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Federal medical tort reform: Has its time come?
Question: Congressional proposals on medical tort reform can be expected to include the following, except:
A. A no-fault system akin to automobile no-fault insurance.
B. A cap on noneconomic damages.
C. “Safe-harbor” immunity against medical negligence.
D. Health courts in place of the judge/jury system to adjudicate claims.
E. Promotion of laws that encourage apologies and error disclosures.
Answer: A. Under the current Republican administration, one can expect legislative efforts at federal tort reform, especially given that Thomas E. Price, MD, the new secretary of the Department of Health & Human Services, is an orthopedic surgeon who has spoken passionately about defensive medicine, damage caps, health tribunals, and practice guidelines. As a former House representative for Georgia, Dr. Price has introduced several tort reform bills, so it is likely that any omnibus federal law will incorporate some of his proposals.1
Over the decades, many states have gone ahead in enacting their own statutes while awaiting federal action. Iowa is the latest example. It recently passed legislation that included a noneconomic damages cap of $250,000, stronger expert witness standards, a certificate of merit in all medical liability lawsuits, and an expansion of its “candor” protections.2 Additional reforms in other states include pretrial screening panels; arbitration; structured periodic payments in lieu of lump sum payments; penalties for frivolous suits; shortened statutes of limitations; making the loser bear all litigation costs; abolishing the collateral source rule, as well as joint and several liability; and limiting attorney contingency fees.
The best-known reform is a cap on noneconomic losses, such as pain and suffering, that doesn’t abridge compensation for economic losses, i.e., medical expenses and lost wages. This provides some predictability because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments.
Interestingly, Dr. Price himself has not pushed for a federal cap on noneconomic damages, but other Republican bills have proposed a cap of $250,000. Many states, such as California, Kansas, and Texas, have seen their cap statutes withstand constitutional challenge. However, other jurisdictions, notably Georgia, Illinois, and Missouri, have ruled them unconstitutional.
California’s law, popularly known as MICRA (Medical Injury Compensation Reform Act), came under renewed attack in 2015 with a wrongful death suit from hemorrhagic complications related to Coumadin (warfarin) use following heart surgery.3 The plaintiff’s constitutional challenges included violation of equal protection, due process, and the right to a jury trial, but these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000, as required under MICRA. A California court of appeal rejected her claim as being “contrary to many well-established legal principles.”
On the other hand, Florida’s Supreme Court recently held in a closely divided decision of 4-3 that the state’s caps were unconstitutional.4 The law limited noneconomic damages in malpractice cases to either $500,000 or $1 million if the injuries were catastrophic. The court ruled that the caps were arbitrary and unfairly hurt the most severely injured. It was unconvinced that they would reduce malpractice insurance rates; at any rate, there was no present crisis to justify the caps. The decision came 3 years after the court had struck down caps in a case of wrongful death.5
Three relative newcomers to the legal landscape – health courts, apology laws, and safe harbors – appear to be taking center stage in any forthcoming federal reform measures.
Health courts
Under this proposal, so-called health panels and tribunals would now adjudicate malpractice claims. Such health courts would dispense with the jury; further, regular judges would be replaced with specialized judges who would make binding determinations. In one version, a panel of medical experts would initially screen the complaint, followed by an administrative health care tribunal that would feature judges with medical expertise. These tribunals would issue binding rulings, but either party could appeal to a state court for a reversal.
In countries such as Scandinavia and New Zealand, these administrative compensation approaches are coupled to a no-fault system and appear to work well. However, unlike auto no-fault and workers’ compensation, the notion of medical no-fault has never caught on in the United States.
As currently construed, health courts evince dramatic departures from traditional rules of civil procedure. For one, the panels may render decisions before discovery has occurred, which would substantially limit a patient’s ability to learn the facts of what had happened to cause the injury. The panel may rely on a standard of “gross negligence” instead of “ordinary negligence,” requiring evidence not merely of substandard care but of recklessness. This would be a heavier burden on the victim, and could be expected to generate stiff opposition from the plaintiff’s bar. In addition, evidentiary rules may be modified, requiring that an appeal show with clear and convincing proof that the tribunal had erred.
Apology law
Disclosure of medical errors to the injured patient is believed to serve as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called apology laws that disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician.
For example, the Ohio Supreme Court ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute.6 Apology laws vary from state to state, and some do not shield admissions regarding causation of error or fault.
However, it is unclear if apology laws work. A recent study from Vanderbilt University reported that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit.7 And for surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
Safe harbors
A proposal released by U.S. House Speaker Paul Ryan (R-Wis.) in June 2016 made reference to “safe harbors” from liability for those adhering to clinical practice guidelines. The Institute of Medicine defines practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”
There are thousands of guidelines that have been developed by medical organizations and governmental agencies, as well as by insurance carriers, managed care organizations, and others. They purport to define the best evidence-based medicine, and if they were arrived at by the consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards.
Theoretically, adherence to guidelines could reduce the practice of defensive medicine and improve the quality of care. However, the available evidence does not indicate that guideline-based safe harbors will prove very effective in reducing malpractice claims: They are inapplicable in 85% of cases, and they have been estimated to eliminate defendants’ payments in less than 1% of claims.
Whether any form of tort reform emerges from the current Congress is as much about politics as it is about justice. It comes at an inopportune time, given the impasse over the health care debate. Still, on June 29, 2017, the U.S. House passed a medical liability reform bill with a vote of 218-210 along party lines that would cap noneconomic damages at $250,000, shorten the statute of limitations to 3 years after the date of injury, and abolish joint and several liability.8 The outlook in the U.S. Senate, however, is anything but certain.
References
1. N Engl J Med. 2017 May 11;376(19):1806-8.
2. “Sweeping new tort reforms will protect Iowa physicians” AMA Wire. June 1, 2017.
3. Chan v. Curran, 237 CA 4th 601 (2015).
4. N. Broward Hospital District v. Kalitan, (Florida Supreme Court, decided June 8, 2017).
5. Estate of Michelle Evette McCall v. U.S., 2014 Fla LEXIS 933 (No. SC 11-1148; March 13, 2014).
6. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).
7. “Sorry is Never Enough: The Effect of State Apology Laws on Medical Malpractice Liability Risk” SSRN. 2016 Dec 10.
8. Protecting Access to Care Act of 2017 (H.R. 1215).
Question: Congressional proposals on medical tort reform can be expected to include the following, except:
A. A no-fault system akin to automobile no-fault insurance.
B. A cap on noneconomic damages.
C. “Safe-harbor” immunity against medical negligence.
D. Health courts in place of the judge/jury system to adjudicate claims.
E. Promotion of laws that encourage apologies and error disclosures.
Answer: A. Under the current Republican administration, one can expect legislative efforts at federal tort reform, especially given that Thomas E. Price, MD, the new secretary of the Department of Health & Human Services, is an orthopedic surgeon who has spoken passionately about defensive medicine, damage caps, health tribunals, and practice guidelines. As a former House representative for Georgia, Dr. Price has introduced several tort reform bills, so it is likely that any omnibus federal law will incorporate some of his proposals.1
Over the decades, many states have gone ahead in enacting their own statutes while awaiting federal action. Iowa is the latest example. It recently passed legislation that included a noneconomic damages cap of $250,000, stronger expert witness standards, a certificate of merit in all medical liability lawsuits, and an expansion of its “candor” protections.2 Additional reforms in other states include pretrial screening panels; arbitration; structured periodic payments in lieu of lump sum payments; penalties for frivolous suits; shortened statutes of limitations; making the loser bear all litigation costs; abolishing the collateral source rule, as well as joint and several liability; and limiting attorney contingency fees.
The best-known reform is a cap on noneconomic losses, such as pain and suffering, that doesn’t abridge compensation for economic losses, i.e., medical expenses and lost wages. This provides some predictability because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments.
Interestingly, Dr. Price himself has not pushed for a federal cap on noneconomic damages, but other Republican bills have proposed a cap of $250,000. Many states, such as California, Kansas, and Texas, have seen their cap statutes withstand constitutional challenge. However, other jurisdictions, notably Georgia, Illinois, and Missouri, have ruled them unconstitutional.
California’s law, popularly known as MICRA (Medical Injury Compensation Reform Act), came under renewed attack in 2015 with a wrongful death suit from hemorrhagic complications related to Coumadin (warfarin) use following heart surgery.3 The plaintiff’s constitutional challenges included violation of equal protection, due process, and the right to a jury trial, but these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000, as required under MICRA. A California court of appeal rejected her claim as being “contrary to many well-established legal principles.”
On the other hand, Florida’s Supreme Court recently held in a closely divided decision of 4-3 that the state’s caps were unconstitutional.4 The law limited noneconomic damages in malpractice cases to either $500,000 or $1 million if the injuries were catastrophic. The court ruled that the caps were arbitrary and unfairly hurt the most severely injured. It was unconvinced that they would reduce malpractice insurance rates; at any rate, there was no present crisis to justify the caps. The decision came 3 years after the court had struck down caps in a case of wrongful death.5
Three relative newcomers to the legal landscape – health courts, apology laws, and safe harbors – appear to be taking center stage in any forthcoming federal reform measures.
Health courts
Under this proposal, so-called health panels and tribunals would now adjudicate malpractice claims. Such health courts would dispense with the jury; further, regular judges would be replaced with specialized judges who would make binding determinations. In one version, a panel of medical experts would initially screen the complaint, followed by an administrative health care tribunal that would feature judges with medical expertise. These tribunals would issue binding rulings, but either party could appeal to a state court for a reversal.
In countries such as Scandinavia and New Zealand, these administrative compensation approaches are coupled to a no-fault system and appear to work well. However, unlike auto no-fault and workers’ compensation, the notion of medical no-fault has never caught on in the United States.
As currently construed, health courts evince dramatic departures from traditional rules of civil procedure. For one, the panels may render decisions before discovery has occurred, which would substantially limit a patient’s ability to learn the facts of what had happened to cause the injury. The panel may rely on a standard of “gross negligence” instead of “ordinary negligence,” requiring evidence not merely of substandard care but of recklessness. This would be a heavier burden on the victim, and could be expected to generate stiff opposition from the plaintiff’s bar. In addition, evidentiary rules may be modified, requiring that an appeal show with clear and convincing proof that the tribunal had erred.
Apology law
Disclosure of medical errors to the injured patient is believed to serve as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called apology laws that disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician.
For example, the Ohio Supreme Court ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute.6 Apology laws vary from state to state, and some do not shield admissions regarding causation of error or fault.
However, it is unclear if apology laws work. A recent study from Vanderbilt University reported that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit.7 And for surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
Safe harbors
A proposal released by U.S. House Speaker Paul Ryan (R-Wis.) in June 2016 made reference to “safe harbors” from liability for those adhering to clinical practice guidelines. The Institute of Medicine defines practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”
There are thousands of guidelines that have been developed by medical organizations and governmental agencies, as well as by insurance carriers, managed care organizations, and others. They purport to define the best evidence-based medicine, and if they were arrived at by the consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards.
Theoretically, adherence to guidelines could reduce the practice of defensive medicine and improve the quality of care. However, the available evidence does not indicate that guideline-based safe harbors will prove very effective in reducing malpractice claims: They are inapplicable in 85% of cases, and they have been estimated to eliminate defendants’ payments in less than 1% of claims.
Whether any form of tort reform emerges from the current Congress is as much about politics as it is about justice. It comes at an inopportune time, given the impasse over the health care debate. Still, on June 29, 2017, the U.S. House passed a medical liability reform bill with a vote of 218-210 along party lines that would cap noneconomic damages at $250,000, shorten the statute of limitations to 3 years after the date of injury, and abolish joint and several liability.8 The outlook in the U.S. Senate, however, is anything but certain.
References
1. N Engl J Med. 2017 May 11;376(19):1806-8.
2. “Sweeping new tort reforms will protect Iowa physicians” AMA Wire. June 1, 2017.
3. Chan v. Curran, 237 CA 4th 601 (2015).
4. N. Broward Hospital District v. Kalitan, (Florida Supreme Court, decided June 8, 2017).
5. Estate of Michelle Evette McCall v. U.S., 2014 Fla LEXIS 933 (No. SC 11-1148; March 13, 2014).
6. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).
7. “Sorry is Never Enough: The Effect of State Apology Laws on Medical Malpractice Liability Risk” SSRN. 2016 Dec 10.
8. Protecting Access to Care Act of 2017 (H.R. 1215).
Question: Congressional proposals on medical tort reform can be expected to include the following, except:
A. A no-fault system akin to automobile no-fault insurance.
B. A cap on noneconomic damages.
C. “Safe-harbor” immunity against medical negligence.
D. Health courts in place of the judge/jury system to adjudicate claims.
E. Promotion of laws that encourage apologies and error disclosures.
Answer: A. Under the current Republican administration, one can expect legislative efforts at federal tort reform, especially given that Thomas E. Price, MD, the new secretary of the Department of Health & Human Services, is an orthopedic surgeon who has spoken passionately about defensive medicine, damage caps, health tribunals, and practice guidelines. As a former House representative for Georgia, Dr. Price has introduced several tort reform bills, so it is likely that any omnibus federal law will incorporate some of his proposals.1
Over the decades, many states have gone ahead in enacting their own statutes while awaiting federal action. Iowa is the latest example. It recently passed legislation that included a noneconomic damages cap of $250,000, stronger expert witness standards, a certificate of merit in all medical liability lawsuits, and an expansion of its “candor” protections.2 Additional reforms in other states include pretrial screening panels; arbitration; structured periodic payments in lieu of lump sum payments; penalties for frivolous suits; shortened statutes of limitations; making the loser bear all litigation costs; abolishing the collateral source rule, as well as joint and several liability; and limiting attorney contingency fees.
The best-known reform is a cap on noneconomic losses, such as pain and suffering, that doesn’t abridge compensation for economic losses, i.e., medical expenses and lost wages. This provides some predictability because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments.
Interestingly, Dr. Price himself has not pushed for a federal cap on noneconomic damages, but other Republican bills have proposed a cap of $250,000. Many states, such as California, Kansas, and Texas, have seen their cap statutes withstand constitutional challenge. However, other jurisdictions, notably Georgia, Illinois, and Missouri, have ruled them unconstitutional.
California’s law, popularly known as MICRA (Medical Injury Compensation Reform Act), came under renewed attack in 2015 with a wrongful death suit from hemorrhagic complications related to Coumadin (warfarin) use following heart surgery.3 The plaintiff’s constitutional challenges included violation of equal protection, due process, and the right to a jury trial, but these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000, as required under MICRA. A California court of appeal rejected her claim as being “contrary to many well-established legal principles.”
On the other hand, Florida’s Supreme Court recently held in a closely divided decision of 4-3 that the state’s caps were unconstitutional.4 The law limited noneconomic damages in malpractice cases to either $500,000 or $1 million if the injuries were catastrophic. The court ruled that the caps were arbitrary and unfairly hurt the most severely injured. It was unconvinced that they would reduce malpractice insurance rates; at any rate, there was no present crisis to justify the caps. The decision came 3 years after the court had struck down caps in a case of wrongful death.5
Three relative newcomers to the legal landscape – health courts, apology laws, and safe harbors – appear to be taking center stage in any forthcoming federal reform measures.
Health courts
Under this proposal, so-called health panels and tribunals would now adjudicate malpractice claims. Such health courts would dispense with the jury; further, regular judges would be replaced with specialized judges who would make binding determinations. In one version, a panel of medical experts would initially screen the complaint, followed by an administrative health care tribunal that would feature judges with medical expertise. These tribunals would issue binding rulings, but either party could appeal to a state court for a reversal.
In countries such as Scandinavia and New Zealand, these administrative compensation approaches are coupled to a no-fault system and appear to work well. However, unlike auto no-fault and workers’ compensation, the notion of medical no-fault has never caught on in the United States.
As currently construed, health courts evince dramatic departures from traditional rules of civil procedure. For one, the panels may render decisions before discovery has occurred, which would substantially limit a patient’s ability to learn the facts of what had happened to cause the injury. The panel may rely on a standard of “gross negligence” instead of “ordinary negligence,” requiring evidence not merely of substandard care but of recklessness. This would be a heavier burden on the victim, and could be expected to generate stiff opposition from the plaintiff’s bar. In addition, evidentiary rules may be modified, requiring that an appeal show with clear and convincing proof that the tribunal had erred.
Apology law
Disclosure of medical errors to the injured patient is believed to serve as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called apology laws that disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician.
For example, the Ohio Supreme Court ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute.6 Apology laws vary from state to state, and some do not shield admissions regarding causation of error or fault.
However, it is unclear if apology laws work. A recent study from Vanderbilt University reported that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit.7 And for surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
Safe harbors
A proposal released by U.S. House Speaker Paul Ryan (R-Wis.) in June 2016 made reference to “safe harbors” from liability for those adhering to clinical practice guidelines. The Institute of Medicine defines practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”
There are thousands of guidelines that have been developed by medical organizations and governmental agencies, as well as by insurance carriers, managed care organizations, and others. They purport to define the best evidence-based medicine, and if they were arrived at by the consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards.
Theoretically, adherence to guidelines could reduce the practice of defensive medicine and improve the quality of care. However, the available evidence does not indicate that guideline-based safe harbors will prove very effective in reducing malpractice claims: They are inapplicable in 85% of cases, and they have been estimated to eliminate defendants’ payments in less than 1% of claims.
Whether any form of tort reform emerges from the current Congress is as much about politics as it is about justice. It comes at an inopportune time, given the impasse over the health care debate. Still, on June 29, 2017, the U.S. House passed a medical liability reform bill with a vote of 218-210 along party lines that would cap noneconomic damages at $250,000, shorten the statute of limitations to 3 years after the date of injury, and abolish joint and several liability.8 The outlook in the U.S. Senate, however, is anything but certain.
References
1. N Engl J Med. 2017 May 11;376(19):1806-8.
2. “Sweeping new tort reforms will protect Iowa physicians” AMA Wire. June 1, 2017.
3. Chan v. Curran, 237 CA 4th 601 (2015).
4. N. Broward Hospital District v. Kalitan, (Florida Supreme Court, decided June 8, 2017).
5. Estate of Michelle Evette McCall v. U.S., 2014 Fla LEXIS 933 (No. SC 11-1148; March 13, 2014).
6. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).
7. “Sorry is Never Enough: The Effect of State Apology Laws on Medical Malpractice Liability Risk” SSRN. 2016 Dec 10.
8. Protecting Access to Care Act of 2017 (H.R. 1215).
Physician liability in opioid deaths
Question: Regarding opioid deaths, which of the following is incorrect?
A. The term refers to accidental or intentional deaths caused mostly by heroin.
B. They are reaching epidemic proportions.
C. May form the basis for a wrongful death lawsuit.
D. May lead to loss of medical license.
E. The physician may face prosecution for homicide.
Answer: A. Opioids are a class of drugs that include the illegal drug heroin, as well as prescription drugs such as fentanyl, oxycodone, hydrocodone, codeine, and morphine. To be sure, opioid deaths occur in addicts from the deliberate or accidental use of heroin; but other opioids, especially painkillers, are also widely implicated. In addition, deaths have resulted from the careless, negligent, reckless, or wanton conduct of doctors who prescribe them without the proper indications or in inappropriate amounts, and then fail to provide careful follow-up.
Physicians may face both civil and criminal liabilities in such a situation. One remedy sought in wrongful death is a civil action, i.e., a malpractice lawsuit against the negligent doctor. The plaintiff is asserting that by violating community professional standards, the physician’s substandard conduct breached his duty of due care and was a proximate cause of the patient’s death. The evidentiary proof that is required to sustain such an allegation is “more probable than not” or “preponderance of evidence,” and expert medical testimony is typically necessary to establish the requisite standard of care and causation. Where there is gross negligence, i.e., egregious conduct that was reckless, the jury may award punitive damages.
Not infrequently, the wayward doctor faces triple liability: a civil lawsuit, state medical board action, and criminal prosecution for homicide. Given the publicity over soaring opioid death rates, one can expect aggressive prosecution of dealers and doctors alike.
This was not the first such case in Oklahoma. In 2014, a 71-year-old pain management doctor pleaded guilty to eight counts of second-degree murder in connection with several drug overdose deaths and will serve 8 years in prison. The doctor had reportedly prescribed more controlled drugs than any other physician in the state of Oklahoma. These drugs included hydrocodone, oxycodone, alprazolam, diazepam (Valium), and carisoprodol (Soma) – as many as 600 pills at a time. He allegedly accepted only cash payment for the office visits, and a review of his patient files revealed inadequate assessment of patient complaints or physical findings to justify the prescriptions.
Other states have been equally aggressive in prosecuting doctors over opioid deaths from reckless prescribing habits.
For the first time, New York in 2014 convicted a doctor of manslaughter in the overdose deaths of patients from oxycodone and alprazolam (Xanax). Some of the patients were prescribed as many as 500-800 pills over a 5- to 6-week period. The defendant, an anesthesiologist and pain management specialist, allegedly saw upward of 90 patients a day in his Queens weekend storefront clinic, charging them on a per-prescription basis. In his defense, he claimed that he was simply trying to help suffering people who misused medications and who misled him (“tough patients and good liars”).
Likewise, a Los Angeles–area doctor was recently convicted of second-degree murder for prescribing painkillers that killed three patients, and he was sentenced to 30 years to life in prison.
According to the Centers for Disease Control and Prevention, both drug overdose and opioid-involved deaths continue to increase in the United States.2 The majority of drug overdose deaths (more than 6 out of 10) involve an opioid, and the number has quadrupled since 1999.2 It has been estimated that more than 18,000 overdose deaths in 2014 involved prescription painkillers, while an additional 10,000 fatalities were attributed to heroin and 5,000 to fentanyl and other synthetic opioids. Overdose deaths exceed motor vehicle accidents as the leading cause of injury-related deaths. About 90 Americans die every day from an opioid overdose, and opioids have been forecast to kill 500,000 Americans over the next decade.
The CDC acknowledges that prescription opioids are a driving factor, noting that since 1999, the amount sold in the United States has nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report.
States such as Missouri, faced with the skyrocketing cost of treating the opioid epidemic, have sued the drug manufacturers, blaming them for their “campaign of fraud and deception.” At the same time, doctors have been deemed the “biggest culprit” for the opioid addiction epidemic, and one author has pointedly asserted that “by refusing to accept their inability to separate pain relief from addiction, physicians have long suffered the sin of hubris – and their patients have paid the price.”3
The U.S. Surgeon General recently took the historic step of writing to all American doctors asking for their help. And the American Medical Association has developed an educational module explaining the epidemic and how opioid misuse is linked to heroin addiction. The module also outlines risk-reducing steps when using opioids for pain relief.4
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. Some of the materials here have appeared in previous columns by the author. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Available at www.foxnews.om/health/2017/06/26/oklahoma-doctor-charged-in-opioid-deaths-5-patients.html. Accessed June 28, 2017.
2. Available at www.cdc.gov/drugoverdose/epidemic/index.html. Accessed June 28, 2017.
3. Available at www.thedailybeast.com/the-doctors-who-started-the-opioid-epidemic. Accessed June 27, 2017.
4. https://www.end-opioid-epidemic.org. Accessed July 5, 2017.
Question: Regarding opioid deaths, which of the following is incorrect?
A. The term refers to accidental or intentional deaths caused mostly by heroin.
B. They are reaching epidemic proportions.
C. May form the basis for a wrongful death lawsuit.
D. May lead to loss of medical license.
E. The physician may face prosecution for homicide.
Answer: A. Opioids are a class of drugs that include the illegal drug heroin, as well as prescription drugs such as fentanyl, oxycodone, hydrocodone, codeine, and morphine. To be sure, opioid deaths occur in addicts from the deliberate or accidental use of heroin; but other opioids, especially painkillers, are also widely implicated. In addition, deaths have resulted from the careless, negligent, reckless, or wanton conduct of doctors who prescribe them without the proper indications or in inappropriate amounts, and then fail to provide careful follow-up.
Physicians may face both civil and criminal liabilities in such a situation. One remedy sought in wrongful death is a civil action, i.e., a malpractice lawsuit against the negligent doctor. The plaintiff is asserting that by violating community professional standards, the physician’s substandard conduct breached his duty of due care and was a proximate cause of the patient’s death. The evidentiary proof that is required to sustain such an allegation is “more probable than not” or “preponderance of evidence,” and expert medical testimony is typically necessary to establish the requisite standard of care and causation. Where there is gross negligence, i.e., egregious conduct that was reckless, the jury may award punitive damages.
Not infrequently, the wayward doctor faces triple liability: a civil lawsuit, state medical board action, and criminal prosecution for homicide. Given the publicity over soaring opioid death rates, one can expect aggressive prosecution of dealers and doctors alike.
This was not the first such case in Oklahoma. In 2014, a 71-year-old pain management doctor pleaded guilty to eight counts of second-degree murder in connection with several drug overdose deaths and will serve 8 years in prison. The doctor had reportedly prescribed more controlled drugs than any other physician in the state of Oklahoma. These drugs included hydrocodone, oxycodone, alprazolam, diazepam (Valium), and carisoprodol (Soma) – as many as 600 pills at a time. He allegedly accepted only cash payment for the office visits, and a review of his patient files revealed inadequate assessment of patient complaints or physical findings to justify the prescriptions.
Other states have been equally aggressive in prosecuting doctors over opioid deaths from reckless prescribing habits.
For the first time, New York in 2014 convicted a doctor of manslaughter in the overdose deaths of patients from oxycodone and alprazolam (Xanax). Some of the patients were prescribed as many as 500-800 pills over a 5- to 6-week period. The defendant, an anesthesiologist and pain management specialist, allegedly saw upward of 90 patients a day in his Queens weekend storefront clinic, charging them on a per-prescription basis. In his defense, he claimed that he was simply trying to help suffering people who misused medications and who misled him (“tough patients and good liars”).
Likewise, a Los Angeles–area doctor was recently convicted of second-degree murder for prescribing painkillers that killed three patients, and he was sentenced to 30 years to life in prison.
According to the Centers for Disease Control and Prevention, both drug overdose and opioid-involved deaths continue to increase in the United States.2 The majority of drug overdose deaths (more than 6 out of 10) involve an opioid, and the number has quadrupled since 1999.2 It has been estimated that more than 18,000 overdose deaths in 2014 involved prescription painkillers, while an additional 10,000 fatalities were attributed to heroin and 5,000 to fentanyl and other synthetic opioids. Overdose deaths exceed motor vehicle accidents as the leading cause of injury-related deaths. About 90 Americans die every day from an opioid overdose, and opioids have been forecast to kill 500,000 Americans over the next decade.
The CDC acknowledges that prescription opioids are a driving factor, noting that since 1999, the amount sold in the United States has nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report.
States such as Missouri, faced with the skyrocketing cost of treating the opioid epidemic, have sued the drug manufacturers, blaming them for their “campaign of fraud and deception.” At the same time, doctors have been deemed the “biggest culprit” for the opioid addiction epidemic, and one author has pointedly asserted that “by refusing to accept their inability to separate pain relief from addiction, physicians have long suffered the sin of hubris – and their patients have paid the price.”3
The U.S. Surgeon General recently took the historic step of writing to all American doctors asking for their help. And the American Medical Association has developed an educational module explaining the epidemic and how opioid misuse is linked to heroin addiction. The module also outlines risk-reducing steps when using opioids for pain relief.4
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. Some of the materials here have appeared in previous columns by the author. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Available at www.foxnews.om/health/2017/06/26/oklahoma-doctor-charged-in-opioid-deaths-5-patients.html. Accessed June 28, 2017.
2. Available at www.cdc.gov/drugoverdose/epidemic/index.html. Accessed June 28, 2017.
3. Available at www.thedailybeast.com/the-doctors-who-started-the-opioid-epidemic. Accessed June 27, 2017.
4. https://www.end-opioid-epidemic.org. Accessed July 5, 2017.
Question: Regarding opioid deaths, which of the following is incorrect?
A. The term refers to accidental or intentional deaths caused mostly by heroin.
B. They are reaching epidemic proportions.
C. May form the basis for a wrongful death lawsuit.
D. May lead to loss of medical license.
E. The physician may face prosecution for homicide.
Answer: A. Opioids are a class of drugs that include the illegal drug heroin, as well as prescription drugs such as fentanyl, oxycodone, hydrocodone, codeine, and morphine. To be sure, opioid deaths occur in addicts from the deliberate or accidental use of heroin; but other opioids, especially painkillers, are also widely implicated. In addition, deaths have resulted from the careless, negligent, reckless, or wanton conduct of doctors who prescribe them without the proper indications or in inappropriate amounts, and then fail to provide careful follow-up.
Physicians may face both civil and criminal liabilities in such a situation. One remedy sought in wrongful death is a civil action, i.e., a malpractice lawsuit against the negligent doctor. The plaintiff is asserting that by violating community professional standards, the physician’s substandard conduct breached his duty of due care and was a proximate cause of the patient’s death. The evidentiary proof that is required to sustain such an allegation is “more probable than not” or “preponderance of evidence,” and expert medical testimony is typically necessary to establish the requisite standard of care and causation. Where there is gross negligence, i.e., egregious conduct that was reckless, the jury may award punitive damages.
Not infrequently, the wayward doctor faces triple liability: a civil lawsuit, state medical board action, and criminal prosecution for homicide. Given the publicity over soaring opioid death rates, one can expect aggressive prosecution of dealers and doctors alike.
This was not the first such case in Oklahoma. In 2014, a 71-year-old pain management doctor pleaded guilty to eight counts of second-degree murder in connection with several drug overdose deaths and will serve 8 years in prison. The doctor had reportedly prescribed more controlled drugs than any other physician in the state of Oklahoma. These drugs included hydrocodone, oxycodone, alprazolam, diazepam (Valium), and carisoprodol (Soma) – as many as 600 pills at a time. He allegedly accepted only cash payment for the office visits, and a review of his patient files revealed inadequate assessment of patient complaints or physical findings to justify the prescriptions.
Other states have been equally aggressive in prosecuting doctors over opioid deaths from reckless prescribing habits.
For the first time, New York in 2014 convicted a doctor of manslaughter in the overdose deaths of patients from oxycodone and alprazolam (Xanax). Some of the patients were prescribed as many as 500-800 pills over a 5- to 6-week period. The defendant, an anesthesiologist and pain management specialist, allegedly saw upward of 90 patients a day in his Queens weekend storefront clinic, charging them on a per-prescription basis. In his defense, he claimed that he was simply trying to help suffering people who misused medications and who misled him (“tough patients and good liars”).
Likewise, a Los Angeles–area doctor was recently convicted of second-degree murder for prescribing painkillers that killed three patients, and he was sentenced to 30 years to life in prison.
According to the Centers for Disease Control and Prevention, both drug overdose and opioid-involved deaths continue to increase in the United States.2 The majority of drug overdose deaths (more than 6 out of 10) involve an opioid, and the number has quadrupled since 1999.2 It has been estimated that more than 18,000 overdose deaths in 2014 involved prescription painkillers, while an additional 10,000 fatalities were attributed to heroin and 5,000 to fentanyl and other synthetic opioids. Overdose deaths exceed motor vehicle accidents as the leading cause of injury-related deaths. About 90 Americans die every day from an opioid overdose, and opioids have been forecast to kill 500,000 Americans over the next decade.
The CDC acknowledges that prescription opioids are a driving factor, noting that since 1999, the amount sold in the United States has nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report.
States such as Missouri, faced with the skyrocketing cost of treating the opioid epidemic, have sued the drug manufacturers, blaming them for their “campaign of fraud and deception.” At the same time, doctors have been deemed the “biggest culprit” for the opioid addiction epidemic, and one author has pointedly asserted that “by refusing to accept their inability to separate pain relief from addiction, physicians have long suffered the sin of hubris – and their patients have paid the price.”3
The U.S. Surgeon General recently took the historic step of writing to all American doctors asking for their help. And the American Medical Association has developed an educational module explaining the epidemic and how opioid misuse is linked to heroin addiction. The module also outlines risk-reducing steps when using opioids for pain relief.4
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. Some of the materials here have appeared in previous columns by the author. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Available at www.foxnews.om/health/2017/06/26/oklahoma-doctor-charged-in-opioid-deaths-5-patients.html. Accessed June 28, 2017.
2. Available at www.cdc.gov/drugoverdose/epidemic/index.html. Accessed June 28, 2017.
3. Available at www.thedailybeast.com/the-doctors-who-started-the-opioid-epidemic. Accessed June 27, 2017.
4. https://www.end-opioid-epidemic.org. Accessed July 5, 2017.
The perils of the National Practitioner Data Bank
Question: With reference to the National Practitioner Data Bank (NPDB), which of the following statements is incorrect?
A. Both court judgments and out-of-court settlements are reportable to the NPDB.
B. Adverse actions by a hospital against a physician are reportable within 15 days.
C. In states with “Disclosure, Apology, and Offer” laws, a prompt settlement through mediation need not be reported.
D. Hospitals, state licensing boards, medical organizations, and the physician himself/herself can access the NPDB.
E. A plaintiff’s attorney cannot access the NPDB for information regarding a defendant.
Answer: C. Congress implemented the NPDB to collect information about an individual doctor’s malpractice and disciplinary histories, with the objective of restricting errant doctors from moving from one state to another.1
Federal law requires medical liability payments stemming from either a court judgment or an out-of-court settlement be reported to the NPDB. An institution’s disciplinary actions against a medical staff member must also be reported. In turn, the NPDB is obligated to make its information available to hospitals, state licensure boards, and legitimate medical organizations charged with granting privileges or membership. A physician also can ask to see his or her own records, but a plaintiff’s attorney cannot access the NPDB unless there is evidence that a hospital failed to query the NPDB as part of its credentialing process.
Some observers have claimed that the NPDB’s existence has hindered settlement negotiations, because many doctors fear being listed in the NPDB, thus significantly diminishing the likelihood of payments to satisfy a claim. It has been stated that within 6 years of NPDB’s inception, the probability that an injured patient’s claim would receive payment had fallen to 59% of the pre-NPDB level.
Many states have enacted so-called “apology laws” that promote full disclosure of medical errors and prompt out-of-court settlements, if warranted. However, the federal Department of Health and Human Services has ruled that all written demands for payment must be reported, even if the cases are resolved under state programs designed for early out-of-court resolution.
For example, a provision in the Oregon law asserts that a payment under the measure’s mediation mechanism “is not a payment resulting from a written claim or demand for payment.” The HHS has rejected this as “explicitly designed to avoid medical malpractice reporting to the NPDB for any claims that are part of the new process that do not proceed to litigation.”
Massachusetts’ 2012 apology law had proposed reporting only those cases where it was determined that a practitioner failed to meet the standard of care. The HHS responded by indicating that all cases had to be reported, regardless of whether care was determined to be up to standards, and that the state’s prelitigation notice to initiate the meditation process qualified as a reportable “written claim.”
Physicians can be impacted greatly by the NPDB. How much of an impact depends in large part on the underlying events and the wording of the report.
An NPDB account of a medical malpractice payment doesn’t necessarily affect a physician’s ability to practice, while those – especially when “severely-worded” – involving denial or restriction of privileges are taken more seriously by state licensing boards and employers. Physicians should therefore play an active role whenever a report to the NPDB appears likely.
The dispute review process is highly technical and requires the knowledge and skill of an experienced health law attorney. To start out, consider making a request to the reporting entity to correct or vacate the report due to error. If the reporting entity declines, the physician may request a review by the HHS and file an accompanying statement seeking to explain the report.
Yet, out of more than 800,000 total reports for all practitioner types captured in the system, apparently only 44,273 included accompanying clarifying statements by the physician. Risk managers have urged vigilance.
For example, it may be that multiple reports involved a single incident, leading to a “piling on” effect. If an adverse decision at one hospital caused a physician’s clinical privileges to be terminated, this might lead the state medical board to restrict the physician’s license. It is necessary to explain that both of these NPDB-reportable events involved the same incident, and that the state board did not have any independent knowledge of anything that was wrong.
Others have advised that one should always clarify one’s involvement, e.g., “I was not the main doctor in the case.” And if dismissed in a malpractice lawsuit, be sure your name or identifying information isn’t included in the judgment or settlement agreement.
Hospital disciplinary actions being far more serious, physicians would do well to familiarize themselves with medical staff bylaws dealing with peer review and investigations. To avoid being reported to the NPDB, physicians must resist adverse actions that would be in effect for more than 30 days and fight attempts to place restrictions or sanctions on their licenses by the hospital or professional societies. Don’t withdraw applications for privileges during an investigation.
The 2015 NPDB Guidebook, the first update in more than 10 years, contains important changes pertaining to hospital adverse actions.2 The regulations now require any “surrender” of privileges while the physician is a subject of an investigation to be a reportable event. Previously, physicians sought to avoid being reported by simply giving up their privileges when an adverse decision appeared imminent.
Surrender includes not renewing one’s hospital privileges or the taking of a leave of absence, and “investigation” is widely defined to include any formal inquiry into a physician’s competence or conduct. And there need not be any “nexus,” i.e., connection, between what is being investigated and the privileges surrendered, in order to be reportable.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Health Care Quality Improvement Act of 1986, 42 U.S.C. 11101 et seq.
2. 2015 NPDB e-Guidebook, available at www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp.
Question: With reference to the National Practitioner Data Bank (NPDB), which of the following statements is incorrect?
A. Both court judgments and out-of-court settlements are reportable to the NPDB.
B. Adverse actions by a hospital against a physician are reportable within 15 days.
C. In states with “Disclosure, Apology, and Offer” laws, a prompt settlement through mediation need not be reported.
D. Hospitals, state licensing boards, medical organizations, and the physician himself/herself can access the NPDB.
E. A plaintiff’s attorney cannot access the NPDB for information regarding a defendant.
Answer: C. Congress implemented the NPDB to collect information about an individual doctor’s malpractice and disciplinary histories, with the objective of restricting errant doctors from moving from one state to another.1
Federal law requires medical liability payments stemming from either a court judgment or an out-of-court settlement be reported to the NPDB. An institution’s disciplinary actions against a medical staff member must also be reported. In turn, the NPDB is obligated to make its information available to hospitals, state licensure boards, and legitimate medical organizations charged with granting privileges or membership. A physician also can ask to see his or her own records, but a plaintiff’s attorney cannot access the NPDB unless there is evidence that a hospital failed to query the NPDB as part of its credentialing process.
Some observers have claimed that the NPDB’s existence has hindered settlement negotiations, because many doctors fear being listed in the NPDB, thus significantly diminishing the likelihood of payments to satisfy a claim. It has been stated that within 6 years of NPDB’s inception, the probability that an injured patient’s claim would receive payment had fallen to 59% of the pre-NPDB level.
Many states have enacted so-called “apology laws” that promote full disclosure of medical errors and prompt out-of-court settlements, if warranted. However, the federal Department of Health and Human Services has ruled that all written demands for payment must be reported, even if the cases are resolved under state programs designed for early out-of-court resolution.
For example, a provision in the Oregon law asserts that a payment under the measure’s mediation mechanism “is not a payment resulting from a written claim or demand for payment.” The HHS has rejected this as “explicitly designed to avoid medical malpractice reporting to the NPDB for any claims that are part of the new process that do not proceed to litigation.”
Massachusetts’ 2012 apology law had proposed reporting only those cases where it was determined that a practitioner failed to meet the standard of care. The HHS responded by indicating that all cases had to be reported, regardless of whether care was determined to be up to standards, and that the state’s prelitigation notice to initiate the meditation process qualified as a reportable “written claim.”
Physicians can be impacted greatly by the NPDB. How much of an impact depends in large part on the underlying events and the wording of the report.
An NPDB account of a medical malpractice payment doesn’t necessarily affect a physician’s ability to practice, while those – especially when “severely-worded” – involving denial or restriction of privileges are taken more seriously by state licensing boards and employers. Physicians should therefore play an active role whenever a report to the NPDB appears likely.
The dispute review process is highly technical and requires the knowledge and skill of an experienced health law attorney. To start out, consider making a request to the reporting entity to correct or vacate the report due to error. If the reporting entity declines, the physician may request a review by the HHS and file an accompanying statement seeking to explain the report.
Yet, out of more than 800,000 total reports for all practitioner types captured in the system, apparently only 44,273 included accompanying clarifying statements by the physician. Risk managers have urged vigilance.
For example, it may be that multiple reports involved a single incident, leading to a “piling on” effect. If an adverse decision at one hospital caused a physician’s clinical privileges to be terminated, this might lead the state medical board to restrict the physician’s license. It is necessary to explain that both of these NPDB-reportable events involved the same incident, and that the state board did not have any independent knowledge of anything that was wrong.
Others have advised that one should always clarify one’s involvement, e.g., “I was not the main doctor in the case.” And if dismissed in a malpractice lawsuit, be sure your name or identifying information isn’t included in the judgment or settlement agreement.
Hospital disciplinary actions being far more serious, physicians would do well to familiarize themselves with medical staff bylaws dealing with peer review and investigations. To avoid being reported to the NPDB, physicians must resist adverse actions that would be in effect for more than 30 days and fight attempts to place restrictions or sanctions on their licenses by the hospital or professional societies. Don’t withdraw applications for privileges during an investigation.
The 2015 NPDB Guidebook, the first update in more than 10 years, contains important changes pertaining to hospital adverse actions.2 The regulations now require any “surrender” of privileges while the physician is a subject of an investigation to be a reportable event. Previously, physicians sought to avoid being reported by simply giving up their privileges when an adverse decision appeared imminent.
Surrender includes not renewing one’s hospital privileges or the taking of a leave of absence, and “investigation” is widely defined to include any formal inquiry into a physician’s competence or conduct. And there need not be any “nexus,” i.e., connection, between what is being investigated and the privileges surrendered, in order to be reportable.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Health Care Quality Improvement Act of 1986, 42 U.S.C. 11101 et seq.
2. 2015 NPDB e-Guidebook, available at www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp.
Question: With reference to the National Practitioner Data Bank (NPDB), which of the following statements is incorrect?
A. Both court judgments and out-of-court settlements are reportable to the NPDB.
B. Adverse actions by a hospital against a physician are reportable within 15 days.
C. In states with “Disclosure, Apology, and Offer” laws, a prompt settlement through mediation need not be reported.
D. Hospitals, state licensing boards, medical organizations, and the physician himself/herself can access the NPDB.
E. A plaintiff’s attorney cannot access the NPDB for information regarding a defendant.
Answer: C. Congress implemented the NPDB to collect information about an individual doctor’s malpractice and disciplinary histories, with the objective of restricting errant doctors from moving from one state to another.1
Federal law requires medical liability payments stemming from either a court judgment or an out-of-court settlement be reported to the NPDB. An institution’s disciplinary actions against a medical staff member must also be reported. In turn, the NPDB is obligated to make its information available to hospitals, state licensure boards, and legitimate medical organizations charged with granting privileges or membership. A physician also can ask to see his or her own records, but a plaintiff’s attorney cannot access the NPDB unless there is evidence that a hospital failed to query the NPDB as part of its credentialing process.
Some observers have claimed that the NPDB’s existence has hindered settlement negotiations, because many doctors fear being listed in the NPDB, thus significantly diminishing the likelihood of payments to satisfy a claim. It has been stated that within 6 years of NPDB’s inception, the probability that an injured patient’s claim would receive payment had fallen to 59% of the pre-NPDB level.
Many states have enacted so-called “apology laws” that promote full disclosure of medical errors and prompt out-of-court settlements, if warranted. However, the federal Department of Health and Human Services has ruled that all written demands for payment must be reported, even if the cases are resolved under state programs designed for early out-of-court resolution.
For example, a provision in the Oregon law asserts that a payment under the measure’s mediation mechanism “is not a payment resulting from a written claim or demand for payment.” The HHS has rejected this as “explicitly designed to avoid medical malpractice reporting to the NPDB for any claims that are part of the new process that do not proceed to litigation.”
Massachusetts’ 2012 apology law had proposed reporting only those cases where it was determined that a practitioner failed to meet the standard of care. The HHS responded by indicating that all cases had to be reported, regardless of whether care was determined to be up to standards, and that the state’s prelitigation notice to initiate the meditation process qualified as a reportable “written claim.”
Physicians can be impacted greatly by the NPDB. How much of an impact depends in large part on the underlying events and the wording of the report.
An NPDB account of a medical malpractice payment doesn’t necessarily affect a physician’s ability to practice, while those – especially when “severely-worded” – involving denial or restriction of privileges are taken more seriously by state licensing boards and employers. Physicians should therefore play an active role whenever a report to the NPDB appears likely.
The dispute review process is highly technical and requires the knowledge and skill of an experienced health law attorney. To start out, consider making a request to the reporting entity to correct or vacate the report due to error. If the reporting entity declines, the physician may request a review by the HHS and file an accompanying statement seeking to explain the report.
Yet, out of more than 800,000 total reports for all practitioner types captured in the system, apparently only 44,273 included accompanying clarifying statements by the physician. Risk managers have urged vigilance.
For example, it may be that multiple reports involved a single incident, leading to a “piling on” effect. If an adverse decision at one hospital caused a physician’s clinical privileges to be terminated, this might lead the state medical board to restrict the physician’s license. It is necessary to explain that both of these NPDB-reportable events involved the same incident, and that the state board did not have any independent knowledge of anything that was wrong.
Others have advised that one should always clarify one’s involvement, e.g., “I was not the main doctor in the case.” And if dismissed in a malpractice lawsuit, be sure your name or identifying information isn’t included in the judgment or settlement agreement.
Hospital disciplinary actions being far more serious, physicians would do well to familiarize themselves with medical staff bylaws dealing with peer review and investigations. To avoid being reported to the NPDB, physicians must resist adverse actions that would be in effect for more than 30 days and fight attempts to place restrictions or sanctions on their licenses by the hospital or professional societies. Don’t withdraw applications for privileges during an investigation.
The 2015 NPDB Guidebook, the first update in more than 10 years, contains important changes pertaining to hospital adverse actions.2 The regulations now require any “surrender” of privileges while the physician is a subject of an investigation to be a reportable event. Previously, physicians sought to avoid being reported by simply giving up their privileges when an adverse decision appeared imminent.
Surrender includes not renewing one’s hospital privileges or the taking of a leave of absence, and “investigation” is widely defined to include any formal inquiry into a physician’s competence or conduct. And there need not be any “nexus,” i.e., connection, between what is being investigated and the privileges surrendered, in order to be reportable.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Health Care Quality Improvement Act of 1986, 42 U.S.C. 11101 et seq.
2. 2015 NPDB e-Guidebook, available at www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp.
Determining patients’ decisional capacity
Question: Mrs. Wong, age 80 years, has vascular dementia, and for the last 2 years has lived in a nursing home. She is forgetful and disoriented to time, person, and place, and totally dependent on others for all of her daily living needs. But she remains verbal and recognizes family members.
Recently, her glomerular filtration rate declined to less than 10% normal, and she has developed symptoms of uremia, i.e., nausea, vomiting, and intractable hiccups. The nephrologist has diagnosed end-stage renal failure and recommends hemodialysis, which will improve her renal symptoms and may extend her life by 1-2 years. But it will do nothing for her underlying dementia, which is progressive and irreversible.
Should she undergo hemodialysis? Choose the best single answer:
A. Mrs. Wong definitely lacks the capacity to decide whether to undergo hemodialysis.
B. A court-appointed guardian should make the decision.
C. Hemodialysis is futile and is medically contraindicated, inhumane, and unethical.
D. Hemodialysis is a life-extending form of comfort care, and therefore cannot be withheld.
E. The choice is hers if she understands the procedure and the consequences of her decision.
Answer: E. The terms competence and capacity are often used interchangeably in the health care context, although there are distinctions. Technically, a patient remains competent until a court says otherwise. On the other hand, the determination of medical decision-making capacity can be made by the attending physician and does not ordinarily require a court hearing.
Medical capacity can be determined by the use of the four-point test, which asks whether:
1. The patient understands the nature of the intervention.
2. The patient understands the consequences of the decision (especially refusal of treatment).
3. The patient is able to communicate his/her wishes.
4. Those wishes are compatible with the patient’s known values.
Courts tend to rule in favor of a finding of capacity. In one case, the court found no evidence that the patient’s “forgetfulness and confusion cause, or relate in any way to, impairment of her ability to understand that, in rejecting the amputation, she is, in effect, choosing death over life.”1
In another, the court opined, “However humble the background, sad and deprived the way of life, each individual should have the choice as to what is done to his body, if he is capable of understanding the consequences. This patient, although suffering from an organic brain disease, in the court’s opinion understands the consequences of his refusal. … I find that he has sufficient capacity and competence to consent to or refuse the proposed surgery.”2
Sometimes capacity is truly lacking. In a Tennessee case, Mary Northern, an elderly woman, refused amputation, denying that gangrene had caused her feet to be “dead, black, shriveled, rotting, and stinking.”3 Instead, she believed that they were merely blackened by soot or dust.
The court declared her incompetent, because she was “incapable of recognizing facts which would be obvious to a person of normal perception.” The court said that if she had acknowledged that her legs were gangrenous but refused amputation because she preferred death to the loss of her feet, she would have been considered competent to refuse surgery.
When the patient lacks capacity, a surrogate steps in. This may be a person previously designated by the patient as having durable power of attorney for health care decisions, and he/she is obligated to give voice to what the patient would have wanted. This is called substituted judgment.
Often, no surrogate has been formally mentioned, and a family member assumes the role; rarely, a court-appointed guardian takes over. When there is no knowledge of the patient’s wishes, the decision is then made in the patient’s best interests.
That a surrogate can make life and death decisions was first enunciated in the seminal case of Karen Ann Quinlan, where the New Jersey Supreme Court famously wrote, “The sad truth, however, is that she is grossly incompetent, and we cannot discern her supposed choice based on the testimony of her previous conversations with friends, where such testimony is without sufficient probative weight. Nevertheless, we have concluded that Karen’s right of privacy may be asserted on her behalf by her guardian under the peculiar circumstances here present.”4
The U.S. Supreme Court in Cruzan v. Director Missouri Department of Health has similarly held that an “incompetent person is not able to make an informed and voluntary choice to exercise a hypothetical right to refuse treatment or any other right. Such a ‘right’ must be exercised for her, if at all, by some sort of surrogate.”5 The court also opined that a state – in this case, Missouri – may apply a clear and convincing evidentiary standard in proceedings where a guardian seeks to discontinue nutrition and hydration.
Clear and convincing evidence is said to exist where there is a finding of high probability, based on evidence “so clear as to leave no substantial doubt” and “sufficiently strong to command the unhesitating assent of every reasonable mind.”
However, where a patient’s wishes are not clear and convincing, a court will be reluctant to order cessation of treatment, as in the landmark case of Wendland v. Wendland, where the California Supreme Court unanimously disallowed the discontinuation of a patient’s tube feedings.6
The patient, Robert Wendland, had regained consciousness after 14 months in a coma, but was left hemiparetic and incontinent, and could not feed by mouth or dress, bathe, and communicate consistently. He did not have an advance directive, but had made statements to the effect he would not want to live in a vegetative state.
His wife, Rose, refused to authorize reinsertion of his dislodged feeding tube, believing that Robert would not have wanted it replaced. The patient’s daughter and brother, as well as the hospital’s ethics committee, county ombudsman, and a court-appointed counsel, all agreed with the decision.
But the patient’s mother, Florence, went to court to block the action. The court determined that Robert’s statements were not clear and convincing, because they did not address his current condition, were not sufficiently specific, and were not necessarily intended to direct his medical care. Further, the patient’s spouse had failed to provide sufficient evidence that her decision was in her husband’s best interests.
Issues surrounding treatment at the end of life can be difficult and elusive. Even where there is an advance medical directive, statements made by patients in the document do not always comport with their eventual treatment decisions.
In a telling study, the authors found that only two-thirds of the time were decisions consistent.7 One-third of patients changed their preferences in the face of actual illness, usually in favor of treatments rejected in advance. Surrogate agreement was only 58%, and surrogates tended to overestimate their loved one’s desire for treatment.
The designation of who may be the legitimate alternative decision maker is another contentious issue, with laws varying widely from state to state.8
All of this may have in part prompted Singapore’s newly enacted Mental Capacity Act,9 which permits a surrogate to make wide-ranging decisions on behalf of an incapacitated person, to specifically exclude decisions regarding life-sustaining treatment and any measure that the physician “reasonably believes is necessary to prevent a serious deterioration” in the patient’s condition.
The decisional responsibility resides in the treating physician, who is obligated by law to make an effort to assist the patient to come to a decision, failing which it is made in the patient’s best interests.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Lane v. Candura, 6 Mass. App. 377 (1978).
2. Matter of Roosevelt Hospital, N.Y.L.J. 13 Jan 1977 p. 7 (Sup. Ct., New York Co.).
3. State Dept Human Resources v. Northern, 563 SW 2d 197 (Tenn. Ct. App., 1978).
4. In the matter of Karen Quinlan, 355 A.2d 647 (N.J., 1976).
5. Cruzan v. Director Missouri Department of Health, 110 S. Ct. 2841 (1990).
6. Wendland v. Wendland, 28 P.3d 151 (Cal., 2001).
7. J Clin Ethics. 1998 Fall;9(3):258-62.
8. N Engl J Med. 2017 Apr 13;376(15):1478-82.
9. Singapore’s Mental Capacity Act (Chapter 177A).
Question: Mrs. Wong, age 80 years, has vascular dementia, and for the last 2 years has lived in a nursing home. She is forgetful and disoriented to time, person, and place, and totally dependent on others for all of her daily living needs. But she remains verbal and recognizes family members.
Recently, her glomerular filtration rate declined to less than 10% normal, and she has developed symptoms of uremia, i.e., nausea, vomiting, and intractable hiccups. The nephrologist has diagnosed end-stage renal failure and recommends hemodialysis, which will improve her renal symptoms and may extend her life by 1-2 years. But it will do nothing for her underlying dementia, which is progressive and irreversible.
Should she undergo hemodialysis? Choose the best single answer:
A. Mrs. Wong definitely lacks the capacity to decide whether to undergo hemodialysis.
B. A court-appointed guardian should make the decision.
C. Hemodialysis is futile and is medically contraindicated, inhumane, and unethical.
D. Hemodialysis is a life-extending form of comfort care, and therefore cannot be withheld.
E. The choice is hers if she understands the procedure and the consequences of her decision.
Answer: E. The terms competence and capacity are often used interchangeably in the health care context, although there are distinctions. Technically, a patient remains competent until a court says otherwise. On the other hand, the determination of medical decision-making capacity can be made by the attending physician and does not ordinarily require a court hearing.
Medical capacity can be determined by the use of the four-point test, which asks whether:
1. The patient understands the nature of the intervention.
2. The patient understands the consequences of the decision (especially refusal of treatment).
3. The patient is able to communicate his/her wishes.
4. Those wishes are compatible with the patient’s known values.
Courts tend to rule in favor of a finding of capacity. In one case, the court found no evidence that the patient’s “forgetfulness and confusion cause, or relate in any way to, impairment of her ability to understand that, in rejecting the amputation, she is, in effect, choosing death over life.”1
In another, the court opined, “However humble the background, sad and deprived the way of life, each individual should have the choice as to what is done to his body, if he is capable of understanding the consequences. This patient, although suffering from an organic brain disease, in the court’s opinion understands the consequences of his refusal. … I find that he has sufficient capacity and competence to consent to or refuse the proposed surgery.”2
Sometimes capacity is truly lacking. In a Tennessee case, Mary Northern, an elderly woman, refused amputation, denying that gangrene had caused her feet to be “dead, black, shriveled, rotting, and stinking.”3 Instead, she believed that they were merely blackened by soot or dust.
The court declared her incompetent, because she was “incapable of recognizing facts which would be obvious to a person of normal perception.” The court said that if she had acknowledged that her legs were gangrenous but refused amputation because she preferred death to the loss of her feet, she would have been considered competent to refuse surgery.
When the patient lacks capacity, a surrogate steps in. This may be a person previously designated by the patient as having durable power of attorney for health care decisions, and he/she is obligated to give voice to what the patient would have wanted. This is called substituted judgment.
Often, no surrogate has been formally mentioned, and a family member assumes the role; rarely, a court-appointed guardian takes over. When there is no knowledge of the patient’s wishes, the decision is then made in the patient’s best interests.
That a surrogate can make life and death decisions was first enunciated in the seminal case of Karen Ann Quinlan, where the New Jersey Supreme Court famously wrote, “The sad truth, however, is that she is grossly incompetent, and we cannot discern her supposed choice based on the testimony of her previous conversations with friends, where such testimony is without sufficient probative weight. Nevertheless, we have concluded that Karen’s right of privacy may be asserted on her behalf by her guardian under the peculiar circumstances here present.”4
The U.S. Supreme Court in Cruzan v. Director Missouri Department of Health has similarly held that an “incompetent person is not able to make an informed and voluntary choice to exercise a hypothetical right to refuse treatment or any other right. Such a ‘right’ must be exercised for her, if at all, by some sort of surrogate.”5 The court also opined that a state – in this case, Missouri – may apply a clear and convincing evidentiary standard in proceedings where a guardian seeks to discontinue nutrition and hydration.
Clear and convincing evidence is said to exist where there is a finding of high probability, based on evidence “so clear as to leave no substantial doubt” and “sufficiently strong to command the unhesitating assent of every reasonable mind.”
However, where a patient’s wishes are not clear and convincing, a court will be reluctant to order cessation of treatment, as in the landmark case of Wendland v. Wendland, where the California Supreme Court unanimously disallowed the discontinuation of a patient’s tube feedings.6
The patient, Robert Wendland, had regained consciousness after 14 months in a coma, but was left hemiparetic and incontinent, and could not feed by mouth or dress, bathe, and communicate consistently. He did not have an advance directive, but had made statements to the effect he would not want to live in a vegetative state.
His wife, Rose, refused to authorize reinsertion of his dislodged feeding tube, believing that Robert would not have wanted it replaced. The patient’s daughter and brother, as well as the hospital’s ethics committee, county ombudsman, and a court-appointed counsel, all agreed with the decision.
But the patient’s mother, Florence, went to court to block the action. The court determined that Robert’s statements were not clear and convincing, because they did not address his current condition, were not sufficiently specific, and were not necessarily intended to direct his medical care. Further, the patient’s spouse had failed to provide sufficient evidence that her decision was in her husband’s best interests.
Issues surrounding treatment at the end of life can be difficult and elusive. Even where there is an advance medical directive, statements made by patients in the document do not always comport with their eventual treatment decisions.
In a telling study, the authors found that only two-thirds of the time were decisions consistent.7 One-third of patients changed their preferences in the face of actual illness, usually in favor of treatments rejected in advance. Surrogate agreement was only 58%, and surrogates tended to overestimate their loved one’s desire for treatment.
The designation of who may be the legitimate alternative decision maker is another contentious issue, with laws varying widely from state to state.8
All of this may have in part prompted Singapore’s newly enacted Mental Capacity Act,9 which permits a surrogate to make wide-ranging decisions on behalf of an incapacitated person, to specifically exclude decisions regarding life-sustaining treatment and any measure that the physician “reasonably believes is necessary to prevent a serious deterioration” in the patient’s condition.
The decisional responsibility resides in the treating physician, who is obligated by law to make an effort to assist the patient to come to a decision, failing which it is made in the patient’s best interests.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Lane v. Candura, 6 Mass. App. 377 (1978).
2. Matter of Roosevelt Hospital, N.Y.L.J. 13 Jan 1977 p. 7 (Sup. Ct., New York Co.).
3. State Dept Human Resources v. Northern, 563 SW 2d 197 (Tenn. Ct. App., 1978).
4. In the matter of Karen Quinlan, 355 A.2d 647 (N.J., 1976).
5. Cruzan v. Director Missouri Department of Health, 110 S. Ct. 2841 (1990).
6. Wendland v. Wendland, 28 P.3d 151 (Cal., 2001).
7. J Clin Ethics. 1998 Fall;9(3):258-62.
8. N Engl J Med. 2017 Apr 13;376(15):1478-82.
9. Singapore’s Mental Capacity Act (Chapter 177A).
Question: Mrs. Wong, age 80 years, has vascular dementia, and for the last 2 years has lived in a nursing home. She is forgetful and disoriented to time, person, and place, and totally dependent on others for all of her daily living needs. But she remains verbal and recognizes family members.
Recently, her glomerular filtration rate declined to less than 10% normal, and she has developed symptoms of uremia, i.e., nausea, vomiting, and intractable hiccups. The nephrologist has diagnosed end-stage renal failure and recommends hemodialysis, which will improve her renal symptoms and may extend her life by 1-2 years. But it will do nothing for her underlying dementia, which is progressive and irreversible.
Should she undergo hemodialysis? Choose the best single answer:
A. Mrs. Wong definitely lacks the capacity to decide whether to undergo hemodialysis.
B. A court-appointed guardian should make the decision.
C. Hemodialysis is futile and is medically contraindicated, inhumane, and unethical.
D. Hemodialysis is a life-extending form of comfort care, and therefore cannot be withheld.
E. The choice is hers if she understands the procedure and the consequences of her decision.
Answer: E. The terms competence and capacity are often used interchangeably in the health care context, although there are distinctions. Technically, a patient remains competent until a court says otherwise. On the other hand, the determination of medical decision-making capacity can be made by the attending physician and does not ordinarily require a court hearing.
Medical capacity can be determined by the use of the four-point test, which asks whether:
1. The patient understands the nature of the intervention.
2. The patient understands the consequences of the decision (especially refusal of treatment).
3. The patient is able to communicate his/her wishes.
4. Those wishes are compatible with the patient’s known values.
Courts tend to rule in favor of a finding of capacity. In one case, the court found no evidence that the patient’s “forgetfulness and confusion cause, or relate in any way to, impairment of her ability to understand that, in rejecting the amputation, she is, in effect, choosing death over life.”1
In another, the court opined, “However humble the background, sad and deprived the way of life, each individual should have the choice as to what is done to his body, if he is capable of understanding the consequences. This patient, although suffering from an organic brain disease, in the court’s opinion understands the consequences of his refusal. … I find that he has sufficient capacity and competence to consent to or refuse the proposed surgery.”2
Sometimes capacity is truly lacking. In a Tennessee case, Mary Northern, an elderly woman, refused amputation, denying that gangrene had caused her feet to be “dead, black, shriveled, rotting, and stinking.”3 Instead, she believed that they were merely blackened by soot or dust.
The court declared her incompetent, because she was “incapable of recognizing facts which would be obvious to a person of normal perception.” The court said that if she had acknowledged that her legs were gangrenous but refused amputation because she preferred death to the loss of her feet, she would have been considered competent to refuse surgery.
When the patient lacks capacity, a surrogate steps in. This may be a person previously designated by the patient as having durable power of attorney for health care decisions, and he/she is obligated to give voice to what the patient would have wanted. This is called substituted judgment.
Often, no surrogate has been formally mentioned, and a family member assumes the role; rarely, a court-appointed guardian takes over. When there is no knowledge of the patient’s wishes, the decision is then made in the patient’s best interests.
That a surrogate can make life and death decisions was first enunciated in the seminal case of Karen Ann Quinlan, where the New Jersey Supreme Court famously wrote, “The sad truth, however, is that she is grossly incompetent, and we cannot discern her supposed choice based on the testimony of her previous conversations with friends, where such testimony is without sufficient probative weight. Nevertheless, we have concluded that Karen’s right of privacy may be asserted on her behalf by her guardian under the peculiar circumstances here present.”4
The U.S. Supreme Court in Cruzan v. Director Missouri Department of Health has similarly held that an “incompetent person is not able to make an informed and voluntary choice to exercise a hypothetical right to refuse treatment or any other right. Such a ‘right’ must be exercised for her, if at all, by some sort of surrogate.”5 The court also opined that a state – in this case, Missouri – may apply a clear and convincing evidentiary standard in proceedings where a guardian seeks to discontinue nutrition and hydration.
Clear and convincing evidence is said to exist where there is a finding of high probability, based on evidence “so clear as to leave no substantial doubt” and “sufficiently strong to command the unhesitating assent of every reasonable mind.”
However, where a patient’s wishes are not clear and convincing, a court will be reluctant to order cessation of treatment, as in the landmark case of Wendland v. Wendland, where the California Supreme Court unanimously disallowed the discontinuation of a patient’s tube feedings.6
The patient, Robert Wendland, had regained consciousness after 14 months in a coma, but was left hemiparetic and incontinent, and could not feed by mouth or dress, bathe, and communicate consistently. He did not have an advance directive, but had made statements to the effect he would not want to live in a vegetative state.
His wife, Rose, refused to authorize reinsertion of his dislodged feeding tube, believing that Robert would not have wanted it replaced. The patient’s daughter and brother, as well as the hospital’s ethics committee, county ombudsman, and a court-appointed counsel, all agreed with the decision.
But the patient’s mother, Florence, went to court to block the action. The court determined that Robert’s statements were not clear and convincing, because they did not address his current condition, were not sufficiently specific, and were not necessarily intended to direct his medical care. Further, the patient’s spouse had failed to provide sufficient evidence that her decision was in her husband’s best interests.
Issues surrounding treatment at the end of life can be difficult and elusive. Even where there is an advance medical directive, statements made by patients in the document do not always comport with their eventual treatment decisions.
In a telling study, the authors found that only two-thirds of the time were decisions consistent.7 One-third of patients changed their preferences in the face of actual illness, usually in favor of treatments rejected in advance. Surrogate agreement was only 58%, and surrogates tended to overestimate their loved one’s desire for treatment.
The designation of who may be the legitimate alternative decision maker is another contentious issue, with laws varying widely from state to state.8
All of this may have in part prompted Singapore’s newly enacted Mental Capacity Act,9 which permits a surrogate to make wide-ranging decisions on behalf of an incapacitated person, to specifically exclude decisions regarding life-sustaining treatment and any measure that the physician “reasonably believes is necessary to prevent a serious deterioration” in the patient’s condition.
The decisional responsibility resides in the treating physician, who is obligated by law to make an effort to assist the patient to come to a decision, failing which it is made in the patient’s best interests.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Lane v. Candura, 6 Mass. App. 377 (1978).
2. Matter of Roosevelt Hospital, N.Y.L.J. 13 Jan 1977 p. 7 (Sup. Ct., New York Co.).
3. State Dept Human Resources v. Northern, 563 SW 2d 197 (Tenn. Ct. App., 1978).
4. In the matter of Karen Quinlan, 355 A.2d 647 (N.J., 1976).
5. Cruzan v. Director Missouri Department of Health, 110 S. Ct. 2841 (1990).
6. Wendland v. Wendland, 28 P.3d 151 (Cal., 2001).
7. J Clin Ethics. 1998 Fall;9(3):258-62.
8. N Engl J Med. 2017 Apr 13;376(15):1478-82.
9. Singapore’s Mental Capacity Act (Chapter 177A).
Update on the False Claims Act
Question: Which of the following is correct?
A. The False Claims Act dates back to the Civil War era.
B. The FCA covers only patently false statements.
C. Material misrepresentation is insufficient.
D. Negligence constitutes a violation.
E. A qui tam lawsuit under FCA refers to a third party who has suffered personal harm.
Answer: A. The False Claims Act (FCA) is an old law, enacted by Congress in 1863 to impose liability for submitting a payment demand to the federal government when there is actual or constructive knowledge that the claim is false.1 Many states now have their own versions of FCA.
Intent to defraud is not a required element, but knowing or reckless disregard of the truth or material misrepresentation are – whereas negligence is insufficient to constitute a violation.
In the health care field, FCA most commonly involves false claims made to Medicare or Medicaid. Pitfalls include billing for noncovered services such as experimental treatments, double billing, unnecessary services, billing the government as the primary payer when inappropriate, or regularly waiving deductibles and copayments.
Other activities that constitute wrongdoing in this context include knowingly using another patient’s name for purposes of federal drug coverage, billing for no-shows, and misrepresenting the diagnosis to justify services.
The electronic medical record enables easy check-offs as documentation of actual work done, and fraud is implicated if the information is deliberately misleading, as in the example of upcoding.
Importantly, physicians are liable for the actions of their office staff, so it is prudent to oversee and supervise all billing activities. Aggrieved or disgruntled employees or contractors, popularly known as whistle-blowers, can file a qui tam action. They stand to collect a substantial bounty, up to 30% of the proceeds. They do not have to show legal standing and need not sustain any personal injury.
FCA prosecutions are daily affairs, with egregious examples regularly making the news headlines. A few random pickings might give you an idea of the problem:
In 2015, in its largest case of health care fraud, the federal Department of Justice filed criminal charges against 243 individuals across the nation. Some of the violations included billings for intensive psychotherapy sessions for noncommunicative dementia patients, simply moving patients to different locations, and fraudulent prescriptions under Medicare Part D.
In 2016, a pain management clinic used “ill-equipped, desperate doctors in dire need of work” to write faked prescriptions for narcotics. The clinic owner, a doctor, was sentenced to 144 months in prison for running what was described as a “pill-mill zoo.”
Arguably, the most dramatic physician case occurred in 2017 and involved a Florida dermatologist who settled with the government for $18 million for treating patients for skin cancer they did not have. The action came from a qui tam lawsuit filed by another dermatologist.
A major development in the false claims law came with last year’s U.S. Supreme Court decision in Universal Health Services v. Escobar.2
This landmark case dealt with claims made by Arbour Counseling Services to the Massachusetts’ Medicaid program for mental health counseling and prescriptions, a satellite mental health facility of Universal Health Services. It turned out that relatively few Arbour employees were actually licensed to provide mental health counseling or authorized to prescribe medications. A death resulted from a reaction to an unlicensed prescription.
In a unanimous decision, the Supreme Court held that there can be FCA liability when a defendant submitting a claim makes specific representations about the goods or services provided but fails to disclose noncompliance with material statutory, regulatory, or contractual requirements. Technically referred to as “implied false certification,” such material omissions may amount to a misrepresentation and may be deemed fraudulent, even if the requirements were not expressly designated as conditions of payment.
In the words of the court, “Today’s decision holds that the claims at issue may be actionable because they do more than merely demand payment; they fall squarely within the rule that representations that state the truth only so far as it goes, while omitting critical qualifying information, can be actionable misrepresentations.”
The implied false certification, or implied fraud, ruling has widespread implications, as it does not require a patently false statement. A material misrepresentation or omission may suffice.
There is concern that this ruling will open the floodgates of FCA prosecution. However, the federal Ninth Circuit Court of Appeals has recently quashed an attempt to invoke the implied certification claim in an FCA suit against DJO Global and Biomet, brought by a medical device salesman and his private investigator. Their rejected whistle-blower suit alleged that the defendants were providing their spinal bone growth stimulation devices for use on the cervical spine, even though Food and Drug Administration approval was for use only on the lumbar spine.
Another concern is, can an alleged wrong prognosis regarding life expectancy amount to a false claim?
Under Medicare rules, a physician certifying that a patient is eligible for hospice care must attest that the condition is terminal, with death expected within 6 months.
AseraCare, a hospice company, was accused of knowingly submitting false claims to Medicare by certifying patients as eligible for hospice who did not have a life expectancy of 6 months or less. The government claimed that the medical records of the 123 patients at issue did not contain clinical information and other documentation that supported the medical prognosis. Thus, AseraCare’s claims for those patients were false.
The case brought out the conflicting views of physicians: Did the medical records supported AseraCare’s certifications that the patients were eligible? The defendants argued that, when hospice-certifying physicians and government medical experts look at the very same medical records and disagree about eligibility, the opinion of one medical expert alone cannot prove falsity without further evidence of an objective falsehood.
AseraCare won a summary judgment defending against the $200 million lawsuit in the U.S. District Court for the Northern District of Alabama.3 In a memorandum opinion, the court began with Blaise Pascal’s axiom that “Contradiction is not a sign of falsity, nor the lack of contradiction the sign of truth.” Federal prosecutors have appealed to the federal 11th Circuit Court of Appeals, which recently heard oral arguments. Its decision is pending.
In support of the hospice center physicians, the American Medical Association and other organizations have filed an amicus brief asserting that a physician’s opinion may be deemed false only if no reasonable physician could hold that opinion.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. 31 U.S. Code, Section 3729(a)(1)(A).
2. Universal Health Services v. United States ex rel. Escobar, 579 U.S. ____ (2016).
3. U.S. ex rel. Paradies et al. v. AseraCare Inc. et al., Case number 2:12-CV-245-KOB, in the U.S. District Court for the Northern District of Alabama.
Question: Which of the following is correct?
A. The False Claims Act dates back to the Civil War era.
B. The FCA covers only patently false statements.
C. Material misrepresentation is insufficient.
D. Negligence constitutes a violation.
E. A qui tam lawsuit under FCA refers to a third party who has suffered personal harm.
Answer: A. The False Claims Act (FCA) is an old law, enacted by Congress in 1863 to impose liability for submitting a payment demand to the federal government when there is actual or constructive knowledge that the claim is false.1 Many states now have their own versions of FCA.
Intent to defraud is not a required element, but knowing or reckless disregard of the truth or material misrepresentation are – whereas negligence is insufficient to constitute a violation.
In the health care field, FCA most commonly involves false claims made to Medicare or Medicaid. Pitfalls include billing for noncovered services such as experimental treatments, double billing, unnecessary services, billing the government as the primary payer when inappropriate, or regularly waiving deductibles and copayments.
Other activities that constitute wrongdoing in this context include knowingly using another patient’s name for purposes of federal drug coverage, billing for no-shows, and misrepresenting the diagnosis to justify services.
The electronic medical record enables easy check-offs as documentation of actual work done, and fraud is implicated if the information is deliberately misleading, as in the example of upcoding.
Importantly, physicians are liable for the actions of their office staff, so it is prudent to oversee and supervise all billing activities. Aggrieved or disgruntled employees or contractors, popularly known as whistle-blowers, can file a qui tam action. They stand to collect a substantial bounty, up to 30% of the proceeds. They do not have to show legal standing and need not sustain any personal injury.
FCA prosecutions are daily affairs, with egregious examples regularly making the news headlines. A few random pickings might give you an idea of the problem:
In 2015, in its largest case of health care fraud, the federal Department of Justice filed criminal charges against 243 individuals across the nation. Some of the violations included billings for intensive psychotherapy sessions for noncommunicative dementia patients, simply moving patients to different locations, and fraudulent prescriptions under Medicare Part D.
In 2016, a pain management clinic used “ill-equipped, desperate doctors in dire need of work” to write faked prescriptions for narcotics. The clinic owner, a doctor, was sentenced to 144 months in prison for running what was described as a “pill-mill zoo.”
Arguably, the most dramatic physician case occurred in 2017 and involved a Florida dermatologist who settled with the government for $18 million for treating patients for skin cancer they did not have. The action came from a qui tam lawsuit filed by another dermatologist.
A major development in the false claims law came with last year’s U.S. Supreme Court decision in Universal Health Services v. Escobar.2
This landmark case dealt with claims made by Arbour Counseling Services to the Massachusetts’ Medicaid program for mental health counseling and prescriptions, a satellite mental health facility of Universal Health Services. It turned out that relatively few Arbour employees were actually licensed to provide mental health counseling or authorized to prescribe medications. A death resulted from a reaction to an unlicensed prescription.
In a unanimous decision, the Supreme Court held that there can be FCA liability when a defendant submitting a claim makes specific representations about the goods or services provided but fails to disclose noncompliance with material statutory, regulatory, or contractual requirements. Technically referred to as “implied false certification,” such material omissions may amount to a misrepresentation and may be deemed fraudulent, even if the requirements were not expressly designated as conditions of payment.
In the words of the court, “Today’s decision holds that the claims at issue may be actionable because they do more than merely demand payment; they fall squarely within the rule that representations that state the truth only so far as it goes, while omitting critical qualifying information, can be actionable misrepresentations.”
The implied false certification, or implied fraud, ruling has widespread implications, as it does not require a patently false statement. A material misrepresentation or omission may suffice.
There is concern that this ruling will open the floodgates of FCA prosecution. However, the federal Ninth Circuit Court of Appeals has recently quashed an attempt to invoke the implied certification claim in an FCA suit against DJO Global and Biomet, brought by a medical device salesman and his private investigator. Their rejected whistle-blower suit alleged that the defendants were providing their spinal bone growth stimulation devices for use on the cervical spine, even though Food and Drug Administration approval was for use only on the lumbar spine.
Another concern is, can an alleged wrong prognosis regarding life expectancy amount to a false claim?
Under Medicare rules, a physician certifying that a patient is eligible for hospice care must attest that the condition is terminal, with death expected within 6 months.
AseraCare, a hospice company, was accused of knowingly submitting false claims to Medicare by certifying patients as eligible for hospice who did not have a life expectancy of 6 months or less. The government claimed that the medical records of the 123 patients at issue did not contain clinical information and other documentation that supported the medical prognosis. Thus, AseraCare’s claims for those patients were false.
The case brought out the conflicting views of physicians: Did the medical records supported AseraCare’s certifications that the patients were eligible? The defendants argued that, when hospice-certifying physicians and government medical experts look at the very same medical records and disagree about eligibility, the opinion of one medical expert alone cannot prove falsity without further evidence of an objective falsehood.
AseraCare won a summary judgment defending against the $200 million lawsuit in the U.S. District Court for the Northern District of Alabama.3 In a memorandum opinion, the court began with Blaise Pascal’s axiom that “Contradiction is not a sign of falsity, nor the lack of contradiction the sign of truth.” Federal prosecutors have appealed to the federal 11th Circuit Court of Appeals, which recently heard oral arguments. Its decision is pending.
In support of the hospice center physicians, the American Medical Association and other organizations have filed an amicus brief asserting that a physician’s opinion may be deemed false only if no reasonable physician could hold that opinion.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. 31 U.S. Code, Section 3729(a)(1)(A).
2. Universal Health Services v. United States ex rel. Escobar, 579 U.S. ____ (2016).
3. U.S. ex rel. Paradies et al. v. AseraCare Inc. et al., Case number 2:12-CV-245-KOB, in the U.S. District Court for the Northern District of Alabama.
Question: Which of the following is correct?
A. The False Claims Act dates back to the Civil War era.
B. The FCA covers only patently false statements.
C. Material misrepresentation is insufficient.
D. Negligence constitutes a violation.
E. A qui tam lawsuit under FCA refers to a third party who has suffered personal harm.
Answer: A. The False Claims Act (FCA) is an old law, enacted by Congress in 1863 to impose liability for submitting a payment demand to the federal government when there is actual or constructive knowledge that the claim is false.1 Many states now have their own versions of FCA.
Intent to defraud is not a required element, but knowing or reckless disregard of the truth or material misrepresentation are – whereas negligence is insufficient to constitute a violation.
In the health care field, FCA most commonly involves false claims made to Medicare or Medicaid. Pitfalls include billing for noncovered services such as experimental treatments, double billing, unnecessary services, billing the government as the primary payer when inappropriate, or regularly waiving deductibles and copayments.
Other activities that constitute wrongdoing in this context include knowingly using another patient’s name for purposes of federal drug coverage, billing for no-shows, and misrepresenting the diagnosis to justify services.
The electronic medical record enables easy check-offs as documentation of actual work done, and fraud is implicated if the information is deliberately misleading, as in the example of upcoding.
Importantly, physicians are liable for the actions of their office staff, so it is prudent to oversee and supervise all billing activities. Aggrieved or disgruntled employees or contractors, popularly known as whistle-blowers, can file a qui tam action. They stand to collect a substantial bounty, up to 30% of the proceeds. They do not have to show legal standing and need not sustain any personal injury.
FCA prosecutions are daily affairs, with egregious examples regularly making the news headlines. A few random pickings might give you an idea of the problem:
In 2015, in its largest case of health care fraud, the federal Department of Justice filed criminal charges against 243 individuals across the nation. Some of the violations included billings for intensive psychotherapy sessions for noncommunicative dementia patients, simply moving patients to different locations, and fraudulent prescriptions under Medicare Part D.
In 2016, a pain management clinic used “ill-equipped, desperate doctors in dire need of work” to write faked prescriptions for narcotics. The clinic owner, a doctor, was sentenced to 144 months in prison for running what was described as a “pill-mill zoo.”
Arguably, the most dramatic physician case occurred in 2017 and involved a Florida dermatologist who settled with the government for $18 million for treating patients for skin cancer they did not have. The action came from a qui tam lawsuit filed by another dermatologist.
A major development in the false claims law came with last year’s U.S. Supreme Court decision in Universal Health Services v. Escobar.2
This landmark case dealt with claims made by Arbour Counseling Services to the Massachusetts’ Medicaid program for mental health counseling and prescriptions, a satellite mental health facility of Universal Health Services. It turned out that relatively few Arbour employees were actually licensed to provide mental health counseling or authorized to prescribe medications. A death resulted from a reaction to an unlicensed prescription.
In a unanimous decision, the Supreme Court held that there can be FCA liability when a defendant submitting a claim makes specific representations about the goods or services provided but fails to disclose noncompliance with material statutory, regulatory, or contractual requirements. Technically referred to as “implied false certification,” such material omissions may amount to a misrepresentation and may be deemed fraudulent, even if the requirements were not expressly designated as conditions of payment.
In the words of the court, “Today’s decision holds that the claims at issue may be actionable because they do more than merely demand payment; they fall squarely within the rule that representations that state the truth only so far as it goes, while omitting critical qualifying information, can be actionable misrepresentations.”
The implied false certification, or implied fraud, ruling has widespread implications, as it does not require a patently false statement. A material misrepresentation or omission may suffice.
There is concern that this ruling will open the floodgates of FCA prosecution. However, the federal Ninth Circuit Court of Appeals has recently quashed an attempt to invoke the implied certification claim in an FCA suit against DJO Global and Biomet, brought by a medical device salesman and his private investigator. Their rejected whistle-blower suit alleged that the defendants were providing their spinal bone growth stimulation devices for use on the cervical spine, even though Food and Drug Administration approval was for use only on the lumbar spine.
Another concern is, can an alleged wrong prognosis regarding life expectancy amount to a false claim?
Under Medicare rules, a physician certifying that a patient is eligible for hospice care must attest that the condition is terminal, with death expected within 6 months.
AseraCare, a hospice company, was accused of knowingly submitting false claims to Medicare by certifying patients as eligible for hospice who did not have a life expectancy of 6 months or less. The government claimed that the medical records of the 123 patients at issue did not contain clinical information and other documentation that supported the medical prognosis. Thus, AseraCare’s claims for those patients were false.
The case brought out the conflicting views of physicians: Did the medical records supported AseraCare’s certifications that the patients were eligible? The defendants argued that, when hospice-certifying physicians and government medical experts look at the very same medical records and disagree about eligibility, the opinion of one medical expert alone cannot prove falsity without further evidence of an objective falsehood.
AseraCare won a summary judgment defending against the $200 million lawsuit in the U.S. District Court for the Northern District of Alabama.3 In a memorandum opinion, the court began with Blaise Pascal’s axiom that “Contradiction is not a sign of falsity, nor the lack of contradiction the sign of truth.” Federal prosecutors have appealed to the federal 11th Circuit Court of Appeals, which recently heard oral arguments. Its decision is pending.
In support of the hospice center physicians, the American Medical Association and other organizations have filed an amicus brief asserting that a physician’s opinion may be deemed false only if no reasonable physician could hold that opinion.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. 31 U.S. Code, Section 3729(a)(1)(A).
2. Universal Health Services v. United States ex rel. Escobar, 579 U.S. ____ (2016).
3. U.S. ex rel. Paradies et al. v. AseraCare Inc. et al., Case number 2:12-CV-245-KOB, in the U.S. District Court for the Northern District of Alabama.
Update on malpractice trends
Question: Recent developments in malpractice include the following:
A. Severity and frequency rates continue to rise.
B. Apology laws appear to be very effective in reducing claims.
C. Litigation surrounds whether an assistant may obtain a patient’s informed consent on behalf of the doctor.
D. A and B.
E. A, B, and C.
Answer: C. Over the past decade, malpractice claims have in fact diminished, accompanied by a leveling or reduction in premiums.1 Rates have plummeted to roughly half of previous levels, averaging six claims per 100 doctors in 2016.
According to The Doctors Company, internists paid an average premium of $15,853, compared with an average of $19,900 in 2006, general surgeons $52,905 instead of $68,186, and obstetricians $72,999, a drop from $93,230. Even claims-plagued Florida’s Dade County has seen a dramatic drop in internist premiums by some $27,000, down to $47,707.2
The latest attack on MICRA, in 2015, concerned a wrongful death suit brought by a woman whose mother died from hemorrhagic complications related to Coumadin use following heart surgery.4 Her constitutional challenges included violation of equal protection, due process, and the right to a jury trial. But these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000 as required by MICRA. A California appeals court rejected her claim as being “contrary to many well-established legal principles.”
Disclosure of medical errors is a relative newcomer as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called “apology laws,” an outgrowth of the communication and resolution programs popularized by the Lexington (Ky.) VA Medical Center, University of Michigan Health System, Harvard’s affiliated institutions, and Colorado’s COPIC Insurance.
Apology laws disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician. For example, the Ohio Supreme Court has ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute, even though the incident took place before the law went into effect.5
However, apology laws do vary from state to state, and some do not shield admissions regarding causation of error or fault.
A recent study suggests that apology laws don’t work. A Vanderbilt University study published online used a unique dataset covering all malpractice claims for 90% of physicians practicing in a single specialty across the country.6 The findings revealed that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit. For surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
The study’s authors concluded that “apology laws are not substitutes for specific physician disclosure programs, and that the experiences of these types of programs are not generalizable to the physician population at large. In other words, simply being allowed to apologize is not enough to reduce malpractice risk.”
In the informed consent arena, the latest development in the law revolves around whether a physician assistant, in lieu of the surgeon himself, can obtain informed consent from a patient.
In Shinal v. Toms,7 Megan Shinal underwent surgery to remove a craniopharyngioma, but it regrew and required re-exploration by Dr. Steven Toms. Dr. Toms testified that Ms. Shinal had agreed that he would determine during the surgery whether he should remove the entire tumor or perform a partial resection. The operation was complicated by a carotid artery perforation, which left the patient with impaired vision and ambulation.
The complaint asserted that Dr. Toms’s physician assistant, not Dr. Toms himself, had provided the actual discussion during the informed consent process, and thus the patient’s consent was invalid.
The jury was allowed to consider the information provided by the doctor’s support staff, and the Superior Court of Pennsylvania affirmed the validity of the patient’s consent, holding that consent is based on the scope of information relayed rather than the identity of the individual communicating the information. This carefully watched case is now on final appeal before the Supreme Court of Pennsylvania.
At a personal level, physicians dread the stress surrounding medical malpractice litigation. The process frontally attacks their competence and consumes much time and energy, notwithstanding there being little or no exposure of personal assets because of insurance protection. Virtually all doctors practice defensive medicine, which has been defined as “deviation from sound medical practice that is induced primarily by a threat of liability.”
At a societal level, defensive medicine is reported to add substantially to the nation’s medical bill. The figure tossed around is $12 billion to $50 billion a year, based mostly on estimates by the American Medical Association and an older study extrapolating potential Medicare savings from litigation over heart disease.8
A more recent report continues to emphasize the high cost of defensive medicine.9 Jackson Healthcare invited 138,686 physicians to participate in a confidential online survey to quantify the costs and impact of defensive medicine. More than 3,000 physicians spanning all states and medical specialties completed the survey; however, this represented only a 2.21% response rate.
The authors concluded that defensive medicine is a significant force driving the high cost of health care in the United States, and that physicians estimate the cost of defensive medicine to be in the $650 billion to $850 billion range, or between 26% and 34% of annual health care costs.
Skeptics question the way the profession defines defensive medicine, pointing out that malpractice concerns may not be the primary reason, as most interventions add some marginal value to patient care. There may also be conflicting motivations of physicians, such as financial or other personal rewards.
Above all, there is no acceptable method for measuring the extent and use of defensive medicine, and survey reports are apt to be misleading because of bias and the lack of controls and baseline data.
Looking ahead, what can we expect for malpractice law under the Trump administration? Tom Price, MD, a former Republican congressman from Georgia, is an orthopedic surgeon and the new secretary of the Department of Health & Human Services. He has previously spoken passionately about tort reforms such as defensive medicine, damage caps, health tribunals, and practice guidelines. Many states have already incorporated some of these measures into their own tort reforms – with salutary results. It remains to be seen whether HHS will deem any omnibus federal legislation necessary at this point.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from my earlier columns in Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. JAMA. 2014 Nov 26;312(20):2146-55.
2. “Malpractice 2017: Do We Need Reform?” Internal Medicine News, March 1, 2017, page 1.
3. Fein v. Permanente, 38 Cal.3d 137 (1985).
4. Chan v. Curran, 237 CA 4th 601 (2015).
5. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).
6. Available at https://papers.ssrn.com/sol3/papers2.cfm?abstract_id=2883693.
7. Shinal v. Toms, 122 A. 3d 1066 (Pa. Super. Ct. 2015).
8. Q J Econ. (1996) 111 (2): 353-390.
9. Available at www.jacksonhealthcare.com/media/8968/defensivemedicine_ebook_final.pdf.
Question: Recent developments in malpractice include the following:
A. Severity and frequency rates continue to rise.
B. Apology laws appear to be very effective in reducing claims.
C. Litigation surrounds whether an assistant may obtain a patient’s informed consent on behalf of the doctor.
D. A and B.
E. A, B, and C.
Answer: C. Over the past decade, malpractice claims have in fact diminished, accompanied by a leveling or reduction in premiums.1 Rates have plummeted to roughly half of previous levels, averaging six claims per 100 doctors in 2016.
According to The Doctors Company, internists paid an average premium of $15,853, compared with an average of $19,900 in 2006, general surgeons $52,905 instead of $68,186, and obstetricians $72,999, a drop from $93,230. Even claims-plagued Florida’s Dade County has seen a dramatic drop in internist premiums by some $27,000, down to $47,707.2
The latest attack on MICRA, in 2015, concerned a wrongful death suit brought by a woman whose mother died from hemorrhagic complications related to Coumadin use following heart surgery.4 Her constitutional challenges included violation of equal protection, due process, and the right to a jury trial. But these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000 as required by MICRA. A California appeals court rejected her claim as being “contrary to many well-established legal principles.”
Disclosure of medical errors is a relative newcomer as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called “apology laws,” an outgrowth of the communication and resolution programs popularized by the Lexington (Ky.) VA Medical Center, University of Michigan Health System, Harvard’s affiliated institutions, and Colorado’s COPIC Insurance.
Apology laws disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician. For example, the Ohio Supreme Court has ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute, even though the incident took place before the law went into effect.5
However, apology laws do vary from state to state, and some do not shield admissions regarding causation of error or fault.
A recent study suggests that apology laws don’t work. A Vanderbilt University study published online used a unique dataset covering all malpractice claims for 90% of physicians practicing in a single specialty across the country.6 The findings revealed that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit. For surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
The study’s authors concluded that “apology laws are not substitutes for specific physician disclosure programs, and that the experiences of these types of programs are not generalizable to the physician population at large. In other words, simply being allowed to apologize is not enough to reduce malpractice risk.”
In the informed consent arena, the latest development in the law revolves around whether a physician assistant, in lieu of the surgeon himself, can obtain informed consent from a patient.
In Shinal v. Toms,7 Megan Shinal underwent surgery to remove a craniopharyngioma, but it regrew and required re-exploration by Dr. Steven Toms. Dr. Toms testified that Ms. Shinal had agreed that he would determine during the surgery whether he should remove the entire tumor or perform a partial resection. The operation was complicated by a carotid artery perforation, which left the patient with impaired vision and ambulation.
The complaint asserted that Dr. Toms’s physician assistant, not Dr. Toms himself, had provided the actual discussion during the informed consent process, and thus the patient’s consent was invalid.
The jury was allowed to consider the information provided by the doctor’s support staff, and the Superior Court of Pennsylvania affirmed the validity of the patient’s consent, holding that consent is based on the scope of information relayed rather than the identity of the individual communicating the information. This carefully watched case is now on final appeal before the Supreme Court of Pennsylvania.
At a personal level, physicians dread the stress surrounding medical malpractice litigation. The process frontally attacks their competence and consumes much time and energy, notwithstanding there being little or no exposure of personal assets because of insurance protection. Virtually all doctors practice defensive medicine, which has been defined as “deviation from sound medical practice that is induced primarily by a threat of liability.”
At a societal level, defensive medicine is reported to add substantially to the nation’s medical bill. The figure tossed around is $12 billion to $50 billion a year, based mostly on estimates by the American Medical Association and an older study extrapolating potential Medicare savings from litigation over heart disease.8
A more recent report continues to emphasize the high cost of defensive medicine.9 Jackson Healthcare invited 138,686 physicians to participate in a confidential online survey to quantify the costs and impact of defensive medicine. More than 3,000 physicians spanning all states and medical specialties completed the survey; however, this represented only a 2.21% response rate.
The authors concluded that defensive medicine is a significant force driving the high cost of health care in the United States, and that physicians estimate the cost of defensive medicine to be in the $650 billion to $850 billion range, or between 26% and 34% of annual health care costs.
Skeptics question the way the profession defines defensive medicine, pointing out that malpractice concerns may not be the primary reason, as most interventions add some marginal value to patient care. There may also be conflicting motivations of physicians, such as financial or other personal rewards.
Above all, there is no acceptable method for measuring the extent and use of defensive medicine, and survey reports are apt to be misleading because of bias and the lack of controls and baseline data.
Looking ahead, what can we expect for malpractice law under the Trump administration? Tom Price, MD, a former Republican congressman from Georgia, is an orthopedic surgeon and the new secretary of the Department of Health & Human Services. He has previously spoken passionately about tort reforms such as defensive medicine, damage caps, health tribunals, and practice guidelines. Many states have already incorporated some of these measures into their own tort reforms – with salutary results. It remains to be seen whether HHS will deem any omnibus federal legislation necessary at this point.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from my earlier columns in Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. JAMA. 2014 Nov 26;312(20):2146-55.
2. “Malpractice 2017: Do We Need Reform?” Internal Medicine News, March 1, 2017, page 1.
3. Fein v. Permanente, 38 Cal.3d 137 (1985).
4. Chan v. Curran, 237 CA 4th 601 (2015).
5. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).
6. Available at https://papers.ssrn.com/sol3/papers2.cfm?abstract_id=2883693.
7. Shinal v. Toms, 122 A. 3d 1066 (Pa. Super. Ct. 2015).
8. Q J Econ. (1996) 111 (2): 353-390.
9. Available at www.jacksonhealthcare.com/media/8968/defensivemedicine_ebook_final.pdf.
Question: Recent developments in malpractice include the following:
A. Severity and frequency rates continue to rise.
B. Apology laws appear to be very effective in reducing claims.
C. Litigation surrounds whether an assistant may obtain a patient’s informed consent on behalf of the doctor.
D. A and B.
E. A, B, and C.
Answer: C. Over the past decade, malpractice claims have in fact diminished, accompanied by a leveling or reduction in premiums.1 Rates have plummeted to roughly half of previous levels, averaging six claims per 100 doctors in 2016.
According to The Doctors Company, internists paid an average premium of $15,853, compared with an average of $19,900 in 2006, general surgeons $52,905 instead of $68,186, and obstetricians $72,999, a drop from $93,230. Even claims-plagued Florida’s Dade County has seen a dramatic drop in internist premiums by some $27,000, down to $47,707.2
The latest attack on MICRA, in 2015, concerned a wrongful death suit brought by a woman whose mother died from hemorrhagic complications related to Coumadin use following heart surgery.4 Her constitutional challenges included violation of equal protection, due process, and the right to a jury trial. But these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000 as required by MICRA. A California appeals court rejected her claim as being “contrary to many well-established legal principles.”
Disclosure of medical errors is a relative newcomer as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called “apology laws,” an outgrowth of the communication and resolution programs popularized by the Lexington (Ky.) VA Medical Center, University of Michigan Health System, Harvard’s affiliated institutions, and Colorado’s COPIC Insurance.
Apology laws disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician. For example, the Ohio Supreme Court has ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute, even though the incident took place before the law went into effect.5
However, apology laws do vary from state to state, and some do not shield admissions regarding causation of error or fault.
A recent study suggests that apology laws don’t work. A Vanderbilt University study published online used a unique dataset covering all malpractice claims for 90% of physicians practicing in a single specialty across the country.6 The findings revealed that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit. For surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
The study’s authors concluded that “apology laws are not substitutes for specific physician disclosure programs, and that the experiences of these types of programs are not generalizable to the physician population at large. In other words, simply being allowed to apologize is not enough to reduce malpractice risk.”
In the informed consent arena, the latest development in the law revolves around whether a physician assistant, in lieu of the surgeon himself, can obtain informed consent from a patient.
In Shinal v. Toms,7 Megan Shinal underwent surgery to remove a craniopharyngioma, but it regrew and required re-exploration by Dr. Steven Toms. Dr. Toms testified that Ms. Shinal had agreed that he would determine during the surgery whether he should remove the entire tumor or perform a partial resection. The operation was complicated by a carotid artery perforation, which left the patient with impaired vision and ambulation.
The complaint asserted that Dr. Toms’s physician assistant, not Dr. Toms himself, had provided the actual discussion during the informed consent process, and thus the patient’s consent was invalid.
The jury was allowed to consider the information provided by the doctor’s support staff, and the Superior Court of Pennsylvania affirmed the validity of the patient’s consent, holding that consent is based on the scope of information relayed rather than the identity of the individual communicating the information. This carefully watched case is now on final appeal before the Supreme Court of Pennsylvania.
At a personal level, physicians dread the stress surrounding medical malpractice litigation. The process frontally attacks their competence and consumes much time and energy, notwithstanding there being little or no exposure of personal assets because of insurance protection. Virtually all doctors practice defensive medicine, which has been defined as “deviation from sound medical practice that is induced primarily by a threat of liability.”
At a societal level, defensive medicine is reported to add substantially to the nation’s medical bill. The figure tossed around is $12 billion to $50 billion a year, based mostly on estimates by the American Medical Association and an older study extrapolating potential Medicare savings from litigation over heart disease.8
A more recent report continues to emphasize the high cost of defensive medicine.9 Jackson Healthcare invited 138,686 physicians to participate in a confidential online survey to quantify the costs and impact of defensive medicine. More than 3,000 physicians spanning all states and medical specialties completed the survey; however, this represented only a 2.21% response rate.
The authors concluded that defensive medicine is a significant force driving the high cost of health care in the United States, and that physicians estimate the cost of defensive medicine to be in the $650 billion to $850 billion range, or between 26% and 34% of annual health care costs.
Skeptics question the way the profession defines defensive medicine, pointing out that malpractice concerns may not be the primary reason, as most interventions add some marginal value to patient care. There may also be conflicting motivations of physicians, such as financial or other personal rewards.
Above all, there is no acceptable method for measuring the extent and use of defensive medicine, and survey reports are apt to be misleading because of bias and the lack of controls and baseline data.
Looking ahead, what can we expect for malpractice law under the Trump administration? Tom Price, MD, a former Republican congressman from Georgia, is an orthopedic surgeon and the new secretary of the Department of Health & Human Services. He has previously spoken passionately about tort reforms such as defensive medicine, damage caps, health tribunals, and practice guidelines. Many states have already incorporated some of these measures into their own tort reforms – with salutary results. It remains to be seen whether HHS will deem any omnibus federal legislation necessary at this point.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from my earlier columns in Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. JAMA. 2014 Nov 26;312(20):2146-55.
2. “Malpractice 2017: Do We Need Reform?” Internal Medicine News, March 1, 2017, page 1.
3. Fein v. Permanente, 38 Cal.3d 137 (1985).
4. Chan v. Curran, 237 CA 4th 601 (2015).
5. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).
6. Available at https://papers.ssrn.com/sol3/papers2.cfm?abstract_id=2883693.
7. Shinal v. Toms, 122 A. 3d 1066 (Pa. Super. Ct. 2015).
8. Q J Econ. (1996) 111 (2): 353-390.
9. Available at www.jacksonhealthcare.com/media/8968/defensivemedicine_ebook_final.pdf.
EMTALA Part III: Case law
This is the third installment of a three-part series.
Question: Based on case law, which of the following statements is most appropriate regarding EMTALA?
A. Prior to updated regulations, jurisdictions were divided as to whether the Emergency Medical Treatment and Labor Act (EMTALA) covered in-hospital patients.
B. CMS (Centers for Medicare & Medicaid Services) has since clarified that EMTALA does not apply to the in-hospital situation absent bad faith, and all courts now abide by this rule.
C. Stabilization and transfer refer only to moving a patient to another hospital or discharging a patient from the emergency department (ED).
D. Stabilization means a patient may never be transferred while unstable.
E. There is an EMTALA exception for futile treatment in the ED.
Answer: A.
Most cases under EMTALA, the federal anti-dumping statute, deal with the failure to screen or to stabilize patients presenting to the emergency department (ED) of a hospital. For a while, jurisdictions were split as to whether the EMTALA statute was equally applicable to inpatients. A typical case concerned Carol James, a renal-failure patient who complained that she developed an emergency vein-graft malfunction in the hospital but was discharged in violation of EMTALA. The condition was not stabilized before discharge, which caused her to have her hand amputated. However, the Ninth Circuit Court dismissed for failure to state a claim, reasoning that this federal statute could not be and was not based upon a claim of medical malpractice. The Court wrote: “Hospitals are often big buildings or complexes of multiple big buildings. It would make no sense for the authority of physicians proposing to transfer a patient from the eleventh floor of building III to be affected by whether a physician was physically present in the emergency room on the first floor of building I. Congress must have been contemplating patients who were in the emergency room …”1
The defendant hospital moved for summary judgment on the basis that she never presented to the ED for examination in the first place. The Court ruled that EMTALA’s “stabilization before transfer” requirement does not apply to individuals that have been admitted to the hospital for inpatient care, reinforcing the rule that EMTALA’s limited purpose was to eliminate patient dumping and not to federalize medical malpractice. The court also held that she had failed to present any evidence that the hospital had actual knowledge of her emergency medical condition when it discharged her, as she had told the doctor that she was “okay,” “fine,” “comfortable,” and “ready to go home.” Under the statute, a plaintiff must first prove the hospital had actual knowledge of an individual’s unstabilized emergency medical condition to succeed on a claim.
On the other hand, in Thornton v. Southwest Detroit Hospital,3 the Sixth Circuit Court deemed the EMTALA stabilization requirement to extend to the inpatient situation. The patient had been in the hospital for an extended stay for treatment of a stroke before being discharged to home care, where her condition worsened. This was a 1990 case, but even after CMS’ revised rule in 2003 clarifying that EMTALA’s obligation ends upon hospital admission, the same Court chose to ignore the regulation. In Moses v. Providence Hospital and Medical Center,4 a hospitalized psychotic patient was discharged in an arguably unstabilized condition and went on to murder his wife some 10 days later. The Sixth Circuit Court ruled that EMTALA was nonetheless applicable.
Litigation over transfer propriety does not always involve another hospital. For example, in Carlisle v. Frisbie Memorial Hospital,5 an intoxicated and suicidal ED patient refused to see a psychiatrist and was handed over to the police and sent to jail. The court ruled that the hospital was in violation of EMTALA by failing to stabilize the patient prior to “transfer.”
Under EMTALA, an unstable patient may still be transferred so long as certain criteria are met, principally if the original hospital lacks the facilities to provide proper treatment, and the benefits of a transfer outweigh the risks. In Cherukuri v. Shalala,6 Dr. Cherukuri, a surgeon, faced suspension of his license and a civil penalty of $100,000 for allegedly violating the stabilization language of EMTALA. He had transferred two patients with head injuries to the trauma center at St. Mary’s Hospital in Huntington without first stopping intra-abdominal hemorrhage and before receiving express consent from the receiving institution. The patients were victims of an auto accident and were initially brought by ambulance in the early morning hours to Williamson Hospital, a small rural hospital in south Williamson, Kentucky, which had no trauma center and no equipment for neuro-monitoring during anesthesia.
Dr. Cherukuri was the on-call ED surgeon that night. An expert testified that stabilization of internal bleeding required an abdominal operation by the surgeon prior to transfer. Dr. Cherukuri was initially found liable, based on the legal conclusion that he “knew or should have known that the benefits [of transfer] did not outweigh the risks.” However, it was undisputed that the condition of the two patients did not deteriorate during transfer. On appeal, the Sixth Circuit Court reversed, finding that Dr. Cherukuri sufficiently stabilized the two patients to permit transfer and alternatively, that he did not have an anesthesiologist available in order for him to operate.
Probably the most unusual and unexpected challenge to EMTALA faced the Fourth Circuit Court when Baby K, an anencephalic infant, presented repeatedly to a hospital ED with respiratory distress.7 Her physicians and the hospital had petitioned withdrawal of ventilator support, arguing that a requirement to provide respiratory assistance would exceed the prevailing standard of medical care, i.e., provision of warmth, nutrition and hydration, because any treatment of the baby’s condition was futile. The baby’s mother however, insisted that respirator care must be continued, invoking the hospital’s obligations under EMTALA’s stabilization requirement. Citing the statute, the Court ruled that EMTALA required all EDs to provide treatment necessary to prevent the material deterioration of the individual’s condition, and that the statute does not contain a “standard of care” exception. The Court wrote: “We recognize the dilemma facing physicians who are requested to provide treatment they consider morally and ethically inappropriate, but we cannot ignore the plain language of the statute because to do so would transcend our judicial function ...”
References
1. James v. Sunrise Hospital, 86 F.3d 885 (9th Cir. 1996).
2. Dollard v. Allen, 260 F. Supp. 2d 1127 (D. Wyo. 2003).
3. Thornton v. Southwest Detroit Hospital, 895 F.2d 1131 (6th Cir. 1990).
4. Moses v. Providence Hospital and Medical Center, 561 F.3d 573 (6th Cir. 2009).
5. Carlisle v. Frisbie Memorial Hospital, 888 A.2d 405 (N.H. 2005).
6. Cherukuri v. Shalala, 175 F.3d 446 (6th Cir. 1999).
7. In re Baby K, 16 F.3d 590 (4th Cir. 1994).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
This is the third installment of a three-part series.
Question: Based on case law, which of the following statements is most appropriate regarding EMTALA?
A. Prior to updated regulations, jurisdictions were divided as to whether the Emergency Medical Treatment and Labor Act (EMTALA) covered in-hospital patients.
B. CMS (Centers for Medicare & Medicaid Services) has since clarified that EMTALA does not apply to the in-hospital situation absent bad faith, and all courts now abide by this rule.
C. Stabilization and transfer refer only to moving a patient to another hospital or discharging a patient from the emergency department (ED).
D. Stabilization means a patient may never be transferred while unstable.
E. There is an EMTALA exception for futile treatment in the ED.
Answer: A.
Most cases under EMTALA, the federal anti-dumping statute, deal with the failure to screen or to stabilize patients presenting to the emergency department (ED) of a hospital. For a while, jurisdictions were split as to whether the EMTALA statute was equally applicable to inpatients. A typical case concerned Carol James, a renal-failure patient who complained that she developed an emergency vein-graft malfunction in the hospital but was discharged in violation of EMTALA. The condition was not stabilized before discharge, which caused her to have her hand amputated. However, the Ninth Circuit Court dismissed for failure to state a claim, reasoning that this federal statute could not be and was not based upon a claim of medical malpractice. The Court wrote: “Hospitals are often big buildings or complexes of multiple big buildings. It would make no sense for the authority of physicians proposing to transfer a patient from the eleventh floor of building III to be affected by whether a physician was physically present in the emergency room on the first floor of building I. Congress must have been contemplating patients who were in the emergency room …”1
The defendant hospital moved for summary judgment on the basis that she never presented to the ED for examination in the first place. The Court ruled that EMTALA’s “stabilization before transfer” requirement does not apply to individuals that have been admitted to the hospital for inpatient care, reinforcing the rule that EMTALA’s limited purpose was to eliminate patient dumping and not to federalize medical malpractice. The court also held that she had failed to present any evidence that the hospital had actual knowledge of her emergency medical condition when it discharged her, as she had told the doctor that she was “okay,” “fine,” “comfortable,” and “ready to go home.” Under the statute, a plaintiff must first prove the hospital had actual knowledge of an individual’s unstabilized emergency medical condition to succeed on a claim.
On the other hand, in Thornton v. Southwest Detroit Hospital,3 the Sixth Circuit Court deemed the EMTALA stabilization requirement to extend to the inpatient situation. The patient had been in the hospital for an extended stay for treatment of a stroke before being discharged to home care, where her condition worsened. This was a 1990 case, but even after CMS’ revised rule in 2003 clarifying that EMTALA’s obligation ends upon hospital admission, the same Court chose to ignore the regulation. In Moses v. Providence Hospital and Medical Center,4 a hospitalized psychotic patient was discharged in an arguably unstabilized condition and went on to murder his wife some 10 days later. The Sixth Circuit Court ruled that EMTALA was nonetheless applicable.
Litigation over transfer propriety does not always involve another hospital. For example, in Carlisle v. Frisbie Memorial Hospital,5 an intoxicated and suicidal ED patient refused to see a psychiatrist and was handed over to the police and sent to jail. The court ruled that the hospital was in violation of EMTALA by failing to stabilize the patient prior to “transfer.”
Under EMTALA, an unstable patient may still be transferred so long as certain criteria are met, principally if the original hospital lacks the facilities to provide proper treatment, and the benefits of a transfer outweigh the risks. In Cherukuri v. Shalala,6 Dr. Cherukuri, a surgeon, faced suspension of his license and a civil penalty of $100,000 for allegedly violating the stabilization language of EMTALA. He had transferred two patients with head injuries to the trauma center at St. Mary’s Hospital in Huntington without first stopping intra-abdominal hemorrhage and before receiving express consent from the receiving institution. The patients were victims of an auto accident and were initially brought by ambulance in the early morning hours to Williamson Hospital, a small rural hospital in south Williamson, Kentucky, which had no trauma center and no equipment for neuro-monitoring during anesthesia.
Dr. Cherukuri was the on-call ED surgeon that night. An expert testified that stabilization of internal bleeding required an abdominal operation by the surgeon prior to transfer. Dr. Cherukuri was initially found liable, based on the legal conclusion that he “knew or should have known that the benefits [of transfer] did not outweigh the risks.” However, it was undisputed that the condition of the two patients did not deteriorate during transfer. On appeal, the Sixth Circuit Court reversed, finding that Dr. Cherukuri sufficiently stabilized the two patients to permit transfer and alternatively, that he did not have an anesthesiologist available in order for him to operate.
Probably the most unusual and unexpected challenge to EMTALA faced the Fourth Circuit Court when Baby K, an anencephalic infant, presented repeatedly to a hospital ED with respiratory distress.7 Her physicians and the hospital had petitioned withdrawal of ventilator support, arguing that a requirement to provide respiratory assistance would exceed the prevailing standard of medical care, i.e., provision of warmth, nutrition and hydration, because any treatment of the baby’s condition was futile. The baby’s mother however, insisted that respirator care must be continued, invoking the hospital’s obligations under EMTALA’s stabilization requirement. Citing the statute, the Court ruled that EMTALA required all EDs to provide treatment necessary to prevent the material deterioration of the individual’s condition, and that the statute does not contain a “standard of care” exception. The Court wrote: “We recognize the dilemma facing physicians who are requested to provide treatment they consider morally and ethically inappropriate, but we cannot ignore the plain language of the statute because to do so would transcend our judicial function ...”
References
1. James v. Sunrise Hospital, 86 F.3d 885 (9th Cir. 1996).
2. Dollard v. Allen, 260 F. Supp. 2d 1127 (D. Wyo. 2003).
3. Thornton v. Southwest Detroit Hospital, 895 F.2d 1131 (6th Cir. 1990).
4. Moses v. Providence Hospital and Medical Center, 561 F.3d 573 (6th Cir. 2009).
5. Carlisle v. Frisbie Memorial Hospital, 888 A.2d 405 (N.H. 2005).
6. Cherukuri v. Shalala, 175 F.3d 446 (6th Cir. 1999).
7. In re Baby K, 16 F.3d 590 (4th Cir. 1994).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
This is the third installment of a three-part series.
Question: Based on case law, which of the following statements is most appropriate regarding EMTALA?
A. Prior to updated regulations, jurisdictions were divided as to whether the Emergency Medical Treatment and Labor Act (EMTALA) covered in-hospital patients.
B. CMS (Centers for Medicare & Medicaid Services) has since clarified that EMTALA does not apply to the in-hospital situation absent bad faith, and all courts now abide by this rule.
C. Stabilization and transfer refer only to moving a patient to another hospital or discharging a patient from the emergency department (ED).
D. Stabilization means a patient may never be transferred while unstable.
E. There is an EMTALA exception for futile treatment in the ED.
Answer: A.
Most cases under EMTALA, the federal anti-dumping statute, deal with the failure to screen or to stabilize patients presenting to the emergency department (ED) of a hospital. For a while, jurisdictions were split as to whether the EMTALA statute was equally applicable to inpatients. A typical case concerned Carol James, a renal-failure patient who complained that she developed an emergency vein-graft malfunction in the hospital but was discharged in violation of EMTALA. The condition was not stabilized before discharge, which caused her to have her hand amputated. However, the Ninth Circuit Court dismissed for failure to state a claim, reasoning that this federal statute could not be and was not based upon a claim of medical malpractice. The Court wrote: “Hospitals are often big buildings or complexes of multiple big buildings. It would make no sense for the authority of physicians proposing to transfer a patient from the eleventh floor of building III to be affected by whether a physician was physically present in the emergency room on the first floor of building I. Congress must have been contemplating patients who were in the emergency room …”1
The defendant hospital moved for summary judgment on the basis that she never presented to the ED for examination in the first place. The Court ruled that EMTALA’s “stabilization before transfer” requirement does not apply to individuals that have been admitted to the hospital for inpatient care, reinforcing the rule that EMTALA’s limited purpose was to eliminate patient dumping and not to federalize medical malpractice. The court also held that she had failed to present any evidence that the hospital had actual knowledge of her emergency medical condition when it discharged her, as she had told the doctor that she was “okay,” “fine,” “comfortable,” and “ready to go home.” Under the statute, a plaintiff must first prove the hospital had actual knowledge of an individual’s unstabilized emergency medical condition to succeed on a claim.
On the other hand, in Thornton v. Southwest Detroit Hospital,3 the Sixth Circuit Court deemed the EMTALA stabilization requirement to extend to the inpatient situation. The patient had been in the hospital for an extended stay for treatment of a stroke before being discharged to home care, where her condition worsened. This was a 1990 case, but even after CMS’ revised rule in 2003 clarifying that EMTALA’s obligation ends upon hospital admission, the same Court chose to ignore the regulation. In Moses v. Providence Hospital and Medical Center,4 a hospitalized psychotic patient was discharged in an arguably unstabilized condition and went on to murder his wife some 10 days later. The Sixth Circuit Court ruled that EMTALA was nonetheless applicable.
Litigation over transfer propriety does not always involve another hospital. For example, in Carlisle v. Frisbie Memorial Hospital,5 an intoxicated and suicidal ED patient refused to see a psychiatrist and was handed over to the police and sent to jail. The court ruled that the hospital was in violation of EMTALA by failing to stabilize the patient prior to “transfer.”
Under EMTALA, an unstable patient may still be transferred so long as certain criteria are met, principally if the original hospital lacks the facilities to provide proper treatment, and the benefits of a transfer outweigh the risks. In Cherukuri v. Shalala,6 Dr. Cherukuri, a surgeon, faced suspension of his license and a civil penalty of $100,000 for allegedly violating the stabilization language of EMTALA. He had transferred two patients with head injuries to the trauma center at St. Mary’s Hospital in Huntington without first stopping intra-abdominal hemorrhage and before receiving express consent from the receiving institution. The patients were victims of an auto accident and were initially brought by ambulance in the early morning hours to Williamson Hospital, a small rural hospital in south Williamson, Kentucky, which had no trauma center and no equipment for neuro-monitoring during anesthesia.
Dr. Cherukuri was the on-call ED surgeon that night. An expert testified that stabilization of internal bleeding required an abdominal operation by the surgeon prior to transfer. Dr. Cherukuri was initially found liable, based on the legal conclusion that he “knew or should have known that the benefits [of transfer] did not outweigh the risks.” However, it was undisputed that the condition of the two patients did not deteriorate during transfer. On appeal, the Sixth Circuit Court reversed, finding that Dr. Cherukuri sufficiently stabilized the two patients to permit transfer and alternatively, that he did not have an anesthesiologist available in order for him to operate.
Probably the most unusual and unexpected challenge to EMTALA faced the Fourth Circuit Court when Baby K, an anencephalic infant, presented repeatedly to a hospital ED with respiratory distress.7 Her physicians and the hospital had petitioned withdrawal of ventilator support, arguing that a requirement to provide respiratory assistance would exceed the prevailing standard of medical care, i.e., provision of warmth, nutrition and hydration, because any treatment of the baby’s condition was futile. The baby’s mother however, insisted that respirator care must be continued, invoking the hospital’s obligations under EMTALA’s stabilization requirement. Citing the statute, the Court ruled that EMTALA required all EDs to provide treatment necessary to prevent the material deterioration of the individual’s condition, and that the statute does not contain a “standard of care” exception. The Court wrote: “We recognize the dilemma facing physicians who are requested to provide treatment they consider morally and ethically inappropriate, but we cannot ignore the plain language of the statute because to do so would transcend our judicial function ...”
References
1. James v. Sunrise Hospital, 86 F.3d 885 (9th Cir. 1996).
2. Dollard v. Allen, 260 F. Supp. 2d 1127 (D. Wyo. 2003).
3. Thornton v. Southwest Detroit Hospital, 895 F.2d 1131 (6th Cir. 1990).
4. Moses v. Providence Hospital and Medical Center, 561 F.3d 573 (6th Cir. 2009).
5. Carlisle v. Frisbie Memorial Hospital, 888 A.2d 405 (N.H. 2005).
6. Cherukuri v. Shalala, 175 F.3d 446 (6th Cir. 1999).
7. In re Baby K, 16 F.3d 590 (4th Cir. 1994).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
Law & Medicine: How case law shapes EMTALA
(This is the second installment of a three-part series.)
Question: Emergency Medical Treatment and Labor Act (EMTALA) litigation has yielded which of the following rules of law?
A. The statute is applicable only when a patient is physically in the hospital’s emergency department (ED).
B. Directing an ambulance away from the ED is a violation of EMTALA.
C. All patients presenting to the ED must have an appropriate medical screening exam conforming to customary standard of care.
D. It is not what is performed in any medical screening exam, but whether it is applied evenly to all patients similarly situated.
E. The U.S. Supreme Court has held that an improper motive behind an unstable transfer is a prerequisite to an EMTALA violation.
Answer: D. In 1986, Congress enacted the Emergency Medical Treatment and Labor Act to ensure that all patients who present themselves to the emergency department are appropriately screened for an emergent medical condition, and if one is present, that they be stabilized prior to transfer or discharge.
In the 3 decades since its enactment, the statute has, as expected, spawned numerous lawsuits. Parts two and three of this series on EMTALA summarize the salient findings and rules of law in several interesting and impactful cases. These cases are neither encyclopedic nor necessarily representative of the types of litigation commonly encountered.
EMTALA is about events in the emergency department. They begin with the patient coming to the ED seeking treatment, and the statute specifically refers to “any individual ... [who] comes to the emergency department and a request is made on the individual’s behalf for examination or treatment for a medical condition.”
But what if the patient has yet to arrive, e.g., in an ambulance en route, and was diverted elsewhere in an unstable condition? In Hawaii’s case of Arrington v. Wong (237 F.3d 1066 [9th Cir. 2001]), the court was faced with whether the requirement that a patient must first “come to” the hospital means his or her literal physical presence in the hospital.
On May 5, 1996, Harold Arrington developed dyspnea while driving to his job as a security guard. En route to the closest medical facility, the Queen’s Medical Center, the ambulance personnel contacted Dr. Norbert Wong, the physician on call, describing the patient as being in severe respiratory distress, speaking one to two words at a time, and breathing about 50 times a minute.
Although Queen’s was not on diversionary status at the time, Dr. Wong thought it was okay for the ambulance to go instead to Tripler Hospital, a more distant hospital, as the patient’s doctor worked there. Unfortunately, by the time the ambulance arrived at Tripler, Mr. Arrington’s condition had deteriorated, and he was pronounced dead shortly after arrival.
The lower court ruled for the defendant, holding that the statute demanded an actual physical presence in the ED, but the 9th Circuit Court of Appeals reversed. It held that under EMTALA, a hospital may divert an ambulance that has contacted its emergency department and is on the way to that hospital only if the hospital is in diversionary status, because the diverting hospital then has a valid, treatment-related reason for doing so.
Such an interpretation of the law works no hardship on the hospital and is consistent with the Centers for Medicare & Medicaid Services’ regulation that “only requires hospitals that offer emergency services to provide screening and stabilizing treatment within the scope of their capabilities.” The 9th Circuit felt that this was consistent with the purpose and language of the EMTALA statute.
The next case, Summers v. Baptist Medical Center (91 F. 3d 1132 [8th Cir. 1996]), addressed the screening aspect of EMTALA, specifically on the distinction between disparity and adequacy in screening procedures. In Summers, the plaintiff fell from a tree while hunting and sustained bilateral hemothoraces, vertebral, rib, and sternal fractures. Incredibly, the diagnosis in the first hospital ED was muscle spasms, and the diagnoses only became clear when he checked into a second hospital 2 days later.
Still, the court ruled that there was no EMTALA violation, and that allegations of substandard care should be addressed under a negligence theory in state courts and not under EMTALA. The court reasoned that under the statute, an “inappropriate” screening is one that is performed in a disparate manner to similarly situated patients, and the hospital itself is usually left to define for itself what is within its capabilities. It is up to the hospital itself to determine what its screening procedures will be and to apply them alike to all patients with comparable complaints.
Likewise, in Vickers v. Nash (78 F.3d 139 [4th Cir. 1996]), an intoxicated patient who sustained a head injury following a fight died 4 days later from an epidural hematoma that was missed. He did have his head laceration treated in the ED, and was observed for 11 hours before discharge. The court ruled that the plaintiffs had failed to prove there was disparate treatment, and that hospitals can only be expected to stabilize emergency medical conditions known to them at the time.
Finally, in its first and thus far only EMTALA case, the U.S. Supreme Court in 1999 looked at whether an improper motive was a prerequisite for a finding of an EMTALA violation regarding stabilization and transfer.
In Roberts v. Galen of Virginia (119 S. Court 685 [1999]), the patient, injured in a truck accident, required a splenectomy and ventilator support. After a prolonged hospital stay, she was about to be moved to a nearby nursing home when she developed a high fever from an infection, and had to be transferred to an acute care facility. Her guardian, Roberts, brought suit, asserting violations of EMTALA’s stabilization and transfer requirements. The hospital argued that no material deterioration of the condition was likely to result from or occur during the transfer, and the district court determined her transfer was not prompted by an improper motive.
On appeal, the 6th Circuit Court of Appeals affirmed, extending its earlier holding that a showing of improper motive was required to make out an inadequate screening claim under EMTALA.
The hospital raised a number of important defenses, which included the physician lacking actual knowledge that the patient had an emergency medical condition, that EMTALA did not apply to in-hospital treatment and discharge decisions, and denying that EMTALA imposes minimum substantive standards of medical care.
The U.S. Supreme Court granted certiorari on the single issue whether the improper motive test should apply to an allegedly wrongful transfer. Overturning the appeals court, it held that Section 1395dd(b) (stabilization and transfer) contained no express or implied “improper motive” requirement. The Supreme Court declined to resolve broader issues under the statute.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
(This is the second installment of a three-part series.)
Question: Emergency Medical Treatment and Labor Act (EMTALA) litigation has yielded which of the following rules of law?
A. The statute is applicable only when a patient is physically in the hospital’s emergency department (ED).
B. Directing an ambulance away from the ED is a violation of EMTALA.
C. All patients presenting to the ED must have an appropriate medical screening exam conforming to customary standard of care.
D. It is not what is performed in any medical screening exam, but whether it is applied evenly to all patients similarly situated.
E. The U.S. Supreme Court has held that an improper motive behind an unstable transfer is a prerequisite to an EMTALA violation.
Answer: D. In 1986, Congress enacted the Emergency Medical Treatment and Labor Act to ensure that all patients who present themselves to the emergency department are appropriately screened for an emergent medical condition, and if one is present, that they be stabilized prior to transfer or discharge.
In the 3 decades since its enactment, the statute has, as expected, spawned numerous lawsuits. Parts two and three of this series on EMTALA summarize the salient findings and rules of law in several interesting and impactful cases. These cases are neither encyclopedic nor necessarily representative of the types of litigation commonly encountered.
EMTALA is about events in the emergency department. They begin with the patient coming to the ED seeking treatment, and the statute specifically refers to “any individual ... [who] comes to the emergency department and a request is made on the individual’s behalf for examination or treatment for a medical condition.”
But what if the patient has yet to arrive, e.g., in an ambulance en route, and was diverted elsewhere in an unstable condition? In Hawaii’s case of Arrington v. Wong (237 F.3d 1066 [9th Cir. 2001]), the court was faced with whether the requirement that a patient must first “come to” the hospital means his or her literal physical presence in the hospital.
On May 5, 1996, Harold Arrington developed dyspnea while driving to his job as a security guard. En route to the closest medical facility, the Queen’s Medical Center, the ambulance personnel contacted Dr. Norbert Wong, the physician on call, describing the patient as being in severe respiratory distress, speaking one to two words at a time, and breathing about 50 times a minute.
Although Queen’s was not on diversionary status at the time, Dr. Wong thought it was okay for the ambulance to go instead to Tripler Hospital, a more distant hospital, as the patient’s doctor worked there. Unfortunately, by the time the ambulance arrived at Tripler, Mr. Arrington’s condition had deteriorated, and he was pronounced dead shortly after arrival.
The lower court ruled for the defendant, holding that the statute demanded an actual physical presence in the ED, but the 9th Circuit Court of Appeals reversed. It held that under EMTALA, a hospital may divert an ambulance that has contacted its emergency department and is on the way to that hospital only if the hospital is in diversionary status, because the diverting hospital then has a valid, treatment-related reason for doing so.
Such an interpretation of the law works no hardship on the hospital and is consistent with the Centers for Medicare & Medicaid Services’ regulation that “only requires hospitals that offer emergency services to provide screening and stabilizing treatment within the scope of their capabilities.” The 9th Circuit felt that this was consistent with the purpose and language of the EMTALA statute.
The next case, Summers v. Baptist Medical Center (91 F. 3d 1132 [8th Cir. 1996]), addressed the screening aspect of EMTALA, specifically on the distinction between disparity and adequacy in screening procedures. In Summers, the plaintiff fell from a tree while hunting and sustained bilateral hemothoraces, vertebral, rib, and sternal fractures. Incredibly, the diagnosis in the first hospital ED was muscle spasms, and the diagnoses only became clear when he checked into a second hospital 2 days later.
Still, the court ruled that there was no EMTALA violation, and that allegations of substandard care should be addressed under a negligence theory in state courts and not under EMTALA. The court reasoned that under the statute, an “inappropriate” screening is one that is performed in a disparate manner to similarly situated patients, and the hospital itself is usually left to define for itself what is within its capabilities. It is up to the hospital itself to determine what its screening procedures will be and to apply them alike to all patients with comparable complaints.
Likewise, in Vickers v. Nash (78 F.3d 139 [4th Cir. 1996]), an intoxicated patient who sustained a head injury following a fight died 4 days later from an epidural hematoma that was missed. He did have his head laceration treated in the ED, and was observed for 11 hours before discharge. The court ruled that the plaintiffs had failed to prove there was disparate treatment, and that hospitals can only be expected to stabilize emergency medical conditions known to them at the time.
Finally, in its first and thus far only EMTALA case, the U.S. Supreme Court in 1999 looked at whether an improper motive was a prerequisite for a finding of an EMTALA violation regarding stabilization and transfer.
In Roberts v. Galen of Virginia (119 S. Court 685 [1999]), the patient, injured in a truck accident, required a splenectomy and ventilator support. After a prolonged hospital stay, she was about to be moved to a nearby nursing home when she developed a high fever from an infection, and had to be transferred to an acute care facility. Her guardian, Roberts, brought suit, asserting violations of EMTALA’s stabilization and transfer requirements. The hospital argued that no material deterioration of the condition was likely to result from or occur during the transfer, and the district court determined her transfer was not prompted by an improper motive.
On appeal, the 6th Circuit Court of Appeals affirmed, extending its earlier holding that a showing of improper motive was required to make out an inadequate screening claim under EMTALA.
The hospital raised a number of important defenses, which included the physician lacking actual knowledge that the patient had an emergency medical condition, that EMTALA did not apply to in-hospital treatment and discharge decisions, and denying that EMTALA imposes minimum substantive standards of medical care.
The U.S. Supreme Court granted certiorari on the single issue whether the improper motive test should apply to an allegedly wrongful transfer. Overturning the appeals court, it held that Section 1395dd(b) (stabilization and transfer) contained no express or implied “improper motive” requirement. The Supreme Court declined to resolve broader issues under the statute.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
(This is the second installment of a three-part series.)
Question: Emergency Medical Treatment and Labor Act (EMTALA) litigation has yielded which of the following rules of law?
A. The statute is applicable only when a patient is physically in the hospital’s emergency department (ED).
B. Directing an ambulance away from the ED is a violation of EMTALA.
C. All patients presenting to the ED must have an appropriate medical screening exam conforming to customary standard of care.
D. It is not what is performed in any medical screening exam, but whether it is applied evenly to all patients similarly situated.
E. The U.S. Supreme Court has held that an improper motive behind an unstable transfer is a prerequisite to an EMTALA violation.
Answer: D. In 1986, Congress enacted the Emergency Medical Treatment and Labor Act to ensure that all patients who present themselves to the emergency department are appropriately screened for an emergent medical condition, and if one is present, that they be stabilized prior to transfer or discharge.
In the 3 decades since its enactment, the statute has, as expected, spawned numerous lawsuits. Parts two and three of this series on EMTALA summarize the salient findings and rules of law in several interesting and impactful cases. These cases are neither encyclopedic nor necessarily representative of the types of litigation commonly encountered.
EMTALA is about events in the emergency department. They begin with the patient coming to the ED seeking treatment, and the statute specifically refers to “any individual ... [who] comes to the emergency department and a request is made on the individual’s behalf for examination or treatment for a medical condition.”
But what if the patient has yet to arrive, e.g., in an ambulance en route, and was diverted elsewhere in an unstable condition? In Hawaii’s case of Arrington v. Wong (237 F.3d 1066 [9th Cir. 2001]), the court was faced with whether the requirement that a patient must first “come to” the hospital means his or her literal physical presence in the hospital.
On May 5, 1996, Harold Arrington developed dyspnea while driving to his job as a security guard. En route to the closest medical facility, the Queen’s Medical Center, the ambulance personnel contacted Dr. Norbert Wong, the physician on call, describing the patient as being in severe respiratory distress, speaking one to two words at a time, and breathing about 50 times a minute.
Although Queen’s was not on diversionary status at the time, Dr. Wong thought it was okay for the ambulance to go instead to Tripler Hospital, a more distant hospital, as the patient’s doctor worked there. Unfortunately, by the time the ambulance arrived at Tripler, Mr. Arrington’s condition had deteriorated, and he was pronounced dead shortly after arrival.
The lower court ruled for the defendant, holding that the statute demanded an actual physical presence in the ED, but the 9th Circuit Court of Appeals reversed. It held that under EMTALA, a hospital may divert an ambulance that has contacted its emergency department and is on the way to that hospital only if the hospital is in diversionary status, because the diverting hospital then has a valid, treatment-related reason for doing so.
Such an interpretation of the law works no hardship on the hospital and is consistent with the Centers for Medicare & Medicaid Services’ regulation that “only requires hospitals that offer emergency services to provide screening and stabilizing treatment within the scope of their capabilities.” The 9th Circuit felt that this was consistent with the purpose and language of the EMTALA statute.
The next case, Summers v. Baptist Medical Center (91 F. 3d 1132 [8th Cir. 1996]), addressed the screening aspect of EMTALA, specifically on the distinction between disparity and adequacy in screening procedures. In Summers, the plaintiff fell from a tree while hunting and sustained bilateral hemothoraces, vertebral, rib, and sternal fractures. Incredibly, the diagnosis in the first hospital ED was muscle spasms, and the diagnoses only became clear when he checked into a second hospital 2 days later.
Still, the court ruled that there was no EMTALA violation, and that allegations of substandard care should be addressed under a negligence theory in state courts and not under EMTALA. The court reasoned that under the statute, an “inappropriate” screening is one that is performed in a disparate manner to similarly situated patients, and the hospital itself is usually left to define for itself what is within its capabilities. It is up to the hospital itself to determine what its screening procedures will be and to apply them alike to all patients with comparable complaints.
Likewise, in Vickers v. Nash (78 F.3d 139 [4th Cir. 1996]), an intoxicated patient who sustained a head injury following a fight died 4 days later from an epidural hematoma that was missed. He did have his head laceration treated in the ED, and was observed for 11 hours before discharge. The court ruled that the plaintiffs had failed to prove there was disparate treatment, and that hospitals can only be expected to stabilize emergency medical conditions known to them at the time.
Finally, in its first and thus far only EMTALA case, the U.S. Supreme Court in 1999 looked at whether an improper motive was a prerequisite for a finding of an EMTALA violation regarding stabilization and transfer.
In Roberts v. Galen of Virginia (119 S. Court 685 [1999]), the patient, injured in a truck accident, required a splenectomy and ventilator support. After a prolonged hospital stay, she was about to be moved to a nearby nursing home when she developed a high fever from an infection, and had to be transferred to an acute care facility. Her guardian, Roberts, brought suit, asserting violations of EMTALA’s stabilization and transfer requirements. The hospital argued that no material deterioration of the condition was likely to result from or occur during the transfer, and the district court determined her transfer was not prompted by an improper motive.
On appeal, the 6th Circuit Court of Appeals affirmed, extending its earlier holding that a showing of improper motive was required to make out an inadequate screening claim under EMTALA.
The hospital raised a number of important defenses, which included the physician lacking actual knowledge that the patient had an emergency medical condition, that EMTALA did not apply to in-hospital treatment and discharge decisions, and denying that EMTALA imposes minimum substantive standards of medical care.
The U.S. Supreme Court granted certiorari on the single issue whether the improper motive test should apply to an allegedly wrongful transfer. Overturning the appeals court, it held that Section 1395dd(b) (stabilization and transfer) contained no express or implied “improper motive” requirement. The Supreme Court declined to resolve broader issues under the statute.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
EMTALA – statutory law
This is the first of a two-part series.
Question: Which of the following statements regarding the Emergency Medical Treatment & Labor Act (EMTALA) is correct?
A. Deals with the standard of care in emergency medicine.
B. Provides safeguards for uninsured and nonpaying patients with an emergency medical condition.
C. Mandates uniform screening and treatment stabilization prior to transfer, irrespective of the hospital’s capability.
D. Is mostly directed at hospitals and emergency department staff doctors, but excludes on-call physicians.
E. Violations can result in fines, loss of Medicare provider participation, or even imprisonment.
Answer: B. In 1985, the CBS investigative news show “60 Minutes” ran an exposé on abuses in the emergency departments of U.S. hospitals, featuring the case of Eugene Barnes, a 32-year-old man brought to the Brookside Hospital emergency department (ED) in San Pablo, Calif., with a penetrating stab wound.
In another case, William Jenness, injured in an auto accident, died after a delayed transfer to a county hospital, because the original hospital required a $1,000 deposit in advance before initiating treatment.
In response to the widespread perception that uninsured patients were being denied treatment in the nation’s emergency departments, Congress enacted the Emergency Medical Treatment & Labor Act.1
Originally referred to as the “antidumping law,” EMTALA was designed to prevent hospitals from transferring financially undesirable patients to public hospitals without providing a medical screening examination and stabilizing treatment prior to transfer.
The purpose and intent of the law is to ensure that all patients who come to the ED have access to emergency services, although the statute itself is silent on payment ability.
EMTALA is not meant to replace or override state tort law, and does not deal with quality of care issues that may arise in the emergency department. Over the 30-year period since its enactment, EMTALA has received mixed reviews, with one scholar complaining that the statute is sloppily drafted and the premise of the statute, silly at best.2
EMTALA defines an emergency medical condition as:
1. A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances, and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, cause serious impairment to bodily functions, or result in serious dysfunction of any bodily organ or part.
2. With respect to a pregnant woman who is having contractions, there is inadequate time to effect a safe transfer to another hospital before delivery, or that transfer may pose a threat to the health or safety of the woman or the unborn child.3
Whether an emergency medical condition exists is determined by a medical screening exam (MSE). EMTALA is about a process directed at the well-being and safety of all patients with a medical emergency who come to the ED, defined as being licensed by the state or held out to the public as a place that provides care for emergency medical conditions. Hospital-based outpatient clinics that handle less than one-third of emergency visits and physician offices are exempt.
All patients who present to the ED seeking treatment are entitled to an MSE, and EDs are required to post such notification on their premises. A triage nurse may not be qualified to conduct the MSE unless he or she possesses special competencies, and has approval from the medical staff and the hospital’s governing body.
It is important that the MSE be documented soon after the patient’s arrival to determine if the medical condition warrants immediate treatment. It is definitely not acceptable to delay performing an MSE while awaiting information on insurance coverage, and one cannot “hold” the patient and delay stabilizing treatment because of the carrier’s insistence on using only certain approved facilities.
EMTALA requires that the screening exam be “appropriate,” but the statute does not define the term except to note that it is to be “within the capability of the hospital’s emergency department.” However, it is generally recognized that triage alone is insufficient, and the screening exam should be based on the patient’s symptoms and performed by a qualified person.
The important point is that it is uniformly applied, without discrimination, to all who seek treatment in the ED. The hospital itself is expected to have in place policies addressing the broad aspects of the screening process in a nondisparate manner.
The second key issue under the EMTALA statute concerns treatment and transfer.4 If an emergency medical condition exists, treatment must be provided until the emergency is resolved or stabilized.
Under the law, a patient is considered stable for transfer (or discharge) if the treating physician determines that no material deterioration is reasonably likely to occur during or as a result of the transfer between facilities. A receiving hospital is obligated to report any individual who has been transferred in an unstable condition in violation of EMTALA.
However, in the event the hospital does not have the capability to stabilize the emergency medical condition, EMTALA mandates an appropriate transfer, under prescribed conditions, to another hospital whose specialized capabilities obligate it to cooperate. The ED physician in the sending hospital will directly request acceptance of such a transfer. If the patient is unstable, the physician must certify that the medical benefits expected from the transfer outweigh the risks, unless the patient insists on a transfer in writing after being informed of the hospital’s obligations under EMTALA and the risks of transfer.
Furthermore, the transferring hospital must: 1. provide ongoing care within its capability until transfer to minimize transfer risks, 2. provide copies of medical records, 3. confirm that the receiving facility has space and qualified personnel to treat the condition and has agreed to accept the transfer, and 4. ensure that the transfer is made with qualified personnel and appropriate medical equipment.
On-call physicians at both transferring and accepting facilities are also subject to EMTALA. The U.S. Department of Health & Human Services’ Office of Inspector General (OIG) has promulgated rules regarding on-call physicians, even touching on reimbursement.
The American College of Emergency Physicians subscribes to the view that hospitals, medical staff, and payers share an ethical responsibility for the provision of emergency care, acknowledging that EDs require a reliable on-call system that provides for the availability of medical staff members for consultation and participation in the evaluation and treatment of emergency patients.5
Penalties for EMTALA violations include fines up to $50,000 per violation, and/or nullification of Medicare provider agreements. There is a 2-year statute of limitations for civil enforcement of any violation,6 carried out by the OIG and the Centers for Medicare & Medicaid Services (CMS).
A receiving facility, having suffered financial loss as a result of another hospital’s violation of EMTALA, can bring suit to recover damages, and patients may bring private lawsuits against hospitals, though not against physicians. EMTALA, being a civil rather than a criminal statute, does not impose any prison terms.
Investigations and citations by the OIG/CMS are common, with about half of all hospitals subjected to EMTALA investigations and a quarter receiving a violation citation over a recent 10-year period.
However, a recently published study covering 2002-2015 found that, despite 40% of investigations ending up with EMTALA violations, only 3% of investigations triggered fines – and none resulted in suspension of Medicare provider participation.7
There were a total of 192 settlements, or an average of 14 per year for the 4,000 hospitals in the United States. Most were for failing to provide screening (75%) and stabilization (42%). The vast majority of violations affected hospitals, and only eight physicians were involved.
Fines against hospitals and physicians totaled $6,357,000 (averages, $33,435 and $25,625, respectively). Patient dumping attributable to insurance or financial discrimination accounted for 15.6% of settlements.
References
1. 42 USC §1395dd et seq.
2. Chest. 2015 Jun;147(6):1691-6.
3. 42 USC §1395dd(a).
4. 42 USC §1395dd(b)(c).
5. “EMTALA and On-call Responsibility for Emergency Department Patients,” American College of Emergency Physicians.
6. 42 USC §1395dd(d).
7. West J Emerg Med. 2016 May;17(3):245-51.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
This is the first of a two-part series.
Question: Which of the following statements regarding the Emergency Medical Treatment & Labor Act (EMTALA) is correct?
A. Deals with the standard of care in emergency medicine.
B. Provides safeguards for uninsured and nonpaying patients with an emergency medical condition.
C. Mandates uniform screening and treatment stabilization prior to transfer, irrespective of the hospital’s capability.
D. Is mostly directed at hospitals and emergency department staff doctors, but excludes on-call physicians.
E. Violations can result in fines, loss of Medicare provider participation, or even imprisonment.
Answer: B. In 1985, the CBS investigative news show “60 Minutes” ran an exposé on abuses in the emergency departments of U.S. hospitals, featuring the case of Eugene Barnes, a 32-year-old man brought to the Brookside Hospital emergency department (ED) in San Pablo, Calif., with a penetrating stab wound.
In another case, William Jenness, injured in an auto accident, died after a delayed transfer to a county hospital, because the original hospital required a $1,000 deposit in advance before initiating treatment.
In response to the widespread perception that uninsured patients were being denied treatment in the nation’s emergency departments, Congress enacted the Emergency Medical Treatment & Labor Act.1
Originally referred to as the “antidumping law,” EMTALA was designed to prevent hospitals from transferring financially undesirable patients to public hospitals without providing a medical screening examination and stabilizing treatment prior to transfer.
The purpose and intent of the law is to ensure that all patients who come to the ED have access to emergency services, although the statute itself is silent on payment ability.
EMTALA is not meant to replace or override state tort law, and does not deal with quality of care issues that may arise in the emergency department. Over the 30-year period since its enactment, EMTALA has received mixed reviews, with one scholar complaining that the statute is sloppily drafted and the premise of the statute, silly at best.2
EMTALA defines an emergency medical condition as:
1. A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances, and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, cause serious impairment to bodily functions, or result in serious dysfunction of any bodily organ or part.
2. With respect to a pregnant woman who is having contractions, there is inadequate time to effect a safe transfer to another hospital before delivery, or that transfer may pose a threat to the health or safety of the woman or the unborn child.3
Whether an emergency medical condition exists is determined by a medical screening exam (MSE). EMTALA is about a process directed at the well-being and safety of all patients with a medical emergency who come to the ED, defined as being licensed by the state or held out to the public as a place that provides care for emergency medical conditions. Hospital-based outpatient clinics that handle less than one-third of emergency visits and physician offices are exempt.
All patients who present to the ED seeking treatment are entitled to an MSE, and EDs are required to post such notification on their premises. A triage nurse may not be qualified to conduct the MSE unless he or she possesses special competencies, and has approval from the medical staff and the hospital’s governing body.
It is important that the MSE be documented soon after the patient’s arrival to determine if the medical condition warrants immediate treatment. It is definitely not acceptable to delay performing an MSE while awaiting information on insurance coverage, and one cannot “hold” the patient and delay stabilizing treatment because of the carrier’s insistence on using only certain approved facilities.
EMTALA requires that the screening exam be “appropriate,” but the statute does not define the term except to note that it is to be “within the capability of the hospital’s emergency department.” However, it is generally recognized that triage alone is insufficient, and the screening exam should be based on the patient’s symptoms and performed by a qualified person.
The important point is that it is uniformly applied, without discrimination, to all who seek treatment in the ED. The hospital itself is expected to have in place policies addressing the broad aspects of the screening process in a nondisparate manner.
The second key issue under the EMTALA statute concerns treatment and transfer.4 If an emergency medical condition exists, treatment must be provided until the emergency is resolved or stabilized.
Under the law, a patient is considered stable for transfer (or discharge) if the treating physician determines that no material deterioration is reasonably likely to occur during or as a result of the transfer between facilities. A receiving hospital is obligated to report any individual who has been transferred in an unstable condition in violation of EMTALA.
However, in the event the hospital does not have the capability to stabilize the emergency medical condition, EMTALA mandates an appropriate transfer, under prescribed conditions, to another hospital whose specialized capabilities obligate it to cooperate. The ED physician in the sending hospital will directly request acceptance of such a transfer. If the patient is unstable, the physician must certify that the medical benefits expected from the transfer outweigh the risks, unless the patient insists on a transfer in writing after being informed of the hospital’s obligations under EMTALA and the risks of transfer.
Furthermore, the transferring hospital must: 1. provide ongoing care within its capability until transfer to minimize transfer risks, 2. provide copies of medical records, 3. confirm that the receiving facility has space and qualified personnel to treat the condition and has agreed to accept the transfer, and 4. ensure that the transfer is made with qualified personnel and appropriate medical equipment.
On-call physicians at both transferring and accepting facilities are also subject to EMTALA. The U.S. Department of Health & Human Services’ Office of Inspector General (OIG) has promulgated rules regarding on-call physicians, even touching on reimbursement.
The American College of Emergency Physicians subscribes to the view that hospitals, medical staff, and payers share an ethical responsibility for the provision of emergency care, acknowledging that EDs require a reliable on-call system that provides for the availability of medical staff members for consultation and participation in the evaluation and treatment of emergency patients.5
Penalties for EMTALA violations include fines up to $50,000 per violation, and/or nullification of Medicare provider agreements. There is a 2-year statute of limitations for civil enforcement of any violation,6 carried out by the OIG and the Centers for Medicare & Medicaid Services (CMS).
A receiving facility, having suffered financial loss as a result of another hospital’s violation of EMTALA, can bring suit to recover damages, and patients may bring private lawsuits against hospitals, though not against physicians. EMTALA, being a civil rather than a criminal statute, does not impose any prison terms.
Investigations and citations by the OIG/CMS are common, with about half of all hospitals subjected to EMTALA investigations and a quarter receiving a violation citation over a recent 10-year period.
However, a recently published study covering 2002-2015 found that, despite 40% of investigations ending up with EMTALA violations, only 3% of investigations triggered fines – and none resulted in suspension of Medicare provider participation.7
There were a total of 192 settlements, or an average of 14 per year for the 4,000 hospitals in the United States. Most were for failing to provide screening (75%) and stabilization (42%). The vast majority of violations affected hospitals, and only eight physicians were involved.
Fines against hospitals and physicians totaled $6,357,000 (averages, $33,435 and $25,625, respectively). Patient dumping attributable to insurance or financial discrimination accounted for 15.6% of settlements.
References
1. 42 USC §1395dd et seq.
2. Chest. 2015 Jun;147(6):1691-6.
3. 42 USC §1395dd(a).
4. 42 USC §1395dd(b)(c).
5. “EMTALA and On-call Responsibility for Emergency Department Patients,” American College of Emergency Physicians.
6. 42 USC §1395dd(d).
7. West J Emerg Med. 2016 May;17(3):245-51.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
This is the first of a two-part series.
Question: Which of the following statements regarding the Emergency Medical Treatment & Labor Act (EMTALA) is correct?
A. Deals with the standard of care in emergency medicine.
B. Provides safeguards for uninsured and nonpaying patients with an emergency medical condition.
C. Mandates uniform screening and treatment stabilization prior to transfer, irrespective of the hospital’s capability.
D. Is mostly directed at hospitals and emergency department staff doctors, but excludes on-call physicians.
E. Violations can result in fines, loss of Medicare provider participation, or even imprisonment.
Answer: B. In 1985, the CBS investigative news show “60 Minutes” ran an exposé on abuses in the emergency departments of U.S. hospitals, featuring the case of Eugene Barnes, a 32-year-old man brought to the Brookside Hospital emergency department (ED) in San Pablo, Calif., with a penetrating stab wound.
In another case, William Jenness, injured in an auto accident, died after a delayed transfer to a county hospital, because the original hospital required a $1,000 deposit in advance before initiating treatment.
In response to the widespread perception that uninsured patients were being denied treatment in the nation’s emergency departments, Congress enacted the Emergency Medical Treatment & Labor Act.1
Originally referred to as the “antidumping law,” EMTALA was designed to prevent hospitals from transferring financially undesirable patients to public hospitals without providing a medical screening examination and stabilizing treatment prior to transfer.
The purpose and intent of the law is to ensure that all patients who come to the ED have access to emergency services, although the statute itself is silent on payment ability.
EMTALA is not meant to replace or override state tort law, and does not deal with quality of care issues that may arise in the emergency department. Over the 30-year period since its enactment, EMTALA has received mixed reviews, with one scholar complaining that the statute is sloppily drafted and the premise of the statute, silly at best.2
EMTALA defines an emergency medical condition as:
1. A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances, and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, cause serious impairment to bodily functions, or result in serious dysfunction of any bodily organ or part.
2. With respect to a pregnant woman who is having contractions, there is inadequate time to effect a safe transfer to another hospital before delivery, or that transfer may pose a threat to the health or safety of the woman or the unborn child.3
Whether an emergency medical condition exists is determined by a medical screening exam (MSE). EMTALA is about a process directed at the well-being and safety of all patients with a medical emergency who come to the ED, defined as being licensed by the state or held out to the public as a place that provides care for emergency medical conditions. Hospital-based outpatient clinics that handle less than one-third of emergency visits and physician offices are exempt.
All patients who present to the ED seeking treatment are entitled to an MSE, and EDs are required to post such notification on their premises. A triage nurse may not be qualified to conduct the MSE unless he or she possesses special competencies, and has approval from the medical staff and the hospital’s governing body.
It is important that the MSE be documented soon after the patient’s arrival to determine if the medical condition warrants immediate treatment. It is definitely not acceptable to delay performing an MSE while awaiting information on insurance coverage, and one cannot “hold” the patient and delay stabilizing treatment because of the carrier’s insistence on using only certain approved facilities.
EMTALA requires that the screening exam be “appropriate,” but the statute does not define the term except to note that it is to be “within the capability of the hospital’s emergency department.” However, it is generally recognized that triage alone is insufficient, and the screening exam should be based on the patient’s symptoms and performed by a qualified person.
The important point is that it is uniformly applied, without discrimination, to all who seek treatment in the ED. The hospital itself is expected to have in place policies addressing the broad aspects of the screening process in a nondisparate manner.
The second key issue under the EMTALA statute concerns treatment and transfer.4 If an emergency medical condition exists, treatment must be provided until the emergency is resolved or stabilized.
Under the law, a patient is considered stable for transfer (or discharge) if the treating physician determines that no material deterioration is reasonably likely to occur during or as a result of the transfer between facilities. A receiving hospital is obligated to report any individual who has been transferred in an unstable condition in violation of EMTALA.
However, in the event the hospital does not have the capability to stabilize the emergency medical condition, EMTALA mandates an appropriate transfer, under prescribed conditions, to another hospital whose specialized capabilities obligate it to cooperate. The ED physician in the sending hospital will directly request acceptance of such a transfer. If the patient is unstable, the physician must certify that the medical benefits expected from the transfer outweigh the risks, unless the patient insists on a transfer in writing after being informed of the hospital’s obligations under EMTALA and the risks of transfer.
Furthermore, the transferring hospital must: 1. provide ongoing care within its capability until transfer to minimize transfer risks, 2. provide copies of medical records, 3. confirm that the receiving facility has space and qualified personnel to treat the condition and has agreed to accept the transfer, and 4. ensure that the transfer is made with qualified personnel and appropriate medical equipment.
On-call physicians at both transferring and accepting facilities are also subject to EMTALA. The U.S. Department of Health & Human Services’ Office of Inspector General (OIG) has promulgated rules regarding on-call physicians, even touching on reimbursement.
The American College of Emergency Physicians subscribes to the view that hospitals, medical staff, and payers share an ethical responsibility for the provision of emergency care, acknowledging that EDs require a reliable on-call system that provides for the availability of medical staff members for consultation and participation in the evaluation and treatment of emergency patients.5
Penalties for EMTALA violations include fines up to $50,000 per violation, and/or nullification of Medicare provider agreements. There is a 2-year statute of limitations for civil enforcement of any violation,6 carried out by the OIG and the Centers for Medicare & Medicaid Services (CMS).
A receiving facility, having suffered financial loss as a result of another hospital’s violation of EMTALA, can bring suit to recover damages, and patients may bring private lawsuits against hospitals, though not against physicians. EMTALA, being a civil rather than a criminal statute, does not impose any prison terms.
Investigations and citations by the OIG/CMS are common, with about half of all hospitals subjected to EMTALA investigations and a quarter receiving a violation citation over a recent 10-year period.
However, a recently published study covering 2002-2015 found that, despite 40% of investigations ending up with EMTALA violations, only 3% of investigations triggered fines – and none resulted in suspension of Medicare provider participation.7
There were a total of 192 settlements, or an average of 14 per year for the 4,000 hospitals in the United States. Most were for failing to provide screening (75%) and stabilization (42%). The vast majority of violations affected hospitals, and only eight physicians were involved.
Fines against hospitals and physicians totaled $6,357,000 (averages, $33,435 and $25,625, respectively). Patient dumping attributable to insurance or financial discrimination accounted for 15.6% of settlements.
References
1. 42 USC §1395dd et seq.
2. Chest. 2015 Jun;147(6):1691-6.
3. 42 USC §1395dd(a).
4. 42 USC §1395dd(b)(c).
5. “EMTALA and On-call Responsibility for Emergency Department Patients,” American College of Emergency Physicians.
6. 42 USC §1395dd(d).
7. West J Emerg Med. 2016 May;17(3):245-51.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
Facing a medical board investigation
(This column is the third of a three-part series.)
Question: The state medical board is requesting the medical records of an angry patient who has filed a formal complaint alleging incompetent care. Your immediate impulse is to rush off a letter defending your treatment – and to include a sarcastic remark about ingratitude.
However, you decided not to respond, choosing to await the scheduled interview with the board investigator. To your surprise, he turned out to be warm and friendly, and his relative youth reminded you of your son. Letting your guard down, you spoke freely during the meeting and showed him the medical records. Later, you appeared at the formal board hearing without legal counsel, as the complainant had not suffered any injury while under your care. Under this scenario, which of the following statements is best?
A. You must never respond in writing to any board inquiry.
B. You should have called your insurance carrier immediately.
C. You trusted the investigator because what you told him could not be introduced as evidence.
D. You correctly assumed that, without injuries, there is no liability.
E. You did not insist on having an attorney, because this is not part of your due process rights.
Answer: B. Who gets into trouble with medical disciplinary boards? In a California study,1 the authors concluded that male physicians were nearly three times as likely to as women physicians, and those who were non–board certified twice as likely to as their board-certified counterparts. Obstetricians, gynecologists, family physicians, general practitioners, and psychiatrists were more likely than internists, whereas pediatricians and radiologists were the least likely. Age had a smaller influence (elevated risk with increasing age), and foreign medical graduates also had an increased risk.
It is true that many board complaints are dismissed and never investigated, but the number of state licensure actions in 2013 was almost four times greater than the number of malpractice payouts. Moreover, board actions against a doctor, unlike a malpractice lawsuit, are premised on substandard or unethical conduct, and do not require a showing of actual patient harm.
A recent news article bemoans the travails of a medical board encounter.2 According to a 2009 report, one of every eight physicians in California was being reported to the board each year, with a quarter of complaints leading to an investigation. In turn, a quarter of investigated complaints led to disciplinary proceedings against the physician.
A medical board investigation begins with a complaint lodged by a patient or some other party such as a pharmacist, nurse, or hospital peer review committee. Some states – e.g., California, Georgia, and Maryland – allow complaints to be anonymous, and many states now allow online submissions, whose ease may be expected to increase the number of filings. Oklahoma, for example, saw its board complaints rise by 40% in the 2 years after permitting this option.
Some complaints such as rudeness and disputes over fees may seem like a minor nuisance, but they can mushroom into new and more serious charges. The medical records may reveal other potential misconduct, such as delinquent record keeping or failure to obtain informed consent.
It is therefore prudent to treat all complaints seriously. A written response is necessary, but it must be cowritten with your attorney. Immediately contact your malpractice insurance carrier once an investigator approaches you, or upon notification by the medical board. Most malpractice policies include coverage for medical board investigations.
The simple rule is not to discuss with anyone – including (especially) the complainant – and await a call from the attorney assigned to you. Better yet, ask for an attorney whose skills you are aware of. Make sure he/she is experienced with board proceedings and not just malpractice litigation. There are legal technicalities that may be of importance, such as statutes of limitations barring board actions or the timely filing of an appeal. Everything should flow from here. The lawyer’s advice will most likely be: “Don’t speak to anyone, including your colleagues; don’t contact the patient or family; and don’t release any records without first consulting me.”
You should together draft a response letter. Whereas the attorney will be attentive to the legal ramifications, only you as the doctor can provide the clinical knowledge, context, and empathy. In formulating any written response where patient care is at issue, heed the following principles:
1. Be honest. Truth always surfaces in due course. Candor and trustworthiness are virtues expected of all doctors.
2. Be accurate. Review carefully all relevant medical records. Pay compulsive attention to factual accuracy.
3. Be focused. Do not ramble on and on regarding unrelated or tangential issues. Focus on what the complaint is about. No one is interested in your views regarding your philosophy of medical practice or the health care system – they do not belong in a complaint response letter.
4. Be humble. Arrogance at this stage may prove disastrous. Adopt a contrite and humble tone. Blame no one, especially the patient.
5. Be a patient advocate. Show that patient well-being is always your first and last concern.
In the preliminary stages, a board investigator may call the doctor, typically taking a friendly and casual approach, and this may lull the physician into saying more than is necessary or releasing the medical records. The shared information can come back to haunt the doctor when it is disclosed in a subsequent hearing.
In some situations, the board may offer an informal settlement conference to resolve the issue and obtain a “consent agreement” from the doctor. Depending on the facts – and the proposed settlement terms – your attorney may instead advise proceeding to a formal hearing to present exculpatory evidence and to confront the complainant.
Physicians are guaranteed the right of due process during an investigation. Timely notice, the right to a hearing, to confront the evidence, and to have legal representation are the basic due process rights. And boards must treat the physician fairly and reasonably.
However, where public harm is an imminent risk, boards have the power to immediately institute a temporary suspension of the doctor’s right to practice. Examples warranting such summary suspensions may include sexual misconduct, inappropriate opioid prescriptions, egregious negligent conduct, or impairment from alcohol or drug abuse.
Boards face a dilemma over these cases, because they need to balance depriving a doctor of due process rights, albeit temporarily, against allowing a bad doctor to pose a clear and present threat to the public. In Texas, 32 summary suspensions took place in 2011, a figure that fell to 13 in 2014.
The aggrieved physician typically has the right to appeal an adverse board decision to the courts, although “courts have no inherent appellate jurisdiction over official acts of administrative agencies except where the legislature has made some statutory provision for judicial review.”3
For example, under California’s Code of Civil Procedure section 1094.5, one has the right to have a Superior Court judge review the board’s decision to determine if there has been an abuse of discretion.
Despite the fact that board administrative proceedings are quasi criminal in nature, most states require only a “preponderance of evidence” to find the doctor guilty. This is the evidentiary standard used in civil cases where only monetary damages are at stake, yet it is used in determining whether a doctor would lose the liberty to practice his or her profession.
However, some jurisdictions – such as California, Florida, and Illinois – call for a higher threshold of guilt, requiring proof with “clear and convincing evidence.”
Finally, in the United Kingdom and countries such as Singapore, a guilty decision requires even more evidence – i.e., proof “beyond reasonable doubt” – which is the threshold required in criminal prosecutions.
References
1. Arch Intern Med. 2004 Mar 22;164(6):653-8.
2. Leigh Page. The Black Cloud of a Medical Board Investigation. Medscape, Dec 23, 2015.
3. Crane v. Cont’l Tel. Co. of Cal., 775 P.2d 705 (Nev. 1989).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
(This column is the third of a three-part series.)
Question: The state medical board is requesting the medical records of an angry patient who has filed a formal complaint alleging incompetent care. Your immediate impulse is to rush off a letter defending your treatment – and to include a sarcastic remark about ingratitude.
However, you decided not to respond, choosing to await the scheduled interview with the board investigator. To your surprise, he turned out to be warm and friendly, and his relative youth reminded you of your son. Letting your guard down, you spoke freely during the meeting and showed him the medical records. Later, you appeared at the formal board hearing without legal counsel, as the complainant had not suffered any injury while under your care. Under this scenario, which of the following statements is best?
A. You must never respond in writing to any board inquiry.
B. You should have called your insurance carrier immediately.
C. You trusted the investigator because what you told him could not be introduced as evidence.
D. You correctly assumed that, without injuries, there is no liability.
E. You did not insist on having an attorney, because this is not part of your due process rights.
Answer: B. Who gets into trouble with medical disciplinary boards? In a California study,1 the authors concluded that male physicians were nearly three times as likely to as women physicians, and those who were non–board certified twice as likely to as their board-certified counterparts. Obstetricians, gynecologists, family physicians, general practitioners, and psychiatrists were more likely than internists, whereas pediatricians and radiologists were the least likely. Age had a smaller influence (elevated risk with increasing age), and foreign medical graduates also had an increased risk.
It is true that many board complaints are dismissed and never investigated, but the number of state licensure actions in 2013 was almost four times greater than the number of malpractice payouts. Moreover, board actions against a doctor, unlike a malpractice lawsuit, are premised on substandard or unethical conduct, and do not require a showing of actual patient harm.
A recent news article bemoans the travails of a medical board encounter.2 According to a 2009 report, one of every eight physicians in California was being reported to the board each year, with a quarter of complaints leading to an investigation. In turn, a quarter of investigated complaints led to disciplinary proceedings against the physician.
A medical board investigation begins with a complaint lodged by a patient or some other party such as a pharmacist, nurse, or hospital peer review committee. Some states – e.g., California, Georgia, and Maryland – allow complaints to be anonymous, and many states now allow online submissions, whose ease may be expected to increase the number of filings. Oklahoma, for example, saw its board complaints rise by 40% in the 2 years after permitting this option.
Some complaints such as rudeness and disputes over fees may seem like a minor nuisance, but they can mushroom into new and more serious charges. The medical records may reveal other potential misconduct, such as delinquent record keeping or failure to obtain informed consent.
It is therefore prudent to treat all complaints seriously. A written response is necessary, but it must be cowritten with your attorney. Immediately contact your malpractice insurance carrier once an investigator approaches you, or upon notification by the medical board. Most malpractice policies include coverage for medical board investigations.
The simple rule is not to discuss with anyone – including (especially) the complainant – and await a call from the attorney assigned to you. Better yet, ask for an attorney whose skills you are aware of. Make sure he/she is experienced with board proceedings and not just malpractice litigation. There are legal technicalities that may be of importance, such as statutes of limitations barring board actions or the timely filing of an appeal. Everything should flow from here. The lawyer’s advice will most likely be: “Don’t speak to anyone, including your colleagues; don’t contact the patient or family; and don’t release any records without first consulting me.”
You should together draft a response letter. Whereas the attorney will be attentive to the legal ramifications, only you as the doctor can provide the clinical knowledge, context, and empathy. In formulating any written response where patient care is at issue, heed the following principles:
1. Be honest. Truth always surfaces in due course. Candor and trustworthiness are virtues expected of all doctors.
2. Be accurate. Review carefully all relevant medical records. Pay compulsive attention to factual accuracy.
3. Be focused. Do not ramble on and on regarding unrelated or tangential issues. Focus on what the complaint is about. No one is interested in your views regarding your philosophy of medical practice or the health care system – they do not belong in a complaint response letter.
4. Be humble. Arrogance at this stage may prove disastrous. Adopt a contrite and humble tone. Blame no one, especially the patient.
5. Be a patient advocate. Show that patient well-being is always your first and last concern.
In the preliminary stages, a board investigator may call the doctor, typically taking a friendly and casual approach, and this may lull the physician into saying more than is necessary or releasing the medical records. The shared information can come back to haunt the doctor when it is disclosed in a subsequent hearing.
In some situations, the board may offer an informal settlement conference to resolve the issue and obtain a “consent agreement” from the doctor. Depending on the facts – and the proposed settlement terms – your attorney may instead advise proceeding to a formal hearing to present exculpatory evidence and to confront the complainant.
Physicians are guaranteed the right of due process during an investigation. Timely notice, the right to a hearing, to confront the evidence, and to have legal representation are the basic due process rights. And boards must treat the physician fairly and reasonably.
However, where public harm is an imminent risk, boards have the power to immediately institute a temporary suspension of the doctor’s right to practice. Examples warranting such summary suspensions may include sexual misconduct, inappropriate opioid prescriptions, egregious negligent conduct, or impairment from alcohol or drug abuse.
Boards face a dilemma over these cases, because they need to balance depriving a doctor of due process rights, albeit temporarily, against allowing a bad doctor to pose a clear and present threat to the public. In Texas, 32 summary suspensions took place in 2011, a figure that fell to 13 in 2014.
The aggrieved physician typically has the right to appeal an adverse board decision to the courts, although “courts have no inherent appellate jurisdiction over official acts of administrative agencies except where the legislature has made some statutory provision for judicial review.”3
For example, under California’s Code of Civil Procedure section 1094.5, one has the right to have a Superior Court judge review the board’s decision to determine if there has been an abuse of discretion.
Despite the fact that board administrative proceedings are quasi criminal in nature, most states require only a “preponderance of evidence” to find the doctor guilty. This is the evidentiary standard used in civil cases where only monetary damages are at stake, yet it is used in determining whether a doctor would lose the liberty to practice his or her profession.
However, some jurisdictions – such as California, Florida, and Illinois – call for a higher threshold of guilt, requiring proof with “clear and convincing evidence.”
Finally, in the United Kingdom and countries such as Singapore, a guilty decision requires even more evidence – i.e., proof “beyond reasonable doubt” – which is the threshold required in criminal prosecutions.
References
1. Arch Intern Med. 2004 Mar 22;164(6):653-8.
2. Leigh Page. The Black Cloud of a Medical Board Investigation. Medscape, Dec 23, 2015.
3. Crane v. Cont’l Tel. Co. of Cal., 775 P.2d 705 (Nev. 1989).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
(This column is the third of a three-part series.)
Question: The state medical board is requesting the medical records of an angry patient who has filed a formal complaint alleging incompetent care. Your immediate impulse is to rush off a letter defending your treatment – and to include a sarcastic remark about ingratitude.
However, you decided not to respond, choosing to await the scheduled interview with the board investigator. To your surprise, he turned out to be warm and friendly, and his relative youth reminded you of your son. Letting your guard down, you spoke freely during the meeting and showed him the medical records. Later, you appeared at the formal board hearing without legal counsel, as the complainant had not suffered any injury while under your care. Under this scenario, which of the following statements is best?
A. You must never respond in writing to any board inquiry.
B. You should have called your insurance carrier immediately.
C. You trusted the investigator because what you told him could not be introduced as evidence.
D. You correctly assumed that, without injuries, there is no liability.
E. You did not insist on having an attorney, because this is not part of your due process rights.
Answer: B. Who gets into trouble with medical disciplinary boards? In a California study,1 the authors concluded that male physicians were nearly three times as likely to as women physicians, and those who were non–board certified twice as likely to as their board-certified counterparts. Obstetricians, gynecologists, family physicians, general practitioners, and psychiatrists were more likely than internists, whereas pediatricians and radiologists were the least likely. Age had a smaller influence (elevated risk with increasing age), and foreign medical graduates also had an increased risk.
It is true that many board complaints are dismissed and never investigated, but the number of state licensure actions in 2013 was almost four times greater than the number of malpractice payouts. Moreover, board actions against a doctor, unlike a malpractice lawsuit, are premised on substandard or unethical conduct, and do not require a showing of actual patient harm.
A recent news article bemoans the travails of a medical board encounter.2 According to a 2009 report, one of every eight physicians in California was being reported to the board each year, with a quarter of complaints leading to an investigation. In turn, a quarter of investigated complaints led to disciplinary proceedings against the physician.
A medical board investigation begins with a complaint lodged by a patient or some other party such as a pharmacist, nurse, or hospital peer review committee. Some states – e.g., California, Georgia, and Maryland – allow complaints to be anonymous, and many states now allow online submissions, whose ease may be expected to increase the number of filings. Oklahoma, for example, saw its board complaints rise by 40% in the 2 years after permitting this option.
Some complaints such as rudeness and disputes over fees may seem like a minor nuisance, but they can mushroom into new and more serious charges. The medical records may reveal other potential misconduct, such as delinquent record keeping or failure to obtain informed consent.
It is therefore prudent to treat all complaints seriously. A written response is necessary, but it must be cowritten with your attorney. Immediately contact your malpractice insurance carrier once an investigator approaches you, or upon notification by the medical board. Most malpractice policies include coverage for medical board investigations.
The simple rule is not to discuss with anyone – including (especially) the complainant – and await a call from the attorney assigned to you. Better yet, ask for an attorney whose skills you are aware of. Make sure he/she is experienced with board proceedings and not just malpractice litigation. There are legal technicalities that may be of importance, such as statutes of limitations barring board actions or the timely filing of an appeal. Everything should flow from here. The lawyer’s advice will most likely be: “Don’t speak to anyone, including your colleagues; don’t contact the patient or family; and don’t release any records without first consulting me.”
You should together draft a response letter. Whereas the attorney will be attentive to the legal ramifications, only you as the doctor can provide the clinical knowledge, context, and empathy. In formulating any written response where patient care is at issue, heed the following principles:
1. Be honest. Truth always surfaces in due course. Candor and trustworthiness are virtues expected of all doctors.
2. Be accurate. Review carefully all relevant medical records. Pay compulsive attention to factual accuracy.
3. Be focused. Do not ramble on and on regarding unrelated or tangential issues. Focus on what the complaint is about. No one is interested in your views regarding your philosophy of medical practice or the health care system – they do not belong in a complaint response letter.
4. Be humble. Arrogance at this stage may prove disastrous. Adopt a contrite and humble tone. Blame no one, especially the patient.
5. Be a patient advocate. Show that patient well-being is always your first and last concern.
In the preliminary stages, a board investigator may call the doctor, typically taking a friendly and casual approach, and this may lull the physician into saying more than is necessary or releasing the medical records. The shared information can come back to haunt the doctor when it is disclosed in a subsequent hearing.
In some situations, the board may offer an informal settlement conference to resolve the issue and obtain a “consent agreement” from the doctor. Depending on the facts – and the proposed settlement terms – your attorney may instead advise proceeding to a formal hearing to present exculpatory evidence and to confront the complainant.
Physicians are guaranteed the right of due process during an investigation. Timely notice, the right to a hearing, to confront the evidence, and to have legal representation are the basic due process rights. And boards must treat the physician fairly and reasonably.
However, where public harm is an imminent risk, boards have the power to immediately institute a temporary suspension of the doctor’s right to practice. Examples warranting such summary suspensions may include sexual misconduct, inappropriate opioid prescriptions, egregious negligent conduct, or impairment from alcohol or drug abuse.
Boards face a dilemma over these cases, because they need to balance depriving a doctor of due process rights, albeit temporarily, against allowing a bad doctor to pose a clear and present threat to the public. In Texas, 32 summary suspensions took place in 2011, a figure that fell to 13 in 2014.
The aggrieved physician typically has the right to appeal an adverse board decision to the courts, although “courts have no inherent appellate jurisdiction over official acts of administrative agencies except where the legislature has made some statutory provision for judicial review.”3
For example, under California’s Code of Civil Procedure section 1094.5, one has the right to have a Superior Court judge review the board’s decision to determine if there has been an abuse of discretion.
Despite the fact that board administrative proceedings are quasi criminal in nature, most states require only a “preponderance of evidence” to find the doctor guilty. This is the evidentiary standard used in civil cases where only monetary damages are at stake, yet it is used in determining whether a doctor would lose the liberty to practice his or her profession.
However, some jurisdictions – such as California, Florida, and Illinois – call for a higher threshold of guilt, requiring proof with “clear and convincing evidence.”
Finally, in the United Kingdom and countries such as Singapore, a guilty decision requires even more evidence – i.e., proof “beyond reasonable doubt” – which is the threshold required in criminal prosecutions.
References
1. Arch Intern Med. 2004 Mar 22;164(6):653-8.
2. Leigh Page. The Black Cloud of a Medical Board Investigation. Medscape, Dec 23, 2015.
3. Crane v. Cont’l Tel. Co. of Cal., 775 P.2d 705 (Nev. 1989).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.