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Dupilumab gains off-label uses as clinicians turn to drug for more indications
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The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.
As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.
The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
A well-tolerated – if expensive – drug
Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.
Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.
“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”
Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.
“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.
Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.
“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.
“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.
Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.
As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.
Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.
“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”
“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”
Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.
“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”
Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.
“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”
Making injections less bothersome
Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.
“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”
Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.
For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”
Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
Off-label dupixent can be expensive, difficult to obtain
The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”
Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.
“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”
The experts who commented have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
.
The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.
As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.
The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
A well-tolerated – if expensive – drug
Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.
Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.
“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”
Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.
“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.
Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.
“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.
“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.
Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.
As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.
Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.
“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”
“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”
Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.
“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”
Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.
“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”
Making injections less bothersome
Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.
“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”
Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.
For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”
Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
Off-label dupixent can be expensive, difficult to obtain
The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”
Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.
“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”
The experts who commented have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
.
The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.
As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.
The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
A well-tolerated – if expensive – drug
Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.
Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.
“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”
Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.
“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.
Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.
“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.
“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.
Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.
As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.
Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.
“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”
“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”
Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.
“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”
Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.
“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”
Making injections less bothersome
Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.
“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”
Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.
For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”
Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
Off-label dupixent can be expensive, difficult to obtain
The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”
Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.
“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”
The experts who commented have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Lymphoma specialist to lead MD Anderson’s cancer medicine division
“My research uncovered a series of physicians who served as ‘clinical champions’ and dramatically sped the process of drug development,” Dr. Flowers recalled in an interview. “This early career research inspired me to become the type of clinical champion that I uncovered.”
Over his career, hematologist-oncologist Dr. Flowers has developed lifesaving therapies for lymphoma, which has transformed into a highly treatable and even curable disease. He’s listed as a coauthor of hundreds of peer-reviewed cancer studies, reports, and medical society guidelines. And he’s revealed stark disparities in blood cancer care: His research shows that non-White patients suffer from worse outcomes, regardless of factors like income and insurance coverage.
The University of Texas MD Anderson Cancer Center, Houston, recently named physician-scientist Dr. Flowers as division head of cancer medicine, a position he’s held on an interim basis. As of Sept. 1, he will permanently oversee 300 faculty and more than 2,000 staff members.
A running start in Seattle
For Dr. Flowers, track and field is a sport that runs in the family. His grandfather was a top runner in both high school and college, and both Dr. Flowers and his brother ran competitively in Seattle, where they grew up. But Dr. Flowers chose a career in oncology, earning a medical degree at Stanford and master’s degrees at both Stanford and the University of Washington, Seattle.
The late Kenneth Melmon, MD, a groundbreaking pharmacologist, was a major influence. “He was one of the first people that I met when I began as an undergraduate at Stanford. We grew to be long-standing friends, and he demonstrated what outstanding mentorship looks like. In our research collaboration, we investigated the work of Dr. Gertrude Elion and Dr. George Hitchings involving the translation of pharmacological data from cellular and animal models to clinically useful drugs including 6-mercaptopurine, allopurinol, azathioprine, acyclovir, and zidovudine.”
The late Oliver Press, MD, a blood cancer specialist, inspired Dr. Flower’s interest in lymphoma. “I began work with him during an internship at the University of Washington. Ollie was a great inspiration and a key leader in the development of innovative therapies for lymphoma. He embodied the role of a clinical champion translating work in radioimmunotherapy to new therapeutics for patients with lymphomas. Working with him ultimately led me to pursue a career in hematology and oncology with a focus on the care for patients with lymphomas.”
Career blooms as lymphoma care advances
Dr. Flowers went on to Emory University, Atlanta, where he served as scientific director of the Research Informatics Shared Resource and a faculty member in the department of biomedical informatics. “I applied my training in informatics and my clinical expertise to support active grants from the Burroughs Wellcome Fund for Innovation in Regulatory Science and from the National Cancer Institute to develop informatics tools for pathology image analysis and prognostic modeling.”
For 13 years, he also served the Winship Cancer Institute as director of the Emory Healthcare lymphoma program (where his patients included Kansas City Chiefs football star Eric Berry), and for 4 years as scientific director of research informatics. Meanwhile, Dr. Flowers helped develop national practice guidelines for the American Society of Clinical Oncology, the American Cancer Society, and the American College of Radiology. He also chaired the ASCO guideline on management of febrile neutropenia.
In 2019, MD Anderson hired Dr. Flowers as chair of the department of lymphoma/myeloma. A year later, he was appointed division head ad interim for cancer medicine.
“Chris is a unique leader who expertly combines mentorship, sponsorship, and bidirectional open, honest communication,” said Sairah Ahmed, MD, associate professor of lymphoma at MD Anderson. “He doesn’t just empower his team to reach their goals. He also inspires those around him to turn vision into reality.”
As Dr. Flowers noted, many patients with lymphoma are now able to recover and live normal lives. He himself played a direct role himself in boosting lifespans.
“I have been fortunate to play a role in the development of several treatments that have led to advances in first-line therapy for patients with aggressive lymphomas. I partnered with others at MD Anderson, including Dr. Sattva Neelapu and Dr. Jason Westin, who have developed novel therapies like chimeric antigen receptor T-cell therapy for patients with relapse lymphomas,” he said. “Leaders in the field at MD Anderson like Dr. Michael Wang have developed new oral treatments for patients with rare lymphoma subtypes like mantle cell lymphoma. Other colleagues such as Dr. Nathan Fowler and Dr. Loretta Nastoupil have focused on the care for patients with indolent lymphomas and developed less-toxic therapies that are now in common use.”
Exposing the disparities in blood cancer care
Dr. Flowers, who’s African American, has also been a leader in health disparity research. In 2016, for example, he was coauthor of a study into non-Hodgkin’s lymphoma that revealed that Blacks in the United States have dramatically lower survival rates than Whites. The 10-year survival rate for Black women with chronic lymphocytic leukemia was just 47%, for example, compared with 66% for White females. “Although incidence rates of lymphoid neoplasms are generally higher among Whites, Black men tend to have poorer survival,” Dr. Flowers and colleagues wrote.
In a 2021 report for the ASCO Educational Book, Dr. Flowers and hematologist-oncologist Demetria Smith-Graziani, MD, now with Emory University, explored disparities across blood cancers and barriers to minority enrollment in clinical trials. “Some approaches that clinicians can apply to address these disparities include increasing systems-level awareness, improving access to care, and reducing biases in clinical setting,” the authors wrote.
Luis Malpica Castillo, MD, assistant professor of lymphoma at MD Anderson Cancer Center, lauded the work of Dr. Flowers in expanding opportunities for minority patients with the disease.
“During the past years, Dr. Flowers’ work has not only had a positive impact on the Texan community, but minority populations living with cancer in the United States and abroad,” he said. “Currently, we are implementing cancer care networks aimed to increase diversity in clinical trials by enrolling a larger number of Hispanic and African American patients, who otherwise may not have benefited from novel therapies. The ultimate goal is to provide high-quality care to all patients living with cancer.”
In addition to his research work, Dr. Flowers is an advocate for diversity within the hematology community. He’s a founding member and former chair of the American Society of Hematology’s Committee on Diversity, Equity and Inclusion (formerly the Committee on Promoting Diversity), and he helped develop the society’s Minority Recruitment Initiative.
What’s next for Dr. Flowers? For one, he plans to continue working as a mentor; he received the ASH Mentor Award in honor of his service in 2022. “I am strongly committed to increasing the number of tenure-track investigators trained in clinical and translational cancer research and to promote their career development.”
And he looks forward to helping develop MD Anderson’s recently announced $2.5 billion hospital in Austin. “This will extend the exceptional care that we provide as the No. 1 cancer center in the United States,” he said. “It will also create new opportunities for research and collaboration with experts at UT Austin.”
When he’s not in clinic, Dr. Flowers embraces his lifelong love of speeding through life on his own two feet. He’s even inspired his children to share his passion. “I run most days of the week,” he said. “Running provides a great opportunity to think and process new research ideas, work through leadership challenges, and sometimes just to relax and let go of the day.”
“My research uncovered a series of physicians who served as ‘clinical champions’ and dramatically sped the process of drug development,” Dr. Flowers recalled in an interview. “This early career research inspired me to become the type of clinical champion that I uncovered.”
Over his career, hematologist-oncologist Dr. Flowers has developed lifesaving therapies for lymphoma, which has transformed into a highly treatable and even curable disease. He’s listed as a coauthor of hundreds of peer-reviewed cancer studies, reports, and medical society guidelines. And he’s revealed stark disparities in blood cancer care: His research shows that non-White patients suffer from worse outcomes, regardless of factors like income and insurance coverage.
The University of Texas MD Anderson Cancer Center, Houston, recently named physician-scientist Dr. Flowers as division head of cancer medicine, a position he’s held on an interim basis. As of Sept. 1, he will permanently oversee 300 faculty and more than 2,000 staff members.
A running start in Seattle
For Dr. Flowers, track and field is a sport that runs in the family. His grandfather was a top runner in both high school and college, and both Dr. Flowers and his brother ran competitively in Seattle, where they grew up. But Dr. Flowers chose a career in oncology, earning a medical degree at Stanford and master’s degrees at both Stanford and the University of Washington, Seattle.
The late Kenneth Melmon, MD, a groundbreaking pharmacologist, was a major influence. “He was one of the first people that I met when I began as an undergraduate at Stanford. We grew to be long-standing friends, and he demonstrated what outstanding mentorship looks like. In our research collaboration, we investigated the work of Dr. Gertrude Elion and Dr. George Hitchings involving the translation of pharmacological data from cellular and animal models to clinically useful drugs including 6-mercaptopurine, allopurinol, azathioprine, acyclovir, and zidovudine.”
The late Oliver Press, MD, a blood cancer specialist, inspired Dr. Flower’s interest in lymphoma. “I began work with him during an internship at the University of Washington. Ollie was a great inspiration and a key leader in the development of innovative therapies for lymphoma. He embodied the role of a clinical champion translating work in radioimmunotherapy to new therapeutics for patients with lymphomas. Working with him ultimately led me to pursue a career in hematology and oncology with a focus on the care for patients with lymphomas.”
Career blooms as lymphoma care advances
Dr. Flowers went on to Emory University, Atlanta, where he served as scientific director of the Research Informatics Shared Resource and a faculty member in the department of biomedical informatics. “I applied my training in informatics and my clinical expertise to support active grants from the Burroughs Wellcome Fund for Innovation in Regulatory Science and from the National Cancer Institute to develop informatics tools for pathology image analysis and prognostic modeling.”
For 13 years, he also served the Winship Cancer Institute as director of the Emory Healthcare lymphoma program (where his patients included Kansas City Chiefs football star Eric Berry), and for 4 years as scientific director of research informatics. Meanwhile, Dr. Flowers helped develop national practice guidelines for the American Society of Clinical Oncology, the American Cancer Society, and the American College of Radiology. He also chaired the ASCO guideline on management of febrile neutropenia.
In 2019, MD Anderson hired Dr. Flowers as chair of the department of lymphoma/myeloma. A year later, he was appointed division head ad interim for cancer medicine.
“Chris is a unique leader who expertly combines mentorship, sponsorship, and bidirectional open, honest communication,” said Sairah Ahmed, MD, associate professor of lymphoma at MD Anderson. “He doesn’t just empower his team to reach their goals. He also inspires those around him to turn vision into reality.”
As Dr. Flowers noted, many patients with lymphoma are now able to recover and live normal lives. He himself played a direct role himself in boosting lifespans.
“I have been fortunate to play a role in the development of several treatments that have led to advances in first-line therapy for patients with aggressive lymphomas. I partnered with others at MD Anderson, including Dr. Sattva Neelapu and Dr. Jason Westin, who have developed novel therapies like chimeric antigen receptor T-cell therapy for patients with relapse lymphomas,” he said. “Leaders in the field at MD Anderson like Dr. Michael Wang have developed new oral treatments for patients with rare lymphoma subtypes like mantle cell lymphoma. Other colleagues such as Dr. Nathan Fowler and Dr. Loretta Nastoupil have focused on the care for patients with indolent lymphomas and developed less-toxic therapies that are now in common use.”
Exposing the disparities in blood cancer care
Dr. Flowers, who’s African American, has also been a leader in health disparity research. In 2016, for example, he was coauthor of a study into non-Hodgkin’s lymphoma that revealed that Blacks in the United States have dramatically lower survival rates than Whites. The 10-year survival rate for Black women with chronic lymphocytic leukemia was just 47%, for example, compared with 66% for White females. “Although incidence rates of lymphoid neoplasms are generally higher among Whites, Black men tend to have poorer survival,” Dr. Flowers and colleagues wrote.
In a 2021 report for the ASCO Educational Book, Dr. Flowers and hematologist-oncologist Demetria Smith-Graziani, MD, now with Emory University, explored disparities across blood cancers and barriers to minority enrollment in clinical trials. “Some approaches that clinicians can apply to address these disparities include increasing systems-level awareness, improving access to care, and reducing biases in clinical setting,” the authors wrote.
Luis Malpica Castillo, MD, assistant professor of lymphoma at MD Anderson Cancer Center, lauded the work of Dr. Flowers in expanding opportunities for minority patients with the disease.
“During the past years, Dr. Flowers’ work has not only had a positive impact on the Texan community, but minority populations living with cancer in the United States and abroad,” he said. “Currently, we are implementing cancer care networks aimed to increase diversity in clinical trials by enrolling a larger number of Hispanic and African American patients, who otherwise may not have benefited from novel therapies. The ultimate goal is to provide high-quality care to all patients living with cancer.”
In addition to his research work, Dr. Flowers is an advocate for diversity within the hematology community. He’s a founding member and former chair of the American Society of Hematology’s Committee on Diversity, Equity and Inclusion (formerly the Committee on Promoting Diversity), and he helped develop the society’s Minority Recruitment Initiative.
What’s next for Dr. Flowers? For one, he plans to continue working as a mentor; he received the ASH Mentor Award in honor of his service in 2022. “I am strongly committed to increasing the number of tenure-track investigators trained in clinical and translational cancer research and to promote their career development.”
And he looks forward to helping develop MD Anderson’s recently announced $2.5 billion hospital in Austin. “This will extend the exceptional care that we provide as the No. 1 cancer center in the United States,” he said. “It will also create new opportunities for research and collaboration with experts at UT Austin.”
When he’s not in clinic, Dr. Flowers embraces his lifelong love of speeding through life on his own two feet. He’s even inspired his children to share his passion. “I run most days of the week,” he said. “Running provides a great opportunity to think and process new research ideas, work through leadership challenges, and sometimes just to relax and let go of the day.”
“My research uncovered a series of physicians who served as ‘clinical champions’ and dramatically sped the process of drug development,” Dr. Flowers recalled in an interview. “This early career research inspired me to become the type of clinical champion that I uncovered.”
Over his career, hematologist-oncologist Dr. Flowers has developed lifesaving therapies for lymphoma, which has transformed into a highly treatable and even curable disease. He’s listed as a coauthor of hundreds of peer-reviewed cancer studies, reports, and medical society guidelines. And he’s revealed stark disparities in blood cancer care: His research shows that non-White patients suffer from worse outcomes, regardless of factors like income and insurance coverage.
The University of Texas MD Anderson Cancer Center, Houston, recently named physician-scientist Dr. Flowers as division head of cancer medicine, a position he’s held on an interim basis. As of Sept. 1, he will permanently oversee 300 faculty and more than 2,000 staff members.
A running start in Seattle
For Dr. Flowers, track and field is a sport that runs in the family. His grandfather was a top runner in both high school and college, and both Dr. Flowers and his brother ran competitively in Seattle, where they grew up. But Dr. Flowers chose a career in oncology, earning a medical degree at Stanford and master’s degrees at both Stanford and the University of Washington, Seattle.
The late Kenneth Melmon, MD, a groundbreaking pharmacologist, was a major influence. “He was one of the first people that I met when I began as an undergraduate at Stanford. We grew to be long-standing friends, and he demonstrated what outstanding mentorship looks like. In our research collaboration, we investigated the work of Dr. Gertrude Elion and Dr. George Hitchings involving the translation of pharmacological data from cellular and animal models to clinically useful drugs including 6-mercaptopurine, allopurinol, azathioprine, acyclovir, and zidovudine.”
The late Oliver Press, MD, a blood cancer specialist, inspired Dr. Flower’s interest in lymphoma. “I began work with him during an internship at the University of Washington. Ollie was a great inspiration and a key leader in the development of innovative therapies for lymphoma. He embodied the role of a clinical champion translating work in radioimmunotherapy to new therapeutics for patients with lymphomas. Working with him ultimately led me to pursue a career in hematology and oncology with a focus on the care for patients with lymphomas.”
Career blooms as lymphoma care advances
Dr. Flowers went on to Emory University, Atlanta, where he served as scientific director of the Research Informatics Shared Resource and a faculty member in the department of biomedical informatics. “I applied my training in informatics and my clinical expertise to support active grants from the Burroughs Wellcome Fund for Innovation in Regulatory Science and from the National Cancer Institute to develop informatics tools for pathology image analysis and prognostic modeling.”
For 13 years, he also served the Winship Cancer Institute as director of the Emory Healthcare lymphoma program (where his patients included Kansas City Chiefs football star Eric Berry), and for 4 years as scientific director of research informatics. Meanwhile, Dr. Flowers helped develop national practice guidelines for the American Society of Clinical Oncology, the American Cancer Society, and the American College of Radiology. He also chaired the ASCO guideline on management of febrile neutropenia.
In 2019, MD Anderson hired Dr. Flowers as chair of the department of lymphoma/myeloma. A year later, he was appointed division head ad interim for cancer medicine.
“Chris is a unique leader who expertly combines mentorship, sponsorship, and bidirectional open, honest communication,” said Sairah Ahmed, MD, associate professor of lymphoma at MD Anderson. “He doesn’t just empower his team to reach their goals. He also inspires those around him to turn vision into reality.”
As Dr. Flowers noted, many patients with lymphoma are now able to recover and live normal lives. He himself played a direct role himself in boosting lifespans.
“I have been fortunate to play a role in the development of several treatments that have led to advances in first-line therapy for patients with aggressive lymphomas. I partnered with others at MD Anderson, including Dr. Sattva Neelapu and Dr. Jason Westin, who have developed novel therapies like chimeric antigen receptor T-cell therapy for patients with relapse lymphomas,” he said. “Leaders in the field at MD Anderson like Dr. Michael Wang have developed new oral treatments for patients with rare lymphoma subtypes like mantle cell lymphoma. Other colleagues such as Dr. Nathan Fowler and Dr. Loretta Nastoupil have focused on the care for patients with indolent lymphomas and developed less-toxic therapies that are now in common use.”
Exposing the disparities in blood cancer care
Dr. Flowers, who’s African American, has also been a leader in health disparity research. In 2016, for example, he was coauthor of a study into non-Hodgkin’s lymphoma that revealed that Blacks in the United States have dramatically lower survival rates than Whites. The 10-year survival rate for Black women with chronic lymphocytic leukemia was just 47%, for example, compared with 66% for White females. “Although incidence rates of lymphoid neoplasms are generally higher among Whites, Black men tend to have poorer survival,” Dr. Flowers and colleagues wrote.
In a 2021 report for the ASCO Educational Book, Dr. Flowers and hematologist-oncologist Demetria Smith-Graziani, MD, now with Emory University, explored disparities across blood cancers and barriers to minority enrollment in clinical trials. “Some approaches that clinicians can apply to address these disparities include increasing systems-level awareness, improving access to care, and reducing biases in clinical setting,” the authors wrote.
Luis Malpica Castillo, MD, assistant professor of lymphoma at MD Anderson Cancer Center, lauded the work of Dr. Flowers in expanding opportunities for minority patients with the disease.
“During the past years, Dr. Flowers’ work has not only had a positive impact on the Texan community, but minority populations living with cancer in the United States and abroad,” he said. “Currently, we are implementing cancer care networks aimed to increase diversity in clinical trials by enrolling a larger number of Hispanic and African American patients, who otherwise may not have benefited from novel therapies. The ultimate goal is to provide high-quality care to all patients living with cancer.”
In addition to his research work, Dr. Flowers is an advocate for diversity within the hematology community. He’s a founding member and former chair of the American Society of Hematology’s Committee on Diversity, Equity and Inclusion (formerly the Committee on Promoting Diversity), and he helped develop the society’s Minority Recruitment Initiative.
What’s next for Dr. Flowers? For one, he plans to continue working as a mentor; he received the ASH Mentor Award in honor of his service in 2022. “I am strongly committed to increasing the number of tenure-track investigators trained in clinical and translational cancer research and to promote their career development.”
And he looks forward to helping develop MD Anderson’s recently announced $2.5 billion hospital in Austin. “This will extend the exceptional care that we provide as the No. 1 cancer center in the United States,” he said. “It will also create new opportunities for research and collaboration with experts at UT Austin.”
When he’s not in clinic, Dr. Flowers embraces his lifelong love of speeding through life on his own two feet. He’s even inspired his children to share his passion. “I run most days of the week,” he said. “Running provides a great opportunity to think and process new research ideas, work through leadership challenges, and sometimes just to relax and let go of the day.”
Long COVID lawsuits coming, but not likely to succeed, experts predict
By now, concerns about COVID-related lawsuits have faded into the rear view mirror for most physicians.
While some say it’s doubtful the claims will succeed, the lawsuits could still create legal headaches for doctors in the form of time and money.
Long COVID claims are defined as complaints that allege that a diagnosis of long COVID was missed or delayed and that caused harm or injury. Lawsuits may also include claims in which patients allege that they were misdiagnosed as having long COVID when they were really suffering from another condition.
So far, a handful of long COVID claims have come down the pipeline, said Peter A. Kolbert, JD, senior vice president of claims and litigation services for Healthcare Risk Advisors, part of TDC Group.
“This is an area that is emerging as we speak,” Mr. Kolbert said. “We are starting to see these claims trickle in.”
In a recent case, for example, a patient sued her primary care physician for negligence, alleging her original SARS-CoV-2 infection was mismanaged and that this led to permanent neuropathy from long COVID. Had the patient been treated appropriately, the patient contends, she would not have developed long COVID or the resulting neuropathy, said Mr. Kolbert. An outcome in the case has not yet been reached, added Mr. Kolbert, who heard about the claim from a colleague.
The increase in the number of lawsuits raises concerns about how courts and juries might decide long COVID claims when so much about the condition is still unknown and best treatment practices are still developing. Research shows that long COVID occurs in at least 10% of cases of SARS-CoV-2 infection, and more than 200 symptoms have been identified. A Kaiser Family Foundation study found that 15% of the U.S. population believe they have experienced the symptoms of long COVID at some point, and 6% of people believe they currently have long COVID.
The risk of long COVID lawsuits underscores the importance of physicians taking proactive steps to protect themselves from liability when treating patients who might have the condition, say legal experts.
“There are legal standards that say new, unestablished scientific principles shouldn’t be first tested by a jury, they should be recognized and established within their [professional] area,” Mr. Kolbert said. “While we are seeing lawsuits related to long COVID, I think it is truly putting the cart before the horse, because there needs to be societal recognition that we’re still learning how to define and treat long COVID.”
What are patients alleging?
In the few long COVID claims that have arisen, some complaints have alleged delay in the recognition and treatment of long COVID, according to Mr. Kolbert. There have also been claims that physicians failed to refer a patient with long COVID to a specialist in a timely way and that this results in the patient’s experiencing chronic fatigue or a neuropathy.
Fatigue is one of the most common symptoms associated with long COVID, according to recent studies. Other symptoms include postexertional malaise, brain fog, and gastrointestinal problems.
Another rising legal theme is failure to adequately communicate with patients about what long COVID is and what it entails.
Whether plaintiffs who bring long COVID claims will be successful in court remains a question.
Andrew D. DeSimone, JD, a Lexington, Ky.–based medical malpractice defense attorney, said he has not seen any claims involving long COVID. He added that a long COVID claim would be challenging to prove, considering the standard of care for treating the condition is still evolving. Plaintiffs in a medical malpractice action must prove that physicians owed a duty of care to the patient, that the doctor breached that duty by failing to conform to the standard of care, and that the breach caused an injury that harmed the patient.
Mr. DeSimone also doubts whether juries would be very sympathetic to such plaintiffs.
“There’s a lot of fatigue around COVID still,” he said. “I don’t know if a jury would buy into someone claiming long COVID. I think the claim would have a hard time gaining traction. Not that it’s impossible.”
Another unanswered question is whether legal protections enacted by states during the pandemic might apply to long COVID claims.
Shortly after the pandemic started, most states enacted laws or executive orders that shielded physicians from liability claims relating to the prevention and treatment of COVID-19, unless gross negligence or willful misconduct is proved. The U.S. Department of Health and Human Services published a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provided liability immunity to health care professionals for any activity related to medical countermeasures against COVID-19.
Some of these state immunities have since expired. Other states have extended their legal protections for short periods. In Indiana, for example, physicians and businesses are protected until Dec. 31, 2024, from civil tort actions that allege damages arising from COVID-19.
It’s possible that in long COVID lawsuits, physicians would be protected by the immunities unless the cases come after the protections expire, said J. Richard Moore, a medical liability defense attorney based in Indianapolis.
“I could foresee long COVID claims that don’t accrue until after December 2024, meaning it only becomes clear that a patient is struggling with long COVID–related symptoms after that date,” he said. “That could result in COVID claims that do not fall under the immunities.”
Mr. Moore said that if long COVID claims become truly problematic, the legislature could extend the immunities.
Other states, such as Washington, have statutes in place that increase the burden of proof for plaintiffs in cases in which care is affected by COVID and/or the treating of COVID. Elizabeth A. Leedom, a Seattle-based medical liability defense attorney, said the law would likely encompass long COVID claims if the care and treatment at issue occurred during the COVID state of emergency.
Compliance with current treatment guidelines is likely to be a good defense against any claim of delay/failure to diagnose COVID, including long COVID, she said.
Mr. Kolbert, however, doubts that the state immunities would protect against the claims.
“Courts are enforcing qualified immunities as to [traditional] COVID claims. However, I suspect that long COVID claims will fall into a category of traditional medical malpractice claim, such as delay in or failure to diagnose,” he said. In such cases, physicians “may not be able to take advantage of state-qualified immunities. Of course, this will depend upon the language of each state’s qualified immunity provisions.”
As for the statute of limitations, the clock generally starts running either when the alleged negligent conduct occurred or when the patient knew or, in the exercise of ordinary diligence, should have known, that they had been harmed by the alleged negligence, Mr. Moore said. Statutes of limitations are state specific, but the majority of states mandate a 2- to 3-year limit between the injury and the filing of a claim.
So, while the statute of limitations may be soon expiring for alleged harm that occurred during the pandemic, for patients newly diagnosed with long COVID or who have just discovered associated injuries, the clock may have just started ticking.
How to protect yourself against suits
Avoiding liability associated with long COVID involves the traditional legal guidance physicians are used to hearing, but with an added factor, Mr. Kolbert said.
There always needs to be communication with patients regarding the disease process, but in this area, there needs to be strong communication as to whether patients have had COVID in the past and what symptoms they are experiencing, he said. Physicians should ensure that patients know that long COVID may present in a variety of ways and that there is no definitive test for long COVID.
Physicians should document when the patient has been instructed to follow up and should take necessary steps to ensure the patient returns for follow-up care, he added.
On the opposite side of the spectrum is making sure not to assume a condition or symptom is the result of long COVID, he said. Care should be taken not to diagnose long COVID without excluding traditional causes.
“Ensure that patients know that COVID is not over, per se, and that science supports vaccination,” Mr. Kolbert said. “The best defense here is a strong communicative offense, engaging with the patient and thoughtfully charting about this.”
A version of this article first appeared on Medscape.com.
By now, concerns about COVID-related lawsuits have faded into the rear view mirror for most physicians.
While some say it’s doubtful the claims will succeed, the lawsuits could still create legal headaches for doctors in the form of time and money.
Long COVID claims are defined as complaints that allege that a diagnosis of long COVID was missed or delayed and that caused harm or injury. Lawsuits may also include claims in which patients allege that they were misdiagnosed as having long COVID when they were really suffering from another condition.
So far, a handful of long COVID claims have come down the pipeline, said Peter A. Kolbert, JD, senior vice president of claims and litigation services for Healthcare Risk Advisors, part of TDC Group.
“This is an area that is emerging as we speak,” Mr. Kolbert said. “We are starting to see these claims trickle in.”
In a recent case, for example, a patient sued her primary care physician for negligence, alleging her original SARS-CoV-2 infection was mismanaged and that this led to permanent neuropathy from long COVID. Had the patient been treated appropriately, the patient contends, she would not have developed long COVID or the resulting neuropathy, said Mr. Kolbert. An outcome in the case has not yet been reached, added Mr. Kolbert, who heard about the claim from a colleague.
The increase in the number of lawsuits raises concerns about how courts and juries might decide long COVID claims when so much about the condition is still unknown and best treatment practices are still developing. Research shows that long COVID occurs in at least 10% of cases of SARS-CoV-2 infection, and more than 200 symptoms have been identified. A Kaiser Family Foundation study found that 15% of the U.S. population believe they have experienced the symptoms of long COVID at some point, and 6% of people believe they currently have long COVID.
The risk of long COVID lawsuits underscores the importance of physicians taking proactive steps to protect themselves from liability when treating patients who might have the condition, say legal experts.
“There are legal standards that say new, unestablished scientific principles shouldn’t be first tested by a jury, they should be recognized and established within their [professional] area,” Mr. Kolbert said. “While we are seeing lawsuits related to long COVID, I think it is truly putting the cart before the horse, because there needs to be societal recognition that we’re still learning how to define and treat long COVID.”
What are patients alleging?
In the few long COVID claims that have arisen, some complaints have alleged delay in the recognition and treatment of long COVID, according to Mr. Kolbert. There have also been claims that physicians failed to refer a patient with long COVID to a specialist in a timely way and that this results in the patient’s experiencing chronic fatigue or a neuropathy.
Fatigue is one of the most common symptoms associated with long COVID, according to recent studies. Other symptoms include postexertional malaise, brain fog, and gastrointestinal problems.
Another rising legal theme is failure to adequately communicate with patients about what long COVID is and what it entails.
Whether plaintiffs who bring long COVID claims will be successful in court remains a question.
Andrew D. DeSimone, JD, a Lexington, Ky.–based medical malpractice defense attorney, said he has not seen any claims involving long COVID. He added that a long COVID claim would be challenging to prove, considering the standard of care for treating the condition is still evolving. Plaintiffs in a medical malpractice action must prove that physicians owed a duty of care to the patient, that the doctor breached that duty by failing to conform to the standard of care, and that the breach caused an injury that harmed the patient.
Mr. DeSimone also doubts whether juries would be very sympathetic to such plaintiffs.
“There’s a lot of fatigue around COVID still,” he said. “I don’t know if a jury would buy into someone claiming long COVID. I think the claim would have a hard time gaining traction. Not that it’s impossible.”
Another unanswered question is whether legal protections enacted by states during the pandemic might apply to long COVID claims.
Shortly after the pandemic started, most states enacted laws or executive orders that shielded physicians from liability claims relating to the prevention and treatment of COVID-19, unless gross negligence or willful misconduct is proved. The U.S. Department of Health and Human Services published a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provided liability immunity to health care professionals for any activity related to medical countermeasures against COVID-19.
Some of these state immunities have since expired. Other states have extended their legal protections for short periods. In Indiana, for example, physicians and businesses are protected until Dec. 31, 2024, from civil tort actions that allege damages arising from COVID-19.
It’s possible that in long COVID lawsuits, physicians would be protected by the immunities unless the cases come after the protections expire, said J. Richard Moore, a medical liability defense attorney based in Indianapolis.
“I could foresee long COVID claims that don’t accrue until after December 2024, meaning it only becomes clear that a patient is struggling with long COVID–related symptoms after that date,” he said. “That could result in COVID claims that do not fall under the immunities.”
Mr. Moore said that if long COVID claims become truly problematic, the legislature could extend the immunities.
Other states, such as Washington, have statutes in place that increase the burden of proof for plaintiffs in cases in which care is affected by COVID and/or the treating of COVID. Elizabeth A. Leedom, a Seattle-based medical liability defense attorney, said the law would likely encompass long COVID claims if the care and treatment at issue occurred during the COVID state of emergency.
Compliance with current treatment guidelines is likely to be a good defense against any claim of delay/failure to diagnose COVID, including long COVID, she said.
Mr. Kolbert, however, doubts that the state immunities would protect against the claims.
“Courts are enforcing qualified immunities as to [traditional] COVID claims. However, I suspect that long COVID claims will fall into a category of traditional medical malpractice claim, such as delay in or failure to diagnose,” he said. In such cases, physicians “may not be able to take advantage of state-qualified immunities. Of course, this will depend upon the language of each state’s qualified immunity provisions.”
As for the statute of limitations, the clock generally starts running either when the alleged negligent conduct occurred or when the patient knew or, in the exercise of ordinary diligence, should have known, that they had been harmed by the alleged negligence, Mr. Moore said. Statutes of limitations are state specific, but the majority of states mandate a 2- to 3-year limit between the injury and the filing of a claim.
So, while the statute of limitations may be soon expiring for alleged harm that occurred during the pandemic, for patients newly diagnosed with long COVID or who have just discovered associated injuries, the clock may have just started ticking.
How to protect yourself against suits
Avoiding liability associated with long COVID involves the traditional legal guidance physicians are used to hearing, but with an added factor, Mr. Kolbert said.
There always needs to be communication with patients regarding the disease process, but in this area, there needs to be strong communication as to whether patients have had COVID in the past and what symptoms they are experiencing, he said. Physicians should ensure that patients know that long COVID may present in a variety of ways and that there is no definitive test for long COVID.
Physicians should document when the patient has been instructed to follow up and should take necessary steps to ensure the patient returns for follow-up care, he added.
On the opposite side of the spectrum is making sure not to assume a condition or symptom is the result of long COVID, he said. Care should be taken not to diagnose long COVID without excluding traditional causes.
“Ensure that patients know that COVID is not over, per se, and that science supports vaccination,” Mr. Kolbert said. “The best defense here is a strong communicative offense, engaging with the patient and thoughtfully charting about this.”
A version of this article first appeared on Medscape.com.
By now, concerns about COVID-related lawsuits have faded into the rear view mirror for most physicians.
While some say it’s doubtful the claims will succeed, the lawsuits could still create legal headaches for doctors in the form of time and money.
Long COVID claims are defined as complaints that allege that a diagnosis of long COVID was missed or delayed and that caused harm or injury. Lawsuits may also include claims in which patients allege that they were misdiagnosed as having long COVID when they were really suffering from another condition.
So far, a handful of long COVID claims have come down the pipeline, said Peter A. Kolbert, JD, senior vice president of claims and litigation services for Healthcare Risk Advisors, part of TDC Group.
“This is an area that is emerging as we speak,” Mr. Kolbert said. “We are starting to see these claims trickle in.”
In a recent case, for example, a patient sued her primary care physician for negligence, alleging her original SARS-CoV-2 infection was mismanaged and that this led to permanent neuropathy from long COVID. Had the patient been treated appropriately, the patient contends, she would not have developed long COVID or the resulting neuropathy, said Mr. Kolbert. An outcome in the case has not yet been reached, added Mr. Kolbert, who heard about the claim from a colleague.
The increase in the number of lawsuits raises concerns about how courts and juries might decide long COVID claims when so much about the condition is still unknown and best treatment practices are still developing. Research shows that long COVID occurs in at least 10% of cases of SARS-CoV-2 infection, and more than 200 symptoms have been identified. A Kaiser Family Foundation study found that 15% of the U.S. population believe they have experienced the symptoms of long COVID at some point, and 6% of people believe they currently have long COVID.
The risk of long COVID lawsuits underscores the importance of physicians taking proactive steps to protect themselves from liability when treating patients who might have the condition, say legal experts.
“There are legal standards that say new, unestablished scientific principles shouldn’t be first tested by a jury, they should be recognized and established within their [professional] area,” Mr. Kolbert said. “While we are seeing lawsuits related to long COVID, I think it is truly putting the cart before the horse, because there needs to be societal recognition that we’re still learning how to define and treat long COVID.”
What are patients alleging?
In the few long COVID claims that have arisen, some complaints have alleged delay in the recognition and treatment of long COVID, according to Mr. Kolbert. There have also been claims that physicians failed to refer a patient with long COVID to a specialist in a timely way and that this results in the patient’s experiencing chronic fatigue or a neuropathy.
Fatigue is one of the most common symptoms associated with long COVID, according to recent studies. Other symptoms include postexertional malaise, brain fog, and gastrointestinal problems.
Another rising legal theme is failure to adequately communicate with patients about what long COVID is and what it entails.
Whether plaintiffs who bring long COVID claims will be successful in court remains a question.
Andrew D. DeSimone, JD, a Lexington, Ky.–based medical malpractice defense attorney, said he has not seen any claims involving long COVID. He added that a long COVID claim would be challenging to prove, considering the standard of care for treating the condition is still evolving. Plaintiffs in a medical malpractice action must prove that physicians owed a duty of care to the patient, that the doctor breached that duty by failing to conform to the standard of care, and that the breach caused an injury that harmed the patient.
Mr. DeSimone also doubts whether juries would be very sympathetic to such plaintiffs.
“There’s a lot of fatigue around COVID still,” he said. “I don’t know if a jury would buy into someone claiming long COVID. I think the claim would have a hard time gaining traction. Not that it’s impossible.”
Another unanswered question is whether legal protections enacted by states during the pandemic might apply to long COVID claims.
Shortly after the pandemic started, most states enacted laws or executive orders that shielded physicians from liability claims relating to the prevention and treatment of COVID-19, unless gross negligence or willful misconduct is proved. The U.S. Department of Health and Human Services published a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provided liability immunity to health care professionals for any activity related to medical countermeasures against COVID-19.
Some of these state immunities have since expired. Other states have extended their legal protections for short periods. In Indiana, for example, physicians and businesses are protected until Dec. 31, 2024, from civil tort actions that allege damages arising from COVID-19.
It’s possible that in long COVID lawsuits, physicians would be protected by the immunities unless the cases come after the protections expire, said J. Richard Moore, a medical liability defense attorney based in Indianapolis.
“I could foresee long COVID claims that don’t accrue until after December 2024, meaning it only becomes clear that a patient is struggling with long COVID–related symptoms after that date,” he said. “That could result in COVID claims that do not fall under the immunities.”
Mr. Moore said that if long COVID claims become truly problematic, the legislature could extend the immunities.
Other states, such as Washington, have statutes in place that increase the burden of proof for plaintiffs in cases in which care is affected by COVID and/or the treating of COVID. Elizabeth A. Leedom, a Seattle-based medical liability defense attorney, said the law would likely encompass long COVID claims if the care and treatment at issue occurred during the COVID state of emergency.
Compliance with current treatment guidelines is likely to be a good defense against any claim of delay/failure to diagnose COVID, including long COVID, she said.
Mr. Kolbert, however, doubts that the state immunities would protect against the claims.
“Courts are enforcing qualified immunities as to [traditional] COVID claims. However, I suspect that long COVID claims will fall into a category of traditional medical malpractice claim, such as delay in or failure to diagnose,” he said. In such cases, physicians “may not be able to take advantage of state-qualified immunities. Of course, this will depend upon the language of each state’s qualified immunity provisions.”
As for the statute of limitations, the clock generally starts running either when the alleged negligent conduct occurred or when the patient knew or, in the exercise of ordinary diligence, should have known, that they had been harmed by the alleged negligence, Mr. Moore said. Statutes of limitations are state specific, but the majority of states mandate a 2- to 3-year limit between the injury and the filing of a claim.
So, while the statute of limitations may be soon expiring for alleged harm that occurred during the pandemic, for patients newly diagnosed with long COVID or who have just discovered associated injuries, the clock may have just started ticking.
How to protect yourself against suits
Avoiding liability associated with long COVID involves the traditional legal guidance physicians are used to hearing, but with an added factor, Mr. Kolbert said.
There always needs to be communication with patients regarding the disease process, but in this area, there needs to be strong communication as to whether patients have had COVID in the past and what symptoms they are experiencing, he said. Physicians should ensure that patients know that long COVID may present in a variety of ways and that there is no definitive test for long COVID.
Physicians should document when the patient has been instructed to follow up and should take necessary steps to ensure the patient returns for follow-up care, he added.
On the opposite side of the spectrum is making sure not to assume a condition or symptom is the result of long COVID, he said. Care should be taken not to diagnose long COVID without excluding traditional causes.
“Ensure that patients know that COVID is not over, per se, and that science supports vaccination,” Mr. Kolbert said. “The best defense here is a strong communicative offense, engaging with the patient and thoughtfully charting about this.”
A version of this article first appeared on Medscape.com.
Could a malpractice insurer drop you when you need it most?
You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.
Professional liability insurance
According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.
And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.
Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.
But it is what the policies don’t pay for that should be of most interest to practitioners.
Exclusions to medical malpractice insurance
All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:
- Reckless or intentional acts.
- Illegal/criminal activities, including theft.
- Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
- Practicing under the influence of alcohol or drugs.
- Altering patient or hospital records.
- Sexual misconduct.
- Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.
It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.
Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
The case
Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.
The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.
However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.
The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.
The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.
A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.
After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
Court and jury decide
In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.
The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.
However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.
The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.
While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
Protecting yourself
The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.
Other ways to protect yourself:
- Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
- Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
- Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
- Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
- The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.
The future
In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.
The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.
In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”
Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
A version of this article first appeared on Medscape.com.
You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.
Professional liability insurance
According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.
And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.
Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.
But it is what the policies don’t pay for that should be of most interest to practitioners.
Exclusions to medical malpractice insurance
All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:
- Reckless or intentional acts.
- Illegal/criminal activities, including theft.
- Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
- Practicing under the influence of alcohol or drugs.
- Altering patient or hospital records.
- Sexual misconduct.
- Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.
It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.
Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
The case
Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.
The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.
However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.
The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.
The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.
A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.
After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
Court and jury decide
In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.
The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.
However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.
The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.
While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
Protecting yourself
The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.
Other ways to protect yourself:
- Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
- Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
- Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
- Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
- The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.
The future
In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.
The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.
In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”
Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
A version of this article first appeared on Medscape.com.
You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.
Professional liability insurance
According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.
And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.
Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.
But it is what the policies don’t pay for that should be of most interest to practitioners.
Exclusions to medical malpractice insurance
All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:
- Reckless or intentional acts.
- Illegal/criminal activities, including theft.
- Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
- Practicing under the influence of alcohol or drugs.
- Altering patient or hospital records.
- Sexual misconduct.
- Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.
It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.
Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
The case
Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.
The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.
However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.
The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.
The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.
A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.
After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
Court and jury decide
In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.
The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.
However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.
The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.
While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
Protecting yourself
The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.
Other ways to protect yourself:
- Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
- Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
- Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
- Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
- The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.
The future
In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.
The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.
In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”
Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
A version of this article first appeared on Medscape.com.
Docs using AI? Some love it, most remain wary
When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.
“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.
Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.
He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”
The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.
Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.
More than half of the respondents not using AI said they first want more evidence that the technology works as intended.
“None of them work as advertised,” said one respondent.
MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.
Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.
Doctors may also be skeptical of AI based on their experience with EHRs, she said.
“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
Drawing the line at patient care
Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.
“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.
Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:
- Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
- Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
- Improving billing operations and predictive analytics.
Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.
They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
Is regulation needed?
Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.
“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.
In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.
Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.
In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.
There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
What should doctors do?
Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.
There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.
“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.
Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
A version of this article appeared on Medscape.com.
When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.
“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.
Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.
He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”
The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.
Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.
More than half of the respondents not using AI said they first want more evidence that the technology works as intended.
“None of them work as advertised,” said one respondent.
MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.
Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.
Doctors may also be skeptical of AI based on their experience with EHRs, she said.
“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
Drawing the line at patient care
Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.
“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.
Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:
- Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
- Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
- Improving billing operations and predictive analytics.
Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.
They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
Is regulation needed?
Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.
“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.
In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.
Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.
In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.
There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
What should doctors do?
Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.
There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.
“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.
Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
A version of this article appeared on Medscape.com.
When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.
“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.
Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.
He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”
The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.
Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.
More than half of the respondents not using AI said they first want more evidence that the technology works as intended.
“None of them work as advertised,” said one respondent.
MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.
Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.
Doctors may also be skeptical of AI based on their experience with EHRs, she said.
“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
Drawing the line at patient care
Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.
“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.
Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:
- Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
- Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
- Improving billing operations and predictive analytics.
Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.
They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
Is regulation needed?
Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.
“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.
In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.
Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.
In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.
There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
What should doctors do?
Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.
There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.
“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.
Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
A version of this article appeared on Medscape.com.
Your practice was bought out by private equity: Now what?
After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.
“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”
Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.
“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”
Blackstone and Ascension St. John did not respond to this news organization’s request for comment.
TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.
Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”
Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.
Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
What should you expect after PE acquisition?
Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.
Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.
“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”
Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.
“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”
When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.
Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.
In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.
PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.
On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.
“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”
Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.
The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.
“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
How to prepare for and cope with PE partnerships
If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.
“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.
When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.
“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”
Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.
“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”
“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”
For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.
Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.
Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.
In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.
She advises physicians who are unhappy after acquisitions to speak up and stick together.
“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
Why is PE so attracted to health care?
PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.
These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.
When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.
At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.
Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.
Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.
A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.
“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.
Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.
“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.
PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.
A version of this article appeared on Medscape.com.
After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.
“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”
Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.
“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”
Blackstone and Ascension St. John did not respond to this news organization’s request for comment.
TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.
Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”
Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.
Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
What should you expect after PE acquisition?
Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.
Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.
“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”
Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.
“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”
When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.
Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.
In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.
PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.
On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.
“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”
Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.
The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.
“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
How to prepare for and cope with PE partnerships
If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.
“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.
When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.
“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”
Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.
“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”
“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”
For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.
Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.
Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.
In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.
She advises physicians who are unhappy after acquisitions to speak up and stick together.
“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
Why is PE so attracted to health care?
PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.
These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.
When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.
At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.
Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.
Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.
A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.
“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.
Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.
“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.
PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.
A version of this article appeared on Medscape.com.
After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.
“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”
Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.
“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”
Blackstone and Ascension St. John did not respond to this news organization’s request for comment.
TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.
Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”
Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.
Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
What should you expect after PE acquisition?
Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.
Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.
“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”
Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.
“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”
When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.
Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.
In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.
PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.
On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.
“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”
Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.
The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.
“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
How to prepare for and cope with PE partnerships
If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.
“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.
When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.
“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”
Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.
“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”
“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”
For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.
Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.
Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.
In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.
She advises physicians who are unhappy after acquisitions to speak up and stick together.
“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
Why is PE so attracted to health care?
PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.
These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.
When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.
At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.
Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.
Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.
A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.
“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.
Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.
“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.
PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.
A version of this article appeared on Medscape.com.
Do the data support psychedelics in addiction therapy?
PARIS – “We need to develop new therapies to treat addiction because of the related cost to society, which is extremely high,” said Bruno Roméo, MD, psychiatrist and addiction specialist at Paul Brousse Hospital in Villejuif, France, at the Paris-based Neuroscience, Psychiatry and Neurology Conference. Dr. Roméo spoke about the current place of psychedelics in the treatment of addiction.
“Smoking and alcohol consumption are the two main preventable causes of death in France,” he said. “Current management strategies for these addictions rarely involve pharmacological therapies, which are not very effective, in any case. We have massive relapse rates, signaling the need to develop other treatments, like psychedelic drugs.”
But what data are available on the efficacy of psychedelics in treating addiction?
Alcohol use disorder
There are few data concerning the role of psychedelics in the treatment of alcohol use disorder, but one controlled, randomized trial evaluated the efficacy of psilocybin. That trial was published in JAMA Psychiatry in 2022.
That study included 95 patients with alcohol use disorder; 49 were treated with psilocybin, and 46 were treated with diphenhydramine.
An initial medication session of psilocybin was given in week 4, then another in week 8 at a higher dose. The number of drinking days, the number of heavy drinking days, and the number of drinks consumed between weeks 32 and 36 were assessed.
The investigators showed that, after two sessions with psilocybin, there was a significant reduction in the number of heavy drinking days. In the control group, between weeks 5 and 36, 20% of days involved heavy drinking, whereas in the psilocybin group, 10% of days involved heavy drinking.
There was also a significant and rapid reduction in the number of drinking days, and this was maintained over time. Between weeks 5 and 36, just over 40% of days were reported as drinking days in the control group versus slightly more than 30% in the psilocybin group.
Similarly, the number of glasses per day was drastically reduced after taking psilocybin, and the effect occurred extremely quickly. Consumption went from six drinks to less than one drink between weeks 5 and 8. Overall, between weeks 5 and 36, the number of drinks consumed per day was more than two in the placebo group and more than one in the psilocybin group.
“Psilocybin was seen as having potential efficacy in treating alcohol use disorder. But we must tread carefully with these results; the profile of the patients enrolled in this study is different to that of the patients we regularly see in our addiction clinics. The patients enrolled in the study reported less than 60% of days as heavy drinking days,” said Dr. Romeo.
Candidates for psilocybin
According to a retrospective survey of 160 respondents that was conducted online at Paul Brousse Hospital, patients with the most severe cases of alcohol use disorder who have the most mystical psychedelic experiences seem to respond best to psilocybin and to reduce their alcohol use. It also appears that patients whose alcohol use decreased the most had lower psychological flexibility on enrollment in the study. (Psychological flexibility is the ability to adapt to change and to cope with positive and negative experiences in real time without being fazed or trying to flee from the situation.) “It’s as if they had a broader capacity for change, and psychedelics helped them more,” said Dr. Roméo.
Smoking cessation
“There are even fewer studies for smoking,” said Dr. Roméo. In a pilot study with 15 patients, the researchers gave two or three doses of psilocybin at 20-30 mg in combination with cognitive-behavioral therapy one session per week for 10 weeks. Thereafter, patients were assessed three times: after 6 months, 12 months, and 30 months.
The results showed a significant reduction in smoking. Patients went from smoking more than 15 cigarettes per day to smoking one to two cigarettes per day before going back up to six cigarettes daily.
Regarding abstinence rates, 12 of 15 patients had stopped smoking after 6 months, 8 of 15 after 1 year, and 7 of 15 after 30 months. “This study produced some interesting results, although caution must obviously be taken due to the very low number of patients enrolled,” said Dr. Roméo.
As is the case for alcohol, a retrospective survey conducted via questionnaire at Paul Brousse Hospital showed that the patients who smoked the most and who had the most mystical psychedelic experiences seemed to respond best to psilocybin and therefore to reduce their tobacco use. It also seemed to be the case that patients who reduced tobacco use the most had lower psychological flexibility on enrollment in the study.
Constraints on psychedelics
“Psychedelics are somewhat effective in treating addiction, but there are various limitations to their use,” said Dr. Roméo.
One of those limitations is societal. Laurence Bézo, MD, of the addiction services clinic at Paul Brousse Hospital, asked doctors to respond to a questionnaire to determine what they thought about psychedelics. To date, 407 have responded, including 280 general practitioners, 50 addiction specialists, and 50 specialist physicians. Overall, 50% think that psychedelics have no therapeutic potential. Three of five doctors also said that psychedelics are dangerous. Just over half thought that their use is associated with a severe risk of aggression aimed at oneself and toward others. Likewise, half think that the risk of dependency is very high and that there is a risk of co-occurring psychiatric disorders. “From the pool of physicians queried, the consensus is that psychedelics are pretty dangerous. People also seem to frown upon prescribing psychedelics in France,” said Dr. Roméo.
Participants went as far as to classify psychedelics as some of the most dangerous drugs out there.
Using a 7-point scale, they classified psychedelics below heroin and cocaine in terms of dangerousness. They are deemed much more harmful than alcohol, tobacco, and cannabis.
“A survey of the public carried out several years ago by leading French market research group IFOP had the exact same findings. Nevertheless, a number of studies have set out to determine how dangerous psychedelics are, and their findings point to this class of drugs as being among the least harmful for the individual patient and those around them. On the contrary, alcohol, heroin, crack cocaine (or even cocaine),methamphetamine, and tobacco were shown to be the most harmful. Additionally, psychedelics have a very low risk of dependency and the lowest risk of lethality. There is complete dissonance between what recent studies show us and what society, and some doctors, think,” said Dr. Roméo.
Besides these assumptions, another constraint to the use of psychedelics relates to methods adopted in related clinical studies. “Due to the effect psychedelics have, in the trials conducted, 9 participants and 9 doctors out of 10 are aware of what they have taken or given, respectively. This is a very important limitation. Nowadays, researchers don’t know how to conduct accurate double-blind studies,” said Dr. Roméo.
In sum, for psychiatrists, psychedelics are promising in addiction therapy, but health care professionals, public authorities, and society as a whole must be better informed about their use, and received ideas must be dispelled.
“The findings need to be replicated, but overall, psychedelics are really quite promising in treating both alcohol and tobacco use disorder. They are generally well tolerated with few serious side effects. There is no deterioration in patients with psychiatric conditions while they are taking psychedelics. And if persistent symptoms of psychosis do occur, which is extremely rare, it’s probably because there are preexisting underlying issues at play. We also don’t see increased blood pressure or any other serious physical anomalies. In a supervised setting, as is the case with studies involving psychotherapeutic support, we can no longer say, in this day and age, that psychedelics are harmful,” said Dr. Roméo.
Dr. Roméo reported no conflicts of interest regarding the content of this article.
This article was translated from the Medscape French Edition and a version appeared on Medscape.com.
PARIS – “We need to develop new therapies to treat addiction because of the related cost to society, which is extremely high,” said Bruno Roméo, MD, psychiatrist and addiction specialist at Paul Brousse Hospital in Villejuif, France, at the Paris-based Neuroscience, Psychiatry and Neurology Conference. Dr. Roméo spoke about the current place of psychedelics in the treatment of addiction.
“Smoking and alcohol consumption are the two main preventable causes of death in France,” he said. “Current management strategies for these addictions rarely involve pharmacological therapies, which are not very effective, in any case. We have massive relapse rates, signaling the need to develop other treatments, like psychedelic drugs.”
But what data are available on the efficacy of psychedelics in treating addiction?
Alcohol use disorder
There are few data concerning the role of psychedelics in the treatment of alcohol use disorder, but one controlled, randomized trial evaluated the efficacy of psilocybin. That trial was published in JAMA Psychiatry in 2022.
That study included 95 patients with alcohol use disorder; 49 were treated with psilocybin, and 46 were treated with diphenhydramine.
An initial medication session of psilocybin was given in week 4, then another in week 8 at a higher dose. The number of drinking days, the number of heavy drinking days, and the number of drinks consumed between weeks 32 and 36 were assessed.
The investigators showed that, after two sessions with psilocybin, there was a significant reduction in the number of heavy drinking days. In the control group, between weeks 5 and 36, 20% of days involved heavy drinking, whereas in the psilocybin group, 10% of days involved heavy drinking.
There was also a significant and rapid reduction in the number of drinking days, and this was maintained over time. Between weeks 5 and 36, just over 40% of days were reported as drinking days in the control group versus slightly more than 30% in the psilocybin group.
Similarly, the number of glasses per day was drastically reduced after taking psilocybin, and the effect occurred extremely quickly. Consumption went from six drinks to less than one drink between weeks 5 and 8. Overall, between weeks 5 and 36, the number of drinks consumed per day was more than two in the placebo group and more than one in the psilocybin group.
“Psilocybin was seen as having potential efficacy in treating alcohol use disorder. But we must tread carefully with these results; the profile of the patients enrolled in this study is different to that of the patients we regularly see in our addiction clinics. The patients enrolled in the study reported less than 60% of days as heavy drinking days,” said Dr. Romeo.
Candidates for psilocybin
According to a retrospective survey of 160 respondents that was conducted online at Paul Brousse Hospital, patients with the most severe cases of alcohol use disorder who have the most mystical psychedelic experiences seem to respond best to psilocybin and to reduce their alcohol use. It also appears that patients whose alcohol use decreased the most had lower psychological flexibility on enrollment in the study. (Psychological flexibility is the ability to adapt to change and to cope with positive and negative experiences in real time without being fazed or trying to flee from the situation.) “It’s as if they had a broader capacity for change, and psychedelics helped them more,” said Dr. Roméo.
Smoking cessation
“There are even fewer studies for smoking,” said Dr. Roméo. In a pilot study with 15 patients, the researchers gave two or three doses of psilocybin at 20-30 mg in combination with cognitive-behavioral therapy one session per week for 10 weeks. Thereafter, patients were assessed three times: after 6 months, 12 months, and 30 months.
The results showed a significant reduction in smoking. Patients went from smoking more than 15 cigarettes per day to smoking one to two cigarettes per day before going back up to six cigarettes daily.
Regarding abstinence rates, 12 of 15 patients had stopped smoking after 6 months, 8 of 15 after 1 year, and 7 of 15 after 30 months. “This study produced some interesting results, although caution must obviously be taken due to the very low number of patients enrolled,” said Dr. Roméo.
As is the case for alcohol, a retrospective survey conducted via questionnaire at Paul Brousse Hospital showed that the patients who smoked the most and who had the most mystical psychedelic experiences seemed to respond best to psilocybin and therefore to reduce their tobacco use. It also seemed to be the case that patients who reduced tobacco use the most had lower psychological flexibility on enrollment in the study.
Constraints on psychedelics
“Psychedelics are somewhat effective in treating addiction, but there are various limitations to their use,” said Dr. Roméo.
One of those limitations is societal. Laurence Bézo, MD, of the addiction services clinic at Paul Brousse Hospital, asked doctors to respond to a questionnaire to determine what they thought about psychedelics. To date, 407 have responded, including 280 general practitioners, 50 addiction specialists, and 50 specialist physicians. Overall, 50% think that psychedelics have no therapeutic potential. Three of five doctors also said that psychedelics are dangerous. Just over half thought that their use is associated with a severe risk of aggression aimed at oneself and toward others. Likewise, half think that the risk of dependency is very high and that there is a risk of co-occurring psychiatric disorders. “From the pool of physicians queried, the consensus is that psychedelics are pretty dangerous. People also seem to frown upon prescribing psychedelics in France,” said Dr. Roméo.
Participants went as far as to classify psychedelics as some of the most dangerous drugs out there.
Using a 7-point scale, they classified psychedelics below heroin and cocaine in terms of dangerousness. They are deemed much more harmful than alcohol, tobacco, and cannabis.
“A survey of the public carried out several years ago by leading French market research group IFOP had the exact same findings. Nevertheless, a number of studies have set out to determine how dangerous psychedelics are, and their findings point to this class of drugs as being among the least harmful for the individual patient and those around them. On the contrary, alcohol, heroin, crack cocaine (or even cocaine),methamphetamine, and tobacco were shown to be the most harmful. Additionally, psychedelics have a very low risk of dependency and the lowest risk of lethality. There is complete dissonance between what recent studies show us and what society, and some doctors, think,” said Dr. Roméo.
Besides these assumptions, another constraint to the use of psychedelics relates to methods adopted in related clinical studies. “Due to the effect psychedelics have, in the trials conducted, 9 participants and 9 doctors out of 10 are aware of what they have taken or given, respectively. This is a very important limitation. Nowadays, researchers don’t know how to conduct accurate double-blind studies,” said Dr. Roméo.
In sum, for psychiatrists, psychedelics are promising in addiction therapy, but health care professionals, public authorities, and society as a whole must be better informed about their use, and received ideas must be dispelled.
“The findings need to be replicated, but overall, psychedelics are really quite promising in treating both alcohol and tobacco use disorder. They are generally well tolerated with few serious side effects. There is no deterioration in patients with psychiatric conditions while they are taking psychedelics. And if persistent symptoms of psychosis do occur, which is extremely rare, it’s probably because there are preexisting underlying issues at play. We also don’t see increased blood pressure or any other serious physical anomalies. In a supervised setting, as is the case with studies involving psychotherapeutic support, we can no longer say, in this day and age, that psychedelics are harmful,” said Dr. Roméo.
Dr. Roméo reported no conflicts of interest regarding the content of this article.
This article was translated from the Medscape French Edition and a version appeared on Medscape.com.
PARIS – “We need to develop new therapies to treat addiction because of the related cost to society, which is extremely high,” said Bruno Roméo, MD, psychiatrist and addiction specialist at Paul Brousse Hospital in Villejuif, France, at the Paris-based Neuroscience, Psychiatry and Neurology Conference. Dr. Roméo spoke about the current place of psychedelics in the treatment of addiction.
“Smoking and alcohol consumption are the two main preventable causes of death in France,” he said. “Current management strategies for these addictions rarely involve pharmacological therapies, which are not very effective, in any case. We have massive relapse rates, signaling the need to develop other treatments, like psychedelic drugs.”
But what data are available on the efficacy of psychedelics in treating addiction?
Alcohol use disorder
There are few data concerning the role of psychedelics in the treatment of alcohol use disorder, but one controlled, randomized trial evaluated the efficacy of psilocybin. That trial was published in JAMA Psychiatry in 2022.
That study included 95 patients with alcohol use disorder; 49 were treated with psilocybin, and 46 were treated with diphenhydramine.
An initial medication session of psilocybin was given in week 4, then another in week 8 at a higher dose. The number of drinking days, the number of heavy drinking days, and the number of drinks consumed between weeks 32 and 36 were assessed.
The investigators showed that, after two sessions with psilocybin, there was a significant reduction in the number of heavy drinking days. In the control group, between weeks 5 and 36, 20% of days involved heavy drinking, whereas in the psilocybin group, 10% of days involved heavy drinking.
There was also a significant and rapid reduction in the number of drinking days, and this was maintained over time. Between weeks 5 and 36, just over 40% of days were reported as drinking days in the control group versus slightly more than 30% in the psilocybin group.
Similarly, the number of glasses per day was drastically reduced after taking psilocybin, and the effect occurred extremely quickly. Consumption went from six drinks to less than one drink between weeks 5 and 8. Overall, between weeks 5 and 36, the number of drinks consumed per day was more than two in the placebo group and more than one in the psilocybin group.
“Psilocybin was seen as having potential efficacy in treating alcohol use disorder. But we must tread carefully with these results; the profile of the patients enrolled in this study is different to that of the patients we regularly see in our addiction clinics. The patients enrolled in the study reported less than 60% of days as heavy drinking days,” said Dr. Romeo.
Candidates for psilocybin
According to a retrospective survey of 160 respondents that was conducted online at Paul Brousse Hospital, patients with the most severe cases of alcohol use disorder who have the most mystical psychedelic experiences seem to respond best to psilocybin and to reduce their alcohol use. It also appears that patients whose alcohol use decreased the most had lower psychological flexibility on enrollment in the study. (Psychological flexibility is the ability to adapt to change and to cope with positive and negative experiences in real time without being fazed or trying to flee from the situation.) “It’s as if they had a broader capacity for change, and psychedelics helped them more,” said Dr. Roméo.
Smoking cessation
“There are even fewer studies for smoking,” said Dr. Roméo. In a pilot study with 15 patients, the researchers gave two or three doses of psilocybin at 20-30 mg in combination with cognitive-behavioral therapy one session per week for 10 weeks. Thereafter, patients were assessed three times: after 6 months, 12 months, and 30 months.
The results showed a significant reduction in smoking. Patients went from smoking more than 15 cigarettes per day to smoking one to two cigarettes per day before going back up to six cigarettes daily.
Regarding abstinence rates, 12 of 15 patients had stopped smoking after 6 months, 8 of 15 after 1 year, and 7 of 15 after 30 months. “This study produced some interesting results, although caution must obviously be taken due to the very low number of patients enrolled,” said Dr. Roméo.
As is the case for alcohol, a retrospective survey conducted via questionnaire at Paul Brousse Hospital showed that the patients who smoked the most and who had the most mystical psychedelic experiences seemed to respond best to psilocybin and therefore to reduce their tobacco use. It also seemed to be the case that patients who reduced tobacco use the most had lower psychological flexibility on enrollment in the study.
Constraints on psychedelics
“Psychedelics are somewhat effective in treating addiction, but there are various limitations to their use,” said Dr. Roméo.
One of those limitations is societal. Laurence Bézo, MD, of the addiction services clinic at Paul Brousse Hospital, asked doctors to respond to a questionnaire to determine what they thought about psychedelics. To date, 407 have responded, including 280 general practitioners, 50 addiction specialists, and 50 specialist physicians. Overall, 50% think that psychedelics have no therapeutic potential. Three of five doctors also said that psychedelics are dangerous. Just over half thought that their use is associated with a severe risk of aggression aimed at oneself and toward others. Likewise, half think that the risk of dependency is very high and that there is a risk of co-occurring psychiatric disorders. “From the pool of physicians queried, the consensus is that psychedelics are pretty dangerous. People also seem to frown upon prescribing psychedelics in France,” said Dr. Roméo.
Participants went as far as to classify psychedelics as some of the most dangerous drugs out there.
Using a 7-point scale, they classified psychedelics below heroin and cocaine in terms of dangerousness. They are deemed much more harmful than alcohol, tobacco, and cannabis.
“A survey of the public carried out several years ago by leading French market research group IFOP had the exact same findings. Nevertheless, a number of studies have set out to determine how dangerous psychedelics are, and their findings point to this class of drugs as being among the least harmful for the individual patient and those around them. On the contrary, alcohol, heroin, crack cocaine (or even cocaine),methamphetamine, and tobacco were shown to be the most harmful. Additionally, psychedelics have a very low risk of dependency and the lowest risk of lethality. There is complete dissonance between what recent studies show us and what society, and some doctors, think,” said Dr. Roméo.
Besides these assumptions, another constraint to the use of psychedelics relates to methods adopted in related clinical studies. “Due to the effect psychedelics have, in the trials conducted, 9 participants and 9 doctors out of 10 are aware of what they have taken or given, respectively. This is a very important limitation. Nowadays, researchers don’t know how to conduct accurate double-blind studies,” said Dr. Roméo.
In sum, for psychiatrists, psychedelics are promising in addiction therapy, but health care professionals, public authorities, and society as a whole must be better informed about their use, and received ideas must be dispelled.
“The findings need to be replicated, but overall, psychedelics are really quite promising in treating both alcohol and tobacco use disorder. They are generally well tolerated with few serious side effects. There is no deterioration in patients with psychiatric conditions while they are taking psychedelics. And if persistent symptoms of psychosis do occur, which is extremely rare, it’s probably because there are preexisting underlying issues at play. We also don’t see increased blood pressure or any other serious physical anomalies. In a supervised setting, as is the case with studies involving psychotherapeutic support, we can no longer say, in this day and age, that psychedelics are harmful,” said Dr. Roméo.
Dr. Roméo reported no conflicts of interest regarding the content of this article.
This article was translated from the Medscape French Edition and a version appeared on Medscape.com.
Ob.gyn. organizations opt for new residency application platform
In a recent joint announcement, the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said the new system, ResidencyCAS, offered by Liaison Centralized Application Service, will replace the Electronic Residency Application Service (ERAS). ERAS was implemented some 25 years ago by the Association of American Medical Colleges.
Efficiencies and lower costs
Potential startup glitches aside, the transition will allegedly lower skyrocketing application fees and provide enhanced efficiencies and a better user experience than ERAS. So far, ob.gyn. is first and the only specialty to jump ship from the established platform. But if other specialties follow suit making the new software the norm, that will have a serious impact on ERAS’s revenues, said J. Bryan Carmody, MD, MPH, a pediatric nephrologist at the Children’s Hospital of the King’s Daughters, Norfolk, Va., who closely monitors and writes about residency selection and discussed the coming transition in a recent blog posting.
“My feeling is that the average program director thinks that ERAS is functional but there are not many, if any, who are in love with ERAS,” Dr. Carmody said in an interview. “I think ERAS will benefit from having a competitor.”
A major drawback for applicants with the removal of ob.gyn. from ERAS, which handles almost all medical specialties, is that those seeking acceptance in more than one specialty will now need to apply twice and incur two sets of costs. “A substantial fraction of applicants do that and now they’ll have to navigate two different systems and collect and format all their documents for both, which will be burdensome,” he said.
Holistic review
According to the ACOG announcement, the new technology promises to manage the deluge of applications more efficiently and, most important, to allow program directors to evaluate candidates holistically in order to better meet the specific needs of different communities.
“The platform makes it much easier to review applicants for important characteristics other than academic, and It will cost applicants about 20% less,” said Maya M. Hammoud, MD, MBA, professor and association chair for education, obstetrics, and gynecology at the University of Michigan, Ann Arbor, and past president of APGO.
So far the announced switch has been positively received. “People are very excited about the change, especially when they see the video,” Dr. Hammoud said.
For Adi Katz, MD, director of gynecology and director of the obstetrics and gynecology residency program at Lenox Hill Hospital, New York, the change signals a step in the right direction, especially when it comes to application reviewing. “The number of applications has been increasing tremendously in the past few years. We have four residency spots and we get almost 900 applications for them, ” she said. “Under the present system it’s hard to give a fair review to all the applicants, and we hope that with change we’ll be able to give each one the attention they deserve.”
An important feature, added Dr. Katz, is that the new software will allow directors to do intuitive, “gut-level” screenings with the help of AI. In this approach, large numbers of candidates can be screened based on intuition in relation to their formal criteria.
Residency program administrators have long sought more holistic ways of screening applicants, and AI has the potential to provide insights into who’s a good fit by finding patterns in very complex data.
“Of course, we won’t know for sure if it’s the right move until we start using the platform,” Dr. Katz said.
“There are many factors beyond academic standing that can help determine which individual applicants would be the best fit for each unique program,” AnnaMarie Connolly, MD, chief of education and academic affairs at ACOG, said in an interview. ”In particular, improved holistic review will allow programs and applicants to better ensure alignment that, for example, considers factors such as applicants’ clinical interests, academic interests, and past life experiences.”
Updated data science is expected better align ob.gyn. programs and applicants, and improve staff efficiency at no cost to programs, Dr. Connolly added. Good alignment of residents with programs is especially important in a patient-interactive specialty such as ob.gyn. Webinars will prepare users to apply the new system.
According to the promotional video, ResidencyCAS integrates all components of application from candidates’ letters and credentials to lists of program directors, applicant reviews, and specialty data analytics. Collecting recommendations and credentials is expected to be streamlined. The software is currently used by 31 U.S. health care professions and across 31,000 programs.
“It’s clear that ob.gyn. residency applicants and ob.gyn. programs have been frustrated by certain aspects of the former application system, one of which being high costs,” Dr. Connolly added. “The feedback we’ve received indicates that programs are excited about a more streamlined process.”
AAMC strikes back
Not all groups are so enthusiastic, however, including, understandably, the AAMC, which expressed “surprise and dismay” at the switch.
“While it is too early to fully understand the consequences of this development – intended and unintended – the AAMC remains committed to creating a fair and equitable process for learners, medical schools, and programs,” wrote AAMC spokespersons David J. Skorton, MD, AAMC’s CEO, and Alison J. Whelan, MD, chief academic officer in a statement. “We are concerned that ob.gyn. program data will no longer be part of the numerous and longstanding AAMC data and research efforts.”
Those efforts include the Residency Readiness Survey, multidecade institution-level data and analytics, and future cross-specialty innovations. Lost with the changeover, the AAMC warned, may be the cross-specialty data it has collected, analyzed, and shared since ERAS’s inception, in particular its advocacy, research, and data support for the ob.gyn. community following the 2022 Supreme Court ruling in Dobbs v. Jackson.
Evolution of specialty application
In a blog posting, Dr. Carmody outlined the evolution of the specialty residency application process. Pre-ERAS application was slow, cumbersome, and done by mail. With the introduction of ERAS, applicants were able to put their information on floppy discs and submit them to the dean’s office, hopefully triggering interview offers via email. The new approach was originally piloted in partnership with ob.gyn. program directors and now ERAS finds itself in a first-in, first-out situation.
Over the years, program directors suffocating under the weight of applications have periodically asked the AAMC to share data or make changes to ERAS protocols or policies, including those on the sharing of collected information. “Its my perception that frustration about the AAMC’s data sharing was one of the things that led to the change,” Dr. Carmody said. While acknowledging that data sharing must be carefully done, he noted that, when program directors asked to see ERAS data to answer important questions, they were often refused.
While it appears that AAMC’s improvement efforts have not gone far or fast enough, the association pointed to significant efforts to streamline applications. It stressed its ongoing commitment to cooperation “with learners, medical schools, and the ERAS program community to further consider the implications of ACOG’s announcement.” It recently announced a collaboration with Thalamus-connecting the docs, a new interview-management software system the AAMC expects will accelerate innovation across the transition-to-residency process.
“We have many questions and few answers at this time,” Dr. Skorton and Dr. Whelan wrote, “and we will work diligently to fully understand the consequences and keep open communication with all of our constituents.”
Financial impact
Ob.gyn., an important but relatively small specialty, represented only 2.8% of the 2022 residency applications on ERAS and $3,362,760 of its $120 million in revenue that year, Dr. Carmody noted. That’s with 2,613 ob.gyn. applicants submitting an average of 63-83 applications depending on their background.
But if the defection of ob.gyn. starts a stampede among program directors in other branches of medicine to ResidencyCAS or some other new platform, that would cost ERAS substantially more.
“The next few years are going to be very telling,” said Dr. Carmody. Although competition may act as a catalyst for needed improvements to ERAS, if momentum grows, the comfortable inertia of staying with a known system may soon be overcome. “And the more specialties that switch, the more that will deprive the AAMC of the revenue it needs to improve the product.”
Dr. Carmody and Dr. Katz disclosed no relevant conflicts of interest with regard to their comments.
In a recent joint announcement, the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said the new system, ResidencyCAS, offered by Liaison Centralized Application Service, will replace the Electronic Residency Application Service (ERAS). ERAS was implemented some 25 years ago by the Association of American Medical Colleges.
Efficiencies and lower costs
Potential startup glitches aside, the transition will allegedly lower skyrocketing application fees and provide enhanced efficiencies and a better user experience than ERAS. So far, ob.gyn. is first and the only specialty to jump ship from the established platform. But if other specialties follow suit making the new software the norm, that will have a serious impact on ERAS’s revenues, said J. Bryan Carmody, MD, MPH, a pediatric nephrologist at the Children’s Hospital of the King’s Daughters, Norfolk, Va., who closely monitors and writes about residency selection and discussed the coming transition in a recent blog posting.
“My feeling is that the average program director thinks that ERAS is functional but there are not many, if any, who are in love with ERAS,” Dr. Carmody said in an interview. “I think ERAS will benefit from having a competitor.”
A major drawback for applicants with the removal of ob.gyn. from ERAS, which handles almost all medical specialties, is that those seeking acceptance in more than one specialty will now need to apply twice and incur two sets of costs. “A substantial fraction of applicants do that and now they’ll have to navigate two different systems and collect and format all their documents for both, which will be burdensome,” he said.
Holistic review
According to the ACOG announcement, the new technology promises to manage the deluge of applications more efficiently and, most important, to allow program directors to evaluate candidates holistically in order to better meet the specific needs of different communities.
“The platform makes it much easier to review applicants for important characteristics other than academic, and It will cost applicants about 20% less,” said Maya M. Hammoud, MD, MBA, professor and association chair for education, obstetrics, and gynecology at the University of Michigan, Ann Arbor, and past president of APGO.
So far the announced switch has been positively received. “People are very excited about the change, especially when they see the video,” Dr. Hammoud said.
For Adi Katz, MD, director of gynecology and director of the obstetrics and gynecology residency program at Lenox Hill Hospital, New York, the change signals a step in the right direction, especially when it comes to application reviewing. “The number of applications has been increasing tremendously in the past few years. We have four residency spots and we get almost 900 applications for them, ” she said. “Under the present system it’s hard to give a fair review to all the applicants, and we hope that with change we’ll be able to give each one the attention they deserve.”
An important feature, added Dr. Katz, is that the new software will allow directors to do intuitive, “gut-level” screenings with the help of AI. In this approach, large numbers of candidates can be screened based on intuition in relation to their formal criteria.
Residency program administrators have long sought more holistic ways of screening applicants, and AI has the potential to provide insights into who’s a good fit by finding patterns in very complex data.
“Of course, we won’t know for sure if it’s the right move until we start using the platform,” Dr. Katz said.
“There are many factors beyond academic standing that can help determine which individual applicants would be the best fit for each unique program,” AnnaMarie Connolly, MD, chief of education and academic affairs at ACOG, said in an interview. ”In particular, improved holistic review will allow programs and applicants to better ensure alignment that, for example, considers factors such as applicants’ clinical interests, academic interests, and past life experiences.”
Updated data science is expected better align ob.gyn. programs and applicants, and improve staff efficiency at no cost to programs, Dr. Connolly added. Good alignment of residents with programs is especially important in a patient-interactive specialty such as ob.gyn. Webinars will prepare users to apply the new system.
According to the promotional video, ResidencyCAS integrates all components of application from candidates’ letters and credentials to lists of program directors, applicant reviews, and specialty data analytics. Collecting recommendations and credentials is expected to be streamlined. The software is currently used by 31 U.S. health care professions and across 31,000 programs.
“It’s clear that ob.gyn. residency applicants and ob.gyn. programs have been frustrated by certain aspects of the former application system, one of which being high costs,” Dr. Connolly added. “The feedback we’ve received indicates that programs are excited about a more streamlined process.”
AAMC strikes back
Not all groups are so enthusiastic, however, including, understandably, the AAMC, which expressed “surprise and dismay” at the switch.
“While it is too early to fully understand the consequences of this development – intended and unintended – the AAMC remains committed to creating a fair and equitable process for learners, medical schools, and programs,” wrote AAMC spokespersons David J. Skorton, MD, AAMC’s CEO, and Alison J. Whelan, MD, chief academic officer in a statement. “We are concerned that ob.gyn. program data will no longer be part of the numerous and longstanding AAMC data and research efforts.”
Those efforts include the Residency Readiness Survey, multidecade institution-level data and analytics, and future cross-specialty innovations. Lost with the changeover, the AAMC warned, may be the cross-specialty data it has collected, analyzed, and shared since ERAS’s inception, in particular its advocacy, research, and data support for the ob.gyn. community following the 2022 Supreme Court ruling in Dobbs v. Jackson.
Evolution of specialty application
In a blog posting, Dr. Carmody outlined the evolution of the specialty residency application process. Pre-ERAS application was slow, cumbersome, and done by mail. With the introduction of ERAS, applicants were able to put their information on floppy discs and submit them to the dean’s office, hopefully triggering interview offers via email. The new approach was originally piloted in partnership with ob.gyn. program directors and now ERAS finds itself in a first-in, first-out situation.
Over the years, program directors suffocating under the weight of applications have periodically asked the AAMC to share data or make changes to ERAS protocols or policies, including those on the sharing of collected information. “Its my perception that frustration about the AAMC’s data sharing was one of the things that led to the change,” Dr. Carmody said. While acknowledging that data sharing must be carefully done, he noted that, when program directors asked to see ERAS data to answer important questions, they were often refused.
While it appears that AAMC’s improvement efforts have not gone far or fast enough, the association pointed to significant efforts to streamline applications. It stressed its ongoing commitment to cooperation “with learners, medical schools, and the ERAS program community to further consider the implications of ACOG’s announcement.” It recently announced a collaboration with Thalamus-connecting the docs, a new interview-management software system the AAMC expects will accelerate innovation across the transition-to-residency process.
“We have many questions and few answers at this time,” Dr. Skorton and Dr. Whelan wrote, “and we will work diligently to fully understand the consequences and keep open communication with all of our constituents.”
Financial impact
Ob.gyn., an important but relatively small specialty, represented only 2.8% of the 2022 residency applications on ERAS and $3,362,760 of its $120 million in revenue that year, Dr. Carmody noted. That’s with 2,613 ob.gyn. applicants submitting an average of 63-83 applications depending on their background.
But if the defection of ob.gyn. starts a stampede among program directors in other branches of medicine to ResidencyCAS or some other new platform, that would cost ERAS substantially more.
“The next few years are going to be very telling,” said Dr. Carmody. Although competition may act as a catalyst for needed improvements to ERAS, if momentum grows, the comfortable inertia of staying with a known system may soon be overcome. “And the more specialties that switch, the more that will deprive the AAMC of the revenue it needs to improve the product.”
Dr. Carmody and Dr. Katz disclosed no relevant conflicts of interest with regard to their comments.
In a recent joint announcement, the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said the new system, ResidencyCAS, offered by Liaison Centralized Application Service, will replace the Electronic Residency Application Service (ERAS). ERAS was implemented some 25 years ago by the Association of American Medical Colleges.
Efficiencies and lower costs
Potential startup glitches aside, the transition will allegedly lower skyrocketing application fees and provide enhanced efficiencies and a better user experience than ERAS. So far, ob.gyn. is first and the only specialty to jump ship from the established platform. But if other specialties follow suit making the new software the norm, that will have a serious impact on ERAS’s revenues, said J. Bryan Carmody, MD, MPH, a pediatric nephrologist at the Children’s Hospital of the King’s Daughters, Norfolk, Va., who closely monitors and writes about residency selection and discussed the coming transition in a recent blog posting.
“My feeling is that the average program director thinks that ERAS is functional but there are not many, if any, who are in love with ERAS,” Dr. Carmody said in an interview. “I think ERAS will benefit from having a competitor.”
A major drawback for applicants with the removal of ob.gyn. from ERAS, which handles almost all medical specialties, is that those seeking acceptance in more than one specialty will now need to apply twice and incur two sets of costs. “A substantial fraction of applicants do that and now they’ll have to navigate two different systems and collect and format all their documents for both, which will be burdensome,” he said.
Holistic review
According to the ACOG announcement, the new technology promises to manage the deluge of applications more efficiently and, most important, to allow program directors to evaluate candidates holistically in order to better meet the specific needs of different communities.
“The platform makes it much easier to review applicants for important characteristics other than academic, and It will cost applicants about 20% less,” said Maya M. Hammoud, MD, MBA, professor and association chair for education, obstetrics, and gynecology at the University of Michigan, Ann Arbor, and past president of APGO.
So far the announced switch has been positively received. “People are very excited about the change, especially when they see the video,” Dr. Hammoud said.
For Adi Katz, MD, director of gynecology and director of the obstetrics and gynecology residency program at Lenox Hill Hospital, New York, the change signals a step in the right direction, especially when it comes to application reviewing. “The number of applications has been increasing tremendously in the past few years. We have four residency spots and we get almost 900 applications for them, ” she said. “Under the present system it’s hard to give a fair review to all the applicants, and we hope that with change we’ll be able to give each one the attention they deserve.”
An important feature, added Dr. Katz, is that the new software will allow directors to do intuitive, “gut-level” screenings with the help of AI. In this approach, large numbers of candidates can be screened based on intuition in relation to their formal criteria.
Residency program administrators have long sought more holistic ways of screening applicants, and AI has the potential to provide insights into who’s a good fit by finding patterns in very complex data.
“Of course, we won’t know for sure if it’s the right move until we start using the platform,” Dr. Katz said.
“There are many factors beyond academic standing that can help determine which individual applicants would be the best fit for each unique program,” AnnaMarie Connolly, MD, chief of education and academic affairs at ACOG, said in an interview. ”In particular, improved holistic review will allow programs and applicants to better ensure alignment that, for example, considers factors such as applicants’ clinical interests, academic interests, and past life experiences.”
Updated data science is expected better align ob.gyn. programs and applicants, and improve staff efficiency at no cost to programs, Dr. Connolly added. Good alignment of residents with programs is especially important in a patient-interactive specialty such as ob.gyn. Webinars will prepare users to apply the new system.
According to the promotional video, ResidencyCAS integrates all components of application from candidates’ letters and credentials to lists of program directors, applicant reviews, and specialty data analytics. Collecting recommendations and credentials is expected to be streamlined. The software is currently used by 31 U.S. health care professions and across 31,000 programs.
“It’s clear that ob.gyn. residency applicants and ob.gyn. programs have been frustrated by certain aspects of the former application system, one of which being high costs,” Dr. Connolly added. “The feedback we’ve received indicates that programs are excited about a more streamlined process.”
AAMC strikes back
Not all groups are so enthusiastic, however, including, understandably, the AAMC, which expressed “surprise and dismay” at the switch.
“While it is too early to fully understand the consequences of this development – intended and unintended – the AAMC remains committed to creating a fair and equitable process for learners, medical schools, and programs,” wrote AAMC spokespersons David J. Skorton, MD, AAMC’s CEO, and Alison J. Whelan, MD, chief academic officer in a statement. “We are concerned that ob.gyn. program data will no longer be part of the numerous and longstanding AAMC data and research efforts.”
Those efforts include the Residency Readiness Survey, multidecade institution-level data and analytics, and future cross-specialty innovations. Lost with the changeover, the AAMC warned, may be the cross-specialty data it has collected, analyzed, and shared since ERAS’s inception, in particular its advocacy, research, and data support for the ob.gyn. community following the 2022 Supreme Court ruling in Dobbs v. Jackson.
Evolution of specialty application
In a blog posting, Dr. Carmody outlined the evolution of the specialty residency application process. Pre-ERAS application was slow, cumbersome, and done by mail. With the introduction of ERAS, applicants were able to put their information on floppy discs and submit them to the dean’s office, hopefully triggering interview offers via email. The new approach was originally piloted in partnership with ob.gyn. program directors and now ERAS finds itself in a first-in, first-out situation.
Over the years, program directors suffocating under the weight of applications have periodically asked the AAMC to share data or make changes to ERAS protocols or policies, including those on the sharing of collected information. “Its my perception that frustration about the AAMC’s data sharing was one of the things that led to the change,” Dr. Carmody said. While acknowledging that data sharing must be carefully done, he noted that, when program directors asked to see ERAS data to answer important questions, they were often refused.
While it appears that AAMC’s improvement efforts have not gone far or fast enough, the association pointed to significant efforts to streamline applications. It stressed its ongoing commitment to cooperation “with learners, medical schools, and the ERAS program community to further consider the implications of ACOG’s announcement.” It recently announced a collaboration with Thalamus-connecting the docs, a new interview-management software system the AAMC expects will accelerate innovation across the transition-to-residency process.
“We have many questions and few answers at this time,” Dr. Skorton and Dr. Whelan wrote, “and we will work diligently to fully understand the consequences and keep open communication with all of our constituents.”
Financial impact
Ob.gyn., an important but relatively small specialty, represented only 2.8% of the 2022 residency applications on ERAS and $3,362,760 of its $120 million in revenue that year, Dr. Carmody noted. That’s with 2,613 ob.gyn. applicants submitting an average of 63-83 applications depending on their background.
But if the defection of ob.gyn. starts a stampede among program directors in other branches of medicine to ResidencyCAS or some other new platform, that would cost ERAS substantially more.
“The next few years are going to be very telling,” said Dr. Carmody. Although competition may act as a catalyst for needed improvements to ERAS, if momentum grows, the comfortable inertia of staying with a known system may soon be overcome. “And the more specialties that switch, the more that will deprive the AAMC of the revenue it needs to improve the product.”
Dr. Carmody and Dr. Katz disclosed no relevant conflicts of interest with regard to their comments.
Better than dialysis? Artificial kidney could be the future
Nearly 90,000 patients in the United States are waiting for a lifesaving kidney transplant, yet only about 25,000 kidney transplants were performed last year. Thousands die each year while they wait. Others are not suitable transplant candidates.
Half a million people are on dialysis, the only transplant alternative for those with kidney failure. This greatly impacts their work, relationships, and quality of life.
Researchers from The Kidney Project hope to solve this public health crisis with a futuristic approach: an implantable bioartificial kidney. That hope is slowly approaching reality. Early prototypes have been tested successfully in preclinical research and clinical trials could lie ahead.
This news organization spoke with two researchers who came up with the idea: nephrologist William Dr. Fissell, MD, of Vanderbilt University in Nashville, Tenn., and Shuvo Dr. Roy, PhD, a biomedical engineer at the University of California, San Francisco. This interview has been edited for length and clarity.
Question: Could you summarize the clinical problem with chronic kidney disease?
Dr. Fissell: Dialysis treatment, although lifesaving, is incomplete. Healthy kidneys do a variety of things that dialysis cannot provide. Transplant is absolutely the best remedy, but donor organs are vanishingly scarce.
Do you envision your implantable, bioartificial kidney as a bridge to transplantation? Or can it be even more, like a bionic organ, as good as a natural organ and thus better than a transplant?
Dr. Roy: We see it initially as a bridge to transplantation or as a better option than dialysis for those who will never get a transplant. We’re not trying to create the “Six Million Dollar Man.” The goal is to keep patients off dialysis – to deliver some, but probably not all, of the benefits of a kidney transplant in a mass-produced device that anybody can receive.
Dr. Fissell: The technology is aimed at people in stage 5 renal disease, the final stage, when kidneys are failing, and dialysis is the only option to maintain life. We want to make dialysis a thing of the past, put dialysis machines in museums like the iron lung, which was so vital to keeping people alive several decades ago but is mostly obsolete today.
How did you two come up with this idea? How did you get started working together?
Dr. Roy: I had just begun my career as a research biomedical engineer when I met Dr. William Fissell, who was then contemplating a career in nephrology. He opened my eyes to the problems faced by patients affected by kidney failure. Through our discussions, we quickly realized that while we could improve dialysis machines, patients needed and deserved something better – a treatment that improves their health while also allowing them to keep a job, travel readily, and consume food and drink without restrictions. Basically, something that works more like a kidney transplant.
How does the artificial kidney differ from dialysis?
Dr. Fissell: Dialysis is an intermittent stop-and-start treatment. The artificial kidney is continuous, around-the-clock treatment. There are a couple of advantages to that. The first is that you can maintain your body’s fluid balance. In dialysis, you get rid of 2-3 days’ worth of fluid in a couple of hours, and that’s very stressful to the heart and maybe to the brain as well. Second advantage is that patients will be able to eat a normal diet. Some waste products that are byproducts of our nutritional intake are slow to leave the body. So in dialysis, we restrict the diet severely and add medicines to soak up extra phosphorus. With a continuous treatment, you can balance excretion and intake.
The other aspect is that dialysis requires an immense amount of disposables. Hundreds of liters of water per patient per treatment, hundreds of thousands of dialysis cartridges and IV bags every year. The artificial kidney doesn’t need a water supply, disposable sorbent, or cartridges.
How does the artificial kidney work?
Dr. Fissell: Just like a healthy kidney. We have a unit that filters the blood so that red blood cells, white blood cells, platelets, antibodies, albumin – all the good stuff that your body worked hard to synthesize – stays in the blood, but a watery soup of toxins and waste is separated out. In a second unit, called the bioreactor, kidney cells concentrate those wastes and toxins into urine.
Dr. Roy: We used a technology called silicon micro-machining to invent an entirely new membrane that mimics a healthy kidney’s filters. It filters the blood just using the patient’s heart as a pump. No electric motors, no batteries, no wires. This lets us have something that’s completely implanted.
We also developed a cell culture of kidney cells that function in an artificial kidney. Normally, cells in a dish don’t fully adopt the features of a cell in the body. We looked at the literature around 3-D printing of organs. We learned that, in addition to fluid flow, stiff scaffolds, like cell culture dishes, trigger specific signals that keep the cells from functioning. We overcame that by looking at the physical microenvironment of the cells – not the hormones and proteins, but instead the fundamentals of the laboratory environment. For example, most organs are soft, yet plastic lab dishes are hard. By using tools that replicated the softness and fluid flow of a healthy kidney, remarkably, these cells functioned better than on a plastic dish.
Would patients need immunosuppressive or anticoagulation medication?
Dr. Fissell: They wouldn’t need either. The structure and chemistry of the device prevents blood from clotting. And the membranes in the device are a physical barrier between the host immune system and the donor cells, so the body won’t reject the device.
What is the state of the technology now?
Dr. Fissell: We have shown the function of the filters and the function of the cells, both separately and together, in preclinical in vivo testing. What we now need to do is construct clinical-grade devices and complete sterility and biocompatibility testing to initiate a human trial. That’s going to take between $12 million and $15 million in device manufacturing.
So it’s more a matter of money than time until the first clinical trials?
Dr. Roy: Yes, exactly. We don’t like to say that a clinical trial will start by such-and-such year. From the very start of the project, we have been resource limited.
A version of this article first appeared on Medscape.com.
Nearly 90,000 patients in the United States are waiting for a lifesaving kidney transplant, yet only about 25,000 kidney transplants were performed last year. Thousands die each year while they wait. Others are not suitable transplant candidates.
Half a million people are on dialysis, the only transplant alternative for those with kidney failure. This greatly impacts their work, relationships, and quality of life.
Researchers from The Kidney Project hope to solve this public health crisis with a futuristic approach: an implantable bioartificial kidney. That hope is slowly approaching reality. Early prototypes have been tested successfully in preclinical research and clinical trials could lie ahead.
This news organization spoke with two researchers who came up with the idea: nephrologist William Dr. Fissell, MD, of Vanderbilt University in Nashville, Tenn., and Shuvo Dr. Roy, PhD, a biomedical engineer at the University of California, San Francisco. This interview has been edited for length and clarity.
Question: Could you summarize the clinical problem with chronic kidney disease?
Dr. Fissell: Dialysis treatment, although lifesaving, is incomplete. Healthy kidneys do a variety of things that dialysis cannot provide. Transplant is absolutely the best remedy, but donor organs are vanishingly scarce.
Do you envision your implantable, bioartificial kidney as a bridge to transplantation? Or can it be even more, like a bionic organ, as good as a natural organ and thus better than a transplant?
Dr. Roy: We see it initially as a bridge to transplantation or as a better option than dialysis for those who will never get a transplant. We’re not trying to create the “Six Million Dollar Man.” The goal is to keep patients off dialysis – to deliver some, but probably not all, of the benefits of a kidney transplant in a mass-produced device that anybody can receive.
Dr. Fissell: The technology is aimed at people in stage 5 renal disease, the final stage, when kidneys are failing, and dialysis is the only option to maintain life. We want to make dialysis a thing of the past, put dialysis machines in museums like the iron lung, which was so vital to keeping people alive several decades ago but is mostly obsolete today.
How did you two come up with this idea? How did you get started working together?
Dr. Roy: I had just begun my career as a research biomedical engineer when I met Dr. William Fissell, who was then contemplating a career in nephrology. He opened my eyes to the problems faced by patients affected by kidney failure. Through our discussions, we quickly realized that while we could improve dialysis machines, patients needed and deserved something better – a treatment that improves their health while also allowing them to keep a job, travel readily, and consume food and drink without restrictions. Basically, something that works more like a kidney transplant.
How does the artificial kidney differ from dialysis?
Dr. Fissell: Dialysis is an intermittent stop-and-start treatment. The artificial kidney is continuous, around-the-clock treatment. There are a couple of advantages to that. The first is that you can maintain your body’s fluid balance. In dialysis, you get rid of 2-3 days’ worth of fluid in a couple of hours, and that’s very stressful to the heart and maybe to the brain as well. Second advantage is that patients will be able to eat a normal diet. Some waste products that are byproducts of our nutritional intake are slow to leave the body. So in dialysis, we restrict the diet severely and add medicines to soak up extra phosphorus. With a continuous treatment, you can balance excretion and intake.
The other aspect is that dialysis requires an immense amount of disposables. Hundreds of liters of water per patient per treatment, hundreds of thousands of dialysis cartridges and IV bags every year. The artificial kidney doesn’t need a water supply, disposable sorbent, or cartridges.
How does the artificial kidney work?
Dr. Fissell: Just like a healthy kidney. We have a unit that filters the blood so that red blood cells, white blood cells, platelets, antibodies, albumin – all the good stuff that your body worked hard to synthesize – stays in the blood, but a watery soup of toxins and waste is separated out. In a second unit, called the bioreactor, kidney cells concentrate those wastes and toxins into urine.
Dr. Roy: We used a technology called silicon micro-machining to invent an entirely new membrane that mimics a healthy kidney’s filters. It filters the blood just using the patient’s heart as a pump. No electric motors, no batteries, no wires. This lets us have something that’s completely implanted.
We also developed a cell culture of kidney cells that function in an artificial kidney. Normally, cells in a dish don’t fully adopt the features of a cell in the body. We looked at the literature around 3-D printing of organs. We learned that, in addition to fluid flow, stiff scaffolds, like cell culture dishes, trigger specific signals that keep the cells from functioning. We overcame that by looking at the physical microenvironment of the cells – not the hormones and proteins, but instead the fundamentals of the laboratory environment. For example, most organs are soft, yet plastic lab dishes are hard. By using tools that replicated the softness and fluid flow of a healthy kidney, remarkably, these cells functioned better than on a plastic dish.
Would patients need immunosuppressive or anticoagulation medication?
Dr. Fissell: They wouldn’t need either. The structure and chemistry of the device prevents blood from clotting. And the membranes in the device are a physical barrier between the host immune system and the donor cells, so the body won’t reject the device.
What is the state of the technology now?
Dr. Fissell: We have shown the function of the filters and the function of the cells, both separately and together, in preclinical in vivo testing. What we now need to do is construct clinical-grade devices and complete sterility and biocompatibility testing to initiate a human trial. That’s going to take between $12 million and $15 million in device manufacturing.
So it’s more a matter of money than time until the first clinical trials?
Dr. Roy: Yes, exactly. We don’t like to say that a clinical trial will start by such-and-such year. From the very start of the project, we have been resource limited.
A version of this article first appeared on Medscape.com.
Nearly 90,000 patients in the United States are waiting for a lifesaving kidney transplant, yet only about 25,000 kidney transplants were performed last year. Thousands die each year while they wait. Others are not suitable transplant candidates.
Half a million people are on dialysis, the only transplant alternative for those with kidney failure. This greatly impacts their work, relationships, and quality of life.
Researchers from The Kidney Project hope to solve this public health crisis with a futuristic approach: an implantable bioartificial kidney. That hope is slowly approaching reality. Early prototypes have been tested successfully in preclinical research and clinical trials could lie ahead.
This news organization spoke with two researchers who came up with the idea: nephrologist William Dr. Fissell, MD, of Vanderbilt University in Nashville, Tenn., and Shuvo Dr. Roy, PhD, a biomedical engineer at the University of California, San Francisco. This interview has been edited for length and clarity.
Question: Could you summarize the clinical problem with chronic kidney disease?
Dr. Fissell: Dialysis treatment, although lifesaving, is incomplete. Healthy kidneys do a variety of things that dialysis cannot provide. Transplant is absolutely the best remedy, but donor organs are vanishingly scarce.
Do you envision your implantable, bioartificial kidney as a bridge to transplantation? Or can it be even more, like a bionic organ, as good as a natural organ and thus better than a transplant?
Dr. Roy: We see it initially as a bridge to transplantation or as a better option than dialysis for those who will never get a transplant. We’re not trying to create the “Six Million Dollar Man.” The goal is to keep patients off dialysis – to deliver some, but probably not all, of the benefits of a kidney transplant in a mass-produced device that anybody can receive.
Dr. Fissell: The technology is aimed at people in stage 5 renal disease, the final stage, when kidneys are failing, and dialysis is the only option to maintain life. We want to make dialysis a thing of the past, put dialysis machines in museums like the iron lung, which was so vital to keeping people alive several decades ago but is mostly obsolete today.
How did you two come up with this idea? How did you get started working together?
Dr. Roy: I had just begun my career as a research biomedical engineer when I met Dr. William Fissell, who was then contemplating a career in nephrology. He opened my eyes to the problems faced by patients affected by kidney failure. Through our discussions, we quickly realized that while we could improve dialysis machines, patients needed and deserved something better – a treatment that improves their health while also allowing them to keep a job, travel readily, and consume food and drink without restrictions. Basically, something that works more like a kidney transplant.
How does the artificial kidney differ from dialysis?
Dr. Fissell: Dialysis is an intermittent stop-and-start treatment. The artificial kidney is continuous, around-the-clock treatment. There are a couple of advantages to that. The first is that you can maintain your body’s fluid balance. In dialysis, you get rid of 2-3 days’ worth of fluid in a couple of hours, and that’s very stressful to the heart and maybe to the brain as well. Second advantage is that patients will be able to eat a normal diet. Some waste products that are byproducts of our nutritional intake are slow to leave the body. So in dialysis, we restrict the diet severely and add medicines to soak up extra phosphorus. With a continuous treatment, you can balance excretion and intake.
The other aspect is that dialysis requires an immense amount of disposables. Hundreds of liters of water per patient per treatment, hundreds of thousands of dialysis cartridges and IV bags every year. The artificial kidney doesn’t need a water supply, disposable sorbent, or cartridges.
How does the artificial kidney work?
Dr. Fissell: Just like a healthy kidney. We have a unit that filters the blood so that red blood cells, white blood cells, platelets, antibodies, albumin – all the good stuff that your body worked hard to synthesize – stays in the blood, but a watery soup of toxins and waste is separated out. In a second unit, called the bioreactor, kidney cells concentrate those wastes and toxins into urine.
Dr. Roy: We used a technology called silicon micro-machining to invent an entirely new membrane that mimics a healthy kidney’s filters. It filters the blood just using the patient’s heart as a pump. No electric motors, no batteries, no wires. This lets us have something that’s completely implanted.
We also developed a cell culture of kidney cells that function in an artificial kidney. Normally, cells in a dish don’t fully adopt the features of a cell in the body. We looked at the literature around 3-D printing of organs. We learned that, in addition to fluid flow, stiff scaffolds, like cell culture dishes, trigger specific signals that keep the cells from functioning. We overcame that by looking at the physical microenvironment of the cells – not the hormones and proteins, but instead the fundamentals of the laboratory environment. For example, most organs are soft, yet plastic lab dishes are hard. By using tools that replicated the softness and fluid flow of a healthy kidney, remarkably, these cells functioned better than on a plastic dish.
Would patients need immunosuppressive or anticoagulation medication?
Dr. Fissell: They wouldn’t need either. The structure and chemistry of the device prevents blood from clotting. And the membranes in the device are a physical barrier between the host immune system and the donor cells, so the body won’t reject the device.
What is the state of the technology now?
Dr. Fissell: We have shown the function of the filters and the function of the cells, both separately and together, in preclinical in vivo testing. What we now need to do is construct clinical-grade devices and complete sterility and biocompatibility testing to initiate a human trial. That’s going to take between $12 million and $15 million in device manufacturing.
So it’s more a matter of money than time until the first clinical trials?
Dr. Roy: Yes, exactly. We don’t like to say that a clinical trial will start by such-and-such year. From the very start of the project, we have been resource limited.
A version of this article first appeared on Medscape.com.
What causes sudden cardiac arrest in young people?
Sudden cardiac arrest is the term given to death that results from a cardiac cause and occurs within an hour of symptoms being observed. If no witnesses are present, sudden cardiac arrest is present if the person had been in apparently good health 24 hours before cardiac death. Fatality is usually a result of sustained ventricular fibrillation or sustained ventricular tachycardia that leads to cardiac arrest.
Recognizing warning signs
Warning signs that should prompt physicians to consider an increased risk of sudden cardiac arrest include the following:
- Unexplained, brief fainting episodes that above all occur with stress, physical activity, or loud noises (for example, alarm ringing)
- Seizures without a clear pathologic EEG result (for example, epilepsy)
- Unexplained accidents or car crashes
- Heart failure or pacemaker dependency before age 50 years
“These are all indications that could point to an underlying heart disease that should be investigated by a medical professional,” explained Silke Kauferstein, PhD, head of the Center for Sudden Cardiac Arrest and Familial Arrhythmia Syndrome at the Institute of Forensic Medicine of the University Frankfurt am Main (Germany), in a podcast by the German Heart Foundation.
Sports rarely responsible
Sudden cardiac arrest has numerous causes. Sudden cardiac arrests in a professional sports environment always attract attention. Yet sports play a less important role in sudden cardiac arrest than is often assumed, even in young individuals.
“The incidence of sudden cardiac arrest is on average 0.7-3 per 100,000 sports players from all age groups,” said Thomas Voigtländer, MD, chair of the German Heart Foundation, in an interview. Men make up 95% of those affected, and 90% of these events occur during recreational sports.
Inherited disorders
The most significant risk factor for sudden cardiac arrest is age; it is often associated with coronary heart disease. This factor can be significant from as early as age 35 years. Among young individuals, sudden cardiac arrest is often a result of congenital heart diseases, such as hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy. Diseases such as long QT syndrome and Brugada syndrome can also lead to sudden cardiac arrest.
Among young sports players who experience sudden cardiac arrest, the cause is often an overlooked hereditary factor. “Cardiac screening is recommended in particular for young, high-performance athletes from around 14 years old,” said Dr. Voigtländer, who is also a cardiologist and medical director of the Agaplesion Bethanien Hospital in Frankfurt.
Testing of family
“If sudden cardiac arrest or an unexplained sudden death occurs at a young age in the family, the primary care practitioner must be aware that this could be due to heart diseases that could affect the rest of the family,” said Dr. Voigtländer.
In these cases, primary care practitioners must connect the other family members to specialist outpatient departments that can test for genetic factors, he added. “Many of these genetic diseases can be treated successfully if they are diagnosed promptly.”
Lack of knowledge
Dr. Kauferstein, who runs such a specialist outpatient department, said, “unfortunately, many affected families do not know that they should be tested as well. This lack of knowledge can also lead to fatal consequences for relatives.”
For this reason, she believes that it is crucial to provide more information to the general population. Sudden cardiac arrest is often the first sign of an underlying heart disease in young, healthy individuals. “We do see warning signals in our in-depth testing of sudden cardiac arrest cases that have often been overlooked,” said Dr. Kauferstein.
This article was translated from the Medscape German Edition. A version appeared on Medscape.com.
Sudden cardiac arrest is the term given to death that results from a cardiac cause and occurs within an hour of symptoms being observed. If no witnesses are present, sudden cardiac arrest is present if the person had been in apparently good health 24 hours before cardiac death. Fatality is usually a result of sustained ventricular fibrillation or sustained ventricular tachycardia that leads to cardiac arrest.
Recognizing warning signs
Warning signs that should prompt physicians to consider an increased risk of sudden cardiac arrest include the following:
- Unexplained, brief fainting episodes that above all occur with stress, physical activity, or loud noises (for example, alarm ringing)
- Seizures without a clear pathologic EEG result (for example, epilepsy)
- Unexplained accidents or car crashes
- Heart failure or pacemaker dependency before age 50 years
“These are all indications that could point to an underlying heart disease that should be investigated by a medical professional,” explained Silke Kauferstein, PhD, head of the Center for Sudden Cardiac Arrest and Familial Arrhythmia Syndrome at the Institute of Forensic Medicine of the University Frankfurt am Main (Germany), in a podcast by the German Heart Foundation.
Sports rarely responsible
Sudden cardiac arrest has numerous causes. Sudden cardiac arrests in a professional sports environment always attract attention. Yet sports play a less important role in sudden cardiac arrest than is often assumed, even in young individuals.
“The incidence of sudden cardiac arrest is on average 0.7-3 per 100,000 sports players from all age groups,” said Thomas Voigtländer, MD, chair of the German Heart Foundation, in an interview. Men make up 95% of those affected, and 90% of these events occur during recreational sports.
Inherited disorders
The most significant risk factor for sudden cardiac arrest is age; it is often associated with coronary heart disease. This factor can be significant from as early as age 35 years. Among young individuals, sudden cardiac arrest is often a result of congenital heart diseases, such as hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy. Diseases such as long QT syndrome and Brugada syndrome can also lead to sudden cardiac arrest.
Among young sports players who experience sudden cardiac arrest, the cause is often an overlooked hereditary factor. “Cardiac screening is recommended in particular for young, high-performance athletes from around 14 years old,” said Dr. Voigtländer, who is also a cardiologist and medical director of the Agaplesion Bethanien Hospital in Frankfurt.
Testing of family
“If sudden cardiac arrest or an unexplained sudden death occurs at a young age in the family, the primary care practitioner must be aware that this could be due to heart diseases that could affect the rest of the family,” said Dr. Voigtländer.
In these cases, primary care practitioners must connect the other family members to specialist outpatient departments that can test for genetic factors, he added. “Many of these genetic diseases can be treated successfully if they are diagnosed promptly.”
Lack of knowledge
Dr. Kauferstein, who runs such a specialist outpatient department, said, “unfortunately, many affected families do not know that they should be tested as well. This lack of knowledge can also lead to fatal consequences for relatives.”
For this reason, she believes that it is crucial to provide more information to the general population. Sudden cardiac arrest is often the first sign of an underlying heart disease in young, healthy individuals. “We do see warning signals in our in-depth testing of sudden cardiac arrest cases that have often been overlooked,” said Dr. Kauferstein.
This article was translated from the Medscape German Edition. A version appeared on Medscape.com.
Sudden cardiac arrest is the term given to death that results from a cardiac cause and occurs within an hour of symptoms being observed. If no witnesses are present, sudden cardiac arrest is present if the person had been in apparently good health 24 hours before cardiac death. Fatality is usually a result of sustained ventricular fibrillation or sustained ventricular tachycardia that leads to cardiac arrest.
Recognizing warning signs
Warning signs that should prompt physicians to consider an increased risk of sudden cardiac arrest include the following:
- Unexplained, brief fainting episodes that above all occur with stress, physical activity, or loud noises (for example, alarm ringing)
- Seizures without a clear pathologic EEG result (for example, epilepsy)
- Unexplained accidents or car crashes
- Heart failure or pacemaker dependency before age 50 years
“These are all indications that could point to an underlying heart disease that should be investigated by a medical professional,” explained Silke Kauferstein, PhD, head of the Center for Sudden Cardiac Arrest and Familial Arrhythmia Syndrome at the Institute of Forensic Medicine of the University Frankfurt am Main (Germany), in a podcast by the German Heart Foundation.
Sports rarely responsible
Sudden cardiac arrest has numerous causes. Sudden cardiac arrests in a professional sports environment always attract attention. Yet sports play a less important role in sudden cardiac arrest than is often assumed, even in young individuals.
“The incidence of sudden cardiac arrest is on average 0.7-3 per 100,000 sports players from all age groups,” said Thomas Voigtländer, MD, chair of the German Heart Foundation, in an interview. Men make up 95% of those affected, and 90% of these events occur during recreational sports.
Inherited disorders
The most significant risk factor for sudden cardiac arrest is age; it is often associated with coronary heart disease. This factor can be significant from as early as age 35 years. Among young individuals, sudden cardiac arrest is often a result of congenital heart diseases, such as hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy. Diseases such as long QT syndrome and Brugada syndrome can also lead to sudden cardiac arrest.
Among young sports players who experience sudden cardiac arrest, the cause is often an overlooked hereditary factor. “Cardiac screening is recommended in particular for young, high-performance athletes from around 14 years old,” said Dr. Voigtländer, who is also a cardiologist and medical director of the Agaplesion Bethanien Hospital in Frankfurt.
Testing of family
“If sudden cardiac arrest or an unexplained sudden death occurs at a young age in the family, the primary care practitioner must be aware that this could be due to heart diseases that could affect the rest of the family,” said Dr. Voigtländer.
In these cases, primary care practitioners must connect the other family members to specialist outpatient departments that can test for genetic factors, he added. “Many of these genetic diseases can be treated successfully if they are diagnosed promptly.”
Lack of knowledge
Dr. Kauferstein, who runs such a specialist outpatient department, said, “unfortunately, many affected families do not know that they should be tested as well. This lack of knowledge can also lead to fatal consequences for relatives.”
For this reason, she believes that it is crucial to provide more information to the general population. Sudden cardiac arrest is often the first sign of an underlying heart disease in young, healthy individuals. “We do see warning signals in our in-depth testing of sudden cardiac arrest cases that have often been overlooked,” said Dr. Kauferstein.
This article was translated from the Medscape German Edition. A version appeared on Medscape.com.