Lacey, 37, is seen by her primary care provider (PCP) as follow-up to a visit she made to the emergency department (ED). She has gone to the ED four times in the past year. Each time, she presents with tachycardia, dyspnea, nausea, numbness in her extremities, and a fear that she is having a heart attack. Despite negative workups at each visit (ECG, cardiac enzymes, complete blood count, toxicology screen, Holter monitoring), Lacey is terrified that the ED doctors are missing something. She is still “rattled” by the chest pain and shortness of breath she experiences. Mild symptoms are persisting, and she is worried that she will have a heart attack and die without the treatment she believes she needs. How do you proceed?

Panic disorder (PD) is characterized by the spontaneous and unexpected occurrence of panic attacks and by at least one month of persistent worry about having another attack or significant maladaptive behaviors related to the attack. Frequency of such attacks can vary from several a day to only a few per year. In a panic attack, an intense fear develops abruptly and peaks within 10 minutes of onset. At least four of the following 13 symptoms must accompany the attack, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5)

• Palpitations, pounding heart, or accelerated heart rate
• Sweating
• Trembling or shaking
• Sensations of shortness of breath or smothering
• Feeling of choking
• Chest pain or discomfort
• Feeling dizzy, unsteady, lightheaded, or faint
• Nausea or abdominal distress
• Derealization (feelings of unreality) or depersonalization (being detached from oneself)
• Fear of losing control or going crazy
• Fear of dying
• Paresthesia (numbness or tingling sensations)
• Chills or hot flushes.¹

Lifetime incidence rates of PD are 1% to 3% for the general population.² A closer look at patients presenting to the ED with chest pain reveals that 17% to 25% meet criteria for PD.^3,4 And an estimated 6% of individuals experiencing a panic attack present to their primary care provider.⁵ Patients with PD tend to use health care resources at a disproportionately high rate.⁶

An international review of PD research suggests the average age of onset is 32 years.⁷ Triggers can vary widely, and no single stressor has been identified. The exact cause of PD is unknown, but a convergence of social and biological influences (including involvement of the amygdala) are implicated in its development.⁶ For individuals who have had a panic attack, 66.5% will have recurrent attacks.⁷ Lifetime prevalence of panic attacks is 13.2%.⁷

Differential goes far beyond myocardial infarction. Many medical conditions can mimic PD symptoms: cardiovascular, pulmonary, and neurologic diseases; endocrine diseases (eg, hyperthyroidism); drug intoxication (eg, stimulants [cocaine, amphetamines]); drug withdrawal (eg, benzodiazepines, alcohol, sedative-hypnotics); and ingestion of excessive quantities of caffeine. Common comorbid medical disorders include asthma, coronary artery disease, cancer, thyroid disease, hypertension, ulcer, and migraine headaches.⁸

When patients present with paniclike symptoms, suspect a possible medical condition when those symptoms include ataxia, altered mental status, or loss of bladder control, or when onset of panic symptoms occur later in life for a patient with no significant psychiatric history.

RULE OUT ORGANIC CAUSES

In addition to obtaining a complete history and doing a physical exam on patients with paniclike symptoms, you’ll also need to ensure that the following are done: a neurologic examination, standard laboratory testing (thyroid function, complete blood cell count, chemistry panel), and possible additional testing (eg, urine toxicology screen and d-dimer assay to exclude pulmonary embolism).

If organic causes are ruled out, focus on a psychiatric assessment, including

• History of the present illness (onset, symptoms, frequency, predisposing/precipitating factors)
• Psychiatric history
• History of substance use
• Family history of psychiatric disorders (especially anxiety disorders)
• Social history (life events, including those preceding the onset of panic; history of child abuse)
• Medications
• Mental status examination
• Safety (PD is associated with higher risk for suicidal ideation).⁹

 

 

TREATMENT INCLUDES CBT AND MEDICATION

PD is a chronic disease with a variable course, but the long-term prognosis is good. PD is usually treated in an outpatient setting. Consider hospitalization if the patient is suicidal, if the potential for life-threatening withdrawal symptoms is high (as with alcohol or benzodiazepines), or if the symptoms are severely debilitating or attempted outpatient treatment is unsuccessful. Pharmacologic and psychotherapeutic interventions are used for PD (see Figure), although there is not enough evidence to recommend one versus the other or combination therapy versus monotherapy.⁹

All Lacey’s test results come back negative, and the psychiatric assessment reveals that she meets the DSM-5 criteria for PD. Counting on the strength of their relationship, her PCP talks to her about PD and discusses treatment options, which include counseling, medication, or both. Lacey agrees to a referral for cognitive behavioral therapy (CBT) with a psychologist embedded at her primary care clinic and to begin taking medication. Her PCP starts her on sertraline 25 mg/d.

In CBT, Lacey’s psychologist teaches her about “fight or flight” and explains that it is a normal physiologic response that can lead to panic. Lacey learns to approach her physical symptoms in a different way, and how to breathe in a way that slows her panic reaction.

Consider SSRIs and SNRIs

Firstline medication is a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI), due to the better tolerability and lower adverse effect profile of these classes compared with the tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs). MAOIs are usually reserved for patients in whom multiple medication trials have failed.

Special considerations. American Psychiatric Association guidelines advise starting with a very low dose of an SSRI or SNRI, such as paroxetine 10 mg/d (although many clinicians start lower, at 5 mg/d), to avoid hypersensitivity reactions. Gradually titrate the dose upward within three to seven days of initiation, until a therapeutic dose is reached over two to six weeks. Schedule follow-up visits for every one to two weeks at the beginning of treatment and every two to four weeks until the therapeutic dose is reached. Assess safety/suicidality at each visit.

Keep in mind that the onset of therapeutic effect is between two and four weeks, but that clinical response can take eight to 12 weeks. Continue pharmacotherapy for at least one year. When discontinuing the medication, taper it slowly, and monitor the patient for withdrawal symptoms and recurrence of PD.⁹

Consider adding a benzodiazepine if symptoms are debilitating.⁹ Keep in mind, though, that the potential for addiction with these medications is high and they are intended to be used for only four to 12 weeks.⁸ Onset of action is within the first week, and a scheduled dosing regimen is preferred to giving the medication as needed. The starting dose (eg, clonazepam 0.25 mg bid) may be increased three to five days following initiation.⁹

Evidence supports the use of CBT for PD

CBT is an evidenced-based treatment for PD.^10-13 Up to 75% of patients treated with CBT are panic free within four months.¹⁰ Other techniques proven effective are progressive muscle relaxation training, breathing retraining, psychoeducation, exposure, and imagery.¹⁴

Treatment with medications and CBT, either combined or used individually, is effective in 80% to 90% of cases.¹⁵ CBT has been shown to decrease the likelihood of relapse in the year following treatment.¹⁵ Good premorbid functioning and a brief duration of symptoms increase the likelihood of a good prognosis.¹⁵

WHEN TO REFER TO A PSYCHIATRIST

Consider referral to a psychiatrist when patients have a comorbid psychiatric condition that complicates the clinical picture (eg, substance abuse disorder), if the diagnosis is uncertain, or if the patient does not respond to one or two adequate trials of medication and psychotherapy. Although psychiatric follow-up is sometimes difficult due to a lack of psychiatrist availability locally, it is a best-practice recommendation.

Ten days after Lacey starts the sertraline 25 mg/d, she calls the PCP to report daily diarrhea. She stopped the sertraline on her own and is asking for another medication. She also expresses her frustration with the severity of the symptoms. She is having three to five panic attacks daily and has been missing many days of work.

On the day of her follow-up PCP appointment, Lacey also sees the psychologist. She reports that she’s been practicing relaxation breathing, tracking her panic attacks, limiting her caffeine intake, and exercising regularly. But the attacks are still occurring.

The PCP switches her to paroxetine 10 mg/d and, due to the severity of the symptoms, prescribes clonazepam 0.5 mg bid. Two weeks later, Lacey reports that she is feeling a little better, has returned to work, and is hopeful that she will be her “normal self again.” The PCP plans to encourage continuation of CBT, titrate the paroxetine to 20 to 40 mg/d based on symptoms, and slowly taper the clonazepam toward discontinuation in the near future.

Lacey, 37, is seen by her primary care provider (PCP) as follow-up to a visit she made to the emergency department (ED). She has gone to the ED four times in the past year. Each time, she presents with tachycardia, dyspnea, nausea, numbness in her extremities, and a fear that she is having a heart attack. Despite negative workups at each visit (ECG, cardiac enzymes, complete blood count, toxicology screen, Holter monitoring), Lacey is terrified that the ED doctors are missing something. She is still “rattled” by the chest pain and shortness of breath she experiences. Mild symptoms are persisting, and she is worried that she will have a heart attack and die without the treatment she believes she needs. How do you proceed?

Panic disorder (PD) is characterized by the spontaneous and unexpected occurrence of panic attacks and by at least one month of persistent worry about having another attack or significant maladaptive behaviors related to the attack. Frequency of such attacks can vary from several a day to only a few per year. In a panic attack, an intense fear develops abruptly and peaks within 10 minutes of onset. At least four of the following 13 symptoms must accompany the attack, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5)

• Palpitations, pounding heart, or accelerated heart rate
• Sweating
• Trembling or shaking
• Sensations of shortness of breath or smothering
• Feeling of choking
• Chest pain or discomfort
• Feeling dizzy, unsteady, lightheaded, or faint
• Nausea or abdominal distress
• Derealization (feelings of unreality) or depersonalization (being detached from oneself)
• Fear of losing control or going crazy
• Fear of dying
• Paresthesia (numbness or tingling sensations)
• Chills or hot flushes.¹

Lifetime incidence rates of PD are 1% to 3% for the general population.² A closer look at patients presenting to the ED with chest pain reveals that 17% to 25% meet criteria for PD.^3,4 And an estimated 6% of individuals experiencing a panic attack present to their primary care provider.⁵ Patients with PD tend to use health care resources at a disproportionately high rate.⁶

An international review of PD research suggests the average age of onset is 32 years.⁷ Triggers can vary widely, and no single stressor has been identified. The exact cause of PD is unknown, but a convergence of social and biological influences (including involvement of the amygdala) are implicated in its development.⁶ For individuals who have had a panic attack, 66.5% will have recurrent attacks.⁷ Lifetime prevalence of panic attacks is 13.2%.⁷

Differential goes far beyond myocardial infarction. Many medical conditions can mimic PD symptoms: cardiovascular, pulmonary, and neurologic diseases; endocrine diseases (eg, hyperthyroidism); drug intoxication (eg, stimulants [cocaine, amphetamines]); drug withdrawal (eg, benzodiazepines, alcohol, sedative-hypnotics); and ingestion of excessive quantities of caffeine. Common comorbid medical disorders include asthma, coronary artery disease, cancer, thyroid disease, hypertension, ulcer, and migraine headaches.⁸

When patients present with paniclike symptoms, suspect a possible medical condition when those symptoms include ataxia, altered mental status, or loss of bladder control, or when onset of panic symptoms occur later in life for a patient with no significant psychiatric history.

RULE OUT ORGANIC CAUSES

In addition to obtaining a complete history and doing a physical exam on patients with paniclike symptoms, you’ll also need to ensure that the following are done: a neurologic examination, standard laboratory testing (thyroid function, complete blood cell count, chemistry panel), and possible additional testing (eg, urine toxicology screen and d-dimer assay to exclude pulmonary embolism).

If organic causes are ruled out, focus on a psychiatric assessment, including

• History of the present illness (onset, symptoms, frequency, predisposing/precipitating factors)
• Psychiatric history
• History of substance use
• Family history of psychiatric disorders (especially anxiety disorders)
• Social history (life events, including those preceding the onset of panic; history of child abuse)
• Medications
• Mental status examination
• Safety (PD is associated with higher risk for suicidal ideation).⁹

 

 

TREATMENT INCLUDES CBT AND MEDICATION

PD is a chronic disease with a variable course, but the long-term prognosis is good. PD is usually treated in an outpatient setting. Consider hospitalization if the patient is suicidal, if the potential for life-threatening withdrawal symptoms is high (as with alcohol or benzodiazepines), or if the symptoms are severely debilitating or attempted outpatient treatment is unsuccessful. Pharmacologic and psychotherapeutic interventions are used for PD (see Figure), although there is not enough evidence to recommend one versus the other or combination therapy versus monotherapy.⁹

All Lacey’s test results come back negative, and the psychiatric assessment reveals that she meets the DSM-5 criteria for PD. Counting on the strength of their relationship, her PCP talks to her about PD and discusses treatment options, which include counseling, medication, or both. Lacey agrees to a referral for cognitive behavioral therapy (CBT) with a psychologist embedded at her primary care clinic and to begin taking medication. Her PCP starts her on sertraline 25 mg/d.

In CBT, Lacey’s psychologist teaches her about “fight or flight” and explains that it is a normal physiologic response that can lead to panic. Lacey learns to approach her physical symptoms in a different way, and how to breathe in a way that slows her panic reaction.

Consider SSRIs and SNRIs

Firstline medication is a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI), due to the better tolerability and lower adverse effect profile of these classes compared with the tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs). MAOIs are usually reserved for patients in whom multiple medication trials have failed.

Special considerations. American Psychiatric Association guidelines advise starting with a very low dose of an SSRI or SNRI, such as paroxetine 10 mg/d (although many clinicians start lower, at 5 mg/d), to avoid hypersensitivity reactions. Gradually titrate the dose upward within three to seven days of initiation, until a therapeutic dose is reached over two to six weeks. Schedule follow-up visits for every one to two weeks at the beginning of treatment and every two to four weeks until the therapeutic dose is reached. Assess safety/suicidality at each visit.

Keep in mind that the onset of therapeutic effect is between two and four weeks, but that clinical response can take eight to 12 weeks. Continue pharmacotherapy for at least one year. When discontinuing the medication, taper it slowly, and monitor the patient for withdrawal symptoms and recurrence of PD.⁹

Consider adding a benzodiazepine if symptoms are debilitating.⁹ Keep in mind, though, that the potential for addiction with these medications is high and they are intended to be used for only four to 12 weeks.⁸ Onset of action is within the first week, and a scheduled dosing regimen is preferred to giving the medication as needed. The starting dose (eg, clonazepam 0.25 mg bid) may be increased three to five days following initiation.⁹

Evidence supports the use of CBT for PD

CBT is an evidenced-based treatment for PD.^10-13 Up to 75% of patients treated with CBT are panic free within four months.¹⁰ Other techniques proven effective are progressive muscle relaxation training, breathing retraining, psychoeducation, exposure, and imagery.¹⁴

Treatment with medications and CBT, either combined or used individually, is effective in 80% to 90% of cases.¹⁵ CBT has been shown to decrease the likelihood of relapse in the year following treatment.¹⁵ Good premorbid functioning and a brief duration of symptoms increase the likelihood of a good prognosis.¹⁵

WHEN TO REFER TO A PSYCHIATRIST

Consider referral to a psychiatrist when patients have a comorbid psychiatric condition that complicates the clinical picture (eg, substance abuse disorder), if the diagnosis is uncertain, or if the patient does not respond to one or two adequate trials of medication and psychotherapy. Although psychiatric follow-up is sometimes difficult due to a lack of psychiatrist availability locally, it is a best-practice recommendation.

Ten days after Lacey starts the sertraline 25 mg/d, she calls the PCP to report daily diarrhea. She stopped the sertraline on her own and is asking for another medication. She also expresses her frustration with the severity of the symptoms. She is having three to five panic attacks daily and has been missing many days of work.

On the day of her follow-up PCP appointment, Lacey also sees the psychologist. She reports that she’s been practicing relaxation breathing, tracking her panic attacks, limiting her caffeine intake, and exercising regularly. But the attacks are still occurring.

The PCP switches her to paroxetine 10 mg/d and, due to the severity of the symptoms, prescribes clonazepam 0.5 mg bid. Two weeks later, Lacey reports that she is feeling a little better, has returned to work, and is hopeful that she will be her “normal self again.” The PCP plans to encourage continuation of CBT, titrate the paroxetine to 20 to 40 mg/d based on symptoms, and slowly taper the clonazepam toward discontinuation in the near future.

Lacey, 37, is seen by her primary care provider (PCP) as follow-up to a visit she made to the emergency department (ED). She has gone to the ED four times in the past year. Each time, she presents with tachycardia, dyspnea, nausea, numbness in her extremities, and a fear that she is having a heart attack. Despite negative workups at each visit (ECG, cardiac enzymes, complete blood count, toxicology screen, Holter monitoring), Lacey is terrified that the ED doctors are missing something. She is still “rattled” by the chest pain and shortness of breath she experiences. Mild symptoms are persisting, and she is worried that she will have a heart attack and die without the treatment she believes she needs. How do you proceed?

Panic disorder (PD) is characterized by the spontaneous and unexpected occurrence of panic attacks and by at least one month of persistent worry about having another attack or significant maladaptive behaviors related to the attack. Frequency of such attacks can vary from several a day to only a few per year. In a panic attack, an intense fear develops abruptly and peaks within 10 minutes of onset. At least four of the following 13 symptoms must accompany the attack, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5)

• Palpitations, pounding heart, or accelerated heart rate
• Sweating
• Trembling or shaking
• Sensations of shortness of breath or smothering
• Feeling of choking
• Chest pain or discomfort
• Feeling dizzy, unsteady, lightheaded, or faint
• Nausea or abdominal distress
• Derealization (feelings of unreality) or depersonalization (being detached from oneself)
• Fear of losing control or going crazy
• Fear of dying
• Paresthesia (numbness or tingling sensations)
• Chills or hot flushes.¹

Lifetime incidence rates of PD are 1% to 3% for the general population.² A closer look at patients presenting to the ED with chest pain reveals that 17% to 25% meet criteria for PD.^3,4 And an estimated 6% of individuals experiencing a panic attack present to their primary care provider.⁵ Patients with PD tend to use health care resources at a disproportionately high rate.⁶

An international review of PD research suggests the average age of onset is 32 years.⁷ Triggers can vary widely, and no single stressor has been identified. The exact cause of PD is unknown, but a convergence of social and biological influences (including involvement of the amygdala) are implicated in its development.⁶ For individuals who have had a panic attack, 66.5% will have recurrent attacks.⁷ Lifetime prevalence of panic attacks is 13.2%.⁷

Differential goes far beyond myocardial infarction. Many medical conditions can mimic PD symptoms: cardiovascular, pulmonary, and neurologic diseases; endocrine diseases (eg, hyperthyroidism); drug intoxication (eg, stimulants [cocaine, amphetamines]); drug withdrawal (eg, benzodiazepines, alcohol, sedative-hypnotics); and ingestion of excessive quantities of caffeine. Common comorbid medical disorders include asthma, coronary artery disease, cancer, thyroid disease, hypertension, ulcer, and migraine headaches.⁸

When patients present with paniclike symptoms, suspect a possible medical condition when those symptoms include ataxia, altered mental status, or loss of bladder control, or when onset of panic symptoms occur later in life for a patient with no significant psychiatric history.

RULE OUT ORGANIC CAUSES

In addition to obtaining a complete history and doing a physical exam on patients with paniclike symptoms, you’ll also need to ensure that the following are done: a neurologic examination, standard laboratory testing (thyroid function, complete blood cell count, chemistry panel), and possible additional testing (eg, urine toxicology screen and d-dimer assay to exclude pulmonary embolism).

If organic causes are ruled out, focus on a psychiatric assessment, including

• History of the present illness (onset, symptoms, frequency, predisposing/precipitating factors)
• Psychiatric history
• History of substance use
• Family history of psychiatric disorders (especially anxiety disorders)
• Social history (life events, including those preceding the onset of panic; history of child abuse)
• Medications
• Mental status examination
• Safety (PD is associated with higher risk for suicidal ideation).⁹

 

 

TREATMENT INCLUDES CBT AND MEDICATION

PD is a chronic disease with a variable course, but the long-term prognosis is good. PD is usually treated in an outpatient setting. Consider hospitalization if the patient is suicidal, if the potential for life-threatening withdrawal symptoms is high (as with alcohol or benzodiazepines), or if the symptoms are severely debilitating or attempted outpatient treatment is unsuccessful. Pharmacologic and psychotherapeutic interventions are used for PD (see Figure), although there is not enough evidence to recommend one versus the other or combination therapy versus monotherapy.⁹

All Lacey’s test results come back negative, and the psychiatric assessment reveals that she meets the DSM-5 criteria for PD. Counting on the strength of their relationship, her PCP talks to her about PD and discusses treatment options, which include counseling, medication, or both. Lacey agrees to a referral for cognitive behavioral therapy (CBT) with a psychologist embedded at her primary care clinic and to begin taking medication. Her PCP starts her on sertraline 25 mg/d.

In CBT, Lacey’s psychologist teaches her about “fight or flight” and explains that it is a normal physiologic response that can lead to panic. Lacey learns to approach her physical symptoms in a different way, and how to breathe in a way that slows her panic reaction.

Consider SSRIs and SNRIs

Firstline medication is a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI), due to the better tolerability and lower adverse effect profile of these classes compared with the tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs). MAOIs are usually reserved for patients in whom multiple medication trials have failed.

Special considerations. American Psychiatric Association guidelines advise starting with a very low dose of an SSRI or SNRI, such as paroxetine 10 mg/d (although many clinicians start lower, at 5 mg/d), to avoid hypersensitivity reactions. Gradually titrate the dose upward within three to seven days of initiation, until a therapeutic dose is reached over two to six weeks. Schedule follow-up visits for every one to two weeks at the beginning of treatment and every two to four weeks until the therapeutic dose is reached. Assess safety/suicidality at each visit.

Keep in mind that the onset of therapeutic effect is between two and four weeks, but that clinical response can take eight to 12 weeks. Continue pharmacotherapy for at least one year. When discontinuing the medication, taper it slowly, and monitor the patient for withdrawal symptoms and recurrence of PD.⁹

Consider adding a benzodiazepine if symptoms are debilitating.⁹ Keep in mind, though, that the potential for addiction with these medications is high and they are intended to be used for only four to 12 weeks.⁸ Onset of action is within the first week, and a scheduled dosing regimen is preferred to giving the medication as needed. The starting dose (eg, clonazepam 0.25 mg bid) may be increased three to five days following initiation.⁹

Evidence supports the use of CBT for PD

CBT is an evidenced-based treatment for PD.^10-13 Up to 75% of patients treated with CBT are panic free within four months.¹⁰ Other techniques proven effective are progressive muscle relaxation training, breathing retraining, psychoeducation, exposure, and imagery.¹⁴

Treatment with medications and CBT, either combined or used individually, is effective in 80% to 90% of cases.¹⁵ CBT has been shown to decrease the likelihood of relapse in the year following treatment.¹⁵ Good premorbid functioning and a brief duration of symptoms increase the likelihood of a good prognosis.¹⁵

WHEN TO REFER TO A PSYCHIATRIST

Consider referral to a psychiatrist when patients have a comorbid psychiatric condition that complicates the clinical picture (eg, substance abuse disorder), if the diagnosis is uncertain, or if the patient does not respond to one or two adequate trials of medication and psychotherapy. Although psychiatric follow-up is sometimes difficult due to a lack of psychiatrist availability locally, it is a best-practice recommendation.

Ten days after Lacey starts the sertraline 25 mg/d, she calls the PCP to report daily diarrhea. She stopped the sertraline on her own and is asking for another medication. She also expresses her frustration with the severity of the symptoms. She is having three to five panic attacks daily and has been missing many days of work.

On the day of her follow-up PCP appointment, Lacey also sees the psychologist. She reports that she’s been practicing relaxation breathing, tracking her panic attacks, limiting her caffeine intake, and exercising regularly. But the attacks are still occurring.

The PCP switches her to paroxetine 10 mg/d and, due to the severity of the symptoms, prescribes clonazepam 0.5 mg bid. Two weeks later, Lacey reports that she is feeling a little better, has returned to work, and is hopeful that she will be her “normal self again.” The PCP plans to encourage continuation of CBT, titrate the paroxetine to 20 to 40 mg/d based on symptoms, and slowly taper the clonazepam toward discontinuation in the near future.

On the morning of February 9, 2018, President Trump signed into law the Bipartisan Budget Act of 2018. The law included legislative priorities that were championed by the ACS and for which staff of the DC office and engaged Fellows of the College have advocated, in some cases, for a number of years.

ACS worked particularly hard in the week leading up to the passage of the Bipartisan Budget Act of 2018 with the goal of ensuring that certain items were included, and certain other items were excluded, in the Continuing Resolution (CR) under consideration by Congress to continue funding the government. The original version of the CR considered and debated by the House of Representatives early in the week included both positive and negative items. The ACS was successful in its efforts to get the Senate to consider a much-improved version of the CR – eliminating a major impediment in the House version. Ultimately, it was the Senate version that was signed into law by President Trump.

The provisions in the Bipartisan Budget Act of 2018 include:

• Flexibility for the Merit-based Incentive Payment System (MIPS) related to how much weight will be ascribed to the Cost component in an individual physician’s MIPS score as well as flexibility in setting the level at which physicians will either receive a positive or negative payment update. Without this flexibility, there was significant concern that Fellows would have significantly greater challenges in avoiding a cut under the MIPS. This language, and the effort to include it, was spearheaded and long championed by the ACS including the drafting of model legislation remedying the problem which was then provided to the leadership and staff of committees of jurisdiction.

• Easing meaningful use (MU) requirements by removing an outdated requirement directing the Secretary of Health and Human Services (HHS) to continue to make meaningful use standards increasingly stringent over time. The ACS has long advocated against increasingly stringent MU requirements that do not lead to improvements in patient care, and feels they are unnecessary and unfair to both patients and providers. Further, easing MU requirements has long been supported by ACS Fellows.

On the morning of February 9, 2018, President Trump signed into law the Bipartisan Budget Act of 2018. The law included legislative priorities that were championed by the ACS and for which staff of the DC office and engaged Fellows of the College have advocated, in some cases, for a number of years.

ACS worked particularly hard in the week leading up to the passage of the Bipartisan Budget Act of 2018 with the goal of ensuring that certain items were included, and certain other items were excluded, in the Continuing Resolution (CR) under consideration by Congress to continue funding the government. The original version of the CR considered and debated by the House of Representatives early in the week included both positive and negative items. The ACS was successful in its efforts to get the Senate to consider a much-improved version of the CR – eliminating a major impediment in the House version. Ultimately, it was the Senate version that was signed into law by President Trump.

The provisions in the Bipartisan Budget Act of 2018 include:

• Flexibility for the Merit-based Incentive Payment System (MIPS) related to how much weight will be ascribed to the Cost component in an individual physician’s MIPS score as well as flexibility in setting the level at which physicians will either receive a positive or negative payment update. Without this flexibility, there was significant concern that Fellows would have significantly greater challenges in avoiding a cut under the MIPS. This language, and the effort to include it, was spearheaded and long championed by the ACS including the drafting of model legislation remedying the problem which was then provided to the leadership and staff of committees of jurisdiction.

• Easing meaningful use (MU) requirements by removing an outdated requirement directing the Secretary of Health and Human Services (HHS) to continue to make meaningful use standards increasingly stringent over time. The ACS has long advocated against increasingly stringent MU requirements that do not lead to improvements in patient care, and feels they are unnecessary and unfair to both patients and providers. Further, easing MU requirements has long been supported by ACS Fellows.

On the morning of February 9, 2018, President Trump signed into law the Bipartisan Budget Act of 2018. The law included legislative priorities that were championed by the ACS and for which staff of the DC office and engaged Fellows of the College have advocated, in some cases, for a number of years.

ACS worked particularly hard in the week leading up to the passage of the Bipartisan Budget Act of 2018 with the goal of ensuring that certain items were included, and certain other items were excluded, in the Continuing Resolution (CR) under consideration by Congress to continue funding the government. The original version of the CR considered and debated by the House of Representatives early in the week included both positive and negative items. The ACS was successful in its efforts to get the Senate to consider a much-improved version of the CR – eliminating a major impediment in the House version. Ultimately, it was the Senate version that was signed into law by President Trump.

The provisions in the Bipartisan Budget Act of 2018 include:

• Flexibility for the Merit-based Incentive Payment System (MIPS) related to how much weight will be ascribed to the Cost component in an individual physician’s MIPS score as well as flexibility in setting the level at which physicians will either receive a positive or negative payment update. Without this flexibility, there was significant concern that Fellows would have significantly greater challenges in avoiding a cut under the MIPS. This language, and the effort to include it, was spearheaded and long championed by the ACS including the drafting of model legislation remedying the problem which was then provided to the leadership and staff of committees of jurisdiction.

• Easing meaningful use (MU) requirements by removing an outdated requirement directing the Secretary of Health and Human Services (HHS) to continue to make meaningful use standards increasingly stringent over time. The ACS has long advocated against increasingly stringent MU requirements that do not lead to improvements in patient care, and feels they are unnecessary and unfair to both patients and providers. Further, easing MU requirements has long been supported by ACS Fellows.

I am a member of several surgical societies, and more than once I’ve extolled the importance of going to meetings as part of my personal definition of a “good” surgeon.

While I mostly enjoy meetings nowadays, it hasn’t always been easy. My first experiences at surgical society meetings were painful. I was 32 years old, just out of training, and didn’t know anyone at the meetings. Receptions were the worst. My only friend sometimes was either my host or my wife. I was surrounded by these old guys, most of whom were famous.

Among the highlights of my life was being invited to join the Western Surgical Association. The year I was elected, J. David Richardson was the President. He gave such a rousing speech that at the President’s Dinner I rallied the courage to speak to the great man. When I called him “Dr. Richardson,” he waved that off and insisted I call him “Dave.” Little did I know that Dave would become one of my personal heroes and play an important part in the path that led to my being in a position to write a column such as this.

I am a member of several surgical societies, and more than once I’ve extolled the importance of going to meetings as part of my personal definition of a “good” surgeon.

While I mostly enjoy meetings nowadays, it hasn’t always been easy. My first experiences at surgical society meetings were painful. I was 32 years old, just out of training, and didn’t know anyone at the meetings. Receptions were the worst. My only friend sometimes was either my host or my wife. I was surrounded by these old guys, most of whom were famous.

Among the highlights of my life was being invited to join the Western Surgical Association. The year I was elected, J. David Richardson was the President. He gave such a rousing speech that at the President’s Dinner I rallied the courage to speak to the great man. When I called him “Dr. Richardson,” he waved that off and insisted I call him “Dave.” Little did I know that Dave would become one of my personal heroes and play an important part in the path that led to my being in a position to write a column such as this.

I am a member of several surgical societies, and more than once I’ve extolled the importance of going to meetings as part of my personal definition of a “good” surgeon.

While I mostly enjoy meetings nowadays, it hasn’t always been easy. My first experiences at surgical society meetings were painful. I was 32 years old, just out of training, and didn’t know anyone at the meetings. Receptions were the worst. My only friend sometimes was either my host or my wife. I was surrounded by these old guys, most of whom were famous.

Among the highlights of my life was being invited to join the Western Surgical Association. The year I was elected, J. David Richardson was the President. He gave such a rousing speech that at the President’s Dinner I rallied the courage to speak to the great man. When I called him “Dr. Richardson,” he waved that off and insisted I call him “Dave.” Little did I know that Dave would become one of my personal heroes and play an important part in the path that led to my being in a position to write a column such as this.

Eileen Metzger Bulger, MD, FACS, chief of trauma and trauma medical director for adults and pediatrics, Harborview Medical Center, Seattle, WA, begins serving as the new Chair of the American College of Surgeons (ACS) Committee on Trauma (COT) this month. Dr. Bulger was appointed as the next COT Chair in October 2017 by the ACS Board of Regents. She is the 20th Chair of the COT, succeeding Ronald M. Stewart, MD, FACS, of San Antonio, TX.

“We look forward to Dr. Bulger’s exceptional vision and leadership as she directs the COT into its 96th year of working to improve the care of the injured patient. She is the perfect person to lead the COT into its next century of transforming care and reducing injuries across the globe,” Dr. Stewart said.

A diplomate of the American Board of Surgery, Dr. Bulger also is board certified in surgical critical care. She earned a medical doctorate at Cornell University Medical College, New York, NY (1992). She completed a residency in general surgery at the University of Washington (UW), Seattle (1992–1999), where she concurrently completed a two-year National Institutes of Health Trauma Research Fellowship during her years of residency training (1995–1997), and then went on to complete a surgical critical care fellowship at UW in 2000.
 

Recognized leadership

Throughout her career, Dr. Bulger has mentored many surgical residents in paper and scholarship competitions. For nearly two decades, she has served as the co-principal or principal investigator of a variety of innovative, grant-funded research projects related to trauma care, some of which focus on improving outcomes for crash injury victims, pediatric patients, and older adults.

Since her initial involvement with the COT in 2002, Dr. Bulger has contributed to many COT activities, often serving in a leadership role. She is a Course Instructor for the internationally recognized Advanced Trauma Life Support® (ATLS®) program, and she served as the COT Washington State Chair (2003–2006); Region X Chief (2006–2012); Chair of the Emergency Medical Services Committee (2011–2015); Chair of the Membership Committee (2014–2017); and Executive Committee member (2014–2017).

The COT is dedicated to all phases of injury care, from prevention to rehabilitation. The committee is supported by a network of 65 state and provincial committees, 11 international committees, and five military committees, and the majority of members are ACS Fellows.

Eileen Metzger Bulger, MD, FACS, chief of trauma and trauma medical director for adults and pediatrics, Harborview Medical Center, Seattle, WA, begins serving as the new Chair of the American College of Surgeons (ACS) Committee on Trauma (COT) this month. Dr. Bulger was appointed as the next COT Chair in October 2017 by the ACS Board of Regents. She is the 20th Chair of the COT, succeeding Ronald M. Stewart, MD, FACS, of San Antonio, TX.

“We look forward to Dr. Bulger’s exceptional vision and leadership as she directs the COT into its 96th year of working to improve the care of the injured patient. She is the perfect person to lead the COT into its next century of transforming care and reducing injuries across the globe,” Dr. Stewart said.

A diplomate of the American Board of Surgery, Dr. Bulger also is board certified in surgical critical care. She earned a medical doctorate at Cornell University Medical College, New York, NY (1992). She completed a residency in general surgery at the University of Washington (UW), Seattle (1992–1999), where she concurrently completed a two-year National Institutes of Health Trauma Research Fellowship during her years of residency training (1995–1997), and then went on to complete a surgical critical care fellowship at UW in 2000.
 

Recognized leadership

Throughout her career, Dr. Bulger has mentored many surgical residents in paper and scholarship competitions. For nearly two decades, she has served as the co-principal or principal investigator of a variety of innovative, grant-funded research projects related to trauma care, some of which focus on improving outcomes for crash injury victims, pediatric patients, and older adults.

Since her initial involvement with the COT in 2002, Dr. Bulger has contributed to many COT activities, often serving in a leadership role. She is a Course Instructor for the internationally recognized Advanced Trauma Life Support® (ATLS®) program, and she served as the COT Washington State Chair (2003–2006); Region X Chief (2006–2012); Chair of the Emergency Medical Services Committee (2011–2015); Chair of the Membership Committee (2014–2017); and Executive Committee member (2014–2017).

The COT is dedicated to all phases of injury care, from prevention to rehabilitation. The committee is supported by a network of 65 state and provincial committees, 11 international committees, and five military committees, and the majority of members are ACS Fellows.

Eileen Metzger Bulger, MD, FACS, chief of trauma and trauma medical director for adults and pediatrics, Harborview Medical Center, Seattle, WA, begins serving as the new Chair of the American College of Surgeons (ACS) Committee on Trauma (COT) this month. Dr. Bulger was appointed as the next COT Chair in October 2017 by the ACS Board of Regents. She is the 20th Chair of the COT, succeeding Ronald M. Stewart, MD, FACS, of San Antonio, TX.

“We look forward to Dr. Bulger’s exceptional vision and leadership as she directs the COT into its 96th year of working to improve the care of the injured patient. She is the perfect person to lead the COT into its next century of transforming care and reducing injuries across the globe,” Dr. Stewart said.

A diplomate of the American Board of Surgery, Dr. Bulger also is board certified in surgical critical care. She earned a medical doctorate at Cornell University Medical College, New York, NY (1992). She completed a residency in general surgery at the University of Washington (UW), Seattle (1992–1999), where she concurrently completed a two-year National Institutes of Health Trauma Research Fellowship during her years of residency training (1995–1997), and then went on to complete a surgical critical care fellowship at UW in 2000.
 

Recognized leadership

Throughout her career, Dr. Bulger has mentored many surgical residents in paper and scholarship competitions. For nearly two decades, she has served as the co-principal or principal investigator of a variety of innovative, grant-funded research projects related to trauma care, some of which focus on improving outcomes for crash injury victims, pediatric patients, and older adults.

Since her initial involvement with the COT in 2002, Dr. Bulger has contributed to many COT activities, often serving in a leadership role. She is a Course Instructor for the internationally recognized Advanced Trauma Life Support® (ATLS®) program, and she served as the COT Washington State Chair (2003–2006); Region X Chief (2006–2012); Chair of the Emergency Medical Services Committee (2011–2015); Chair of the Membership Committee (2014–2017); and Executive Committee member (2014–2017).

The COT is dedicated to all phases of injury care, from prevention to rehabilitation. The committee is supported by a network of 65 state and provincial committees, 11 international committees, and five military committees, and the majority of members are ACS Fellows.

On February 9, Congress passed and President Trump signed into law the Bipartisan Budget Act of 2018. The law addresses many key physician and patient issues, including important technical corrections to the Merit-based Incentive Payment System (MIPS) that the American College of Surgeons (ACS) strongly favors.

The law addresses several other ACS priorities, including:

The addition of a long-term funding extension (10 years) for the Children’s Health Insurance Program (CHIP), ensuring that children continue to have access to surgical care

The inclusion of language that eases electronic health record system meaningful use requirements, alleviating some of the burdens imposed on physicians and their practices

Additional funding to address the opioid epidemic and to support the work of the National Institutes of Health Repeal of the Independent Payment Advisory Board

For more information, contact Mark Lukaszewski, ACS Congressional Lobbyist, at mlukaszewski@facs.org.






 

On February 9, Congress passed and President Trump signed into law the Bipartisan Budget Act of 2018. The law addresses many key physician and patient issues, including important technical corrections to the Merit-based Incentive Payment System (MIPS) that the American College of Surgeons (ACS) strongly favors.

The law addresses several other ACS priorities, including:

The addition of a long-term funding extension (10 years) for the Children’s Health Insurance Program (CHIP), ensuring that children continue to have access to surgical care

The inclusion of language that eases electronic health record system meaningful use requirements, alleviating some of the burdens imposed on physicians and their practices

Additional funding to address the opioid epidemic and to support the work of the National Institutes of Health Repeal of the Independent Payment Advisory Board

For more information, contact Mark Lukaszewski, ACS Congressional Lobbyist, at mlukaszewski@facs.org.






 

On February 9, Congress passed and President Trump signed into law the Bipartisan Budget Act of 2018. The law addresses many key physician and patient issues, including important technical corrections to the Merit-based Incentive Payment System (MIPS) that the American College of Surgeons (ACS) strongly favors.

The law addresses several other ACS priorities, including:

The addition of a long-term funding extension (10 years) for the Children’s Health Insurance Program (CHIP), ensuring that children continue to have access to surgical care

The inclusion of language that eases electronic health record system meaningful use requirements, alleviating some of the burdens imposed on physicians and their practices

Additional funding to address the opioid epidemic and to support the work of the National Institutes of Health Repeal of the Independent Payment Advisory Board

For more information, contact Mark Lukaszewski, ACS Congressional Lobbyist, at mlukaszewski@facs.org.






 

The American Medical Association (AMA) Interim Meeting of the House of Delegates (HOD) took place November 11–14, 2017, in Honolulu, HI. A total of 532 delegates were in attendance to debate the policy implications of 36 reports and 99 resolutions.

The American College of Surgeons (ACS) sent a six-member delegation to the meeting. The ACS also participates in AMA activities in other capacities, including in the AMA Young Physician Section Assembly, the AMA Resident and Fellow Section Assembly, and the AMA Council on Medical Education. These three groups met in conjunction with the HOD meeting. See the sidebar on page 74 for the list of ACS delegates and their other AMA roles.
 

ACS cosponsored issues

The AMA HOD brings together a variety of perspectives in medicine, and the job of the ACS delegation is to shape AMA policy consistent with College priorities. One way the ACS achieves this objective is by cosponsoring resolutions that have been submitted by other delegations and that are relevant to the College Fellowship. The ACS delegation cosponsored the following three resolutions at the November meeting—two on scope-of-practice issues and one on physician payment—all of which were adopted.

Resolution 214, Advanced Practice Registered Nurse (APRN) Compact, was initiated by the American Society of Anesthesiologists and strengthened with amendments. AMA policy opposes enactment of the Advanced APRN Multistate Compact because of its potential to supersede state laws that require APRNs to practice under physician supervision, as well as legislation that authorizes the independent practice of medicine by any individual who has not completed the state’s requirement for licensure to practice medicine. The AMA will convene an in-person meeting of relevant physician stakeholders to create a consistent national strategy to prevent fulfillment of the APRN Compact.

Resolution 230, Oppose Physician Assistant Independent Practice, with support from a spectrum of state medical and national specialty societies, continued the theme of opposition to legislation or regulation that allows physician extenders—in this case physician assistants—to practice independently. Another resolution addressed the emerging advanced physician assistant degree known as doctor of medical science. The AMA opposes holders of this degree from being recognized as a new category of health care practitioners licensed for the independent practice of medicine.

Resolution 808, Opposition to Reduced Payment for the 25-Modifier, was offered by the American Academy of Dermatology. The resolution was a response to private insurers discounting evaluation and management (E/M) codes by 50 percent when linked through the 25-modifier to a procedure on the same day. This resolution passed as simplified by amendment to have AMA aggressively and immediately advocate, through any legal means possible (such as direct payor negotiations, regulations, legislation, or litigation), for non-reduced allowable payment of appropriately reported 25-modifier E/M codes when linked with procedures.
 

Other HOD-adopted resolutions of interest

BOT (Board of Trustees) Report 5, Effective Peer Review, amended the AMA Physician and Medical Staff Member Bill of Rights to add “protection from any retaliatory actions” to the list of immunity rights when physicians participate in good faith peer-review activities. In testimony at the reference committee, the delegation highlighted the value of the new ACS “red book,” Optimal Resources for Surgical Quality and Safety, for establishing peer-review standards in surgical care.

Council on Science and Public Health Report 2, Targeted Education to Increase Organ Donation, amended the AMA policy, Methods to Increase the U.S. Organ Donor Pool. As a result, the AMA supports studies that evaluate the effectiveness of mandated choice and presumed consent models for increasing organ donation and urges development of effective methods to inform populations with historically low participation rates about donating.

Resolution 953, Fees for Taking Maintenance of Certification (MOC) Examination, amended AMA MOC policy to assert that the MOC process should reflect the cost of development and administration of the MOC components, ensure a fair fee structure, and not hinder patient care. The AMA will advocate that value in MOC includes cost-effectiveness with full financial transparency, respect for physicians’ time and patient care commitments, alignment of MOC requirements with other regulator and payor requirements, and adherence to an evidence basis for both MOC content and processes.

Not every item was viewed favorably at the AMA meeting. Council on Ethical and Judicial Affairs (CEJA) Report 1, Competence, Self-Assessment and Self-Awareness, sought to provide guidance for physicians in determining their own competence when practicing medicine. The council observed, “As an ethical responsibility, competence encompasses more than medical knowledge and skill. It requires physicians to understand that as a practical matter in the care of actual patients, competence is fluid and dependent on context.” Considerable testimony emphasized a lack of reliable tools and available resources to assist physicians in self-assessment. Thus, the report was referred back to CEJA for more work.
 

Surgical caucus

In addition to facilitating an agenda review and business meeting for surgeons, anesthesiologists, and emergency physicians, the caucus sponsored a popular education session, Hazards of the Deep: Trauma in Paradise. Michael Hayashi, MD, FACS, Chair of the Hawaii Committee on Trauma, discussed system challenges in caring for injured patients from geographically remote and less populated areas. Lieutenant Matthew Brown, MC, USN, an undersea/diving medical officer stationed at Pearl Harbor, HI, shared insights about injuries and medical conditions experienced by scuba divers, swimmers, surfers, and other beach enthusiasts.
 

Leadership transition

After extended service on the delegation, including eight years as Chair, Dr. Armstrong bid “aloha” to the HOD as a retiring delegate. Dr. Turner has accepted the role as Chair, maintaining continued College leadership in the HOD.
 

Next meeting

The next meeting of the AMA HOD is scheduled for June 9–13 in Chicago, IL. In addition to debate on numerous issues, elections for AMA officers, trustees, and councils will be held at the meeting. Surgeons with suggestions for potential resolutions or questions about ACS activities at the AMA HOD should e-mail ahp@facs.org
 

ACS Delegation at the AMA HOD

John H. Armstrong, MD, FACS (Delegation Chair), acute care surgery, Tampa, FL

Brian J. Gavitt, MD, MPH (also Young Physicians Section delegate), general surgery, Cincinnati, OH

Jacob Moalem, MD, FACS, general surgery, Rochester, NY

Leigh A. Neumayer, MD, FACS, general surgery, Tucson, AZ; Chair, ACS Board of Regents

Naveen F. Sangji, MD (also Resident and Fellow Section delegate), general surgery resident, Boston, MA

Patricia L. Turner, MD, FACS, general surgery, Chicago, IL; Director, ACS Division of Member Services; member and immediate past-chair, AMA Council on Medical EducationDr. Armstrong is affiliate associate professor of surgery, University of South Florida Morsani College of Medicine, Tampa, and former Florida Surgeon General and Secretary of Health (2012–2016). He is a member, ACS Health Policy and Advocacy Group, and Past-Chair, ACS Professional Association political action committee (ACSPA-SurgeonsPAC).



Mr. Sutton is Manager, State Affairs, ACS Division of Advocacy and Health Policy.

The American Medical Association (AMA) Interim Meeting of the House of Delegates (HOD) took place November 11–14, 2017, in Honolulu, HI. A total of 532 delegates were in attendance to debate the policy implications of 36 reports and 99 resolutions.

The American College of Surgeons (ACS) sent a six-member delegation to the meeting. The ACS also participates in AMA activities in other capacities, including in the AMA Young Physician Section Assembly, the AMA Resident and Fellow Section Assembly, and the AMA Council on Medical Education. These three groups met in conjunction with the HOD meeting. See the sidebar on page 74 for the list of ACS delegates and their other AMA roles.
 

ACS cosponsored issues

The AMA HOD brings together a variety of perspectives in medicine, and the job of the ACS delegation is to shape AMA policy consistent with College priorities. One way the ACS achieves this objective is by cosponsoring resolutions that have been submitted by other delegations and that are relevant to the College Fellowship. The ACS delegation cosponsored the following three resolutions at the November meeting—two on scope-of-practice issues and one on physician payment—all of which were adopted.

Resolution 214, Advanced Practice Registered Nurse (APRN) Compact, was initiated by the American Society of Anesthesiologists and strengthened with amendments. AMA policy opposes enactment of the Advanced APRN Multistate Compact because of its potential to supersede state laws that require APRNs to practice under physician supervision, as well as legislation that authorizes the independent practice of medicine by any individual who has not completed the state’s requirement for licensure to practice medicine. The AMA will convene an in-person meeting of relevant physician stakeholders to create a consistent national strategy to prevent fulfillment of the APRN Compact.

Resolution 230, Oppose Physician Assistant Independent Practice, with support from a spectrum of state medical and national specialty societies, continued the theme of opposition to legislation or regulation that allows physician extenders—in this case physician assistants—to practice independently. Another resolution addressed the emerging advanced physician assistant degree known as doctor of medical science. The AMA opposes holders of this degree from being recognized as a new category of health care practitioners licensed for the independent practice of medicine.

Resolution 808, Opposition to Reduced Payment for the 25-Modifier, was offered by the American Academy of Dermatology. The resolution was a response to private insurers discounting evaluation and management (E/M) codes by 50 percent when linked through the 25-modifier to a procedure on the same day. This resolution passed as simplified by amendment to have AMA aggressively and immediately advocate, through any legal means possible (such as direct payor negotiations, regulations, legislation, or litigation), for non-reduced allowable payment of appropriately reported 25-modifier E/M codes when linked with procedures.
 

Other HOD-adopted resolutions of interest

BOT (Board of Trustees) Report 5, Effective Peer Review, amended the AMA Physician and Medical Staff Member Bill of Rights to add “protection from any retaliatory actions” to the list of immunity rights when physicians participate in good faith peer-review activities. In testimony at the reference committee, the delegation highlighted the value of the new ACS “red book,” Optimal Resources for Surgical Quality and Safety, for establishing peer-review standards in surgical care.

Council on Science and Public Health Report 2, Targeted Education to Increase Organ Donation, amended the AMA policy, Methods to Increase the U.S. Organ Donor Pool. As a result, the AMA supports studies that evaluate the effectiveness of mandated choice and presumed consent models for increasing organ donation and urges development of effective methods to inform populations with historically low participation rates about donating.

Resolution 953, Fees for Taking Maintenance of Certification (MOC) Examination, amended AMA MOC policy to assert that the MOC process should reflect the cost of development and administration of the MOC components, ensure a fair fee structure, and not hinder patient care. The AMA will advocate that value in MOC includes cost-effectiveness with full financial transparency, respect for physicians’ time and patient care commitments, alignment of MOC requirements with other regulator and payor requirements, and adherence to an evidence basis for both MOC content and processes.

Not every item was viewed favorably at the AMA meeting. Council on Ethical and Judicial Affairs (CEJA) Report 1, Competence, Self-Assessment and Self-Awareness, sought to provide guidance for physicians in determining their own competence when practicing medicine. The council observed, “As an ethical responsibility, competence encompasses more than medical knowledge and skill. It requires physicians to understand that as a practical matter in the care of actual patients, competence is fluid and dependent on context.” Considerable testimony emphasized a lack of reliable tools and available resources to assist physicians in self-assessment. Thus, the report was referred back to CEJA for more work.
 

Surgical caucus

In addition to facilitating an agenda review and business meeting for surgeons, anesthesiologists, and emergency physicians, the caucus sponsored a popular education session, Hazards of the Deep: Trauma in Paradise. Michael Hayashi, MD, FACS, Chair of the Hawaii Committee on Trauma, discussed system challenges in caring for injured patients from geographically remote and less populated areas. Lieutenant Matthew Brown, MC, USN, an undersea/diving medical officer stationed at Pearl Harbor, HI, shared insights about injuries and medical conditions experienced by scuba divers, swimmers, surfers, and other beach enthusiasts.
 

Leadership transition

After extended service on the delegation, including eight years as Chair, Dr. Armstrong bid “aloha” to the HOD as a retiring delegate. Dr. Turner has accepted the role as Chair, maintaining continued College leadership in the HOD.
 

Next meeting

The next meeting of the AMA HOD is scheduled for June 9–13 in Chicago, IL. In addition to debate on numerous issues, elections for AMA officers, trustees, and councils will be held at the meeting. Surgeons with suggestions for potential resolutions or questions about ACS activities at the AMA HOD should e-mail ahp@facs.org
 

ACS Delegation at the AMA HOD

John H. Armstrong, MD, FACS (Delegation Chair), acute care surgery, Tampa, FL

Brian J. Gavitt, MD, MPH (also Young Physicians Section delegate), general surgery, Cincinnati, OH

Jacob Moalem, MD, FACS, general surgery, Rochester, NY

Leigh A. Neumayer, MD, FACS, general surgery, Tucson, AZ; Chair, ACS Board of Regents

Naveen F. Sangji, MD (also Resident and Fellow Section delegate), general surgery resident, Boston, MA

Patricia L. Turner, MD, FACS, general surgery, Chicago, IL; Director, ACS Division of Member Services; member and immediate past-chair, AMA Council on Medical EducationDr. Armstrong is affiliate associate professor of surgery, University of South Florida Morsani College of Medicine, Tampa, and former Florida Surgeon General and Secretary of Health (2012–2016). He is a member, ACS Health Policy and Advocacy Group, and Past-Chair, ACS Professional Association political action committee (ACSPA-SurgeonsPAC).



Mr. Sutton is Manager, State Affairs, ACS Division of Advocacy and Health Policy.

The American Medical Association (AMA) Interim Meeting of the House of Delegates (HOD) took place November 11–14, 2017, in Honolulu, HI. A total of 532 delegates were in attendance to debate the policy implications of 36 reports and 99 resolutions.

The American College of Surgeons (ACS) sent a six-member delegation to the meeting. The ACS also participates in AMA activities in other capacities, including in the AMA Young Physician Section Assembly, the AMA Resident and Fellow Section Assembly, and the AMA Council on Medical Education. These three groups met in conjunction with the HOD meeting. See the sidebar on page 74 for the list of ACS delegates and their other AMA roles.
 

ACS cosponsored issues

The AMA HOD brings together a variety of perspectives in medicine, and the job of the ACS delegation is to shape AMA policy consistent with College priorities. One way the ACS achieves this objective is by cosponsoring resolutions that have been submitted by other delegations and that are relevant to the College Fellowship. The ACS delegation cosponsored the following three resolutions at the November meeting—two on scope-of-practice issues and one on physician payment—all of which were adopted.

Resolution 214, Advanced Practice Registered Nurse (APRN) Compact, was initiated by the American Society of Anesthesiologists and strengthened with amendments. AMA policy opposes enactment of the Advanced APRN Multistate Compact because of its potential to supersede state laws that require APRNs to practice under physician supervision, as well as legislation that authorizes the independent practice of medicine by any individual who has not completed the state’s requirement for licensure to practice medicine. The AMA will convene an in-person meeting of relevant physician stakeholders to create a consistent national strategy to prevent fulfillment of the APRN Compact.

Resolution 230, Oppose Physician Assistant Independent Practice, with support from a spectrum of state medical and national specialty societies, continued the theme of opposition to legislation or regulation that allows physician extenders—in this case physician assistants—to practice independently. Another resolution addressed the emerging advanced physician assistant degree known as doctor of medical science. The AMA opposes holders of this degree from being recognized as a new category of health care practitioners licensed for the independent practice of medicine.

Resolution 808, Opposition to Reduced Payment for the 25-Modifier, was offered by the American Academy of Dermatology. The resolution was a response to private insurers discounting evaluation and management (E/M) codes by 50 percent when linked through the 25-modifier to a procedure on the same day. This resolution passed as simplified by amendment to have AMA aggressively and immediately advocate, through any legal means possible (such as direct payor negotiations, regulations, legislation, or litigation), for non-reduced allowable payment of appropriately reported 25-modifier E/M codes when linked with procedures.
 

Other HOD-adopted resolutions of interest

BOT (Board of Trustees) Report 5, Effective Peer Review, amended the AMA Physician and Medical Staff Member Bill of Rights to add “protection from any retaliatory actions” to the list of immunity rights when physicians participate in good faith peer-review activities. In testimony at the reference committee, the delegation highlighted the value of the new ACS “red book,” Optimal Resources for Surgical Quality and Safety, for establishing peer-review standards in surgical care.

Council on Science and Public Health Report 2, Targeted Education to Increase Organ Donation, amended the AMA policy, Methods to Increase the U.S. Organ Donor Pool. As a result, the AMA supports studies that evaluate the effectiveness of mandated choice and presumed consent models for increasing organ donation and urges development of effective methods to inform populations with historically low participation rates about donating.

Resolution 953, Fees for Taking Maintenance of Certification (MOC) Examination, amended AMA MOC policy to assert that the MOC process should reflect the cost of development and administration of the MOC components, ensure a fair fee structure, and not hinder patient care. The AMA will advocate that value in MOC includes cost-effectiveness with full financial transparency, respect for physicians’ time and patient care commitments, alignment of MOC requirements with other regulator and payor requirements, and adherence to an evidence basis for both MOC content and processes.

Not every item was viewed favorably at the AMA meeting. Council on Ethical and Judicial Affairs (CEJA) Report 1, Competence, Self-Assessment and Self-Awareness, sought to provide guidance for physicians in determining their own competence when practicing medicine. The council observed, “As an ethical responsibility, competence encompasses more than medical knowledge and skill. It requires physicians to understand that as a practical matter in the care of actual patients, competence is fluid and dependent on context.” Considerable testimony emphasized a lack of reliable tools and available resources to assist physicians in self-assessment. Thus, the report was referred back to CEJA for more work.
 

Surgical caucus

In addition to facilitating an agenda review and business meeting for surgeons, anesthesiologists, and emergency physicians, the caucus sponsored a popular education session, Hazards of the Deep: Trauma in Paradise. Michael Hayashi, MD, FACS, Chair of the Hawaii Committee on Trauma, discussed system challenges in caring for injured patients from geographically remote and less populated areas. Lieutenant Matthew Brown, MC, USN, an undersea/diving medical officer stationed at Pearl Harbor, HI, shared insights about injuries and medical conditions experienced by scuba divers, swimmers, surfers, and other beach enthusiasts.
 

Leadership transition

After extended service on the delegation, including eight years as Chair, Dr. Armstrong bid “aloha” to the HOD as a retiring delegate. Dr. Turner has accepted the role as Chair, maintaining continued College leadership in the HOD.
 

Next meeting

The next meeting of the AMA HOD is scheduled for June 9–13 in Chicago, IL. In addition to debate on numerous issues, elections for AMA officers, trustees, and councils will be held at the meeting. Surgeons with suggestions for potential resolutions or questions about ACS activities at the AMA HOD should e-mail ahp@facs.org
 

ACS Delegation at the AMA HOD

John H. Armstrong, MD, FACS (Delegation Chair), acute care surgery, Tampa, FL

Brian J. Gavitt, MD, MPH (also Young Physicians Section delegate), general surgery, Cincinnati, OH

Jacob Moalem, MD, FACS, general surgery, Rochester, NY

Leigh A. Neumayer, MD, FACS, general surgery, Tucson, AZ; Chair, ACS Board of Regents

Naveen F. Sangji, MD (also Resident and Fellow Section delegate), general surgery resident, Boston, MA

Patricia L. Turner, MD, FACS, general surgery, Chicago, IL; Director, ACS Division of Member Services; member and immediate past-chair, AMA Council on Medical EducationDr. Armstrong is affiliate associate professor of surgery, University of South Florida Morsani College of Medicine, Tampa, and former Florida Surgeon General and Secretary of Health (2012–2016). He is a member, ACS Health Policy and Advocacy Group, and Past-Chair, ACS Professional Association political action committee (ACSPA-SurgeonsPAC).



Mr. Sutton is Manager, State Affairs, ACS Division of Advocacy and Health Policy.

Registration is open to attend an American College of Surgeons (ACS) 2018 General Surgery Coding Workshop. With Medicare and third-party payor policy and coding changes taking effect this year, it is imperative that surgeons have accurate and up-to-date information to protect their reimbursements and optimize efficiency.

During the coding workshop, you will learn how to report surgical procedures and medical services and will have access to the tools necessary to succeed, including a coding workbook to keep for future reference with checklists, resource guides, templates, and examples. Physicians receive up to 6.5 AMA PRA Category 1 Credits™ for each day of participation. In addition, each day of the workshop meets AAPC guidelines for 6.5 continuing education units.

The ACS will offer the following five remaining coding workshops in 2018:

Chicago, IL, April 12–13

New York, NY, May 17–19

Nashville, TN, August 9–10

Chicago, IL, November 1–3

The ACS also will offer a three-day course, including a day devoted to trauma and critical care coding at the New York City and (November) Chicago workshops.

Register for a course at www.karenzupko.com/workshops2/gensurg-workshops/. For more information about the 2018 ACS coding workshops, visit the ACS website www.facs.org/advocacy/practmanagement/workshops or e-mail practicemanagement@facs.org.

Registration is open to attend an American College of Surgeons (ACS) 2018 General Surgery Coding Workshop. With Medicare and third-party payor policy and coding changes taking effect this year, it is imperative that surgeons have accurate and up-to-date information to protect their reimbursements and optimize efficiency.

During the coding workshop, you will learn how to report surgical procedures and medical services and will have access to the tools necessary to succeed, including a coding workbook to keep for future reference with checklists, resource guides, templates, and examples. Physicians receive up to 6.5 AMA PRA Category 1 Credits™ for each day of participation. In addition, each day of the workshop meets AAPC guidelines for 6.5 continuing education units.

The ACS will offer the following five remaining coding workshops in 2018:

Chicago, IL, April 12–13

New York, NY, May 17–19

Nashville, TN, August 9–10

Chicago, IL, November 1–3

The ACS also will offer a three-day course, including a day devoted to trauma and critical care coding at the New York City and (November) Chicago workshops.

Register for a course at www.karenzupko.com/workshops2/gensurg-workshops/. For more information about the 2018 ACS coding workshops, visit the ACS website www.facs.org/advocacy/practmanagement/workshops or e-mail practicemanagement@facs.org.

Registration is open to attend an American College of Surgeons (ACS) 2018 General Surgery Coding Workshop. With Medicare and third-party payor policy and coding changes taking effect this year, it is imperative that surgeons have accurate and up-to-date information to protect their reimbursements and optimize efficiency.

During the coding workshop, you will learn how to report surgical procedures and medical services and will have access to the tools necessary to succeed, including a coding workbook to keep for future reference with checklists, resource guides, templates, and examples. Physicians receive up to 6.5 AMA PRA Category 1 Credits™ for each day of participation. In addition, each day of the workshop meets AAPC guidelines for 6.5 continuing education units.

The ACS will offer the following five remaining coding workshops in 2018:

Chicago, IL, April 12–13

New York, NY, May 17–19

Nashville, TN, August 9–10

Chicago, IL, November 1–3

The ACS also will offer a three-day course, including a day devoted to trauma and critical care coding at the New York City and (November) Chicago workshops.

Register for a course at www.karenzupko.com/workshops2/gensurg-workshops/. For more information about the 2018 ACS coding workshops, visit the ACS website www.facs.org/advocacy/practmanagement/workshops or e-mail practicemanagement@facs.org.

To help address the severe shortage of surgeons in Sub-Saharan Africa, the American College of Surgeons (ACS) and the College of Surgeons of East, Central, and Southern Africa (COSECSA) have developed a scholarship program to support women in surgical residency, help them complete their training, and encourage other women in medicine to consider surgery as a profession. 

The program is open to senior female surgical residents enrolled in the COSECSA region. Each $2,500 scholarship will go toward educational expenses, including accreditation, the fellowship examination, and five-years of membership dues to COSECSA and the ACS.  Applicants should include a personal statement indicating future goals, a current curriculum vitae, and a letter of support from the surgical training program director.  Completed applications should be sent via e-mail to scholarships@cosecsa.org and will be reviewed in conjunction with the Operation Giving Back committee. 

Applications are due no later than April 1.  Contact OGB@facs.org with any questions. 

To help address the severe shortage of surgeons in Sub-Saharan Africa, the American College of Surgeons (ACS) and the College of Surgeons of East, Central, and Southern Africa (COSECSA) have developed a scholarship program to support women in surgical residency, help them complete their training, and encourage other women in medicine to consider surgery as a profession. 

The program is open to senior female surgical residents enrolled in the COSECSA region. Each $2,500 scholarship will go toward educational expenses, including accreditation, the fellowship examination, and five-years of membership dues to COSECSA and the ACS.  Applicants should include a personal statement indicating future goals, a current curriculum vitae, and a letter of support from the surgical training program director.  Completed applications should be sent via e-mail to scholarships@cosecsa.org and will be reviewed in conjunction with the Operation Giving Back committee. 

Applications are due no later than April 1.  Contact OGB@facs.org with any questions. 

To help address the severe shortage of surgeons in Sub-Saharan Africa, the American College of Surgeons (ACS) and the College of Surgeons of East, Central, and Southern Africa (COSECSA) have developed a scholarship program to support women in surgical residency, help them complete their training, and encourage other women in medicine to consider surgery as a profession. 

The program is open to senior female surgical residents enrolled in the COSECSA region. Each $2,500 scholarship will go toward educational expenses, including accreditation, the fellowship examination, and five-years of membership dues to COSECSA and the ACS.  Applicants should include a personal statement indicating future goals, a current curriculum vitae, and a letter of support from the surgical training program director.  Completed applications should be sent via e-mail to scholarships@cosecsa.org and will be reviewed in conjunction with the Operation Giving Back committee. 

Applications are due no later than April 1.  Contact OGB@facs.org with any questions. 

A third autologous stem cell transplantation (ASCT) is feasible and provides clinical benefit to patients with relapsed multiple myeloma, according to findings from a retrospective study.

The benefits appear to be most pronounced in patients who had a long duration of response to the previous ASCT, the researchers wrote in Biology of Blood and Marrow Transplantation.

“A salvage third ASCT is of value for patients with relapsed multiple myeloma,” Laurent Garderet, MD, of the department of hematology, Hôpital Saint Antoine, Paris, and coauthors wrote in the report.

A third transplantation is most commonly used in patients who relapse following tandem ASCT. Less often, it is done in patients who receive upfront ASCT, relapse, undergo a second ASCT, and relapse again.

“The first scenario gives much better results, due in part to a better remission status at the third ASCT with no signs of increased [second primary malignancy],” the researchers wrote.

In that group, median overall survival was greater than 5 years if the relapse occurred 3 years or more after the initial tandem ASCT, study results show.

The retrospective analysis, based on European Society for Blood and Marrow Transplantation data, included 570 patients who had undergone a third ASCT between 1997 and 2010. Of that group, 482 patients (81%) received the third transplantation after tandem ASCT and subsequent relapse, and 88 (15%) received it after second relapse.

After third ASCT, overall survival was 33 months in the larger tandem transplant group with 61 months of follow-up, and 15 months in the smaller group of patients who received two salvage ASCTs after 48 months of follow-up.

Median progression-free survival was 13 and 8 months for the tandem ASCT and two-salvage–ASCT groups, respectively, while 100-day nonrelapse mortality was 4% and 7%, respectively.

For both groups, better outcomes were associated with longer duration of remission after the second ASCT, the researchers reported.

Moreover, the time from second ASCT to relapse was the only favorable prognostic factor associated with survival after third ASCT in a multivariate analysis of the patients who relapsed following tandem transplant. The hazard ratio for relapse occurring between 18 and 36 months vs. within 18 months was 0.62 (95% confidence interval, 0.47-0.82; P = .01); for relapse after 36 months, the HR was 0.35 (95% CI, 0.25-0.49; P less than .001).

The researchers acknowledged that, beyond transplant, treatment of myeloma has changed substantially in recent years and could change the clinical picture for patients undergoing a third ASCT.

“The availability of novel agents may further improve the response to a third ASCT, rather than impairing its usefulness in the salvage setting, by enhancing the depth of response before ASCT, which could result in improved durability of the outcome,” they wrote.

The researchers reported having no financial disclosures related to this study.

SOURCE: Garderet L et al. Biol Blood Marrow Transplant. 2018 Feb 3. doi: 10.1016/j.bbmt.2018.01.035.

A third autologous stem cell transplantation (ASCT) is feasible and provides clinical benefit to patients with relapsed multiple myeloma, according to findings from a retrospective study.

The benefits appear to be most pronounced in patients who had a long duration of response to the previous ASCT, the researchers wrote in Biology of Blood and Marrow Transplantation.

“A salvage third ASCT is of value for patients with relapsed multiple myeloma,” Laurent Garderet, MD, of the department of hematology, Hôpital Saint Antoine, Paris, and coauthors wrote in the report.

A third transplantation is most commonly used in patients who relapse following tandem ASCT. Less often, it is done in patients who receive upfront ASCT, relapse, undergo a second ASCT, and relapse again.

“The first scenario gives much better results, due in part to a better remission status at the third ASCT with no signs of increased [second primary malignancy],” the researchers wrote.

In that group, median overall survival was greater than 5 years if the relapse occurred 3 years or more after the initial tandem ASCT, study results show.

The retrospective analysis, based on European Society for Blood and Marrow Transplantation data, included 570 patients who had undergone a third ASCT between 1997 and 2010. Of that group, 482 patients (81%) received the third transplantation after tandem ASCT and subsequent relapse, and 88 (15%) received it after second relapse.

After third ASCT, overall survival was 33 months in the larger tandem transplant group with 61 months of follow-up, and 15 months in the smaller group of patients who received two salvage ASCTs after 48 months of follow-up.

Median progression-free survival was 13 and 8 months for the tandem ASCT and two-salvage–ASCT groups, respectively, while 100-day nonrelapse mortality was 4% and 7%, respectively.

For both groups, better outcomes were associated with longer duration of remission after the second ASCT, the researchers reported.

Moreover, the time from second ASCT to relapse was the only favorable prognostic factor associated with survival after third ASCT in a multivariate analysis of the patients who relapsed following tandem transplant. The hazard ratio for relapse occurring between 18 and 36 months vs. within 18 months was 0.62 (95% confidence interval, 0.47-0.82; P = .01); for relapse after 36 months, the HR was 0.35 (95% CI, 0.25-0.49; P less than .001).

The researchers acknowledged that, beyond transplant, treatment of myeloma has changed substantially in recent years and could change the clinical picture for patients undergoing a third ASCT.

“The availability of novel agents may further improve the response to a third ASCT, rather than impairing its usefulness in the salvage setting, by enhancing the depth of response before ASCT, which could result in improved durability of the outcome,” they wrote.

The researchers reported having no financial disclosures related to this study.

SOURCE: Garderet L et al. Biol Blood Marrow Transplant. 2018 Feb 3. doi: 10.1016/j.bbmt.2018.01.035.

A third autologous stem cell transplantation (ASCT) is feasible and provides clinical benefit to patients with relapsed multiple myeloma, according to findings from a retrospective study.

The benefits appear to be most pronounced in patients who had a long duration of response to the previous ASCT, the researchers wrote in Biology of Blood and Marrow Transplantation.

“A salvage third ASCT is of value for patients with relapsed multiple myeloma,” Laurent Garderet, MD, of the department of hematology, Hôpital Saint Antoine, Paris, and coauthors wrote in the report.

A third transplantation is most commonly used in patients who relapse following tandem ASCT. Less often, it is done in patients who receive upfront ASCT, relapse, undergo a second ASCT, and relapse again.

“The first scenario gives much better results, due in part to a better remission status at the third ASCT with no signs of increased [second primary malignancy],” the researchers wrote.

In that group, median overall survival was greater than 5 years if the relapse occurred 3 years or more after the initial tandem ASCT, study results show.

The retrospective analysis, based on European Society for Blood and Marrow Transplantation data, included 570 patients who had undergone a third ASCT between 1997 and 2010. Of that group, 482 patients (81%) received the third transplantation after tandem ASCT and subsequent relapse, and 88 (15%) received it after second relapse.

After third ASCT, overall survival was 33 months in the larger tandem transplant group with 61 months of follow-up, and 15 months in the smaller group of patients who received two salvage ASCTs after 48 months of follow-up.

Median progression-free survival was 13 and 8 months for the tandem ASCT and two-salvage–ASCT groups, respectively, while 100-day nonrelapse mortality was 4% and 7%, respectively.

For both groups, better outcomes were associated with longer duration of remission after the second ASCT, the researchers reported.

Moreover, the time from second ASCT to relapse was the only favorable prognostic factor associated with survival after third ASCT in a multivariate analysis of the patients who relapsed following tandem transplant. The hazard ratio for relapse occurring between 18 and 36 months vs. within 18 months was 0.62 (95% confidence interval, 0.47-0.82; P = .01); for relapse after 36 months, the HR was 0.35 (95% CI, 0.25-0.49; P less than .001).

The researchers acknowledged that, beyond transplant, treatment of myeloma has changed substantially in recent years and could change the clinical picture for patients undergoing a third ASCT.

“The availability of novel agents may further improve the response to a third ASCT, rather than impairing its usefulness in the salvage setting, by enhancing the depth of response before ASCT, which could result in improved durability of the outcome,” they wrote.

The researchers reported having no financial disclosures related to this study.

SOURCE: Garderet L et al. Biol Blood Marrow Transplant. 2018 Feb 3. doi: 10.1016/j.bbmt.2018.01.035.

An extremely rare genetic variant that affects the maturation, migration, and death of neurons appears to be responsible for about 7% of cases of juvenile myoclonic epilepsy.

Variants of the intestinal-cell kinase gene (ICK) occurred in 12 members of a family affected by the disorder and were confirmed in 22 of 310 additional patients, Julia N. Bailey, PhD, of the University of California, Los Angeles, and her colleagues reported in the March 15 issue of the New England Journal of Medicine.

SilverV/Thinkstock

SOURCE: Bailey J et al. N Engl J Med. 2018;378:1018-28

An extremely rare genetic variant that affects the maturation, migration, and death of neurons appears to be responsible for about 7% of cases of juvenile myoclonic epilepsy.

Variants of the intestinal-cell kinase gene (ICK) occurred in 12 members of a family affected by the disorder and were confirmed in 22 of 310 additional patients, Julia N. Bailey, PhD, of the University of California, Los Angeles, and her colleagues reported in the March 15 issue of the New England Journal of Medicine.

SilverV/Thinkstock

SOURCE: Bailey J et al. N Engl J Med. 2018;378:1018-28

An extremely rare genetic variant that affects the maturation, migration, and death of neurons appears to be responsible for about 7% of cases of juvenile myoclonic epilepsy.

Variants of the intestinal-cell kinase gene (ICK) occurred in 12 members of a family affected by the disorder and were confirmed in 22 of 310 additional patients, Julia N. Bailey, PhD, of the University of California, Los Angeles, and her colleagues reported in the March 15 issue of the New England Journal of Medicine.

SilverV/Thinkstock

SOURCE: Bailey J et al. N Engl J Med. 2018;378:1018-28