapy, is a potential benefit for this group of patients,” Dr. Jukema and coauthors wrote.

Prior CABG

Of the ODYSSEY OUTCOMES patients, 1,025 had an index CABG after ACS, 1,003 had CABG before ACS, and the remaining 16,896 had no such procedure.

Hazard ratios for both MACE and death in all CABG categories were consistent with the overall results of ODYSSEY OUTCOMES, the investigators wrote. Specifically, alirocumab reduced MACE and death in the overall study, with HRs of 0.85 for both endpoints.

The ARRs in MACE with alirocumab were 1.3% for no CABG, 0.9% for index CABG, and 6.4% for prior CABG (P = .0007), while ARRs in death with the treatment were 0.4%, 0.5%, and 3.6% (P = .03) for those categories, respectively. In this analysis, the investigators calculated the number needed to treat to prevent one primary or secondary endpoint over the median 2.8 years of follow-up. The numbers needed to treat were 16 for prior CABG, 111 for index, and 77 for no prior CABG.

“Although the relative benefit of alirocumab versus placebo is consistent regardless of prior CABG status, those with prior CABG achieve substantially greater absolute risk reduction and consequently lower number needed to treat,” wrote the authors of the analysis, led by Shaun G. Goodman, MD, MSc, of St. Michael’s Hospital, Toronto.

Funding for the ODYSSEY OUTCOMES trial and its subanalyses was provided by Sanofi and Regeneron. Authors of the analyses reported disclosures related to Sanofi, Regeneron, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and others.

SOURCES: Goodman SG et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.015; Jukema JW et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.03.013.

Patients at very high risk of adverse cardiovascular outcomes derive substantial benefit from proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition, according to results of two analyses from the ODYSSEY OUTCOMES trial.

In one prespecified analysis, the PCSK9 inhibitor alirocumab was linked to improved cardiovascular outcomes in patients with prior coronary artery bypass grafting (CABG), while in the other, researchers wrote that alirocumab showed a “large absolute benefit” in patients with polyvascular disease, which they defined as the presence of concomitant peripheral artery disease, cerebrovascular disease, or both.

These reports on alirocumab outcomes in patients with prior CABG and polyvascular disease appear in the Journal of the American College of Cardiology.

Prior CABG and polyvascular disease were both associated with markedly elevated risks of major adverse coronary events (MACE) and death, investigators wrote in the reports.

The ODYSSEY OUTCOMES trial included 18,924 patients with recent acute coronary syndrome (ACS) and high atherogenic lipoproteins despite intensive statin treatment. The primary outcome was MACE, comprising a composite of coronary heart disease death, nonfatal MI, ischemic stroke, or unstable angina requiring hospitalization. During a median 2.8 years of follow-up, this outcome occurred in 9.5% of the overall population randomized to alirocumab and 11.1% of those on placebo, for a statistically significant and clinically meaningful 15% relative risk reduction.

Polyvascular disease

In the trial population, 1,405 patients had polyvascular disease in at least two beds, including a coronary artery, plus either peripheral artery or cerebrovascular, while 149 had polyvascular disease in all three beds. The remainder, including 17,370 patients, were classified as having monovascular disease.

The incidences of MACE for placebo-treated patients with monovascular disease, two-bed polyvascular disease, and three-bed polyvascular disease were 10.0%, 22.2%, and 39.7%, respectively. Alirocumab treatment resulted in an absolute risk reduction for MACE of 1.4%, 1.9%, and 13.0%, for those respective groups (P = .0006).

Similarly, the incidence of the secondary endpoint of death for placebo-treated patients was 3.5%, 10.0%, and 21.8%, and the ARR with alirocumab was 0.4%, 1.3%, and 16.2% (P = .002), according to their reported data.

These results suggest that patients with polyvascular disease are an “easily identifiable subgroup” of ACS patients with a high absolute risk of MACE and death, according to the investigators, led by J. Wouter Jukema, MD, PhD, of Leiden (the Netherlands) University Medical Center.

“The large absolute benefit of PCSK9 inhibition with alirocumab, when added to high-intensity statin therapy, is a potential benefit for this group of patients,” Dr. Jukema and coauthors wrote.

Prior CABG

Of the ODYSSEY OUTCOMES patients, 1,025 had an index CABG after ACS, 1,003 had CABG before ACS, and the remaining 16,896 had no such procedure.

Hazard ratios for both MACE and death in all CABG categories were consistent with the overall results of ODYSSEY OUTCOMES, the investigators wrote. Specifically, alirocumab reduced MACE and death in the overall study, with HRs of 0.85 for both endpoints.

The ARRs in MACE with alirocumab were 1.3% for no CABG, 0.9% for index CABG, and 6.4% for prior CABG (P = .0007), while ARRs in death with the treatment were 0.4%, 0.5%, and 3.6% (P = .03) for those categories, respectively. In this analysis, the investigators calculated the number needed to treat to prevent one primary or secondary endpoint over the median 2.8 years of follow-up. The numbers needed to treat were 16 for prior CABG, 111 for index, and 77 for no prior CABG.

“Although the relative benefit of alirocumab versus placebo is consistent regardless of prior CABG status, those with prior CABG achieve substantially greater absolute risk reduction and consequently lower number needed to treat,” wrote the authors of the analysis, led by Shaun G. Goodman, MD, MSc, of St. Michael’s Hospital, Toronto.

Funding for the ODYSSEY OUTCOMES trial and its subanalyses was provided by Sanofi and Regeneron. Authors of the analyses reported disclosures related to Sanofi, Regeneron, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and others.

SOURCES: Goodman SG et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.015; Jukema JW et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.03.013.

Patients at very high risk of adverse cardiovascular outcomes derive substantial benefit from proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition, according to results of two analyses from the ODYSSEY OUTCOMES trial.

In one prespecified analysis, the PCSK9 inhibitor alirocumab was linked to improved cardiovascular outcomes in patients with prior coronary artery bypass grafting (CABG), while in the other, researchers wrote that alirocumab showed a “large absolute benefit” in patients with polyvascular disease, which they defined as the presence of concomitant peripheral artery disease, cerebrovascular disease, or both.

These reports on alirocumab outcomes in patients with prior CABG and polyvascular disease appear in the Journal of the American College of Cardiology.

Prior CABG and polyvascular disease were both associated with markedly elevated risks of major adverse coronary events (MACE) and death, investigators wrote in the reports.

The ODYSSEY OUTCOMES trial included 18,924 patients with recent acute coronary syndrome (ACS) and high atherogenic lipoproteins despite intensive statin treatment. The primary outcome was MACE, comprising a composite of coronary heart disease death, nonfatal MI, ischemic stroke, or unstable angina requiring hospitalization. During a median 2.8 years of follow-up, this outcome occurred in 9.5% of the overall population randomized to alirocumab and 11.1% of those on placebo, for a statistically significant and clinically meaningful 15% relative risk reduction.

Polyvascular disease

In the trial population, 1,405 patients had polyvascular disease in at least two beds, including a coronary artery, plus either peripheral artery or cerebrovascular, while 149 had polyvascular disease in all three beds. The remainder, including 17,370 patients, were classified as having monovascular disease.

The incidences of MACE for placebo-treated patients with monovascular disease, two-bed polyvascular disease, and three-bed polyvascular disease were 10.0%, 22.2%, and 39.7%, respectively. Alirocumab treatment resulted in an absolute risk reduction for MACE of 1.4%, 1.9%, and 13.0%, for those respective groups (P = .0006).

Similarly, the incidence of the secondary endpoint of death for placebo-treated patients was 3.5%, 10.0%, and 21.8%, and the ARR with alirocumab was 0.4%, 1.3%, and 16.2% (P = .002), according to their reported data.

These results suggest that patients with polyvascular disease are an “easily identifiable subgroup” of ACS patients with a high absolute risk of MACE and death, according to the investigators, led by J. Wouter Jukema, MD, PhD, of Leiden (the Netherlands) University Medical Center.

“The large absolute benefit of PCSK9 inhibition with alirocumab, when added to high-intensity statin therapy, is a potential benefit for this group of patients,” Dr. Jukema and coauthors wrote.

Prior CABG

Of the ODYSSEY OUTCOMES patients, 1,025 had an index CABG after ACS, 1,003 had CABG before ACS, and the remaining 16,896 had no such procedure.

Hazard ratios for both MACE and death in all CABG categories were consistent with the overall results of ODYSSEY OUTCOMES, the investigators wrote. Specifically, alirocumab reduced MACE and death in the overall study, with HRs of 0.85 for both endpoints.

The ARRs in MACE with alirocumab were 1.3% for no CABG, 0.9% for index CABG, and 6.4% for prior CABG (P = .0007), while ARRs in death with the treatment were 0.4%, 0.5%, and 3.6% (P = .03) for those categories, respectively. In this analysis, the investigators calculated the number needed to treat to prevent one primary or secondary endpoint over the median 2.8 years of follow-up. The numbers needed to treat were 16 for prior CABG, 111 for index, and 77 for no prior CABG.

“Although the relative benefit of alirocumab versus placebo is consistent regardless of prior CABG status, those with prior CABG achieve substantially greater absolute risk reduction and consequently lower number needed to treat,” wrote the authors of the analysis, led by Shaun G. Goodman, MD, MSc, of St. Michael’s Hospital, Toronto.

Funding for the ODYSSEY OUTCOMES trial and its subanalyses was provided by Sanofi and Regeneron. Authors of the analyses reported disclosures related to Sanofi, Regeneron, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and others.

SOURCES: Goodman SG et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.015; Jukema JW et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.03.013.

SEATTLE – Rady Children’s Hospital in San Diego has been doing continuous positive airway pressure for infants with bronchiolitis on the general pediatrics floors safely and with no problems for nearly 20 years, according to a presentation at Pediatric Hospital Medicine.

It’s newsworthy because “very, very few” hospitals do bronchiolitis continuous positive airway pressure (CPAP) outside of the ICU. “The perception is that there are complications, and you might miss kids that are really sick if you keep them on the floor.” However, “we have been doing it safely for so long that no one thinks twice about it,” said Christiane Lenzen, MD, a pediatric hospitalist at Rady and an assistant clinical professor of pediatrics at the University of California, San Diego.

It doesn’t matter if children have congenital heart disease, chronic lung disease, or other problems, she said, “if they are stable enough for the floor, we will see if it’s okay.”

Rady’s hand was forced on the issue because it has a large catchment area but limited ICU beds, so for practical reasons and within certain limits, CPAP moved to the floors. One of Dr. Lenzen’s colleagues noted that, as long as there’s nurse and respiratory leadership buy in, “it’s actually quite easy to pull off in a very safe manner.”

Rady has a significant advantage over community hospitals and other places considering the approach, because it has onsite pediatric ICU services for when things head south. Over the past 3 or so years, 52% of the children the pediatric hospital medicine service started on CPAP (168/324) had to be transferred to the ICU; 17% were ultimately intubated.

Many of those transfers were caused by comorbidities, not CPAP failure, but other times children needed greater respiratory support; in general, the floor CPAP limit is 6 cm H₂O and a fraction of inspired oxygen of 50%. Also, sometimes children needed to be sedated for CPAP, which isn’t done on the floor.

With the 52% transfer rate, “I would worry about patients who are sick enough to need CPAP staying” in a hospital without quick access to ICU services, Dr. Lenzen said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Even so, among 324 children who at least initially were treated with CPAP on the floor – out of 2,424 admitted to the pediatric hospital medicine service with bronchiolitis – there hasn’t been a single pneumothorax, aspiration event, or CPAP equipment–related injury, she said.

CPAP on the floor has several benefits. ICU resources are conserved, patient handoffs and the work of transfers into and out of the ICU are avoided, families don’t have to get used to a new treatment team, and infants aren’t subjected to the jarring ICU environment.

For it to work, though, staff “really need to be on top of this,” and “it needs to be very tightly controlled” with order sets and other measures, the presenters said. There’s regular training at Rady for nurses, respiratory therapists, and hospitalists on CPAP equipment, airway management, monitoring, troubleshooting, and other essentials.

Almost all children on the pediatric floors have a trial of high-flow nasal cannula with an upper limit of 8 L/min. If the Respiratory Assessment Score hasn’t improved in an hour, CPAP is considered. If a child is admitted with a score above 10 and they seem to be worsening, they go straight to CPAP.

Children alternate between nasal prongs and nasal masks to prevent pressure necrosis, and are kept nil per os while on CPAP. They are on continual pulse oximetry and cardiorespiratory monitoring. Vital signs and respiratory scores are checked frequently, more so for children who are struggling.

The patient-to-nurse ratio drops from the usual 4:1 to 3:1 when a child goes on CPAP, and to 2:1 if necessary. Traveling nurses aren’t allowed to take CPAP cases.

The presenters didn’t report any disclosures.

This article was updated 8/27/19.

[email protected]

SEATTLE – Rady Children’s Hospital in San Diego has been doing continuous positive airway pressure for infants with bronchiolitis on the general pediatrics floors safely and with no problems for nearly 20 years, according to a presentation at Pediatric Hospital Medicine.

It’s newsworthy because “very, very few” hospitals do bronchiolitis continuous positive airway pressure (CPAP) outside of the ICU. “The perception is that there are complications, and you might miss kids that are really sick if you keep them on the floor.” However, “we have been doing it safely for so long that no one thinks twice about it,” said Christiane Lenzen, MD, a pediatric hospitalist at Rady and an assistant clinical professor of pediatrics at the University of California, San Diego.

It doesn’t matter if children have congenital heart disease, chronic lung disease, or other problems, she said, “if they are stable enough for the floor, we will see if it’s okay.”

Rady’s hand was forced on the issue because it has a large catchment area but limited ICU beds, so for practical reasons and within certain limits, CPAP moved to the floors. One of Dr. Lenzen’s colleagues noted that, as long as there’s nurse and respiratory leadership buy in, “it’s actually quite easy to pull off in a very safe manner.”

Rady has a significant advantage over community hospitals and other places considering the approach, because it has onsite pediatric ICU services for when things head south. Over the past 3 or so years, 52% of the children the pediatric hospital medicine service started on CPAP (168/324) had to be transferred to the ICU; 17% were ultimately intubated.

Many of those transfers were caused by comorbidities, not CPAP failure, but other times children needed greater respiratory support; in general, the floor CPAP limit is 6 cm H₂O and a fraction of inspired oxygen of 50%. Also, sometimes children needed to be sedated for CPAP, which isn’t done on the floor.

With the 52% transfer rate, “I would worry about patients who are sick enough to need CPAP staying” in a hospital without quick access to ICU services, Dr. Lenzen said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Even so, among 324 children who at least initially were treated with CPAP on the floor – out of 2,424 admitted to the pediatric hospital medicine service with bronchiolitis – there hasn’t been a single pneumothorax, aspiration event, or CPAP equipment–related injury, she said.

CPAP on the floor has several benefits. ICU resources are conserved, patient handoffs and the work of transfers into and out of the ICU are avoided, families don’t have to get used to a new treatment team, and infants aren’t subjected to the jarring ICU environment.

For it to work, though, staff “really need to be on top of this,” and “it needs to be very tightly controlled” with order sets and other measures, the presenters said. There’s regular training at Rady for nurses, respiratory therapists, and hospitalists on CPAP equipment, airway management, monitoring, troubleshooting, and other essentials.

Almost all children on the pediatric floors have a trial of high-flow nasal cannula with an upper limit of 8 L/min. If the Respiratory Assessment Score hasn’t improved in an hour, CPAP is considered. If a child is admitted with a score above 10 and they seem to be worsening, they go straight to CPAP.

Children alternate between nasal prongs and nasal masks to prevent pressure necrosis, and are kept nil per os while on CPAP. They are on continual pulse oximetry and cardiorespiratory monitoring. Vital signs and respiratory scores are checked frequently, more so for children who are struggling.

The patient-to-nurse ratio drops from the usual 4:1 to 3:1 when a child goes on CPAP, and to 2:1 if necessary. Traveling nurses aren’t allowed to take CPAP cases.

The presenters didn’t report any disclosures.

This article was updated 8/27/19.

[email protected]

SEATTLE – Rady Children’s Hospital in San Diego has been doing continuous positive airway pressure for infants with bronchiolitis on the general pediatrics floors safely and with no problems for nearly 20 years, according to a presentation at Pediatric Hospital Medicine.

It’s newsworthy because “very, very few” hospitals do bronchiolitis continuous positive airway pressure (CPAP) outside of the ICU. “The perception is that there are complications, and you might miss kids that are really sick if you keep them on the floor.” However, “we have been doing it safely for so long that no one thinks twice about it,” said Christiane Lenzen, MD, a pediatric hospitalist at Rady and an assistant clinical professor of pediatrics at the University of California, San Diego.

It doesn’t matter if children have congenital heart disease, chronic lung disease, or other problems, she said, “if they are stable enough for the floor, we will see if it’s okay.”

Rady’s hand was forced on the issue because it has a large catchment area but limited ICU beds, so for practical reasons and within certain limits, CPAP moved to the floors. One of Dr. Lenzen’s colleagues noted that, as long as there’s nurse and respiratory leadership buy in, “it’s actually quite easy to pull off in a very safe manner.”

Rady has a significant advantage over community hospitals and other places considering the approach, because it has onsite pediatric ICU services for when things head south. Over the past 3 or so years, 52% of the children the pediatric hospital medicine service started on CPAP (168/324) had to be transferred to the ICU; 17% were ultimately intubated.

Many of those transfers were caused by comorbidities, not CPAP failure, but other times children needed greater respiratory support; in general, the floor CPAP limit is 6 cm H₂O and a fraction of inspired oxygen of 50%. Also, sometimes children needed to be sedated for CPAP, which isn’t done on the floor.

With the 52% transfer rate, “I would worry about patients who are sick enough to need CPAP staying” in a hospital without quick access to ICU services, Dr. Lenzen said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Even so, among 324 children who at least initially were treated with CPAP on the floor – out of 2,424 admitted to the pediatric hospital medicine service with bronchiolitis – there hasn’t been a single pneumothorax, aspiration event, or CPAP equipment–related injury, she said.

CPAP on the floor has several benefits. ICU resources are conserved, patient handoffs and the work of transfers into and out of the ICU are avoided, families don’t have to get used to a new treatment team, and infants aren’t subjected to the jarring ICU environment.

For it to work, though, staff “really need to be on top of this,” and “it needs to be very tightly controlled” with order sets and other measures, the presenters said. There’s regular training at Rady for nurses, respiratory therapists, and hospitalists on CPAP equipment, airway management, monitoring, troubleshooting, and other essentials.

Almost all children on the pediatric floors have a trial of high-flow nasal cannula with an upper limit of 8 L/min. If the Respiratory Assessment Score hasn’t improved in an hour, CPAP is considered. If a child is admitted with a score above 10 and they seem to be worsening, they go straight to CPAP.

Children alternate between nasal prongs and nasal masks to prevent pressure necrosis, and are kept nil per os while on CPAP. They are on continual pulse oximetry and cardiorespiratory monitoring. Vital signs and respiratory scores are checked frequently, more so for children who are struggling.

The patient-to-nurse ratio drops from the usual 4:1 to 3:1 when a child goes on CPAP, and to 2:1 if necessary. Traveling nurses aren’t allowed to take CPAP cases.

The presenters didn’t report any disclosures.

This article was updated 8/27/19.

[email protected]

If you’re looking to have the best remote user experience on SVSConnect, download the Member Centric app. Don’t limit your time on the community to only when you have a desktop or laptop computer available. The app gives you easy access to the Open Forum, member directory and shared resources directly from your mobile device. You're able to download this from either Google Play or the App Store. Read how to download the app here.

As always, use your SVS credentials to sign in and reach out to [email protected] with questions.

If you’re looking to have the best remote user experience on SVSConnect, download the Member Centric app. Don’t limit your time on the community to only when you have a desktop or laptop computer available. The app gives you easy access to the Open Forum, member directory and shared resources directly from your mobile device. You're able to download this from either Google Play or the App Store. Read how to download the app here.

As always, use your SVS credentials to sign in and reach out to [email protected] with questions.

If you’re looking to have the best remote user experience on SVSConnect, download the Member Centric app. Don’t limit your time on the community to only when you have a desktop or laptop computer available. The app gives you easy access to the Open Forum, member directory and shared resources directly from your mobile device. You're able to download this from either Google Play or the App Store. Read how to download the app here.

As always, use your SVS credentials to sign in and reach out to [email protected] with questions.

The third membership deadline of 2019 is a few short days away on Sept. 1. SVS members enjoy many benefits such as SVSConnect, discounted pricing on publications and meeting registration, practice management resources and much more. Visit the membership page and start your application today. If you have any questions, please contact the SVS membership department at [email protected].

The third membership deadline of 2019 is a few short days away on Sept. 1. SVS members enjoy many benefits such as SVSConnect, discounted pricing on publications and meeting registration, practice management resources and much more. Visit the membership page and start your application today. If you have any questions, please contact the SVS membership department at [email protected].

The third membership deadline of 2019 is a few short days away on Sept. 1. SVS members enjoy many benefits such as SVSConnect, discounted pricing on publications and meeting registration, practice management resources and much more. Visit the membership page and start your application today. If you have any questions, please contact the SVS membership department at [email protected].

The Society for Vascular Surgery seeks proposals for invited sessions for the 2020 Vascular Annual Meeting, to be held June 17 to 20 in Toronto, Ontario, Canada. Scientific sessions will be June 18 to 20 and exhibits will be open June 18 to 19. Proposals should include the session's educational benefit, a short outline of the program topic, session goals and target audience, among other information. Obtain the information/submission form here and send in before tomorrow, Aug. 28. Email completed forms to [email protected].

The Society for Vascular Surgery seeks proposals for invited sessions for the 2020 Vascular Annual Meeting, to be held June 17 to 20 in Toronto, Ontario, Canada. Scientific sessions will be June 18 to 20 and exhibits will be open June 18 to 19. Proposals should include the session's educational benefit, a short outline of the program topic, session goals and target audience, among other information. Obtain the information/submission form here and send in before tomorrow, Aug. 28. Email completed forms to [email protected].

The Society for Vascular Surgery seeks proposals for invited sessions for the 2020 Vascular Annual Meeting, to be held June 17 to 20 in Toronto, Ontario, Canada. Scientific sessions will be June 18 to 20 and exhibits will be open June 18 to 19. Proposals should include the session's educational benefit, a short outline of the program topic, session goals and target audience, among other information. Obtain the information/submission form here and send in before tomorrow, Aug. 28. Email completed forms to [email protected].

Last year, the SVS Foundation updated and rewrote its popular patient education fliers. These are designed to fulfill the Foundation’s mission to support patient education, vascular health and community awareness of vascular disease. SVS members are encouraged to download and print the fliers to use in their offices. If you’ve taken advantage of these fliers, we’d like to hear how you’ve benefited from them. Please take this short survey and provide your feedback. If you have yet to see the fliers, view them here.

Last year, the SVS Foundation updated and rewrote its popular patient education fliers. These are designed to fulfill the Foundation’s mission to support patient education, vascular health and community awareness of vascular disease. SVS members are encouraged to download and print the fliers to use in their offices. If you’ve taken advantage of these fliers, we’d like to hear how you’ve benefited from them. Please take this short survey and provide your feedback. If you have yet to see the fliers, view them here.

Last year, the SVS Foundation updated and rewrote its popular patient education fliers. These are designed to fulfill the Foundation’s mission to support patient education, vascular health and community awareness of vascular disease. SVS members are encouraged to download and print the fliers to use in their offices. If you’ve taken advantage of these fliers, we’d like to hear how you’ve benefited from them. Please take this short survey and provide your feedback. If you have yet to see the fliers, view them here.

Bob has been coming to therapy for a few months now. Initially, we met every week, but as his depression lifted, he asked to space the sessions out to twice a month, even as he continues to struggle with many challenges in his life. The cost, he says, is prohibitive, and while Bob believed he had good commercial insurance coverage, he’s learned a few things about insurance and mental health care.

Bob was referred to me by his internist. He knew I did not participate in his insurance network, but his policy covers out-of-network care. He’d had a number of imaging studies and then knee surgery earlier in the year, so he believed he’d met his deductible. He learned that, while he’d met his in-network deductible, he’d had no out-of-network expenses and there was a separate, much higher deductible – one he was not likely to meet with outpatient psychiatric care. In fact, the full cost of his treatment was not being subtracted from the deductible he needed to meet, but rather he was getting credit for lower usual and customary evaluation and management and psychotherapy fees for each session. It became clear that it would be many months – if ever – before Bob could expect any reimbursement for his out-of-network visits.

What Bob didn’t know was that, had he decided to switch to an in-network psychiatrist, he might well have trouble finding one, since half of psychiatrists don’t participate with any health insurance plans. And if he did see an in-network psychiatrist, he would likely need to find a separate in-network social worker or psychologist for psychotherapy, because most in-network psychiatrists see patients for short medication-management appointments. While the insurance companies would give Bob a list of providers, those lists are not kept up to date and include psychiatrists who have died, moved, aren’t taking new patients, or who have retired. The insurance company clearly states on its voicemail that verification of services does not guarantee payment, and Bob was told that the only way he could be certain of the reimbursement would be to submit the claims and wait. He went into treatment fully understanding that he might get no help with the cost from his health insurance.

When I first started in private practice in the 1990s, I joined only one panel. An older colleague told me I was foolish to hesitate, and that soon the panels would fill and it would be too late; psychiatrists wouldn’t be able to get on to the panels and would be unable to attract patients. A few years later, that same psychiatrist withdrew from all the insurance panels he was on; working on their terms was not rewarding. This division of in-network and out-of-network care is crucial to managed care: They must attract panels of doctors who will work for lower rates or with stipulations on how the doctor practices in order to save money.

But managed care came with a price: An entire administration was created to oversee the regulation of treatment. With time, some aspects of care management have vanished; it has been years since I have been asked to fill out a treatment plan to justify a need for outpatient psychotherapy. In Bob’s case, it’s clear how they save money; since he will not reach his high deductible, he will bear the full cost of his psychotherapy. Other patients who cannot afford to go out of network may give up searching and decide to go without treatment – this is not always an easy service to negotiate when one is distressed and compromised. Half of people with serious psychiatric disorders are not in treatment, and barriers to getting care are certainly one reason why.

Many psychiatrists have discovered that they can maintain a practice without being on insurance panels, as managed care only works if there are enough players willing to toss the ball. As psychiatrists have shied away from these panels, insurers have raised their reimbursement rates, and in Maryland, Medicaid also has had to raise their rates. The struggle has become one of how to get enough mental health professionals, and psychiatrists in particular, to join insurance panels in what is a shortage field.

Maybe the question of how to get enough psychiatrists to participate with insurance panels is now the wrong question. Perhaps there are better ways to spend health care dollars than on the administration and management that come with limiting which doctors patients can see. The logistics of in-network versus out-of-network care are an expensive one, and create unconscionable scenarios in other fields. For example, such scenarios include ones in which a patient is brought in for emergency care to a facility where the doctors are not in network, or a patient has a procedure with an in-network surgeon but is unaware that the anesthesiologist or other members of the care team are not on the panel.

What if insurers controlled costs by setting a reasonable fee they would pay for services and paid any licensed physician for these services? Would market forces sort this out? Would fees then set to one which insurers would be willing to pay and physicians would be willing to accept? Or would those who are ill and impoverished be blocked from getting any care? What if we tried a whole new paradigm for psychiatric care?

Richard G. Frank, PhD, is a professor of health economics at Harvard. He specializes in mental health economics and is coauthor of the book “Better But Not Well: Mental Health Policy in the United States Since 1950” (Baltimore: Johns Hopkins University Press, 2006). Dr. Frank is a proponent of insurance panels.

“In the world we live in, we need to have panels; they are essential to controlling cost. They create a balance in terms of cost and utilization control in ways that protect patients, and they create a way for the insurance companies to bargain,” he said.

Dr. Frank noted that the concept that insurers should pay a set reasonable fee to any physician a patient wants to see has been tried. “It’s called ‘reference pricing,’ and when they did that with hip replacement surgery in California, it just hasn’t worked out. Patients ended up getting larger bills than they anticipated.

“The issues with psychiatry are different,” he continued. “There is a lot of bad behavior on the part of insurers and it’s an issue of parity. We shouldn’t let insurers differentially pay psychiatrists less. They have had an incentive to reduce the availability of mental health care and it’s bad for patients. It’s about lower payments to psychiatrists and the way those payments are currently structured drives patients out of care and defeats the purpose of insurance.”

Steven Sharfstein, MD, is the former CEO of Sheppard Pratt Health Systems, a past president of the American Psychiatric Association, and coauthor of several books on the economics of psychiatry. He refers to the current practice of credentialing network psychiatrists as a means of “rationing by supply.”

“The networks create a barrier to accessing care. I don’t think it’s an efficient way to take on the high cost of care, and it creates a tiered system.” Like Dr. Frank, Dr. Sharfstein believes parity is a large part of the problem. When asked about the idea of ending networks and establishing uniform deductibles and reimbursement rates, Dr. Sharfstein replied: “It really depends. We would need fees to hit a sweet spot that supports care while controlling costs.”

One thing is clear: With the current paradigm, it is often difficult to access treatment, and the well-insured patients may bear a significant and disproportionate cost (if not the entire cost) for getting care. Many who need care do not get it, regardless of their insurance status. Our status quo for psychiatric care falls short and I don’t predict that psychiatrists will rush to join networks so long as the demand for psychiatrists is greater than the supply.

Might another financial model work better? We know the system is lacking and one option, as Dr. Frank suggests, is to find solutions within the current model. But perhaps the question should not be one of how to get more psychiatrists to join networks, but of how to rework the system without the assumption that networks are the only way. While Bob is pleased that his symptoms are getting better and he’s managed a way to tackle his own bills, it’s certainly time to explore new ways of delivering and reimbursing psychiatric care.

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle of Inpatient Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016), and has a private practice in Baltimore.

Bob has been coming to therapy for a few months now. Initially, we met every week, but as his depression lifted, he asked to space the sessions out to twice a month, even as he continues to struggle with many challenges in his life. The cost, he says, is prohibitive, and while Bob believed he had good commercial insurance coverage, he’s learned a few things about insurance and mental health care.

Bob was referred to me by his internist. He knew I did not participate in his insurance network, but his policy covers out-of-network care. He’d had a number of imaging studies and then knee surgery earlier in the year, so he believed he’d met his deductible. He learned that, while he’d met his in-network deductible, he’d had no out-of-network expenses and there was a separate, much higher deductible – one he was not likely to meet with outpatient psychiatric care. In fact, the full cost of his treatment was not being subtracted from the deductible he needed to meet, but rather he was getting credit for lower usual and customary evaluation and management and psychotherapy fees for each session. It became clear that it would be many months – if ever – before Bob could expect any reimbursement for his out-of-network visits.

What Bob didn’t know was that, had he decided to switch to an in-network psychiatrist, he might well have trouble finding one, since half of psychiatrists don’t participate with any health insurance plans. And if he did see an in-network psychiatrist, he would likely need to find a separate in-network social worker or psychologist for psychotherapy, because most in-network psychiatrists see patients for short medication-management appointments. While the insurance companies would give Bob a list of providers, those lists are not kept up to date and include psychiatrists who have died, moved, aren’t taking new patients, or who have retired. The insurance company clearly states on its voicemail that verification of services does not guarantee payment, and Bob was told that the only way he could be certain of the reimbursement would be to submit the claims and wait. He went into treatment fully understanding that he might get no help with the cost from his health insurance.

When I first started in private practice in the 1990s, I joined only one panel. An older colleague told me I was foolish to hesitate, and that soon the panels would fill and it would be too late; psychiatrists wouldn’t be able to get on to the panels and would be unable to attract patients. A few years later, that same psychiatrist withdrew from all the insurance panels he was on; working on their terms was not rewarding. This division of in-network and out-of-network care is crucial to managed care: They must attract panels of doctors who will work for lower rates or with stipulations on how the doctor practices in order to save money.

But managed care came with a price: An entire administration was created to oversee the regulation of treatment. With time, some aspects of care management have vanished; it has been years since I have been asked to fill out a treatment plan to justify a need for outpatient psychotherapy. In Bob’s case, it’s clear how they save money; since he will not reach his high deductible, he will bear the full cost of his psychotherapy. Other patients who cannot afford to go out of network may give up searching and decide to go without treatment – this is not always an easy service to negotiate when one is distressed and compromised. Half of people with serious psychiatric disorders are not in treatment, and barriers to getting care are certainly one reason why.

Many psychiatrists have discovered that they can maintain a practice without being on insurance panels, as managed care only works if there are enough players willing to toss the ball. As psychiatrists have shied away from these panels, insurers have raised their reimbursement rates, and in Maryland, Medicaid also has had to raise their rates. The struggle has become one of how to get enough mental health professionals, and psychiatrists in particular, to join insurance panels in what is a shortage field.

Maybe the question of how to get enough psychiatrists to participate with insurance panels is now the wrong question. Perhaps there are better ways to spend health care dollars than on the administration and management that come with limiting which doctors patients can see. The logistics of in-network versus out-of-network care are an expensive one, and create unconscionable scenarios in other fields. For example, such scenarios include ones in which a patient is brought in for emergency care to a facility where the doctors are not in network, or a patient has a procedure with an in-network surgeon but is unaware that the anesthesiologist or other members of the care team are not on the panel.

What if insurers controlled costs by setting a reasonable fee they would pay for services and paid any licensed physician for these services? Would market forces sort this out? Would fees then set to one which insurers would be willing to pay and physicians would be willing to accept? Or would those who are ill and impoverished be blocked from getting any care? What if we tried a whole new paradigm for psychiatric care?

Richard G. Frank, PhD, is a professor of health economics at Harvard. He specializes in mental health economics and is coauthor of the book “Better But Not Well: Mental Health Policy in the United States Since 1950” (Baltimore: Johns Hopkins University Press, 2006). Dr. Frank is a proponent of insurance panels.

“In the world we live in, we need to have panels; they are essential to controlling cost. They create a balance in terms of cost and utilization control in ways that protect patients, and they create a way for the insurance companies to bargain,” he said.

Dr. Frank noted that the concept that insurers should pay a set reasonable fee to any physician a patient wants to see has been tried. “It’s called ‘reference pricing,’ and when they did that with hip replacement surgery in California, it just hasn’t worked out. Patients ended up getting larger bills than they anticipated.

“The issues with psychiatry are different,” he continued. “There is a lot of bad behavior on the part of insurers and it’s an issue of parity. We shouldn’t let insurers differentially pay psychiatrists less. They have had an incentive to reduce the availability of mental health care and it’s bad for patients. It’s about lower payments to psychiatrists and the way those payments are currently structured drives patients out of care and defeats the purpose of insurance.”

Steven Sharfstein, MD, is the former CEO of Sheppard Pratt Health Systems, a past president of the American Psychiatric Association, and coauthor of several books on the economics of psychiatry. He refers to the current practice of credentialing network psychiatrists as a means of “rationing by supply.”

“The networks create a barrier to accessing care. I don’t think it’s an efficient way to take on the high cost of care, and it creates a tiered system.” Like Dr. Frank, Dr. Sharfstein believes parity is a large part of the problem. When asked about the idea of ending networks and establishing uniform deductibles and reimbursement rates, Dr. Sharfstein replied: “It really depends. We would need fees to hit a sweet spot that supports care while controlling costs.”

One thing is clear: With the current paradigm, it is often difficult to access treatment, and the well-insured patients may bear a significant and disproportionate cost (if not the entire cost) for getting care. Many who need care do not get it, regardless of their insurance status. Our status quo for psychiatric care falls short and I don’t predict that psychiatrists will rush to join networks so long as the demand for psychiatrists is greater than the supply.

Might another financial model work better? We know the system is lacking and one option, as Dr. Frank suggests, is to find solutions within the current model. But perhaps the question should not be one of how to get more psychiatrists to join networks, but of how to rework the system without the assumption that networks are the only way. While Bob is pleased that his symptoms are getting better and he’s managed a way to tackle his own bills, it’s certainly time to explore new ways of delivering and reimbursing psychiatric care.

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle of Inpatient Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016), and has a private practice in Baltimore.

Bob has been coming to therapy for a few months now. Initially, we met every week, but as his depression lifted, he asked to space the sessions out to twice a month, even as he continues to struggle with many challenges in his life. The cost, he says, is prohibitive, and while Bob believed he had good commercial insurance coverage, he’s learned a few things about insurance and mental health care.

Bob was referred to me by his internist. He knew I did not participate in his insurance network, but his policy covers out-of-network care. He’d had a number of imaging studies and then knee surgery earlier in the year, so he believed he’d met his deductible. He learned that, while he’d met his in-network deductible, he’d had no out-of-network expenses and there was a separate, much higher deductible – one he was not likely to meet with outpatient psychiatric care. In fact, the full cost of his treatment was not being subtracted from the deductible he needed to meet, but rather he was getting credit for lower usual and customary evaluation and management and psychotherapy fees for each session. It became clear that it would be many months – if ever – before Bob could expect any reimbursement for his out-of-network visits.

What Bob didn’t know was that, had he decided to switch to an in-network psychiatrist, he might well have trouble finding one, since half of psychiatrists don’t participate with any health insurance plans. And if he did see an in-network psychiatrist, he would likely need to find a separate in-network social worker or psychologist for psychotherapy, because most in-network psychiatrists see patients for short medication-management appointments. While the insurance companies would give Bob a list of providers, those lists are not kept up to date and include psychiatrists who have died, moved, aren’t taking new patients, or who have retired. The insurance company clearly states on its voicemail that verification of services does not guarantee payment, and Bob was told that the only way he could be certain of the reimbursement would be to submit the claims and wait. He went into treatment fully understanding that he might get no help with the cost from his health insurance.

When I first started in private practice in the 1990s, I joined only one panel. An older colleague told me I was foolish to hesitate, and that soon the panels would fill and it would be too late; psychiatrists wouldn’t be able to get on to the panels and would be unable to attract patients. A few years later, that same psychiatrist withdrew from all the insurance panels he was on; working on their terms was not rewarding. This division of in-network and out-of-network care is crucial to managed care: They must attract panels of doctors who will work for lower rates or with stipulations on how the doctor practices in order to save money.

But managed care came with a price: An entire administration was created to oversee the regulation of treatment. With time, some aspects of care management have vanished; it has been years since I have been asked to fill out a treatment plan to justify a need for outpatient psychotherapy. In Bob’s case, it’s clear how they save money; since he will not reach his high deductible, he will bear the full cost of his psychotherapy. Other patients who cannot afford to go out of network may give up searching and decide to go without treatment – this is not always an easy service to negotiate when one is distressed and compromised. Half of people with serious psychiatric disorders are not in treatment, and barriers to getting care are certainly one reason why.

Many psychiatrists have discovered that they can maintain a practice without being on insurance panels, as managed care only works if there are enough players willing to toss the ball. As psychiatrists have shied away from these panels, insurers have raised their reimbursement rates, and in Maryland, Medicaid also has had to raise their rates. The struggle has become one of how to get enough mental health professionals, and psychiatrists in particular, to join insurance panels in what is a shortage field.

Maybe the question of how to get enough psychiatrists to participate with insurance panels is now the wrong question. Perhaps there are better ways to spend health care dollars than on the administration and management that come with limiting which doctors patients can see. The logistics of in-network versus out-of-network care are an expensive one, and create unconscionable scenarios in other fields. For example, such scenarios include ones in which a patient is brought in for emergency care to a facility where the doctors are not in network, or a patient has a procedure with an in-network surgeon but is unaware that the anesthesiologist or other members of the care team are not on the panel.

What if insurers controlled costs by setting a reasonable fee they would pay for services and paid any licensed physician for these services? Would market forces sort this out? Would fees then set to one which insurers would be willing to pay and physicians would be willing to accept? Or would those who are ill and impoverished be blocked from getting any care? What if we tried a whole new paradigm for psychiatric care?

Richard G. Frank, PhD, is a professor of health economics at Harvard. He specializes in mental health economics and is coauthor of the book “Better But Not Well: Mental Health Policy in the United States Since 1950” (Baltimore: Johns Hopkins University Press, 2006). Dr. Frank is a proponent of insurance panels.

“In the world we live in, we need to have panels; they are essential to controlling cost. They create a balance in terms of cost and utilization control in ways that protect patients, and they create a way for the insurance companies to bargain,” he said.

Dr. Frank noted that the concept that insurers should pay a set reasonable fee to any physician a patient wants to see has been tried. “It’s called ‘reference pricing,’ and when they did that with hip replacement surgery in California, it just hasn’t worked out. Patients ended up getting larger bills than they anticipated.

“The issues with psychiatry are different,” he continued. “There is a lot of bad behavior on the part of insurers and it’s an issue of parity. We shouldn’t let insurers differentially pay psychiatrists less. They have had an incentive to reduce the availability of mental health care and it’s bad for patients. It’s about lower payments to psychiatrists and the way those payments are currently structured drives patients out of care and defeats the purpose of insurance.”

Steven Sharfstein, MD, is the former CEO of Sheppard Pratt Health Systems, a past president of the American Psychiatric Association, and coauthor of several books on the economics of psychiatry. He refers to the current practice of credentialing network psychiatrists as a means of “rationing by supply.”

“The networks create a barrier to accessing care. I don’t think it’s an efficient way to take on the high cost of care, and it creates a tiered system.” Like Dr. Frank, Dr. Sharfstein believes parity is a large part of the problem. When asked about the idea of ending networks and establishing uniform deductibles and reimbursement rates, Dr. Sharfstein replied: “It really depends. We would need fees to hit a sweet spot that supports care while controlling costs.”

One thing is clear: With the current paradigm, it is often difficult to access treatment, and the well-insured patients may bear a significant and disproportionate cost (if not the entire cost) for getting care. Many who need care do not get it, regardless of their insurance status. Our status quo for psychiatric care falls short and I don’t predict that psychiatrists will rush to join networks so long as the demand for psychiatrists is greater than the supply.

Might another financial model work better? We know the system is lacking and one option, as Dr. Frank suggests, is to find solutions within the current model. But perhaps the question should not be one of how to get more psychiatrists to join networks, but of how to rework the system without the assumption that networks are the only way. While Bob is pleased that his symptoms are getting better and he’s managed a way to tackle his own bills, it’s certainly time to explore new ways of delivering and reimbursing psychiatric care.

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle of Inpatient Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016), and has a private practice in Baltimore.

Pretreatment CT data may help identify responders to immunotherapy in ovarian cancer, according to a new study.

Specifically, fewer sites of disease and lower intratumor heterogeneity on contrast-enhanced CT may indicate a higher likelihood of durable response to immune checkpoint inhibitors, according to results of the retrospective study, recently published in JCO Precision Oncology.

“Our results suggest that quantitative analysis of baseline contrast-enhanced CT may facilitate the delivery of precision medicine to patients with ovarian cancer by identifying patients who may benefit from immunotherapy,” wrote Yuki Himoto, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues.

The study leverages findings from the emerging field of radiomics, which the investigators note allows for “virtual sampling” of tumor heterogeneity within a single lesion and between lesions.

“This information may complement molecular profiling in personalizing medical decisions,” Dr. Himoto and coauthors explained.

The study cohort included 75 patients with recurrent ovarian cancer who were enrolled in ongoing, prospective trials of immunotherapy, according to the researchers. Of that group, just under one in five derived a durable clinical benefit, defined as progression-free survival lasting at least 24 weeks.

In univariable analysis, they found a number of contrast-enhanced CT variables were linked to durable clinical benefit, including fewer disease sites, lower cluster-site entropy and dissimilarity, which they wrote were an indicator of lower intertumor heterogeneity, and higher energy in the largest-volume lesion, which they described as an indicator of lower intratumor heterogeneity.

However, in multivariable analysis, the only variables that were still associated with durable clinical benefit were fewer disease sites (odds ratio, 1.64; 95% confidence interval, 1.19-2.27; P = .012) and higher energy in the largest lesion (odds ratio, 1.41; 95% CI, 1.11-1.81; P = .006), according to the report.

Those two factors combined were a composite indicator of durable clinical benefit (C-index, 0.821).

These findings could represent a step forward in the provision of immunotherapy in ovarian cancer, which exhibits poor response to immune checkpoint inhibitors, compared with some other cancer types, the investigators wrote.

More insights are needed, however, to help personalize the selection of immunotherapy in ovarian cancer, including a better understanding of cancer immune reactions and retooling of immune response criteria, they added.

“Composite multimodal multifaceted biomarkers that noninvasively capture spatiotemporal tumor heterogeneity will likely be necessary to comprehensively assess immune the tumor microenvironment and serve as clinical decision support for prognosis inference and prediction of response,” Dr. Himoto and associates wrote.

The study was supported by the National Cancer Institute, among other sources. Study authors reported disclosures related to Merck, Bristol-Myers Squibb, Genentech, Celgene, AstraZeneca, Y-mAbs Therapeutics, and others.

SOURCE: Himoto Y et al. JCO Precis Oncol. 2019 Aug 13. doi: 10.1200/PO.19.00038.

Pretreatment CT data may help identify responders to immunotherapy in ovarian cancer, according to a new study.

Specifically, fewer sites of disease and lower intratumor heterogeneity on contrast-enhanced CT may indicate a higher likelihood of durable response to immune checkpoint inhibitors, according to results of the retrospective study, recently published in JCO Precision Oncology.

“Our results suggest that quantitative analysis of baseline contrast-enhanced CT may facilitate the delivery of precision medicine to patients with ovarian cancer by identifying patients who may benefit from immunotherapy,” wrote Yuki Himoto, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues.

The study leverages findings from the emerging field of radiomics, which the investigators note allows for “virtual sampling” of tumor heterogeneity within a single lesion and between lesions.

“This information may complement molecular profiling in personalizing medical decisions,” Dr. Himoto and coauthors explained.

The study cohort included 75 patients with recurrent ovarian cancer who were enrolled in ongoing, prospective trials of immunotherapy, according to the researchers. Of that group, just under one in five derived a durable clinical benefit, defined as progression-free survival lasting at least 24 weeks.

In univariable analysis, they found a number of contrast-enhanced CT variables were linked to durable clinical benefit, including fewer disease sites, lower cluster-site entropy and dissimilarity, which they wrote were an indicator of lower intertumor heterogeneity, and higher energy in the largest-volume lesion, which they described as an indicator of lower intratumor heterogeneity.

However, in multivariable analysis, the only variables that were still associated with durable clinical benefit were fewer disease sites (odds ratio, 1.64; 95% confidence interval, 1.19-2.27; P = .012) and higher energy in the largest lesion (odds ratio, 1.41; 95% CI, 1.11-1.81; P = .006), according to the report.

Those two factors combined were a composite indicator of durable clinical benefit (C-index, 0.821).

These findings could represent a step forward in the provision of immunotherapy in ovarian cancer, which exhibits poor response to immune checkpoint inhibitors, compared with some other cancer types, the investigators wrote.

More insights are needed, however, to help personalize the selection of immunotherapy in ovarian cancer, including a better understanding of cancer immune reactions and retooling of immune response criteria, they added.

“Composite multimodal multifaceted biomarkers that noninvasively capture spatiotemporal tumor heterogeneity will likely be necessary to comprehensively assess immune the tumor microenvironment and serve as clinical decision support for prognosis inference and prediction of response,” Dr. Himoto and associates wrote.

The study was supported by the National Cancer Institute, among other sources. Study authors reported disclosures related to Merck, Bristol-Myers Squibb, Genentech, Celgene, AstraZeneca, Y-mAbs Therapeutics, and others.

SOURCE: Himoto Y et al. JCO Precis Oncol. 2019 Aug 13. doi: 10.1200/PO.19.00038.

Pretreatment CT data may help identify responders to immunotherapy in ovarian cancer, according to a new study.

Specifically, fewer sites of disease and lower intratumor heterogeneity on contrast-enhanced CT may indicate a higher likelihood of durable response to immune checkpoint inhibitors, according to results of the retrospective study, recently published in JCO Precision Oncology.

“Our results suggest that quantitative analysis of baseline contrast-enhanced CT may facilitate the delivery of precision medicine to patients with ovarian cancer by identifying patients who may benefit from immunotherapy,” wrote Yuki Himoto, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues.

The study leverages findings from the emerging field of radiomics, which the investigators note allows for “virtual sampling” of tumor heterogeneity within a single lesion and between lesions.

“This information may complement molecular profiling in personalizing medical decisions,” Dr. Himoto and coauthors explained.

The study cohort included 75 patients with recurrent ovarian cancer who were enrolled in ongoing, prospective trials of immunotherapy, according to the researchers. Of that group, just under one in five derived a durable clinical benefit, defined as progression-free survival lasting at least 24 weeks.

In univariable analysis, they found a number of contrast-enhanced CT variables were linked to durable clinical benefit, including fewer disease sites, lower cluster-site entropy and dissimilarity, which they wrote were an indicator of lower intertumor heterogeneity, and higher energy in the largest-volume lesion, which they described as an indicator of lower intratumor heterogeneity.

However, in multivariable analysis, the only variables that were still associated with durable clinical benefit were fewer disease sites (odds ratio, 1.64; 95% confidence interval, 1.19-2.27; P = .012) and higher energy in the largest lesion (odds ratio, 1.41; 95% CI, 1.11-1.81; P = .006), according to the report.

Those two factors combined were a composite indicator of durable clinical benefit (C-index, 0.821).

These findings could represent a step forward in the provision of immunotherapy in ovarian cancer, which exhibits poor response to immune checkpoint inhibitors, compared with some other cancer types, the investigators wrote.

More insights are needed, however, to help personalize the selection of immunotherapy in ovarian cancer, including a better understanding of cancer immune reactions and retooling of immune response criteria, they added.

“Composite multimodal multifaceted biomarkers that noninvasively capture spatiotemporal tumor heterogeneity will likely be necessary to comprehensively assess immune the tumor microenvironment and serve as clinical decision support for prognosis inference and prediction of response,” Dr. Himoto and associates wrote.

The study was supported by the National Cancer Institute, among other sources. Study authors reported disclosures related to Merck, Bristol-Myers Squibb, Genentech, Celgene, AstraZeneca, Y-mAbs Therapeutics, and others.

SOURCE: Himoto Y et al. JCO Precis Oncol. 2019 Aug 13. doi: 10.1200/PO.19.00038.