When Is Sexual Behavior Out of Control?

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Changed
Thu, 08/08/2024 - 11:02

A 25-year-old man comes in with a pulled muscle. You ask if he has anything else to discuss. Sheepishly, he says he is concerned about his use of pornography. 

A 45-year-old woman struggling with depression finds herself persistently seeking sex outside the bounds of her long-term relationship. Her partner is threatening to leave. She is devastated and tells you she doesn’t understand her own behavior. 

Do these patients have some form of sex addiction? How should a primary care clinician intervene? Is a referral to a 12-step program for sex addiction the right choice? What other options exist? Is a diagnosis — let alone treatment — possible or appropriate? 
 

‘Who Are You Calling “Abnormal” ’?

Normal is not a meaningful concept in human sexual behavior. To quote the sex therapist Marty Klein, PhD: “Normal is just a setting on the dryer.” 

The same goes among partners: What is “normal” for one person in a sexual relationship may discomfit another. In partnerships, we have differences around all sorts of issues, from finances to parenting to how to load the dishwasher. Why should sex, sexual desire, and sexual frequency be different? 

Remember: Shame, fear, and secrecy often play a role in perpetuating behaviors that cause distress. Helping our patients accept and embrace their whole selves can provide important healing, relief from anxiety, and may even help them regulate their actions. Feeling less shame, fear, and secrecy may facilitate safer choices about sex, as well as testing and treatment for sexually transmitted infections.

The International Classification of Diseases-11 includes compulsive sexual behavior disorder (CSBD)as an attempt to create consensus around a complicated, and hotly debated, problem to facilitate diagnosis and research. Syndromes similar to CSBD have had many names: “hypersexual disorder,” “sexual addiction,” “sexual compulsivity,” and “out-of-control sexual behavior.” A sizable cohort of the sexuality research community casts doubt on whether CSBD is even a discrete diagnosis. 

According to the ICD-11, CSBD is characterized by “intense, repetitive sexual impulses or urges that are experienced as irresistible or uncontrollable” and result in significant distress or functional impairment.

This diagnosis has several important rule-outs. First, paraphilias, defined as a set of nonconsensual sexual behaviors and interests, are excluded. Another is that distress exclusively related to moral judgment or social disapproval is not sufficient for a diagnosis of CSBD. Finally, the diagnosis hinges on distress and does not rely on frequency of any type of sexual behavior. Some people experience significant distress over behaviors in which they engage infrequently, whereas others may have no distress from activities in which they engage quite frequently. 

In one study from Germany, 5% of men and 3% of women met criteria for CSBD. A small US study found the number to be 10% and 7%, respectively. The diagnosis is not simple. Compulsive sexual behavior can be secondary to other mental health or medical conditions. Behaviors sometimes confused with CSBD can result from neurologic diseases, such as frontal brain lesions or frontotemporal dementia, as well as the use of substances and medications that enhance dopaminergic activity. 

Impaired control over sexual impulses occurs in manic and hypomanic episodes. Compulsive sexual behavior frequently co-occurs with mood disorders, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, and substance use disorders. Those meeting criteria for CSBD may engage in sexual behaviors as a way of coping with depression, anxiety, boredom, loneliness, or other negative affective states.  

The diagnosis of CSBD may be useful for clinicians. However, many, perhaps most, patients who present with concerns about their sexual behavior will fail to meet most criteria for CSBD. Their problem is of shorter duration, related to morality, external disapproval, lack of sexual health information, and anxiety about diverse erotic interests. It may be helpful for them to understand that they are not in the grip of a lifelong disorder but are experiencing common life challenges. 

Societal concerns about sexually explicit media, often called pornography, are complex, conflicting, and catastrophizing. Some studies indicate that sexually explicit media are positive for both individual and relational sexual satisfaction; other studies have found negative effects on sexual function. Concerns about pornography often are conflated with taboos about solo sexual activity. Ironically, use of pornography is associated with fear of addiction to pornography, creating a spiral of negative self-perception

Consequences of sexual behavior may induce distress, even if a person doesn’t meet criteria for CSBD, such as potential dissolution of a marriage, loss of a job, excessive spending, sexually transmitted infections, other health concerns, and even legal problems. Sexual behavior might not be the central issue but rather an offshoot of relational distress, a mental health disorder, or a dysfunctional coping style. 

Guilt and shame can act as potent contributors to maintaining the behaviors as well as promoting secrecy around them. Sexual medicine experts recommend avoiding interventions that increase the experience of discrimination and stigma and avoiding the pathologization of the behaviors of sexually diverse individuals. As in so many aspects of medical care, we must walk in our patients’ shoes and avoid imposing on them our own moral or religious values. 
 

 

 

What Can a Primary Care Provider Do?  

When a patient is concerned about sexual behavior that feels out of control, primary care providers have an important role in evaluating for neurologic disease or side effects related to the use of medication or other substances, and facilitating psychiatric assessment to evaluate for mental health comorbidities, past trauma, and associated attachment disorders

Our patients need resources to tease out the individual and relational problems that may arise. Seek out well-trained sex therapy colleagues in your community. The American Association of Sexuality Educators, Counselors, and Therapists (AASECT) is one certifying body in the United States for sex therapy. 

Because of the heterogeneity of those who present with out-of-control sexual behavior, no one treatment fits all. Twelve-step programs, especially those with a focus on sexual “abstinence,” may not be the best choice. Many psychotherapeutic modalities are effective and often focus on addressing underlying or unrecognized mental health concerns, provide training on self-regulation and urge management, and relationship skills. Most important, the therapist needs to be sexologically informed and aware of their own biases around sexuality. Medical treatments are not recommended without concurrent psychological intervention. 

Relational sex therapy can help couples create clear relational agreements that work for both parties (or, in polyamorous relationships, everyone involved). Relational distress also may be a stimulus for individual psychotherapy. 

Back to these two patients. 

The 25-year-old could be counseled that use of sexually explicit media and solo sex are not inherently bad or damaging. When used for pleasure and enjoyment, they do not lead to problems with partnered sex or cause sexual dysfunction. Counseling him to move toward social engagement and life goals, rather than away from pornography, may be all that is necessary. 

Our second patient probably will need more intensive treatment, including medication management for her mood and referral to a certified sex therapist who has expertise in working with out-of-control sexual behavior. When she returns to see you in follow-up, she ideally expresses reduced shame, more autonomy, and renewed connection to her values, and she is keeping her relational agreements without sacrificing her sexual needs. 
 

Dr. Kranz is medical director, Rochester Center for Sexual Wellness; assistant professor of Clinical Family Medicine and Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, New York. Dr. Kranz has disclosed no relevant financial relationships. Dr. Rosen is director of Behavioral Health, Rochester Center for Sexual Wellness, Rochester, New York. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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A 25-year-old man comes in with a pulled muscle. You ask if he has anything else to discuss. Sheepishly, he says he is concerned about his use of pornography. 

A 45-year-old woman struggling with depression finds herself persistently seeking sex outside the bounds of her long-term relationship. Her partner is threatening to leave. She is devastated and tells you she doesn’t understand her own behavior. 

Do these patients have some form of sex addiction? How should a primary care clinician intervene? Is a referral to a 12-step program for sex addiction the right choice? What other options exist? Is a diagnosis — let alone treatment — possible or appropriate? 
 

‘Who Are You Calling “Abnormal” ’?

Normal is not a meaningful concept in human sexual behavior. To quote the sex therapist Marty Klein, PhD: “Normal is just a setting on the dryer.” 

The same goes among partners: What is “normal” for one person in a sexual relationship may discomfit another. In partnerships, we have differences around all sorts of issues, from finances to parenting to how to load the dishwasher. Why should sex, sexual desire, and sexual frequency be different? 

Remember: Shame, fear, and secrecy often play a role in perpetuating behaviors that cause distress. Helping our patients accept and embrace their whole selves can provide important healing, relief from anxiety, and may even help them regulate their actions. Feeling less shame, fear, and secrecy may facilitate safer choices about sex, as well as testing and treatment for sexually transmitted infections.

The International Classification of Diseases-11 includes compulsive sexual behavior disorder (CSBD)as an attempt to create consensus around a complicated, and hotly debated, problem to facilitate diagnosis and research. Syndromes similar to CSBD have had many names: “hypersexual disorder,” “sexual addiction,” “sexual compulsivity,” and “out-of-control sexual behavior.” A sizable cohort of the sexuality research community casts doubt on whether CSBD is even a discrete diagnosis. 

According to the ICD-11, CSBD is characterized by “intense, repetitive sexual impulses or urges that are experienced as irresistible or uncontrollable” and result in significant distress or functional impairment.

This diagnosis has several important rule-outs. First, paraphilias, defined as a set of nonconsensual sexual behaviors and interests, are excluded. Another is that distress exclusively related to moral judgment or social disapproval is not sufficient for a diagnosis of CSBD. Finally, the diagnosis hinges on distress and does not rely on frequency of any type of sexual behavior. Some people experience significant distress over behaviors in which they engage infrequently, whereas others may have no distress from activities in which they engage quite frequently. 

In one study from Germany, 5% of men and 3% of women met criteria for CSBD. A small US study found the number to be 10% and 7%, respectively. The diagnosis is not simple. Compulsive sexual behavior can be secondary to other mental health or medical conditions. Behaviors sometimes confused with CSBD can result from neurologic diseases, such as frontal brain lesions or frontotemporal dementia, as well as the use of substances and medications that enhance dopaminergic activity. 

Impaired control over sexual impulses occurs in manic and hypomanic episodes. Compulsive sexual behavior frequently co-occurs with mood disorders, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, and substance use disorders. Those meeting criteria for CSBD may engage in sexual behaviors as a way of coping with depression, anxiety, boredom, loneliness, or other negative affective states.  

The diagnosis of CSBD may be useful for clinicians. However, many, perhaps most, patients who present with concerns about their sexual behavior will fail to meet most criteria for CSBD. Their problem is of shorter duration, related to morality, external disapproval, lack of sexual health information, and anxiety about diverse erotic interests. It may be helpful for them to understand that they are not in the grip of a lifelong disorder but are experiencing common life challenges. 

Societal concerns about sexually explicit media, often called pornography, are complex, conflicting, and catastrophizing. Some studies indicate that sexually explicit media are positive for both individual and relational sexual satisfaction; other studies have found negative effects on sexual function. Concerns about pornography often are conflated with taboos about solo sexual activity. Ironically, use of pornography is associated with fear of addiction to pornography, creating a spiral of negative self-perception

Consequences of sexual behavior may induce distress, even if a person doesn’t meet criteria for CSBD, such as potential dissolution of a marriage, loss of a job, excessive spending, sexually transmitted infections, other health concerns, and even legal problems. Sexual behavior might not be the central issue but rather an offshoot of relational distress, a mental health disorder, or a dysfunctional coping style. 

Guilt and shame can act as potent contributors to maintaining the behaviors as well as promoting secrecy around them. Sexual medicine experts recommend avoiding interventions that increase the experience of discrimination and stigma and avoiding the pathologization of the behaviors of sexually diverse individuals. As in so many aspects of medical care, we must walk in our patients’ shoes and avoid imposing on them our own moral or religious values. 
 

 

 

What Can a Primary Care Provider Do?  

When a patient is concerned about sexual behavior that feels out of control, primary care providers have an important role in evaluating for neurologic disease or side effects related to the use of medication or other substances, and facilitating psychiatric assessment to evaluate for mental health comorbidities, past trauma, and associated attachment disorders

Our patients need resources to tease out the individual and relational problems that may arise. Seek out well-trained sex therapy colleagues in your community. The American Association of Sexuality Educators, Counselors, and Therapists (AASECT) is one certifying body in the United States for sex therapy. 

Because of the heterogeneity of those who present with out-of-control sexual behavior, no one treatment fits all. Twelve-step programs, especially those with a focus on sexual “abstinence,” may not be the best choice. Many psychotherapeutic modalities are effective and often focus on addressing underlying or unrecognized mental health concerns, provide training on self-regulation and urge management, and relationship skills. Most important, the therapist needs to be sexologically informed and aware of their own biases around sexuality. Medical treatments are not recommended without concurrent psychological intervention. 

Relational sex therapy can help couples create clear relational agreements that work for both parties (or, in polyamorous relationships, everyone involved). Relational distress also may be a stimulus for individual psychotherapy. 

Back to these two patients. 

The 25-year-old could be counseled that use of sexually explicit media and solo sex are not inherently bad or damaging. When used for pleasure and enjoyment, they do not lead to problems with partnered sex or cause sexual dysfunction. Counseling him to move toward social engagement and life goals, rather than away from pornography, may be all that is necessary. 

Our second patient probably will need more intensive treatment, including medication management for her mood and referral to a certified sex therapist who has expertise in working with out-of-control sexual behavior. When she returns to see you in follow-up, she ideally expresses reduced shame, more autonomy, and renewed connection to her values, and she is keeping her relational agreements without sacrificing her sexual needs. 
 

Dr. Kranz is medical director, Rochester Center for Sexual Wellness; assistant professor of Clinical Family Medicine and Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, New York. Dr. Kranz has disclosed no relevant financial relationships. Dr. Rosen is director of Behavioral Health, Rochester Center for Sexual Wellness, Rochester, New York. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

A 25-year-old man comes in with a pulled muscle. You ask if he has anything else to discuss. Sheepishly, he says he is concerned about his use of pornography. 

A 45-year-old woman struggling with depression finds herself persistently seeking sex outside the bounds of her long-term relationship. Her partner is threatening to leave. She is devastated and tells you she doesn’t understand her own behavior. 

Do these patients have some form of sex addiction? How should a primary care clinician intervene? Is a referral to a 12-step program for sex addiction the right choice? What other options exist? Is a diagnosis — let alone treatment — possible or appropriate? 
 

‘Who Are You Calling “Abnormal” ’?

Normal is not a meaningful concept in human sexual behavior. To quote the sex therapist Marty Klein, PhD: “Normal is just a setting on the dryer.” 

The same goes among partners: What is “normal” for one person in a sexual relationship may discomfit another. In partnerships, we have differences around all sorts of issues, from finances to parenting to how to load the dishwasher. Why should sex, sexual desire, and sexual frequency be different? 

Remember: Shame, fear, and secrecy often play a role in perpetuating behaviors that cause distress. Helping our patients accept and embrace their whole selves can provide important healing, relief from anxiety, and may even help them regulate their actions. Feeling less shame, fear, and secrecy may facilitate safer choices about sex, as well as testing and treatment for sexually transmitted infections.

The International Classification of Diseases-11 includes compulsive sexual behavior disorder (CSBD)as an attempt to create consensus around a complicated, and hotly debated, problem to facilitate diagnosis and research. Syndromes similar to CSBD have had many names: “hypersexual disorder,” “sexual addiction,” “sexual compulsivity,” and “out-of-control sexual behavior.” A sizable cohort of the sexuality research community casts doubt on whether CSBD is even a discrete diagnosis. 

According to the ICD-11, CSBD is characterized by “intense, repetitive sexual impulses or urges that are experienced as irresistible or uncontrollable” and result in significant distress or functional impairment.

This diagnosis has several important rule-outs. First, paraphilias, defined as a set of nonconsensual sexual behaviors and interests, are excluded. Another is that distress exclusively related to moral judgment or social disapproval is not sufficient for a diagnosis of CSBD. Finally, the diagnosis hinges on distress and does not rely on frequency of any type of sexual behavior. Some people experience significant distress over behaviors in which they engage infrequently, whereas others may have no distress from activities in which they engage quite frequently. 

In one study from Germany, 5% of men and 3% of women met criteria for CSBD. A small US study found the number to be 10% and 7%, respectively. The diagnosis is not simple. Compulsive sexual behavior can be secondary to other mental health or medical conditions. Behaviors sometimes confused with CSBD can result from neurologic diseases, such as frontal brain lesions or frontotemporal dementia, as well as the use of substances and medications that enhance dopaminergic activity. 

Impaired control over sexual impulses occurs in manic and hypomanic episodes. Compulsive sexual behavior frequently co-occurs with mood disorders, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, and substance use disorders. Those meeting criteria for CSBD may engage in sexual behaviors as a way of coping with depression, anxiety, boredom, loneliness, or other negative affective states.  

The diagnosis of CSBD may be useful for clinicians. However, many, perhaps most, patients who present with concerns about their sexual behavior will fail to meet most criteria for CSBD. Their problem is of shorter duration, related to morality, external disapproval, lack of sexual health information, and anxiety about diverse erotic interests. It may be helpful for them to understand that they are not in the grip of a lifelong disorder but are experiencing common life challenges. 

Societal concerns about sexually explicit media, often called pornography, are complex, conflicting, and catastrophizing. Some studies indicate that sexually explicit media are positive for both individual and relational sexual satisfaction; other studies have found negative effects on sexual function. Concerns about pornography often are conflated with taboos about solo sexual activity. Ironically, use of pornography is associated with fear of addiction to pornography, creating a spiral of negative self-perception

Consequences of sexual behavior may induce distress, even if a person doesn’t meet criteria for CSBD, such as potential dissolution of a marriage, loss of a job, excessive spending, sexually transmitted infections, other health concerns, and even legal problems. Sexual behavior might not be the central issue but rather an offshoot of relational distress, a mental health disorder, or a dysfunctional coping style. 

Guilt and shame can act as potent contributors to maintaining the behaviors as well as promoting secrecy around them. Sexual medicine experts recommend avoiding interventions that increase the experience of discrimination and stigma and avoiding the pathologization of the behaviors of sexually diverse individuals. As in so many aspects of medical care, we must walk in our patients’ shoes and avoid imposing on them our own moral or religious values. 
 

 

 

What Can a Primary Care Provider Do?  

When a patient is concerned about sexual behavior that feels out of control, primary care providers have an important role in evaluating for neurologic disease or side effects related to the use of medication or other substances, and facilitating psychiatric assessment to evaluate for mental health comorbidities, past trauma, and associated attachment disorders

Our patients need resources to tease out the individual and relational problems that may arise. Seek out well-trained sex therapy colleagues in your community. The American Association of Sexuality Educators, Counselors, and Therapists (AASECT) is one certifying body in the United States for sex therapy. 

Because of the heterogeneity of those who present with out-of-control sexual behavior, no one treatment fits all. Twelve-step programs, especially those with a focus on sexual “abstinence,” may not be the best choice. Many psychotherapeutic modalities are effective and often focus on addressing underlying or unrecognized mental health concerns, provide training on self-regulation and urge management, and relationship skills. Most important, the therapist needs to be sexologically informed and aware of their own biases around sexuality. Medical treatments are not recommended without concurrent psychological intervention. 

Relational sex therapy can help couples create clear relational agreements that work for both parties (or, in polyamorous relationships, everyone involved). Relational distress also may be a stimulus for individual psychotherapy. 

Back to these two patients. 

The 25-year-old could be counseled that use of sexually explicit media and solo sex are not inherently bad or damaging. When used for pleasure and enjoyment, they do not lead to problems with partnered sex or cause sexual dysfunction. Counseling him to move toward social engagement and life goals, rather than away from pornography, may be all that is necessary. 

Our second patient probably will need more intensive treatment, including medication management for her mood and referral to a certified sex therapist who has expertise in working with out-of-control sexual behavior. When she returns to see you in follow-up, she ideally expresses reduced shame, more autonomy, and renewed connection to her values, and she is keeping her relational agreements without sacrificing her sexual needs. 
 

Dr. Kranz is medical director, Rochester Center for Sexual Wellness; assistant professor of Clinical Family Medicine and Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, New York. Dr. Kranz has disclosed no relevant financial relationships. Dr. Rosen is director of Behavioral Health, Rochester Center for Sexual Wellness, Rochester, New York. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Insurers’ Rules and AI for Preauthorization: ‘Ethically Nuts,’ Says Ethicist

Article Type
Changed
Thu, 08/01/2024 - 12:24

This transcript has been edited for clarity

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City. 

There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.

I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.

Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. We’re not getting a neutral review by third parties of the appropriateness of treatment recommendations or somebody saying, this is the standard of care and this is what ought to happen.

We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine. 

We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.

We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.

If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review? 

Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.

Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.

This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.

There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.

This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.

I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.

Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.

A version of this article first appeared on Medscape.com.

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This transcript has been edited for clarity

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City. 

There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.

I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.

Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. We’re not getting a neutral review by third parties of the appropriateness of treatment recommendations or somebody saying, this is the standard of care and this is what ought to happen.

We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine. 

We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.

We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.

If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review? 

Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.

Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.

This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.

There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.

This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.

I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.

Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City. 

There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.

I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.

Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. We’re not getting a neutral review by third parties of the appropriateness of treatment recommendations or somebody saying, this is the standard of care and this is what ought to happen.

We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine. 

We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.

We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.

If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review? 

Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.

Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.

This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.

There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.

This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.

I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.

Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.

A version of this article first appeared on Medscape.com.

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Statins: So Misunderstood

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Recently, a patient of mine was hospitalized with chest pain. She was diagnosed with an acute coronary syndrome and started on a statin in addition to a beta-blocker, aspirin, and clopidogrel. After discharge, she had symptoms of dizziness and recurrent chest pain and her first thought was to stop the statin because she believed that her symptoms were statin-related side effects. I will cover a few areas where I think that there are some misunderstandings about statins.

Statins Are Not Bad For the Liver

When lovastatin first became available for prescription in the 1980s, frequent monitoring of transaminases was recommended. Patients and healthcare professionals became accustomed to frequent liver tests to monitor for statin toxicity, and to this day, some healthcare professionals still obtain liver function tests for this purpose.

But is there a reason to do this? Pfeffer and colleagues reported on the results of over 112,000 people enrolled in the West of Scotland Coronary Protection trial and found that the percentage of patients with any abnormal liver function test was similar (> 3 times the upper limit of normal for ALT) for patients taking pravastatin (1.4%) and for patients taking placebo (1.4%).1 A panel of liver experts concurred that statin-associated transaminase elevations were not indicative of liver damage or dysfunction.2 Furthermore, they noted that chronic liver disease and compensated cirrhosis were not contraindications to statin use.

Dr. Douglas S. Paauw

In a small study, use of low-dose atorvastatin in patients with nonalcoholic steatohepatitis improved transaminase values in 75% of patients and liver steatosis and nonalcoholic fatty liver disease activity scores were significantly improved on biopsy in most of the patients.3 The US Food and Drug Administration (FDA) removed the recommendation for routine regular monitoring of liver function for patients on statins in 2012.4

Statins Do Not Cause Muscle Pain in Most Patients

Most muscle pain occurring in patients on statins is not due to the statin although patient concerns about muscle pain are common. In a meta-analysis of 19 large statin trials, 27.1% of participants treated with a statin reported at least one episode of muscle pain or weakness during a median of 4.3 years, compared with 26.6% of participants treated with placebo.5 Muscle pain for any reason is common, and patients on statins may stop therapy because of the symptoms.

Cohen and colleagues performed a survey of past and current statin users, asking about muscle symptoms.6 Muscle-related side effects were reported by 60% of former statin users and 25% of current users.

Herrett and colleagues performed an extensive series of n-of-1 trials involving 200 patients who had stopped or were considering stopping statins because of muscle symptoms.7 Participants received either 2-month blocks of atorvastatin 20 mg or 2-month blocks of placebo, six times. They rated their muscle symptoms on a visual analogue scale at the end of each block. There was no difference in muscle symptom scores between the statin and placebo periods.

Wood and colleagues took it a step further when they planned an n-of-1 trial that included statin, placebo, and no treatment.8 Each participant received four bottles of atorvastatin 20 mg, four bottles of placebo, and four empty bottles. Each month they used treatment from the bottles based on a random sequence and reported daily symptom scores. The mean symptom intensity score was 8.0 during no-tablet months, 15.4 during placebo months (P < .001, compared with no-tablet months), and 16.3 during statin months (P < .001, compared with no-tablet months; P = .39, compared with placebo).
 

 

 

Statins Are Likely Helpful In the Very Elderly

Should we be using statins for primary prevention in our very old patients? For many years the answer was generally “no” on the basis of a lack of evidence. Patients in their 80s often were not included in clinical trials. The much used American Heart Association risk calculator stops at age 79. Given the prevalence of coronary artery disease in patients as they reach their 80s, wouldn’t primary prevention really be secondary prevention? Xu and colleagues in a recent study compared outcomes for patients who were treated with statins for primary prevention with a group who were not. In the patients aged 75-84 there was a risk reduction for major cardiovascular events of 1.2% over 5 years, and for those 85 and older the risk reduction was 4.4%. Importantly, there were no significantly increased risks for myopathies and liver dysfunction in either age group.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. Pfeffer MA et al. Circulation. 2002;105(20):2341-6.

2. Cohen DE et al. Am J Cardiol. 2006;97(8A):77C-81C.

3. Hyogo H et al. Metabolism. 2008;57(12):1711-8.

4. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. 2012 Feb 28.

5. Cholesterol Treatment Trialists’ Collaboration. Lancet. 2022;400(10355):832-45.

6. Cohen JD et al. J Clin Lipidol. 2012;6(3):208-15.

7. Herrett E et al. BMJ. 2021 Feb 24;372:n1355.

8. Wood FA et al. N Engl J Med. 2020;383(22):2182-4.

9. Xu W et al. Ann Intern Med. 2024;177(6):701-10.

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Recently, a patient of mine was hospitalized with chest pain. She was diagnosed with an acute coronary syndrome and started on a statin in addition to a beta-blocker, aspirin, and clopidogrel. After discharge, she had symptoms of dizziness and recurrent chest pain and her first thought was to stop the statin because she believed that her symptoms were statin-related side effects. I will cover a few areas where I think that there are some misunderstandings about statins.

Statins Are Not Bad For the Liver

When lovastatin first became available for prescription in the 1980s, frequent monitoring of transaminases was recommended. Patients and healthcare professionals became accustomed to frequent liver tests to monitor for statin toxicity, and to this day, some healthcare professionals still obtain liver function tests for this purpose.

But is there a reason to do this? Pfeffer and colleagues reported on the results of over 112,000 people enrolled in the West of Scotland Coronary Protection trial and found that the percentage of patients with any abnormal liver function test was similar (> 3 times the upper limit of normal for ALT) for patients taking pravastatin (1.4%) and for patients taking placebo (1.4%).1 A panel of liver experts concurred that statin-associated transaminase elevations were not indicative of liver damage or dysfunction.2 Furthermore, they noted that chronic liver disease and compensated cirrhosis were not contraindications to statin use.

Dr. Douglas S. Paauw

In a small study, use of low-dose atorvastatin in patients with nonalcoholic steatohepatitis improved transaminase values in 75% of patients and liver steatosis and nonalcoholic fatty liver disease activity scores were significantly improved on biopsy in most of the patients.3 The US Food and Drug Administration (FDA) removed the recommendation for routine regular monitoring of liver function for patients on statins in 2012.4

Statins Do Not Cause Muscle Pain in Most Patients

Most muscle pain occurring in patients on statins is not due to the statin although patient concerns about muscle pain are common. In a meta-analysis of 19 large statin trials, 27.1% of participants treated with a statin reported at least one episode of muscle pain or weakness during a median of 4.3 years, compared with 26.6% of participants treated with placebo.5 Muscle pain for any reason is common, and patients on statins may stop therapy because of the symptoms.

Cohen and colleagues performed a survey of past and current statin users, asking about muscle symptoms.6 Muscle-related side effects were reported by 60% of former statin users and 25% of current users.

Herrett and colleagues performed an extensive series of n-of-1 trials involving 200 patients who had stopped or were considering stopping statins because of muscle symptoms.7 Participants received either 2-month blocks of atorvastatin 20 mg or 2-month blocks of placebo, six times. They rated their muscle symptoms on a visual analogue scale at the end of each block. There was no difference in muscle symptom scores between the statin and placebo periods.

Wood and colleagues took it a step further when they planned an n-of-1 trial that included statin, placebo, and no treatment.8 Each participant received four bottles of atorvastatin 20 mg, four bottles of placebo, and four empty bottles. Each month they used treatment from the bottles based on a random sequence and reported daily symptom scores. The mean symptom intensity score was 8.0 during no-tablet months, 15.4 during placebo months (P < .001, compared with no-tablet months), and 16.3 during statin months (P < .001, compared with no-tablet months; P = .39, compared with placebo).
 

 

 

Statins Are Likely Helpful In the Very Elderly

Should we be using statins for primary prevention in our very old patients? For many years the answer was generally “no” on the basis of a lack of evidence. Patients in their 80s often were not included in clinical trials. The much used American Heart Association risk calculator stops at age 79. Given the prevalence of coronary artery disease in patients as they reach their 80s, wouldn’t primary prevention really be secondary prevention? Xu and colleagues in a recent study compared outcomes for patients who were treated with statins for primary prevention with a group who were not. In the patients aged 75-84 there was a risk reduction for major cardiovascular events of 1.2% over 5 years, and for those 85 and older the risk reduction was 4.4%. Importantly, there were no significantly increased risks for myopathies and liver dysfunction in either age group.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. Pfeffer MA et al. Circulation. 2002;105(20):2341-6.

2. Cohen DE et al. Am J Cardiol. 2006;97(8A):77C-81C.

3. Hyogo H et al. Metabolism. 2008;57(12):1711-8.

4. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. 2012 Feb 28.

5. Cholesterol Treatment Trialists’ Collaboration. Lancet. 2022;400(10355):832-45.

6. Cohen JD et al. J Clin Lipidol. 2012;6(3):208-15.

7. Herrett E et al. BMJ. 2021 Feb 24;372:n1355.

8. Wood FA et al. N Engl J Med. 2020;383(22):2182-4.

9. Xu W et al. Ann Intern Med. 2024;177(6):701-10.

Recently, a patient of mine was hospitalized with chest pain. She was diagnosed with an acute coronary syndrome and started on a statin in addition to a beta-blocker, aspirin, and clopidogrel. After discharge, she had symptoms of dizziness and recurrent chest pain and her first thought was to stop the statin because she believed that her symptoms were statin-related side effects. I will cover a few areas where I think that there are some misunderstandings about statins.

Statins Are Not Bad For the Liver

When lovastatin first became available for prescription in the 1980s, frequent monitoring of transaminases was recommended. Patients and healthcare professionals became accustomed to frequent liver tests to monitor for statin toxicity, and to this day, some healthcare professionals still obtain liver function tests for this purpose.

But is there a reason to do this? Pfeffer and colleagues reported on the results of over 112,000 people enrolled in the West of Scotland Coronary Protection trial and found that the percentage of patients with any abnormal liver function test was similar (> 3 times the upper limit of normal for ALT) for patients taking pravastatin (1.4%) and for patients taking placebo (1.4%).1 A panel of liver experts concurred that statin-associated transaminase elevations were not indicative of liver damage or dysfunction.2 Furthermore, they noted that chronic liver disease and compensated cirrhosis were not contraindications to statin use.

Dr. Douglas S. Paauw

In a small study, use of low-dose atorvastatin in patients with nonalcoholic steatohepatitis improved transaminase values in 75% of patients and liver steatosis and nonalcoholic fatty liver disease activity scores were significantly improved on biopsy in most of the patients.3 The US Food and Drug Administration (FDA) removed the recommendation for routine regular monitoring of liver function for patients on statins in 2012.4

Statins Do Not Cause Muscle Pain in Most Patients

Most muscle pain occurring in patients on statins is not due to the statin although patient concerns about muscle pain are common. In a meta-analysis of 19 large statin trials, 27.1% of participants treated with a statin reported at least one episode of muscle pain or weakness during a median of 4.3 years, compared with 26.6% of participants treated with placebo.5 Muscle pain for any reason is common, and patients on statins may stop therapy because of the symptoms.

Cohen and colleagues performed a survey of past and current statin users, asking about muscle symptoms.6 Muscle-related side effects were reported by 60% of former statin users and 25% of current users.

Herrett and colleagues performed an extensive series of n-of-1 trials involving 200 patients who had stopped or were considering stopping statins because of muscle symptoms.7 Participants received either 2-month blocks of atorvastatin 20 mg or 2-month blocks of placebo, six times. They rated their muscle symptoms on a visual analogue scale at the end of each block. There was no difference in muscle symptom scores between the statin and placebo periods.

Wood and colleagues took it a step further when they planned an n-of-1 trial that included statin, placebo, and no treatment.8 Each participant received four bottles of atorvastatin 20 mg, four bottles of placebo, and four empty bottles. Each month they used treatment from the bottles based on a random sequence and reported daily symptom scores. The mean symptom intensity score was 8.0 during no-tablet months, 15.4 during placebo months (P < .001, compared with no-tablet months), and 16.3 during statin months (P < .001, compared with no-tablet months; P = .39, compared with placebo).
 

 

 

Statins Are Likely Helpful In the Very Elderly

Should we be using statins for primary prevention in our very old patients? For many years the answer was generally “no” on the basis of a lack of evidence. Patients in their 80s often were not included in clinical trials. The much used American Heart Association risk calculator stops at age 79. Given the prevalence of coronary artery disease in patients as they reach their 80s, wouldn’t primary prevention really be secondary prevention? Xu and colleagues in a recent study compared outcomes for patients who were treated with statins for primary prevention with a group who were not. In the patients aged 75-84 there was a risk reduction for major cardiovascular events of 1.2% over 5 years, and for those 85 and older the risk reduction was 4.4%. Importantly, there were no significantly increased risks for myopathies and liver dysfunction in either age group.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. Pfeffer MA et al. Circulation. 2002;105(20):2341-6.

2. Cohen DE et al. Am J Cardiol. 2006;97(8A):77C-81C.

3. Hyogo H et al. Metabolism. 2008;57(12):1711-8.

4. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. 2012 Feb 28.

5. Cholesterol Treatment Trialists’ Collaboration. Lancet. 2022;400(10355):832-45.

6. Cohen JD et al. J Clin Lipidol. 2012;6(3):208-15.

7. Herrett E et al. BMJ. 2021 Feb 24;372:n1355.

8. Wood FA et al. N Engl J Med. 2020;383(22):2182-4.

9. Xu W et al. Ann Intern Med. 2024;177(6):701-10.

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The Shield Sign of Cutaneous Metastases Is Associated With Carcinoma Hemorrhagiectoides

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The Shield Sign of Cutaneous Metastases Is Associated With Carcinoma Hemorrhagiectoides

To the Editor:

We read with interest the Case Letter from Wang et al1 (Cutis. 2023;112:E13-E15) of a 60-year-old man whose metastatic salivary duct adenocarcinoma manifested with the shield sign as well as carcinoma hemorrhagiectoides. Cutaneous metastases have seldom been described in association with salivary duct carcinoma.2-7 In addition, carcinoma hemorrhagiectoides–associated shield sign has not been commonly reported.5,8-12

Salivary duct carcinoma—an uncommon head and neck malignancy characterized by androgen receptor expression—rarely is associated with cutaneous metastases. Based on a PubMed search of articles indexed for MEDLINE using the terms cutaneous, metastatic, salivary duct carcinoma, and/or skin, including the patient described by Wang et al,1 there have been 8 individuals with cutaneous metastases from this cancer. The morphology of the cutaneous metastases has varied from angiomatous to angiokeratomalike (black and keratotic) papules, bullae, macules (red), papules and nodules (erythematous and scaly), plaques (cellulitislike and confluent that were purpuric, hemorrhagic, and violaceous), pseudovesicles, purpuric papules, subcutaneous nodules, and an ulcer (superficial and mimicked a basal cell carcinoma).1-7 Remarkably, 4 of 8 patients (50%) with salivary duct carcinoma cutaneous metastases presented with a shield sign,5,7 including the case reported by Wang et al.1

The shield sign is a distinctive clinical manifestation of cutaneous metastasis.10 It was named to describe the skin metastases located predominantly on the chest area that would be covered by a medieval knight’s shield5,10,12; metastatic lesions also have been noted on the proximal arm and/or the upper back in a similar distribution.8,9 To date, based on a PubMed search of articles indexed for MEDLINE using the search terms breast cancer, carcinoma, hemorrhagiectoides, metastases, salivary duct carcinoma, shield, and/or sign, the shield sign has been described in 6 patients with cutaneous metastases either from salivary duct carcinoma (4 patients)1,5,7 or breast cancer (2 patients).8,9 The shield sign pathologically corresponds to carcinoma hemorrhagiectoides, an inflammatory pattern of cutaneous metastases.5,11

Inflammatory cutaneous metastatic carcinoma has 3 distinctive clinical and pathologic manifestations.11 Carcinoma erysipelatoides and carcinoma telangiectoides were the earlier described variants.11 In 2012, carcinoma hemorrhagiectoides was described as the third pattern of inflammatory cutaneous metastasis.5

Carcinoma erysipelatoides, which clinically mimics cutaneous streptococcal cellulitis, appears as a well-defined erythematous patch or plaque; the tumor cells can be found in the lymphatic vessels and either are absent or minimally present in the dermis. Carcinoma telangiectoides, which clinically mimics idiopathic telangiectases, appears as an erythematous patch with prominent telangiectases; the tumor cells can be found in the blood vessels and are either absent or minimally present in the dermis. Carcinoma hemorrhagiectoides appears as purpuric or violaceous indurated plaques; the tumor cells are not only found in the blood vessels, in the lymphatic vessels, or both, but also can be mildly to extensively present in the dermis.5,10,11

In conclusion, the shield sign is a unique presentation of inflammatory cutaneous metastatic carcinoma, which is associated with carcinoma hemorrhagiectoides. The clinical features of the infiltrated plaques correspond to the presence of tumor cells in the blood vessels, lymphatic vessels, and the dermis; in addition, the purpuric and violaceous appearance correlates with the presence of extravasated erythrocytes or hemorrhage in the dermis. To date, half of the patients with skin metastases from salivary duct carcinoma have presented with carcinoma hemorrhagiectoides–associated shield sign.

Authors’ Response

We appreciate and welcome the comments provided by the authors. Drawing attention to unusual pathologic manifestations of cutaneous metastatic salivary duct carcinoma manifesting with the shield sign, the authors present a comprehensive review of 3 distinctive presentations: carcinoma erysipelatoides, carcinoma telangiectoides, and carcinoma hemorrhagiectoides. The inclusion of these variants enriches the discussion and makes this letter a valuable addition to the literature on cutaneous metastatic carcinoma, particularly metastatic salivary duct carcinoma.

Xintong Wang, MD; William H. Westra, MD

From the Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, New York.

The authors report no conflict of interest.

References
  1. Wang X, Vyas NS, Alghamdi AA, et al. Cutaneous presentation of metastatic salivary duct carcinoma. Cutis. 2023;112:E13-E15.
  2. Pollock JL, Catalano E. Metastatic ductal carcinoma of the parotid gland in a patient with sarcoidosis. Arch Dermatol. 1979;115:1098-1099.
  3. Pollock JL. Metastatic carcinoma of the parotid gland resembling carcinoma of the breast. J Am Acad Dermatol. 1996;34:1093.
  4. Aygit AC, Top H, Cakir B, et al. Salivary duct carcinoma of the parotid gland metastasizing to the skin: a case report and review of the literature. Am J Dermatopathol. 2005;27:48-50.
  5. Cohen PR, Prieto VG, Piha-Paul SA, et al. The “shield sign” in two men with metastatic salivary duct carcinoma to the skin: cutaneous metastases presenting as carcinoma hemorrhagiectoides. J Clin Aesthet Dermatol. 2012;5:27-36.
  6. Chakari W, Andersen L, Anderson JL. Cutaneous metastases from salivary duct carcinoma of the submandibular gland. Case Rep Dermatol. 2017;9:254-258.
  7. Shin JY, Eun DH, Lee JY, et al. A case of cutaneous metastases of salivary duct carcinoma mimicking radiation recall dermatitis. Ann Dermatol. 2020;32:436-438.
  8. Aravena RC, Aravena DC, Velasco MJ, et al. Carcinoma hemorrhagiectoides: case report of an uncommon presentation of cutaneous metastatic breast carcinoma. Dermatol Online J. 2017;23:13030/qt3hn3z850.
  9. Smith KA, Basko-Plluska J, Kothari AD, et al. Cutaneous metastatic breast adenocarcinoma. Cutis. 2020;105:E20-E22.
  10. Cohen PR, Kurzrock R. Cutaneous metastatic cancer: carcinoma hemorrhagiectoides presenting as the shield sign. Cureus. 2021;13:e12627.
  11. Cohen PR. Pleomorphic appearance of breast cancer cutaneous metastases. Cureus. 2021;13:e20301.
  12. Cohen PR, Prieto VG, Kurzrock R. Tumor lysis syndrome: introduction of a cutaneous variant and a new classification system. Cureus. 2021;13:e13816.
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Author and Disclosure Information

Dr. Cohen is from the Department of Dermatology, University of California, Davis Medical Center, Sacramento, and Touro University California College of Osteopathic Medicine, Vallejo. Dr. Prieto is from the Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston. Dr. Kurzrock is from the Department of Medicine, Medical College of Wisconsin Cancer Center, Milwaukee; Mellowes Center for Genome Sciences and Precision Medicine, Medical College of Wisconsin, Milwaukee; Clinical Trials Unit, Worldwide Innovative Network (WIN) for Personalized Cancer Therapy, Villejuif, France; and University of Nebraska, Omaha.

Dr. Cohen reports no conflict of interest. Dr. Prieto is a consultant for Castle Biosciences, Merck & Co, and Myriad Pharma. Dr. Kurzrock has received research funding from Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant Health, Incyte Corporation, Konica Minolta, MedImmune, Merck Serono, OmniSeq, Pfizer, Sequenom, Takeda Pharmaceutical Company, and TopAlliance Biosciences; has received consultant and/or speaker fees and/or has been on an advisory board for Actuate Therapeutics, Caris Life Sciences, Datar Cancer Genetics, Neomed, Pfizer, Roche, and XBiotech; has an equity interest in CureMatch and IDbyDNA; serves on the board of CureMatch and CureMetrix; and is a co-founder of CureMatch.

Correspondence: Philip R. Cohen, MD, 10991 Twinleaf Court, San Diego, CA 92131 (mitehead@gmail.com).

Cutis. 2024 July;114(1):E41-E42. doi:10.12788/cutis.1066

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Dr. Cohen is from the Department of Dermatology, University of California, Davis Medical Center, Sacramento, and Touro University California College of Osteopathic Medicine, Vallejo. Dr. Prieto is from the Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston. Dr. Kurzrock is from the Department of Medicine, Medical College of Wisconsin Cancer Center, Milwaukee; Mellowes Center for Genome Sciences and Precision Medicine, Medical College of Wisconsin, Milwaukee; Clinical Trials Unit, Worldwide Innovative Network (WIN) for Personalized Cancer Therapy, Villejuif, France; and University of Nebraska, Omaha.

Dr. Cohen reports no conflict of interest. Dr. Prieto is a consultant for Castle Biosciences, Merck & Co, and Myriad Pharma. Dr. Kurzrock has received research funding from Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant Health, Incyte Corporation, Konica Minolta, MedImmune, Merck Serono, OmniSeq, Pfizer, Sequenom, Takeda Pharmaceutical Company, and TopAlliance Biosciences; has received consultant and/or speaker fees and/or has been on an advisory board for Actuate Therapeutics, Caris Life Sciences, Datar Cancer Genetics, Neomed, Pfizer, Roche, and XBiotech; has an equity interest in CureMatch and IDbyDNA; serves on the board of CureMatch and CureMetrix; and is a co-founder of CureMatch.

Correspondence: Philip R. Cohen, MD, 10991 Twinleaf Court, San Diego, CA 92131 (mitehead@gmail.com).

Cutis. 2024 July;114(1):E41-E42. doi:10.12788/cutis.1066

Author and Disclosure Information

Dr. Cohen is from the Department of Dermatology, University of California, Davis Medical Center, Sacramento, and Touro University California College of Osteopathic Medicine, Vallejo. Dr. Prieto is from the Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston. Dr. Kurzrock is from the Department of Medicine, Medical College of Wisconsin Cancer Center, Milwaukee; Mellowes Center for Genome Sciences and Precision Medicine, Medical College of Wisconsin, Milwaukee; Clinical Trials Unit, Worldwide Innovative Network (WIN) for Personalized Cancer Therapy, Villejuif, France; and University of Nebraska, Omaha.

Dr. Cohen reports no conflict of interest. Dr. Prieto is a consultant for Castle Biosciences, Merck & Co, and Myriad Pharma. Dr. Kurzrock has received research funding from Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant Health, Incyte Corporation, Konica Minolta, MedImmune, Merck Serono, OmniSeq, Pfizer, Sequenom, Takeda Pharmaceutical Company, and TopAlliance Biosciences; has received consultant and/or speaker fees and/or has been on an advisory board for Actuate Therapeutics, Caris Life Sciences, Datar Cancer Genetics, Neomed, Pfizer, Roche, and XBiotech; has an equity interest in CureMatch and IDbyDNA; serves on the board of CureMatch and CureMetrix; and is a co-founder of CureMatch.

Correspondence: Philip R. Cohen, MD, 10991 Twinleaf Court, San Diego, CA 92131 (mitehead@gmail.com).

Cutis. 2024 July;114(1):E41-E42. doi:10.12788/cutis.1066

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Article PDF

To the Editor:

We read with interest the Case Letter from Wang et al1 (Cutis. 2023;112:E13-E15) of a 60-year-old man whose metastatic salivary duct adenocarcinoma manifested with the shield sign as well as carcinoma hemorrhagiectoides. Cutaneous metastases have seldom been described in association with salivary duct carcinoma.2-7 In addition, carcinoma hemorrhagiectoides–associated shield sign has not been commonly reported.5,8-12

Salivary duct carcinoma—an uncommon head and neck malignancy characterized by androgen receptor expression—rarely is associated with cutaneous metastases. Based on a PubMed search of articles indexed for MEDLINE using the terms cutaneous, metastatic, salivary duct carcinoma, and/or skin, including the patient described by Wang et al,1 there have been 8 individuals with cutaneous metastases from this cancer. The morphology of the cutaneous metastases has varied from angiomatous to angiokeratomalike (black and keratotic) papules, bullae, macules (red), papules and nodules (erythematous and scaly), plaques (cellulitislike and confluent that were purpuric, hemorrhagic, and violaceous), pseudovesicles, purpuric papules, subcutaneous nodules, and an ulcer (superficial and mimicked a basal cell carcinoma).1-7 Remarkably, 4 of 8 patients (50%) with salivary duct carcinoma cutaneous metastases presented with a shield sign,5,7 including the case reported by Wang et al.1

The shield sign is a distinctive clinical manifestation of cutaneous metastasis.10 It was named to describe the skin metastases located predominantly on the chest area that would be covered by a medieval knight’s shield5,10,12; metastatic lesions also have been noted on the proximal arm and/or the upper back in a similar distribution.8,9 To date, based on a PubMed search of articles indexed for MEDLINE using the search terms breast cancer, carcinoma, hemorrhagiectoides, metastases, salivary duct carcinoma, shield, and/or sign, the shield sign has been described in 6 patients with cutaneous metastases either from salivary duct carcinoma (4 patients)1,5,7 or breast cancer (2 patients).8,9 The shield sign pathologically corresponds to carcinoma hemorrhagiectoides, an inflammatory pattern of cutaneous metastases.5,11

Inflammatory cutaneous metastatic carcinoma has 3 distinctive clinical and pathologic manifestations.11 Carcinoma erysipelatoides and carcinoma telangiectoides were the earlier described variants.11 In 2012, carcinoma hemorrhagiectoides was described as the third pattern of inflammatory cutaneous metastasis.5

Carcinoma erysipelatoides, which clinically mimics cutaneous streptococcal cellulitis, appears as a well-defined erythematous patch or plaque; the tumor cells can be found in the lymphatic vessels and either are absent or minimally present in the dermis. Carcinoma telangiectoides, which clinically mimics idiopathic telangiectases, appears as an erythematous patch with prominent telangiectases; the tumor cells can be found in the blood vessels and are either absent or minimally present in the dermis. Carcinoma hemorrhagiectoides appears as purpuric or violaceous indurated plaques; the tumor cells are not only found in the blood vessels, in the lymphatic vessels, or both, but also can be mildly to extensively present in the dermis.5,10,11

In conclusion, the shield sign is a unique presentation of inflammatory cutaneous metastatic carcinoma, which is associated with carcinoma hemorrhagiectoides. The clinical features of the infiltrated plaques correspond to the presence of tumor cells in the blood vessels, lymphatic vessels, and the dermis; in addition, the purpuric and violaceous appearance correlates with the presence of extravasated erythrocytes or hemorrhage in the dermis. To date, half of the patients with skin metastases from salivary duct carcinoma have presented with carcinoma hemorrhagiectoides–associated shield sign.

Authors’ Response

We appreciate and welcome the comments provided by the authors. Drawing attention to unusual pathologic manifestations of cutaneous metastatic salivary duct carcinoma manifesting with the shield sign, the authors present a comprehensive review of 3 distinctive presentations: carcinoma erysipelatoides, carcinoma telangiectoides, and carcinoma hemorrhagiectoides. The inclusion of these variants enriches the discussion and makes this letter a valuable addition to the literature on cutaneous metastatic carcinoma, particularly metastatic salivary duct carcinoma.

Xintong Wang, MD; William H. Westra, MD

From the Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, New York.

The authors report no conflict of interest.

To the Editor:

We read with interest the Case Letter from Wang et al1 (Cutis. 2023;112:E13-E15) of a 60-year-old man whose metastatic salivary duct adenocarcinoma manifested with the shield sign as well as carcinoma hemorrhagiectoides. Cutaneous metastases have seldom been described in association with salivary duct carcinoma.2-7 In addition, carcinoma hemorrhagiectoides–associated shield sign has not been commonly reported.5,8-12

Salivary duct carcinoma—an uncommon head and neck malignancy characterized by androgen receptor expression—rarely is associated with cutaneous metastases. Based on a PubMed search of articles indexed for MEDLINE using the terms cutaneous, metastatic, salivary duct carcinoma, and/or skin, including the patient described by Wang et al,1 there have been 8 individuals with cutaneous metastases from this cancer. The morphology of the cutaneous metastases has varied from angiomatous to angiokeratomalike (black and keratotic) papules, bullae, macules (red), papules and nodules (erythematous and scaly), plaques (cellulitislike and confluent that were purpuric, hemorrhagic, and violaceous), pseudovesicles, purpuric papules, subcutaneous nodules, and an ulcer (superficial and mimicked a basal cell carcinoma).1-7 Remarkably, 4 of 8 patients (50%) with salivary duct carcinoma cutaneous metastases presented with a shield sign,5,7 including the case reported by Wang et al.1

The shield sign is a distinctive clinical manifestation of cutaneous metastasis.10 It was named to describe the skin metastases located predominantly on the chest area that would be covered by a medieval knight’s shield5,10,12; metastatic lesions also have been noted on the proximal arm and/or the upper back in a similar distribution.8,9 To date, based on a PubMed search of articles indexed for MEDLINE using the search terms breast cancer, carcinoma, hemorrhagiectoides, metastases, salivary duct carcinoma, shield, and/or sign, the shield sign has been described in 6 patients with cutaneous metastases either from salivary duct carcinoma (4 patients)1,5,7 or breast cancer (2 patients).8,9 The shield sign pathologically corresponds to carcinoma hemorrhagiectoides, an inflammatory pattern of cutaneous metastases.5,11

Inflammatory cutaneous metastatic carcinoma has 3 distinctive clinical and pathologic manifestations.11 Carcinoma erysipelatoides and carcinoma telangiectoides were the earlier described variants.11 In 2012, carcinoma hemorrhagiectoides was described as the third pattern of inflammatory cutaneous metastasis.5

Carcinoma erysipelatoides, which clinically mimics cutaneous streptococcal cellulitis, appears as a well-defined erythematous patch or plaque; the tumor cells can be found in the lymphatic vessels and either are absent or minimally present in the dermis. Carcinoma telangiectoides, which clinically mimics idiopathic telangiectases, appears as an erythematous patch with prominent telangiectases; the tumor cells can be found in the blood vessels and are either absent or minimally present in the dermis. Carcinoma hemorrhagiectoides appears as purpuric or violaceous indurated plaques; the tumor cells are not only found in the blood vessels, in the lymphatic vessels, or both, but also can be mildly to extensively present in the dermis.5,10,11

In conclusion, the shield sign is a unique presentation of inflammatory cutaneous metastatic carcinoma, which is associated with carcinoma hemorrhagiectoides. The clinical features of the infiltrated plaques correspond to the presence of tumor cells in the blood vessels, lymphatic vessels, and the dermis; in addition, the purpuric and violaceous appearance correlates with the presence of extravasated erythrocytes or hemorrhage in the dermis. To date, half of the patients with skin metastases from salivary duct carcinoma have presented with carcinoma hemorrhagiectoides–associated shield sign.

Authors’ Response

We appreciate and welcome the comments provided by the authors. Drawing attention to unusual pathologic manifestations of cutaneous metastatic salivary duct carcinoma manifesting with the shield sign, the authors present a comprehensive review of 3 distinctive presentations: carcinoma erysipelatoides, carcinoma telangiectoides, and carcinoma hemorrhagiectoides. The inclusion of these variants enriches the discussion and makes this letter a valuable addition to the literature on cutaneous metastatic carcinoma, particularly metastatic salivary duct carcinoma.

Xintong Wang, MD; William H. Westra, MD

From the Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, New York.

The authors report no conflict of interest.

References
  1. Wang X, Vyas NS, Alghamdi AA, et al. Cutaneous presentation of metastatic salivary duct carcinoma. Cutis. 2023;112:E13-E15.
  2. Pollock JL, Catalano E. Metastatic ductal carcinoma of the parotid gland in a patient with sarcoidosis. Arch Dermatol. 1979;115:1098-1099.
  3. Pollock JL. Metastatic carcinoma of the parotid gland resembling carcinoma of the breast. J Am Acad Dermatol. 1996;34:1093.
  4. Aygit AC, Top H, Cakir B, et al. Salivary duct carcinoma of the parotid gland metastasizing to the skin: a case report and review of the literature. Am J Dermatopathol. 2005;27:48-50.
  5. Cohen PR, Prieto VG, Piha-Paul SA, et al. The “shield sign” in two men with metastatic salivary duct carcinoma to the skin: cutaneous metastases presenting as carcinoma hemorrhagiectoides. J Clin Aesthet Dermatol. 2012;5:27-36.
  6. Chakari W, Andersen L, Anderson JL. Cutaneous metastases from salivary duct carcinoma of the submandibular gland. Case Rep Dermatol. 2017;9:254-258.
  7. Shin JY, Eun DH, Lee JY, et al. A case of cutaneous metastases of salivary duct carcinoma mimicking radiation recall dermatitis. Ann Dermatol. 2020;32:436-438.
  8. Aravena RC, Aravena DC, Velasco MJ, et al. Carcinoma hemorrhagiectoides: case report of an uncommon presentation of cutaneous metastatic breast carcinoma. Dermatol Online J. 2017;23:13030/qt3hn3z850.
  9. Smith KA, Basko-Plluska J, Kothari AD, et al. Cutaneous metastatic breast adenocarcinoma. Cutis. 2020;105:E20-E22.
  10. Cohen PR, Kurzrock R. Cutaneous metastatic cancer: carcinoma hemorrhagiectoides presenting as the shield sign. Cureus. 2021;13:e12627.
  11. Cohen PR. Pleomorphic appearance of breast cancer cutaneous metastases. Cureus. 2021;13:e20301.
  12. Cohen PR, Prieto VG, Kurzrock R. Tumor lysis syndrome: introduction of a cutaneous variant and a new classification system. Cureus. 2021;13:e13816.
References
  1. Wang X, Vyas NS, Alghamdi AA, et al. Cutaneous presentation of metastatic salivary duct carcinoma. Cutis. 2023;112:E13-E15.
  2. Pollock JL, Catalano E. Metastatic ductal carcinoma of the parotid gland in a patient with sarcoidosis. Arch Dermatol. 1979;115:1098-1099.
  3. Pollock JL. Metastatic carcinoma of the parotid gland resembling carcinoma of the breast. J Am Acad Dermatol. 1996;34:1093.
  4. Aygit AC, Top H, Cakir B, et al. Salivary duct carcinoma of the parotid gland metastasizing to the skin: a case report and review of the literature. Am J Dermatopathol. 2005;27:48-50.
  5. Cohen PR, Prieto VG, Piha-Paul SA, et al. The “shield sign” in two men with metastatic salivary duct carcinoma to the skin: cutaneous metastases presenting as carcinoma hemorrhagiectoides. J Clin Aesthet Dermatol. 2012;5:27-36.
  6. Chakari W, Andersen L, Anderson JL. Cutaneous metastases from salivary duct carcinoma of the submandibular gland. Case Rep Dermatol. 2017;9:254-258.
  7. Shin JY, Eun DH, Lee JY, et al. A case of cutaneous metastases of salivary duct carcinoma mimicking radiation recall dermatitis. Ann Dermatol. 2020;32:436-438.
  8. Aravena RC, Aravena DC, Velasco MJ, et al. Carcinoma hemorrhagiectoides: case report of an uncommon presentation of cutaneous metastatic breast carcinoma. Dermatol Online J. 2017;23:13030/qt3hn3z850.
  9. Smith KA, Basko-Plluska J, Kothari AD, et al. Cutaneous metastatic breast adenocarcinoma. Cutis. 2020;105:E20-E22.
  10. Cohen PR, Kurzrock R. Cutaneous metastatic cancer: carcinoma hemorrhagiectoides presenting as the shield sign. Cureus. 2021;13:e12627.
  11. Cohen PR. Pleomorphic appearance of breast cancer cutaneous metastases. Cureus. 2021;13:e20301.
  12. Cohen PR, Prieto VG, Kurzrock R. Tumor lysis syndrome: introduction of a cutaneous variant and a new classification system. Cureus. 2021;13:e13816.
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Undiagnosed, Untreated Tardive Dyskinesia, Hinders Adherence to Antipsychotics

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This transcript has been edited for clarity.

Tardive dyskinesia is a chronic, potentially irreversible, hyperkinetic movement disorder. And the challenge with tardive dyskinesia is that it’s underdiagnosed and undertreated. With the expanded use of dopamine receptor–blocking agents, there are about 7.5 million Americans who are now exposed and at risk for tardive dyskinesia.

It’s thought that about 500,000-750,000 of these patients may in fact have tardive dyskinesia, but only 15% are treated. So why are people not being treated for tardive dyskinesia? Well, there are a number of possible answers.

Until a few years ago, there were no Food and Drug Administration (FDA)–approved treatments for tardive dyskinesia, and these antipsychotic medications that the patients were taking, in many cases, were potentially lifesaving drugs, so they couldn’t simply be stopped. As a result of that, I think physicians developed a certain psychic blindness to identifying tardive dyskinesia, because it was their drugs that were causing the disease and yet they couldn’t be stopped. So, there really wasn’t much they could do in terms of making the diagnosis.

In addition, they were trained that tardive dyskinesia doesn’t have much impact on patients. But we now know, through surveys and other studies, that tardive dyskinesia can have a tremendous impact on patients and on your ability to treat the patient’s underlying mental health issues. It’s estimated that 50% of patients with tardive dyskinesia actually reduce the amount of antipsychotic medication they’re taking on their own, and about 40% may in fact stop their antipsychotic medication altogether.

Thirty-five percent of patients stopped seeing their doctor after they developed tardive dyskinesia, and about 20% of patients actually told other patients not to take their antipsychotic medication. So, tardive dyskinesia is impacting your ability to treat patients. In addition, it impacts the patients themselves. Nearly three out of four patients with tardive dyskinesia said, in surveys, that it caused severe impact on their psychosocial functioning.

It also impacted caregivers, with 70% of caregivers saying that the patients with tardive dyskinesia made them more anxious and limited them socially. So, we have this tremendous impact from tardive dyskinesia.

In addition, physicians sometimes don’t identify tardive dyskinesia correctly. They mistake it for another movement disorder: drug-induced parkinsonism. Or it falls under the rubric of extrapyramidal symptoms (EPS), and they were trained that you treat EPS with benztropine. The challenge with that is that benztropine is only indicated for acute dystonia or for drug-induced parkinsonism. It actually makes tardive dyskinesia worse. And, in the product insert for benztropine, it’s recommended that it should not be used in tardive dyskinesia. So if you have a patient whom you suspect has tardive dyskinesia, you have to discontinue the benztropine. That’s a really important first step.

And then, what else should you do? There are now two FDA-approved treatments for tardive dyskinesia. These are valbenazine and deutetrabenazine. Both of these drugs have been demonstrated in large double-blind, placebo-controlled studies to reduce tardive dyskinesia, as measured by the Abnormal Involuntary Movement Scale, by about 30%. These drugs have been demonstrated to be safe and well tolerated, with the main side effect being somnolence.

Some people can also develop parkinsonism. Why could there be Parkinsonism? This is because vesicular monoamine transporter 2 (VMAT2) inhibitors work by reducing the amount of dopamine that can be packaged in the presynaptic neuron. That means that less dopamine is available to the synapse, and this reduces movement. The American Psychiatric Association has issued guidelines for the treatment of tardive dyskinesia and has said that moderate to severe tardive dyskinesia should be treated first-line with VMAT2 inhibitors and that mild tardive dyskinesia should also be treated with VMAT2 inhibitors if the tardive dyskinesia is impacting the patient.

Given the impact that tardive dyskinesia has on patients and caregivers, and the physician’s ability to treat these patients’ mental health issues, we need to become aggressive and treat the tardive dyskinesia so that patients can improve and be able to have their movements treated without impacting their underlying mental health issues.

Daniel Kremens, professor, Department of Neurology, Sidney Kimmel Medical College, Thomas Jefferson University, codirector, Parkinson’s Disease and Movement Disorders Division, Jack and Vickie Farber Center for Neuroscience, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, has disclosed relevant financial relationships with Teva Pharmaceuticals, AbbVie, Merz, Allergan, Bial, Cerevel, Amneal, Acadia, Supernus, Adamas, Acorda, Kyowa Kirin, and Neurocrine.

A version of this article first appeared on Medscape.com.

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This transcript has been edited for clarity.

Tardive dyskinesia is a chronic, potentially irreversible, hyperkinetic movement disorder. And the challenge with tardive dyskinesia is that it’s underdiagnosed and undertreated. With the expanded use of dopamine receptor–blocking agents, there are about 7.5 million Americans who are now exposed and at risk for tardive dyskinesia.

It’s thought that about 500,000-750,000 of these patients may in fact have tardive dyskinesia, but only 15% are treated. So why are people not being treated for tardive dyskinesia? Well, there are a number of possible answers.

Until a few years ago, there were no Food and Drug Administration (FDA)–approved treatments for tardive dyskinesia, and these antipsychotic medications that the patients were taking, in many cases, were potentially lifesaving drugs, so they couldn’t simply be stopped. As a result of that, I think physicians developed a certain psychic blindness to identifying tardive dyskinesia, because it was their drugs that were causing the disease and yet they couldn’t be stopped. So, there really wasn’t much they could do in terms of making the diagnosis.

In addition, they were trained that tardive dyskinesia doesn’t have much impact on patients. But we now know, through surveys and other studies, that tardive dyskinesia can have a tremendous impact on patients and on your ability to treat the patient’s underlying mental health issues. It’s estimated that 50% of patients with tardive dyskinesia actually reduce the amount of antipsychotic medication they’re taking on their own, and about 40% may in fact stop their antipsychotic medication altogether.

Thirty-five percent of patients stopped seeing their doctor after they developed tardive dyskinesia, and about 20% of patients actually told other patients not to take their antipsychotic medication. So, tardive dyskinesia is impacting your ability to treat patients. In addition, it impacts the patients themselves. Nearly three out of four patients with tardive dyskinesia said, in surveys, that it caused severe impact on their psychosocial functioning.

It also impacted caregivers, with 70% of caregivers saying that the patients with tardive dyskinesia made them more anxious and limited them socially. So, we have this tremendous impact from tardive dyskinesia.

In addition, physicians sometimes don’t identify tardive dyskinesia correctly. They mistake it for another movement disorder: drug-induced parkinsonism. Or it falls under the rubric of extrapyramidal symptoms (EPS), and they were trained that you treat EPS with benztropine. The challenge with that is that benztropine is only indicated for acute dystonia or for drug-induced parkinsonism. It actually makes tardive dyskinesia worse. And, in the product insert for benztropine, it’s recommended that it should not be used in tardive dyskinesia. So if you have a patient whom you suspect has tardive dyskinesia, you have to discontinue the benztropine. That’s a really important first step.

And then, what else should you do? There are now two FDA-approved treatments for tardive dyskinesia. These are valbenazine and deutetrabenazine. Both of these drugs have been demonstrated in large double-blind, placebo-controlled studies to reduce tardive dyskinesia, as measured by the Abnormal Involuntary Movement Scale, by about 30%. These drugs have been demonstrated to be safe and well tolerated, with the main side effect being somnolence.

Some people can also develop parkinsonism. Why could there be Parkinsonism? This is because vesicular monoamine transporter 2 (VMAT2) inhibitors work by reducing the amount of dopamine that can be packaged in the presynaptic neuron. That means that less dopamine is available to the synapse, and this reduces movement. The American Psychiatric Association has issued guidelines for the treatment of tardive dyskinesia and has said that moderate to severe tardive dyskinesia should be treated first-line with VMAT2 inhibitors and that mild tardive dyskinesia should also be treated with VMAT2 inhibitors if the tardive dyskinesia is impacting the patient.

Given the impact that tardive dyskinesia has on patients and caregivers, and the physician’s ability to treat these patients’ mental health issues, we need to become aggressive and treat the tardive dyskinesia so that patients can improve and be able to have their movements treated without impacting their underlying mental health issues.

Daniel Kremens, professor, Department of Neurology, Sidney Kimmel Medical College, Thomas Jefferson University, codirector, Parkinson’s Disease and Movement Disorders Division, Jack and Vickie Farber Center for Neuroscience, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, has disclosed relevant financial relationships with Teva Pharmaceuticals, AbbVie, Merz, Allergan, Bial, Cerevel, Amneal, Acadia, Supernus, Adamas, Acorda, Kyowa Kirin, and Neurocrine.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Tardive dyskinesia is a chronic, potentially irreversible, hyperkinetic movement disorder. And the challenge with tardive dyskinesia is that it’s underdiagnosed and undertreated. With the expanded use of dopamine receptor–blocking agents, there are about 7.5 million Americans who are now exposed and at risk for tardive dyskinesia.

It’s thought that about 500,000-750,000 of these patients may in fact have tardive dyskinesia, but only 15% are treated. So why are people not being treated for tardive dyskinesia? Well, there are a number of possible answers.

Until a few years ago, there were no Food and Drug Administration (FDA)–approved treatments for tardive dyskinesia, and these antipsychotic medications that the patients were taking, in many cases, were potentially lifesaving drugs, so they couldn’t simply be stopped. As a result of that, I think physicians developed a certain psychic blindness to identifying tardive dyskinesia, because it was their drugs that were causing the disease and yet they couldn’t be stopped. So, there really wasn’t much they could do in terms of making the diagnosis.

In addition, they were trained that tardive dyskinesia doesn’t have much impact on patients. But we now know, through surveys and other studies, that tardive dyskinesia can have a tremendous impact on patients and on your ability to treat the patient’s underlying mental health issues. It’s estimated that 50% of patients with tardive dyskinesia actually reduce the amount of antipsychotic medication they’re taking on their own, and about 40% may in fact stop their antipsychotic medication altogether.

Thirty-five percent of patients stopped seeing their doctor after they developed tardive dyskinesia, and about 20% of patients actually told other patients not to take their antipsychotic medication. So, tardive dyskinesia is impacting your ability to treat patients. In addition, it impacts the patients themselves. Nearly three out of four patients with tardive dyskinesia said, in surveys, that it caused severe impact on their psychosocial functioning.

It also impacted caregivers, with 70% of caregivers saying that the patients with tardive dyskinesia made them more anxious and limited them socially. So, we have this tremendous impact from tardive dyskinesia.

In addition, physicians sometimes don’t identify tardive dyskinesia correctly. They mistake it for another movement disorder: drug-induced parkinsonism. Or it falls under the rubric of extrapyramidal symptoms (EPS), and they were trained that you treat EPS with benztropine. The challenge with that is that benztropine is only indicated for acute dystonia or for drug-induced parkinsonism. It actually makes tardive dyskinesia worse. And, in the product insert for benztropine, it’s recommended that it should not be used in tardive dyskinesia. So if you have a patient whom you suspect has tardive dyskinesia, you have to discontinue the benztropine. That’s a really important first step.

And then, what else should you do? There are now two FDA-approved treatments for tardive dyskinesia. These are valbenazine and deutetrabenazine. Both of these drugs have been demonstrated in large double-blind, placebo-controlled studies to reduce tardive dyskinesia, as measured by the Abnormal Involuntary Movement Scale, by about 30%. These drugs have been demonstrated to be safe and well tolerated, with the main side effect being somnolence.

Some people can also develop parkinsonism. Why could there be Parkinsonism? This is because vesicular monoamine transporter 2 (VMAT2) inhibitors work by reducing the amount of dopamine that can be packaged in the presynaptic neuron. That means that less dopamine is available to the synapse, and this reduces movement. The American Psychiatric Association has issued guidelines for the treatment of tardive dyskinesia and has said that moderate to severe tardive dyskinesia should be treated first-line with VMAT2 inhibitors and that mild tardive dyskinesia should also be treated with VMAT2 inhibitors if the tardive dyskinesia is impacting the patient.

Given the impact that tardive dyskinesia has on patients and caregivers, and the physician’s ability to treat these patients’ mental health issues, we need to become aggressive and treat the tardive dyskinesia so that patients can improve and be able to have their movements treated without impacting their underlying mental health issues.

Daniel Kremens, professor, Department of Neurology, Sidney Kimmel Medical College, Thomas Jefferson University, codirector, Parkinson’s Disease and Movement Disorders Division, Jack and Vickie Farber Center for Neuroscience, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, has disclosed relevant financial relationships with Teva Pharmaceuticals, AbbVie, Merz, Allergan, Bial, Cerevel, Amneal, Acadia, Supernus, Adamas, Acorda, Kyowa Kirin, and Neurocrine.

A version of this article first appeared on Medscape.com.

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Retirement Planning for Gastroenterologists

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Mon, 07/29/2024 - 16:35

Retirement planning starts the day we start our careers. Whenever we start any project, it is always worthwhile to learn how the project works, what we want to pursue and achieve with the project, how to exit the project, and when is the right time to exit.

As physicians, gastroenterologists go through several years of vigorous training, years spent studying, researching, practicing, and juggling between work and life, trying to lead a well-balanced life. With all the years of medical training, we do not get the same level of education in financial planning in order to attain financial stability, financial empowerment, or resources that we need to put in place for a successful retirement.

Dr. Appalaneni
Dr. Vasu Appalaneni

Many physicians like to work and provide services as long as they can, provided the physical and mental capacity permits. Retirement planning should start as early as possible — at your first job, with the first paycheck. Having a strategic plan and understanding several personal factors can help one make this journey successful.

Retirement involves planning at multiple levels, including but not limited to financial planning, transition planning, healthcare coverage, estate planning, and social, leisure, and emotional planning.
 

Financial Planning

Financial planning starts with investments in 401k, IRA, defined benefit, and defined contribution plans, as early as possible and to the maximum extent possible. It is beneficial to contribute at the first opportunity and contribute enough to the employer retirement plan to earn the full employer match. Also consider capital investment opportunities that match your risk appetite and returns, as these compound and grow over time. This can be done by adjusting personal expenses and lifestyle, giving priority to savings and future wealth management, and auto-escalation of permitted retirement contributions annually.

Assessing your financial situation periodically to determine retirement needs based on how long you intend to work and preferred lifestyle post retirement (travel, leisurely activities, etc.) is important. It is also pertinent to align revenue earned, expenses made, and wealth saved to support post-retirement life. Consider hiring a financial advisor who has the best interests in your personal wealth management. These are usually found with reputable institutions at a fixed percentage cost. Finding a trustworthy knowledgeable advisor is the key. Learning from your colleagues, networking, and learning from friends in and out of healthcare are good resources to find the right financial advisor.

Healthcare expenses should be planned as well as part of financial planning. Short-term and long-term disability and long-term care expenses should be investigated when planning for healthcare needs.
 

Transition Planning

Timing of retirement is based on factors such as age, financial status, personal health and preferences. The transition can be facilitated by better communication with colleagues, partners, employer, staff, and patients. Identifying a successor and planning for continuity of care of the patients, such as transitioning patients to another provider, is important as well. This may involve hiring a new associate, merging with another practice, or selling the practice.

 

 

Healthcare Coverage

One of the biggest expenses with retirement is healthcare coverage. Healthcare coverage options need to be analyzed which may include Medicare eligibility, enrollment, potential needs after retirement, including preventative care, treatment of chronic conditions, long term care services, and unexpected health outcomes and consequences.

Lifestyle and Travel Planning

Reflect on the retirement lifestyle, hobbies, and passions to be explored. Some activities like volunteer work, continuing educational opportunities, and advisory work, will help maintain physical and mental health. Consider downsizing living arrangements to align with retirement lifestyle goals which may include relocating to a different area as it fits your needs.

Legal and Estate Planning

Review and update legal documents including power of attorney, healthcare directives, will, trusts, and periodically ensure that these documents reflect your wishes.

Professional Development

Retirement may not mean quitting work completely. Some may look at this as an opportunity for professional development and pivoting to a different career that suits their lifestyle and needs. Gastroenterologists may contribute to the field and stay connected by being mentors, advisors, or, industry partners; being involved in national organizations; leading purposeful projects; or teaching part-time or on a volunteer basis.

Emotional and Social Support

Being a physician and a leader on treatment teams after so many years, some may feel lonely and unproductive with a lack of purpose in retirement; while others are excited about the free time they gained to pursue other activities and projects.

The process can be emotionally challenging even for well-prepared individuals. Finding friends, family, and professionals who can support you through this process will be helpful as you go through the uncertainties, anxiety, and fear during this phase of life. Think of developing hobbies and interests and nurturing networks outside of work environment that will keep you engaged and content during this transition.

Gastroenterologists can plan for a financially secure, emotionally fulfilling, and professionally satisfying transition tailored to their needs and preferences. Seeking help from financial advisors, legal experts, mentors, and other professionals who can provide valuable advice, support, and guidance is crucial during this process.

Do what you love and love what you do.

Dr. Appalaneni is a gastroenterologist at Dayton Gastroenterology in Beavercreek, Ohio, and a clinical assistant professor at Boonshoft School of Medicine, Wright State University in Dayton, Ohio. This article is not a financial planning document, nor legal advice; these are the author’s learnings, experiences, and opinions and are not considered financial advice.

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Retirement planning starts the day we start our careers. Whenever we start any project, it is always worthwhile to learn how the project works, what we want to pursue and achieve with the project, how to exit the project, and when is the right time to exit.

As physicians, gastroenterologists go through several years of vigorous training, years spent studying, researching, practicing, and juggling between work and life, trying to lead a well-balanced life. With all the years of medical training, we do not get the same level of education in financial planning in order to attain financial stability, financial empowerment, or resources that we need to put in place for a successful retirement.

Dr. Appalaneni
Dr. Vasu Appalaneni

Many physicians like to work and provide services as long as they can, provided the physical and mental capacity permits. Retirement planning should start as early as possible — at your first job, with the first paycheck. Having a strategic plan and understanding several personal factors can help one make this journey successful.

Retirement involves planning at multiple levels, including but not limited to financial planning, transition planning, healthcare coverage, estate planning, and social, leisure, and emotional planning.
 

Financial Planning

Financial planning starts with investments in 401k, IRA, defined benefit, and defined contribution plans, as early as possible and to the maximum extent possible. It is beneficial to contribute at the first opportunity and contribute enough to the employer retirement plan to earn the full employer match. Also consider capital investment opportunities that match your risk appetite and returns, as these compound and grow over time. This can be done by adjusting personal expenses and lifestyle, giving priority to savings and future wealth management, and auto-escalation of permitted retirement contributions annually.

Assessing your financial situation periodically to determine retirement needs based on how long you intend to work and preferred lifestyle post retirement (travel, leisurely activities, etc.) is important. It is also pertinent to align revenue earned, expenses made, and wealth saved to support post-retirement life. Consider hiring a financial advisor who has the best interests in your personal wealth management. These are usually found with reputable institutions at a fixed percentage cost. Finding a trustworthy knowledgeable advisor is the key. Learning from your colleagues, networking, and learning from friends in and out of healthcare are good resources to find the right financial advisor.

Healthcare expenses should be planned as well as part of financial planning. Short-term and long-term disability and long-term care expenses should be investigated when planning for healthcare needs.
 

Transition Planning

Timing of retirement is based on factors such as age, financial status, personal health and preferences. The transition can be facilitated by better communication with colleagues, partners, employer, staff, and patients. Identifying a successor and planning for continuity of care of the patients, such as transitioning patients to another provider, is important as well. This may involve hiring a new associate, merging with another practice, or selling the practice.

 

 

Healthcare Coverage

One of the biggest expenses with retirement is healthcare coverage. Healthcare coverage options need to be analyzed which may include Medicare eligibility, enrollment, potential needs after retirement, including preventative care, treatment of chronic conditions, long term care services, and unexpected health outcomes and consequences.

Lifestyle and Travel Planning

Reflect on the retirement lifestyle, hobbies, and passions to be explored. Some activities like volunteer work, continuing educational opportunities, and advisory work, will help maintain physical and mental health. Consider downsizing living arrangements to align with retirement lifestyle goals which may include relocating to a different area as it fits your needs.

Legal and Estate Planning

Review and update legal documents including power of attorney, healthcare directives, will, trusts, and periodically ensure that these documents reflect your wishes.

Professional Development

Retirement may not mean quitting work completely. Some may look at this as an opportunity for professional development and pivoting to a different career that suits their lifestyle and needs. Gastroenterologists may contribute to the field and stay connected by being mentors, advisors, or, industry partners; being involved in national organizations; leading purposeful projects; or teaching part-time or on a volunteer basis.

Emotional and Social Support

Being a physician and a leader on treatment teams after so many years, some may feel lonely and unproductive with a lack of purpose in retirement; while others are excited about the free time they gained to pursue other activities and projects.

The process can be emotionally challenging even for well-prepared individuals. Finding friends, family, and professionals who can support you through this process will be helpful as you go through the uncertainties, anxiety, and fear during this phase of life. Think of developing hobbies and interests and nurturing networks outside of work environment that will keep you engaged and content during this transition.

Gastroenterologists can plan for a financially secure, emotionally fulfilling, and professionally satisfying transition tailored to their needs and preferences. Seeking help from financial advisors, legal experts, mentors, and other professionals who can provide valuable advice, support, and guidance is crucial during this process.

Do what you love and love what you do.

Dr. Appalaneni is a gastroenterologist at Dayton Gastroenterology in Beavercreek, Ohio, and a clinical assistant professor at Boonshoft School of Medicine, Wright State University in Dayton, Ohio. This article is not a financial planning document, nor legal advice; these are the author’s learnings, experiences, and opinions and are not considered financial advice.

Retirement planning starts the day we start our careers. Whenever we start any project, it is always worthwhile to learn how the project works, what we want to pursue and achieve with the project, how to exit the project, and when is the right time to exit.

As physicians, gastroenterologists go through several years of vigorous training, years spent studying, researching, practicing, and juggling between work and life, trying to lead a well-balanced life. With all the years of medical training, we do not get the same level of education in financial planning in order to attain financial stability, financial empowerment, or resources that we need to put in place for a successful retirement.

Dr. Appalaneni
Dr. Vasu Appalaneni

Many physicians like to work and provide services as long as they can, provided the physical and mental capacity permits. Retirement planning should start as early as possible — at your first job, with the first paycheck. Having a strategic plan and understanding several personal factors can help one make this journey successful.

Retirement involves planning at multiple levels, including but not limited to financial planning, transition planning, healthcare coverage, estate planning, and social, leisure, and emotional planning.
 

Financial Planning

Financial planning starts with investments in 401k, IRA, defined benefit, and defined contribution plans, as early as possible and to the maximum extent possible. It is beneficial to contribute at the first opportunity and contribute enough to the employer retirement plan to earn the full employer match. Also consider capital investment opportunities that match your risk appetite and returns, as these compound and grow over time. This can be done by adjusting personal expenses and lifestyle, giving priority to savings and future wealth management, and auto-escalation of permitted retirement contributions annually.

Assessing your financial situation periodically to determine retirement needs based on how long you intend to work and preferred lifestyle post retirement (travel, leisurely activities, etc.) is important. It is also pertinent to align revenue earned, expenses made, and wealth saved to support post-retirement life. Consider hiring a financial advisor who has the best interests in your personal wealth management. These are usually found with reputable institutions at a fixed percentage cost. Finding a trustworthy knowledgeable advisor is the key. Learning from your colleagues, networking, and learning from friends in and out of healthcare are good resources to find the right financial advisor.

Healthcare expenses should be planned as well as part of financial planning. Short-term and long-term disability and long-term care expenses should be investigated when planning for healthcare needs.
 

Transition Planning

Timing of retirement is based on factors such as age, financial status, personal health and preferences. The transition can be facilitated by better communication with colleagues, partners, employer, staff, and patients. Identifying a successor and planning for continuity of care of the patients, such as transitioning patients to another provider, is important as well. This may involve hiring a new associate, merging with another practice, or selling the practice.

 

 

Healthcare Coverage

One of the biggest expenses with retirement is healthcare coverage. Healthcare coverage options need to be analyzed which may include Medicare eligibility, enrollment, potential needs after retirement, including preventative care, treatment of chronic conditions, long term care services, and unexpected health outcomes and consequences.

Lifestyle and Travel Planning

Reflect on the retirement lifestyle, hobbies, and passions to be explored. Some activities like volunteer work, continuing educational opportunities, and advisory work, will help maintain physical and mental health. Consider downsizing living arrangements to align with retirement lifestyle goals which may include relocating to a different area as it fits your needs.

Legal and Estate Planning

Review and update legal documents including power of attorney, healthcare directives, will, trusts, and periodically ensure that these documents reflect your wishes.

Professional Development

Retirement may not mean quitting work completely. Some may look at this as an opportunity for professional development and pivoting to a different career that suits their lifestyle and needs. Gastroenterologists may contribute to the field and stay connected by being mentors, advisors, or, industry partners; being involved in national organizations; leading purposeful projects; or teaching part-time or on a volunteer basis.

Emotional and Social Support

Being a physician and a leader on treatment teams after so many years, some may feel lonely and unproductive with a lack of purpose in retirement; while others are excited about the free time they gained to pursue other activities and projects.

The process can be emotionally challenging even for well-prepared individuals. Finding friends, family, and professionals who can support you through this process will be helpful as you go through the uncertainties, anxiety, and fear during this phase of life. Think of developing hobbies and interests and nurturing networks outside of work environment that will keep you engaged and content during this transition.

Gastroenterologists can plan for a financially secure, emotionally fulfilling, and professionally satisfying transition tailored to their needs and preferences. Seeking help from financial advisors, legal experts, mentors, and other professionals who can provide valuable advice, support, and guidance is crucial during this process.

Do what you love and love what you do.

Dr. Appalaneni is a gastroenterologist at Dayton Gastroenterology in Beavercreek, Ohio, and a clinical assistant professor at Boonshoft School of Medicine, Wright State University in Dayton, Ohio. This article is not a financial planning document, nor legal advice; these are the author’s learnings, experiences, and opinions and are not considered financial advice.

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Fed Worker Health Plans Ban Maximizers and Copay Accumulators: Why Not for the Rest of the US?

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Changed
Mon, 07/29/2024 - 11:51

The escalating costs of medications and the prevalence of medical bankruptcy in our country have drawn criticism from governments, regulators, and the media. Federal and state governments are exploring various strategies to mitigate this issue, including the Inflation Reduction Act (IRA) for drug price negotiations and the establishment of state Pharmaceutical Drug Affordability Boards (PDABs). However, it’s uncertain whether these measures will effectively reduce patients’ medication expenses, given the tendency of pharmacy benefit managers (PBMs) to favor more expensive drugs on their formularies and the implementation challenges faced by PDABs.

The question then arises: How can we promptly assist patients, especially those with multiple chronic conditions, in affording their healthcare? Many of these patients are enrolled in high-deductible plans and struggle to cover all their medical and pharmacy costs.

Dr. Madelaine A. Feldman

A significant obstacle to healthcare affordability emerged in 2018 with the introduction of Copay Accumulator Programs by PBMs. These programs prevent patients from applying manufacturer copay cards toward their deductible and maximum out-of-pocket (OOP) costs. The impact of these policies has been devastating, leading to decreased adherence to medications and delayed necessary medical procedures, such as colonoscopies. Copay accumulators do nothing to address the high cost of medical care. They merely shift the burden from insurance companies to patients.

There is a direct solution to help patients, particularly those burdened with high pharmacy bills, afford their medical care. It would be that all payments from patients, including manufacturer copay cards, count toward their deductible and maximum OOP costs. This should apply regardless of whether the insurance plan is fully funded or a self-insured employer plan. This would be an immediate step toward making healthcare more affordable for patients.
 

Copay Accumulator Programs

How did these detrimental policies, which have been proven to harm patients, originate? It’s interesting that health insurance policies for federal employees do not allow these programs and yet the federal government has done little to protect its citizens from these egregious policies. More on that later.

In 2018, insurance companies and PBMs conceived an idea to introduce what they called copay accumulator adjustment programs. These programs would prevent the use of manufacturer copay cards from counting toward patient deductibles or OOP maximums. They justified this by arguing that manufacturer copay cards encouraged patients to opt for higher-priced brand drugs when lower-cost generics were available.

However, data from IQVIA contradicts this claim. An analysis of copay card usage from 2013 to 2017 revealed that a mere 0.4% of these cards were used for brand-name drugs that had already lost their exclusivity. This indicates that the vast majority of copay cards were not being used to purchase more expensive brand-name drugs when cheaper, generic alternatives were available.

Another argument put forth by one of the large PBMs was that patients with high deductibles don’t have enough “skin in the game” due to their low premiums, and therefore don’t deserve to have their deductible covered by a copay card. This raises the question, “Does a patient with hemophilia or systemic lupus who can’t afford a low deductible plan not have ‘skin in the game’? Is that a fair assessment?” It’s disconcerting to see a multibillion-dollar company dictating who deserves to have their deductible covered. These policies clearly disproportionately harm patients with chronic illnesses, especially those with high deductibles. As a result, many organizations have labeled these policies as discriminatory.

Following the implementation of accumulator programs in 2018 and 2019, many patients were unaware that their copay cards weren’t contributing toward their deductibles. They were taken aback when specialty pharmacies informed them of owing substantial amounts because of unmet deductibles. Consequently, patients discontinued their medications, leading to disease progression and increased costs. The only downside for health insurers and PBMs was the negative publicity associated with patients losing medication access.
 

 

 

Maximizer Programs

By the end of 2019, the three major PBMs had devised a strategy to keep patients on their medication throughout the year, without counting copay cards toward the deductible, and found a way to profit more from these cards, sometimes quadrupling their value. This was the birth of the maximizer programs.

Maximizers exploit a “loophole” in the Affordable Care Act (ACA). The ACA defines Essential Healthcare Benefits (EHB); anything not listed as an EHB is deemed “non-essential.” As a result, neither personal payments nor copay cards count toward deductibles or OOP maximums. Patients were informed that neither their own money nor manufacturer copay cards would count toward their deductible/OOP max.

One of my patients was warned that without enrolling in the maximizer program through SaveOnSP (owned by Express Scripts), she would bear the full cost of the drug, and nothing would count toward her OOP max. Frightened, she enrolled and surrendered her manufacturer copay card to SaveOnSP. Maximizers pocket the maximum value of the copay card, even if it exceeds the insurance plan’s yearly cost share by threefold or more. To do this legally, PBMs increase the patient’s original cost share amount during the plan year to match the value of the manufacturer copay card.
 

Combating These Programs

Nineteen states, the District of Columbia, and Puerto Rico have outlawed copay accumulators in health plans under state jurisdiction. I personally testified in Louisiana, leading to a ban in our state. CSRO’s award-winning map tool can show if your state has passed the ban on copay accumulator programs. However, many states have not passed bans on copay accumulators and self-insured employer groups, which fall under the Department of Labor and not state regulation, are still unaffected. There is also proposed federal legislation, the “Help Ensure Lower Patient Copays Act,” that would prohibit the use of copay accumulators in exchange plans. Despite having bipartisan support, it is having a hard time getting across the finish line in Congress.

In 2020, the Department of Health and Human Services (HHS) issued a rule prohibiting accumulator programs in all plans if the product was a brand name without a generic alternative. Unfortunately, this rule was rescinded in 2021, allowing copay accumulators even if a lower-cost generic was available.

In a positive turn of events, the US District Court of the District of Columbia overturned the 2021 rule in late 2023, reinstating the 2020 ban on copay accumulators. However, HHS has yet to enforce this ban.
 

Double Standard

Why is it that our federal government refrains from enforcing bans on copay accumulators for the American public, yet the US Office of Personnel Management (OPM) in its 2024 health plan for federal employees has explicitly stated that it “will decline any arrangements which may manipulate the prescription drug benefit design or incorporate any programs such as copay maximizers, copay optimizers, or other similar programs as these types of benefit designs are not in the best interest of enrollees or the Government.”

If such practices are deemed unsuitable for federal employees, why are they considered acceptable for the rest of the American population? This discrepancy raises important questions about healthcare equity.

In conclusion, the prevalence of medical bankruptcy in our country is a pressing issue that requires immediate attention. The introduction of copay accumulator programs and maximizers by PBMs has led to decreased adherence to needed medications, as well as delay in important medical procedures, exacerbating this situation. An across-the-board ban on these programs would offer immediate relief to many families that no longer can afford needed care.

It is clear that more needs to be done to ensure that all patients, regardless of their financial situation or the nature of their health insurance plan, can afford the healthcare they need. This includes ensuring that patients are not penalized for using manufacturer copay cards to help cover their costs. As we move forward, it is crucial that we continue to advocate for policies that prioritize the health and well-being of all patients.
 

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

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The escalating costs of medications and the prevalence of medical bankruptcy in our country have drawn criticism from governments, regulators, and the media. Federal and state governments are exploring various strategies to mitigate this issue, including the Inflation Reduction Act (IRA) for drug price negotiations and the establishment of state Pharmaceutical Drug Affordability Boards (PDABs). However, it’s uncertain whether these measures will effectively reduce patients’ medication expenses, given the tendency of pharmacy benefit managers (PBMs) to favor more expensive drugs on their formularies and the implementation challenges faced by PDABs.

The question then arises: How can we promptly assist patients, especially those with multiple chronic conditions, in affording their healthcare? Many of these patients are enrolled in high-deductible plans and struggle to cover all their medical and pharmacy costs.

Dr. Madelaine A. Feldman

A significant obstacle to healthcare affordability emerged in 2018 with the introduction of Copay Accumulator Programs by PBMs. These programs prevent patients from applying manufacturer copay cards toward their deductible and maximum out-of-pocket (OOP) costs. The impact of these policies has been devastating, leading to decreased adherence to medications and delayed necessary medical procedures, such as colonoscopies. Copay accumulators do nothing to address the high cost of medical care. They merely shift the burden from insurance companies to patients.

There is a direct solution to help patients, particularly those burdened with high pharmacy bills, afford their medical care. It would be that all payments from patients, including manufacturer copay cards, count toward their deductible and maximum OOP costs. This should apply regardless of whether the insurance plan is fully funded or a self-insured employer plan. This would be an immediate step toward making healthcare more affordable for patients.
 

Copay Accumulator Programs

How did these detrimental policies, which have been proven to harm patients, originate? It’s interesting that health insurance policies for federal employees do not allow these programs and yet the federal government has done little to protect its citizens from these egregious policies. More on that later.

In 2018, insurance companies and PBMs conceived an idea to introduce what they called copay accumulator adjustment programs. These programs would prevent the use of manufacturer copay cards from counting toward patient deductibles or OOP maximums. They justified this by arguing that manufacturer copay cards encouraged patients to opt for higher-priced brand drugs when lower-cost generics were available.

However, data from IQVIA contradicts this claim. An analysis of copay card usage from 2013 to 2017 revealed that a mere 0.4% of these cards were used for brand-name drugs that had already lost their exclusivity. This indicates that the vast majority of copay cards were not being used to purchase more expensive brand-name drugs when cheaper, generic alternatives were available.

Another argument put forth by one of the large PBMs was that patients with high deductibles don’t have enough “skin in the game” due to their low premiums, and therefore don’t deserve to have their deductible covered by a copay card. This raises the question, “Does a patient with hemophilia or systemic lupus who can’t afford a low deductible plan not have ‘skin in the game’? Is that a fair assessment?” It’s disconcerting to see a multibillion-dollar company dictating who deserves to have their deductible covered. These policies clearly disproportionately harm patients with chronic illnesses, especially those with high deductibles. As a result, many organizations have labeled these policies as discriminatory.

Following the implementation of accumulator programs in 2018 and 2019, many patients were unaware that their copay cards weren’t contributing toward their deductibles. They were taken aback when specialty pharmacies informed them of owing substantial amounts because of unmet deductibles. Consequently, patients discontinued their medications, leading to disease progression and increased costs. The only downside for health insurers and PBMs was the negative publicity associated with patients losing medication access.
 

 

 

Maximizer Programs

By the end of 2019, the three major PBMs had devised a strategy to keep patients on their medication throughout the year, without counting copay cards toward the deductible, and found a way to profit more from these cards, sometimes quadrupling their value. This was the birth of the maximizer programs.

Maximizers exploit a “loophole” in the Affordable Care Act (ACA). The ACA defines Essential Healthcare Benefits (EHB); anything not listed as an EHB is deemed “non-essential.” As a result, neither personal payments nor copay cards count toward deductibles or OOP maximums. Patients were informed that neither their own money nor manufacturer copay cards would count toward their deductible/OOP max.

One of my patients was warned that without enrolling in the maximizer program through SaveOnSP (owned by Express Scripts), she would bear the full cost of the drug, and nothing would count toward her OOP max. Frightened, she enrolled and surrendered her manufacturer copay card to SaveOnSP. Maximizers pocket the maximum value of the copay card, even if it exceeds the insurance plan’s yearly cost share by threefold or more. To do this legally, PBMs increase the patient’s original cost share amount during the plan year to match the value of the manufacturer copay card.
 

Combating These Programs

Nineteen states, the District of Columbia, and Puerto Rico have outlawed copay accumulators in health plans under state jurisdiction. I personally testified in Louisiana, leading to a ban in our state. CSRO’s award-winning map tool can show if your state has passed the ban on copay accumulator programs. However, many states have not passed bans on copay accumulators and self-insured employer groups, which fall under the Department of Labor and not state regulation, are still unaffected. There is also proposed federal legislation, the “Help Ensure Lower Patient Copays Act,” that would prohibit the use of copay accumulators in exchange plans. Despite having bipartisan support, it is having a hard time getting across the finish line in Congress.

In 2020, the Department of Health and Human Services (HHS) issued a rule prohibiting accumulator programs in all plans if the product was a brand name without a generic alternative. Unfortunately, this rule was rescinded in 2021, allowing copay accumulators even if a lower-cost generic was available.

In a positive turn of events, the US District Court of the District of Columbia overturned the 2021 rule in late 2023, reinstating the 2020 ban on copay accumulators. However, HHS has yet to enforce this ban.
 

Double Standard

Why is it that our federal government refrains from enforcing bans on copay accumulators for the American public, yet the US Office of Personnel Management (OPM) in its 2024 health plan for federal employees has explicitly stated that it “will decline any arrangements which may manipulate the prescription drug benefit design or incorporate any programs such as copay maximizers, copay optimizers, or other similar programs as these types of benefit designs are not in the best interest of enrollees or the Government.”

If such practices are deemed unsuitable for federal employees, why are they considered acceptable for the rest of the American population? This discrepancy raises important questions about healthcare equity.

In conclusion, the prevalence of medical bankruptcy in our country is a pressing issue that requires immediate attention. The introduction of copay accumulator programs and maximizers by PBMs has led to decreased adherence to needed medications, as well as delay in important medical procedures, exacerbating this situation. An across-the-board ban on these programs would offer immediate relief to many families that no longer can afford needed care.

It is clear that more needs to be done to ensure that all patients, regardless of their financial situation or the nature of their health insurance plan, can afford the healthcare they need. This includes ensuring that patients are not penalized for using manufacturer copay cards to help cover their costs. As we move forward, it is crucial that we continue to advocate for policies that prioritize the health and well-being of all patients.
 

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

The escalating costs of medications and the prevalence of medical bankruptcy in our country have drawn criticism from governments, regulators, and the media. Federal and state governments are exploring various strategies to mitigate this issue, including the Inflation Reduction Act (IRA) for drug price negotiations and the establishment of state Pharmaceutical Drug Affordability Boards (PDABs). However, it’s uncertain whether these measures will effectively reduce patients’ medication expenses, given the tendency of pharmacy benefit managers (PBMs) to favor more expensive drugs on their formularies and the implementation challenges faced by PDABs.

The question then arises: How can we promptly assist patients, especially those with multiple chronic conditions, in affording their healthcare? Many of these patients are enrolled in high-deductible plans and struggle to cover all their medical and pharmacy costs.

Dr. Madelaine A. Feldman

A significant obstacle to healthcare affordability emerged in 2018 with the introduction of Copay Accumulator Programs by PBMs. These programs prevent patients from applying manufacturer copay cards toward their deductible and maximum out-of-pocket (OOP) costs. The impact of these policies has been devastating, leading to decreased adherence to medications and delayed necessary medical procedures, such as colonoscopies. Copay accumulators do nothing to address the high cost of medical care. They merely shift the burden from insurance companies to patients.

There is a direct solution to help patients, particularly those burdened with high pharmacy bills, afford their medical care. It would be that all payments from patients, including manufacturer copay cards, count toward their deductible and maximum OOP costs. This should apply regardless of whether the insurance plan is fully funded or a self-insured employer plan. This would be an immediate step toward making healthcare more affordable for patients.
 

Copay Accumulator Programs

How did these detrimental policies, which have been proven to harm patients, originate? It’s interesting that health insurance policies for federal employees do not allow these programs and yet the federal government has done little to protect its citizens from these egregious policies. More on that later.

In 2018, insurance companies and PBMs conceived an idea to introduce what they called copay accumulator adjustment programs. These programs would prevent the use of manufacturer copay cards from counting toward patient deductibles or OOP maximums. They justified this by arguing that manufacturer copay cards encouraged patients to opt for higher-priced brand drugs when lower-cost generics were available.

However, data from IQVIA contradicts this claim. An analysis of copay card usage from 2013 to 2017 revealed that a mere 0.4% of these cards were used for brand-name drugs that had already lost their exclusivity. This indicates that the vast majority of copay cards were not being used to purchase more expensive brand-name drugs when cheaper, generic alternatives were available.

Another argument put forth by one of the large PBMs was that patients with high deductibles don’t have enough “skin in the game” due to their low premiums, and therefore don’t deserve to have their deductible covered by a copay card. This raises the question, “Does a patient with hemophilia or systemic lupus who can’t afford a low deductible plan not have ‘skin in the game’? Is that a fair assessment?” It’s disconcerting to see a multibillion-dollar company dictating who deserves to have their deductible covered. These policies clearly disproportionately harm patients with chronic illnesses, especially those with high deductibles. As a result, many organizations have labeled these policies as discriminatory.

Following the implementation of accumulator programs in 2018 and 2019, many patients were unaware that their copay cards weren’t contributing toward their deductibles. They were taken aback when specialty pharmacies informed them of owing substantial amounts because of unmet deductibles. Consequently, patients discontinued their medications, leading to disease progression and increased costs. The only downside for health insurers and PBMs was the negative publicity associated with patients losing medication access.
 

 

 

Maximizer Programs

By the end of 2019, the three major PBMs had devised a strategy to keep patients on their medication throughout the year, without counting copay cards toward the deductible, and found a way to profit more from these cards, sometimes quadrupling their value. This was the birth of the maximizer programs.

Maximizers exploit a “loophole” in the Affordable Care Act (ACA). The ACA defines Essential Healthcare Benefits (EHB); anything not listed as an EHB is deemed “non-essential.” As a result, neither personal payments nor copay cards count toward deductibles or OOP maximums. Patients were informed that neither their own money nor manufacturer copay cards would count toward their deductible/OOP max.

One of my patients was warned that without enrolling in the maximizer program through SaveOnSP (owned by Express Scripts), she would bear the full cost of the drug, and nothing would count toward her OOP max. Frightened, she enrolled and surrendered her manufacturer copay card to SaveOnSP. Maximizers pocket the maximum value of the copay card, even if it exceeds the insurance plan’s yearly cost share by threefold or more. To do this legally, PBMs increase the patient’s original cost share amount during the plan year to match the value of the manufacturer copay card.
 

Combating These Programs

Nineteen states, the District of Columbia, and Puerto Rico have outlawed copay accumulators in health plans under state jurisdiction. I personally testified in Louisiana, leading to a ban in our state. CSRO’s award-winning map tool can show if your state has passed the ban on copay accumulator programs. However, many states have not passed bans on copay accumulators and self-insured employer groups, which fall under the Department of Labor and not state regulation, are still unaffected. There is also proposed federal legislation, the “Help Ensure Lower Patient Copays Act,” that would prohibit the use of copay accumulators in exchange plans. Despite having bipartisan support, it is having a hard time getting across the finish line in Congress.

In 2020, the Department of Health and Human Services (HHS) issued a rule prohibiting accumulator programs in all plans if the product was a brand name without a generic alternative. Unfortunately, this rule was rescinded in 2021, allowing copay accumulators even if a lower-cost generic was available.

In a positive turn of events, the US District Court of the District of Columbia overturned the 2021 rule in late 2023, reinstating the 2020 ban on copay accumulators. However, HHS has yet to enforce this ban.
 

Double Standard

Why is it that our federal government refrains from enforcing bans on copay accumulators for the American public, yet the US Office of Personnel Management (OPM) in its 2024 health plan for federal employees has explicitly stated that it “will decline any arrangements which may manipulate the prescription drug benefit design or incorporate any programs such as copay maximizers, copay optimizers, or other similar programs as these types of benefit designs are not in the best interest of enrollees or the Government.”

If such practices are deemed unsuitable for federal employees, why are they considered acceptable for the rest of the American population? This discrepancy raises important questions about healthcare equity.

In conclusion, the prevalence of medical bankruptcy in our country is a pressing issue that requires immediate attention. The introduction of copay accumulator programs and maximizers by PBMs has led to decreased adherence to needed medications, as well as delay in important medical procedures, exacerbating this situation. An across-the-board ban on these programs would offer immediate relief to many families that no longer can afford needed care.

It is clear that more needs to be done to ensure that all patients, regardless of their financial situation or the nature of their health insurance plan, can afford the healthcare they need. This includes ensuring that patients are not penalized for using manufacturer copay cards to help cover their costs. As we move forward, it is crucial that we continue to advocate for policies that prioritize the health and well-being of all patients.
 

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

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Navigating and Negotiating Maternity/Paternity Leave in Private Practice

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Changed
Mon, 07/29/2024 - 13:50

Marybeth Spanarkel, MD, a Duke University School of Medicine alumna (1979), completed her internal medicine and gastroenterology training at the University of Pennsylvania, National Institutes of Health, and Johns Hopkins. Initially groomed for an academic role, she chose a clinical position in private practice at Duke Regional Hospital in Durham, North Carolina, where she worked for 25 years.

At age 59, Dr. Spanarkel suffered a neck injury leading to permanent C5-6 radiculopathy, which abruptly ended her career as a clinical gastroenterologist. Since then, she has been a passionate advocate for ergonomic reform in endoscopy. Currently, she is the senior medical adviser and cofounder of ColoWrap, a device designed to improve colonoscopy procedures and reduce ergonomic risk.

Dr. Spanarkel
Dr. Marybeth Spanarkel


Dr. Spanarkel spoke with GI & Hepatology News about the issues that gastroenterologists should consider when negotiating maternity/paternity leave in private practice.
 

Would you share with the readers your experience with maternity leave in private practice?

As a mother of four, I had two children during my GI fellowship, and received my full salary each time for a 3-month maternity leave. My third child arrived in the time period between leaving my academic position and starting in private practice. My fourth child was born after 2 years in private practice, and I took 3 weeks off. Fortunately, I was not asked to pay upfront overhead fees in my 15-person practice. However, my reduced productivity during that time was factored into my salary calculations, leading to a decreased income for the following 6 months.

How does pregnancy affect your performance and productivity as a GI physician?

We” may be having a baby, but “You” are pregnant. While some may experience few symptoms, most pregnant doctors deal with problems such as nausea and extreme fatigue, especially in the first trimester. The third trimester may result in reduced physical agility, particularly when performing procedures. Even in uncomplicated pregnancies, balancing the physiologic changes with the demands of a full-time GI role can be strenuous. And this doesn’t even take into account potential infertility issues, pregnancy complications, or newborn concerns that physicians may encounter.

And after childbirth?

Post childbirth, despite a supportive partner, the primary responsibilities such as feeding, nursing support, and bonding often fall on the biological mother. These duties are superimposed on the doctor’s own recovery and postpartum changes. While the United States commonly recognizes 3 months as a standard maternity leave, some European countries advocate for up to 12 months, demonstrating again that this is not an “overnight” transition.

In the past, GI doctors were mostly male, but now there’s a growing number of females in the field. Despite this shift, studies still highlight continued gender disparities in salaries and leadership opportunities, and support for pregnancy-related issues has been largely under-addressed.1,2,3

How do academic centers manage maternity leave?

In academic centers or large healthcare settings, maternity leave policies are more standardized compared with private practice. Doctors are salaried depending on their level of training and experience and then they are assigned a mix of clinical, research, teaching, and/or administrative duties.

Typically, maternity leave in these centers is a standard 3-month period, often combining paid time off (PTO) with unpaid or paid leave. In some cases, short- or long-term disability payments are available, especially for complications. But, the financial impact of a doctor’s maternity leave on the overall unit is usually minimal due to the number of participants in the system. The extra workload is diffused over a larger number of doctors, so the new schedule is generally manageable.4 And since the salary of the employee/physician includes a portion of nonclinical time (administrative, teaching, research), the actual decrease in revenue isn’t that dramatic.
 

How about maternity leave in private practice?

Maternity leave in private practice, especially if there is only a small number of partners, is handled entirely differently. Think of a household budget (rent, utilities, salaries, benefits, insurance) that is shared by “roommates,” the other partners in the group. To understand how maternity leave affects a private practice, you have to understand how your private practice operates.

Typically, newly hired private practice physicians receive a set salary, with the expectation that their patient revenue will eventually cover both their share of overhead and their salary. The practice might set a monthly quota, offering a bonus for exceeding it, or they may retain the extra revenue until the physician becomes a full partner.

Income in private practice is almost entirely generated by seeing patients and performing procedures, as opposed to non-reimbursable activities such as committee meetings or lectures. Physicians learn to be highly efficient with their time, a standard also expected of their employees. They have more control over their schedules, vacation time, and patient/procedure load. Since income is affected only after overhead costs are covered, each doctor’s approach to workload and pace doesn’t typically concern the other partners. Some physicians may be highly aggressive and efficient (and thus increase their salaries), while others may prefer a slower pace due to external responsibilities.

This arrangement is often seen as fair because the established practice helps you get started by providing the environment for you to generate revenue. This includes patient referrals, office space, and staff. In return, the practice not only hopes you will achieve its goals/quotas but may expect a return on its investment in you.

Additionally, access to shared passive revenue streams, such as a pathology lab, clinical research trials, or facility fees from an endoscopy center, may only be available once a certain level of productivity or full partnership is reached.

The initial years in private practice can be seen as a trial period. Your professional reputation, liability, and patient population are more directly in your own hands. Decision-making, patient management, and potential complications are more wholly your responsibility, which can feel isolating. However, providing excellent care can build your reputation, as satisfied patients will seek you out and generate more referrals. During this time, you need to demonstrate to your prospective partners your commitment to delivering high-quality patient care and to meeting certain minimum standards of volume. If clinical medicine is your passion, the right private practice role can be a fulfilling platform where you do what you love to do and simultaneously are well compensated for it.
 

 

 

How does taking maternity affect shared overhead?

Any physician requiring “leave” will affect the overall revenue of a practice. Issues regarding maternity leave in private practice can also be applied to adoption, paternity, surrogacy, foster care, or medical leave. For instance, if the cumulative overhead is $100k per month in a practice with five doctors, each doctor contributes $20k monthly, totaling $240k each annually.

For example, Dr. “Jones” generates $480k in charges/collections, so after paying his share of overhead, his salary is $240k for the year. In contrast, Dr. “Smith” works more intensely, doubling the patients and procedures of Dr. “Jones,” and generates $960k. After deducting the overhead, his salary is $720k, more than twice his partner’s salary.

Let’s say the practice is considering hiring a new doctor who is 2 months pregnant. If he/she generates $380k in charges in the first year but owes $240k in shared overhead, his/her salary would be $140k, which is not very attractive as a “starting salary” for a highly competent, well-trained GI physician. In extreme cases, with high overhead and low productivity, there might be no revenue for salary once the overhead is paid.
 

In private practice, is there hesitancy hiring a pregnant person?

While it’s illegal to inquire about pregnancy during employment interviews, partners in private practice might still hesitate to hire a pregnant person. Concerns include sharing overhead costs, handling extra calls or emergencies, and wanting new physicians to contribute equally.

However, this viewpoint can be shortsighted. Three months of maternity leave is a minor “blip” in a 30-year career. Supporting a partner during maternity leave can lead to reciprocal benefits later, as older partners might also face personal or medical needs. Adopting a flexible, empathetic approach toward partners can foster goodwill, potentially enhancing revenue, teamwork, and patient care over a long-term career. The value of empathy should not be underestimated.
 

What should you consider when you are applying for a new private practice job?

When applying for a private practice position, here are some key points to consider:

  • If possible, have your children while employed by a large healthcare system with an established leave policy.
  • In a private practice job, ensure the employment contract clearly outlines the terms of medical leave (maternity, paternity, adoption, illness), including details on overhead, benefits, salary, call schedule, and the path to full partnership. Consider having a lawyer review the contract.
  • Inquire about how other types of leave, like sabbatical, personal, family, military, or medical, are managed. Understand the implications for salary and overhead, for example, in cases of a partner needing extended leave for surgery or rehabilitation.
  • Review the requirements for becoming a full partner, particularly if this includes potential future passive income sources. Does maternity leave (or other types of leave) alter this path?
  • Examine the entire benefit package, with a focus on long-term disability policies, considering the statistics on both temporary and permanent disability among GI doctors.5
  • Negotiate terms for overhead during leave. Options might include a long term or interest-free loan to cover the 3-month sum, a 50% reduction in overhead charges, or “overhead protection insurance” where a designated policy covers overhead for partners on medical leave.

Remember, a brief leave in a 30-year career is relatively minor. Prioritize taking enough time for yourself and your child. Concentrate on long term fairness when engaged in salary negotiations. Don’t rush back; there will be time later to compensate for a temporary decrease in salary, but limited opportunities to spend age-specific time with your young child.

References

1. Butkus R, et al. Achieving Gender Equity in Physician Compensation and Career Advancement: A Position Paper of the American College of Physicians. Ann Intern Med. 2018 May 15. doi: 10.7326/M17-3438.

2. American Medical Association. Advancing Gender Equity in Medicine: Resources for physicians. 2024 Feb 28.

3. Devi J, et al. Fixing the leaky pipeline: gender imbalance in gastroenterology in Asia-Pacific region. J Gastroenterol Hepatol. 2023 Sept. doi: 10.1111/jgh.16353.

4. Mahadevan U, et al. Closing the gender gap: building a successful career and leadership in research as a female gastroenterologist. Lancet Gastroenterol Hepatol. 2022 Jun. doi: 10.1016/S2468-1253(22)00135-2.

5. Murphy R. Know your maternity leave options. 2024 Apr 4.

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Marybeth Spanarkel, MD, a Duke University School of Medicine alumna (1979), completed her internal medicine and gastroenterology training at the University of Pennsylvania, National Institutes of Health, and Johns Hopkins. Initially groomed for an academic role, she chose a clinical position in private practice at Duke Regional Hospital in Durham, North Carolina, where she worked for 25 years.

At age 59, Dr. Spanarkel suffered a neck injury leading to permanent C5-6 radiculopathy, which abruptly ended her career as a clinical gastroenterologist. Since then, she has been a passionate advocate for ergonomic reform in endoscopy. Currently, she is the senior medical adviser and cofounder of ColoWrap, a device designed to improve colonoscopy procedures and reduce ergonomic risk.

Dr. Spanarkel
Dr. Marybeth Spanarkel


Dr. Spanarkel spoke with GI & Hepatology News about the issues that gastroenterologists should consider when negotiating maternity/paternity leave in private practice.
 

Would you share with the readers your experience with maternity leave in private practice?

As a mother of four, I had two children during my GI fellowship, and received my full salary each time for a 3-month maternity leave. My third child arrived in the time period between leaving my academic position and starting in private practice. My fourth child was born after 2 years in private practice, and I took 3 weeks off. Fortunately, I was not asked to pay upfront overhead fees in my 15-person practice. However, my reduced productivity during that time was factored into my salary calculations, leading to a decreased income for the following 6 months.

How does pregnancy affect your performance and productivity as a GI physician?

We” may be having a baby, but “You” are pregnant. While some may experience few symptoms, most pregnant doctors deal with problems such as nausea and extreme fatigue, especially in the first trimester. The third trimester may result in reduced physical agility, particularly when performing procedures. Even in uncomplicated pregnancies, balancing the physiologic changes with the demands of a full-time GI role can be strenuous. And this doesn’t even take into account potential infertility issues, pregnancy complications, or newborn concerns that physicians may encounter.

And after childbirth?

Post childbirth, despite a supportive partner, the primary responsibilities such as feeding, nursing support, and bonding often fall on the biological mother. These duties are superimposed on the doctor’s own recovery and postpartum changes. While the United States commonly recognizes 3 months as a standard maternity leave, some European countries advocate for up to 12 months, demonstrating again that this is not an “overnight” transition.

In the past, GI doctors were mostly male, but now there’s a growing number of females in the field. Despite this shift, studies still highlight continued gender disparities in salaries and leadership opportunities, and support for pregnancy-related issues has been largely under-addressed.1,2,3

How do academic centers manage maternity leave?

In academic centers or large healthcare settings, maternity leave policies are more standardized compared with private practice. Doctors are salaried depending on their level of training and experience and then they are assigned a mix of clinical, research, teaching, and/or administrative duties.

Typically, maternity leave in these centers is a standard 3-month period, often combining paid time off (PTO) with unpaid or paid leave. In some cases, short- or long-term disability payments are available, especially for complications. But, the financial impact of a doctor’s maternity leave on the overall unit is usually minimal due to the number of participants in the system. The extra workload is diffused over a larger number of doctors, so the new schedule is generally manageable.4 And since the salary of the employee/physician includes a portion of nonclinical time (administrative, teaching, research), the actual decrease in revenue isn’t that dramatic.
 

How about maternity leave in private practice?

Maternity leave in private practice, especially if there is only a small number of partners, is handled entirely differently. Think of a household budget (rent, utilities, salaries, benefits, insurance) that is shared by “roommates,” the other partners in the group. To understand how maternity leave affects a private practice, you have to understand how your private practice operates.

Typically, newly hired private practice physicians receive a set salary, with the expectation that their patient revenue will eventually cover both their share of overhead and their salary. The practice might set a monthly quota, offering a bonus for exceeding it, or they may retain the extra revenue until the physician becomes a full partner.

Income in private practice is almost entirely generated by seeing patients and performing procedures, as opposed to non-reimbursable activities such as committee meetings or lectures. Physicians learn to be highly efficient with their time, a standard also expected of their employees. They have more control over their schedules, vacation time, and patient/procedure load. Since income is affected only after overhead costs are covered, each doctor’s approach to workload and pace doesn’t typically concern the other partners. Some physicians may be highly aggressive and efficient (and thus increase their salaries), while others may prefer a slower pace due to external responsibilities.

This arrangement is often seen as fair because the established practice helps you get started by providing the environment for you to generate revenue. This includes patient referrals, office space, and staff. In return, the practice not only hopes you will achieve its goals/quotas but may expect a return on its investment in you.

Additionally, access to shared passive revenue streams, such as a pathology lab, clinical research trials, or facility fees from an endoscopy center, may only be available once a certain level of productivity or full partnership is reached.

The initial years in private practice can be seen as a trial period. Your professional reputation, liability, and patient population are more directly in your own hands. Decision-making, patient management, and potential complications are more wholly your responsibility, which can feel isolating. However, providing excellent care can build your reputation, as satisfied patients will seek you out and generate more referrals. During this time, you need to demonstrate to your prospective partners your commitment to delivering high-quality patient care and to meeting certain minimum standards of volume. If clinical medicine is your passion, the right private practice role can be a fulfilling platform where you do what you love to do and simultaneously are well compensated for it.
 

 

 

How does taking maternity affect shared overhead?

Any physician requiring “leave” will affect the overall revenue of a practice. Issues regarding maternity leave in private practice can also be applied to adoption, paternity, surrogacy, foster care, or medical leave. For instance, if the cumulative overhead is $100k per month in a practice with five doctors, each doctor contributes $20k monthly, totaling $240k each annually.

For example, Dr. “Jones” generates $480k in charges/collections, so after paying his share of overhead, his salary is $240k for the year. In contrast, Dr. “Smith” works more intensely, doubling the patients and procedures of Dr. “Jones,” and generates $960k. After deducting the overhead, his salary is $720k, more than twice his partner’s salary.

Let’s say the practice is considering hiring a new doctor who is 2 months pregnant. If he/she generates $380k in charges in the first year but owes $240k in shared overhead, his/her salary would be $140k, which is not very attractive as a “starting salary” for a highly competent, well-trained GI physician. In extreme cases, with high overhead and low productivity, there might be no revenue for salary once the overhead is paid.
 

In private practice, is there hesitancy hiring a pregnant person?

While it’s illegal to inquire about pregnancy during employment interviews, partners in private practice might still hesitate to hire a pregnant person. Concerns include sharing overhead costs, handling extra calls or emergencies, and wanting new physicians to contribute equally.

However, this viewpoint can be shortsighted. Three months of maternity leave is a minor “blip” in a 30-year career. Supporting a partner during maternity leave can lead to reciprocal benefits later, as older partners might also face personal or medical needs. Adopting a flexible, empathetic approach toward partners can foster goodwill, potentially enhancing revenue, teamwork, and patient care over a long-term career. The value of empathy should not be underestimated.
 

What should you consider when you are applying for a new private practice job?

When applying for a private practice position, here are some key points to consider:

  • If possible, have your children while employed by a large healthcare system with an established leave policy.
  • In a private practice job, ensure the employment contract clearly outlines the terms of medical leave (maternity, paternity, adoption, illness), including details on overhead, benefits, salary, call schedule, and the path to full partnership. Consider having a lawyer review the contract.
  • Inquire about how other types of leave, like sabbatical, personal, family, military, or medical, are managed. Understand the implications for salary and overhead, for example, in cases of a partner needing extended leave for surgery or rehabilitation.
  • Review the requirements for becoming a full partner, particularly if this includes potential future passive income sources. Does maternity leave (or other types of leave) alter this path?
  • Examine the entire benefit package, with a focus on long-term disability policies, considering the statistics on both temporary and permanent disability among GI doctors.5
  • Negotiate terms for overhead during leave. Options might include a long term or interest-free loan to cover the 3-month sum, a 50% reduction in overhead charges, or “overhead protection insurance” where a designated policy covers overhead for partners on medical leave.

Remember, a brief leave in a 30-year career is relatively minor. Prioritize taking enough time for yourself and your child. Concentrate on long term fairness when engaged in salary negotiations. Don’t rush back; there will be time later to compensate for a temporary decrease in salary, but limited opportunities to spend age-specific time with your young child.

References

1. Butkus R, et al. Achieving Gender Equity in Physician Compensation and Career Advancement: A Position Paper of the American College of Physicians. Ann Intern Med. 2018 May 15. doi: 10.7326/M17-3438.

2. American Medical Association. Advancing Gender Equity in Medicine: Resources for physicians. 2024 Feb 28.

3. Devi J, et al. Fixing the leaky pipeline: gender imbalance in gastroenterology in Asia-Pacific region. J Gastroenterol Hepatol. 2023 Sept. doi: 10.1111/jgh.16353.

4. Mahadevan U, et al. Closing the gender gap: building a successful career and leadership in research as a female gastroenterologist. Lancet Gastroenterol Hepatol. 2022 Jun. doi: 10.1016/S2468-1253(22)00135-2.

5. Murphy R. Know your maternity leave options. 2024 Apr 4.

Marybeth Spanarkel, MD, a Duke University School of Medicine alumna (1979), completed her internal medicine and gastroenterology training at the University of Pennsylvania, National Institutes of Health, and Johns Hopkins. Initially groomed for an academic role, she chose a clinical position in private practice at Duke Regional Hospital in Durham, North Carolina, where she worked for 25 years.

At age 59, Dr. Spanarkel suffered a neck injury leading to permanent C5-6 radiculopathy, which abruptly ended her career as a clinical gastroenterologist. Since then, she has been a passionate advocate for ergonomic reform in endoscopy. Currently, she is the senior medical adviser and cofounder of ColoWrap, a device designed to improve colonoscopy procedures and reduce ergonomic risk.

Dr. Spanarkel
Dr. Marybeth Spanarkel


Dr. Spanarkel spoke with GI & Hepatology News about the issues that gastroenterologists should consider when negotiating maternity/paternity leave in private practice.
 

Would you share with the readers your experience with maternity leave in private practice?

As a mother of four, I had two children during my GI fellowship, and received my full salary each time for a 3-month maternity leave. My third child arrived in the time period between leaving my academic position and starting in private practice. My fourth child was born after 2 years in private practice, and I took 3 weeks off. Fortunately, I was not asked to pay upfront overhead fees in my 15-person practice. However, my reduced productivity during that time was factored into my salary calculations, leading to a decreased income for the following 6 months.

How does pregnancy affect your performance and productivity as a GI physician?

We” may be having a baby, but “You” are pregnant. While some may experience few symptoms, most pregnant doctors deal with problems such as nausea and extreme fatigue, especially in the first trimester. The third trimester may result in reduced physical agility, particularly when performing procedures. Even in uncomplicated pregnancies, balancing the physiologic changes with the demands of a full-time GI role can be strenuous. And this doesn’t even take into account potential infertility issues, pregnancy complications, or newborn concerns that physicians may encounter.

And after childbirth?

Post childbirth, despite a supportive partner, the primary responsibilities such as feeding, nursing support, and bonding often fall on the biological mother. These duties are superimposed on the doctor’s own recovery and postpartum changes. While the United States commonly recognizes 3 months as a standard maternity leave, some European countries advocate for up to 12 months, demonstrating again that this is not an “overnight” transition.

In the past, GI doctors were mostly male, but now there’s a growing number of females in the field. Despite this shift, studies still highlight continued gender disparities in salaries and leadership opportunities, and support for pregnancy-related issues has been largely under-addressed.1,2,3

How do academic centers manage maternity leave?

In academic centers or large healthcare settings, maternity leave policies are more standardized compared with private practice. Doctors are salaried depending on their level of training and experience and then they are assigned a mix of clinical, research, teaching, and/or administrative duties.

Typically, maternity leave in these centers is a standard 3-month period, often combining paid time off (PTO) with unpaid or paid leave. In some cases, short- or long-term disability payments are available, especially for complications. But, the financial impact of a doctor’s maternity leave on the overall unit is usually minimal due to the number of participants in the system. The extra workload is diffused over a larger number of doctors, so the new schedule is generally manageable.4 And since the salary of the employee/physician includes a portion of nonclinical time (administrative, teaching, research), the actual decrease in revenue isn’t that dramatic.
 

How about maternity leave in private practice?

Maternity leave in private practice, especially if there is only a small number of partners, is handled entirely differently. Think of a household budget (rent, utilities, salaries, benefits, insurance) that is shared by “roommates,” the other partners in the group. To understand how maternity leave affects a private practice, you have to understand how your private practice operates.

Typically, newly hired private practice physicians receive a set salary, with the expectation that their patient revenue will eventually cover both their share of overhead and their salary. The practice might set a monthly quota, offering a bonus for exceeding it, or they may retain the extra revenue until the physician becomes a full partner.

Income in private practice is almost entirely generated by seeing patients and performing procedures, as opposed to non-reimbursable activities such as committee meetings or lectures. Physicians learn to be highly efficient with their time, a standard also expected of their employees. They have more control over their schedules, vacation time, and patient/procedure load. Since income is affected only after overhead costs are covered, each doctor’s approach to workload and pace doesn’t typically concern the other partners. Some physicians may be highly aggressive and efficient (and thus increase their salaries), while others may prefer a slower pace due to external responsibilities.

This arrangement is often seen as fair because the established practice helps you get started by providing the environment for you to generate revenue. This includes patient referrals, office space, and staff. In return, the practice not only hopes you will achieve its goals/quotas but may expect a return on its investment in you.

Additionally, access to shared passive revenue streams, such as a pathology lab, clinical research trials, or facility fees from an endoscopy center, may only be available once a certain level of productivity or full partnership is reached.

The initial years in private practice can be seen as a trial period. Your professional reputation, liability, and patient population are more directly in your own hands. Decision-making, patient management, and potential complications are more wholly your responsibility, which can feel isolating. However, providing excellent care can build your reputation, as satisfied patients will seek you out and generate more referrals. During this time, you need to demonstrate to your prospective partners your commitment to delivering high-quality patient care and to meeting certain minimum standards of volume. If clinical medicine is your passion, the right private practice role can be a fulfilling platform where you do what you love to do and simultaneously are well compensated for it.
 

 

 

How does taking maternity affect shared overhead?

Any physician requiring “leave” will affect the overall revenue of a practice. Issues regarding maternity leave in private practice can also be applied to adoption, paternity, surrogacy, foster care, or medical leave. For instance, if the cumulative overhead is $100k per month in a practice with five doctors, each doctor contributes $20k monthly, totaling $240k each annually.

For example, Dr. “Jones” generates $480k in charges/collections, so after paying his share of overhead, his salary is $240k for the year. In contrast, Dr. “Smith” works more intensely, doubling the patients and procedures of Dr. “Jones,” and generates $960k. After deducting the overhead, his salary is $720k, more than twice his partner’s salary.

Let’s say the practice is considering hiring a new doctor who is 2 months pregnant. If he/she generates $380k in charges in the first year but owes $240k in shared overhead, his/her salary would be $140k, which is not very attractive as a “starting salary” for a highly competent, well-trained GI physician. In extreme cases, with high overhead and low productivity, there might be no revenue for salary once the overhead is paid.
 

In private practice, is there hesitancy hiring a pregnant person?

While it’s illegal to inquire about pregnancy during employment interviews, partners in private practice might still hesitate to hire a pregnant person. Concerns include sharing overhead costs, handling extra calls or emergencies, and wanting new physicians to contribute equally.

However, this viewpoint can be shortsighted. Three months of maternity leave is a minor “blip” in a 30-year career. Supporting a partner during maternity leave can lead to reciprocal benefits later, as older partners might also face personal or medical needs. Adopting a flexible, empathetic approach toward partners can foster goodwill, potentially enhancing revenue, teamwork, and patient care over a long-term career. The value of empathy should not be underestimated.
 

What should you consider when you are applying for a new private practice job?

When applying for a private practice position, here are some key points to consider:

  • If possible, have your children while employed by a large healthcare system with an established leave policy.
  • In a private practice job, ensure the employment contract clearly outlines the terms of medical leave (maternity, paternity, adoption, illness), including details on overhead, benefits, salary, call schedule, and the path to full partnership. Consider having a lawyer review the contract.
  • Inquire about how other types of leave, like sabbatical, personal, family, military, or medical, are managed. Understand the implications for salary and overhead, for example, in cases of a partner needing extended leave for surgery or rehabilitation.
  • Review the requirements for becoming a full partner, particularly if this includes potential future passive income sources. Does maternity leave (or other types of leave) alter this path?
  • Examine the entire benefit package, with a focus on long-term disability policies, considering the statistics on both temporary and permanent disability among GI doctors.5
  • Negotiate terms for overhead during leave. Options might include a long term or interest-free loan to cover the 3-month sum, a 50% reduction in overhead charges, or “overhead protection insurance” where a designated policy covers overhead for partners on medical leave.

Remember, a brief leave in a 30-year career is relatively minor. Prioritize taking enough time for yourself and your child. Concentrate on long term fairness when engaged in salary negotiations. Don’t rush back; there will be time later to compensate for a temporary decrease in salary, but limited opportunities to spend age-specific time with your young child.

References

1. Butkus R, et al. Achieving Gender Equity in Physician Compensation and Career Advancement: A Position Paper of the American College of Physicians. Ann Intern Med. 2018 May 15. doi: 10.7326/M17-3438.

2. American Medical Association. Advancing Gender Equity in Medicine: Resources for physicians. 2024 Feb 28.

3. Devi J, et al. Fixing the leaky pipeline: gender imbalance in gastroenterology in Asia-Pacific region. J Gastroenterol Hepatol. 2023 Sept. doi: 10.1111/jgh.16353.

4. Mahadevan U, et al. Closing the gender gap: building a successful career and leadership in research as a female gastroenterologist. Lancet Gastroenterol Hepatol. 2022 Jun. doi: 10.1016/S2468-1253(22)00135-2.

5. Murphy R. Know your maternity leave options. 2024 Apr 4.

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Gluconolactone

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Changed
Fri, 07/26/2024 - 15:37

 

Gluconolactone, 3,4,5-trihydroxy-6-(hydroxymethyl) oxan-2-one (C6H10O6), is known to display antioxidant, moisturizing, and soothing activity as well as enhance skin barrier function and protect elastin fibers from UV-engendered damage.1 This derivative of oxidized glucose lactone is present naturally in bread, cheese, fruit juices, honey, tofu, and wine, and is used as a food additive in Europe.1,2 In dermatology, it is most often used in chemical peels.

Polyhydroxy acids (PHAs) were discovered about 3 decades ago to exert similar functions as alpha hydroxy acids without provoking sensory irritation reactions. Gluconolactone along with lactobionic acid were the identified PHAs and further characterized as delivering more humectant and moisturizing activity than alpha hydroxy acids and effective in combination with retinoic acid to treat adult acne and with retinyl acetate to confer antiaging benefits.3 It is typically added to products for its skin-conditioning qualities, resulting in smoother, brighter, more toned skin.4 This column focuses on recent studies using this bioactive agent for dermatologic purposes.
 

Split-Face Studies Show Various Benefits

peepo/E+/Getty Images

In 2023, Jarząbek-Perz and colleagues conducted a split-face evaluation to assess the effects on various skin parameters (ie, hydration, pH, sebum, and transepidermal water loss [TEWL]) of gluconolactone and oxybrasion, compared with gluconolactone and microneedling. Twenty-one White women underwent a series of three split-face treatments at 1-week intervals. Chemical peels with 10% gluconolactone were performed on the whole face. The right side of the face was also treated with oxybrasion and the left with microneedle mesotherapy. Skin parameters were measured before the first and third treatments and 2 weeks following the final treatment. Photos were taken before and after the study. Both treatments resulted in improved hydration and reductions in sebum, pH, and TEWL. No statistically significant differences were noted between the treatment protocols. The researchers concluded that gluconolactone peels can be effectively combined with oxybrasion or microneedle mesotherapy to enhance skin hydration and to secure the hydrolipid barrier.5

Later that year, the same team evaluated pH, sebum levels, and TEWL before, during, and after several applications of 10% and 30% gluconolactone chemical peels in a split-face model in 16 female participants. The investigators conducted three procedures on both sides of the face, taking measurements on the forehead, periorbital area, on the cheek, and on the nose wing before, during, and 7 days after the final treatment. They found statistically significant improvements in sebum levels in the cheeks after the treatment series. Also, pH values were lower at each measurement site after each procedure. TEWL levels were significantly diminished around the eyes, as well as the left forehead and right cheek, with no significant discrepancy between gluconolactone concentrations. The researchers concluded that gluconolactone plays a major role in reducing cutaneous pH and TEWL and imparts a regulatory effect on sebum.1

Two years earlier, Jarząbek-Perz and colleagues assessed skin moisture in a split-face model in 16 healthy women after the application of 10% and 30% gluconolactone. Investigators measured skin moisture before and after each of three treatments and a week after the final treatment from the forehead, periorbital area, and on the cheek. They observed no significant discrepancies between the 10% and 30% formulations, but a significant elevation in facial skin hydration was found to be promoted by gluconolactone. The investigators concluded that gluconolactone is an effective moisturizer for care of dry skin.6

Topical Formulation

In 2023, Zerbinati and colleagues determined that a gluconolactone-based lotion that they had begun testing 2 years earlier was safe and effective for dermatologic applications, with the noncomedogenic formulation found suitable as an antiaging agent, particularly as it treats aging-related pore dilatation.7,8

Acne Treatment

In 2019, Kantikosum and colleagues conducted a double-blind, within-person comparative study to assess the efficacy of various cosmeceutical ingredients, including gluconolactone, glycolic acid, licochalcone A, and salicylic acid, combined with the acne treatment adapalene vs adapalene monotherapy for mild to moderate acne. Each of 25 subjects over 28 days applied a product mixed with 0.1% adapalene on one side of the face, and 0.1% adapalene alone on the other side of the face once nightly. The VISIA camera system spot score pointed to a statistically significant improvement on the combination sides. Differences in lesion reduction and severity were within acceptable margins, the authors reported. They concluded that the cosmeceutical combinations yielded similar benefits as adapalene alone, with the combination formulations decreasing acne complications.9

Potential Use as an Antifibrotic Agent

Baumann Cosmetic &amp; Research Institute
Dr. Leslie S. Baumann

In 2018, Jayamani and colleagues investigated the antifibrotic characteristics of glucono-delta-lactone, a known acidifier, to ascertain if it could directly suppress collagen fibrils or even cause them to disintegrate. The researchers noted that collagen fibrillation is pH dependent, and that glucono-delta-lactone was found to exert a concentration-dependent suppression of fibrils and disintegration of preformed collagen fibrils with the antifibrotic function of the compound ascribed to its capacity to decrease pH. Further, glucono-delta-lactone appeared to emerge as an ideal antifibrotic agent as it left intact the triple helical structure of collagen after treatment. The investigators concluded that glucono-delta-lactone provides the foundation for developing antifibrotic agents intended to treat disorders characterized by collagen deposition.10

Conclusion

Gluconolactone emerged in the 1990s as a PHA useful in skin peels as an alternative to alpha hydroxy acids because of its nonirritating qualities. Since then, its soothing, hydrating, and, in particular, antiacne and antiaging qualities have become established. Wider applications of this versatile agent for dermatologic purposes are likely to be further investigated.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as a ecommerce solution. Write to her at dermnews@mdedge.com.

References

1. Jarząbek-Perz S et al. J Cosmet Dermatol. 2023 Dec;22(12):3305-3312..

2. Qin X et al. Front Physiol. 2022 Mar 14;13:856699.

3. Grimes PE et al. Cutis. 2004 Feb;73(2 Suppl):3-13.

4. Glaser DA. Facial Plast Surg Clin North Am. 2003 May;11(2):219-227.

5. Jarząbek-Perz S et al. Skin Res Technol. 2023 Jun;29(6):e13353.

6. Jarząbek-Perz S et al. Skin Res Technol. 2021 Sep;27(5):925-930.

7. Zerbinati N et al. Molecules. 2021 Dec 15;26(24):7592.

8. Zerbinati Net al. Pharmaceuticals (Basel). 2023 Apr 27;16(5):655.

9. Kantikosum K et al. Clin Cosmet Investig Dermatol. 2019 Feb 19;12:151-161.

10. Jayamani J et al. Int J Biol Macromol. 2018 Feb;107(Pt A):175-185.

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Gluconolactone, 3,4,5-trihydroxy-6-(hydroxymethyl) oxan-2-one (C6H10O6), is known to display antioxidant, moisturizing, and soothing activity as well as enhance skin barrier function and protect elastin fibers from UV-engendered damage.1 This derivative of oxidized glucose lactone is present naturally in bread, cheese, fruit juices, honey, tofu, and wine, and is used as a food additive in Europe.1,2 In dermatology, it is most often used in chemical peels.

Polyhydroxy acids (PHAs) were discovered about 3 decades ago to exert similar functions as alpha hydroxy acids without provoking sensory irritation reactions. Gluconolactone along with lactobionic acid were the identified PHAs and further characterized as delivering more humectant and moisturizing activity than alpha hydroxy acids and effective in combination with retinoic acid to treat adult acne and with retinyl acetate to confer antiaging benefits.3 It is typically added to products for its skin-conditioning qualities, resulting in smoother, brighter, more toned skin.4 This column focuses on recent studies using this bioactive agent for dermatologic purposes.
 

Split-Face Studies Show Various Benefits

peepo/E+/Getty Images

In 2023, Jarząbek-Perz and colleagues conducted a split-face evaluation to assess the effects on various skin parameters (ie, hydration, pH, sebum, and transepidermal water loss [TEWL]) of gluconolactone and oxybrasion, compared with gluconolactone and microneedling. Twenty-one White women underwent a series of three split-face treatments at 1-week intervals. Chemical peels with 10% gluconolactone were performed on the whole face. The right side of the face was also treated with oxybrasion and the left with microneedle mesotherapy. Skin parameters were measured before the first and third treatments and 2 weeks following the final treatment. Photos were taken before and after the study. Both treatments resulted in improved hydration and reductions in sebum, pH, and TEWL. No statistically significant differences were noted between the treatment protocols. The researchers concluded that gluconolactone peels can be effectively combined with oxybrasion or microneedle mesotherapy to enhance skin hydration and to secure the hydrolipid barrier.5

Later that year, the same team evaluated pH, sebum levels, and TEWL before, during, and after several applications of 10% and 30% gluconolactone chemical peels in a split-face model in 16 female participants. The investigators conducted three procedures on both sides of the face, taking measurements on the forehead, periorbital area, on the cheek, and on the nose wing before, during, and 7 days after the final treatment. They found statistically significant improvements in sebum levels in the cheeks after the treatment series. Also, pH values were lower at each measurement site after each procedure. TEWL levels were significantly diminished around the eyes, as well as the left forehead and right cheek, with no significant discrepancy between gluconolactone concentrations. The researchers concluded that gluconolactone plays a major role in reducing cutaneous pH and TEWL and imparts a regulatory effect on sebum.1

Two years earlier, Jarząbek-Perz and colleagues assessed skin moisture in a split-face model in 16 healthy women after the application of 10% and 30% gluconolactone. Investigators measured skin moisture before and after each of three treatments and a week after the final treatment from the forehead, periorbital area, and on the cheek. They observed no significant discrepancies between the 10% and 30% formulations, but a significant elevation in facial skin hydration was found to be promoted by gluconolactone. The investigators concluded that gluconolactone is an effective moisturizer for care of dry skin.6

Topical Formulation

In 2023, Zerbinati and colleagues determined that a gluconolactone-based lotion that they had begun testing 2 years earlier was safe and effective for dermatologic applications, with the noncomedogenic formulation found suitable as an antiaging agent, particularly as it treats aging-related pore dilatation.7,8

Acne Treatment

In 2019, Kantikosum and colleagues conducted a double-blind, within-person comparative study to assess the efficacy of various cosmeceutical ingredients, including gluconolactone, glycolic acid, licochalcone A, and salicylic acid, combined with the acne treatment adapalene vs adapalene monotherapy for mild to moderate acne. Each of 25 subjects over 28 days applied a product mixed with 0.1% adapalene on one side of the face, and 0.1% adapalene alone on the other side of the face once nightly. The VISIA camera system spot score pointed to a statistically significant improvement on the combination sides. Differences in lesion reduction and severity were within acceptable margins, the authors reported. They concluded that the cosmeceutical combinations yielded similar benefits as adapalene alone, with the combination formulations decreasing acne complications.9

Potential Use as an Antifibrotic Agent

Baumann Cosmetic &amp; Research Institute
Dr. Leslie S. Baumann

In 2018, Jayamani and colleagues investigated the antifibrotic characteristics of glucono-delta-lactone, a known acidifier, to ascertain if it could directly suppress collagen fibrils or even cause them to disintegrate. The researchers noted that collagen fibrillation is pH dependent, and that glucono-delta-lactone was found to exert a concentration-dependent suppression of fibrils and disintegration of preformed collagen fibrils with the antifibrotic function of the compound ascribed to its capacity to decrease pH. Further, glucono-delta-lactone appeared to emerge as an ideal antifibrotic agent as it left intact the triple helical structure of collagen after treatment. The investigators concluded that glucono-delta-lactone provides the foundation for developing antifibrotic agents intended to treat disorders characterized by collagen deposition.10

Conclusion

Gluconolactone emerged in the 1990s as a PHA useful in skin peels as an alternative to alpha hydroxy acids because of its nonirritating qualities. Since then, its soothing, hydrating, and, in particular, antiacne and antiaging qualities have become established. Wider applications of this versatile agent for dermatologic purposes are likely to be further investigated.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as a ecommerce solution. Write to her at dermnews@mdedge.com.

References

1. Jarząbek-Perz S et al. J Cosmet Dermatol. 2023 Dec;22(12):3305-3312..

2. Qin X et al. Front Physiol. 2022 Mar 14;13:856699.

3. Grimes PE et al. Cutis. 2004 Feb;73(2 Suppl):3-13.

4. Glaser DA. Facial Plast Surg Clin North Am. 2003 May;11(2):219-227.

5. Jarząbek-Perz S et al. Skin Res Technol. 2023 Jun;29(6):e13353.

6. Jarząbek-Perz S et al. Skin Res Technol. 2021 Sep;27(5):925-930.

7. Zerbinati N et al. Molecules. 2021 Dec 15;26(24):7592.

8. Zerbinati Net al. Pharmaceuticals (Basel). 2023 Apr 27;16(5):655.

9. Kantikosum K et al. Clin Cosmet Investig Dermatol. 2019 Feb 19;12:151-161.

10. Jayamani J et al. Int J Biol Macromol. 2018 Feb;107(Pt A):175-185.

 

Gluconolactone, 3,4,5-trihydroxy-6-(hydroxymethyl) oxan-2-one (C6H10O6), is known to display antioxidant, moisturizing, and soothing activity as well as enhance skin barrier function and protect elastin fibers from UV-engendered damage.1 This derivative of oxidized glucose lactone is present naturally in bread, cheese, fruit juices, honey, tofu, and wine, and is used as a food additive in Europe.1,2 In dermatology, it is most often used in chemical peels.

Polyhydroxy acids (PHAs) were discovered about 3 decades ago to exert similar functions as alpha hydroxy acids without provoking sensory irritation reactions. Gluconolactone along with lactobionic acid were the identified PHAs and further characterized as delivering more humectant and moisturizing activity than alpha hydroxy acids and effective in combination with retinoic acid to treat adult acne and with retinyl acetate to confer antiaging benefits.3 It is typically added to products for its skin-conditioning qualities, resulting in smoother, brighter, more toned skin.4 This column focuses on recent studies using this bioactive agent for dermatologic purposes.
 

Split-Face Studies Show Various Benefits

peepo/E+/Getty Images

In 2023, Jarząbek-Perz and colleagues conducted a split-face evaluation to assess the effects on various skin parameters (ie, hydration, pH, sebum, and transepidermal water loss [TEWL]) of gluconolactone and oxybrasion, compared with gluconolactone and microneedling. Twenty-one White women underwent a series of three split-face treatments at 1-week intervals. Chemical peels with 10% gluconolactone were performed on the whole face. The right side of the face was also treated with oxybrasion and the left with microneedle mesotherapy. Skin parameters were measured before the first and third treatments and 2 weeks following the final treatment. Photos were taken before and after the study. Both treatments resulted in improved hydration and reductions in sebum, pH, and TEWL. No statistically significant differences were noted between the treatment protocols. The researchers concluded that gluconolactone peels can be effectively combined with oxybrasion or microneedle mesotherapy to enhance skin hydration and to secure the hydrolipid barrier.5

Later that year, the same team evaluated pH, sebum levels, and TEWL before, during, and after several applications of 10% and 30% gluconolactone chemical peels in a split-face model in 16 female participants. The investigators conducted three procedures on both sides of the face, taking measurements on the forehead, periorbital area, on the cheek, and on the nose wing before, during, and 7 days after the final treatment. They found statistically significant improvements in sebum levels in the cheeks after the treatment series. Also, pH values were lower at each measurement site after each procedure. TEWL levels were significantly diminished around the eyes, as well as the left forehead and right cheek, with no significant discrepancy between gluconolactone concentrations. The researchers concluded that gluconolactone plays a major role in reducing cutaneous pH and TEWL and imparts a regulatory effect on sebum.1

Two years earlier, Jarząbek-Perz and colleagues assessed skin moisture in a split-face model in 16 healthy women after the application of 10% and 30% gluconolactone. Investigators measured skin moisture before and after each of three treatments and a week after the final treatment from the forehead, periorbital area, and on the cheek. They observed no significant discrepancies between the 10% and 30% formulations, but a significant elevation in facial skin hydration was found to be promoted by gluconolactone. The investigators concluded that gluconolactone is an effective moisturizer for care of dry skin.6

Topical Formulation

In 2023, Zerbinati and colleagues determined that a gluconolactone-based lotion that they had begun testing 2 years earlier was safe and effective for dermatologic applications, with the noncomedogenic formulation found suitable as an antiaging agent, particularly as it treats aging-related pore dilatation.7,8

Acne Treatment

In 2019, Kantikosum and colleagues conducted a double-blind, within-person comparative study to assess the efficacy of various cosmeceutical ingredients, including gluconolactone, glycolic acid, licochalcone A, and salicylic acid, combined with the acne treatment adapalene vs adapalene monotherapy for mild to moderate acne. Each of 25 subjects over 28 days applied a product mixed with 0.1% adapalene on one side of the face, and 0.1% adapalene alone on the other side of the face once nightly. The VISIA camera system spot score pointed to a statistically significant improvement on the combination sides. Differences in lesion reduction and severity were within acceptable margins, the authors reported. They concluded that the cosmeceutical combinations yielded similar benefits as adapalene alone, with the combination formulations decreasing acne complications.9

Potential Use as an Antifibrotic Agent

Baumann Cosmetic &amp; Research Institute
Dr. Leslie S. Baumann

In 2018, Jayamani and colleagues investigated the antifibrotic characteristics of glucono-delta-lactone, a known acidifier, to ascertain if it could directly suppress collagen fibrils or even cause them to disintegrate. The researchers noted that collagen fibrillation is pH dependent, and that glucono-delta-lactone was found to exert a concentration-dependent suppression of fibrils and disintegration of preformed collagen fibrils with the antifibrotic function of the compound ascribed to its capacity to decrease pH. Further, glucono-delta-lactone appeared to emerge as an ideal antifibrotic agent as it left intact the triple helical structure of collagen after treatment. The investigators concluded that glucono-delta-lactone provides the foundation for developing antifibrotic agents intended to treat disorders characterized by collagen deposition.10

Conclusion

Gluconolactone emerged in the 1990s as a PHA useful in skin peels as an alternative to alpha hydroxy acids because of its nonirritating qualities. Since then, its soothing, hydrating, and, in particular, antiacne and antiaging qualities have become established. Wider applications of this versatile agent for dermatologic purposes are likely to be further investigated.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions, a SaaS company used to generate skin care routines in office and as a ecommerce solution. Write to her at dermnews@mdedge.com.

References

1. Jarząbek-Perz S et al. J Cosmet Dermatol. 2023 Dec;22(12):3305-3312..

2. Qin X et al. Front Physiol. 2022 Mar 14;13:856699.

3. Grimes PE et al. Cutis. 2004 Feb;73(2 Suppl):3-13.

4. Glaser DA. Facial Plast Surg Clin North Am. 2003 May;11(2):219-227.

5. Jarząbek-Perz S et al. Skin Res Technol. 2023 Jun;29(6):e13353.

6. Jarząbek-Perz S et al. Skin Res Technol. 2021 Sep;27(5):925-930.

7. Zerbinati N et al. Molecules. 2021 Dec 15;26(24):7592.

8. Zerbinati Net al. Pharmaceuticals (Basel). 2023 Apr 27;16(5):655.

9. Kantikosum K et al. Clin Cosmet Investig Dermatol. 2019 Feb 19;12:151-161.

10. Jayamani J et al. Int J Biol Macromol. 2018 Feb;107(Pt A):175-185.

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The Rise of the Scribes

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Changed
Fri, 07/26/2024 - 09:27

 

“We really aren’t taking care of records — we’re taking care of people.”Dr. Lawrence Weed

What is the purpose of a progress note? Anyone? Yes, you there. “Insurance billing?” Yes, that’s a good one. Anyone else? “To remember what you did?” Excellent. Another? Yes, that’s right, for others to follow along in your care. These are all good reasons for a progress note to exist. But they aren’t the whole story. Let’s start at the beginning.

Charts were once a collection of paper sheets with handwritten notes. Sometimes illegible, sometimes beautiful, always efficient. A progress note back then could be just 10 characters, AK, LN2, X,X,X,X,X (with X’s marking nitrogen sprays). Then came the healthcare K-Pg event: the conversion to EMRs. Those doctors who survived evolved into computer programmers, creating blocks of text from a few keystrokes. But like toddler-sized Legos, the blocks made it impossible to build a note that is nuanced or precise. Worse yet, many notes consisting of blocks from one note added awkwardly to a new note, creating grotesque structures unrecognizable as anything that should exist in nature. Words and numbers, but no information.

Newtown grafitti / flickr / CC BY-2.0
Paper medical records

Thanks to the eternity of EMR, these creations live on, hideous and useless. They waste not only the server’s energy but also our time. Few things are more maddening than scrolling to reach the bottom of another physician’s note only to find there is nothing there.

Whose fault is this? Anyone? Yes, that’s right, insurers. As there are probably no payers in this audience, let’s blame them. I agree, the crushing burden of documentation-to-get-reimbursed has forced us to create “notes” that add no value to us but add up points for us to get paid for them. CMS, payers, prior authorizations, and now even patients, it seems we are documenting for lots of people except for us. There isn’t time to satisfy all and this significant burden for every encounter is a proximate cause for doctors despair. Until now.

In 2024, came our story’s deus ex machina: the AI scribe. A tool that can listen to a doctor visit, then from the ether, generate a note. A fully formed, comprehensive, sometimes pretty note that satisfies all audiences. Dr. Larry Weed must be dancing in heaven. It was Dr. Weed who led us from the nicotine-stained logs of the 1950s to the powerful problem-based notes we use today, an innovation that rivals the stethoscope in its impact.

Professor Weed also predicted that computers would be important to capture and make sense of patient data, helping us make accurate diagnoses and efficient plans. Again, he was right. He would surely be advocating to take advantage of AI scribes’ marvelous ability to capture salient data and present it in the form of a problem-oriented medical record.

AI scribes will be ubiquitous soon; I’m fast and even for me they save time. They also allow, for the first time in a decade, to turn from the glow of a screen to actually face the patient – we no longer have to scribe and care simultaneously. Hallelujah. And yet, lest I disappoint you without a twist, it seems with AI scribes, like EMRs we lose a little something too.

Like self-driving cars or ChatGPT-generated letters, they remove cognitive loads. They are lovely when you have to multitask or are trying to recall a visit from hours (days) ago. Using them, you’ll feel faster, lighter, freer, happier. But what’s missing is the thinking. At the end, you have an exquisite note, but you didn’t write it. It has the salient points, but none of the mental work to create it. AI scribes subvert the valuable work of synthesis. That was the critical part of Dr. Weed’s discovery: writing problem-oriented notes helped us think better.

Kaiser Permanente
Dr. Jeffrey Benabio

Writing allows for the friction that helps us process what is going on with a patient. It allows for the discovery of diagnoses and prompts plans. When I was an intern, one of my attendings would hand write notes, succinctly showing what he had observed and was thinking. He’d sketch diagrams in the chart, for example, to help illustrate how we’d work though the toxic, metabolic, and infectious etiologies of acute liver failure. Sublime.

The act of writing also helps remind us there is a person attached to these words. Like a handwritten sympathy card, it is intimate, human. Even using our EMR, I’d still often type sentences that help tell the patient’s story. “Her sister just died. Utterly devastated. I’ll forward chart to Bob (her PCP) to check in on her.” Or: “Scratch golfer wants to know why he is getting so many SCCs now. ‘Like bankruptcy, gradually then suddenly,’ I explained. I think I broke through.”

Since we’ve concluded the purpose of a note is mostly to capture data, AI scribes are a godsend. They do so with remarkable quality and efficiency. We’ll just have to remember if the diagnosis is unclear, then it might help to write the note out yourself. And even when done by the AI machine, we might add human touches now and again lest there be no art left in what we do.

“For sale. Sun hat. Never worn.”

 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at dermnews@mdedge.com.

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“We really aren’t taking care of records — we’re taking care of people.”Dr. Lawrence Weed

What is the purpose of a progress note? Anyone? Yes, you there. “Insurance billing?” Yes, that’s a good one. Anyone else? “To remember what you did?” Excellent. Another? Yes, that’s right, for others to follow along in your care. These are all good reasons for a progress note to exist. But they aren’t the whole story. Let’s start at the beginning.

Charts were once a collection of paper sheets with handwritten notes. Sometimes illegible, sometimes beautiful, always efficient. A progress note back then could be just 10 characters, AK, LN2, X,X,X,X,X (with X’s marking nitrogen sprays). Then came the healthcare K-Pg event: the conversion to EMRs. Those doctors who survived evolved into computer programmers, creating blocks of text from a few keystrokes. But like toddler-sized Legos, the blocks made it impossible to build a note that is nuanced or precise. Worse yet, many notes consisting of blocks from one note added awkwardly to a new note, creating grotesque structures unrecognizable as anything that should exist in nature. Words and numbers, but no information.

Newtown grafitti / flickr / CC BY-2.0
Paper medical records

Thanks to the eternity of EMR, these creations live on, hideous and useless. They waste not only the server’s energy but also our time. Few things are more maddening than scrolling to reach the bottom of another physician’s note only to find there is nothing there.

Whose fault is this? Anyone? Yes, that’s right, insurers. As there are probably no payers in this audience, let’s blame them. I agree, the crushing burden of documentation-to-get-reimbursed has forced us to create “notes” that add no value to us but add up points for us to get paid for them. CMS, payers, prior authorizations, and now even patients, it seems we are documenting for lots of people except for us. There isn’t time to satisfy all and this significant burden for every encounter is a proximate cause for doctors despair. Until now.

In 2024, came our story’s deus ex machina: the AI scribe. A tool that can listen to a doctor visit, then from the ether, generate a note. A fully formed, comprehensive, sometimes pretty note that satisfies all audiences. Dr. Larry Weed must be dancing in heaven. It was Dr. Weed who led us from the nicotine-stained logs of the 1950s to the powerful problem-based notes we use today, an innovation that rivals the stethoscope in its impact.

Professor Weed also predicted that computers would be important to capture and make sense of patient data, helping us make accurate diagnoses and efficient plans. Again, he was right. He would surely be advocating to take advantage of AI scribes’ marvelous ability to capture salient data and present it in the form of a problem-oriented medical record.

AI scribes will be ubiquitous soon; I’m fast and even for me they save time. They also allow, for the first time in a decade, to turn from the glow of a screen to actually face the patient – we no longer have to scribe and care simultaneously. Hallelujah. And yet, lest I disappoint you without a twist, it seems with AI scribes, like EMRs we lose a little something too.

Like self-driving cars or ChatGPT-generated letters, they remove cognitive loads. They are lovely when you have to multitask or are trying to recall a visit from hours (days) ago. Using them, you’ll feel faster, lighter, freer, happier. But what’s missing is the thinking. At the end, you have an exquisite note, but you didn’t write it. It has the salient points, but none of the mental work to create it. AI scribes subvert the valuable work of synthesis. That was the critical part of Dr. Weed’s discovery: writing problem-oriented notes helped us think better.

Kaiser Permanente
Dr. Jeffrey Benabio

Writing allows for the friction that helps us process what is going on with a patient. It allows for the discovery of diagnoses and prompts plans. When I was an intern, one of my attendings would hand write notes, succinctly showing what he had observed and was thinking. He’d sketch diagrams in the chart, for example, to help illustrate how we’d work though the toxic, metabolic, and infectious etiologies of acute liver failure. Sublime.

The act of writing also helps remind us there is a person attached to these words. Like a handwritten sympathy card, it is intimate, human. Even using our EMR, I’d still often type sentences that help tell the patient’s story. “Her sister just died. Utterly devastated. I’ll forward chart to Bob (her PCP) to check in on her.” Or: “Scratch golfer wants to know why he is getting so many SCCs now. ‘Like bankruptcy, gradually then suddenly,’ I explained. I think I broke through.”

Since we’ve concluded the purpose of a note is mostly to capture data, AI scribes are a godsend. They do so with remarkable quality and efficiency. We’ll just have to remember if the diagnosis is unclear, then it might help to write the note out yourself. And even when done by the AI machine, we might add human touches now and again lest there be no art left in what we do.

“For sale. Sun hat. Never worn.”

 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at dermnews@mdedge.com.

 

“We really aren’t taking care of records — we’re taking care of people.”Dr. Lawrence Weed

What is the purpose of a progress note? Anyone? Yes, you there. “Insurance billing?” Yes, that’s a good one. Anyone else? “To remember what you did?” Excellent. Another? Yes, that’s right, for others to follow along in your care. These are all good reasons for a progress note to exist. But they aren’t the whole story. Let’s start at the beginning.

Charts were once a collection of paper sheets with handwritten notes. Sometimes illegible, sometimes beautiful, always efficient. A progress note back then could be just 10 characters, AK, LN2, X,X,X,X,X (with X’s marking nitrogen sprays). Then came the healthcare K-Pg event: the conversion to EMRs. Those doctors who survived evolved into computer programmers, creating blocks of text from a few keystrokes. But like toddler-sized Legos, the blocks made it impossible to build a note that is nuanced or precise. Worse yet, many notes consisting of blocks from one note added awkwardly to a new note, creating grotesque structures unrecognizable as anything that should exist in nature. Words and numbers, but no information.

Newtown grafitti / flickr / CC BY-2.0
Paper medical records

Thanks to the eternity of EMR, these creations live on, hideous and useless. They waste not only the server’s energy but also our time. Few things are more maddening than scrolling to reach the bottom of another physician’s note only to find there is nothing there.

Whose fault is this? Anyone? Yes, that’s right, insurers. As there are probably no payers in this audience, let’s blame them. I agree, the crushing burden of documentation-to-get-reimbursed has forced us to create “notes” that add no value to us but add up points for us to get paid for them. CMS, payers, prior authorizations, and now even patients, it seems we are documenting for lots of people except for us. There isn’t time to satisfy all and this significant burden for every encounter is a proximate cause for doctors despair. Until now.

In 2024, came our story’s deus ex machina: the AI scribe. A tool that can listen to a doctor visit, then from the ether, generate a note. A fully formed, comprehensive, sometimes pretty note that satisfies all audiences. Dr. Larry Weed must be dancing in heaven. It was Dr. Weed who led us from the nicotine-stained logs of the 1950s to the powerful problem-based notes we use today, an innovation that rivals the stethoscope in its impact.

Professor Weed also predicted that computers would be important to capture and make sense of patient data, helping us make accurate diagnoses and efficient plans. Again, he was right. He would surely be advocating to take advantage of AI scribes’ marvelous ability to capture salient data and present it in the form of a problem-oriented medical record.

AI scribes will be ubiquitous soon; I’m fast and even for me they save time. They also allow, for the first time in a decade, to turn from the glow of a screen to actually face the patient – we no longer have to scribe and care simultaneously. Hallelujah. And yet, lest I disappoint you without a twist, it seems with AI scribes, like EMRs we lose a little something too.

Like self-driving cars or ChatGPT-generated letters, they remove cognitive loads. They are lovely when you have to multitask or are trying to recall a visit from hours (days) ago. Using them, you’ll feel faster, lighter, freer, happier. But what’s missing is the thinking. At the end, you have an exquisite note, but you didn’t write it. It has the salient points, but none of the mental work to create it. AI scribes subvert the valuable work of synthesis. That was the critical part of Dr. Weed’s discovery: writing problem-oriented notes helped us think better.

Kaiser Permanente
Dr. Jeffrey Benabio

Writing allows for the friction that helps us process what is going on with a patient. It allows for the discovery of diagnoses and prompts plans. When I was an intern, one of my attendings would hand write notes, succinctly showing what he had observed and was thinking. He’d sketch diagrams in the chart, for example, to help illustrate how we’d work though the toxic, metabolic, and infectious etiologies of acute liver failure. Sublime.

The act of writing also helps remind us there is a person attached to these words. Like a handwritten sympathy card, it is intimate, human. Even using our EMR, I’d still often type sentences that help tell the patient’s story. “Her sister just died. Utterly devastated. I’ll forward chart to Bob (her PCP) to check in on her.” Or: “Scratch golfer wants to know why he is getting so many SCCs now. ‘Like bankruptcy, gradually then suddenly,’ I explained. I think I broke through.”

Since we’ve concluded the purpose of a note is mostly to capture data, AI scribes are a godsend. They do so with remarkable quality and efficiency. We’ll just have to remember if the diagnosis is unclear, then it might help to write the note out yourself. And even when done by the AI machine, we might add human touches now and again lest there be no art left in what we do.

“For sale. Sun hat. Never worn.”

 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at dermnews@mdedge.com.

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