Practice Management

I enjoyed Dr. Jonas’s article, “A new model of care to return holism to family medicine” (J Fam Pract. 2020;69:493-498).

However, I wanted to point out that for more than 100 years the concept of the patient-centered medical home, and the outgrowth of that, has been part of osteopathic medical education, founded by A.T. Still, MD, in the 1800s.

Congratulations to the allopathic medicine profession for recognizing its significance.

Steven Shapiro, DO
Fenton, MI

I enjoyed Dr. Jonas’s article, “A new model of care to return holism to family medicine” (J Fam Pract. 2020;69:493-498).

However, I wanted to point out that for more than 100 years the concept of the patient-centered medical home, and the outgrowth of that, has been part of osteopathic medical education, founded by A.T. Still, MD, in the 1800s.

Congratulations to the allopathic medicine profession for recognizing its significance.

Steven Shapiro, DO
Fenton, MI

I enjoyed Dr. Jonas’s article, “A new model of care to return holism to family medicine” (J Fam Pract. 2020;69:493-498).

However, I wanted to point out that for more than 100 years the concept of the patient-centered medical home, and the outgrowth of that, has been part of osteopathic medical education, founded by A.T. Still, MD, in the 1800s.

Congratulations to the allopathic medicine profession for recognizing its significance.

Steven Shapiro, DO
Fenton, MI

In 2020, COVID-19 disrupted our medical system, and life in general. In the 1980s, the AIDS epidemic devastated communities and overwhelmed hospitals. There were lessons learned from the AIDS epidemic that can be applied to the current situation.

Patients with HIV-spectrum illness faced stigmatization and societal indifference, including rejection by family members, increased rates of suicide, fears of sexual and/or intrauterine transmission, substance abuse issues, and alterations of body image for those with wasting syndromes and disfiguring Kaposi lesions. AIDS prevention strategies such as the provision of condoms and needle exchange programs were controversial, and many caregivers exposed to contaminated fluids had to endure months of antiretroviral treatment.

Similar to the AIDS epidemic, the COVID-19 pandemic has had significant psychological implications for patients and caregivers. Patients with COVID-19 infections also face feelings of guilt over potentially exposing a family member to the virus; devastating socioeconomic issues; restrictive hospital visitation policies for family members; disease news oversaturation; and feelings of hopelessness. People with AIDS in the 1980s faced the possibility of dying alone, and there was initial skepticism about medications to treat HIV—just as some individuals are now uneasy about recently introduced coronavirus vaccines.

Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers and depoliticizing prevention strategies.

The similarities of both diseases allow us some foresight on how to deal with current COVID-19 issues. Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers, creating advocacy and support groups for when a patient’s family is unavailable, instilling public confidence in treatment options, maintaining staff morale, addressing substance abuse (due to COVID-related stress), and depoliticizing prevention strategies. Addressing these issues is especially critical for minority populations.

As respected medical care leaders, we can provide and draw extra attention to the needs of patients’ family members and health care personnel during this COVID-19 pandemic. Hopefully, the distribution of vaccines will shorten some of our communal and professional distress.

Robert Frierson, MD
Steven Lippmann, MD
Louisville, KY

In 2020, COVID-19 disrupted our medical system, and life in general. In the 1980s, the AIDS epidemic devastated communities and overwhelmed hospitals. There were lessons learned from the AIDS epidemic that can be applied to the current situation.

Patients with HIV-spectrum illness faced stigmatization and societal indifference, including rejection by family members, increased rates of suicide, fears of sexual and/or intrauterine transmission, substance abuse issues, and alterations of body image for those with wasting syndromes and disfiguring Kaposi lesions. AIDS prevention strategies such as the provision of condoms and needle exchange programs were controversial, and many caregivers exposed to contaminated fluids had to endure months of antiretroviral treatment.

Similar to the AIDS epidemic, the COVID-19 pandemic has had significant psychological implications for patients and caregivers. Patients with COVID-19 infections also face feelings of guilt over potentially exposing a family member to the virus; devastating socioeconomic issues; restrictive hospital visitation policies for family members; disease news oversaturation; and feelings of hopelessness. People with AIDS in the 1980s faced the possibility of dying alone, and there was initial skepticism about medications to treat HIV—just as some individuals are now uneasy about recently introduced coronavirus vaccines.

Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers and depoliticizing prevention strategies.

The similarities of both diseases allow us some foresight on how to deal with current COVID-19 issues. Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers, creating advocacy and support groups for when a patient’s family is unavailable, instilling public confidence in treatment options, maintaining staff morale, addressing substance abuse (due to COVID-related stress), and depoliticizing prevention strategies. Addressing these issues is especially critical for minority populations.

As respected medical care leaders, we can provide and draw extra attention to the needs of patients’ family members and health care personnel during this COVID-19 pandemic. Hopefully, the distribution of vaccines will shorten some of our communal and professional distress.

Robert Frierson, MD
Steven Lippmann, MD
Louisville, KY

In 2020, COVID-19 disrupted our medical system, and life in general. In the 1980s, the AIDS epidemic devastated communities and overwhelmed hospitals. There were lessons learned from the AIDS epidemic that can be applied to the current situation.

Patients with HIV-spectrum illness faced stigmatization and societal indifference, including rejection by family members, increased rates of suicide, fears of sexual and/or intrauterine transmission, substance abuse issues, and alterations of body image for those with wasting syndromes and disfiguring Kaposi lesions. AIDS prevention strategies such as the provision of condoms and needle exchange programs were controversial, and many caregivers exposed to contaminated fluids had to endure months of antiretroviral treatment.

Similar to the AIDS epidemic, the COVID-19 pandemic has had significant psychological implications for patients and caregivers. Patients with COVID-19 infections also face feelings of guilt over potentially exposing a family member to the virus; devastating socioeconomic issues; restrictive hospital visitation policies for family members; disease news oversaturation; and feelings of hopelessness. People with AIDS in the 1980s faced the possibility of dying alone, and there was initial skepticism about medications to treat HIV—just as some individuals are now uneasy about recently introduced coronavirus vaccines.

Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers and depoliticizing prevention strategies.

The similarities of both diseases allow us some foresight on how to deal with current COVID-19 issues. Looking back on the AIDS epidemic should teach us to prioritize attending to the mental health of sufferers and caregivers, creating advocacy and support groups for when a patient’s family is unavailable, instilling public confidence in treatment options, maintaining staff morale, addressing substance abuse (due to COVID-related stress), and depoliticizing prevention strategies. Addressing these issues is especially critical for minority populations.

As respected medical care leaders, we can provide and draw extra attention to the needs of patients’ family members and health care personnel during this COVID-19 pandemic. Hopefully, the distribution of vaccines will shorten some of our communal and professional distress.

Robert Frierson, MD
Steven Lippmann, MD
Louisville, KY

An initiative designed to improve sharing of patient data may provide “tremendous benefits” in cancer care and research, according to authors of a review article.

The goals of the initiative, called Minimal Common Oncology Data Elements (mCODE), were to identify the data elements in electronic health records that are “essential” for making treatment decisions and create “a standardized computable data format” that would improve the exchange of data across EHRs, according to the mCODE website.

Travis J. Osterman, DO, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues described the mCODE initiative in a review published in JCO Clinical Cancer Informatics.

At present, commercially available EHRs are poorly designed to support modern oncology workflow, requiring laborious data entry and lacking a common library of oncology-specific discrete data elements. As an example, most EHRs poorly support the needs of precision oncology and clinical genetics, since next-generation sequencing and genetic test results are almost universally reported in PDF files.

In addition, basic, operational oncology data (e.g., cancer staging, adverse event documentation, response to treatment, etc.) are captured in EHRs primarily as an unstructured narrative.

Computable, analytical data are found for only the small percentage of patients in clinical trials. Even then, some degree of manual data abstraction is regularly required.

Interoperability of EHRs between practices and health care institutions is often so poor that the transfer of basic cancer-related information as analyzable data is difficult or even impossible.
 

Making progress: The 21st Century Cures Act

The American Society of Clinical Oncology has a more than 15-year history of developing oncology data standards. Unfortunately, progress in implementing these standards has been glacially slow. Impediments have included:

• A lack of conformance with clinical workflows.
• Failure to test standards on specific-use cases during pilot testing.
• A focus on data exchange, rather than the practical impediments to data entry.
• Poor engagement with EHR vendors in distributing clinical information modules with an oncology-specific focus
• Instability of data interoperability technologies.

The 21st Century Cures Act, which became law in December 2016, mandated improvement in the interoperability of health information through the development of data standards and application programming interfaces.

In early 2020, final rules for implementation required technology vendors to employ application programming interfaces using a single interoperability resource. In addition, payers were required to use the United States Core Data for Interoperability Standard for data exchange. These requirements were intended to provide patients with access to their own health care data “without special effort.”

As a fortunate byproduct, since EHR vendors are required to implement application program interfaces using the Health Level Seven International (HL7) Fast Healthcare Interoperability Resource (FHIR) Specification, the final rules could enable systems like mCODE to be more easily integrated with existing EHRs.
 

Lessons from CancerLinQ

ASCO created the health technology platform CancerLinQ in 2014, envisioning that it could become an oncology-focused learning health system – a system in which internal data and experience are systematically integrated with external evidence, allowing knowledge to be put into practice.

CancerLinQ extracts data from EHRs and other sources via direct software connections. CancerLinQ then aggregates, harmonizes, and normalizes the data in a cloud-based environment.

The data are available to participating practices for quality improvement in patient care and secondary research. In 2020, records of cancer patients in the CancerLinQ database surpassed 2 million.

CancerLinQ has been successful. However, because of the nature of the EHR ecosystem and the scope and variability of data capture by clinicians, supporting a true learning health system has proven to be a formidable task. Postprocessing manual review using trained human curators is laborious and unsustainable.

The CancerLinQ experience illustrated that basic cancer-pertinent data should be standardized in the EHR and collected prospectively.
 

The mCODE model

The mCODE initiative seeks to facilitate progress in care quality, clinical research, and health care policy by developing and maintaining a standard, computable, interoperable data format.

Guiding principles that were adopted early in mCODE’s development included:

• A collaborative, noncommercial, use case–driven developmental model.
• Iterative processes.
• User-driven development, refinement, and maintenance.
• Low ongoing maintenance requirements.

A foundational moment in mCODE’s development involved achieving consensus among stakeholders that the project would fail if EHR vendors required additional data entry by users.

After pilot work, a real-world endpoints project, working-group deliberation, public comment, and refinement, the final data standard included six primary domains: patient, disease, laboratory data/vital signs, genomics, treatment, and outcome.

Each domain is further divided into several concepts with specific associated data elements. The data elements are modeled into value sets that specify the possible values for the data element.

To test mCODE, eight organizations representing oncology EHR vendors, standards developers, and research organizations participated in a cancer interoperability track. The comments helped refine mCODE version 1.0, which was released in March 2020 and is accessible via the mCODE website.

Additions will likely be reviewed by a technical review group after external piloting of new use cases.
 

Innovation, not regulation

Every interaction between a patient and care provider yields information that could lead to improved safety and better outcomes. To be successful, the information must be collected in a computable format so it can be aggregated with data from other patients, analyzed without manual curation, and shared through interoperable systems. Those data should also be secure enough to protect the privacy of individual patients.

mCODE is a consensus data standard for oncology that provides an infrastructure to share patient data between oncology practices and health care systems while promising little to no additional data entry on the part of clinicians. Adoption by sites will be critical, however.

Publishing the standard through the HL7 FHIR technology demonstrated to EHR vendors and regulatory agencies the stability of HL7, an essential requirement for its incorporation into software.

EHR vendors and others are engaged in the CodeX HL7 FHIR Accelerator to design projects to expand and/or modify mCODE. Their creativity and innovativeness via the external advisory mCODE council and/or CodeX will be encouraged to help mCODE reach its full potential.

As part of CodeX, the Community of Practice, an open forum for end users, was established to provide regular updates about mCODE-related initiatives and use cases to solicit in-progress input, according to Robert S. Miller, MD, medical director of CancerLinQ and an author of the mCODE review.

For mCODE to be embraced by all stakeholders, there should be no additional regulations. By engaging stakeholders in an enterprise that supports innovation and collaboration – without additional regulation – mCODE could maximize the potential of EHRs that, until now, have assisted us only marginally in accomplishing those goals.

mCODE is a joint venture of ASCO/CancerLinQ, the Alliance for Clinical Trials in Oncology Foundation, the MITRE Corporation, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Dr. Osterman disclosed a grant from the National Cancer Institute and relationships with Infostratix, eHealth, AstraZeneca, Outcomes Insights, Biodesix, MD Outlook, GenomOncology, Cota Healthcare, GE Healthcare, and Microsoft. Dr. Miller and the third review author disclosed no conflicts of interest.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

An initiative designed to improve sharing of patient data may provide “tremendous benefits” in cancer care and research, according to authors of a review article.

The goals of the initiative, called Minimal Common Oncology Data Elements (mCODE), were to identify the data elements in electronic health records that are “essential” for making treatment decisions and create “a standardized computable data format” that would improve the exchange of data across EHRs, according to the mCODE website.

Travis J. Osterman, DO, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues described the mCODE initiative in a review published in JCO Clinical Cancer Informatics.

At present, commercially available EHRs are poorly designed to support modern oncology workflow, requiring laborious data entry and lacking a common library of oncology-specific discrete data elements. As an example, most EHRs poorly support the needs of precision oncology and clinical genetics, since next-generation sequencing and genetic test results are almost universally reported in PDF files.

In addition, basic, operational oncology data (e.g., cancer staging, adverse event documentation, response to treatment, etc.) are captured in EHRs primarily as an unstructured narrative.

Computable, analytical data are found for only the small percentage of patients in clinical trials. Even then, some degree of manual data abstraction is regularly required.

Interoperability of EHRs between practices and health care institutions is often so poor that the transfer of basic cancer-related information as analyzable data is difficult or even impossible.
 

Making progress: The 21st Century Cures Act

The American Society of Clinical Oncology has a more than 15-year history of developing oncology data standards. Unfortunately, progress in implementing these standards has been glacially slow. Impediments have included:

• A lack of conformance with clinical workflows.
• Failure to test standards on specific-use cases during pilot testing.
• A focus on data exchange, rather than the practical impediments to data entry.
• Poor engagement with EHR vendors in distributing clinical information modules with an oncology-specific focus
• Instability of data interoperability technologies.

The 21st Century Cures Act, which became law in December 2016, mandated improvement in the interoperability of health information through the development of data standards and application programming interfaces.

In early 2020, final rules for implementation required technology vendors to employ application programming interfaces using a single interoperability resource. In addition, payers were required to use the United States Core Data for Interoperability Standard for data exchange. These requirements were intended to provide patients with access to their own health care data “without special effort.”

As a fortunate byproduct, since EHR vendors are required to implement application program interfaces using the Health Level Seven International (HL7) Fast Healthcare Interoperability Resource (FHIR) Specification, the final rules could enable systems like mCODE to be more easily integrated with existing EHRs.
 

Lessons from CancerLinQ

ASCO created the health technology platform CancerLinQ in 2014, envisioning that it could become an oncology-focused learning health system – a system in which internal data and experience are systematically integrated with external evidence, allowing knowledge to be put into practice.

CancerLinQ extracts data from EHRs and other sources via direct software connections. CancerLinQ then aggregates, harmonizes, and normalizes the data in a cloud-based environment.

The data are available to participating practices for quality improvement in patient care and secondary research. In 2020, records of cancer patients in the CancerLinQ database surpassed 2 million.

CancerLinQ has been successful. However, because of the nature of the EHR ecosystem and the scope and variability of data capture by clinicians, supporting a true learning health system has proven to be a formidable task. Postprocessing manual review using trained human curators is laborious and unsustainable.

The CancerLinQ experience illustrated that basic cancer-pertinent data should be standardized in the EHR and collected prospectively.
 

The mCODE model

The mCODE initiative seeks to facilitate progress in care quality, clinical research, and health care policy by developing and maintaining a standard, computable, interoperable data format.

Guiding principles that were adopted early in mCODE’s development included:

• A collaborative, noncommercial, use case–driven developmental model.
• Iterative processes.
• User-driven development, refinement, and maintenance.
• Low ongoing maintenance requirements.

A foundational moment in mCODE’s development involved achieving consensus among stakeholders that the project would fail if EHR vendors required additional data entry by users.

After pilot work, a real-world endpoints project, working-group deliberation, public comment, and refinement, the final data standard included six primary domains: patient, disease, laboratory data/vital signs, genomics, treatment, and outcome.

Each domain is further divided into several concepts with specific associated data elements. The data elements are modeled into value sets that specify the possible values for the data element.

To test mCODE, eight organizations representing oncology EHR vendors, standards developers, and research organizations participated in a cancer interoperability track. The comments helped refine mCODE version 1.0, which was released in March 2020 and is accessible via the mCODE website.

Additions will likely be reviewed by a technical review group after external piloting of new use cases.
 

Innovation, not regulation

Every interaction between a patient and care provider yields information that could lead to improved safety and better outcomes. To be successful, the information must be collected in a computable format so it can be aggregated with data from other patients, analyzed without manual curation, and shared through interoperable systems. Those data should also be secure enough to protect the privacy of individual patients.

mCODE is a consensus data standard for oncology that provides an infrastructure to share patient data between oncology practices and health care systems while promising little to no additional data entry on the part of clinicians. Adoption by sites will be critical, however.

Publishing the standard through the HL7 FHIR technology demonstrated to EHR vendors and regulatory agencies the stability of HL7, an essential requirement for its incorporation into software.

EHR vendors and others are engaged in the CodeX HL7 FHIR Accelerator to design projects to expand and/or modify mCODE. Their creativity and innovativeness via the external advisory mCODE council and/or CodeX will be encouraged to help mCODE reach its full potential.

As part of CodeX, the Community of Practice, an open forum for end users, was established to provide regular updates about mCODE-related initiatives and use cases to solicit in-progress input, according to Robert S. Miller, MD, medical director of CancerLinQ and an author of the mCODE review.

For mCODE to be embraced by all stakeholders, there should be no additional regulations. By engaging stakeholders in an enterprise that supports innovation and collaboration – without additional regulation – mCODE could maximize the potential of EHRs that, until now, have assisted us only marginally in accomplishing those goals.

mCODE is a joint venture of ASCO/CancerLinQ, the Alliance for Clinical Trials in Oncology Foundation, the MITRE Corporation, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Dr. Osterman disclosed a grant from the National Cancer Institute and relationships with Infostratix, eHealth, AstraZeneca, Outcomes Insights, Biodesix, MD Outlook, GenomOncology, Cota Healthcare, GE Healthcare, and Microsoft. Dr. Miller and the third review author disclosed no conflicts of interest.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

An initiative designed to improve sharing of patient data may provide “tremendous benefits” in cancer care and research, according to authors of a review article.

The goals of the initiative, called Minimal Common Oncology Data Elements (mCODE), were to identify the data elements in electronic health records that are “essential” for making treatment decisions and create “a standardized computable data format” that would improve the exchange of data across EHRs, according to the mCODE website.

Travis J. Osterman, DO, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues described the mCODE initiative in a review published in JCO Clinical Cancer Informatics.

At present, commercially available EHRs are poorly designed to support modern oncology workflow, requiring laborious data entry and lacking a common library of oncology-specific discrete data elements. As an example, most EHRs poorly support the needs of precision oncology and clinical genetics, since next-generation sequencing and genetic test results are almost universally reported in PDF files.

In addition, basic, operational oncology data (e.g., cancer staging, adverse event documentation, response to treatment, etc.) are captured in EHRs primarily as an unstructured narrative.

Computable, analytical data are found for only the small percentage of patients in clinical trials. Even then, some degree of manual data abstraction is regularly required.

Interoperability of EHRs between practices and health care institutions is often so poor that the transfer of basic cancer-related information as analyzable data is difficult or even impossible.
 

Making progress: The 21st Century Cures Act

The American Society of Clinical Oncology has a more than 15-year history of developing oncology data standards. Unfortunately, progress in implementing these standards has been glacially slow. Impediments have included:

• A lack of conformance with clinical workflows.
• Failure to test standards on specific-use cases during pilot testing.
• A focus on data exchange, rather than the practical impediments to data entry.
• Poor engagement with EHR vendors in distributing clinical information modules with an oncology-specific focus
• Instability of data interoperability technologies.

The 21st Century Cures Act, which became law in December 2016, mandated improvement in the interoperability of health information through the development of data standards and application programming interfaces.

In early 2020, final rules for implementation required technology vendors to employ application programming interfaces using a single interoperability resource. In addition, payers were required to use the United States Core Data for Interoperability Standard for data exchange. These requirements were intended to provide patients with access to their own health care data “without special effort.”

As a fortunate byproduct, since EHR vendors are required to implement application program interfaces using the Health Level Seven International (HL7) Fast Healthcare Interoperability Resource (FHIR) Specification, the final rules could enable systems like mCODE to be more easily integrated with existing EHRs.
 

Lessons from CancerLinQ

ASCO created the health technology platform CancerLinQ in 2014, envisioning that it could become an oncology-focused learning health system – a system in which internal data and experience are systematically integrated with external evidence, allowing knowledge to be put into practice.

CancerLinQ extracts data from EHRs and other sources via direct software connections. CancerLinQ then aggregates, harmonizes, and normalizes the data in a cloud-based environment.

The data are available to participating practices for quality improvement in patient care and secondary research. In 2020, records of cancer patients in the CancerLinQ database surpassed 2 million.

CancerLinQ has been successful. However, because of the nature of the EHR ecosystem and the scope and variability of data capture by clinicians, supporting a true learning health system has proven to be a formidable task. Postprocessing manual review using trained human curators is laborious and unsustainable.

The CancerLinQ experience illustrated that basic cancer-pertinent data should be standardized in the EHR and collected prospectively.
 

The mCODE model

The mCODE initiative seeks to facilitate progress in care quality, clinical research, and health care policy by developing and maintaining a standard, computable, interoperable data format.

Guiding principles that were adopted early in mCODE’s development included:

• A collaborative, noncommercial, use case–driven developmental model.
• Iterative processes.
• User-driven development, refinement, and maintenance.
• Low ongoing maintenance requirements.

A foundational moment in mCODE’s development involved achieving consensus among stakeholders that the project would fail if EHR vendors required additional data entry by users.

After pilot work, a real-world endpoints project, working-group deliberation, public comment, and refinement, the final data standard included six primary domains: patient, disease, laboratory data/vital signs, genomics, treatment, and outcome.

Each domain is further divided into several concepts with specific associated data elements. The data elements are modeled into value sets that specify the possible values for the data element.

To test mCODE, eight organizations representing oncology EHR vendors, standards developers, and research organizations participated in a cancer interoperability track. The comments helped refine mCODE version 1.0, which was released in March 2020 and is accessible via the mCODE website.

Additions will likely be reviewed by a technical review group after external piloting of new use cases.
 

Innovation, not regulation

Every interaction between a patient and care provider yields information that could lead to improved safety and better outcomes. To be successful, the information must be collected in a computable format so it can be aggregated with data from other patients, analyzed without manual curation, and shared through interoperable systems. Those data should also be secure enough to protect the privacy of individual patients.

mCODE is a consensus data standard for oncology that provides an infrastructure to share patient data between oncology practices and health care systems while promising little to no additional data entry on the part of clinicians. Adoption by sites will be critical, however.

Publishing the standard through the HL7 FHIR technology demonstrated to EHR vendors and regulatory agencies the stability of HL7, an essential requirement for its incorporation into software.

EHR vendors and others are engaged in the CodeX HL7 FHIR Accelerator to design projects to expand and/or modify mCODE. Their creativity and innovativeness via the external advisory mCODE council and/or CodeX will be encouraged to help mCODE reach its full potential.

As part of CodeX, the Community of Practice, an open forum for end users, was established to provide regular updates about mCODE-related initiatives and use cases to solicit in-progress input, according to Robert S. Miller, MD, medical director of CancerLinQ and an author of the mCODE review.

For mCODE to be embraced by all stakeholders, there should be no additional regulations. By engaging stakeholders in an enterprise that supports innovation and collaboration – without additional regulation – mCODE could maximize the potential of EHRs that, until now, have assisted us only marginally in accomplishing those goals.

mCODE is a joint venture of ASCO/CancerLinQ, the Alliance for Clinical Trials in Oncology Foundation, the MITRE Corporation, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Dr. Osterman disclosed a grant from the National Cancer Institute and relationships with Infostratix, eHealth, AstraZeneca, Outcomes Insights, Biodesix, MD Outlook, GenomOncology, Cota Healthcare, GE Healthcare, and Microsoft. Dr. Miller and the third review author disclosed no conflicts of interest.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

CASE Young woman with family history of breast cancer detects lump

Two weeks after noting a lump on her breast when her cat happened to jump on her in that spot, a 28-year-old woman (G0) went to her primary care provider. She was referred to her gynecologist; breast imaging, ultrasonography, and mammography were obtained, with microcalcifications noted. A fine needle aspiration diagnosed intraductal malignancy. The surgical breast tissue specimen was estrogen receptor (ER)- and progestogen receptor (PR)-positive and HER2-negative. Other tumor markers were obtained, including carcinoembryonic antigen, and tissue polypeptide specific antigen, p53, cathepsin D, cyclin E, and nestin, but results were not available.

With regard to family history, the woman’s mother and maternal grandmother had a history of breast cancer. The patient and her family underwent gene testing. The patient was found to be BRCA1- and BRCA2-positive; her mother was BRCA1-positive, an older sister was BRCA2-positive, and her grandmother was not tested.

The question arose in light of her family history as to why she was not tested for BRCA and appropriately counseled by her gynecologist prior to the cancer diagnosis. Litigation was initiated. While the case did not go forward regarding litigation, it is indeed a case in point. (Please note that this is a hypothetical case. It is based on a composite of several cases.)
 

Medical considerations

Breast cancer is the most common type of cancer affecting women in the Western world.¹ Advances in clinical testing for gene mutations have escalated and allowed for identification of patients at increased risk for breast and ovarian cancer. Along with these advances come professional liability risk. After looking at the medical considerations for BRCA1 and 2 testing, we will consider a number of important legal issues. In the view of some commentators, the failure to diagnose genetic mutations in patients predisposed to cancer is “poised to become the next wave of medical professional liability lawsuits.”²

BRCA1 and BRCA2 genes provide tumor suppressor proteins, and assessment for mutations is recommended for individuals at high risk for breast and/or ovarian cancer; mutations in BRCA genes cause DNA damage, which increases the chance of developing cancer. The other way to look at it is, BRCA1 and 2 are tumor suppressor genes that are integrally involved with DNA damage control. Once there is a mutation, it adversely affects the beneficial effects of the gene. Mutations in these genes account for 5% to 10% of all hereditary breast cancers.³ Of note, men with BRCA2 are at increased risk for prostate cancer.

A patient who presents to her gynecologist stating that there is a family history of breast cancer, without knowledge of genetic components, presents a challenge (and a medicolegal risk) for the provider to assess. Prediction models have been used to determine specific patient risk for carrying a genetic mutation with resultant breast cancer development.⁴ Risk prediction models do not appear to be a good answer to predicting who is more likely to develop breast or ovarian cancer, however. A Mayo model may assist (FIGURE).⁵ Clinicians should also be aware of other models of risk assessment, including the Gail Model (TABLE 1).⁶

Continue to: Guidelines for genetic testing...

Guidelines for genetic testing

The American College of Obstetricians and Gynecologists states that patient medical history and family history are paramount in obtaining information regarding risk for breast and ovarian cancer. First- and second-degree relatives are allocated to this category. Information regarding age of diagnosis, maternal and paternal lineage, and ethnic background can imply a need for genetic testing (TABLE 2).^7,8 A number of genetics national organizations have participated in recommendations and include the American College of Medical Genetics and Genomics, the National Society for Genetic Counselors, and the Society of Gynecologic Oncology.⁷

The question always surfaces, could the clinical outcome of the cancer when diagnosed have been changed if screening were undertaken, with earlier diagnosis, or prevented with prophylactic mastectomy, and changed the end result. In addition, it is well known that breast augmentation mammoplasty alters the ability to accurately evaluate mammograms. Patients considering this type of plastic surgery, ideally, should be counselled accordingly.⁹

Bottom line, we as clinicians must be cognizant of both ACOG and United States Preventive Services Task Force (USPSTF) recommendations regarding screening and gene testing for women considered high risk for breast cancer based on family history.⁷

Legal considerations

The case presented demonstrates that the discovery of the BRCA1 and BRCA2 genes, and reliable tests for determining the existence of the genes, brought with them legal issues as well as medical advantages. We look at professional liability (malpractice) questions this technology raises, and then consider the outcome of the hypothetical case. (BRCA is used here to apply broadly—not only to BRCA1 and 2 but also to PALB2, CHEK2, and similar genetic abnormalities.)

To date, the most visible BRCA legal issues covered in cases and law reviews have focused more on patent law than malpractice. The most important of these was a decision of the US Supreme Court in Association for Molecular Pathology v Myriad Genetics.¹⁰ The US Patent Office was granting patents to companies finding useful, naturally occurring segments of human DNA, and had granted Myriad several patents on BRCA1 and BRCA2 genes. This patent policy had the potential to seriously interfere with broad scientific use of these genes.¹¹ Fortunately, the Supreme Court stepped in and unanimously invalidated such patents. It held that a “naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” The Court noted, “Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible ‘new . . . composition[s] of matter.’”⁸ The Court did allow the patenting of tests for specific gene structures, and artificial changes in naturally occurring genes.

Malpractice and BRCA

While the BRCA patent wars have lingered, the potential for a significant increase in BRCA-related malpractice cases is of increasing concern. Like most malpractice liability, these new claims are based on very old principles of negligence.¹² To prevail, the plaintiff (ordinarily, an injured patient) must demonstrate 4 things:

• A duty. That is, the physician owed a duty to the injured party. Usually (but not always) that requires a professional relationship between the physician and the person injured.
• A breach of that duty. Malpractice liability is based on the fact that the physician did something that a reasonably careful physician (generally, of the same specialty) would not have done, or that the physician failed to do something that a reasonable physician would have done. This usually means that the profession itself sees what the physician did (or did not do) as medically inappropriate. In medical malpractice cases, that is ordinarily measured by what the usual or common practice is among prudent physicians. In rare circumstances, courts have found the standard practice of a profession to be negligent. Where, for example, it was custom for a professional not to give an eye pressure test to anyone under age 40, a court found that common standard to be inappropriate.¹³ In the words of Judge Learned Hand (speaking about a different case), “a whole calling may have unduly lagged in the adoption of new and available devices. It never may set its own tests.”¹⁴ Underlying negligence is a cost-benefit analysis (discussed below).
• Damages. There must have been some damage that courts recognize, usually loss of money or opportunity to work, the cost of care, pain and suffering, or loss of enjoyment/quality of life. In malpractice, many states now recognize the “loss of chance” or the “loss of a chance.” That means, if a “physician negligently fails to diagnose a curable disease, and the patient is harmed by the disease, the physician should be liable for causing the ‘loss of a chance of a cure.’”¹⁵ (Delay in diagnosis is the most common reason for claims in breast cancer care.)¹⁶
• Causation. The breach of duty (negligence) must have caused the damages. The causation must have been reasonably close. If a driver drives through a stop sign, or a physician misreads a test, and someone is injured but there is no connection between the negligence and the injury, there is not tort liability.

The 4 elements of malpractice just described are raised in some way in the possible liability associated with BRCA testing. We next look at the ways in which liability may arise from that testing (or lack of it).

Underlying much of the following discussion is the “cost-benefit” consideration noted above. This concept is that the total cost (financial and health) of testing should be compared with the value of the benefits of testing, taking into account the probabilities that the testing will result in better health outcomes. BRCA testing, for example, is essentially cost-free in terms of physical risk. Its financial cost, while not trivial, is not great, and it is commonly covered by health insurance.¹⁷ In terms of benefits, the testing has the potential for providing critical information in making treatment decisions for a meaningful percentage of patients and their families. There are many ways of analyzing the liability risks of genetic malpractice,^7,18 and the following is intended to discuss some of the greatest risks related to BRCA testing.

Continue to: Areas of liability...

 

 

Areas of liability

The failure to recommend a test. The circumstances in which BRCA testing should be undertaken are set out by professional organizations (noted above). These recommendations are not static, however. They change from time to time. Given the potential harm caused by the failure to test in relevant circumstances, malpractice liability is certainly a possibility when the failure to recommend a test to a patient results in a cancer that might have been prevented had the genetic problem been identified in a timely manner. The circumstances in which testing should be considered continue to change, placing an obligation on clinicians to stay well informed of changing genetic understandings. Another risk is that one specialist may assume that it is the job of another specialist to order the test. Whatever the cause of the failure to test, or unnecessary delay in testing, it appears to be the primary basis for BRCA liability.

The failure to properly interpret a test. Any test that is misinterpreted may lead to harm for the patient. A false negative, of course, may mean that preventive treatment that could have been undertaken will be foregone, as a “loss of a chance.” On the other hand, a false positive can lead to radical, unnecessary surgery or treatment. If a misinterpretation occurred because of carelessness by the testing organization, or confusion by a practitioner, there is a likelihood of negligence.¹⁹

A different form of “misinterpretation” could be reasonable—and not negligent. Advances in scientific-medical understanding may result in the outcome of tests being reconsidered and changed. That has been the case with genetic testing and breast cancer. The availability of multiple breast cancer SNPs (single nucleotide polymorphisms), and combining this information with other risk factors for example, results in a polygenic risk score that may be at odds with the level of risk from earlier testing.^20,21 This naturally leads to the question of when later, updated testing should be recommended to look for a better current interpretation.^22,23

The failure to act on BRCA test results. Testing is of no value, of course, if the results are not used properly. Test results or analyses that are not sent to the proper physicians, or are somehow ignored when properly directed, is a “never” event—it should never happen. It almost always would be considered negligence, and if the patient were injured, could lead to liability. Amazingly, one study found that, in genetic testing liability cases, nearly 20% of the claims arose from failure to return test results to patients.²⁴ In addition, when a patient is found to be BRCA-positive, there is an obligation to discuss the options for dealing with the increased risk associated with the gene mutation(s), as well as to recommend the prudent course of action or to refer the patient to someone who will have that discussion.

Informed consent to the patient. BRCA testing requires informed consent. The physical risks of the testing process are minimal, of course, but it carries a number of other emotional and family risks. The informed consent process is an invitation to an honest discussion between clinicians and patients. It should be an opportunity to discuss what the testing is, and is not, and what the test may mean for treatment. It may also be an opportunity to discuss the implications for other members of the patient’s family (noted below).

One element of informed consent is a discussion of the consequences of failure to consent, or to undertake one of the alternatives. In the case of BRCA testing, this is especially important in cases in which a patient expresses a hesitancy to be tested with an “I’d rather not know philosophy.” Although clinicians should not practice law, some patient concerns about discrimination may be addressed by the protection that the federal Genetic Information Nondiscrimination Act (GINA) and other laws provide (which prohibit insurance and employment discrimination based on genetic information). A good source of information about GINA and related nondiscrimination laws is provided by the National Human Genome Research Institute.²⁵ In addition, the National Institutes of Health has a website that may be helpful to many patients²⁶ (and a much more complex site for health professionals).²⁷ At the same time, courts have resisted plaintiffs/patients who have tried to use informed consent as a way of suing for failure to offer genetic testing.^28,29

The failure to refer. In some cases, a patient should be formally referred for genetics consultation. The considerations here are similar to other circumstances in modern, fast developing medical practice that require special sensitivity to those occasions in which a patient will benefit from additional expertise. It is a principle that the AMA Council on Ethical and Judicial Affairs has expressed this way: “In the absence of adequate expertise in pretest and posttest counseling, a physician should refer the patient to an appropriate specialist.”³⁰ The failure to refer, when that deviates from acceptable practice, may result in liability.

Informing others. BRCA testing is an area of medicine in which results may be of great significance not only to the patient but also to the patient’s family.³¹ Physicians should counsel patients on the importance of informing relatives about relevant results and “should make themselves available to assist patients in communicating with relatives to discuss opportunities for counseling and testing, as appropriate.”³⁰ The question may arise, however, of whether in some circumstances physicians should go a step further in ensuring relatives receive important information regarding their loved one’s health.³² The law has been reluctant to impose liability to “third parties” (someone not a patient). Duties usually arise through the physician-patient relationship. There are exceptions. Perhaps the best known has been the obligation of mental health professionals to take action to protect third parties from patients who have made believable threats against identifiable victims.³³ There are indications that some courts could find, in extreme circumstances, a “duty to warn” nonpatients in some instances where it is essential to inform third parties that they should receive a specific form of genetic testing.^34,35 Such a duty would, of course, have to protect the privacy rights of the patient to the maximum extent possible. A general duty of this type has not been established widely, but may be part of the future.

Continue to: Was there liability in our example case?...

Was there liability in our example case?

The hypothetical case provided above suggests that there could be liability. Routine medical history by the primary care physician would have produced the fact that the patient’s mother, sister, and maternal grandmother had breast cancer. That would clearly have put her in a category of those who should have received genetic testing. Yet, she was not tested until after her cancer was found. From the limited facts we have, it appears that this timeline of events would have been outside accepted practice—and negligent. The case was not pursued by the patient, however, and this may represent the current state of liability for BRCA issues.

The extent of liability seems to be significant

Our discussion of liability suggests that there is significant potential for BRCA testing negligence within practice, and that the damages in these cases could be substantial. Yet the predicted “tsunami” of malpractice lawsuits related to genetic testing has not appeared.^36,37 One study of cases in the United States (through 2016) found a “slowly rising tide” of liability cases instead of a tsunami,²⁴ as the number of claims made was low. On the other hand, the payments where damages were awarded were an order of magnitude larger than other malpractice cases—a mean of $5.3 million and median of $2 million. This is compared with mean values in the range of $275,000 to $600,000 in other areas of malpractice.

The majority of the genetic malpractice cases involve prenatal and newborn testing, and diagnosis/susceptibility/pharmacogenomic accounting for about 25% of cases. In terms of type of errors claimed, approximately 50% were diagnostic-interpretation errors, 30% failure to offer testing, nearly 20% failure to return test results to the patients, and a few remaining cases of failure to properly treat in light of genetic testing.²⁴

Despite a few very large payments, however, the fact remains that there is a surprisingly low number of genetics malpractice cases. Gary Marchant and colleagues suggest that several reasons may account for this:

• the clinical implementation of genetic science has been slower than expected
• the lack of expertise of many physicians in genetic science
• expert witnesses have sometimes been hard to find
• the lack of understanding by plaintiffs’ attorneys of genetic malpractice
• potential plaintiffs’ lack of understanding of the nature of genetic testing and the harms resulting from genetic negligence.^17,24,37

The tide is slowly coming in

By all appearances, there is every reason to think that genetic malpractice will be increasing, and that the recent past of much higher damages per claim paid in the genetics area will be part of that tide. The National Human Genome Research LawSeq project has suggested a number of useful ways of dealing with the liability issues.¹⁸ In addition to the BRCA issues that we have considered in this article for ObGyns, there are other critical issues of prenatal and newborn genetic testing.³⁸ But those are topics for another day. ●

CASE Young woman with family history of breast cancer detects lump

Two weeks after noting a lump on her breast when her cat happened to jump on her in that spot, a 28-year-old woman (G0) went to her primary care provider. She was referred to her gynecologist; breast imaging, ultrasonography, and mammography were obtained, with microcalcifications noted. A fine needle aspiration diagnosed intraductal malignancy. The surgical breast tissue specimen was estrogen receptor (ER)- and progestogen receptor (PR)-positive and HER2-negative. Other tumor markers were obtained, including carcinoembryonic antigen, and tissue polypeptide specific antigen, p53, cathepsin D, cyclin E, and nestin, but results were not available.

With regard to family history, the woman’s mother and maternal grandmother had a history of breast cancer. The patient and her family underwent gene testing. The patient was found to be BRCA1- and BRCA2-positive; her mother was BRCA1-positive, an older sister was BRCA2-positive, and her grandmother was not tested.

The question arose in light of her family history as to why she was not tested for BRCA and appropriately counseled by her gynecologist prior to the cancer diagnosis. Litigation was initiated. While the case did not go forward regarding litigation, it is indeed a case in point. (Please note that this is a hypothetical case. It is based on a composite of several cases.)
 

Medical considerations

Breast cancer is the most common type of cancer affecting women in the Western world.¹ Advances in clinical testing for gene mutations have escalated and allowed for identification of patients at increased risk for breast and ovarian cancer. Along with these advances come professional liability risk. After looking at the medical considerations for BRCA1 and 2 testing, we will consider a number of important legal issues. In the view of some commentators, the failure to diagnose genetic mutations in patients predisposed to cancer is “poised to become the next wave of medical professional liability lawsuits.”²

BRCA1 and BRCA2 genes provide tumor suppressor proteins, and assessment for mutations is recommended for individuals at high risk for breast and/or ovarian cancer; mutations in BRCA genes cause DNA damage, which increases the chance of developing cancer. The other way to look at it is, BRCA1 and 2 are tumor suppressor genes that are integrally involved with DNA damage control. Once there is a mutation, it adversely affects the beneficial effects of the gene. Mutations in these genes account for 5% to 10% of all hereditary breast cancers.³ Of note, men with BRCA2 are at increased risk for prostate cancer.

A patient who presents to her gynecologist stating that there is a family history of breast cancer, without knowledge of genetic components, presents a challenge (and a medicolegal risk) for the provider to assess. Prediction models have been used to determine specific patient risk for carrying a genetic mutation with resultant breast cancer development.⁴ Risk prediction models do not appear to be a good answer to predicting who is more likely to develop breast or ovarian cancer, however. A Mayo model may assist (FIGURE).⁵ Clinicians should also be aware of other models of risk assessment, including the Gail Model (TABLE 1).⁶

Continue to: Guidelines for genetic testing...

Guidelines for genetic testing

The American College of Obstetricians and Gynecologists states that patient medical history and family history are paramount in obtaining information regarding risk for breast and ovarian cancer. First- and second-degree relatives are allocated to this category. Information regarding age of diagnosis, maternal and paternal lineage, and ethnic background can imply a need for genetic testing (TABLE 2).^7,8 A number of genetics national organizations have participated in recommendations and include the American College of Medical Genetics and Genomics, the National Society for Genetic Counselors, and the Society of Gynecologic Oncology.⁷

The question always surfaces, could the clinical outcome of the cancer when diagnosed have been changed if screening were undertaken, with earlier diagnosis, or prevented with prophylactic mastectomy, and changed the end result. In addition, it is well known that breast augmentation mammoplasty alters the ability to accurately evaluate mammograms. Patients considering this type of plastic surgery, ideally, should be counselled accordingly.⁹

Bottom line, we as clinicians must be cognizant of both ACOG and United States Preventive Services Task Force (USPSTF) recommendations regarding screening and gene testing for women considered high risk for breast cancer based on family history.⁷

Legal considerations

The case presented demonstrates that the discovery of the BRCA1 and BRCA2 genes, and reliable tests for determining the existence of the genes, brought with them legal issues as well as medical advantages. We look at professional liability (malpractice) questions this technology raises, and then consider the outcome of the hypothetical case. (BRCA is used here to apply broadly—not only to BRCA1 and 2 but also to PALB2, CHEK2, and similar genetic abnormalities.)

To date, the most visible BRCA legal issues covered in cases and law reviews have focused more on patent law than malpractice. The most important of these was a decision of the US Supreme Court in Association for Molecular Pathology v Myriad Genetics.¹⁰ The US Patent Office was granting patents to companies finding useful, naturally occurring segments of human DNA, and had granted Myriad several patents on BRCA1 and BRCA2 genes. This patent policy had the potential to seriously interfere with broad scientific use of these genes.¹¹ Fortunately, the Supreme Court stepped in and unanimously invalidated such patents. It held that a “naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” The Court noted, “Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible ‘new . . . composition[s] of matter.’”⁸ The Court did allow the patenting of tests for specific gene structures, and artificial changes in naturally occurring genes.

Malpractice and BRCA

While the BRCA patent wars have lingered, the potential for a significant increase in BRCA-related malpractice cases is of increasing concern. Like most malpractice liability, these new claims are based on very old principles of negligence.¹² To prevail, the plaintiff (ordinarily, an injured patient) must demonstrate 4 things:

• A duty. That is, the physician owed a duty to the injured party. Usually (but not always) that requires a professional relationship between the physician and the person injured.
• A breach of that duty. Malpractice liability is based on the fact that the physician did something that a reasonably careful physician (generally, of the same specialty) would not have done, or that the physician failed to do something that a reasonable physician would have done. This usually means that the profession itself sees what the physician did (or did not do) as medically inappropriate. In medical malpractice cases, that is ordinarily measured by what the usual or common practice is among prudent physicians. In rare circumstances, courts have found the standard practice of a profession to be negligent. Where, for example, it was custom for a professional not to give an eye pressure test to anyone under age 40, a court found that common standard to be inappropriate.¹³ In the words of Judge Learned Hand (speaking about a different case), “a whole calling may have unduly lagged in the adoption of new and available devices. It never may set its own tests.”¹⁴ Underlying negligence is a cost-benefit analysis (discussed below).
• Damages. There must have been some damage that courts recognize, usually loss of money or opportunity to work, the cost of care, pain and suffering, or loss of enjoyment/quality of life. In malpractice, many states now recognize the “loss of chance” or the “loss of a chance.” That means, if a “physician negligently fails to diagnose a curable disease, and the patient is harmed by the disease, the physician should be liable for causing the ‘loss of a chance of a cure.’”¹⁵ (Delay in diagnosis is the most common reason for claims in breast cancer care.)¹⁶
• Causation. The breach of duty (negligence) must have caused the damages. The causation must have been reasonably close. If a driver drives through a stop sign, or a physician misreads a test, and someone is injured but there is no connection between the negligence and the injury, there is not tort liability.

The 4 elements of malpractice just described are raised in some way in the possible liability associated with BRCA testing. We next look at the ways in which liability may arise from that testing (or lack of it).

Underlying much of the following discussion is the “cost-benefit” consideration noted above. This concept is that the total cost (financial and health) of testing should be compared with the value of the benefits of testing, taking into account the probabilities that the testing will result in better health outcomes. BRCA testing, for example, is essentially cost-free in terms of physical risk. Its financial cost, while not trivial, is not great, and it is commonly covered by health insurance.¹⁷ In terms of benefits, the testing has the potential for providing critical information in making treatment decisions for a meaningful percentage of patients and their families. There are many ways of analyzing the liability risks of genetic malpractice,^7,18 and the following is intended to discuss some of the greatest risks related to BRCA testing.

Continue to: Areas of liability...

 

 

Areas of liability

The failure to recommend a test. The circumstances in which BRCA testing should be undertaken are set out by professional organizations (noted above). These recommendations are not static, however. They change from time to time. Given the potential harm caused by the failure to test in relevant circumstances, malpractice liability is certainly a possibility when the failure to recommend a test to a patient results in a cancer that might have been prevented had the genetic problem been identified in a timely manner. The circumstances in which testing should be considered continue to change, placing an obligation on clinicians to stay well informed of changing genetic understandings. Another risk is that one specialist may assume that it is the job of another specialist to order the test. Whatever the cause of the failure to test, or unnecessary delay in testing, it appears to be the primary basis for BRCA liability.

The failure to properly interpret a test. Any test that is misinterpreted may lead to harm for the patient. A false negative, of course, may mean that preventive treatment that could have been undertaken will be foregone, as a “loss of a chance.” On the other hand, a false positive can lead to radical, unnecessary surgery or treatment. If a misinterpretation occurred because of carelessness by the testing organization, or confusion by a practitioner, there is a likelihood of negligence.¹⁹

A different form of “misinterpretation” could be reasonable—and not negligent. Advances in scientific-medical understanding may result in the outcome of tests being reconsidered and changed. That has been the case with genetic testing and breast cancer. The availability of multiple breast cancer SNPs (single nucleotide polymorphisms), and combining this information with other risk factors for example, results in a polygenic risk score that may be at odds with the level of risk from earlier testing.^20,21 This naturally leads to the question of when later, updated testing should be recommended to look for a better current interpretation.^22,23

The failure to act on BRCA test results. Testing is of no value, of course, if the results are not used properly. Test results or analyses that are not sent to the proper physicians, or are somehow ignored when properly directed, is a “never” event—it should never happen. It almost always would be considered negligence, and if the patient were injured, could lead to liability. Amazingly, one study found that, in genetic testing liability cases, nearly 20% of the claims arose from failure to return test results to patients.²⁴ In addition, when a patient is found to be BRCA-positive, there is an obligation to discuss the options for dealing with the increased risk associated with the gene mutation(s), as well as to recommend the prudent course of action or to refer the patient to someone who will have that discussion.

Informed consent to the patient. BRCA testing requires informed consent. The physical risks of the testing process are minimal, of course, but it carries a number of other emotional and family risks. The informed consent process is an invitation to an honest discussion between clinicians and patients. It should be an opportunity to discuss what the testing is, and is not, and what the test may mean for treatment. It may also be an opportunity to discuss the implications for other members of the patient’s family (noted below).

One element of informed consent is a discussion of the consequences of failure to consent, or to undertake one of the alternatives. In the case of BRCA testing, this is especially important in cases in which a patient expresses a hesitancy to be tested with an “I’d rather not know philosophy.” Although clinicians should not practice law, some patient concerns about discrimination may be addressed by the protection that the federal Genetic Information Nondiscrimination Act (GINA) and other laws provide (which prohibit insurance and employment discrimination based on genetic information). A good source of information about GINA and related nondiscrimination laws is provided by the National Human Genome Research Institute.²⁵ In addition, the National Institutes of Health has a website that may be helpful to many patients²⁶ (and a much more complex site for health professionals).²⁷ At the same time, courts have resisted plaintiffs/patients who have tried to use informed consent as a way of suing for failure to offer genetic testing.^28,29

The failure to refer. In some cases, a patient should be formally referred for genetics consultation. The considerations here are similar to other circumstances in modern, fast developing medical practice that require special sensitivity to those occasions in which a patient will benefit from additional expertise. It is a principle that the AMA Council on Ethical and Judicial Affairs has expressed this way: “In the absence of adequate expertise in pretest and posttest counseling, a physician should refer the patient to an appropriate specialist.”³⁰ The failure to refer, when that deviates from acceptable practice, may result in liability.

Informing others. BRCA testing is an area of medicine in which results may be of great significance not only to the patient but also to the patient’s family.³¹ Physicians should counsel patients on the importance of informing relatives about relevant results and “should make themselves available to assist patients in communicating with relatives to discuss opportunities for counseling and testing, as appropriate.”³⁰ The question may arise, however, of whether in some circumstances physicians should go a step further in ensuring relatives receive important information regarding their loved one’s health.³² The law has been reluctant to impose liability to “third parties” (someone not a patient). Duties usually arise through the physician-patient relationship. There are exceptions. Perhaps the best known has been the obligation of mental health professionals to take action to protect third parties from patients who have made believable threats against identifiable victims.³³ There are indications that some courts could find, in extreme circumstances, a “duty to warn” nonpatients in some instances where it is essential to inform third parties that they should receive a specific form of genetic testing.^34,35 Such a duty would, of course, have to protect the privacy rights of the patient to the maximum extent possible. A general duty of this type has not been established widely, but may be part of the future.

Continue to: Was there liability in our example case?...

Was there liability in our example case?

The hypothetical case provided above suggests that there could be liability. Routine medical history by the primary care physician would have produced the fact that the patient’s mother, sister, and maternal grandmother had breast cancer. That would clearly have put her in a category of those who should have received genetic testing. Yet, she was not tested until after her cancer was found. From the limited facts we have, it appears that this timeline of events would have been outside accepted practice—and negligent. The case was not pursued by the patient, however, and this may represent the current state of liability for BRCA issues.

The extent of liability seems to be significant

Our discussion of liability suggests that there is significant potential for BRCA testing negligence within practice, and that the damages in these cases could be substantial. Yet the predicted “tsunami” of malpractice lawsuits related to genetic testing has not appeared.^36,37 One study of cases in the United States (through 2016) found a “slowly rising tide” of liability cases instead of a tsunami,²⁴ as the number of claims made was low. On the other hand, the payments where damages were awarded were an order of magnitude larger than other malpractice cases—a mean of $5.3 million and median of $2 million. This is compared with mean values in the range of $275,000 to $600,000 in other areas of malpractice.

The majority of the genetic malpractice cases involve prenatal and newborn testing, and diagnosis/susceptibility/pharmacogenomic accounting for about 25% of cases. In terms of type of errors claimed, approximately 50% were diagnostic-interpretation errors, 30% failure to offer testing, nearly 20% failure to return test results to the patients, and a few remaining cases of failure to properly treat in light of genetic testing.²⁴

Despite a few very large payments, however, the fact remains that there is a surprisingly low number of genetics malpractice cases. Gary Marchant and colleagues suggest that several reasons may account for this:

• the clinical implementation of genetic science has been slower than expected
• the lack of expertise of many physicians in genetic science
• expert witnesses have sometimes been hard to find
• the lack of understanding by plaintiffs’ attorneys of genetic malpractice
• potential plaintiffs’ lack of understanding of the nature of genetic testing and the harms resulting from genetic negligence.^17,24,37

The tide is slowly coming in

By all appearances, there is every reason to think that genetic malpractice will be increasing, and that the recent past of much higher damages per claim paid in the genetics area will be part of that tide. The National Human Genome Research LawSeq project has suggested a number of useful ways of dealing with the liability issues.¹⁸ In addition to the BRCA issues that we have considered in this article for ObGyns, there are other critical issues of prenatal and newborn genetic testing.³⁸ But those are topics for another day. ●

CASE Young woman with family history of breast cancer detects lump

Two weeks after noting a lump on her breast when her cat happened to jump on her in that spot, a 28-year-old woman (G0) went to her primary care provider. She was referred to her gynecologist; breast imaging, ultrasonography, and mammography were obtained, with microcalcifications noted. A fine needle aspiration diagnosed intraductal malignancy. The surgical breast tissue specimen was estrogen receptor (ER)- and progestogen receptor (PR)-positive and HER2-negative. Other tumor markers were obtained, including carcinoembryonic antigen, and tissue polypeptide specific antigen, p53, cathepsin D, cyclin E, and nestin, but results were not available.

With regard to family history, the woman’s mother and maternal grandmother had a history of breast cancer. The patient and her family underwent gene testing. The patient was found to be BRCA1- and BRCA2-positive; her mother was BRCA1-positive, an older sister was BRCA2-positive, and her grandmother was not tested.

The question arose in light of her family history as to why she was not tested for BRCA and appropriately counseled by her gynecologist prior to the cancer diagnosis. Litigation was initiated. While the case did not go forward regarding litigation, it is indeed a case in point. (Please note that this is a hypothetical case. It is based on a composite of several cases.)
 

Medical considerations

Breast cancer is the most common type of cancer affecting women in the Western world.¹ Advances in clinical testing for gene mutations have escalated and allowed for identification of patients at increased risk for breast and ovarian cancer. Along with these advances come professional liability risk. After looking at the medical considerations for BRCA1 and 2 testing, we will consider a number of important legal issues. In the view of some commentators, the failure to diagnose genetic mutations in patients predisposed to cancer is “poised to become the next wave of medical professional liability lawsuits.”²

BRCA1 and BRCA2 genes provide tumor suppressor proteins, and assessment for mutations is recommended for individuals at high risk for breast and/or ovarian cancer; mutations in BRCA genes cause DNA damage, which increases the chance of developing cancer. The other way to look at it is, BRCA1 and 2 are tumor suppressor genes that are integrally involved with DNA damage control. Once there is a mutation, it adversely affects the beneficial effects of the gene. Mutations in these genes account for 5% to 10% of all hereditary breast cancers.³ Of note, men with BRCA2 are at increased risk for prostate cancer.

A patient who presents to her gynecologist stating that there is a family history of breast cancer, without knowledge of genetic components, presents a challenge (and a medicolegal risk) for the provider to assess. Prediction models have been used to determine specific patient risk for carrying a genetic mutation with resultant breast cancer development.⁴ Risk prediction models do not appear to be a good answer to predicting who is more likely to develop breast or ovarian cancer, however. A Mayo model may assist (FIGURE).⁵ Clinicians should also be aware of other models of risk assessment, including the Gail Model (TABLE 1).⁶

Continue to: Guidelines for genetic testing...

Guidelines for genetic testing

The American College of Obstetricians and Gynecologists states that patient medical history and family history are paramount in obtaining information regarding risk for breast and ovarian cancer. First- and second-degree relatives are allocated to this category. Information regarding age of diagnosis, maternal and paternal lineage, and ethnic background can imply a need for genetic testing (TABLE 2).^7,8 A number of genetics national organizations have participated in recommendations and include the American College of Medical Genetics and Genomics, the National Society for Genetic Counselors, and the Society of Gynecologic Oncology.⁷

The question always surfaces, could the clinical outcome of the cancer when diagnosed have been changed if screening were undertaken, with earlier diagnosis, or prevented with prophylactic mastectomy, and changed the end result. In addition, it is well known that breast augmentation mammoplasty alters the ability to accurately evaluate mammograms. Patients considering this type of plastic surgery, ideally, should be counselled accordingly.⁹

Bottom line, we as clinicians must be cognizant of both ACOG and United States Preventive Services Task Force (USPSTF) recommendations regarding screening and gene testing for women considered high risk for breast cancer based on family history.⁷

Legal considerations

The case presented demonstrates that the discovery of the BRCA1 and BRCA2 genes, and reliable tests for determining the existence of the genes, brought with them legal issues as well as medical advantages. We look at professional liability (malpractice) questions this technology raises, and then consider the outcome of the hypothetical case. (BRCA is used here to apply broadly—not only to BRCA1 and 2 but also to PALB2, CHEK2, and similar genetic abnormalities.)

To date, the most visible BRCA legal issues covered in cases and law reviews have focused more on patent law than malpractice. The most important of these was a decision of the US Supreme Court in Association for Molecular Pathology v Myriad Genetics.¹⁰ The US Patent Office was granting patents to companies finding useful, naturally occurring segments of human DNA, and had granted Myriad several patents on BRCA1 and BRCA2 genes. This patent policy had the potential to seriously interfere with broad scientific use of these genes.¹¹ Fortunately, the Supreme Court stepped in and unanimously invalidated such patents. It held that a “naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” The Court noted, “Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible ‘new . . . composition[s] of matter.’”⁸ The Court did allow the patenting of tests for specific gene structures, and artificial changes in naturally occurring genes.

Malpractice and BRCA

While the BRCA patent wars have lingered, the potential for a significant increase in BRCA-related malpractice cases is of increasing concern. Like most malpractice liability, these new claims are based on very old principles of negligence.¹² To prevail, the plaintiff (ordinarily, an injured patient) must demonstrate 4 things:

• A duty. That is, the physician owed a duty to the injured party. Usually (but not always) that requires a professional relationship between the physician and the person injured.
• A breach of that duty. Malpractice liability is based on the fact that the physician did something that a reasonably careful physician (generally, of the same specialty) would not have done, or that the physician failed to do something that a reasonable physician would have done. This usually means that the profession itself sees what the physician did (or did not do) as medically inappropriate. In medical malpractice cases, that is ordinarily measured by what the usual or common practice is among prudent physicians. In rare circumstances, courts have found the standard practice of a profession to be negligent. Where, for example, it was custom for a professional not to give an eye pressure test to anyone under age 40, a court found that common standard to be inappropriate.¹³ In the words of Judge Learned Hand (speaking about a different case), “a whole calling may have unduly lagged in the adoption of new and available devices. It never may set its own tests.”¹⁴ Underlying negligence is a cost-benefit analysis (discussed below).
• Damages. There must have been some damage that courts recognize, usually loss of money or opportunity to work, the cost of care, pain and suffering, or loss of enjoyment/quality of life. In malpractice, many states now recognize the “loss of chance” or the “loss of a chance.” That means, if a “physician negligently fails to diagnose a curable disease, and the patient is harmed by the disease, the physician should be liable for causing the ‘loss of a chance of a cure.’”¹⁵ (Delay in diagnosis is the most common reason for claims in breast cancer care.)¹⁶
• Causation. The breach of duty (negligence) must have caused the damages. The causation must have been reasonably close. If a driver drives through a stop sign, or a physician misreads a test, and someone is injured but there is no connection between the negligence and the injury, there is not tort liability.

The 4 elements of malpractice just described are raised in some way in the possible liability associated with BRCA testing. We next look at the ways in which liability may arise from that testing (or lack of it).

Underlying much of the following discussion is the “cost-benefit” consideration noted above. This concept is that the total cost (financial and health) of testing should be compared with the value of the benefits of testing, taking into account the probabilities that the testing will result in better health outcomes. BRCA testing, for example, is essentially cost-free in terms of physical risk. Its financial cost, while not trivial, is not great, and it is commonly covered by health insurance.¹⁷ In terms of benefits, the testing has the potential for providing critical information in making treatment decisions for a meaningful percentage of patients and their families. There are many ways of analyzing the liability risks of genetic malpractice,^7,18 and the following is intended to discuss some of the greatest risks related to BRCA testing.

Continue to: Areas of liability...

 

 

Areas of liability

The failure to recommend a test. The circumstances in which BRCA testing should be undertaken are set out by professional organizations (noted above). These recommendations are not static, however. They change from time to time. Given the potential harm caused by the failure to test in relevant circumstances, malpractice liability is certainly a possibility when the failure to recommend a test to a patient results in a cancer that might have been prevented had the genetic problem been identified in a timely manner. The circumstances in which testing should be considered continue to change, placing an obligation on clinicians to stay well informed of changing genetic understandings. Another risk is that one specialist may assume that it is the job of another specialist to order the test. Whatever the cause of the failure to test, or unnecessary delay in testing, it appears to be the primary basis for BRCA liability.

The failure to properly interpret a test. Any test that is misinterpreted may lead to harm for the patient. A false negative, of course, may mean that preventive treatment that could have been undertaken will be foregone, as a “loss of a chance.” On the other hand, a false positive can lead to radical, unnecessary surgery or treatment. If a misinterpretation occurred because of carelessness by the testing organization, or confusion by a practitioner, there is a likelihood of negligence.¹⁹

A different form of “misinterpretation” could be reasonable—and not negligent. Advances in scientific-medical understanding may result in the outcome of tests being reconsidered and changed. That has been the case with genetic testing and breast cancer. The availability of multiple breast cancer SNPs (single nucleotide polymorphisms), and combining this information with other risk factors for example, results in a polygenic risk score that may be at odds with the level of risk from earlier testing.^20,21 This naturally leads to the question of when later, updated testing should be recommended to look for a better current interpretation.^22,23

The failure to act on BRCA test results. Testing is of no value, of course, if the results are not used properly. Test results or analyses that are not sent to the proper physicians, or are somehow ignored when properly directed, is a “never” event—it should never happen. It almost always would be considered negligence, and if the patient were injured, could lead to liability. Amazingly, one study found that, in genetic testing liability cases, nearly 20% of the claims arose from failure to return test results to patients.²⁴ In addition, when a patient is found to be BRCA-positive, there is an obligation to discuss the options for dealing with the increased risk associated with the gene mutation(s), as well as to recommend the prudent course of action or to refer the patient to someone who will have that discussion.

Informed consent to the patient. BRCA testing requires informed consent. The physical risks of the testing process are minimal, of course, but it carries a number of other emotional and family risks. The informed consent process is an invitation to an honest discussion between clinicians and patients. It should be an opportunity to discuss what the testing is, and is not, and what the test may mean for treatment. It may also be an opportunity to discuss the implications for other members of the patient’s family (noted below).

One element of informed consent is a discussion of the consequences of failure to consent, or to undertake one of the alternatives. In the case of BRCA testing, this is especially important in cases in which a patient expresses a hesitancy to be tested with an “I’d rather not know philosophy.” Although clinicians should not practice law, some patient concerns about discrimination may be addressed by the protection that the federal Genetic Information Nondiscrimination Act (GINA) and other laws provide (which prohibit insurance and employment discrimination based on genetic information). A good source of information about GINA and related nondiscrimination laws is provided by the National Human Genome Research Institute.²⁵ In addition, the National Institutes of Health has a website that may be helpful to many patients²⁶ (and a much more complex site for health professionals).²⁷ At the same time, courts have resisted plaintiffs/patients who have tried to use informed consent as a way of suing for failure to offer genetic testing.^28,29

The failure to refer. In some cases, a patient should be formally referred for genetics consultation. The considerations here are similar to other circumstances in modern, fast developing medical practice that require special sensitivity to those occasions in which a patient will benefit from additional expertise. It is a principle that the AMA Council on Ethical and Judicial Affairs has expressed this way: “In the absence of adequate expertise in pretest and posttest counseling, a physician should refer the patient to an appropriate specialist.”³⁰ The failure to refer, when that deviates from acceptable practice, may result in liability.

Informing others. BRCA testing is an area of medicine in which results may be of great significance not only to the patient but also to the patient’s family.³¹ Physicians should counsel patients on the importance of informing relatives about relevant results and “should make themselves available to assist patients in communicating with relatives to discuss opportunities for counseling and testing, as appropriate.”³⁰ The question may arise, however, of whether in some circumstances physicians should go a step further in ensuring relatives receive important information regarding their loved one’s health.³² The law has been reluctant to impose liability to “third parties” (someone not a patient). Duties usually arise through the physician-patient relationship. There are exceptions. Perhaps the best known has been the obligation of mental health professionals to take action to protect third parties from patients who have made believable threats against identifiable victims.³³ There are indications that some courts could find, in extreme circumstances, a “duty to warn” nonpatients in some instances where it is essential to inform third parties that they should receive a specific form of genetic testing.^34,35 Such a duty would, of course, have to protect the privacy rights of the patient to the maximum extent possible. A general duty of this type has not been established widely, but may be part of the future.

Continue to: Was there liability in our example case?...

Was there liability in our example case?

The hypothetical case provided above suggests that there could be liability. Routine medical history by the primary care physician would have produced the fact that the patient’s mother, sister, and maternal grandmother had breast cancer. That would clearly have put her in a category of those who should have received genetic testing. Yet, she was not tested until after her cancer was found. From the limited facts we have, it appears that this timeline of events would have been outside accepted practice—and negligent. The case was not pursued by the patient, however, and this may represent the current state of liability for BRCA issues.

The extent of liability seems to be significant

Our discussion of liability suggests that there is significant potential for BRCA testing negligence within practice, and that the damages in these cases could be substantial. Yet the predicted “tsunami” of malpractice lawsuits related to genetic testing has not appeared.^36,37 One study of cases in the United States (through 2016) found a “slowly rising tide” of liability cases instead of a tsunami,²⁴ as the number of claims made was low. On the other hand, the payments where damages were awarded were an order of magnitude larger than other malpractice cases—a mean of $5.3 million and median of $2 million. This is compared with mean values in the range of $275,000 to $600,000 in other areas of malpractice.

The majority of the genetic malpractice cases involve prenatal and newborn testing, and diagnosis/susceptibility/pharmacogenomic accounting for about 25% of cases. In terms of type of errors claimed, approximately 50% were diagnostic-interpretation errors, 30% failure to offer testing, nearly 20% failure to return test results to the patients, and a few remaining cases of failure to properly treat in light of genetic testing.²⁴

Despite a few very large payments, however, the fact remains that there is a surprisingly low number of genetics malpractice cases. Gary Marchant and colleagues suggest that several reasons may account for this:

• the clinical implementation of genetic science has been slower than expected
• the lack of expertise of many physicians in genetic science
• expert witnesses have sometimes been hard to find
• the lack of understanding by plaintiffs’ attorneys of genetic malpractice
• potential plaintiffs’ lack of understanding of the nature of genetic testing and the harms resulting from genetic negligence.^17,24,37

The tide is slowly coming in

By all appearances, there is every reason to think that genetic malpractice will be increasing, and that the recent past of much higher damages per claim paid in the genetics area will be part of that tide. The National Human Genome Research LawSeq project has suggested a number of useful ways of dealing with the liability issues.¹⁸ In addition to the BRCA issues that we have considered in this article for ObGyns, there are other critical issues of prenatal and newborn genetic testing.³⁸ But those are topics for another day. ●

Sarah Sofka, MD, FACP, noticed a pattern. As program director for the internal medicine (IM) residency at West Virginia University, Morgantown, she was informed when residents were sent to counseling because they were affected by burnout, depression, or anxiety. When trainees returned from these visits, many told her the same thing: They wished they had sought help sooner.

IM residents and their families had access to free counseling at WVU, but few used the resource, says Dr. Sofka. “So, we thought, let’s just schedule all of our residents for a therapy visit so they can go and see what it’s like,” she said. “This will hopefully decrease the stigma for seeking mental health care. If everybody’s going, it’s not a big deal.”

In July 2015, Dr. Sofka and her colleagues launched a universal well-being assessment program for the IM residents at WVU. The program leaders automatically scheduled first- and second-year residents for a visit to the faculty staff assistance program counselors. The visits were not mandatory, and residents could choose not to go; but if they did go, they received the entire day of their visit off from work.

Five and a half years after launching their program, Dr. Sofka and her colleagues conducted one of the first studies of the efficacy of an opt-out approach for resident mental wellness. They found that the program led to more counseling visits that were resident initiated and fewer that were mandated, suggesting that residents were seeking help proactively after having to at least consider it.

Opt-out counseling is a recent concept in residency programs – one that’s attracting interest from training programs across the country. Brown University, Providence, R.I.; the University of Colorado at Denver, Aurora; University of Pennsylvania, Philadelphia; and the University of California, San Francisco have at least one residency program that uses the approach.

No time, no access, plenty of stigma

Burnout and mental health are known to be major concerns for health care workers, especially trainees. College graduates starting medical education have lower rates of burnout and depression, compared with demographically matched peers; however, once they’ve started training, medical students, residents, and fellows are more likely to be burned out and exhibit symptoms of depression. The ongoing COVID-19 pandemic is further fraying the well-being of overworked and traumatized health care professionals, and experts predict a mental health crisis will follow the viral crisis.

The Accreditation Council for Graduate Medical Education recently mandated that programs offer wellness services to trainees. Yet this doesn’t mean they are always used; well-known barriers stand between residents, medical students, and physicians and their receiving effective mental health treatment.

“A lack of transparency and clear messaging around what is available, who provides the services, and how to access these services can be a major barrier,” says Erene Stergiopoulos, MD, a second-year psychiatry resident at the University of Toronto. In addition, there can be considerable lag between when a resident realizes they need help and when they manage to find a provider and schedule an appointment, says Dr. Meeks.

How the opt-out approach works

“The idea is by making it opt-out, you really normalize it,” says Maneesh Batra, MD, MPH, associate director of the University of Washington, Seattle, Children’s Hospital residency program. Similar approaches have proven effective at shaping human behavior in other health care settings, including boosting testing rates for HIV and increasing immunization rates for childhood vaccines, Dr. Batra says.

In general, opt-out programs acknowledge that people are busy and won’t take that extra step or click that extra button if they don’t have to, says Oana Tomescu, MD, PhD, associate professor of clinical medicine and pediatrics at the University of Pennsylvania, Philadelphia.

In 2018, Dr. Sofka and her colleagues at WVU conducted a survey that showed that a majority of residents thought favorably of their opt-out program and said they would return to counseling for follow-up care. In their most recent study, published in the Journal of Graduate Medical Education in 2021, Dr. Sofka and her colleagues found that residents did just that – only 8 of 239 opted out of universally scheduled visits. Resident-initiated visits increased significantly from zero during the 2014-2015 academic year to 23 in 2018-2019. Between those periods, program-mandated visits decreased significantly from 12 to 3.

The initiative has succeeded in creating a culture of openness and caring at WVU, says 2nd-year internal medicine resident Nistha Modi, MD. “It sets the tone for the program – we talk about mental health openly,” says Dr. Modi.

Crucially, the counselors work out of a different building than the hospital where Dr. Modi and her fellow residents work and use a separate electronic medical record system to protect resident privacy. This is hugely important for medical trainees, note Dr. Tomescu, Dr. Gold, and many other experts. The therapists understand residency and medical education, and there is no limit to the number of visits a resident or fellow can make with the program counselors, says Dr. Modi.

Opt-out programs offer a counterbalance to many negative tendencies in residency, says Dr. Meeks. “We’ve normalized so many things that are not healthy and productive. ... We need to counterbalance that with normalizing help seeking. And it’s really difficult to normalize something that’s not part of a system.”
 

Costs, concerns, and systematic support

Providing unlimited, free counseling for trainees can be very beneficial, but it requires adequate funding and personnel resources. Offering unlimited access means that an institution has to follow through in making this degree of care available while also ensuring that the system doesn’t get overwhelmed or is unable to accommodate very sick individuals, says Dr. Gold.

Another concern that experts like Dr. Batra, Dr. Moffit, and Dr. Gold share is that residents who go to their scheduled appointments may not completely buy into the experience because it wasn’t their idea in the first place. Participation alone doesn’t necessarily indicate full acceptance. Program personnel don’t intend for these appointments to be thought of as mandatory, yet residents may still experience them that way. Several leading resident well-being programs instead emphasize outreach to trainees, institutional support, and accessible mental health resources that are – and feel – entirely voluntary.

“If I tell someone that they have to do something, it’s very different than if they arrive at that conclusion for themselves,” says Dr. Batra. “That’s how life works.”

When it comes to cost, a recent study published in Academic Medicine provides encouraging data. At the University of Colorado, an opt-out pilot program for IM and pediatrics interns during the 2017-2018 academic year cost just $940 total, equal to $11.75 per intern. As in West Virginia, the program in Colorado covered the cost of the visit, interns were provided a half day off (whether they attended their appointment or not), and the visits and surveys were entirely optional and confidential. During the 1-year pilot program, 29% of 80 interns attended the scheduled appointment, 56% opted out in advance, and 15% didn’t show up. The majority of interns who were surveyed (85%), however, thought the program should continue and that it had a positive effect on their wellness even if they didn’t attend their appointment.

In West Virginia, program costs are higher. The program has $20,000 in annual funding to cover the opt-out program and unlimited counseling visits for residents and fellows. With that funding, Dr. Sofka and her colleagues were also able to expand the program slightly last year to schedule all the critical care faculty for counseling visits. Cost is a barrier to expanding these services to the entire institution, which Dr. Sofka says she hopes to do one day.

Research in this area is still preliminary. The WVU and Colorado studies provide some of the first evidence in support of an opt-out approach. Eventually, it would be beneficial for multicenter studies and longitudinal research to track the effects of such programs over time, say Dr. Sofka and Ajay Major, MD, MBA, one of the study’s coauthors and a hematology/oncology fellow at the University of Chicago.

Whether a program goes with an opt-out approach or not, the systematic supports – protecting resident privacy, providing flexible scheduling, and more – are crucial.

As Dr. Tomescu notes, wellness shouldn’t be just something trainees have to do. “The key with really working on burnout at a huge level is for all programs and schools to recognize that it’s a shared responsibility.”

“I felt very fortunate that I was able to get some help throughout residency,” says Dr. Modi. “About how to be a better daughter. How to be content with things I have in life. How to be happy, and grateful. With the kind of job we have, I think we sometimes forget to be grateful.”

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

Sarah Sofka, MD, FACP, noticed a pattern. As program director for the internal medicine (IM) residency at West Virginia University, Morgantown, she was informed when residents were sent to counseling because they were affected by burnout, depression, or anxiety. When trainees returned from these visits, many told her the same thing: They wished they had sought help sooner.

IM residents and their families had access to free counseling at WVU, but few used the resource, says Dr. Sofka. “So, we thought, let’s just schedule all of our residents for a therapy visit so they can go and see what it’s like,” she said. “This will hopefully decrease the stigma for seeking mental health care. If everybody’s going, it’s not a big deal.”

In July 2015, Dr. Sofka and her colleagues launched a universal well-being assessment program for the IM residents at WVU. The program leaders automatically scheduled first- and second-year residents for a visit to the faculty staff assistance program counselors. The visits were not mandatory, and residents could choose not to go; but if they did go, they received the entire day of their visit off from work.

Five and a half years after launching their program, Dr. Sofka and her colleagues conducted one of the first studies of the efficacy of an opt-out approach for resident mental wellness. They found that the program led to more counseling visits that were resident initiated and fewer that were mandated, suggesting that residents were seeking help proactively after having to at least consider it.

Opt-out counseling is a recent concept in residency programs – one that’s attracting interest from training programs across the country. Brown University, Providence, R.I.; the University of Colorado at Denver, Aurora; University of Pennsylvania, Philadelphia; and the University of California, San Francisco have at least one residency program that uses the approach.

No time, no access, plenty of stigma

Burnout and mental health are known to be major concerns for health care workers, especially trainees. College graduates starting medical education have lower rates of burnout and depression, compared with demographically matched peers; however, once they’ve started training, medical students, residents, and fellows are more likely to be burned out and exhibit symptoms of depression. The ongoing COVID-19 pandemic is further fraying the well-being of overworked and traumatized health care professionals, and experts predict a mental health crisis will follow the viral crisis.

The Accreditation Council for Graduate Medical Education recently mandated that programs offer wellness services to trainees. Yet this doesn’t mean they are always used; well-known barriers stand between residents, medical students, and physicians and their receiving effective mental health treatment.

“A lack of transparency and clear messaging around what is available, who provides the services, and how to access these services can be a major barrier,” says Erene Stergiopoulos, MD, a second-year psychiatry resident at the University of Toronto. In addition, there can be considerable lag between when a resident realizes they need help and when they manage to find a provider and schedule an appointment, says Dr. Meeks.

How the opt-out approach works

“The idea is by making it opt-out, you really normalize it,” says Maneesh Batra, MD, MPH, associate director of the University of Washington, Seattle, Children’s Hospital residency program. Similar approaches have proven effective at shaping human behavior in other health care settings, including boosting testing rates for HIV and increasing immunization rates for childhood vaccines, Dr. Batra says.

In general, opt-out programs acknowledge that people are busy and won’t take that extra step or click that extra button if they don’t have to, says Oana Tomescu, MD, PhD, associate professor of clinical medicine and pediatrics at the University of Pennsylvania, Philadelphia.

In 2018, Dr. Sofka and her colleagues at WVU conducted a survey that showed that a majority of residents thought favorably of their opt-out program and said they would return to counseling for follow-up care. In their most recent study, published in the Journal of Graduate Medical Education in 2021, Dr. Sofka and her colleagues found that residents did just that – only 8 of 239 opted out of universally scheduled visits. Resident-initiated visits increased significantly from zero during the 2014-2015 academic year to 23 in 2018-2019. Between those periods, program-mandated visits decreased significantly from 12 to 3.

The initiative has succeeded in creating a culture of openness and caring at WVU, says 2nd-year internal medicine resident Nistha Modi, MD. “It sets the tone for the program – we talk about mental health openly,” says Dr. Modi.

Crucially, the counselors work out of a different building than the hospital where Dr. Modi and her fellow residents work and use a separate electronic medical record system to protect resident privacy. This is hugely important for medical trainees, note Dr. Tomescu, Dr. Gold, and many other experts. The therapists understand residency and medical education, and there is no limit to the number of visits a resident or fellow can make with the program counselors, says Dr. Modi.

Opt-out programs offer a counterbalance to many negative tendencies in residency, says Dr. Meeks. “We’ve normalized so many things that are not healthy and productive. ... We need to counterbalance that with normalizing help seeking. And it’s really difficult to normalize something that’s not part of a system.”
 

Costs, concerns, and systematic support

Providing unlimited, free counseling for trainees can be very beneficial, but it requires adequate funding and personnel resources. Offering unlimited access means that an institution has to follow through in making this degree of care available while also ensuring that the system doesn’t get overwhelmed or is unable to accommodate very sick individuals, says Dr. Gold.

Another concern that experts like Dr. Batra, Dr. Moffit, and Dr. Gold share is that residents who go to their scheduled appointments may not completely buy into the experience because it wasn’t their idea in the first place. Participation alone doesn’t necessarily indicate full acceptance. Program personnel don’t intend for these appointments to be thought of as mandatory, yet residents may still experience them that way. Several leading resident well-being programs instead emphasize outreach to trainees, institutional support, and accessible mental health resources that are – and feel – entirely voluntary.

“If I tell someone that they have to do something, it’s very different than if they arrive at that conclusion for themselves,” says Dr. Batra. “That’s how life works.”

When it comes to cost, a recent study published in Academic Medicine provides encouraging data. At the University of Colorado, an opt-out pilot program for IM and pediatrics interns during the 2017-2018 academic year cost just $940 total, equal to $11.75 per intern. As in West Virginia, the program in Colorado covered the cost of the visit, interns were provided a half day off (whether they attended their appointment or not), and the visits and surveys were entirely optional and confidential. During the 1-year pilot program, 29% of 80 interns attended the scheduled appointment, 56% opted out in advance, and 15% didn’t show up. The majority of interns who were surveyed (85%), however, thought the program should continue and that it had a positive effect on their wellness even if they didn’t attend their appointment.

In West Virginia, program costs are higher. The program has $20,000 in annual funding to cover the opt-out program and unlimited counseling visits for residents and fellows. With that funding, Dr. Sofka and her colleagues were also able to expand the program slightly last year to schedule all the critical care faculty for counseling visits. Cost is a barrier to expanding these services to the entire institution, which Dr. Sofka says she hopes to do one day.

Research in this area is still preliminary. The WVU and Colorado studies provide some of the first evidence in support of an opt-out approach. Eventually, it would be beneficial for multicenter studies and longitudinal research to track the effects of such programs over time, say Dr. Sofka and Ajay Major, MD, MBA, one of the study’s coauthors and a hematology/oncology fellow at the University of Chicago.

Whether a program goes with an opt-out approach or not, the systematic supports – protecting resident privacy, providing flexible scheduling, and more – are crucial.

As Dr. Tomescu notes, wellness shouldn’t be just something trainees have to do. “The key with really working on burnout at a huge level is for all programs and schools to recognize that it’s a shared responsibility.”

“I felt very fortunate that I was able to get some help throughout residency,” says Dr. Modi. “About how to be a better daughter. How to be content with things I have in life. How to be happy, and grateful. With the kind of job we have, I think we sometimes forget to be grateful.”

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

Sarah Sofka, MD, FACP, noticed a pattern. As program director for the internal medicine (IM) residency at West Virginia University, Morgantown, she was informed when residents were sent to counseling because they were affected by burnout, depression, or anxiety. When trainees returned from these visits, many told her the same thing: They wished they had sought help sooner.

IM residents and their families had access to free counseling at WVU, but few used the resource, says Dr. Sofka. “So, we thought, let’s just schedule all of our residents for a therapy visit so they can go and see what it’s like,” she said. “This will hopefully decrease the stigma for seeking mental health care. If everybody’s going, it’s not a big deal.”

In July 2015, Dr. Sofka and her colleagues launched a universal well-being assessment program for the IM residents at WVU. The program leaders automatically scheduled first- and second-year residents for a visit to the faculty staff assistance program counselors. The visits were not mandatory, and residents could choose not to go; but if they did go, they received the entire day of their visit off from work.

Five and a half years after launching their program, Dr. Sofka and her colleagues conducted one of the first studies of the efficacy of an opt-out approach for resident mental wellness. They found that the program led to more counseling visits that were resident initiated and fewer that were mandated, suggesting that residents were seeking help proactively after having to at least consider it.

Opt-out counseling is a recent concept in residency programs – one that’s attracting interest from training programs across the country. Brown University, Providence, R.I.; the University of Colorado at Denver, Aurora; University of Pennsylvania, Philadelphia; and the University of California, San Francisco have at least one residency program that uses the approach.

No time, no access, plenty of stigma

Burnout and mental health are known to be major concerns for health care workers, especially trainees. College graduates starting medical education have lower rates of burnout and depression, compared with demographically matched peers; however, once they’ve started training, medical students, residents, and fellows are more likely to be burned out and exhibit symptoms of depression. The ongoing COVID-19 pandemic is further fraying the well-being of overworked and traumatized health care professionals, and experts predict a mental health crisis will follow the viral crisis.

The Accreditation Council for Graduate Medical Education recently mandated that programs offer wellness services to trainees. Yet this doesn’t mean they are always used; well-known barriers stand between residents, medical students, and physicians and their receiving effective mental health treatment.

“A lack of transparency and clear messaging around what is available, who provides the services, and how to access these services can be a major barrier,” says Erene Stergiopoulos, MD, a second-year psychiatry resident at the University of Toronto. In addition, there can be considerable lag between when a resident realizes they need help and when they manage to find a provider and schedule an appointment, says Dr. Meeks.

How the opt-out approach works

“The idea is by making it opt-out, you really normalize it,” says Maneesh Batra, MD, MPH, associate director of the University of Washington, Seattle, Children’s Hospital residency program. Similar approaches have proven effective at shaping human behavior in other health care settings, including boosting testing rates for HIV and increasing immunization rates for childhood vaccines, Dr. Batra says.

In general, opt-out programs acknowledge that people are busy and won’t take that extra step or click that extra button if they don’t have to, says Oana Tomescu, MD, PhD, associate professor of clinical medicine and pediatrics at the University of Pennsylvania, Philadelphia.

In 2018, Dr. Sofka and her colleagues at WVU conducted a survey that showed that a majority of residents thought favorably of their opt-out program and said they would return to counseling for follow-up care. In their most recent study, published in the Journal of Graduate Medical Education in 2021, Dr. Sofka and her colleagues found that residents did just that – only 8 of 239 opted out of universally scheduled visits. Resident-initiated visits increased significantly from zero during the 2014-2015 academic year to 23 in 2018-2019. Between those periods, program-mandated visits decreased significantly from 12 to 3.

The initiative has succeeded in creating a culture of openness and caring at WVU, says 2nd-year internal medicine resident Nistha Modi, MD. “It sets the tone for the program – we talk about mental health openly,” says Dr. Modi.

Crucially, the counselors work out of a different building than the hospital where Dr. Modi and her fellow residents work and use a separate electronic medical record system to protect resident privacy. This is hugely important for medical trainees, note Dr. Tomescu, Dr. Gold, and many other experts. The therapists understand residency and medical education, and there is no limit to the number of visits a resident or fellow can make with the program counselors, says Dr. Modi.

Opt-out programs offer a counterbalance to many negative tendencies in residency, says Dr. Meeks. “We’ve normalized so many things that are not healthy and productive. ... We need to counterbalance that with normalizing help seeking. And it’s really difficult to normalize something that’s not part of a system.”
 

Costs, concerns, and systematic support

Providing unlimited, free counseling for trainees can be very beneficial, but it requires adequate funding and personnel resources. Offering unlimited access means that an institution has to follow through in making this degree of care available while also ensuring that the system doesn’t get overwhelmed or is unable to accommodate very sick individuals, says Dr. Gold.

Another concern that experts like Dr. Batra, Dr. Moffit, and Dr. Gold share is that residents who go to their scheduled appointments may not completely buy into the experience because it wasn’t their idea in the first place. Participation alone doesn’t necessarily indicate full acceptance. Program personnel don’t intend for these appointments to be thought of as mandatory, yet residents may still experience them that way. Several leading resident well-being programs instead emphasize outreach to trainees, institutional support, and accessible mental health resources that are – and feel – entirely voluntary.

“If I tell someone that they have to do something, it’s very different than if they arrive at that conclusion for themselves,” says Dr. Batra. “That’s how life works.”

When it comes to cost, a recent study published in Academic Medicine provides encouraging data. At the University of Colorado, an opt-out pilot program for IM and pediatrics interns during the 2017-2018 academic year cost just $940 total, equal to $11.75 per intern. As in West Virginia, the program in Colorado covered the cost of the visit, interns were provided a half day off (whether they attended their appointment or not), and the visits and surveys were entirely optional and confidential. During the 1-year pilot program, 29% of 80 interns attended the scheduled appointment, 56% opted out in advance, and 15% didn’t show up. The majority of interns who were surveyed (85%), however, thought the program should continue and that it had a positive effect on their wellness even if they didn’t attend their appointment.

In West Virginia, program costs are higher. The program has $20,000 in annual funding to cover the opt-out program and unlimited counseling visits for residents and fellows. With that funding, Dr. Sofka and her colleagues were also able to expand the program slightly last year to schedule all the critical care faculty for counseling visits. Cost is a barrier to expanding these services to the entire institution, which Dr. Sofka says she hopes to do one day.

Research in this area is still preliminary. The WVU and Colorado studies provide some of the first evidence in support of an opt-out approach. Eventually, it would be beneficial for multicenter studies and longitudinal research to track the effects of such programs over time, say Dr. Sofka and Ajay Major, MD, MBA, one of the study’s coauthors and a hematology/oncology fellow at the University of Chicago.

Whether a program goes with an opt-out approach or not, the systematic supports – protecting resident privacy, providing flexible scheduling, and more – are crucial.

As Dr. Tomescu notes, wellness shouldn’t be just something trainees have to do. “The key with really working on burnout at a huge level is for all programs and schools to recognize that it’s a shared responsibility.”

“I felt very fortunate that I was able to get some help throughout residency,” says Dr. Modi. “About how to be a better daughter. How to be content with things I have in life. How to be happy, and grateful. With the kind of job we have, I think we sometimes forget to be grateful.”

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

Disclaimer: This article is for educational purposes only. All examples are hypothetical and aim to illustrate common clinical scenarios and challenges gastroenterologists may encounter within their scope of practice. The content herein should not be interpreted as legal advice for individual cases nor a substitute for seeking the advice of an attorney.

There are unique potential stressors faced by the gastroenterologist at each career stage, some more so early on. One such stressor, and one particularly important in a procedure-intensive specialty like GI, is medical professional liability (MPL), historically termed “medical malpractice.” Between 2009 and 2018, GI was the second-highest internal medicine subspecialty in both MPL claims made and claims paid,¹ yet instruction on MPL risk and mitigation is scarce in fellowship, as is the available GI-related literature on the topic. This scarcity may generate untoward stress and unnecessarily expose gastroenterologists to avoidable MPL pitfalls. Therefore, it is vital for GI trainees, early-career gastroenterologists, and even seasoned gastroenterologists to have a working and updated knowledge of the general principles of MPL and GI-specific considerations. Such understanding can help preserve physician well-being, increase professional satisfaction, strengthen the doctor-patient relationship, and improve health care outcomes.²

To this end, we herein provide a focused review of the following: key MPL concepts, trends in MPL claims, GI-related MPL risk scenarios and considerations, adverse provider defensive mechanisms, documentation tenets, challenges posed by telemedicine, and the concept of “vicarious liability.”
 

Key MPL concepts

MPL falls under the umbrella of tort law, which itself falls under the umbrella of civil law; that is, civil (as opposed to criminal) justice governs torts – including but not limited to MPL claims – as well as other areas of law concerning noncriminal injury.³ A “tort” is a “civil wrong that unfairly causes another to experience loss or harm resulting in legal liability.”³ MPL claims assert the tort of negligence (similar to the concept of “incompetence”) and endeavor to compensate the harmed patient/individual while simultaneously dissuading suboptimal medical care by the provider in the future.^4,5 A successful MPL claim must prove four overlapping elements: that the tortfeasor (here, the gastroenterologist) owed a duty of care to the injured party and breached that duty, which caused damages.⁶ Given that MPL cases exist within tort law rather than criminal law, the burden of proof for these cases is not “beyond a reasonable doubt”; instead, it’s “to a reasonable medical probability.”⁷

Trends in MPL claims

According to data compiled by the MPL Association, 278,220 MPL claims were made in the United States from 1985 to 2012.^3,8-10 Among these, 1.8% involved gastroenterologists, which puts it at 17th place out of the 20 specialties surveyed.⁹ While the number of paid claims over this time frame decreased in GI by 34.6% (from 18.5 to 12.1 cases per 1,000 physician-years), there was a concurrent 23.3% increase in average claim compensation; essentially, there were fewer paid GI-related claims but there were higher payouts per paid claim.^11,12 From 2009 to 2018, average legal defense costs for paid GI-related claims were $97,392, and average paid amount was $330,876.¹

GI-related MPL risk scenarios and considerations

Many MPL claims relate to situations involving medical errors or adverse events (AEs), be they procedural or nonprocedural. However other aspects of GI also carry MPL risk.

Informed consent

MPL claims may be made not only on the grounds of inadequately informed consent but also inadequately informed refusal.^5,13,14 While standards for adequate informed consent vary by state, most states apply the “reasonable patient standard,” i.e., assuming an average patient with enough information to be an active participant in the medical decision-making process. Generally, informed consent should ensure that the patient understands the nature of the procedure/treatment being proposed, there is a discussion of the risks and benefits of undergoing and not undergoing the procedure/treatment, reasonable alternatives are presented, the risks and benefits associated with these alternatives are discussed, and the patient’s comprehension of these things is assessed (Figure).¹⁵ Additionally, informed consent should be tailored to each patient and GI procedure/treatment on a case-by-case basis rather than using a one-size-fits-all approach. Moreover, documentation of the patient’s understanding of the (tailored) information provided can concurrently improve quality of the consent and potentially decrease MPL risk (Figure).¹⁶

Endoscopic procedures

Procedure-related MPL claims represent approximately 25% of all GI-related claims (8,17). Among these, 52% involve colonoscopy, 16% involve endoscopic retrograde cholangiopancreatography (ERCP), and 11% involve esophagogastroduodenoscopy.⁸ Albeit generally safe, colonoscopy, as with esophagogastroduodenoscopy, is subject to rare but serious AEs.^18,19 Risk of these AEs may be accentuated in certain scenarios (such as severe colonic inflammation or coagulopathy) and, as discussed earlier, may merit tailored informed consent. Regardless of the procedure, in the event of postprocedural development of signs/symptoms (such as tachycardia, fever, chest or abdominal discomfort, or hypotension) indicating a potential AE, stabilizing measures and evaluation (such as blood work and imaging) should be undertaken, and hospital admission (if not already hospitalized) should be considered until discharge is deemed safe.¹⁹

ERCP-related MPL claims, for many years, have had the highest average compensation of any GI procedure.¹¹ Though discussion of advanced procedures is beyond the scope of this article, it is worth mentioning the observation that most of such claims involve an allegation that the procedure was not indicated (for example, that it was performed based on inadequate evidence of pancreatobiliary pathology), or was for diagnostic purposes (for example, being done instead of noninvasive imaging) rather than therapeutic.^20-23 This emphasizes the importance of appropriate procedure indications.

Percutaneous endoscopic gastrostomy (PEG) placement merits special mention given it can be complicated by ethical challenges (for example, needing a surrogate decision-maker’s consent or representing medical futility) and has a relatively high potential for MPL claims. PEG placement carries a low AE rate (0.1%-1%), but these AEs may result in high morbidity/mortality, in part because of the underlying comorbidities of patients needing PEG placement.^24,25 Also, timing of a patient’s demise may coincide with PEG placement, thereby prompting (possibly unfounded) perceptions of causality.^24-27 Therefore, such scenarios merit unique additional preprocedure safeguards. For instance, for patients lacking capacity to provide informed consent, especially when family members may differ on whether PEG should be placed, it is advisable to ask the family to select one surrogate decision-maker (if there’s no advance directive) to whom the gastroenterologist should discuss both the risks, benefits, and goals of PEG placement in the context of the patient’s overall clinical trajectory/life expectancy and the need for consent (or refusal) based on what the patient would have wished. In addition, having a medical professional witness this discussion may be useful.²⁷
 

Antithrombotic agents

Periprocedural management of antithrombotics, including anticoagulants and antiplatelets, can pose challenges for the gastroenterologist. While clinical practice guidelines exist to guide decision-making in this regard, the variables involved may extend beyond the expertise of the gastroenterologist.²⁸ For instance, in addition to the procedural risk for bleeding, the indication for antithrombotic therapy, risk of a thrombotic event, duration of action of the antithrombotic, and available bridging options should all be considered according to recommendations.^28,29 While requiring more time on the part of the gastroenterologist, the optimal periprocedural management of antithrombotic agents would usually involve discussion with the provider managing antithrombotic therapy to best conduct a risk-benefit assessment regarding if (and how long) the antithrombotic therapy should be held (Figure). This shared decision-making, which should also include the patient, may help decrease MPL risk and improve outcomes.

Provider defense mechanisms

Physicians may engage in various defensive behaviors in an attempt to mitigate MPL risk; however, these behaviors may, paradoxically, increase risk.^30,31

Assurance behaviors

Assurance behaviors refer to the practice of recommending or performing additional services (such as medications, imaging, procedures, and referrals) that are not clearly indicated.^2,30,31 Assurance behaviors are driven by fear of MPL risk and/or missing a potential diagnosis. Recent studies have estimated that more than 50% of gastroenterologists worldwide have performed additional invasive procedures without clear indications, and that nearly one-third of endoscopic procedures annually have questionable indications.^30,32 While assurance behaviors may seem likely to decrease MPL risk, overall, they may inadvertently increase AE and MPL risk, as well as health care expenditures.^3,30,32

Avoidance behaviors

Avoidance behaviors refer to providers avoiding participation in potentially high-risk clinical interventions (for example, the actual procedures), including those for which they are credentialed/certified proficient.^30,31 Two clinical scenarios that illustrate this behavior include the following: An advanced endoscopist credentialed to perform ERCP might refer a “high-risk” elderly patient with cholangitis to another provider to perform said ERCP or for percutaneous transhepatic drainage (in the absence of a clear benefit to such), or a gastroenterologist might refer a patient to interventional gastroenterology for resection of a large polyp even though gastroenterologists are usually proficient in this skill and may feel comfortable performing the resection themselves. Avoidance behaviors are driven by a fear of MPL risk and can have several negative consequences.³³ For example, patients may not receive indicated interventions. Additionally, patients may have to wait longer for an intervention because they are referred to another provider, which also increases potential for loss to follow-up.^2,30,31 This may be viewed as noncompliance with the standard of care, among other hazards, thereby increasing MPL risk.

Documentation tenets

Thorough documentation can decrease MPL risk, especially since it is often used as legal evidence.¹⁶ Documenting, for instance, preprocedure discussion of potential risk of AEs (such as bleeding or perforation) or procedural failure (for example, missed lesions)can protect gastroenterologists (Figure).¹⁶ While, as discussed previously, these should be covered in the informed consent process (which itself reduces MPL risk), proof of compliance in providing adequate informed consent must come in the form of documentation that indicates that the process took place and specifically what topics were discussed therein. MPL risk may be further decreased by documenting steps taken during a procedure and anatomic landmarks encountered to offer proof of technical competency and compliance with standards of care (Figure).^16,34 In this context, it is worth recalling the adage: “If it’s not documented, it did not occur.”

Curbside consults versus consultation

Also germane here is the topic of whether documentation is needed for “curbside consults.” The uncertainty is, in part, semantic; that is, at what point does a “curbside” become a consultation? A curbside is a general question or query (such as anything that could also be answered by searching the Internet or reference materials) in response to which information is provided; once it involves provision of medical advice for a specific patient (for example, when patient identifiers have been shared or their EHR has been accessed), it constitutes a consultation. Based on these definitions, a curbside need not be documented, whereas a consultation – even if seemingly trivial – should be.

Consideration of language and cultural factors

Language barriers should be considered when the gastroenterologist is communicating with the patient, and such efforts, whenever made, should be documented to best protect against MPL.^16,35 These considerations arise not only during the consent process but when obtaining a history, providing postprocedure instructions, and during follow-ups. To this end, 24/7 telephone interpreter services may assist the gastroenterologist (when one is communicating with non–English speakers and is not medically certified in the patient’s native/preferred language) and strengthen trust in the provider-patient relationship.³⁶ Additionally, written materials (such as consent forms, procedural information) in patients’ native/preferred languages should be provided, when available, to enhance patient understanding and participation in care (Figure).³⁵

Challenges posed by telemedicine

The COVID-19 pandemic has rapidly led to more virtual encounters. While increased utilization of telemedicine platforms may make health care more accessible, it does not lessen the clinicians’ duty to patients and may actually expose them to greater MPL risk.^18,37,38 Therefore, the provider must be cognizant of two key principles to mitigate MPL risk in the context of telemedicine encounters. First, the same standard of care applies to virtual and in-person encounters.^18,37,38 Second, patient privacy and HIPAA regulations are not waived during telemedicine encounters, and breaches of such may result in an MPL claim.^18,37,38

With regard to the first principle, for patients who have not been physically examined (such as when a telemedicine visit was substituted for an in-person clinic encounter), gastroenterologists should not overlook requesting timely preprocedure anesthesia consultation or obtaining additional laboratory studies as needed to ensure safety and the same standard of care. Moreover, particularly in the context of pandemic-related decreased procedural capacity, triaging procedures can be especially challenging. Standardized institutional criteria which prioritize certain diagnoses/conditions over others, leaving room for justifiable exceptions, are advisable.
 

Vicarious liability

“Vicarious liability” is defined as that extending to persons who have not committed a wrong but on whose behalf wrongdoers acted.³⁹ Therefore, gastroenterologists may be liable not only for their own actions but also for those of personnel they supervise (such as fellow trainees and non–physician practitioners).³⁹ Vicarious liability aims to ensure that systemic checks and balances are in place so that, if failure occurs, harm can still be mitigated and/or avoided, as illustrated by Reason’s “Swiss Cheese Model.”⁴⁰

Conclusion

Any gastroenterologist can experience an MPL claim. Such an experience can be especially stressful and confusing to early-career clinicians, especially if they’re unfamiliar with legal proceedings. Although MPL principles are not often taught in medical school or residency, it is important for gastroenterologists to be informed regarding tenets of MPL and cognizant of clinical situations which have relatively higher MPL risk. This can assuage untoward angst regarding MPL and highlight proactive risk-mitigation strategies. In general, gastroenterologist practices that can mitigate MPL risk include effective communication; adequate informed consent/refusal; documentation of preprocedure counseling, periprocedure events, and postprocedure recommendations; and maintenance of proper certification and privileging.

Dr. Azizian and Dr. Dalai are with the University of California, Los Angeles and the department of medicine at Olive View–UCLA Medical Center, Sylmar, Calif. They are co–first authors of this paper. Dr. Dalai is also with the division of gastroenterology at the University of New Mexico, Albuquerque. Dr. Adams is with the Center for Clinical Management Research in Veterans Affairs Ann Arbor Healthcare System, the division of gastroenterology at the University of Michigan Health System, and the Institute for Healthcare Policy and Innovation, all in Ann Arbor, Mich. Dr. Tabibian is with UCLA and the division of gastroenterology at Olive View–UCLA Medical Center. The authors have no conflicts of interest.

References

1. 2020 Data Sharing Project Gastroenterology 2009-2018. Inside Medical Liability: Second Quarter. Accessed 2020 Dec 6.

2. Mello MM et al. Health Aff (Millwood). 2004 Jul-Aug;23(4):42-53.

3. Adams MA et al. JAMA. 2014 Oct;312(13):1348-9.

4. Pegalis SE. American Law of Medical Malpractice 3d, Vol. 2. St. Paul, Minn.: Thomson Reuters, 2005.

5. Feld LD et al. Am J Gastroenterol. 2018 Nov;113(11):1577-9.

6. Sawyer v. Wight, 196 F. Supp. 2d 220, 226 (E.D.N.Y. 2002).

7. Michael A. Sita v. Long Island Jewish-Hillside Medical Center, 22 A.D.3d 743 (N.Y. App. Div. 2005).

8. Conklin LS et al. Clin Gastroenterol Hepatol. 2008 Jun;6(6):677-81.

9. Jena AB et al. N Engl J Med. 2011 Aug 18;365(7):629-36.

10. Kane CK. “Policy Research Perspectives Medical Liability Claim Frequency: A 2007-2008 Snapshot of Physicians.” Chicago: American Medical Association, 2010.

11. Hernandez LV et al. World J Gastrointest Endosc. 2013 Apr 16;5(4):169-73.

12. Schaffer AC et al. JAMA Intern Med. 2017 May 1;177(5):710-8.

13. Natanson v. Kline, 186 Kan. 393, 409, 350 P.2d 1093, 1106, decision clarified on denial of reh’g, 187 Kan. 186, 354 P.2d 670 (1960).

14. Truman v. Thomas, 27 Cal. 3d 285, 292, 611 P.2d 902, 906 (1980).

15. Shah P et al. Informed Consent, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2020 Jan. Updated 2020 Aug 22.

16. Rex DK. Clin Gastroenterol Hepatol. 2013 Jul;11(7):768-73.

17. Gerstenberger PD, Plumeri PA. Gastrointest Endosc. Mar-Apr 1993;39(2):132-8.

18. Adams MA and Allen JI. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2392-6.e1.

19. Ahlawat R et al. Esophagogastroduodenoscopy, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2020 Jan. Updated 2020 Dec 9.

20. Cotton PB. Gastrointest Endosc. 2006 Mar;63(3):378-82.

21. Cotton PB. Gastrointest Endosc. 2010 Oct;72(4):904.

22. Adamson TE et al. West J Med. 1989 Mar;150(3):356-60.

23. Trap R et al. Endoscopy. 1999 Feb;31(2):125-30.

24. Funaki B. Semin Intervent Radiol. 2015 Mar;32(1):61-4.

25. Feeding Tube Nursing Home and Hospital Malpractice. Miller & Zois, Attorneys at Law. Accessed 2020 Jun 20.

26. Medical Malpractice Lawsuit Brings $750,000 Settlement: Death of 82-year-old woman from sepsis due to improper placement of feeding tube. Lubin & Meyers PC. Accessed 2020 Jun 20.

27. Brendel RW et al. Med Clin North Am. 2010 Nov;94(6):1229-40, xi-ii.

28. ASGE Standards of Practice Committee; Acosta RD et al. Gastrointest Endosc. 2016 Jan;83(1):3-16.

29. Saleem S and Thomas AL. Cureus. 2018 Jun 25;10(6):e2878.

30. Hiyama T et al. World J Gastroenterol. 2006 Dec 21;12(47):7671-5.

31. Studdert DM et al. JAMA. 2005 Jun 1;293(21):2609-17.

32. Shaheen NJ et al. Gastroenterology. 2018 May;154(7):1993-2003.

33. Oza VM et al. Clin Gastroenterol Hepatol. 2016 Feb;14(2):172-4.

34. Feld AD. Gastrointest Endosc Clin N Am. 2002 Jan;12(1):171-9, viii-ix.

35. Lee JS et al. J Gen Intern Med. 2017 Aug;32(8):863-70.

36. Forrow L and Kontrimas JC. J Gen Intern Med. 2017 Aug;32(8):855-7.

37. Moses RE et al. Am J Gastroenterol. 2014 Aug;109(8):1128-32.

38. Tabibian JH. “The Evolution of Telehealth.” Guidepoint: Legal Solutions Blog. Accessed 2020 Aug 12.

39. Feld AD. Am J Gastroenterol. 2004 Sep;99(9):1641-4.

40. Reason J. BMJ. 2000;320(7237):768‐70.

Disclaimer: This article is for educational purposes only. All examples are hypothetical and aim to illustrate common clinical scenarios and challenges gastroenterologists may encounter within their scope of practice. The content herein should not be interpreted as legal advice for individual cases nor a substitute for seeking the advice of an attorney.

There are unique potential stressors faced by the gastroenterologist at each career stage, some more so early on. One such stressor, and one particularly important in a procedure-intensive specialty like GI, is medical professional liability (MPL), historically termed “medical malpractice.” Between 2009 and 2018, GI was the second-highest internal medicine subspecialty in both MPL claims made and claims paid,¹ yet instruction on MPL risk and mitigation is scarce in fellowship, as is the available GI-related literature on the topic. This scarcity may generate untoward stress and unnecessarily expose gastroenterologists to avoidable MPL pitfalls. Therefore, it is vital for GI trainees, early-career gastroenterologists, and even seasoned gastroenterologists to have a working and updated knowledge of the general principles of MPL and GI-specific considerations. Such understanding can help preserve physician well-being, increase professional satisfaction, strengthen the doctor-patient relationship, and improve health care outcomes.²

To this end, we herein provide a focused review of the following: key MPL concepts, trends in MPL claims, GI-related MPL risk scenarios and considerations, adverse provider defensive mechanisms, documentation tenets, challenges posed by telemedicine, and the concept of “vicarious liability.”
 

Key MPL concepts

MPL falls under the umbrella of tort law, which itself falls under the umbrella of civil law; that is, civil (as opposed to criminal) justice governs torts – including but not limited to MPL claims – as well as other areas of law concerning noncriminal injury.³ A “tort” is a “civil wrong that unfairly causes another to experience loss or harm resulting in legal liability.”³ MPL claims assert the tort of negligence (similar to the concept of “incompetence”) and endeavor to compensate the harmed patient/individual while simultaneously dissuading suboptimal medical care by the provider in the future.^4,5 A successful MPL claim must prove four overlapping elements: that the tortfeasor (here, the gastroenterologist) owed a duty of care to the injured party and breached that duty, which caused damages.⁶ Given that MPL cases exist within tort law rather than criminal law, the burden of proof for these cases is not “beyond a reasonable doubt”; instead, it’s “to a reasonable medical probability.”⁷

Trends in MPL claims

According to data compiled by the MPL Association, 278,220 MPL claims were made in the United States from 1985 to 2012.^3,8-10 Among these, 1.8% involved gastroenterologists, which puts it at 17th place out of the 20 specialties surveyed.⁹ While the number of paid claims over this time frame decreased in GI by 34.6% (from 18.5 to 12.1 cases per 1,000 physician-years), there was a concurrent 23.3% increase in average claim compensation; essentially, there were fewer paid GI-related claims but there were higher payouts per paid claim.^11,12 From 2009 to 2018, average legal defense costs for paid GI-related claims were $97,392, and average paid amount was $330,876.¹

GI-related MPL risk scenarios and considerations

Many MPL claims relate to situations involving medical errors or adverse events (AEs), be they procedural or nonprocedural. However other aspects of GI also carry MPL risk.

Informed consent

MPL claims may be made not only on the grounds of inadequately informed consent but also inadequately informed refusal.^5,13,14 While standards for adequate informed consent vary by state, most states apply the “reasonable patient standard,” i.e., assuming an average patient with enough information to be an active participant in the medical decision-making process. Generally, informed consent should ensure that the patient understands the nature of the procedure/treatment being proposed, there is a discussion of the risks and benefits of undergoing and not undergoing the procedure/treatment, reasonable alternatives are presented, the risks and benefits associated with these alternatives are discussed, and the patient’s comprehension of these things is assessed (Figure).¹⁵ Additionally, informed consent should be tailored to each patient and GI procedure/treatment on a case-by-case basis rather than using a one-size-fits-all approach. Moreover, documentation of the patient’s understanding of the (tailored) information provided can concurrently improve quality of the consent and potentially decrease MPL risk (Figure).¹⁶

Endoscopic procedures

Procedure-related MPL claims represent approximately 25% of all GI-related claims (8,17). Among these, 52% involve colonoscopy, 16% involve endoscopic retrograde cholangiopancreatography (ERCP), and 11% involve esophagogastroduodenoscopy.⁸ Albeit generally safe, colonoscopy, as with esophagogastroduodenoscopy, is subject to rare but serious AEs.^18,19 Risk of these AEs may be accentuated in certain scenarios (such as severe colonic inflammation or coagulopathy) and, as discussed earlier, may merit tailored informed consent. Regardless of the procedure, in the event of postprocedural development of signs/symptoms (such as tachycardia, fever, chest or abdominal discomfort, or hypotension) indicating a potential AE, stabilizing measures and evaluation (such as blood work and imaging) should be undertaken, and hospital admission (if not already hospitalized) should be considered until discharge is deemed safe.¹⁹

ERCP-related MPL claims, for many years, have had the highest average compensation of any GI procedure.¹¹ Though discussion of advanced procedures is beyond the scope of this article, it is worth mentioning the observation that most of such claims involve an allegation that the procedure was not indicated (for example, that it was performed based on inadequate evidence of pancreatobiliary pathology), or was for diagnostic purposes (for example, being done instead of noninvasive imaging) rather than therapeutic.^20-23 This emphasizes the importance of appropriate procedure indications.

Percutaneous endoscopic gastrostomy (PEG) placement merits special mention given it can be complicated by ethical challenges (for example, needing a surrogate decision-maker’s consent or representing medical futility) and has a relatively high potential for MPL claims. PEG placement carries a low AE rate (0.1%-1%), but these AEs may result in high morbidity/mortality, in part because of the underlying comorbidities of patients needing PEG placement.^24,25 Also, timing of a patient’s demise may coincide with PEG placement, thereby prompting (possibly unfounded) perceptions of causality.^24-27 Therefore, such scenarios merit unique additional preprocedure safeguards. For instance, for patients lacking capacity to provide informed consent, especially when family members may differ on whether PEG should be placed, it is advisable to ask the family to select one surrogate decision-maker (if there’s no advance directive) to whom the gastroenterologist should discuss both the risks, benefits, and goals of PEG placement in the context of the patient’s overall clinical trajectory/life expectancy and the need for consent (or refusal) based on what the patient would have wished. In addition, having a medical professional witness this discussion may be useful.²⁷
 

Antithrombotic agents

Periprocedural management of antithrombotics, including anticoagulants and antiplatelets, can pose challenges for the gastroenterologist. While clinical practice guidelines exist to guide decision-making in this regard, the variables involved may extend beyond the expertise of the gastroenterologist.²⁸ For instance, in addition to the procedural risk for bleeding, the indication for antithrombotic therapy, risk of a thrombotic event, duration of action of the antithrombotic, and available bridging options should all be considered according to recommendations.^28,29 While requiring more time on the part of the gastroenterologist, the optimal periprocedural management of antithrombotic agents would usually involve discussion with the provider managing antithrombotic therapy to best conduct a risk-benefit assessment regarding if (and how long) the antithrombotic therapy should be held (Figure). This shared decision-making, which should also include the patient, may help decrease MPL risk and improve outcomes.

Provider defense mechanisms

Physicians may engage in various defensive behaviors in an attempt to mitigate MPL risk; however, these behaviors may, paradoxically, increase risk.^30,31

Assurance behaviors

Assurance behaviors refer to the practice of recommending or performing additional services (such as medications, imaging, procedures, and referrals) that are not clearly indicated.^2,30,31 Assurance behaviors are driven by fear of MPL risk and/or missing a potential diagnosis. Recent studies have estimated that more than 50% of gastroenterologists worldwide have performed additional invasive procedures without clear indications, and that nearly one-third of endoscopic procedures annually have questionable indications.^30,32 While assurance behaviors may seem likely to decrease MPL risk, overall, they may inadvertently increase AE and MPL risk, as well as health care expenditures.^3,30,32

Avoidance behaviors

Avoidance behaviors refer to providers avoiding participation in potentially high-risk clinical interventions (for example, the actual procedures), including those for which they are credentialed/certified proficient.^30,31 Two clinical scenarios that illustrate this behavior include the following: An advanced endoscopist credentialed to perform ERCP might refer a “high-risk” elderly patient with cholangitis to another provider to perform said ERCP or for percutaneous transhepatic drainage (in the absence of a clear benefit to such), or a gastroenterologist might refer a patient to interventional gastroenterology for resection of a large polyp even though gastroenterologists are usually proficient in this skill and may feel comfortable performing the resection themselves. Avoidance behaviors are driven by a fear of MPL risk and can have several negative consequences.³³ For example, patients may not receive indicated interventions. Additionally, patients may have to wait longer for an intervention because they are referred to another provider, which also increases potential for loss to follow-up.^2,30,31 This may be viewed as noncompliance with the standard of care, among other hazards, thereby increasing MPL risk.

Documentation tenets

Thorough documentation can decrease MPL risk, especially since it is often used as legal evidence.¹⁶ Documenting, for instance, preprocedure discussion of potential risk of AEs (such as bleeding or perforation) or procedural failure (for example, missed lesions)can protect gastroenterologists (Figure).¹⁶ While, as discussed previously, these should be covered in the informed consent process (which itself reduces MPL risk), proof of compliance in providing adequate informed consent must come in the form of documentation that indicates that the process took place and specifically what topics were discussed therein. MPL risk may be further decreased by documenting steps taken during a procedure and anatomic landmarks encountered to offer proof of technical competency and compliance with standards of care (Figure).^16,34 In this context, it is worth recalling the adage: “If it’s not documented, it did not occur.”

Curbside consults versus consultation

Also germane here is the topic of whether documentation is needed for “curbside consults.” The uncertainty is, in part, semantic; that is, at what point does a “curbside” become a consultation? A curbside is a general question or query (such as anything that could also be answered by searching the Internet or reference materials) in response to which information is provided; once it involves provision of medical advice for a specific patient (for example, when patient identifiers have been shared or their EHR has been accessed), it constitutes a consultation. Based on these definitions, a curbside need not be documented, whereas a consultation – even if seemingly trivial – should be.

Consideration of language and cultural factors

Language barriers should be considered when the gastroenterologist is communicating with the patient, and such efforts, whenever made, should be documented to best protect against MPL.^16,35 These considerations arise not only during the consent process but when obtaining a history, providing postprocedure instructions, and during follow-ups. To this end, 24/7 telephone interpreter services may assist the gastroenterologist (when one is communicating with non–English speakers and is not medically certified in the patient’s native/preferred language) and strengthen trust in the provider-patient relationship.³⁶ Additionally, written materials (such as consent forms, procedural information) in patients’ native/preferred languages should be provided, when available, to enhance patient understanding and participation in care (Figure).³⁵

Challenges posed by telemedicine

The COVID-19 pandemic has rapidly led to more virtual encounters. While increased utilization of telemedicine platforms may make health care more accessible, it does not lessen the clinicians’ duty to patients and may actually expose them to greater MPL risk.^18,37,38 Therefore, the provider must be cognizant of two key principles to mitigate MPL risk in the context of telemedicine encounters. First, the same standard of care applies to virtual and in-person encounters.^18,37,38 Second, patient privacy and HIPAA regulations are not waived during telemedicine encounters, and breaches of such may result in an MPL claim.^18,37,38

With regard to the first principle, for patients who have not been physically examined (such as when a telemedicine visit was substituted for an in-person clinic encounter), gastroenterologists should not overlook requesting timely preprocedure anesthesia consultation or obtaining additional laboratory studies as needed to ensure safety and the same standard of care. Moreover, particularly in the context of pandemic-related decreased procedural capacity, triaging procedures can be especially challenging. Standardized institutional criteria which prioritize certain diagnoses/conditions over others, leaving room for justifiable exceptions, are advisable.
 

Vicarious liability

“Vicarious liability” is defined as that extending to persons who have not committed a wrong but on whose behalf wrongdoers acted.³⁹ Therefore, gastroenterologists may be liable not only for their own actions but also for those of personnel they supervise (such as fellow trainees and non–physician practitioners).³⁹ Vicarious liability aims to ensure that systemic checks and balances are in place so that, if failure occurs, harm can still be mitigated and/or avoided, as illustrated by Reason’s “Swiss Cheese Model.”⁴⁰

Conclusion

Any gastroenterologist can experience an MPL claim. Such an experience can be especially stressful and confusing to early-career clinicians, especially if they’re unfamiliar with legal proceedings. Although MPL principles are not often taught in medical school or residency, it is important for gastroenterologists to be informed regarding tenets of MPL and cognizant of clinical situations which have relatively higher MPL risk. This can assuage untoward angst regarding MPL and highlight proactive risk-mitigation strategies. In general, gastroenterologist practices that can mitigate MPL risk include effective communication; adequate informed consent/refusal; documentation of preprocedure counseling, periprocedure events, and postprocedure recommendations; and maintenance of proper certification and privileging.

Dr. Azizian and Dr. Dalai are with the University of California, Los Angeles and the department of medicine at Olive View–UCLA Medical Center, Sylmar, Calif. They are co–first authors of this paper. Dr. Dalai is also with the division of gastroenterology at the University of New Mexico, Albuquerque. Dr. Adams is with the Center for Clinical Management Research in Veterans Affairs Ann Arbor Healthcare System, the division of gastroenterology at the University of Michigan Health System, and the Institute for Healthcare Policy and Innovation, all in Ann Arbor, Mich. Dr. Tabibian is with UCLA and the division of gastroenterology at Olive View–UCLA Medical Center. The authors have no conflicts of interest.

References

1. 2020 Data Sharing Project Gastroenterology 2009-2018. Inside Medical Liability: Second Quarter. Accessed 2020 Dec 6.

2. Mello MM et al. Health Aff (Millwood). 2004 Jul-Aug;23(4):42-53.

3. Adams MA et al. JAMA. 2014 Oct;312(13):1348-9.

4. Pegalis SE. American Law of Medical Malpractice 3d, Vol. 2. St. Paul, Minn.: Thomson Reuters, 2005.

5. Feld LD et al. Am J Gastroenterol. 2018 Nov;113(11):1577-9.

6. Sawyer v. Wight, 196 F. Supp. 2d 220, 226 (E.D.N.Y. 2002).

7. Michael A. Sita v. Long Island Jewish-Hillside Medical Center, 22 A.D.3d 743 (N.Y. App. Div. 2005).

8. Conklin LS et al. Clin Gastroenterol Hepatol. 2008 Jun;6(6):677-81.

9. Jena AB et al. N Engl J Med. 2011 Aug 18;365(7):629-36.

10. Kane CK. “Policy Research Perspectives Medical Liability Claim Frequency: A 2007-2008 Snapshot of Physicians.” Chicago: American Medical Association, 2010.

11. Hernandez LV et al. World J Gastrointest Endosc. 2013 Apr 16;5(4):169-73.

12. Schaffer AC et al. JAMA Intern Med. 2017 May 1;177(5):710-8.

13. Natanson v. Kline, 186 Kan. 393, 409, 350 P.2d 1093, 1106, decision clarified on denial of reh’g, 187 Kan. 186, 354 P.2d 670 (1960).

14. Truman v. Thomas, 27 Cal. 3d 285, 292, 611 P.2d 902, 906 (1980).

15. Shah P et al. Informed Consent, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2020 Jan. Updated 2020 Aug 22.

16. Rex DK. Clin Gastroenterol Hepatol. 2013 Jul;11(7):768-73.

17. Gerstenberger PD, Plumeri PA. Gastrointest Endosc. Mar-Apr 1993;39(2):132-8.

18. Adams MA and Allen JI. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2392-6.e1.

19. Ahlawat R et al. Esophagogastroduodenoscopy, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2020 Jan. Updated 2020 Dec 9.

20. Cotton PB. Gastrointest Endosc. 2006 Mar;63(3):378-82.

21. Cotton PB. Gastrointest Endosc. 2010 Oct;72(4):904.

22. Adamson TE et al. West J Med. 1989 Mar;150(3):356-60.

23. Trap R et al. Endoscopy. 1999 Feb;31(2):125-30.

24. Funaki B. Semin Intervent Radiol. 2015 Mar;32(1):61-4.

25. Feeding Tube Nursing Home and Hospital Malpractice. Miller & Zois, Attorneys at Law. Accessed 2020 Jun 20.

26. Medical Malpractice Lawsuit Brings $750,000 Settlement: Death of 82-year-old woman from sepsis due to improper placement of feeding tube. Lubin & Meyers PC. Accessed 2020 Jun 20.

27. Brendel RW et al. Med Clin North Am. 2010 Nov;94(6):1229-40, xi-ii.

28. ASGE Standards of Practice Committee; Acosta RD et al. Gastrointest Endosc. 2016 Jan;83(1):3-16.

29. Saleem S and Thomas AL. Cureus. 2018 Jun 25;10(6):e2878.

30. Hiyama T et al. World J Gastroenterol. 2006 Dec 21;12(47):7671-5.

31. Studdert DM et al. JAMA. 2005 Jun 1;293(21):2609-17.

32. Shaheen NJ et al. Gastroenterology. 2018 May;154(7):1993-2003.

33. Oza VM et al. Clin Gastroenterol Hepatol. 2016 Feb;14(2):172-4.

34. Feld AD. Gastrointest Endosc Clin N Am. 2002 Jan;12(1):171-9, viii-ix.

35. Lee JS et al. J Gen Intern Med. 2017 Aug;32(8):863-70.

36. Forrow L and Kontrimas JC. J Gen Intern Med. 2017 Aug;32(8):855-7.

37. Moses RE et al. Am J Gastroenterol. 2014 Aug;109(8):1128-32.

38. Tabibian JH. “The Evolution of Telehealth.” Guidepoint: Legal Solutions Blog. Accessed 2020 Aug 12.

39. Feld AD. Am J Gastroenterol. 2004 Sep;99(9):1641-4.

40. Reason J. BMJ. 2000;320(7237):768‐70.

Disclaimer: This article is for educational purposes only. All examples are hypothetical and aim to illustrate common clinical scenarios and challenges gastroenterologists may encounter within their scope of practice. The content herein should not be interpreted as legal advice for individual cases nor a substitute for seeking the advice of an attorney.

There are unique potential stressors faced by the gastroenterologist at each career stage, some more so early on. One such stressor, and one particularly important in a procedure-intensive specialty like GI, is medical professional liability (MPL), historically termed “medical malpractice.” Between 2009 and 2018, GI was the second-highest internal medicine subspecialty in both MPL claims made and claims paid,¹ yet instruction on MPL risk and mitigation is scarce in fellowship, as is the available GI-related literature on the topic. This scarcity may generate untoward stress and unnecessarily expose gastroenterologists to avoidable MPL pitfalls. Therefore, it is vital for GI trainees, early-career gastroenterologists, and even seasoned gastroenterologists to have a working and updated knowledge of the general principles of MPL and GI-specific considerations. Such understanding can help preserve physician well-being, increase professional satisfaction, strengthen the doctor-patient relationship, and improve health care outcomes.²

To this end, we herein provide a focused review of the following: key MPL concepts, trends in MPL claims, GI-related MPL risk scenarios and considerations, adverse provider defensive mechanisms, documentation tenets, challenges posed by telemedicine, and the concept of “vicarious liability.”
 

Key MPL concepts

MPL falls under the umbrella of tort law, which itself falls under the umbrella of civil law; that is, civil (as opposed to criminal) justice governs torts – including but not limited to MPL claims – as well as other areas of law concerning noncriminal injury.³ A “tort” is a “civil wrong that unfairly causes another to experience loss or harm resulting in legal liability.”³ MPL claims assert the tort of negligence (similar to the concept of “incompetence”) and endeavor to compensate the harmed patient/individual while simultaneously dissuading suboptimal medical care by the provider in the future.^4,5 A successful MPL claim must prove four overlapping elements: that the tortfeasor (here, the gastroenterologist) owed a duty of care to the injured party and breached that duty, which caused damages.⁶ Given that MPL cases exist within tort law rather than criminal law, the burden of proof for these cases is not “beyond a reasonable doubt”; instead, it’s “to a reasonable medical probability.”⁷

Trends in MPL claims

According to data compiled by the MPL Association, 278,220 MPL claims were made in the United States from 1985 to 2012.^3,8-10 Among these, 1.8% involved gastroenterologists, which puts it at 17th place out of the 20 specialties surveyed.⁹ While the number of paid claims over this time frame decreased in GI by 34.6% (from 18.5 to 12.1 cases per 1,000 physician-years), there was a concurrent 23.3% increase in average claim compensation; essentially, there were fewer paid GI-related claims but there were higher payouts per paid claim.^11,12 From 2009 to 2018, average legal defense costs for paid GI-related claims were $97,392, and average paid amount was $330,876.¹

GI-related MPL risk scenarios and considerations

Many MPL claims relate to situations involving medical errors or adverse events (AEs), be they procedural or nonprocedural. However other aspects of GI also carry MPL risk.

Informed consent

MPL claims may be made not only on the grounds of inadequately informed consent but also inadequately informed refusal.^5,13,14 While standards for adequate informed consent vary by state, most states apply the “reasonable patient standard,” i.e., assuming an average patient with enough information to be an active participant in the medical decision-making process. Generally, informed consent should ensure that the patient understands the nature of the procedure/treatment being proposed, there is a discussion of the risks and benefits of undergoing and not undergoing the procedure/treatment, reasonable alternatives are presented, the risks and benefits associated with these alternatives are discussed, and the patient’s comprehension of these things is assessed (Figure).¹⁵ Additionally, informed consent should be tailored to each patient and GI procedure/treatment on a case-by-case basis rather than using a one-size-fits-all approach. Moreover, documentation of the patient’s understanding of the (tailored) information provided can concurrently improve quality of the consent and potentially decrease MPL risk (Figure).¹⁶

Endoscopic procedures

Procedure-related MPL claims represent approximately 25% of all GI-related claims (8,17). Among these, 52% involve colonoscopy, 16% involve endoscopic retrograde cholangiopancreatography (ERCP), and 11% involve esophagogastroduodenoscopy.⁸ Albeit generally safe, colonoscopy, as with esophagogastroduodenoscopy, is subject to rare but serious AEs.^18,19 Risk of these AEs may be accentuated in certain scenarios (such as severe colonic inflammation or coagulopathy) and, as discussed earlier, may merit tailored informed consent. Regardless of the procedure, in the event of postprocedural development of signs/symptoms (such as tachycardia, fever, chest or abdominal discomfort, or hypotension) indicating a potential AE, stabilizing measures and evaluation (such as blood work and imaging) should be undertaken, and hospital admission (if not already hospitalized) should be considered until discharge is deemed safe.¹⁹

ERCP-related MPL claims, for many years, have had the highest average compensation of any GI procedure.¹¹ Though discussion of advanced procedures is beyond the scope of this article, it is worth mentioning the observation that most of such claims involve an allegation that the procedure was not indicated (for example, that it was performed based on inadequate evidence of pancreatobiliary pathology), or was for diagnostic purposes (for example, being done instead of noninvasive imaging) rather than therapeutic.^20-23 This emphasizes the importance of appropriate procedure indications.

Percutaneous endoscopic gastrostomy (PEG) placement merits special mention given it can be complicated by ethical challenges (for example, needing a surrogate decision-maker’s consent or representing medical futility) and has a relatively high potential for MPL claims. PEG placement carries a low AE rate (0.1%-1%), but these AEs may result in high morbidity/mortality, in part because of the underlying comorbidities of patients needing PEG placement.^24,25 Also, timing of a patient’s demise may coincide with PEG placement, thereby prompting (possibly unfounded) perceptions of causality.^24-27 Therefore, such scenarios merit unique additional preprocedure safeguards. For instance, for patients lacking capacity to provide informed consent, especially when family members may differ on whether PEG should be placed, it is advisable to ask the family to select one surrogate decision-maker (if there’s no advance directive) to whom the gastroenterologist should discuss both the risks, benefits, and goals of PEG placement in the context of the patient’s overall clinical trajectory/life expectancy and the need for consent (or refusal) based on what the patient would have wished. In addition, having a medical professional witness this discussion may be useful.²⁷
 

Antithrombotic agents

Periprocedural management of antithrombotics, including anticoagulants and antiplatelets, can pose challenges for the gastroenterologist. While clinical practice guidelines exist to guide decision-making in this regard, the variables involved may extend beyond the expertise of the gastroenterologist.²⁸ For instance, in addition to the procedural risk for bleeding, the indication for antithrombotic therapy, risk of a thrombotic event, duration of action of the antithrombotic, and available bridging options should all be considered according to recommendations.^28,29 While requiring more time on the part of the gastroenterologist, the optimal periprocedural management of antithrombotic agents would usually involve discussion with the provider managing antithrombotic therapy to best conduct a risk-benefit assessment regarding if (and how long) the antithrombotic therapy should be held (Figure). This shared decision-making, which should also include the patient, may help decrease MPL risk and improve outcomes.

Provider defense mechanisms

Physicians may engage in various defensive behaviors in an attempt to mitigate MPL risk; however, these behaviors may, paradoxically, increase risk.^30,31

Assurance behaviors

Assurance behaviors refer to the practice of recommending or performing additional services (such as medications, imaging, procedures, and referrals) that are not clearly indicated.^2,30,31 Assurance behaviors are driven by fear of MPL risk and/or missing a potential diagnosis. Recent studies have estimated that more than 50% of gastroenterologists worldwide have performed additional invasive procedures without clear indications, and that nearly one-third of endoscopic procedures annually have questionable indications.^30,32 While assurance behaviors may seem likely to decrease MPL risk, overall, they may inadvertently increase AE and MPL risk, as well as health care expenditures.^3,30,32

Avoidance behaviors

Avoidance behaviors refer to providers avoiding participation in potentially high-risk clinical interventions (for example, the actual procedures), including those for which they are credentialed/certified proficient.^30,31 Two clinical scenarios that illustrate this behavior include the following: An advanced endoscopist credentialed to perform ERCP might refer a “high-risk” elderly patient with cholangitis to another provider to perform said ERCP or for percutaneous transhepatic drainage (in the absence of a clear benefit to such), or a gastroenterologist might refer a patient to interventional gastroenterology for resection of a large polyp even though gastroenterologists are usually proficient in this skill and may feel comfortable performing the resection themselves. Avoidance behaviors are driven by a fear of MPL risk and can have several negative consequences.³³ For example, patients may not receive indicated interventions. Additionally, patients may have to wait longer for an intervention because they are referred to another provider, which also increases potential for loss to follow-up.^2,30,31 This may be viewed as noncompliance with the standard of care, among other hazards, thereby increasing MPL risk.

Documentation tenets

Thorough documentation can decrease MPL risk, especially since it is often used as legal evidence.¹⁶ Documenting, for instance, preprocedure discussion of potential risk of AEs (such as bleeding or perforation) or procedural failure (for example, missed lesions)can protect gastroenterologists (Figure).¹⁶ While, as discussed previously, these should be covered in the informed consent process (which itself reduces MPL risk), proof of compliance in providing adequate informed consent must come in the form of documentation that indicates that the process took place and specifically what topics were discussed therein. MPL risk may be further decreased by documenting steps taken during a procedure and anatomic landmarks encountered to offer proof of technical competency and compliance with standards of care (Figure).^16,34 In this context, it is worth recalling the adage: “If it’s not documented, it did not occur.”

Curbside consults versus consultation

Also germane here is the topic of whether documentation is needed for “curbside consults.” The uncertainty is, in part, semantic; that is, at what point does a “curbside” become a consultation? A curbside is a general question or query (such as anything that could also be answered by searching the Internet or reference materials) in response to which information is provided; once it involves provision of medical advice for a specific patient (for example, when patient identifiers have been shared or their EHR has been accessed), it constitutes a consultation. Based on these definitions, a curbside need not be documented, whereas a consultation – even if seemingly trivial – should be.

Consideration of language and cultural factors

Language barriers should be considered when the gastroenterologist is communicating with the patient, and such efforts, whenever made, should be documented to best protect against MPL.^16,35 These considerations arise not only during the consent process but when obtaining a history, providing postprocedure instructions, and during follow-ups. To this end, 24/7 telephone interpreter services may assist the gastroenterologist (when one is communicating with non–English speakers and is not medically certified in the patient’s native/preferred language) and strengthen trust in the provider-patient relationship.³⁶ Additionally, written materials (such as consent forms, procedural information) in patients’ native/preferred languages should be provided, when available, to enhance patient understanding and participation in care (Figure).³⁵

Challenges posed by telemedicine

The COVID-19 pandemic has rapidly led to more virtual encounters. While increased utilization of telemedicine platforms may make health care more accessible, it does not lessen the clinicians’ duty to patients and may actually expose them to greater MPL risk.^18,37,38 Therefore, the provider must be cognizant of two key principles to mitigate MPL risk in the context of telemedicine encounters. First, the same standard of care applies to virtual and in-person encounters.^18,37,38 Second, patient privacy and HIPAA regulations are not waived during telemedicine encounters, and breaches of such may result in an MPL claim.^18,37,38

With regard to the first principle, for patients who have not been physically examined (such as when a telemedicine visit was substituted for an in-person clinic encounter), gastroenterologists should not overlook requesting timely preprocedure anesthesia consultation or obtaining additional laboratory studies as needed to ensure safety and the same standard of care. Moreover, particularly in the context of pandemic-related decreased procedural capacity, triaging procedures can be especially challenging. Standardized institutional criteria which prioritize certain diagnoses/conditions over others, leaving room for justifiable exceptions, are advisable.
 

Vicarious liability

“Vicarious liability” is defined as that extending to persons who have not committed a wrong but on whose behalf wrongdoers acted.³⁹ Therefore, gastroenterologists may be liable not only for their own actions but also for those of personnel they supervise (such as fellow trainees and non–physician practitioners).³⁹ Vicarious liability aims to ensure that systemic checks and balances are in place so that, if failure occurs, harm can still be mitigated and/or avoided, as illustrated by Reason’s “Swiss Cheese Model.”⁴⁰

Conclusion

Any gastroenterologist can experience an MPL claim. Such an experience can be especially stressful and confusing to early-career clinicians, especially if they’re unfamiliar with legal proceedings. Although MPL principles are not often taught in medical school or residency, it is important for gastroenterologists to be informed regarding tenets of MPL and cognizant of clinical situations which have relatively higher MPL risk. This can assuage untoward angst regarding MPL and highlight proactive risk-mitigation strategies. In general, gastroenterologist practices that can mitigate MPL risk include effective communication; adequate informed consent/refusal; documentation of preprocedure counseling, periprocedure events, and postprocedure recommendations; and maintenance of proper certification and privileging.

Dr. Azizian and Dr. Dalai are with the University of California, Los Angeles and the department of medicine at Olive View–UCLA Medical Center, Sylmar, Calif. They are co–first authors of this paper. Dr. Dalai is also with the division of gastroenterology at the University of New Mexico, Albuquerque. Dr. Adams is with the Center for Clinical Management Research in Veterans Affairs Ann Arbor Healthcare System, the division of gastroenterology at the University of Michigan Health System, and the Institute for Healthcare Policy and Innovation, all in Ann Arbor, Mich. Dr. Tabibian is with UCLA and the division of gastroenterology at Olive View–UCLA Medical Center. The authors have no conflicts of interest.

References

1. 2020 Data Sharing Project Gastroenterology 2009-2018. Inside Medical Liability: Second Quarter. Accessed 2020 Dec 6.

2. Mello MM et al. Health Aff (Millwood). 2004 Jul-Aug;23(4):42-53.

3. Adams MA et al. JAMA. 2014 Oct;312(13):1348-9.

4. Pegalis SE. American Law of Medical Malpractice 3d, Vol. 2. St. Paul, Minn.: Thomson Reuters, 2005.

5. Feld LD et al. Am J Gastroenterol. 2018 Nov;113(11):1577-9.

6. Sawyer v. Wight, 196 F. Supp. 2d 220, 226 (E.D.N.Y. 2002).

7. Michael A. Sita v. Long Island Jewish-Hillside Medical Center, 22 A.D.3d 743 (N.Y. App. Div. 2005).

8. Conklin LS et al. Clin Gastroenterol Hepatol. 2008 Jun;6(6):677-81.

9. Jena AB et al. N Engl J Med. 2011 Aug 18;365(7):629-36.

10. Kane CK. “Policy Research Perspectives Medical Liability Claim Frequency: A 2007-2008 Snapshot of Physicians.” Chicago: American Medical Association, 2010.

11. Hernandez LV et al. World J Gastrointest Endosc. 2013 Apr 16;5(4):169-73.

12. Schaffer AC et al. JAMA Intern Med. 2017 May 1;177(5):710-8.

13. Natanson v. Kline, 186 Kan. 393, 409, 350 P.2d 1093, 1106, decision clarified on denial of reh’g, 187 Kan. 186, 354 P.2d 670 (1960).

14. Truman v. Thomas, 27 Cal. 3d 285, 292, 611 P.2d 902, 906 (1980).

15. Shah P et al. Informed Consent, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2020 Jan. Updated 2020 Aug 22.

16. Rex DK. Clin Gastroenterol Hepatol. 2013 Jul;11(7):768-73.

17. Gerstenberger PD, Plumeri PA. Gastrointest Endosc. Mar-Apr 1993;39(2):132-8.

18. Adams MA and Allen JI. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2392-6.e1.

19. Ahlawat R et al. Esophagogastroduodenoscopy, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2020 Jan. Updated 2020 Dec 9.

20. Cotton PB. Gastrointest Endosc. 2006 Mar;63(3):378-82.

21. Cotton PB. Gastrointest Endosc. 2010 Oct;72(4):904.

22. Adamson TE et al. West J Med. 1989 Mar;150(3):356-60.

23. Trap R et al. Endoscopy. 1999 Feb;31(2):125-30.

24. Funaki B. Semin Intervent Radiol. 2015 Mar;32(1):61-4.

25. Feeding Tube Nursing Home and Hospital Malpractice. Miller & Zois, Attorneys at Law. Accessed 2020 Jun 20.

26. Medical Malpractice Lawsuit Brings $750,000 Settlement: Death of 82-year-old woman from sepsis due to improper placement of feeding tube. Lubin & Meyers PC. Accessed 2020 Jun 20.

27. Brendel RW et al. Med Clin North Am. 2010 Nov;94(6):1229-40, xi-ii.

28. ASGE Standards of Practice Committee; Acosta RD et al. Gastrointest Endosc. 2016 Jan;83(1):3-16.

29. Saleem S and Thomas AL. Cureus. 2018 Jun 25;10(6):e2878.

30. Hiyama T et al. World J Gastroenterol. 2006 Dec 21;12(47):7671-5.

31. Studdert DM et al. JAMA. 2005 Jun 1;293(21):2609-17.

32. Shaheen NJ et al. Gastroenterology. 2018 May;154(7):1993-2003.

33. Oza VM et al. Clin Gastroenterol Hepatol. 2016 Feb;14(2):172-4.

34. Feld AD. Gastrointest Endosc Clin N Am. 2002 Jan;12(1):171-9, viii-ix.

35. Lee JS et al. J Gen Intern Med. 2017 Aug;32(8):863-70.

36. Forrow L and Kontrimas JC. J Gen Intern Med. 2017 Aug;32(8):855-7.

37. Moses RE et al. Am J Gastroenterol. 2014 Aug;109(8):1128-32.

38. Tabibian JH. “The Evolution of Telehealth.” Guidepoint: Legal Solutions Blog. Accessed 2020 Aug 12.

39. Feld AD. Am J Gastroenterol. 2004 Sep;99(9):1641-4.

40. Reason J. BMJ. 2000;320(7237):768‐70.

In 2019, the   2 Current Procedural Terminology (CPT) codes for skin biopsies (11100 and 11101) were replaced with 6 new CPT codes that   specify biopsy technique   and associated procedural complexity. ^1,2 Prior to the coding changes, all biopsies were reimbursed at the same payment level, but a punch biopsy (11104; national nonfacility Medicare payment, $133.29) is now reimbursed more than a shave biopsy (11102; national nonfacility Medicare payment, $106.42). ³ We sought to evaluate whether the decrease in reimbursement for shave biopsies and concurrent increase in reimbursement for punch biopsies led to a shift from shave to punch biopsy utilization.

Methods

We examined shave and punch biopsies submitted for pathologic examination at Brigham and Women’s Hospital, Massachusetts General Hospital, and Massachusetts General Physician’s Organization (all in Boston, Massachusetts), and Penn Medicine, University of Pennsylvania Health System (Philadelphia, Pennsylvania), in May 2018 vs May 2019 (four months after new codes were implemented). This study was approved by Partners HealthCare (Boston, Massachusetts) and the University of Pennsylvania institutional review boards.

We included shave and punch biopsies of skin performed by physician dermatologists and mid-level providers (ie, physician assistants, nurse practitioners) at dermatology practices. All biopsies performed by a technique other than shave or punch, unspecified biopsy type, consultation cases, nonskin biopsies (eg, mucosa), and biopsies performed at nondermatology practices were excluded. We also excluded biopsies by providers who were not present during both study periods to account for provider mix.

Statistical Analysis
To evaluate for changes in the ratio of shave to punch biopsy utilization over time, we performed χ² tests. Because care practices may differ between private and academic settings as well as between physicians and mid-level providers, we performed subgroup analyses by practice setting and provider type.⁴

Results

We identified 11,785 biopsies (12.11% of which were punch) submitted for pathologic examination in May 2018 compared to 11,291 biopsies (12.08% of which were punch) in May 2019 (Table). The overall use of punch biopsies relative to shave biopsies did not change between the years. There was a relative decrease in punch biopsy use among academic practices (−1.88%; P=.032) and a relative increase in punch biopsy use among private practices (+0.90%; P=.043). Provider type was not associated with differing utilization of biopsy type.

Comment

Overall, there was not a considerable shift in utilization behavior from shave to punch biopsies after the introduction of new coding changes. However, our study does demonstrate a small yet significant increase in punch biopsy utilization among private practices, and a decrease among academic practices. Although the change in biopsy utilization behavior is small in magnitude, it may have a substantial impact when extrapolated to behavior across the entire United States.

We were unable to assess additional factors, such as clinical diagnosis, body site, and cosmetic concerns, that may impact biopsy type selection in this study. Although we included multiple study sites to improve generalizability, our findings may not be representative of all biopsies performed in the dermatology setting. The baseline difference in relative punch biopsy use in academic vs private practices may reflect differences in patient populations and chief concerns, but assuming these features are stable over a 1-year time period, our findings should remain valid. Future studies should focus on qualitative evaluations of physician decision-making and evaluate whether similar trends persist over time.

Conclusion

Skin biopsy utilization trends among differing practice and provider types should continue to be monitored to assess for longitudinal trends in utilization within the context of updated billing codes and associated reimbursements.

In 2019, the   2 Current Procedural Terminology (CPT) codes for skin biopsies (11100 and 11101) were replaced with 6 new CPT codes that   specify biopsy technique   and associated procedural complexity. ^1,2 Prior to the coding changes, all biopsies were reimbursed at the same payment level, but a punch biopsy (11104; national nonfacility Medicare payment, $133.29) is now reimbursed more than a shave biopsy (11102; national nonfacility Medicare payment, $106.42). ³ We sought to evaluate whether the decrease in reimbursement for shave biopsies and concurrent increase in reimbursement for punch biopsies led to a shift from shave to punch biopsy utilization.

Methods

We examined shave and punch biopsies submitted for pathologic examination at Brigham and Women’s Hospital, Massachusetts General Hospital, and Massachusetts General Physician’s Organization (all in Boston, Massachusetts), and Penn Medicine, University of Pennsylvania Health System (Philadelphia, Pennsylvania), in May 2018 vs May 2019 (four months after new codes were implemented). This study was approved by Partners HealthCare (Boston, Massachusetts) and the University of Pennsylvania institutional review boards.

We included shave and punch biopsies of skin performed by physician dermatologists and mid-level providers (ie, physician assistants, nurse practitioners) at dermatology practices. All biopsies performed by a technique other than shave or punch, unspecified biopsy type, consultation cases, nonskin biopsies (eg, mucosa), and biopsies performed at nondermatology practices were excluded. We also excluded biopsies by providers who were not present during both study periods to account for provider mix.

Statistical Analysis
To evaluate for changes in the ratio of shave to punch biopsy utilization over time, we performed χ² tests. Because care practices may differ between private and academic settings as well as between physicians and mid-level providers, we performed subgroup analyses by practice setting and provider type.⁴

Results

We identified 11,785 biopsies (12.11% of which were punch) submitted for pathologic examination in May 2018 compared to 11,291 biopsies (12.08% of which were punch) in May 2019 (Table). The overall use of punch biopsies relative to shave biopsies did not change between the years. There was a relative decrease in punch biopsy use among academic practices (−1.88%; P=.032) and a relative increase in punch biopsy use among private practices (+0.90%; P=.043). Provider type was not associated with differing utilization of biopsy type.

Comment

Overall, there was not a considerable shift in utilization behavior from shave to punch biopsies after the introduction of new coding changes. However, our study does demonstrate a small yet significant increase in punch biopsy utilization among private practices, and a decrease among academic practices. Although the change in biopsy utilization behavior is small in magnitude, it may have a substantial impact when extrapolated to behavior across the entire United States.

We were unable to assess additional factors, such as clinical diagnosis, body site, and cosmetic concerns, that may impact biopsy type selection in this study. Although we included multiple study sites to improve generalizability, our findings may not be representative of all biopsies performed in the dermatology setting. The baseline difference in relative punch biopsy use in academic vs private practices may reflect differences in patient populations and chief concerns, but assuming these features are stable over a 1-year time period, our findings should remain valid. Future studies should focus on qualitative evaluations of physician decision-making and evaluate whether similar trends persist over time.

Conclusion

Skin biopsy utilization trends among differing practice and provider types should continue to be monitored to assess for longitudinal trends in utilization within the context of updated billing codes and associated reimbursements.

In 2019, the   2 Current Procedural Terminology (CPT) codes for skin biopsies (11100 and 11101) were replaced with 6 new CPT codes that   specify biopsy technique   and associated procedural complexity. ^1,2 Prior to the coding changes, all biopsies were reimbursed at the same payment level, but a punch biopsy (11104; national nonfacility Medicare payment, $133.29) is now reimbursed more than a shave biopsy (11102; national nonfacility Medicare payment, $106.42). ³ We sought to evaluate whether the decrease in reimbursement for shave biopsies and concurrent increase in reimbursement for punch biopsies led to a shift from shave to punch biopsy utilization.

Methods

We examined shave and punch biopsies submitted for pathologic examination at Brigham and Women’s Hospital, Massachusetts General Hospital, and Massachusetts General Physician’s Organization (all in Boston, Massachusetts), and Penn Medicine, University of Pennsylvania Health System (Philadelphia, Pennsylvania), in May 2018 vs May 2019 (four months after new codes were implemented). This study was approved by Partners HealthCare (Boston, Massachusetts) and the University of Pennsylvania institutional review boards.

We included shave and punch biopsies of skin performed by physician dermatologists and mid-level providers (ie, physician assistants, nurse practitioners) at dermatology practices. All biopsies performed by a technique other than shave or punch, unspecified biopsy type, consultation cases, nonskin biopsies (eg, mucosa), and biopsies performed at nondermatology practices were excluded. We also excluded biopsies by providers who were not present during both study periods to account for provider mix.

Statistical Analysis
To evaluate for changes in the ratio of shave to punch biopsy utilization over time, we performed χ² tests. Because care practices may differ between private and academic settings as well as between physicians and mid-level providers, we performed subgroup analyses by practice setting and provider type.⁴

Results

We identified 11,785 biopsies (12.11% of which were punch) submitted for pathologic examination in May 2018 compared to 11,291 biopsies (12.08% of which were punch) in May 2019 (Table). The overall use of punch biopsies relative to shave biopsies did not change between the years. There was a relative decrease in punch biopsy use among academic practices (−1.88%; P=.032) and a relative increase in punch biopsy use among private practices (+0.90%; P=.043). Provider type was not associated with differing utilization of biopsy type.

Comment

Overall, there was not a considerable shift in utilization behavior from shave to punch biopsies after the introduction of new coding changes. However, our study does demonstrate a small yet significant increase in punch biopsy utilization among private practices, and a decrease among academic practices. Although the change in biopsy utilization behavior is small in magnitude, it may have a substantial impact when extrapolated to behavior across the entire United States.

We were unable to assess additional factors, such as clinical diagnosis, body site, and cosmetic concerns, that may impact biopsy type selection in this study. Although we included multiple study sites to improve generalizability, our findings may not be representative of all biopsies performed in the dermatology setting. The baseline difference in relative punch biopsy use in academic vs private practices may reflect differences in patient populations and chief concerns, but assuming these features are stable over a 1-year time period, our findings should remain valid. Future studies should focus on qualitative evaluations of physician decision-making and evaluate whether similar trends persist over time.

Conclusion

Skin biopsy utilization trends among differing practice and provider types should continue to be monitored to assess for longitudinal trends in utilization within the context of updated billing codes and associated reimbursements.

A 16-minute podcast from JAMA: The Journal of the American Medical Association that attempts to discuss structural racism in the U.S. health care system has stirred conversation on social media about the handling and promotion of the episode.

Published on Feb. 23, the episode is hosted on JAMA’s learning platform for doctors and is available for continuing medical education credits.

“No physician is racist, so how can there be structural racism in health care? An explanation of the idea by doctors for doctors in this user-friendly podcast,” JAMA wrote in a Twitter post to promote the episode. That tweet has since been deleted.

“Systemic and interpersonal racism both still exist in our country — they must be rooted out. I do not share the JAMA host’s belief of doing away with the word ‘racism’ will help us be more successful in ending inequities that exists across racial and ethnic lines,” Dr. Katz said. “Further, I believe that we will only produce an equitable society when social and political structures do not continue to produce and perpetuate disparate results based on social race and ethnicity.”

Dr. Katz reiterated that both interpersonal and structural racism continue to exist in the United States, “and it is woefully naive to say that no physician is a racist just because the Civil Rights Act of 1964 forbade it.”

He also recommended JAMA use this controversy “as a learning opportunity for continued dialogue and create another podcast series as an open conversation that invites diverse experts in the field to have an open discussion about structural racism in healthcare.”

The podcast and JAMA’s tweet promoting it were widely criticized on Twitter. In interviews with WebMD, many doctors expressed disbelief that such a respected journal would lend its name to this podcast episode.

B. Bobby Chiong, MD, a radiologist in New York, said although JAMA’s effort to engage with its audience about racism is laudable, it missed the mark.

“I think the backlash comes from how they tried to make a podcast about the subject and somehow made themselves an example of unconscious bias and unfamiliarity with just how embedded in our system is structural racism,” he said. 

Perhaps the podcast’s worst offense was its failure to address the painful history of racial bias in this country that still permeates the medical community, says Tamara Saint-Surin, MD, assistant professor at the University of North Carolina at Chapel Hill.

“For physicians in leadership to have the belief that structural racism does not exist in medicine, they don’t really appreciate what affects their patients and what their patients were dealing with,” Dr. Saint-Surin said in an interview. “It was a very harmful podcast and goes to show we still have so much work to do.”

Along with a flawed premise, she says, the podcast was not nearly long enough to address such a nuanced issue. And Dr. Livingston focused on interpersonal racism rather than structural racism, she said, failing to address widespread problems such as higher rates of asthma among Black populations living in areas with poor air quality.

The number of Black doctors remains low and the lack of representation adds to an environment already rife with racism, according to many medical professionals.

Shirlene Obuobi, MD, an internal medicine doctor in Chicago, said JAMA failed to live up to its own standards by publishing material that lacked research and expertise.

“I can’t submit a clinical trial to JAMA without them combing through methods with a fine-tooth comb,” Dr. Obuobi said. “They didn’t uphold the standards they normally apply to anyone else.”

Both the editor of JAMA and the head of the American Medical Association issued statements criticizing the episode and the tweet that promoted it.

JAMA Editor-in-Chief Howard Bauchner, MD, said, “The language of the tweet, and some portions of the podcast, do not reflect my commitment as editorial leader of JAMA and JAMA Network to call out and discuss the adverse effects of injustice, inequity, and racism in society and medicine as JAMA has done for many years.” He said JAMA will schedule a future podcast to address the concerns raised about the recent episode.

AMA CEO James L. Madara, MD, said, “The AMA’s House of Delegates passed policy stating that racism is structural, systemic, cultural, and interpersonal, and we are deeply disturbed – and angered – by a recent JAMA podcast that questioned the existence of structural racism and the affiliated tweet that promoted the podcast and stated ‘no physician is racist, so how can there be structural racism in health care?’ ”

He continued: “JAMA has editorial independence from AMA, but this tweet and podcast are inconsistent with the policies and views of AMA, and I’m concerned about and acknowledge the harms they have caused. Structural racism in health care and our society exists, and it is incumbent on all of us to fix it.”

This article was updated 3/5/21.

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

A 16-minute podcast from JAMA: The Journal of the American Medical Association that attempts to discuss structural racism in the U.S. health care system has stirred conversation on social media about the handling and promotion of the episode.

Published on Feb. 23, the episode is hosted on JAMA’s learning platform for doctors and is available for continuing medical education credits.

“No physician is racist, so how can there be structural racism in health care? An explanation of the idea by doctors for doctors in this user-friendly podcast,” JAMA wrote in a Twitter post to promote the episode. That tweet has since been deleted.

“Systemic and interpersonal racism both still exist in our country — they must be rooted out. I do not share the JAMA host’s belief of doing away with the word ‘racism’ will help us be more successful in ending inequities that exists across racial and ethnic lines,” Dr. Katz said. “Further, I believe that we will only produce an equitable society when social and political structures do not continue to produce and perpetuate disparate results based on social race and ethnicity.”

Dr. Katz reiterated that both interpersonal and structural racism continue to exist in the United States, “and it is woefully naive to say that no physician is a racist just because the Civil Rights Act of 1964 forbade it.”

He also recommended JAMA use this controversy “as a learning opportunity for continued dialogue and create another podcast series as an open conversation that invites diverse experts in the field to have an open discussion about structural racism in healthcare.”

The podcast and JAMA’s tweet promoting it were widely criticized on Twitter. In interviews with WebMD, many doctors expressed disbelief that such a respected journal would lend its name to this podcast episode.

B. Bobby Chiong, MD, a radiologist in New York, said although JAMA’s effort to engage with its audience about racism is laudable, it missed the mark.

“I think the backlash comes from how they tried to make a podcast about the subject and somehow made themselves an example of unconscious bias and unfamiliarity with just how embedded in our system is structural racism,” he said. 

Perhaps the podcast’s worst offense was its failure to address the painful history of racial bias in this country that still permeates the medical community, says Tamara Saint-Surin, MD, assistant professor at the University of North Carolina at Chapel Hill.

“For physicians in leadership to have the belief that structural racism does not exist in medicine, they don’t really appreciate what affects their patients and what their patients were dealing with,” Dr. Saint-Surin said in an interview. “It was a very harmful podcast and goes to show we still have so much work to do.”

Along with a flawed premise, she says, the podcast was not nearly long enough to address such a nuanced issue. And Dr. Livingston focused on interpersonal racism rather than structural racism, she said, failing to address widespread problems such as higher rates of asthma among Black populations living in areas with poor air quality.

The number of Black doctors remains low and the lack of representation adds to an environment already rife with racism, according to many medical professionals.

Shirlene Obuobi, MD, an internal medicine doctor in Chicago, said JAMA failed to live up to its own standards by publishing material that lacked research and expertise.

“I can’t submit a clinical trial to JAMA without them combing through methods with a fine-tooth comb,” Dr. Obuobi said. “They didn’t uphold the standards they normally apply to anyone else.”

Both the editor of JAMA and the head of the American Medical Association issued statements criticizing the episode and the tweet that promoted it.

JAMA Editor-in-Chief Howard Bauchner, MD, said, “The language of the tweet, and some portions of the podcast, do not reflect my commitment as editorial leader of JAMA and JAMA Network to call out and discuss the adverse effects of injustice, inequity, and racism in society and medicine as JAMA has done for many years.” He said JAMA will schedule a future podcast to address the concerns raised about the recent episode.

AMA CEO James L. Madara, MD, said, “The AMA’s House of Delegates passed policy stating that racism is structural, systemic, cultural, and interpersonal, and we are deeply disturbed – and angered – by a recent JAMA podcast that questioned the existence of structural racism and the affiliated tweet that promoted the podcast and stated ‘no physician is racist, so how can there be structural racism in health care?’ ”

He continued: “JAMA has editorial independence from AMA, but this tweet and podcast are inconsistent with the policies and views of AMA, and I’m concerned about and acknowledge the harms they have caused. Structural racism in health care and our society exists, and it is incumbent on all of us to fix it.”

This article was updated 3/5/21.

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

A 16-minute podcast from JAMA: The Journal of the American Medical Association that attempts to discuss structural racism in the U.S. health care system has stirred conversation on social media about the handling and promotion of the episode.

Published on Feb. 23, the episode is hosted on JAMA’s learning platform for doctors and is available for continuing medical education credits.

“No physician is racist, so how can there be structural racism in health care? An explanation of the idea by doctors for doctors in this user-friendly podcast,” JAMA wrote in a Twitter post to promote the episode. That tweet has since been deleted.

“Systemic and interpersonal racism both still exist in our country — they must be rooted out. I do not share the JAMA host’s belief of doing away with the word ‘racism’ will help us be more successful in ending inequities that exists across racial and ethnic lines,” Dr. Katz said. “Further, I believe that we will only produce an equitable society when social and political structures do not continue to produce and perpetuate disparate results based on social race and ethnicity.”

Dr. Katz reiterated that both interpersonal and structural racism continue to exist in the United States, “and it is woefully naive to say that no physician is a racist just because the Civil Rights Act of 1964 forbade it.”

He also recommended JAMA use this controversy “as a learning opportunity for continued dialogue and create another podcast series as an open conversation that invites diverse experts in the field to have an open discussion about structural racism in healthcare.”

The podcast and JAMA’s tweet promoting it were widely criticized on Twitter. In interviews with WebMD, many doctors expressed disbelief that such a respected journal would lend its name to this podcast episode.

B. Bobby Chiong, MD, a radiologist in New York, said although JAMA’s effort to engage with its audience about racism is laudable, it missed the mark.

“I think the backlash comes from how they tried to make a podcast about the subject and somehow made themselves an example of unconscious bias and unfamiliarity with just how embedded in our system is structural racism,” he said. 

Perhaps the podcast’s worst offense was its failure to address the painful history of racial bias in this country that still permeates the medical community, says Tamara Saint-Surin, MD, assistant professor at the University of North Carolina at Chapel Hill.

“For physicians in leadership to have the belief that structural racism does not exist in medicine, they don’t really appreciate what affects their patients and what their patients were dealing with,” Dr. Saint-Surin said in an interview. “It was a very harmful podcast and goes to show we still have so much work to do.”

Along with a flawed premise, she says, the podcast was not nearly long enough to address such a nuanced issue. And Dr. Livingston focused on interpersonal racism rather than structural racism, she said, failing to address widespread problems such as higher rates of asthma among Black populations living in areas with poor air quality.

The number of Black doctors remains low and the lack of representation adds to an environment already rife with racism, according to many medical professionals.

Shirlene Obuobi, MD, an internal medicine doctor in Chicago, said JAMA failed to live up to its own standards by publishing material that lacked research and expertise.

“I can’t submit a clinical trial to JAMA without them combing through methods with a fine-tooth comb,” Dr. Obuobi said. “They didn’t uphold the standards they normally apply to anyone else.”

Both the editor of JAMA and the head of the American Medical Association issued statements criticizing the episode and the tweet that promoted it.

JAMA Editor-in-Chief Howard Bauchner, MD, said, “The language of the tweet, and some portions of the podcast, do not reflect my commitment as editorial leader of JAMA and JAMA Network to call out and discuss the adverse effects of injustice, inequity, and racism in society and medicine as JAMA has done for many years.” He said JAMA will schedule a future podcast to address the concerns raised about the recent episode.

AMA CEO James L. Madara, MD, said, “The AMA’s House of Delegates passed policy stating that racism is structural, systemic, cultural, and interpersonal, and we are deeply disturbed – and angered – by a recent JAMA podcast that questioned the existence of structural racism and the affiliated tweet that promoted the podcast and stated ‘no physician is racist, so how can there be structural racism in health care?’ ”

He continued: “JAMA has editorial independence from AMA, but this tweet and podcast are inconsistent with the policies and views of AMA, and I’m concerned about and acknowledge the harms they have caused. Structural racism in health care and our society exists, and it is incumbent on all of us to fix it.”

This article was updated 3/5/21.

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

One of the biggest conundrums of the COVID-19 pandemic has been the simultaneous panic-hiring of medical professionals in hot spots and significant downsizing of staff across the country. From huge hospital systems to private practices, the stoppage of breast reductions and knee replacements, not to mention the drops in motor vehicle accidents and bar fights, have quieted operating rooms and emergency departments and put doctors’ jobs on the chopping block. A widely cited survey suggests that 21% of doctors have had a work reduction due to COVID-19.

For many American doctors, this is their first extended period of unemployment. Unlike engineers or those with MBAs who might see their fortunes rise and fall with the whims of recessions and boom times, physicians are not exactly accustomed to being laid off. However, doctors were already smarting for years due to falling salaries and decreased autonomy, punctuated by endless clicks on electronic medical records software.

Now, the twin shock of income loss and feeling unwanted in a pandemic – when, you know, medicine might seem especially essential – has doctors resorting to a bizarre array of side gigs, “fun-employment” activities, or outright career overhauls.

Stephanie Eschenbach Morgan, MD, a breast radiologist in North Carolina, trained for 10 years after college before earning a true physician’s salary.

“Being furloughed was awful. Initially, it was only going to be 2 weeks, and then it turned into 2 months with no pay,” she reflected.

Dr. Eschenbach Morgan and her surgeon husband, who lost a full quarter’s salary, had to ask for grace periods on their credit card and mortgage payments because they had paid a large tax bill right before the pandemic began. “We couldn’t get any stimulus help, so that added insult to injury,” she said.

With her time spent waiting in a holding pattern, Dr. Eschenbach Morgan homeschooled her two young children and started putting a home gym together. She went on a home organizing spree, started a garden, and, perhaps most impressively, caught up with 5 years of photo albums.

A bonus she noted: “I didn’t set an alarm for 2 months.”

Shella Farooki, MD, a radiologist in California, was also focused on homeschooling, itself a demanding job, and veered toward retirement. When one of her work contracts furloughed her (“at one point, I made $30K a month for [their business]”), she started saving money at home, teaching the kids, and applied for a Paycheck Protection Program loan. Her husband, a hospitalist, had had his shifts cut. Dr. Farooki tried a radiology artificial intelligence firm but backed out when she was asked to read 9,200 studies for them for $2,000 per month.

Now, she thinks about leaving medicine “every day.”

Some doctors are questioning whether they should be in medicine in the first place. Family medicine physician Jonathan Polak, MD, faced with his own pink slip, turned to pink T-shirts instead. His girlfriend manages an outlet of the teen fashion retailer Justice. Dr. Polak, who finished his residency just 2 years ago, didn’t hesitate to take a $10-an-hour gig as a stock doc, once even finding himself delivering a shelving unit from the shuttering store to a physician fleeing the city for rural New Hampshire to “escape.”

There’s no escape for him – yet. Saddled with “astronomical” student loans, he had considered grocery store work as well. Dr. Polak knows he can’t work part time or go into teaching long term, as he might like.

Even so, he’s doing everything he can to not be in patient care for the long haul – it’s just not what he thought it would be.

“The culture of medicine, bureaucracy, endless paperwork and charting, and threat of litigation sucks a lot of the joy out of it to the point that I don’t see myself doing it forever when imagining myself 5-10 years into it.”

Still, he recently took an 18-month hospital contract that will force him to move to Florida, but he’s also been turning himself into a veritable Renaissance man; composing music, training for an ultramarathon, studying the latest medical findings, roadtripping, and launching a podcast about dog grooming with a master groomer. “We found parallels between medicine and dog grooming,” he says, somewhat convincingly.

Also working the ruff life is Jen Tserng, MD, a former forensic pathologist who landed on news websites in recent years for becoming a professional dogwalker and housesitter without a permanent home. Dr. Tserng knows doctors were restless and unhappy before COVID-19, their thoughts wandering where the grass might be greener.

As her profile grew, she found her inbox gathering messages from disaffected medical minions: students with a fear of failing or staring down residency application season and employed doctors sick of the constant grind. As she recounted those de facto life coach conversations (“What do you really enjoy?” “Do you really like dogs?”) by phone from New York, she said matter-of-factly, “They don’t call because of COVID. They call because they hate their lives.”

Michelle Mudge-Riley, MD, a physician in Texas, has been seeing this shift for some time as well. She recently held a virtual version of her Physicians Helping Physicians conference, where doctors hear from their peers working successfully in fields like pharmaceuticals and real estate investing.

When COVID-19 hit, Dr. Mudge-Riley quickly pivoted to a virtual platform, where the MDs and DOs huddled in breakout rooms having honest chats about their fears and tentative hopes about their new careers.

“There has been increased interest in nonclinical exploration into full- and part-time careers, as well as side hustles, since COVID began,” she said. “Many physicians have had their hours or pay cut, and some have been laid off. Others are furloughed. Some just want out of an environment where they don’t feel safe.”

An ear, nose, and throat surgeon, Maansi Doshi, MD, from central California, didn’t feel safe – so she left. She had returned from India sick with a mystery virus right as the pandemic began (she said her COVID-19 tests were all negative) and was waiting to get well enough to go back to her private practice job. However, she said she clashed with Trump-supporting colleagues she feared might not be taking the pandemic seriously enough.

Finally getting over a relapse of her mystery virus, Dr. Doshi emailed her resignation in May. Her husband, family practice doctor Mark Mangiapane, MD, gave his job notice weeks later in solidarity because he worked in the same building. Together, they have embraced gardening, a Peloton splurge, and learning business skills to open private practices – solo primary care for him; ENT with a focus on her favorite surgery, rhinoplasty, for her.

Dr. Mangiapane had considered editing medical brochures and also tried to apply for a job as a county public health officer in rural California, but he received his own shock when he learned the county intended to open schools in the midst of the pandemic despite advisement to the contrary by the former health officer.

He retreated from job listings altogether after hearing his would-be peers were getting death threats – targeting their children.

Both doctors felt COVID-19 pushed them beyond their comfort zones. “If COVID hadn’t happened, I would be working. ... Be ‘owned.’ In a weird way, COVID made me more independent and take a risk with my career.”

Obstetrician Kwandaa Roberts, MD, certainly did; she took a budding interest in decorating dollhouses straight to Instagram and national news fame, and she is now a TV-show expert on “Sell This House.”

Like Dr. Doshi and Dr. Mangiapane, Dr. Polak wants to be more in control of his future – even if selling T-shirts at a mall means a certain loss of status along the way.

“Aside from my passion to learn and to have that connection with people, I went into medicine ... because of the job security I thought existed,” he said. “I would say that my getting furloughed has changed my view of the United States in a dramatic way. I do not feel as confident in the U.S. economy and general way of life as I did a year ago. And I am taking a number of steps to put myself in a more fluid, adaptable position in case another crisis like this occurs or if the current state of things worsens.”

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

One of the biggest conundrums of the COVID-19 pandemic has been the simultaneous panic-hiring of medical professionals in hot spots and significant downsizing of staff across the country. From huge hospital systems to private practices, the stoppage of breast reductions and knee replacements, not to mention the drops in motor vehicle accidents and bar fights, have quieted operating rooms and emergency departments and put doctors’ jobs on the chopping block. A widely cited survey suggests that 21% of doctors have had a work reduction due to COVID-19.

For many American doctors, this is their first extended period of unemployment. Unlike engineers or those with MBAs who might see their fortunes rise and fall with the whims of recessions and boom times, physicians are not exactly accustomed to being laid off. However, doctors were already smarting for years due to falling salaries and decreased autonomy, punctuated by endless clicks on electronic medical records software.

Now, the twin shock of income loss and feeling unwanted in a pandemic – when, you know, medicine might seem especially essential – has doctors resorting to a bizarre array of side gigs, “fun-employment” activities, or outright career overhauls.

Stephanie Eschenbach Morgan, MD, a breast radiologist in North Carolina, trained for 10 years after college before earning a true physician’s salary.

“Being furloughed was awful. Initially, it was only going to be 2 weeks, and then it turned into 2 months with no pay,” she reflected.

Dr. Eschenbach Morgan and her surgeon husband, who lost a full quarter’s salary, had to ask for grace periods on their credit card and mortgage payments because they had paid a large tax bill right before the pandemic began. “We couldn’t get any stimulus help, so that added insult to injury,” she said.

With her time spent waiting in a holding pattern, Dr. Eschenbach Morgan homeschooled her two young children and started putting a home gym together. She went on a home organizing spree, started a garden, and, perhaps most impressively, caught up with 5 years of photo albums.

A bonus she noted: “I didn’t set an alarm for 2 months.”

Shella Farooki, MD, a radiologist in California, was also focused on homeschooling, itself a demanding job, and veered toward retirement. When one of her work contracts furloughed her (“at one point, I made $30K a month for [their business]”), she started saving money at home, teaching the kids, and applied for a Paycheck Protection Program loan. Her husband, a hospitalist, had had his shifts cut. Dr. Farooki tried a radiology artificial intelligence firm but backed out when she was asked to read 9,200 studies for them for $2,000 per month.

Now, she thinks about leaving medicine “every day.”

Some doctors are questioning whether they should be in medicine in the first place. Family medicine physician Jonathan Polak, MD, faced with his own pink slip, turned to pink T-shirts instead. His girlfriend manages an outlet of the teen fashion retailer Justice. Dr. Polak, who finished his residency just 2 years ago, didn’t hesitate to take a $10-an-hour gig as a stock doc, once even finding himself delivering a shelving unit from the shuttering store to a physician fleeing the city for rural New Hampshire to “escape.”

There’s no escape for him – yet. Saddled with “astronomical” student loans, he had considered grocery store work as well. Dr. Polak knows he can’t work part time or go into teaching long term, as he might like.

Even so, he’s doing everything he can to not be in patient care for the long haul – it’s just not what he thought it would be.

“The culture of medicine, bureaucracy, endless paperwork and charting, and threat of litigation sucks a lot of the joy out of it to the point that I don’t see myself doing it forever when imagining myself 5-10 years into it.”

Still, he recently took an 18-month hospital contract that will force him to move to Florida, but he’s also been turning himself into a veritable Renaissance man; composing music, training for an ultramarathon, studying the latest medical findings, roadtripping, and launching a podcast about dog grooming with a master groomer. “We found parallels between medicine and dog grooming,” he says, somewhat convincingly.

Also working the ruff life is Jen Tserng, MD, a former forensic pathologist who landed on news websites in recent years for becoming a professional dogwalker and housesitter without a permanent home. Dr. Tserng knows doctors were restless and unhappy before COVID-19, their thoughts wandering where the grass might be greener.

As her profile grew, she found her inbox gathering messages from disaffected medical minions: students with a fear of failing or staring down residency application season and employed doctors sick of the constant grind. As she recounted those de facto life coach conversations (“What do you really enjoy?” “Do you really like dogs?”) by phone from New York, she said matter-of-factly, “They don’t call because of COVID. They call because they hate their lives.”

Michelle Mudge-Riley, MD, a physician in Texas, has been seeing this shift for some time as well. She recently held a virtual version of her Physicians Helping Physicians conference, where doctors hear from their peers working successfully in fields like pharmaceuticals and real estate investing.

When COVID-19 hit, Dr. Mudge-Riley quickly pivoted to a virtual platform, where the MDs and DOs huddled in breakout rooms having honest chats about their fears and tentative hopes about their new careers.

“There has been increased interest in nonclinical exploration into full- and part-time careers, as well as side hustles, since COVID began,” she said. “Many physicians have had their hours or pay cut, and some have been laid off. Others are furloughed. Some just want out of an environment where they don’t feel safe.”

An ear, nose, and throat surgeon, Maansi Doshi, MD, from central California, didn’t feel safe – so she left. She had returned from India sick with a mystery virus right as the pandemic began (she said her COVID-19 tests were all negative) and was waiting to get well enough to go back to her private practice job. However, she said she clashed with Trump-supporting colleagues she feared might not be taking the pandemic seriously enough.

Finally getting over a relapse of her mystery virus, Dr. Doshi emailed her resignation in May. Her husband, family practice doctor Mark Mangiapane, MD, gave his job notice weeks later in solidarity because he worked in the same building. Together, they have embraced gardening, a Peloton splurge, and learning business skills to open private practices – solo primary care for him; ENT with a focus on her favorite surgery, rhinoplasty, for her.

Dr. Mangiapane had considered editing medical brochures and also tried to apply for a job as a county public health officer in rural California, but he received his own shock when he learned the county intended to open schools in the midst of the pandemic despite advisement to the contrary by the former health officer.

He retreated from job listings altogether after hearing his would-be peers were getting death threats – targeting their children.

Both doctors felt COVID-19 pushed them beyond their comfort zones. “If COVID hadn’t happened, I would be working. ... Be ‘owned.’ In a weird way, COVID made me more independent and take a risk with my career.”

Obstetrician Kwandaa Roberts, MD, certainly did; she took a budding interest in decorating dollhouses straight to Instagram and national news fame, and she is now a TV-show expert on “Sell This House.”

Like Dr. Doshi and Dr. Mangiapane, Dr. Polak wants to be more in control of his future – even if selling T-shirts at a mall means a certain loss of status along the way.

“Aside from my passion to learn and to have that connection with people, I went into medicine ... because of the job security I thought existed,” he said. “I would say that my getting furloughed has changed my view of the United States in a dramatic way. I do not feel as confident in the U.S. economy and general way of life as I did a year ago. And I am taking a number of steps to put myself in a more fluid, adaptable position in case another crisis like this occurs or if the current state of things worsens.”

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

One of the biggest conundrums of the COVID-19 pandemic has been the simultaneous panic-hiring of medical professionals in hot spots and significant downsizing of staff across the country. From huge hospital systems to private practices, the stoppage of breast reductions and knee replacements, not to mention the drops in motor vehicle accidents and bar fights, have quieted operating rooms and emergency departments and put doctors’ jobs on the chopping block. A widely cited survey suggests that 21% of doctors have had a work reduction due to COVID-19.

For many American doctors, this is their first extended period of unemployment. Unlike engineers or those with MBAs who might see their fortunes rise and fall with the whims of recessions and boom times, physicians are not exactly accustomed to being laid off. However, doctors were already smarting for years due to falling salaries and decreased autonomy, punctuated by endless clicks on electronic medical records software.

Now, the twin shock of income loss and feeling unwanted in a pandemic – when, you know, medicine might seem especially essential – has doctors resorting to a bizarre array of side gigs, “fun-employment” activities, or outright career overhauls.

Stephanie Eschenbach Morgan, MD, a breast radiologist in North Carolina, trained for 10 years after college before earning a true physician’s salary.

“Being furloughed was awful. Initially, it was only going to be 2 weeks, and then it turned into 2 months with no pay,” she reflected.

Dr. Eschenbach Morgan and her surgeon husband, who lost a full quarter’s salary, had to ask for grace periods on their credit card and mortgage payments because they had paid a large tax bill right before the pandemic began. “We couldn’t get any stimulus help, so that added insult to injury,” she said.

With her time spent waiting in a holding pattern, Dr. Eschenbach Morgan homeschooled her two young children and started putting a home gym together. She went on a home organizing spree, started a garden, and, perhaps most impressively, caught up with 5 years of photo albums.

A bonus she noted: “I didn’t set an alarm for 2 months.”

Shella Farooki, MD, a radiologist in California, was also focused on homeschooling, itself a demanding job, and veered toward retirement. When one of her work contracts furloughed her (“at one point, I made $30K a month for [their business]”), she started saving money at home, teaching the kids, and applied for a Paycheck Protection Program loan. Her husband, a hospitalist, had had his shifts cut. Dr. Farooki tried a radiology artificial intelligence firm but backed out when she was asked to read 9,200 studies for them for $2,000 per month.

Now, she thinks about leaving medicine “every day.”

Some doctors are questioning whether they should be in medicine in the first place. Family medicine physician Jonathan Polak, MD, faced with his own pink slip, turned to pink T-shirts instead. His girlfriend manages an outlet of the teen fashion retailer Justice. Dr. Polak, who finished his residency just 2 years ago, didn’t hesitate to take a $10-an-hour gig as a stock doc, once even finding himself delivering a shelving unit from the shuttering store to a physician fleeing the city for rural New Hampshire to “escape.”

There’s no escape for him – yet. Saddled with “astronomical” student loans, he had considered grocery store work as well. Dr. Polak knows he can’t work part time or go into teaching long term, as he might like.

Even so, he’s doing everything he can to not be in patient care for the long haul – it’s just not what he thought it would be.

“The culture of medicine, bureaucracy, endless paperwork and charting, and threat of litigation sucks a lot of the joy out of it to the point that I don’t see myself doing it forever when imagining myself 5-10 years into it.”

Still, he recently took an 18-month hospital contract that will force him to move to Florida, but he’s also been turning himself into a veritable Renaissance man; composing music, training for an ultramarathon, studying the latest medical findings, roadtripping, and launching a podcast about dog grooming with a master groomer. “We found parallels between medicine and dog grooming,” he says, somewhat convincingly.

Also working the ruff life is Jen Tserng, MD, a former forensic pathologist who landed on news websites in recent years for becoming a professional dogwalker and housesitter without a permanent home. Dr. Tserng knows doctors were restless and unhappy before COVID-19, their thoughts wandering where the grass might be greener.

As her profile grew, she found her inbox gathering messages from disaffected medical minions: students with a fear of failing or staring down residency application season and employed doctors sick of the constant grind. As she recounted those de facto life coach conversations (“What do you really enjoy?” “Do you really like dogs?”) by phone from New York, she said matter-of-factly, “They don’t call because of COVID. They call because they hate their lives.”

Michelle Mudge-Riley, MD, a physician in Texas, has been seeing this shift for some time as well. She recently held a virtual version of her Physicians Helping Physicians conference, where doctors hear from their peers working successfully in fields like pharmaceuticals and real estate investing.

When COVID-19 hit, Dr. Mudge-Riley quickly pivoted to a virtual platform, where the MDs and DOs huddled in breakout rooms having honest chats about their fears and tentative hopes about their new careers.

“There has been increased interest in nonclinical exploration into full- and part-time careers, as well as side hustles, since COVID began,” she said. “Many physicians have had their hours or pay cut, and some have been laid off. Others are furloughed. Some just want out of an environment where they don’t feel safe.”

An ear, nose, and throat surgeon, Maansi Doshi, MD, from central California, didn’t feel safe – so she left. She had returned from India sick with a mystery virus right as the pandemic began (she said her COVID-19 tests were all negative) and was waiting to get well enough to go back to her private practice job. However, she said she clashed with Trump-supporting colleagues she feared might not be taking the pandemic seriously enough.

Finally getting over a relapse of her mystery virus, Dr. Doshi emailed her resignation in May. Her husband, family practice doctor Mark Mangiapane, MD, gave his job notice weeks later in solidarity because he worked in the same building. Together, they have embraced gardening, a Peloton splurge, and learning business skills to open private practices – solo primary care for him; ENT with a focus on her favorite surgery, rhinoplasty, for her.

Dr. Mangiapane had considered editing medical brochures and also tried to apply for a job as a county public health officer in rural California, but he received his own shock when he learned the county intended to open schools in the midst of the pandemic despite advisement to the contrary by the former health officer.

He retreated from job listings altogether after hearing his would-be peers were getting death threats – targeting their children.

Both doctors felt COVID-19 pushed them beyond their comfort zones. “If COVID hadn’t happened, I would be working. ... Be ‘owned.’ In a weird way, COVID made me more independent and take a risk with my career.”

Obstetrician Kwandaa Roberts, MD, certainly did; she took a budding interest in decorating dollhouses straight to Instagram and national news fame, and she is now a TV-show expert on “Sell This House.”

Like Dr. Doshi and Dr. Mangiapane, Dr. Polak wants to be more in control of his future – even if selling T-shirts at a mall means a certain loss of status along the way.

“Aside from my passion to learn and to have that connection with people, I went into medicine ... because of the job security I thought existed,” he said. “I would say that my getting furloughed has changed my view of the United States in a dramatic way. I do not feel as confident in the U.S. economy and general way of life as I did a year ago. And I am taking a number of steps to put myself in a more fluid, adaptable position in case another crisis like this occurs or if the current state of things worsens.”

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

The Journal of Family Practice rightfully places a high priority on evidence-based practice by including “strength of evidence” qualifiers to help physicians analyze scientific studies and emphasizing campaigns that encourage good stewardship of medical resources. The editorial “When patients don’t get the care they should” (J Fam Pract. 2020;69:427) struck on an often-neglected aspect of evidence-based practice: the increase in care provided by nonphysician practitioners.

Henry Silver, MD, created the first pediatric nurse practitioner (NP) training program at the University of Colorado in 1965. That same year, Eugene Stead, MD, created the first physician assistant (PA) program at Duke University. The goal of both professions was simple: to create physician extenders to reach medically needy patients in underserved areas. But over the past 20 years, NPs and PAs have increasingly sought—and legislatively gained—independent practice, the right to treat patients without physician supervision.

Studies show that nonphysician practitioners order more labs and radiographic tests and prescribe more medications— including antibiotics—than physicians.

Here’s where evidence-based practice comes in. Despite claims by NP advocates that “50 years of evidence” shows safe and effective practice, the truth is that there is no scientific evidence that nonphysicians can practice safely and effectively without physician supervision. The best meta-analysis of nurse practitioner care, a Cochrane review, found only 18 studies of adequate quality to analyze.¹ Of these, only 3 were performed in the United States, and every single study in the Cochrane review involved nurses working under physician supervision or following physician-­created protocols. Yes, even supposedly independent NPs in Mary Mundinger’s famous 2000 study were practicing under a collaborating physician, as required by New York statute at the time. In addition, NPs in the study were assigned a physician mentor and received an additional 9 months of training with medical residents.

Regarding the emphasis for physicians to “choose wisely,” research raises concerns about an overuse of health care resources by nonphysician practitioners.Studies show that nonphysician practitioners order more labs² and radiographic tests³ than physicians; prescribe more medications, including opioids,⁴ antipsychotics,⁴ and antibiotics⁵ than physicians; place lower-quality referrals than physicians⁶; and perform significantly more biopsies than physicians to diagnose malignant neoplasms in patients < 65 years.⁷ 

As the rate of nonphysician practitioners increases (significantly outpacing the growth of physicians), we must be cognizant of the rising risks to our patients in the absence of appropriate physician oversight.⁸ This issue is so concerning to me that I co-authored a book on the subject.⁸ I encourage all physicians to educate themselves on this topic and make practice decisions with the evidence in mind.

The Journal of Family Practice rightfully places a high priority on evidence-based practice by including “strength of evidence” qualifiers to help physicians analyze scientific studies and emphasizing campaigns that encourage good stewardship of medical resources. The editorial “When patients don’t get the care they should” (J Fam Pract. 2020;69:427) struck on an often-neglected aspect of evidence-based practice: the increase in care provided by nonphysician practitioners.

Henry Silver, MD, created the first pediatric nurse practitioner (NP) training program at the University of Colorado in 1965. That same year, Eugene Stead, MD, created the first physician assistant (PA) program at Duke University. The goal of both professions was simple: to create physician extenders to reach medically needy patients in underserved areas. But over the past 20 years, NPs and PAs have increasingly sought—and legislatively gained—independent practice, the right to treat patients without physician supervision.

Studies show that nonphysician practitioners order more labs and radiographic tests and prescribe more medications— including antibiotics—than physicians.

Here’s where evidence-based practice comes in. Despite claims by NP advocates that “50 years of evidence” shows safe and effective practice, the truth is that there is no scientific evidence that nonphysicians can practice safely and effectively without physician supervision. The best meta-analysis of nurse practitioner care, a Cochrane review, found only 18 studies of adequate quality to analyze.¹ Of these, only 3 were performed in the United States, and every single study in the Cochrane review involved nurses working under physician supervision or following physician-­created protocols. Yes, even supposedly independent NPs in Mary Mundinger’s famous 2000 study were practicing under a collaborating physician, as required by New York statute at the time. In addition, NPs in the study were assigned a physician mentor and received an additional 9 months of training with medical residents.

Regarding the emphasis for physicians to “choose wisely,” research raises concerns about an overuse of health care resources by nonphysician practitioners.Studies show that nonphysician practitioners order more labs² and radiographic tests³ than physicians; prescribe more medications, including opioids,⁴ antipsychotics,⁴ and antibiotics⁵ than physicians; place lower-quality referrals than physicians⁶; and perform significantly more biopsies than physicians to diagnose malignant neoplasms in patients < 65 years.⁷ 

As the rate of nonphysician practitioners increases (significantly outpacing the growth of physicians), we must be cognizant of the rising risks to our patients in the absence of appropriate physician oversight.⁸ This issue is so concerning to me that I co-authored a book on the subject.⁸ I encourage all physicians to educate themselves on this topic and make practice decisions with the evidence in mind.

The Journal of Family Practice rightfully places a high priority on evidence-based practice by including “strength of evidence” qualifiers to help physicians analyze scientific studies and emphasizing campaigns that encourage good stewardship of medical resources. The editorial “When patients don’t get the care they should” (J Fam Pract. 2020;69:427) struck on an often-neglected aspect of evidence-based practice: the increase in care provided by nonphysician practitioners.

Henry Silver, MD, created the first pediatric nurse practitioner (NP) training program at the University of Colorado in 1965. That same year, Eugene Stead, MD, created the first physician assistant (PA) program at Duke University. The goal of both professions was simple: to create physician extenders to reach medically needy patients in underserved areas. But over the past 20 years, NPs and PAs have increasingly sought—and legislatively gained—independent practice, the right to treat patients without physician supervision.

Studies show that nonphysician practitioners order more labs and radiographic tests and prescribe more medications— including antibiotics—than physicians.

Here’s where evidence-based practice comes in. Despite claims by NP advocates that “50 years of evidence” shows safe and effective practice, the truth is that there is no scientific evidence that nonphysicians can practice safely and effectively without physician supervision. The best meta-analysis of nurse practitioner care, a Cochrane review, found only 18 studies of adequate quality to analyze.¹ Of these, only 3 were performed in the United States, and every single study in the Cochrane review involved nurses working under physician supervision or following physician-­created protocols. Yes, even supposedly independent NPs in Mary Mundinger’s famous 2000 study were practicing under a collaborating physician, as required by New York statute at the time. In addition, NPs in the study were assigned a physician mentor and received an additional 9 months of training with medical residents.

Regarding the emphasis for physicians to “choose wisely,” research raises concerns about an overuse of health care resources by nonphysician practitioners.Studies show that nonphysician practitioners order more labs² and radiographic tests³ than physicians; prescribe more medications, including opioids,⁴ antipsychotics,⁴ and antibiotics⁵ than physicians; place lower-quality referrals than physicians⁶; and perform significantly more biopsies than physicians to diagnose malignant neoplasms in patients < 65 years.⁷ 

As the rate of nonphysician practitioners increases (significantly outpacing the growth of physicians), we must be cognizant of the rising risks to our patients in the absence of appropriate physician oversight.⁸ This issue is so concerning to me that I co-authored a book on the subject.⁸ I encourage all physicians to educate themselves on this topic and make practice decisions with the evidence in mind.