Law & Medicine

A new federal rule opens the door for physicians in California and Texas to take advantage of student loan forgiveness, possibly bringing much-needed relief to those with cumbersome debt loads after repayments resumed last month. However, the timing is critical, as some doctors may need to consolidate their loans by December 31 to remain eligible.

Updated guidelines for the Public Service Loan Forgiveness Program (PSLF) took effect in July, expanding the number of potential borrowers who could have their federal student loan balances wiped clean after working full time in a government or nonprofit role and making 120 monthly loan payments.

But loan forgiveness also hinges on having the correct employment type and requires applicants to be a “direct hire” of the organization. State laws in California and Texas prohibit nonprofit hospitals and health care entities from directly hiring physicians — a loophole that has barred doctors in those locations from applying.

Both states’ medical and hospital associations worked with the US Department of Education (DOE) to offer an exception. California and Texas physicians can now satisfy the employment type condition by having a written contract or medical staff privileges with a nonprofit hospital or facility, even if the physician is part of a for-profit sole proprietorship, partnership, or medical group.

Eligible loans cannot be in default and must have been received through the Direct Loan Program, which includes Parent PLUS loans. Doctors with non-qualifying student loans, such as Federal Family Education Loans, can become PSLF-eligible and have past time worked counted toward the requirements if they consolidate into a direct loan by December 31.

The California Medical Association (CMA) has an online guide to help doctors and employers navigate the new rules.

The change comes just in time because California and Texas need to expand their physician workforces by tens of thousands over the next decade. “This program will allow us to retain and recruit new physicians to our states to address our growing physician shortages and access to care challenges for the patients who need us most,” Texas Medical Association president Rick W. Snyder II, MD, said in a statement.

Physicians should use the PSLF Help Tool to complete the forgiveness application, said Ashley Harrington, senior advisor at the DOE. During a free on-demand webinar hosted by CMA, she said the form has been streamlined and will ask applicants to list the nonprofit entity where they provide care, its employer identification number, the length of time worked there, and the average hours worked per week. The employer must sign to certify the physician’s reported hours.

Ideally, physicians should submit a PSLF form annually or each time they change jobs, but they can also wait until the end of the 10 years to submit the form, said Ms. Harrington.

With the average medical education loan debt exceeding $200,000, CMA president Donaldo Hernandez, MD, said the rule will ensure low-income and minority students can consider medical careers.

California family medicine physician Ashley Paydar, DO, said that she has already applied for PSLF and found the process relatively easy. While she awaits final approval, she’s planning for the future. “Loan forgiveness will allow me to do a fellowship and save for my children›s college so they can pursue higher education without the debt,” she said.

Still, employers have no legal obligation to certify physicians’ hours, and many may express hesitation as they try to understand the new guidelines, said Long Do, JD, partner at Athene Law in San Francisco and speaker during the webinar. He urged physicians to have patience when working through the application process.

A version of this article appeared on Medscape.com.

A new federal rule opens the door for physicians in California and Texas to take advantage of student loan forgiveness, possibly bringing much-needed relief to those with cumbersome debt loads after repayments resumed last month. However, the timing is critical, as some doctors may need to consolidate their loans by December 31 to remain eligible.

Updated guidelines for the Public Service Loan Forgiveness Program (PSLF) took effect in July, expanding the number of potential borrowers who could have their federal student loan balances wiped clean after working full time in a government or nonprofit role and making 120 monthly loan payments.

But loan forgiveness also hinges on having the correct employment type and requires applicants to be a “direct hire” of the organization. State laws in California and Texas prohibit nonprofit hospitals and health care entities from directly hiring physicians — a loophole that has barred doctors in those locations from applying.

Both states’ medical and hospital associations worked with the US Department of Education (DOE) to offer an exception. California and Texas physicians can now satisfy the employment type condition by having a written contract or medical staff privileges with a nonprofit hospital or facility, even if the physician is part of a for-profit sole proprietorship, partnership, or medical group.

Eligible loans cannot be in default and must have been received through the Direct Loan Program, which includes Parent PLUS loans. Doctors with non-qualifying student loans, such as Federal Family Education Loans, can become PSLF-eligible and have past time worked counted toward the requirements if they consolidate into a direct loan by December 31.

The California Medical Association (CMA) has an online guide to help doctors and employers navigate the new rules.

The change comes just in time because California and Texas need to expand their physician workforces by tens of thousands over the next decade. “This program will allow us to retain and recruit new physicians to our states to address our growing physician shortages and access to care challenges for the patients who need us most,” Texas Medical Association president Rick W. Snyder II, MD, said in a statement.

Physicians should use the PSLF Help Tool to complete the forgiveness application, said Ashley Harrington, senior advisor at the DOE. During a free on-demand webinar hosted by CMA, she said the form has been streamlined and will ask applicants to list the nonprofit entity where they provide care, its employer identification number, the length of time worked there, and the average hours worked per week. The employer must sign to certify the physician’s reported hours.

Ideally, physicians should submit a PSLF form annually or each time they change jobs, but they can also wait until the end of the 10 years to submit the form, said Ms. Harrington.

With the average medical education loan debt exceeding $200,000, CMA president Donaldo Hernandez, MD, said the rule will ensure low-income and minority students can consider medical careers.

California family medicine physician Ashley Paydar, DO, said that she has already applied for PSLF and found the process relatively easy. While she awaits final approval, she’s planning for the future. “Loan forgiveness will allow me to do a fellowship and save for my children›s college so they can pursue higher education without the debt,” she said.

Still, employers have no legal obligation to certify physicians’ hours, and many may express hesitation as they try to understand the new guidelines, said Long Do, JD, partner at Athene Law in San Francisco and speaker during the webinar. He urged physicians to have patience when working through the application process.

A version of this article appeared on Medscape.com.

A new federal rule opens the door for physicians in California and Texas to take advantage of student loan forgiveness, possibly bringing much-needed relief to those with cumbersome debt loads after repayments resumed last month. However, the timing is critical, as some doctors may need to consolidate their loans by December 31 to remain eligible.

Updated guidelines for the Public Service Loan Forgiveness Program (PSLF) took effect in July, expanding the number of potential borrowers who could have their federal student loan balances wiped clean after working full time in a government or nonprofit role and making 120 monthly loan payments.

But loan forgiveness also hinges on having the correct employment type and requires applicants to be a “direct hire” of the organization. State laws in California and Texas prohibit nonprofit hospitals and health care entities from directly hiring physicians — a loophole that has barred doctors in those locations from applying.

Both states’ medical and hospital associations worked with the US Department of Education (DOE) to offer an exception. California and Texas physicians can now satisfy the employment type condition by having a written contract or medical staff privileges with a nonprofit hospital or facility, even if the physician is part of a for-profit sole proprietorship, partnership, or medical group.

Eligible loans cannot be in default and must have been received through the Direct Loan Program, which includes Parent PLUS loans. Doctors with non-qualifying student loans, such as Federal Family Education Loans, can become PSLF-eligible and have past time worked counted toward the requirements if they consolidate into a direct loan by December 31.

The California Medical Association (CMA) has an online guide to help doctors and employers navigate the new rules.

The change comes just in time because California and Texas need to expand their physician workforces by tens of thousands over the next decade. “This program will allow us to retain and recruit new physicians to our states to address our growing physician shortages and access to care challenges for the patients who need us most,” Texas Medical Association president Rick W. Snyder II, MD, said in a statement.

Physicians should use the PSLF Help Tool to complete the forgiveness application, said Ashley Harrington, senior advisor at the DOE. During a free on-demand webinar hosted by CMA, she said the form has been streamlined and will ask applicants to list the nonprofit entity where they provide care, its employer identification number, the length of time worked there, and the average hours worked per week. The employer must sign to certify the physician’s reported hours.

Ideally, physicians should submit a PSLF form annually or each time they change jobs, but they can also wait until the end of the 10 years to submit the form, said Ms. Harrington.

With the average medical education loan debt exceeding $200,000, CMA president Donaldo Hernandez, MD, said the rule will ensure low-income and minority students can consider medical careers.

California family medicine physician Ashley Paydar, DO, said that she has already applied for PSLF and found the process relatively easy. While she awaits final approval, she’s planning for the future. “Loan forgiveness will allow me to do a fellowship and save for my children›s college so they can pursue higher education without the debt,” she said.

Still, employers have no legal obligation to certify physicians’ hours, and many may express hesitation as they try to understand the new guidelines, said Long Do, JD, partner at Athene Law in San Francisco and speaker during the webinar. He urged physicians to have patience when working through the application process.

A version of this article appeared on Medscape.com.

An analysis of 61 cities in the United States where employers allow paid work absences for preventive medical services, such as breast and colon cancer screenings, shows that having the option of paid leave does in fact influence one’s decision to have preventive cancer screenings.

“Our results provide evidence for policymakers considering legislative or regulatory solutions to address insufficient screening adherence and highlight an understudied benefit of expanding paid sick leave coverage,” wrote authors who were led by Kevin Callison, PhD, of the Tulane University School of Public Health and Tropical Medicine, New Orleans.

The findings were published earlier this year in the New England Journal of Medicine.

Despite an Affordable Care Act provision eliminating most cost-sharing for cancer screening, the rate for recommended breast and colorectal cancer screening among U.S. adults is lower than 70%. Work commitments, time constraints, and the prospect of lost wages are frequently cited as contributing factors to this underuse of preventive care. Researchers hypothesized that having paid sick leave coverage for the use of preventive services could improve adherence to cancer screening guidelines. With continued failure to pass a bill mandating federal paid sick leave legislation, nearly 30% of the nation’s workforce lacks this coverage. Rates are lower for low-income workers, women, and underserved racial and ethnic groups, the authors write.

Coverage mandates have become politically contentious, as evidenced by the fact that their passage by some states (n = 17), counties (n = 4) and cities (n = 18) has been met by many states (n = 18) passing preemption laws banning municipalities from adopting the laws.

In this study, researchers examined the rate of colorectal and breast cancer screening at 12- and 24-month intervals among people living in one of 61 cities. Before paid sick leave mandates were put in place, cancer screening rates were similar across the board. But once mandates were put in place, cancer screening rates were higher among workers affected by the mandate by 1.31% (95% confidence interval, 0.28-2.34) for 12-month colorectal cancer screening, 1.56% (95% CI, 0.33-2.79) for 24-month colorectal cancer screening, 1.22% (95% CI, −0.20 to 2.64) for 12-month mammography, and 2.07% (95% CI, 0.15-3.99) for 24-month mammography.

“Although these appear to be modest effects, spread across a large population, these indicate a fairly substantial gain in cancer screenings,” Dr. Callison said.

Prior studies showing positive associations between having paid sick leave coverage and whether someone receives cancer screenings are likely confounded by selection bias because they compare workers who have such coverage to those who do not, Dr. Callison and colleagues state in their paper.

“Although the lack of paid sick leave coverage may hinder access to preventive care, current evidence is insufficient to draw meaningful conclusions about its relationship to cancer screening,” the authors write, citing that particularly health conscious workers may take jobs offering sick leave coverage.

Through quasi-experimental design, the present study aimed to overcome such confounding issues. Its analytic sample, using administrative data from the Merative MarketScan Research Databases, encompassed approximately 2.5 million person-specific records per year for the colorectal cancer screening sample. The researchers’ mammography sample included 1.3 million person-specific records per year of the period examined.

The associations cited above translate into relative colorectal cancer screening increases of 8.1% in the 12-month adjusted model and a 5.9% relative increase from the premandate rate in the 24-month adjusted model. The rate was 1.56 percentage points (95% CI, 0.33-2.79) higher in the cities subject to the paid sick leave mandates (a 5.9% relative increase from the premandate rate). For screening mammography in the cities subject to the mandates, the 12-month adjusted 1.22% increase (95% CI, –0.20 to 2.64) represented a 2.5% relative increase from the premandate level. The adjusted 24-month rate increase of 2.07% (95% CI, 0.15-4.00) represented a 3.3% relative increase from premandate rates.

“However, these estimates are averages across all workers in our sample, many of whom likely already had paid sick leave coverage prior to the enactment of a mandate,” Dr. Callison said in the interview. “In fact, in other work related to this project, we estimated that about 28% of private sector workers gain paid sick leave when a mandate is enacted. So then, if we scale our findings by the share of workers actually gaining paid sick leave coverage, our estimates are much larger – a 9%-12% increase in screening mammography and a 21%-29% increase in colorectal cancer screening.”

Dr. Callison and his team are in the process of developing a follow-up proposal that would examine the effects of paid sick leave on downstream outcomes of the cancer care continuum, such as timing from diagnosis to treatment initiation. “We also hope to examine who benefits from these additional screens and what they mean for health equity. Data limitations prevented us from exploring that issue in the current study,” he said.

Dr. Callison had no conflicts associated with this study.

An analysis of 61 cities in the United States where employers allow paid work absences for preventive medical services, such as breast and colon cancer screenings, shows that having the option of paid leave does in fact influence one’s decision to have preventive cancer screenings.

“Our results provide evidence for policymakers considering legislative or regulatory solutions to address insufficient screening adherence and highlight an understudied benefit of expanding paid sick leave coverage,” wrote authors who were led by Kevin Callison, PhD, of the Tulane University School of Public Health and Tropical Medicine, New Orleans.

The findings were published earlier this year in the New England Journal of Medicine.

Despite an Affordable Care Act provision eliminating most cost-sharing for cancer screening, the rate for recommended breast and colorectal cancer screening among U.S. adults is lower than 70%. Work commitments, time constraints, and the prospect of lost wages are frequently cited as contributing factors to this underuse of preventive care. Researchers hypothesized that having paid sick leave coverage for the use of preventive services could improve adherence to cancer screening guidelines. With continued failure to pass a bill mandating federal paid sick leave legislation, nearly 30% of the nation’s workforce lacks this coverage. Rates are lower for low-income workers, women, and underserved racial and ethnic groups, the authors write.

Coverage mandates have become politically contentious, as evidenced by the fact that their passage by some states (n = 17), counties (n = 4) and cities (n = 18) has been met by many states (n = 18) passing preemption laws banning municipalities from adopting the laws.

In this study, researchers examined the rate of colorectal and breast cancer screening at 12- and 24-month intervals among people living in one of 61 cities. Before paid sick leave mandates were put in place, cancer screening rates were similar across the board. But once mandates were put in place, cancer screening rates were higher among workers affected by the mandate by 1.31% (95% confidence interval, 0.28-2.34) for 12-month colorectal cancer screening, 1.56% (95% CI, 0.33-2.79) for 24-month colorectal cancer screening, 1.22% (95% CI, −0.20 to 2.64) for 12-month mammography, and 2.07% (95% CI, 0.15-3.99) for 24-month mammography.

“Although these appear to be modest effects, spread across a large population, these indicate a fairly substantial gain in cancer screenings,” Dr. Callison said.

Prior studies showing positive associations between having paid sick leave coverage and whether someone receives cancer screenings are likely confounded by selection bias because they compare workers who have such coverage to those who do not, Dr. Callison and colleagues state in their paper.

“Although the lack of paid sick leave coverage may hinder access to preventive care, current evidence is insufficient to draw meaningful conclusions about its relationship to cancer screening,” the authors write, citing that particularly health conscious workers may take jobs offering sick leave coverage.

Through quasi-experimental design, the present study aimed to overcome such confounding issues. Its analytic sample, using administrative data from the Merative MarketScan Research Databases, encompassed approximately 2.5 million person-specific records per year for the colorectal cancer screening sample. The researchers’ mammography sample included 1.3 million person-specific records per year of the period examined.

The associations cited above translate into relative colorectal cancer screening increases of 8.1% in the 12-month adjusted model and a 5.9% relative increase from the premandate rate in the 24-month adjusted model. The rate was 1.56 percentage points (95% CI, 0.33-2.79) higher in the cities subject to the paid sick leave mandates (a 5.9% relative increase from the premandate rate). For screening mammography in the cities subject to the mandates, the 12-month adjusted 1.22% increase (95% CI, –0.20 to 2.64) represented a 2.5% relative increase from the premandate level. The adjusted 24-month rate increase of 2.07% (95% CI, 0.15-4.00) represented a 3.3% relative increase from premandate rates.

“However, these estimates are averages across all workers in our sample, many of whom likely already had paid sick leave coverage prior to the enactment of a mandate,” Dr. Callison said in the interview. “In fact, in other work related to this project, we estimated that about 28% of private sector workers gain paid sick leave when a mandate is enacted. So then, if we scale our findings by the share of workers actually gaining paid sick leave coverage, our estimates are much larger – a 9%-12% increase in screening mammography and a 21%-29% increase in colorectal cancer screening.”

Dr. Callison and his team are in the process of developing a follow-up proposal that would examine the effects of paid sick leave on downstream outcomes of the cancer care continuum, such as timing from diagnosis to treatment initiation. “We also hope to examine who benefits from these additional screens and what they mean for health equity. Data limitations prevented us from exploring that issue in the current study,” he said.

Dr. Callison had no conflicts associated with this study.

An analysis of 61 cities in the United States where employers allow paid work absences for preventive medical services, such as breast and colon cancer screenings, shows that having the option of paid leave does in fact influence one’s decision to have preventive cancer screenings.

“Our results provide evidence for policymakers considering legislative or regulatory solutions to address insufficient screening adherence and highlight an understudied benefit of expanding paid sick leave coverage,” wrote authors who were led by Kevin Callison, PhD, of the Tulane University School of Public Health and Tropical Medicine, New Orleans.

The findings were published earlier this year in the New England Journal of Medicine.

Despite an Affordable Care Act provision eliminating most cost-sharing for cancer screening, the rate for recommended breast and colorectal cancer screening among U.S. adults is lower than 70%. Work commitments, time constraints, and the prospect of lost wages are frequently cited as contributing factors to this underuse of preventive care. Researchers hypothesized that having paid sick leave coverage for the use of preventive services could improve adherence to cancer screening guidelines. With continued failure to pass a bill mandating federal paid sick leave legislation, nearly 30% of the nation’s workforce lacks this coverage. Rates are lower for low-income workers, women, and underserved racial and ethnic groups, the authors write.

Coverage mandates have become politically contentious, as evidenced by the fact that their passage by some states (n = 17), counties (n = 4) and cities (n = 18) has been met by many states (n = 18) passing preemption laws banning municipalities from adopting the laws.

In this study, researchers examined the rate of colorectal and breast cancer screening at 12- and 24-month intervals among people living in one of 61 cities. Before paid sick leave mandates were put in place, cancer screening rates were similar across the board. But once mandates were put in place, cancer screening rates were higher among workers affected by the mandate by 1.31% (95% confidence interval, 0.28-2.34) for 12-month colorectal cancer screening, 1.56% (95% CI, 0.33-2.79) for 24-month colorectal cancer screening, 1.22% (95% CI, −0.20 to 2.64) for 12-month mammography, and 2.07% (95% CI, 0.15-3.99) for 24-month mammography.

“Although these appear to be modest effects, spread across a large population, these indicate a fairly substantial gain in cancer screenings,” Dr. Callison said.

Prior studies showing positive associations between having paid sick leave coverage and whether someone receives cancer screenings are likely confounded by selection bias because they compare workers who have such coverage to those who do not, Dr. Callison and colleagues state in their paper.

“Although the lack of paid sick leave coverage may hinder access to preventive care, current evidence is insufficient to draw meaningful conclusions about its relationship to cancer screening,” the authors write, citing that particularly health conscious workers may take jobs offering sick leave coverage.

Through quasi-experimental design, the present study aimed to overcome such confounding issues. Its analytic sample, using administrative data from the Merative MarketScan Research Databases, encompassed approximately 2.5 million person-specific records per year for the colorectal cancer screening sample. The researchers’ mammography sample included 1.3 million person-specific records per year of the period examined.

The associations cited above translate into relative colorectal cancer screening increases of 8.1% in the 12-month adjusted model and a 5.9% relative increase from the premandate rate in the 24-month adjusted model. The rate was 1.56 percentage points (95% CI, 0.33-2.79) higher in the cities subject to the paid sick leave mandates (a 5.9% relative increase from the premandate rate). For screening mammography in the cities subject to the mandates, the 12-month adjusted 1.22% increase (95% CI, –0.20 to 2.64) represented a 2.5% relative increase from the premandate level. The adjusted 24-month rate increase of 2.07% (95% CI, 0.15-4.00) represented a 3.3% relative increase from premandate rates.

“However, these estimates are averages across all workers in our sample, many of whom likely already had paid sick leave coverage prior to the enactment of a mandate,” Dr. Callison said in the interview. “In fact, in other work related to this project, we estimated that about 28% of private sector workers gain paid sick leave when a mandate is enacted. So then, if we scale our findings by the share of workers actually gaining paid sick leave coverage, our estimates are much larger – a 9%-12% increase in screening mammography and a 21%-29% increase in colorectal cancer screening.”

Dr. Callison and his team are in the process of developing a follow-up proposal that would examine the effects of paid sick leave on downstream outcomes of the cancer care continuum, such as timing from diagnosis to treatment initiation. “We also hope to examine who benefits from these additional screens and what they mean for health equity. Data limitations prevented us from exploring that issue in the current study,” he said.

Dr. Callison had no conflicts associated with this study.

The increased risk for diabetes following COVID-19 infection has persisted into the Omicron era, but vaccination against SARS-CoV-2 appears to diminish that likelihood, new data suggest.

The findings, from more than 20,000 patients in the Cedars-Sinai Health System in Los Angeles, suggest that “continued efforts to prevent COVID-19 infection may be beneficial to patient health until we develop better understanding of the effects of potential long-term effects of COVID-19,” lead author Alan C. Kwan, MD, of the department of cardiology at Cedars Sinai’s Smidt Heart Institute, said in an interview.

Several studies conducted early in the pandemic suggested increased risks for both new-onset diabetes and cardiometabolic diseases following COVID-19 infection, possibly because of persistent inflammation contributing to insulin resistance.

However, it hasn’t been clear if those risks have persisted with the more recent predominance of the less-virulent Omicron variant or whether the COVID-19 vaccine influences the risk. This new study suggests that both are the case.

“Our results verify that the risk of developing type 2 diabetes after a COVID-19 infection was not just an early observation but, in fact, a real risk that has, unfortunately, persisted through the Omicron era,” Dr. Kwan noted.

“While the level of evidence by our study and others may not reach the degree needed to affect formal guidelines at this time, we believe it is reasonable to have increased clinical suspicion for diabetes after COVID-19 infection and a lower threshold for testing,” he added.

Moreover, “we believe that our study and others suggest the potential role of COVID-19 to affect cardiovascular risk, and so both prevention of COVID-19 infection, through reasonable personal practices and vaccination, and an increased attention to cardiovascular health after COVID-19 infection is warranted.”

The findings were published online in JAMA Network Open.

Dr. Kwan and colleagues analyzed data for a total of 23,709 patients treated (inpatient and outpatient) for at least one COVID-19 infection between March 2020 and June 2022.

Rates of new-onset diabetes (using ICD-10 codes, primarily type 2 diabetes), hypertension, and hyperlipidemia were all elevated in the 90 days following COVID-19 infection compared with the 90 days prior. The same was true of two diagnoses unrelated to COVID-19, urinary tract infection and gastroesophageal reflux, used as benchmarks of health care engagement.

The highest odds for post versus preinfection were for diabetes (odds ratio, 2.35; P < .001), followed by hypertension (OR, 1.54; P < .001), the benchmark diagnoses (OR, 1.42; P < .001), and hyperlipidemia (OR, 1.22; P = .03).

Following adjustments, the risk versus the benchmark conditions for new-onset diabetes before versus after COVID-19 was significantly elevated (OR, 1.58; P < .001), while the risks for hypertension and hyperlipidemia versus benchmark diagnoses were not (OR, 1.06; P = .52 and 0.91, P = .43, respectively).

The diabetes risk after versus before COVID-19 infection was higher among those who had not been vaccinated (OR, 1.78; P < .001), compared with those who had received the vaccine (OR, 1.07; P = .80).

However, there was no significant interaction between vaccination and diabetes diagnosis (P = .08). “For this reason, we believe our data are suggestive of a protective effect in the population who received vaccination prior to infection, but [this is] not definitive,” Dr. Kwan said.

There were no apparent interactions by age, sex, or pre-existing cardiovascular risk factors, including hypertension or hyperlipidemia. Age, sex, and timing of index infection regarding the Omicron variant were not associated with an increased risk of a new cardiometabolic diagnosis before or after COVID-19 infection in any of the models.

Dr. Kwan said in an interview: “We have continued to be surprised by the evolving understanding of the SARS-CoV-2 virus and the effects on human health. In the beginning of the pandemic it was framed as a purely respiratory virus, which we now know to be a severely limited description of all of its potential effects on the human body. We believe that our research and others raise a concern for increased cardiometabolic risk after COVID infection.”

He added that, “while knowledge is incomplete on this topic, we believe that clinical providers may wish to have a higher degree of suspicion for both diabetes and risk of future cardiac events in patients after COVID infection, and that continued efforts to prevent COVID infection may be beneficial to patient health until we develop better understanding of the potential long-term effects of COVID.”

This study was funded by the Erika J. Glazer Family Foundation, the Doris Duke Charitable Foundation, and grants from the National Institutes of Health. Dr. Kwan reported receiving grants from the Doris Duke Charitable Foundation during the conduct of the study.

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

The increased risk for diabetes following COVID-19 infection has persisted into the Omicron era, but vaccination against SARS-CoV-2 appears to diminish that likelihood, new data suggest.

The findings, from more than 20,000 patients in the Cedars-Sinai Health System in Los Angeles, suggest that “continued efforts to prevent COVID-19 infection may be beneficial to patient health until we develop better understanding of the effects of potential long-term effects of COVID-19,” lead author Alan C. Kwan, MD, of the department of cardiology at Cedars Sinai’s Smidt Heart Institute, said in an interview.

Several studies conducted early in the pandemic suggested increased risks for both new-onset diabetes and cardiometabolic diseases following COVID-19 infection, possibly because of persistent inflammation contributing to insulin resistance.

However, it hasn’t been clear if those risks have persisted with the more recent predominance of the less-virulent Omicron variant or whether the COVID-19 vaccine influences the risk. This new study suggests that both are the case.

“Our results verify that the risk of developing type 2 diabetes after a COVID-19 infection was not just an early observation but, in fact, a real risk that has, unfortunately, persisted through the Omicron era,” Dr. Kwan noted.

“While the level of evidence by our study and others may not reach the degree needed to affect formal guidelines at this time, we believe it is reasonable to have increased clinical suspicion for diabetes after COVID-19 infection and a lower threshold for testing,” he added.

Moreover, “we believe that our study and others suggest the potential role of COVID-19 to affect cardiovascular risk, and so both prevention of COVID-19 infection, through reasonable personal practices and vaccination, and an increased attention to cardiovascular health after COVID-19 infection is warranted.”

The findings were published online in JAMA Network Open.

Dr. Kwan and colleagues analyzed data for a total of 23,709 patients treated (inpatient and outpatient) for at least one COVID-19 infection between March 2020 and June 2022.

Rates of new-onset diabetes (using ICD-10 codes, primarily type 2 diabetes), hypertension, and hyperlipidemia were all elevated in the 90 days following COVID-19 infection compared with the 90 days prior. The same was true of two diagnoses unrelated to COVID-19, urinary tract infection and gastroesophageal reflux, used as benchmarks of health care engagement.

The highest odds for post versus preinfection were for diabetes (odds ratio, 2.35; P < .001), followed by hypertension (OR, 1.54; P < .001), the benchmark diagnoses (OR, 1.42; P < .001), and hyperlipidemia (OR, 1.22; P = .03).

Following adjustments, the risk versus the benchmark conditions for new-onset diabetes before versus after COVID-19 was significantly elevated (OR, 1.58; P < .001), while the risks for hypertension and hyperlipidemia versus benchmark diagnoses were not (OR, 1.06; P = .52 and 0.91, P = .43, respectively).

The diabetes risk after versus before COVID-19 infection was higher among those who had not been vaccinated (OR, 1.78; P < .001), compared with those who had received the vaccine (OR, 1.07; P = .80).

However, there was no significant interaction between vaccination and diabetes diagnosis (P = .08). “For this reason, we believe our data are suggestive of a protective effect in the population who received vaccination prior to infection, but [this is] not definitive,” Dr. Kwan said.

There were no apparent interactions by age, sex, or pre-existing cardiovascular risk factors, including hypertension or hyperlipidemia. Age, sex, and timing of index infection regarding the Omicron variant were not associated with an increased risk of a new cardiometabolic diagnosis before or after COVID-19 infection in any of the models.

Dr. Kwan said in an interview: “We have continued to be surprised by the evolving understanding of the SARS-CoV-2 virus and the effects on human health. In the beginning of the pandemic it was framed as a purely respiratory virus, which we now know to be a severely limited description of all of its potential effects on the human body. We believe that our research and others raise a concern for increased cardiometabolic risk after COVID infection.”

He added that, “while knowledge is incomplete on this topic, we believe that clinical providers may wish to have a higher degree of suspicion for both diabetes and risk of future cardiac events in patients after COVID infection, and that continued efforts to prevent COVID infection may be beneficial to patient health until we develop better understanding of the potential long-term effects of COVID.”

This study was funded by the Erika J. Glazer Family Foundation, the Doris Duke Charitable Foundation, and grants from the National Institutes of Health. Dr. Kwan reported receiving grants from the Doris Duke Charitable Foundation during the conduct of the study.

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

The increased risk for diabetes following COVID-19 infection has persisted into the Omicron era, but vaccination against SARS-CoV-2 appears to diminish that likelihood, new data suggest.

The findings, from more than 20,000 patients in the Cedars-Sinai Health System in Los Angeles, suggest that “continued efforts to prevent COVID-19 infection may be beneficial to patient health until we develop better understanding of the effects of potential long-term effects of COVID-19,” lead author Alan C. Kwan, MD, of the department of cardiology at Cedars Sinai’s Smidt Heart Institute, said in an interview.

Several studies conducted early in the pandemic suggested increased risks for both new-onset diabetes and cardiometabolic diseases following COVID-19 infection, possibly because of persistent inflammation contributing to insulin resistance.

However, it hasn’t been clear if those risks have persisted with the more recent predominance of the less-virulent Omicron variant or whether the COVID-19 vaccine influences the risk. This new study suggests that both are the case.

“Our results verify that the risk of developing type 2 diabetes after a COVID-19 infection was not just an early observation but, in fact, a real risk that has, unfortunately, persisted through the Omicron era,” Dr. Kwan noted.

“While the level of evidence by our study and others may not reach the degree needed to affect formal guidelines at this time, we believe it is reasonable to have increased clinical suspicion for diabetes after COVID-19 infection and a lower threshold for testing,” he added.

Moreover, “we believe that our study and others suggest the potential role of COVID-19 to affect cardiovascular risk, and so both prevention of COVID-19 infection, through reasonable personal practices and vaccination, and an increased attention to cardiovascular health after COVID-19 infection is warranted.”

The findings were published online in JAMA Network Open.

Dr. Kwan and colleagues analyzed data for a total of 23,709 patients treated (inpatient and outpatient) for at least one COVID-19 infection between March 2020 and June 2022.

Rates of new-onset diabetes (using ICD-10 codes, primarily type 2 diabetes), hypertension, and hyperlipidemia were all elevated in the 90 days following COVID-19 infection compared with the 90 days prior. The same was true of two diagnoses unrelated to COVID-19, urinary tract infection and gastroesophageal reflux, used as benchmarks of health care engagement.

The highest odds for post versus preinfection were for diabetes (odds ratio, 2.35; P < .001), followed by hypertension (OR, 1.54; P < .001), the benchmark diagnoses (OR, 1.42; P < .001), and hyperlipidemia (OR, 1.22; P = .03).

Following adjustments, the risk versus the benchmark conditions for new-onset diabetes before versus after COVID-19 was significantly elevated (OR, 1.58; P < .001), while the risks for hypertension and hyperlipidemia versus benchmark diagnoses were not (OR, 1.06; P = .52 and 0.91, P = .43, respectively).

The diabetes risk after versus before COVID-19 infection was higher among those who had not been vaccinated (OR, 1.78; P < .001), compared with those who had received the vaccine (OR, 1.07; P = .80).

However, there was no significant interaction between vaccination and diabetes diagnosis (P = .08). “For this reason, we believe our data are suggestive of a protective effect in the population who received vaccination prior to infection, but [this is] not definitive,” Dr. Kwan said.

There were no apparent interactions by age, sex, or pre-existing cardiovascular risk factors, including hypertension or hyperlipidemia. Age, sex, and timing of index infection regarding the Omicron variant were not associated with an increased risk of a new cardiometabolic diagnosis before or after COVID-19 infection in any of the models.

Dr. Kwan said in an interview: “We have continued to be surprised by the evolving understanding of the SARS-CoV-2 virus and the effects on human health. In the beginning of the pandemic it was framed as a purely respiratory virus, which we now know to be a severely limited description of all of its potential effects on the human body. We believe that our research and others raise a concern for increased cardiometabolic risk after COVID infection.”

He added that, “while knowledge is incomplete on this topic, we believe that clinical providers may wish to have a higher degree of suspicion for both diabetes and risk of future cardiac events in patients after COVID infection, and that continued efforts to prevent COVID infection may be beneficial to patient health until we develop better understanding of the potential long-term effects of COVID.”

This study was funded by the Erika J. Glazer Family Foundation, the Doris Duke Charitable Foundation, and grants from the National Institutes of Health. Dr. Kwan reported receiving grants from the Doris Duke Charitable Foundation during the conduct of the study.

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

Among men who have not been vaccinated against COVID-19, having low levels of testosterone may increase the risk of hospitalization from the disease – but hormone therapy appears to reduce the likelihood of severe COVID, researchers have found.

Low testosterone has long been linked to multiple chronic conditions, including obesity, heart disease, and type 2 diabetes, as well as acute conditions, such as heart attack and stroke. A study published earlier in the pandemic suggested that suppressing the sex hormone might protect against COVID-19. The new study, published in JAMA Network Open, is among the first to suggest a link between low testosterone and the risk for severe COVID.

Researchers at Washington University in St. Louis evaluated data from 723 unvaccinated men who had been infected with SARS-CoV-2. Of those, 116 had been diagnosed with hypogonadism, and 180 were receiving testosterone supplementation.

The study found that men whose testosterone levels were less than 200 ng/dL were 2.4 times more likely to experience a severe case of COVID-19 that required hospitalization than were those with normal levels of the hormone. The study accounted for the fact that participants with low testosterone were also more likely to have comorbidities such as diabetes and obesity.

Paresh Dandona, MD, PhD, distinguished professor of medicine and endocrinology at the State University of New York at Buffalo, called the findings “very exciting” and “fundamental.”

“In the world of hypogonadism, this is the first to show that low testosterone makes you vulnerable” to COVID, added Dr. Dandona, who was not involved with the research.

Men who were receiving hormone replacement therapy were at lower risk of hospitalization, compared with those who were not receiving treatment, the study found.

“Testosterone therapy seemed to negate the harmful effects of COVID,” said Sandeep Dhindsa, MD, an endocrinologist at Saint Louis University and lead author of the study.

Approximately 50% more men have died from confirmed COVID-19 than women since the start of the pandemic, according to the Sex, Gender and COVID-19 Project. Previous findings suggesting that sex may be a risk factor for death from COVID prompted researchers to consider whether hormones may play a role in the increased risk among men and whether treatments that suppress androgen levels could cut hospitalizations, but researchers consistently found that androgen suppression was not effective.

“There are other reasons women might be doing better – they may have followed public health guidelines a lot better,” according to Abhinav Diwan, MD, professor of medicine at Washington University in St. Louis, who helped conduct the new study. “It may be chromosomal and not necessarily just hormonal. The differences between men and women go beyond one factor.”

According to the researchers, the findings do not suggest that hormone therapy be used as a preventive measure against COVID.

“We don’t want patients to get excited and start to ask their doctors for testosterone,” Dr. Dhindsa said.

However, viewing low testosterone as a risk factor for COVID could be considered a shift in thinking for some clinicians, according to Dr. Dandana.

“All obese and all [men with] type 2 diabetes should be tested for testosterone, which is the practice in my clinic right now, even if they have no symptoms,” Dr. Dandana said. “Certainly, those with symptoms [of low testosterone] but no diagnosis, they should be tested, too.”

Participants in the study were infected with SARS-CoV-2 early in 2020, before vaccines were available. The researchers did not assess whether the rate of hospitalizations among participants with low testosterone would be different had they been vaccinated.

“Whatever benefits we saw with testosterone might be minor compared to getting the vaccine,” Dr. Dhindsa said.

Dr. Diwan agreed. “COVID hospitalization continues to be a problem, the strains are evolving, and new vaccines are coming in,” he said. “The bottom line is to get vaccinated.”

Dr. Dhindsa has received personal fees from Bayer and Acerus Pharmaceuticals and grants from Clarus Therapeutics outside the submitted work. Dr. Diwan has served as a consultant for the interpretation of echocardiograms for clinical trials for Clario (previously ERT) and has received nonfinancial support from Dewpoint Therapeutics outside the submitted work. Dr. Dandana has disclosed no relevant financial relationships.

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

Among men who have not been vaccinated against COVID-19, having low levels of testosterone may increase the risk of hospitalization from the disease – but hormone therapy appears to reduce the likelihood of severe COVID, researchers have found.

Low testosterone has long been linked to multiple chronic conditions, including obesity, heart disease, and type 2 diabetes, as well as acute conditions, such as heart attack and stroke. A study published earlier in the pandemic suggested that suppressing the sex hormone might protect against COVID-19. The new study, published in JAMA Network Open, is among the first to suggest a link between low testosterone and the risk for severe COVID.

Researchers at Washington University in St. Louis evaluated data from 723 unvaccinated men who had been infected with SARS-CoV-2. Of those, 116 had been diagnosed with hypogonadism, and 180 were receiving testosterone supplementation.

The study found that men whose testosterone levels were less than 200 ng/dL were 2.4 times more likely to experience a severe case of COVID-19 that required hospitalization than were those with normal levels of the hormone. The study accounted for the fact that participants with low testosterone were also more likely to have comorbidities such as diabetes and obesity.

Paresh Dandona, MD, PhD, distinguished professor of medicine and endocrinology at the State University of New York at Buffalo, called the findings “very exciting” and “fundamental.”

“In the world of hypogonadism, this is the first to show that low testosterone makes you vulnerable” to COVID, added Dr. Dandona, who was not involved with the research.

Men who were receiving hormone replacement therapy were at lower risk of hospitalization, compared with those who were not receiving treatment, the study found.

“Testosterone therapy seemed to negate the harmful effects of COVID,” said Sandeep Dhindsa, MD, an endocrinologist at Saint Louis University and lead author of the study.

Approximately 50% more men have died from confirmed COVID-19 than women since the start of the pandemic, according to the Sex, Gender and COVID-19 Project. Previous findings suggesting that sex may be a risk factor for death from COVID prompted researchers to consider whether hormones may play a role in the increased risk among men and whether treatments that suppress androgen levels could cut hospitalizations, but researchers consistently found that androgen suppression was not effective.

“There are other reasons women might be doing better – they may have followed public health guidelines a lot better,” according to Abhinav Diwan, MD, professor of medicine at Washington University in St. Louis, who helped conduct the new study. “It may be chromosomal and not necessarily just hormonal. The differences between men and women go beyond one factor.”

According to the researchers, the findings do not suggest that hormone therapy be used as a preventive measure against COVID.

“We don’t want patients to get excited and start to ask their doctors for testosterone,” Dr. Dhindsa said.

However, viewing low testosterone as a risk factor for COVID could be considered a shift in thinking for some clinicians, according to Dr. Dandana.

“All obese and all [men with] type 2 diabetes should be tested for testosterone, which is the practice in my clinic right now, even if they have no symptoms,” Dr. Dandana said. “Certainly, those with symptoms [of low testosterone] but no diagnosis, they should be tested, too.”

Participants in the study were infected with SARS-CoV-2 early in 2020, before vaccines were available. The researchers did not assess whether the rate of hospitalizations among participants with low testosterone would be different had they been vaccinated.

“Whatever benefits we saw with testosterone might be minor compared to getting the vaccine,” Dr. Dhindsa said.

Dr. Diwan agreed. “COVID hospitalization continues to be a problem, the strains are evolving, and new vaccines are coming in,” he said. “The bottom line is to get vaccinated.”

Dr. Dhindsa has received personal fees from Bayer and Acerus Pharmaceuticals and grants from Clarus Therapeutics outside the submitted work. Dr. Diwan has served as a consultant for the interpretation of echocardiograms for clinical trials for Clario (previously ERT) and has received nonfinancial support from Dewpoint Therapeutics outside the submitted work. Dr. Dandana has disclosed no relevant financial relationships.

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

Among men who have not been vaccinated against COVID-19, having low levels of testosterone may increase the risk of hospitalization from the disease – but hormone therapy appears to reduce the likelihood of severe COVID, researchers have found.

Low testosterone has long been linked to multiple chronic conditions, including obesity, heart disease, and type 2 diabetes, as well as acute conditions, such as heart attack and stroke. A study published earlier in the pandemic suggested that suppressing the sex hormone might protect against COVID-19. The new study, published in JAMA Network Open, is among the first to suggest a link between low testosterone and the risk for severe COVID.

Researchers at Washington University in St. Louis evaluated data from 723 unvaccinated men who had been infected with SARS-CoV-2. Of those, 116 had been diagnosed with hypogonadism, and 180 were receiving testosterone supplementation.

The study found that men whose testosterone levels were less than 200 ng/dL were 2.4 times more likely to experience a severe case of COVID-19 that required hospitalization than were those with normal levels of the hormone. The study accounted for the fact that participants with low testosterone were also more likely to have comorbidities such as diabetes and obesity.

Paresh Dandona, MD, PhD, distinguished professor of medicine and endocrinology at the State University of New York at Buffalo, called the findings “very exciting” and “fundamental.”

“In the world of hypogonadism, this is the first to show that low testosterone makes you vulnerable” to COVID, added Dr. Dandona, who was not involved with the research.

Men who were receiving hormone replacement therapy were at lower risk of hospitalization, compared with those who were not receiving treatment, the study found.

“Testosterone therapy seemed to negate the harmful effects of COVID,” said Sandeep Dhindsa, MD, an endocrinologist at Saint Louis University and lead author of the study.

Approximately 50% more men have died from confirmed COVID-19 than women since the start of the pandemic, according to the Sex, Gender and COVID-19 Project. Previous findings suggesting that sex may be a risk factor for death from COVID prompted researchers to consider whether hormones may play a role in the increased risk among men and whether treatments that suppress androgen levels could cut hospitalizations, but researchers consistently found that androgen suppression was not effective.

“There are other reasons women might be doing better – they may have followed public health guidelines a lot better,” according to Abhinav Diwan, MD, professor of medicine at Washington University in St. Louis, who helped conduct the new study. “It may be chromosomal and not necessarily just hormonal. The differences between men and women go beyond one factor.”

According to the researchers, the findings do not suggest that hormone therapy be used as a preventive measure against COVID.

“We don’t want patients to get excited and start to ask their doctors for testosterone,” Dr. Dhindsa said.

However, viewing low testosterone as a risk factor for COVID could be considered a shift in thinking for some clinicians, according to Dr. Dandana.

“All obese and all [men with] type 2 diabetes should be tested for testosterone, which is the practice in my clinic right now, even if they have no symptoms,” Dr. Dandana said. “Certainly, those with symptoms [of low testosterone] but no diagnosis, they should be tested, too.”

Participants in the study were infected with SARS-CoV-2 early in 2020, before vaccines were available. The researchers did not assess whether the rate of hospitalizations among participants with low testosterone would be different had they been vaccinated.

“Whatever benefits we saw with testosterone might be minor compared to getting the vaccine,” Dr. Dhindsa said.

Dr. Diwan agreed. “COVID hospitalization continues to be a problem, the strains are evolving, and new vaccines are coming in,” he said. “The bottom line is to get vaccinated.”

Dr. Dhindsa has received personal fees from Bayer and Acerus Pharmaceuticals and grants from Clarus Therapeutics outside the submitted work. Dr. Diwan has served as a consultant for the interpretation of echocardiograms for clinical trials for Clario (previously ERT) and has received nonfinancial support from Dewpoint Therapeutics outside the submitted work. Dr. Dandana has disclosed no relevant financial relationships.

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

A complaint filed with the U.S. Department of Justice (DOJ) alleges that Alabama’s Medicaid program is illegally denying curative drug treatment for hepatitis C virus (HCV) infection to people with substance use disorder.

The complaint was filed May 9 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School, in partnership with AIDS Alabama.

It alleges that Alabama Medicaid has a policy of denying HCV treatment to people who have used illegal drugs or alcohol in the past 6 months.

CHLPI and AIDS Alabama argue that these restrictions violate the Americans With Disabilities Act, which protects people who are disabled because of substance use disorder.

“Forced sobriety policies don’t just unfairly prevent people with substance use disorder from accessing life-saving treatment; they also severely hamper public health efforts to stop the spread of the disease,” Kevin Costello, CHLPI’s litigation director, said in a statement.

“These policies are rooted in stigma, not science, and they violate antidiscrimination provisions of the Americans With Disabilities Act,” Mr. Costello said.

Filing an administrative complaint against Alabama is “an important milestone in fighting sobriety restrictions,” he added.
 

Morally wrong

Kathie Hiers, CEO of AIDS Alabama, noted that Alabama’s health outcomes are among the worst in the nation.

“Policies that prevent adequate medical care from being provided must end. HCV now has a cure, and withholding that cure from Alabamians based on a moral judgment is wrong and certainly doesn’t follow the science,” Ms. Hiers added.

Direct-acting antiviral (DAA) therapy can cure up to 99% of people living with HCV.

The complaint against Alabama Medicaid builds on CHLPI’s successful policy advocacy and litigation campaigns to expand access to DAA therapy in state Medicaid programs across the country.

Since 2017, 19 states have removed treatment restrictions that were based on drug or alcohol use. In other states, however, “severe, illegal sobriety restrictions remain,” according to CHLPI.

Alabama, Mississippi, Arkansas, South Carolina, and South Dakota still require Medicaid enrollees with HCV to prove they have not used drugs or alcohol for 6 months before they can receive treatment. Iowa, North Dakota, and West Virginia have a 3-month abstinence requirement.

The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend DAA therapy for all patients with chronic HCV infection, regardless of drug or alcohol use.

CHLPI intends to expand this “enforcement campaign” to all states where sobriety restrictions persist.

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

A complaint filed with the U.S. Department of Justice (DOJ) alleges that Alabama’s Medicaid program is illegally denying curative drug treatment for hepatitis C virus (HCV) infection to people with substance use disorder.

The complaint was filed May 9 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School, in partnership with AIDS Alabama.

It alleges that Alabama Medicaid has a policy of denying HCV treatment to people who have used illegal drugs or alcohol in the past 6 months.

CHLPI and AIDS Alabama argue that these restrictions violate the Americans With Disabilities Act, which protects people who are disabled because of substance use disorder.

“Forced sobriety policies don’t just unfairly prevent people with substance use disorder from accessing life-saving treatment; they also severely hamper public health efforts to stop the spread of the disease,” Kevin Costello, CHLPI’s litigation director, said in a statement.

“These policies are rooted in stigma, not science, and they violate antidiscrimination provisions of the Americans With Disabilities Act,” Mr. Costello said.

Filing an administrative complaint against Alabama is “an important milestone in fighting sobriety restrictions,” he added.
 

Morally wrong

Kathie Hiers, CEO of AIDS Alabama, noted that Alabama’s health outcomes are among the worst in the nation.

“Policies that prevent adequate medical care from being provided must end. HCV now has a cure, and withholding that cure from Alabamians based on a moral judgment is wrong and certainly doesn’t follow the science,” Ms. Hiers added.

Direct-acting antiviral (DAA) therapy can cure up to 99% of people living with HCV.

The complaint against Alabama Medicaid builds on CHLPI’s successful policy advocacy and litigation campaigns to expand access to DAA therapy in state Medicaid programs across the country.

Since 2017, 19 states have removed treatment restrictions that were based on drug or alcohol use. In other states, however, “severe, illegal sobriety restrictions remain,” according to CHLPI.

Alabama, Mississippi, Arkansas, South Carolina, and South Dakota still require Medicaid enrollees with HCV to prove they have not used drugs or alcohol for 6 months before they can receive treatment. Iowa, North Dakota, and West Virginia have a 3-month abstinence requirement.

The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend DAA therapy for all patients with chronic HCV infection, regardless of drug or alcohol use.

CHLPI intends to expand this “enforcement campaign” to all states where sobriety restrictions persist.

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

A complaint filed with the U.S. Department of Justice (DOJ) alleges that Alabama’s Medicaid program is illegally denying curative drug treatment for hepatitis C virus (HCV) infection to people with substance use disorder.

The complaint was filed May 9 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School, in partnership with AIDS Alabama.

It alleges that Alabama Medicaid has a policy of denying HCV treatment to people who have used illegal drugs or alcohol in the past 6 months.

CHLPI and AIDS Alabama argue that these restrictions violate the Americans With Disabilities Act, which protects people who are disabled because of substance use disorder.

“Forced sobriety policies don’t just unfairly prevent people with substance use disorder from accessing life-saving treatment; they also severely hamper public health efforts to stop the spread of the disease,” Kevin Costello, CHLPI’s litigation director, said in a statement.

“These policies are rooted in stigma, not science, and they violate antidiscrimination provisions of the Americans With Disabilities Act,” Mr. Costello said.

Filing an administrative complaint against Alabama is “an important milestone in fighting sobriety restrictions,” he added.
 

Morally wrong

Kathie Hiers, CEO of AIDS Alabama, noted that Alabama’s health outcomes are among the worst in the nation.

“Policies that prevent adequate medical care from being provided must end. HCV now has a cure, and withholding that cure from Alabamians based on a moral judgment is wrong and certainly doesn’t follow the science,” Ms. Hiers added.

Direct-acting antiviral (DAA) therapy can cure up to 99% of people living with HCV.

The complaint against Alabama Medicaid builds on CHLPI’s successful policy advocacy and litigation campaigns to expand access to DAA therapy in state Medicaid programs across the country.

Since 2017, 19 states have removed treatment restrictions that were based on drug or alcohol use. In other states, however, “severe, illegal sobriety restrictions remain,” according to CHLPI.

Alabama, Mississippi, Arkansas, South Carolina, and South Dakota still require Medicaid enrollees with HCV to prove they have not used drugs or alcohol for 6 months before they can receive treatment. Iowa, North Dakota, and West Virginia have a 3-month abstinence requirement.

The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend DAA therapy for all patients with chronic HCV infection, regardless of drug or alcohol use.

CHLPI intends to expand this “enforcement campaign” to all states where sobriety restrictions persist.

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

Emergency responders to the World Trade Center (WTC) attack in 2001 paid a significant physical cost for their service in the form of exposure to chemicals, dust, and airborne particulates causally linked to hepatotoxicity. As we near the 20th anniversary of these attacks, researchers have determined that those responders who arrived at the WTC site earlier have a significantly higher prevalence of hepatic steatosis compared with those who arrived in the days that followed.

911_Firefighters_resting_web.jpg

“This research is some of the first to suggest that there may be a link between the amount of exposure experienced by responders to the WTC site and the higher likelihood of excessive accumulation of fat in their livers,” study author Artit Jirapatnakul, PhD, of Icahn School of Medicine at Mount Sinai, New York, said in an interview. These findings were published in the American Journal of Industrial Medicine.

Jiraptnakul_Artit_NY_web.jpg

The excessive accumulation of liver fat is an indicator of liver injury, which can also predict subsequent future disease, such as cirrhosis, liver failure, and liver cancer.

Dr. Jirapatnakul said that arrival time to the WTC disaster may prove an important factor for predicting the risk of liver disease in this population and directing treatment to them accordingly.

“By identifying individuals with markers of liver injury, such as excess fat, we can offer referral to liver specialists and thereby open the door to early treatment,” he said.

“Our most important message is that many liver diseases can be treated if caught early,” Dr. Jirapatnakul added. “Early detection requires proactive monitoring because most liver diseases have few, if any, symptoms during the early stages.”

More than 20,000 men and women who responded to the WTC site on Sept. 11, 2001, were exposed to particulate matter and chemicals known to cause liver damage and increase the risk of toxicant‐associated fatty liver disease. These responders have been offered screening and treatment of different conditions associated with the attack, including CT lung cancer screening for those meeting age and smoking status criteria.
 

Measuring the impact of response time on the liver

To investigate the dose-response association between WTC site exposure intensity and the risk of hepatic steatosis, Dr. Jirapatnakul and colleagues reviewed low-dose CT chest scans of all participants in the WTC General Responders Cohort (GRC) who had available laboratory data within a 12-month period from their first scan following the Sept. 11, 2001, attack. Only CT chest scans performed between Sept. 11, 2001, and Dec. 31, 2018, were collected and reviewed in the study.

A total of 1,788 WTC responders were included (83.7% were male; mean age at time of attack, 42.5 years). Up to 56% of WTC responders in the study were White, and 20.4% of responders were current smokers. The mean body mass index of the group was 30.1 kg/m².

The investigators stratified dust exposure into five groups according to when the responders arrived at the WTC site: Sept. 11, 2001, in the dust cloud; Sept. 11, no dust cloud (same-day arrival); Sept. 12 or 13 (second‐ and third‐day arrival); Sept. 14 to the end of September (fourth‐day arrival); and October and beyond.

The median duration between Sept. 11, 2001, and the earliest available CT scan was 11.3 years. Liver density was measured via Statistics‐based Liver Density Estimation from Imaging, a previously validated algorithm, with a slice thickness of 1.25 mm or below. On their earliest CT, approximately 14.4% (n = 258) of responders had liver attenuation < 40 Hounsfield units (HU). The prevalence of liver attenuation < 40 HU was 17% for responders who arrived on the day of the attack, 16% for responders who arrived at the site on Sept. 12 or 13, 10.9% for responders who arrived Sept. 14 through 30, and 9% for responders who arrived at the WTC site on Oct. 1, 2001, or later (P =.0015).

There was a statistically significant trend of increasing liver steatosis with earlier times of arrival (P <.0001). The WTC arrival time retained its status as a significant independent factor for decreased liver attenuation in an analysis adjusted for sex, age, race, smoking status, alcohol use, body mass index, diabetes, gastroesophageal reflux disease, and forced expiratory volume in 1 second.

Dr. Jirapatnakul said that the next step will be to determine whether WTC responders with excessive liver fat also have increased liver scarring. In addition, he and his colleagues are working to establish a registry to collect information on the impact of liver disease as it relates to quality of life in members of the WTC GRC.
 

Importance of disease severity

Another direction of future research will be to differentiate between those with only hepatic steatosis, those with inflammation from hepatic steatosis (steatohepatitis), and those with hepatic fibrosis which is the most concerning outcome from fatty liver diseases, according to Albert Do, MD, clinical director of the fatty liver disease program at Yale University, New Haven, Conn.

“It is the latter group of patients which we are most concerned about, given this is the group at highest risk for harm from liver disease,” added Dr. Do, who wasn’t involved in the research study. “The degree of steatosis is not closely linked with subsequent inflammation nor hepatic fibrosis, and so linkage of disease severity to specific occupational exposures and timing is needed to determine the allocation of support for patients who had suffered harm from fatty liver disease.”

Dr. Do noted that additional research will also need to identify the specific exposure that may be causing hepatic steatosis in early WTC responders. “Currently, only a small number of medications are known to cause this,” he explained, “and thus such knowledge will help us further understand occupational exposures and their associated risks.”

The researchers received study funding from the National Institute for Occupational Safety and Health. They disclosed conflicts of interest with Genentech, AstraZeneca, Pfizer, Bayer Healthcare, Gilead Sciences, and Boehringer Ingelheim. Dr. Do had no conflicts to declare.

Emergency responders to the World Trade Center (WTC) attack in 2001 paid a significant physical cost for their service in the form of exposure to chemicals, dust, and airborne particulates causally linked to hepatotoxicity. As we near the 20th anniversary of these attacks, researchers have determined that those responders who arrived at the WTC site earlier have a significantly higher prevalence of hepatic steatosis compared with those who arrived in the days that followed.

911_Firefighters_resting_web.jpg

“This research is some of the first to suggest that there may be a link between the amount of exposure experienced by responders to the WTC site and the higher likelihood of excessive accumulation of fat in their livers,” study author Artit Jirapatnakul, PhD, of Icahn School of Medicine at Mount Sinai, New York, said in an interview. These findings were published in the American Journal of Industrial Medicine.

Jiraptnakul_Artit_NY_web.jpg

The excessive accumulation of liver fat is an indicator of liver injury, which can also predict subsequent future disease, such as cirrhosis, liver failure, and liver cancer.

Dr. Jirapatnakul said that arrival time to the WTC disaster may prove an important factor for predicting the risk of liver disease in this population and directing treatment to them accordingly.

“By identifying individuals with markers of liver injury, such as excess fat, we can offer referral to liver specialists and thereby open the door to early treatment,” he said.

“Our most important message is that many liver diseases can be treated if caught early,” Dr. Jirapatnakul added. “Early detection requires proactive monitoring because most liver diseases have few, if any, symptoms during the early stages.”

More than 20,000 men and women who responded to the WTC site on Sept. 11, 2001, were exposed to particulate matter and chemicals known to cause liver damage and increase the risk of toxicant‐associated fatty liver disease. These responders have been offered screening and treatment of different conditions associated with the attack, including CT lung cancer screening for those meeting age and smoking status criteria.
 

Measuring the impact of response time on the liver

To investigate the dose-response association between WTC site exposure intensity and the risk of hepatic steatosis, Dr. Jirapatnakul and colleagues reviewed low-dose CT chest scans of all participants in the WTC General Responders Cohort (GRC) who had available laboratory data within a 12-month period from their first scan following the Sept. 11, 2001, attack. Only CT chest scans performed between Sept. 11, 2001, and Dec. 31, 2018, were collected and reviewed in the study.

A total of 1,788 WTC responders were included (83.7% were male; mean age at time of attack, 42.5 years). Up to 56% of WTC responders in the study were White, and 20.4% of responders were current smokers. The mean body mass index of the group was 30.1 kg/m².

The investigators stratified dust exposure into five groups according to when the responders arrived at the WTC site: Sept. 11, 2001, in the dust cloud; Sept. 11, no dust cloud (same-day arrival); Sept. 12 or 13 (second‐ and third‐day arrival); Sept. 14 to the end of September (fourth‐day arrival); and October and beyond.

The median duration between Sept. 11, 2001, and the earliest available CT scan was 11.3 years. Liver density was measured via Statistics‐based Liver Density Estimation from Imaging, a previously validated algorithm, with a slice thickness of 1.25 mm or below. On their earliest CT, approximately 14.4% (n = 258) of responders had liver attenuation < 40 Hounsfield units (HU). The prevalence of liver attenuation < 40 HU was 17% for responders who arrived on the day of the attack, 16% for responders who arrived at the site on Sept. 12 or 13, 10.9% for responders who arrived Sept. 14 through 30, and 9% for responders who arrived at the WTC site on Oct. 1, 2001, or later (P =.0015).

There was a statistically significant trend of increasing liver steatosis with earlier times of arrival (P <.0001). The WTC arrival time retained its status as a significant independent factor for decreased liver attenuation in an analysis adjusted for sex, age, race, smoking status, alcohol use, body mass index, diabetes, gastroesophageal reflux disease, and forced expiratory volume in 1 second.

Dr. Jirapatnakul said that the next step will be to determine whether WTC responders with excessive liver fat also have increased liver scarring. In addition, he and his colleagues are working to establish a registry to collect information on the impact of liver disease as it relates to quality of life in members of the WTC GRC.
 

Importance of disease severity

Another direction of future research will be to differentiate between those with only hepatic steatosis, those with inflammation from hepatic steatosis (steatohepatitis), and those with hepatic fibrosis which is the most concerning outcome from fatty liver diseases, according to Albert Do, MD, clinical director of the fatty liver disease program at Yale University, New Haven, Conn.

“It is the latter group of patients which we are most concerned about, given this is the group at highest risk for harm from liver disease,” added Dr. Do, who wasn’t involved in the research study. “The degree of steatosis is not closely linked with subsequent inflammation nor hepatic fibrosis, and so linkage of disease severity to specific occupational exposures and timing is needed to determine the allocation of support for patients who had suffered harm from fatty liver disease.”

Dr. Do noted that additional research will also need to identify the specific exposure that may be causing hepatic steatosis in early WTC responders. “Currently, only a small number of medications are known to cause this,” he explained, “and thus such knowledge will help us further understand occupational exposures and their associated risks.”

The researchers received study funding from the National Institute for Occupational Safety and Health. They disclosed conflicts of interest with Genentech, AstraZeneca, Pfizer, Bayer Healthcare, Gilead Sciences, and Boehringer Ingelheim. Dr. Do had no conflicts to declare.

Emergency responders to the World Trade Center (WTC) attack in 2001 paid a significant physical cost for their service in the form of exposure to chemicals, dust, and airborne particulates causally linked to hepatotoxicity. As we near the 20th anniversary of these attacks, researchers have determined that those responders who arrived at the WTC site earlier have a significantly higher prevalence of hepatic steatosis compared with those who arrived in the days that followed.

911_Firefighters_resting_web.jpg

“This research is some of the first to suggest that there may be a link between the amount of exposure experienced by responders to the WTC site and the higher likelihood of excessive accumulation of fat in their livers,” study author Artit Jirapatnakul, PhD, of Icahn School of Medicine at Mount Sinai, New York, said in an interview. These findings were published in the American Journal of Industrial Medicine.

Jiraptnakul_Artit_NY_web.jpg

The excessive accumulation of liver fat is an indicator of liver injury, which can also predict subsequent future disease, such as cirrhosis, liver failure, and liver cancer.

Dr. Jirapatnakul said that arrival time to the WTC disaster may prove an important factor for predicting the risk of liver disease in this population and directing treatment to them accordingly.

“By identifying individuals with markers of liver injury, such as excess fat, we can offer referral to liver specialists and thereby open the door to early treatment,” he said.

“Our most important message is that many liver diseases can be treated if caught early,” Dr. Jirapatnakul added. “Early detection requires proactive monitoring because most liver diseases have few, if any, symptoms during the early stages.”

More than 20,000 men and women who responded to the WTC site on Sept. 11, 2001, were exposed to particulate matter and chemicals known to cause liver damage and increase the risk of toxicant‐associated fatty liver disease. These responders have been offered screening and treatment of different conditions associated with the attack, including CT lung cancer screening for those meeting age and smoking status criteria.
 

Measuring the impact of response time on the liver

To investigate the dose-response association between WTC site exposure intensity and the risk of hepatic steatosis, Dr. Jirapatnakul and colleagues reviewed low-dose CT chest scans of all participants in the WTC General Responders Cohort (GRC) who had available laboratory data within a 12-month period from their first scan following the Sept. 11, 2001, attack. Only CT chest scans performed between Sept. 11, 2001, and Dec. 31, 2018, were collected and reviewed in the study.

A total of 1,788 WTC responders were included (83.7% were male; mean age at time of attack, 42.5 years). Up to 56% of WTC responders in the study were White, and 20.4% of responders were current smokers. The mean body mass index of the group was 30.1 kg/m².

The investigators stratified dust exposure into five groups according to when the responders arrived at the WTC site: Sept. 11, 2001, in the dust cloud; Sept. 11, no dust cloud (same-day arrival); Sept. 12 or 13 (second‐ and third‐day arrival); Sept. 14 to the end of September (fourth‐day arrival); and October and beyond.

The median duration between Sept. 11, 2001, and the earliest available CT scan was 11.3 years. Liver density was measured via Statistics‐based Liver Density Estimation from Imaging, a previously validated algorithm, with a slice thickness of 1.25 mm or below. On their earliest CT, approximately 14.4% (n = 258) of responders had liver attenuation < 40 Hounsfield units (HU). The prevalence of liver attenuation < 40 HU was 17% for responders who arrived on the day of the attack, 16% for responders who arrived at the site on Sept. 12 or 13, 10.9% for responders who arrived Sept. 14 through 30, and 9% for responders who arrived at the WTC site on Oct. 1, 2001, or later (P =.0015).

There was a statistically significant trend of increasing liver steatosis with earlier times of arrival (P <.0001). The WTC arrival time retained its status as a significant independent factor for decreased liver attenuation in an analysis adjusted for sex, age, race, smoking status, alcohol use, body mass index, diabetes, gastroesophageal reflux disease, and forced expiratory volume in 1 second.

Dr. Jirapatnakul said that the next step will be to determine whether WTC responders with excessive liver fat also have increased liver scarring. In addition, he and his colleagues are working to establish a registry to collect information on the impact of liver disease as it relates to quality of life in members of the WTC GRC.
 

Importance of disease severity

Another direction of future research will be to differentiate between those with only hepatic steatosis, those with inflammation from hepatic steatosis (steatohepatitis), and those with hepatic fibrosis which is the most concerning outcome from fatty liver diseases, according to Albert Do, MD, clinical director of the fatty liver disease program at Yale University, New Haven, Conn.

“It is the latter group of patients which we are most concerned about, given this is the group at highest risk for harm from liver disease,” added Dr. Do, who wasn’t involved in the research study. “The degree of steatosis is not closely linked with subsequent inflammation nor hepatic fibrosis, and so linkage of disease severity to specific occupational exposures and timing is needed to determine the allocation of support for patients who had suffered harm from fatty liver disease.”

Dr. Do noted that additional research will also need to identify the specific exposure that may be causing hepatic steatosis in early WTC responders. “Currently, only a small number of medications are known to cause this,” he explained, “and thus such knowledge will help us further understand occupational exposures and their associated risks.”

The researchers received study funding from the National Institute for Occupational Safety and Health. They disclosed conflicts of interest with Genentech, AstraZeneca, Pfizer, Bayer Healthcare, Gilead Sciences, and Boehringer Ingelheim. Dr. Do had no conflicts to declare.

Question: Mr. M, a car mechanic, was treated with long-term ACTH and Kenalog after he developed severe contact dermatitis from daily exposure to petroleum-based solvents. His subsequent course was complicated by cataracts and osteoporosis. Which of the following is true in case he files a malpractice action?



A. Treatment with steroids was medically indicated for Mr. Mechanic’s dermatologic condition, so the doctor could not have breached the standard of care.

B. Under the “Learned Intermediary” doctrine, both the manufacturer and the prescribing doctor are jointly liable.

C. Corticosteroids are a known cause of osteoporosis and other complications, but not of cataracts, so that part of the malpractice action should be thrown out.

D. The plaintiff would prevail even if he could not find an expert witnesses to testify as to standard of care, since it is “common knowledge” that steroids cause osteoporosis.

E. Lack of informed consent may be his best legal theory of liability, as many jurisdictions now use the patient-centered standard, which does not require expert testimony.



Answer: E. The above hypothetical was modified from an old Montana case¹ in which the patient failed in his negligence lawsuit because he did not have expert witnesses to testify as to standard of care and to adequacy of warning label. However, in some jurisdictions under today’s case law, informed consent relies on a subjective, i.e., patient-oriented standard, and expert testimony is unnecessary to prove breach of duty, although still needed to prove causation.
 

Steroid-related litigation

Steroid-related malpractice litigation is quite prevalent. In a retrospective study of a tertiary medical center from 1996 to 2008, Nash and coworkers identified 83 such cases.² Steroids were prescribed for pain (23%), asthma or another pulmonary condition (20%), a dermatologic condition (18%), an autoimmune condition (17%), or allergies (6%).

Tan_Siang_Yong_web.jpg

Learned intermediary

“Drug reps” have a responsibility to inform doctors of both benefits and risks of their medications, a process termed “fair balance.” Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not the drug manufacturer. This is termed the “learned intermediary” doctrine, which is also applicable to medical devices such as dialysis equipment, breast implants, and blood products.

The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through their sales reps and in the package insert and PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. However, where known complications were undisclosed to the FDA and the profession, then plaintiff attorneys can file class action lawsuits directed at the manufacturer.
 

Complications

Complications arising out of the use of steroids are typical examples of medical products liability. This may be on the basis of the doctor having prescribed the medication without a proper indication or where contraindicated, or may have prescribed “the wrong dose for the wrong patient by the wrong route.” In addition, there may have been a lack of informed consent, i.e., failure to explain the underlying condition and the material risks associated with using the drug. Other acts of negligence, e.g., vicarious liability, may also apply.

Corticosteroids such as Prednisone, Decadron, Kenalog, etc., are widely prescribed, and can cause serious complications, especially when used in high doses for extended periods. Examples include suppression of the immune system with supervening infections, steroid osteoporosis and fractures,³ aseptic necrosis, steroid diabetes, hypertension, emotional changes, weight gain, cataracts, neurological complications, and many others. As in all malpractice actions, the plaintiff bears the burden of proof covering the four requisite tort elements, i.e., duty, breach of duty, causation, and damages. Expert testimony is almost always needed in a professional negligence lawsuit.

Aseptic necrosis is a feared complication of steroid therapy.

A recent report⁴ featured a nurse in her 40s who developed aseptic necrosis of the right shoulder and both hips after taking high dose prednisone for 6 months. She was being treated for idiopathic thrombocytopenic purpura by a hematologist as well as sarcoidosis by a pulmonologist. The plaintiff claimed that both defendants negligently prescribed the medication for an extended period of time without proper monitoring, which caused her severe bone complications requiring a hip and shoulder replacement. The defendants maintained that the steroid medication was necessary to treat the life-threatening conditions from which the plaintiff suffered and that the dosage was carefully monitored and was not excessive. However, in a jury trial, the defendant hematologist and pulmonologist were each found 50% negligent, and the patient was awarded $4.1 million in damages.

In a case⁵ of steroid-related neurological sequelae, a Colorado jury awarded $14.9 million to a couple against an outpatient surgery center for negligently administering an epidural dose of Kenalog that rendered the patient paraplegic, and for failure to obtain informed consent. The jury awarded the woman, age 57, approximately $1.7 million in past and future medical expenses; $3.2 million in unspecified economic damages; and $6.5 million in past and future noneconomic damages such as pain and suffering. Her husband will receive $3.5 million in past and future noneconomic damages for loss of consortium, according to the verdict. Two years before the injection date of 2013, the drug maker had announced that Kenalog should not be used for epidural procedures because of cord complications including infarction and paraplegia.
 

Contributory role

The putative offending drug does not have to be the sole cause of injury; if it played a contributory role, the court may find the presence of liability. For example, a Kansas appeals court⁶ upheld a jury award of $2.88 million in the case of a 40-year-old man who took his life after neurologic complications followed an epidural injection. During one of patient’s visits for chronic low back pain, the defendant-anesthesiologist administered an epidural steroid injection into an area left swollen from a previous injection.

The patient developed neurologic symptoms, and lumbar puncture yielded green pus caused by methicillin-resistant Staphylococcus aureus. He went on to develop arachnoiditis, which left him with impotence, incontinence, and excruciating pain. His lawsuit contended the injection needle had passed through an infected edematous area, causing meningitis and arachnoiditis. Before the case went to trial, the patient took his life because of unremitting pain.

In March 2014, a Johnson County jury found the doctor 75% at fault and the clinic 25% at fault and awarded damages, which were reduced to $1.67 million because Kansas caps noneconomic damages at $250,000. The court rejected the defendants’ argument that the trial judge improperly instructed the jury it could find liability only if negligence “caused” rather than merely “contributed to” the patient’s death, holding that “... one who contributes to a wrongful death is a cause of that death as contemplated by the wrongful death statute.”
 

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu .
 

References

1. Hill v. Squibb Sons, E.R, 592 P.2d 1383 (Mont. 1979).

2. Nash JJ et al, Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011; 144:10-5.

3. Buckley L. et al, Glucocorticoid-Induced Osteoporosis. N Engl J Med 2018; 379:2547-56.

4. Zarin’s Jury Verdict: Review and Analysis. Article ID 40229, Philadelphia County.

5. Robbin Smith et al. v. The Surgery Center at Lone Tree, 2015-CV-30922, Douglas County District Court, Colo. Verdict for plaintiff, March 23, 2017.

6. Burnette v. Kimber L. Eubanks, M.D., & Paincare, P.A., 379 P.3d 372 (Kan. Ct. App. 2016).

Question: Mr. M, a car mechanic, was treated with long-term ACTH and Kenalog after he developed severe contact dermatitis from daily exposure to petroleum-based solvents. His subsequent course was complicated by cataracts and osteoporosis. Which of the following is true in case he files a malpractice action?



A. Treatment with steroids was medically indicated for Mr. Mechanic’s dermatologic condition, so the doctor could not have breached the standard of care.

B. Under the “Learned Intermediary” doctrine, both the manufacturer and the prescribing doctor are jointly liable.

C. Corticosteroids are a known cause of osteoporosis and other complications, but not of cataracts, so that part of the malpractice action should be thrown out.

D. The plaintiff would prevail even if he could not find an expert witnesses to testify as to standard of care, since it is “common knowledge” that steroids cause osteoporosis.

E. Lack of informed consent may be his best legal theory of liability, as many jurisdictions now use the patient-centered standard, which does not require expert testimony.



Answer: E. The above hypothetical was modified from an old Montana case¹ in which the patient failed in his negligence lawsuit because he did not have expert witnesses to testify as to standard of care and to adequacy of warning label. However, in some jurisdictions under today’s case law, informed consent relies on a subjective, i.e., patient-oriented standard, and expert testimony is unnecessary to prove breach of duty, although still needed to prove causation.
 

Steroid-related litigation

Steroid-related malpractice litigation is quite prevalent. In a retrospective study of a tertiary medical center from 1996 to 2008, Nash and coworkers identified 83 such cases.² Steroids were prescribed for pain (23%), asthma or another pulmonary condition (20%), a dermatologic condition (18%), an autoimmune condition (17%), or allergies (6%).

Tan_Siang_Yong_web.jpg

Learned intermediary

“Drug reps” have a responsibility to inform doctors of both benefits and risks of their medications, a process termed “fair balance.” Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not the drug manufacturer. This is termed the “learned intermediary” doctrine, which is also applicable to medical devices such as dialysis equipment, breast implants, and blood products.

The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through their sales reps and in the package insert and PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. However, where known complications were undisclosed to the FDA and the profession, then plaintiff attorneys can file class action lawsuits directed at the manufacturer.
 

Complications

Complications arising out of the use of steroids are typical examples of medical products liability. This may be on the basis of the doctor having prescribed the medication without a proper indication or where contraindicated, or may have prescribed “the wrong dose for the wrong patient by the wrong route.” In addition, there may have been a lack of informed consent, i.e., failure to explain the underlying condition and the material risks associated with using the drug. Other acts of negligence, e.g., vicarious liability, may also apply.

Corticosteroids such as Prednisone, Decadron, Kenalog, etc., are widely prescribed, and can cause serious complications, especially when used in high doses for extended periods. Examples include suppression of the immune system with supervening infections, steroid osteoporosis and fractures,³ aseptic necrosis, steroid diabetes, hypertension, emotional changes, weight gain, cataracts, neurological complications, and many others. As in all malpractice actions, the plaintiff bears the burden of proof covering the four requisite tort elements, i.e., duty, breach of duty, causation, and damages. Expert testimony is almost always needed in a professional negligence lawsuit.

Aseptic necrosis is a feared complication of steroid therapy.

A recent report⁴ featured a nurse in her 40s who developed aseptic necrosis of the right shoulder and both hips after taking high dose prednisone for 6 months. She was being treated for idiopathic thrombocytopenic purpura by a hematologist as well as sarcoidosis by a pulmonologist. The plaintiff claimed that both defendants negligently prescribed the medication for an extended period of time without proper monitoring, which caused her severe bone complications requiring a hip and shoulder replacement. The defendants maintained that the steroid medication was necessary to treat the life-threatening conditions from which the plaintiff suffered and that the dosage was carefully monitored and was not excessive. However, in a jury trial, the defendant hematologist and pulmonologist were each found 50% negligent, and the patient was awarded $4.1 million in damages.

In a case⁵ of steroid-related neurological sequelae, a Colorado jury awarded $14.9 million to a couple against an outpatient surgery center for negligently administering an epidural dose of Kenalog that rendered the patient paraplegic, and for failure to obtain informed consent. The jury awarded the woman, age 57, approximately $1.7 million in past and future medical expenses; $3.2 million in unspecified economic damages; and $6.5 million in past and future noneconomic damages such as pain and suffering. Her husband will receive $3.5 million in past and future noneconomic damages for loss of consortium, according to the verdict. Two years before the injection date of 2013, the drug maker had announced that Kenalog should not be used for epidural procedures because of cord complications including infarction and paraplegia.
 

Contributory role

The putative offending drug does not have to be the sole cause of injury; if it played a contributory role, the court may find the presence of liability. For example, a Kansas appeals court⁶ upheld a jury award of $2.88 million in the case of a 40-year-old man who took his life after neurologic complications followed an epidural injection. During one of patient’s visits for chronic low back pain, the defendant-anesthesiologist administered an epidural steroid injection into an area left swollen from a previous injection.

The patient developed neurologic symptoms, and lumbar puncture yielded green pus caused by methicillin-resistant Staphylococcus aureus. He went on to develop arachnoiditis, which left him with impotence, incontinence, and excruciating pain. His lawsuit contended the injection needle had passed through an infected edematous area, causing meningitis and arachnoiditis. Before the case went to trial, the patient took his life because of unremitting pain.

In March 2014, a Johnson County jury found the doctor 75% at fault and the clinic 25% at fault and awarded damages, which were reduced to $1.67 million because Kansas caps noneconomic damages at $250,000. The court rejected the defendants’ argument that the trial judge improperly instructed the jury it could find liability only if negligence “caused” rather than merely “contributed to” the patient’s death, holding that “... one who contributes to a wrongful death is a cause of that death as contemplated by the wrongful death statute.”
 

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu .
 

References

1. Hill v. Squibb Sons, E.R, 592 P.2d 1383 (Mont. 1979).

2. Nash JJ et al, Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011; 144:10-5.

3. Buckley L. et al, Glucocorticoid-Induced Osteoporosis. N Engl J Med 2018; 379:2547-56.

4. Zarin’s Jury Verdict: Review and Analysis. Article ID 40229, Philadelphia County.

5. Robbin Smith et al. v. The Surgery Center at Lone Tree, 2015-CV-30922, Douglas County District Court, Colo. Verdict for plaintiff, March 23, 2017.

6. Burnette v. Kimber L. Eubanks, M.D., & Paincare, P.A., 379 P.3d 372 (Kan. Ct. App. 2016).

Question: Mr. M, a car mechanic, was treated with long-term ACTH and Kenalog after he developed severe contact dermatitis from daily exposure to petroleum-based solvents. His subsequent course was complicated by cataracts and osteoporosis. Which of the following is true in case he files a malpractice action?



A. Treatment with steroids was medically indicated for Mr. Mechanic’s dermatologic condition, so the doctor could not have breached the standard of care.

B. Under the “Learned Intermediary” doctrine, both the manufacturer and the prescribing doctor are jointly liable.

C. Corticosteroids are a known cause of osteoporosis and other complications, but not of cataracts, so that part of the malpractice action should be thrown out.

D. The plaintiff would prevail even if he could not find an expert witnesses to testify as to standard of care, since it is “common knowledge” that steroids cause osteoporosis.

E. Lack of informed consent may be his best legal theory of liability, as many jurisdictions now use the patient-centered standard, which does not require expert testimony.



Answer: E. The above hypothetical was modified from an old Montana case¹ in which the patient failed in his negligence lawsuit because he did not have expert witnesses to testify as to standard of care and to adequacy of warning label. However, in some jurisdictions under today’s case law, informed consent relies on a subjective, i.e., patient-oriented standard, and expert testimony is unnecessary to prove breach of duty, although still needed to prove causation.
 

Steroid-related litigation

Steroid-related malpractice litigation is quite prevalent. In a retrospective study of a tertiary medical center from 1996 to 2008, Nash and coworkers identified 83 such cases.² Steroids were prescribed for pain (23%), asthma or another pulmonary condition (20%), a dermatologic condition (18%), an autoimmune condition (17%), or allergies (6%).

Tan_Siang_Yong_web.jpg

Learned intermediary

“Drug reps” have a responsibility to inform doctors of both benefits and risks of their medications, a process termed “fair balance.” Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not the drug manufacturer. This is termed the “learned intermediary” doctrine, which is also applicable to medical devices such as dialysis equipment, breast implants, and blood products.

The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through their sales reps and in the package insert and PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. However, where known complications were undisclosed to the FDA and the profession, then plaintiff attorneys can file class action lawsuits directed at the manufacturer.
 

Complications

Complications arising out of the use of steroids are typical examples of medical products liability. This may be on the basis of the doctor having prescribed the medication without a proper indication or where contraindicated, or may have prescribed “the wrong dose for the wrong patient by the wrong route.” In addition, there may have been a lack of informed consent, i.e., failure to explain the underlying condition and the material risks associated with using the drug. Other acts of negligence, e.g., vicarious liability, may also apply.

Corticosteroids such as Prednisone, Decadron, Kenalog, etc., are widely prescribed, and can cause serious complications, especially when used in high doses for extended periods. Examples include suppression of the immune system with supervening infections, steroid osteoporosis and fractures,³ aseptic necrosis, steroid diabetes, hypertension, emotional changes, weight gain, cataracts, neurological complications, and many others. As in all malpractice actions, the plaintiff bears the burden of proof covering the four requisite tort elements, i.e., duty, breach of duty, causation, and damages. Expert testimony is almost always needed in a professional negligence lawsuit.

Aseptic necrosis is a feared complication of steroid therapy.

A recent report⁴ featured a nurse in her 40s who developed aseptic necrosis of the right shoulder and both hips after taking high dose prednisone for 6 months. She was being treated for idiopathic thrombocytopenic purpura by a hematologist as well as sarcoidosis by a pulmonologist. The plaintiff claimed that both defendants negligently prescribed the medication for an extended period of time without proper monitoring, which caused her severe bone complications requiring a hip and shoulder replacement. The defendants maintained that the steroid medication was necessary to treat the life-threatening conditions from which the plaintiff suffered and that the dosage was carefully monitored and was not excessive. However, in a jury trial, the defendant hematologist and pulmonologist were each found 50% negligent, and the patient was awarded $4.1 million in damages.

In a case⁵ of steroid-related neurological sequelae, a Colorado jury awarded $14.9 million to a couple against an outpatient surgery center for negligently administering an epidural dose of Kenalog that rendered the patient paraplegic, and for failure to obtain informed consent. The jury awarded the woman, age 57, approximately $1.7 million in past and future medical expenses; $3.2 million in unspecified economic damages; and $6.5 million in past and future noneconomic damages such as pain and suffering. Her husband will receive $3.5 million in past and future noneconomic damages for loss of consortium, according to the verdict. Two years before the injection date of 2013, the drug maker had announced that Kenalog should not be used for epidural procedures because of cord complications including infarction and paraplegia.
 

Contributory role

The putative offending drug does not have to be the sole cause of injury; if it played a contributory role, the court may find the presence of liability. For example, a Kansas appeals court⁶ upheld a jury award of $2.88 million in the case of a 40-year-old man who took his life after neurologic complications followed an epidural injection. During one of patient’s visits for chronic low back pain, the defendant-anesthesiologist administered an epidural steroid injection into an area left swollen from a previous injection.

The patient developed neurologic symptoms, and lumbar puncture yielded green pus caused by methicillin-resistant Staphylococcus aureus. He went on to develop arachnoiditis, which left him with impotence, incontinence, and excruciating pain. His lawsuit contended the injection needle had passed through an infected edematous area, causing meningitis and arachnoiditis. Before the case went to trial, the patient took his life because of unremitting pain.

In March 2014, a Johnson County jury found the doctor 75% at fault and the clinic 25% at fault and awarded damages, which were reduced to $1.67 million because Kansas caps noneconomic damages at $250,000. The court rejected the defendants’ argument that the trial judge improperly instructed the jury it could find liability only if negligence “caused” rather than merely “contributed to” the patient’s death, holding that “... one who contributes to a wrongful death is a cause of that death as contemplated by the wrongful death statute.”
 

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu .
 

References

1. Hill v. Squibb Sons, E.R, 592 P.2d 1383 (Mont. 1979).

2. Nash JJ et al, Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011; 144:10-5.

3. Buckley L. et al, Glucocorticoid-Induced Osteoporosis. N Engl J Med 2018; 379:2547-56.

4. Zarin’s Jury Verdict: Review and Analysis. Article ID 40229, Philadelphia County.

5. Robbin Smith et al. v. The Surgery Center at Lone Tree, 2015-CV-30922, Douglas County District Court, Colo. Verdict for plaintiff, March 23, 2017.

6. Burnette v. Kimber L. Eubanks, M.D., & Paincare, P.A., 379 P.3d 372 (Kan. Ct. App. 2016).

On August 22, 2014, a baby girl was born healthy and at full term. She was discharged on August 24 after a routine hospital stay. A day later, the infant’s mother called the pediatrician’s emergency after-hours hotline, in distress. She was concerned because the infant had not had a bowel movement since August 23. She was also concerned that each feeding was lasting an hour. A nurse told the mother that her concerns would be discussed in a routine follow-up appointment scheduled for the next morning.

At the appointment, the pediatrician noted the infant was having feeding problems and had lost 11% of her at-birth weight. The pediatrician also noted a high respiratory rate and abnormal skin coloring. However, the pediatrician concluded that the infant’s feeding problems had resolved, reassured the parents she was healthy, and discharged her, telling her parents to return in 2 weeks.

On August 29, the mother again called the pediatrician’s office, this time with concerns over a decrease in the infant’s feeding. A nurse told her to bring the infant to the emergency department (ED). At the ED, the infant was found to have lost 12% of her weight since birth and to be severely dehydrated. Due to hypovolemia, health care providers could not complete lab tests on the infant until aggressive resuscitation had been performed for 4 hours. The infant’s lab values showed she had hypernatremia, which put her at risk for brain injury through a decrease in cellular hydration, increased vascular permeability, or elevated intracranial pressure.

The infant did sustain a permanent brain injury from the condition: right-side paralysis. Her multi-organ failure from dehydration also caused significant damage to her left kidney, which stopped functioning altogether in 2017.

The infant sued her pediatrician and his office. Plaintiff’s counsel stated that the infant’s early weight loss was a red flag and that the standard of care required the pediatrician to order in-office follow-up within 24 hours to confirm if the loss had been corrected. Plaintiff’s counsel also alleged the baby’s respiratory rate and poor coloring were also red flags for dehydration. He further alleged that if the infant had returned to the office, her weight loss would have prompted supplementation before the dehydration caused her brain injury.

VERDICT

The case was settled for $1,375,000.

COMMENTARY

This case merits discussion because it involves a type of patient many clinicians see in practice. Complaints of newborn and infant feeding problems are common. Most cases require reassurance and troubleshooting about common feeding problems—but the clinician must be on the lookout for serious issues. Thus, it is helpful to revisit expected newborn feeding, stooling, and weight status.

Continue to: With regard to feeding...

With regard to feeding, breastfed infants should receive between 8-12 feeds per day during the newborn hospitalization.¹ Bottlefed infants should be fed 20 kcal per 30 mL of iron-containing formula. Infants are fed on demand, and the duration of the feeding should not exceed 4 hours. The volume of the feed for the first few days of life should be 15-30 mL per feed.

For breastfed infants, clinicians should be attentive to issues that can impact nutrition, including latching difficulties, pain, mastitis, blocked duct, and engorgement. These can limit nutrition and be extremely upsetting to the mother.

Stooling frequency for newborns varies and depends on whether the infant is bottle fed or breast fed. During the first week of life, infants pass a mean of 4 stools per day.² Breastfed infants may have as few as one stool per day, increasing as mother’s milk production increases.²

With regard to weight loss, term infants may lose up to 10% of their birth weight in the first few days of life, which is typically regained in 10 to 14 days.¹ Infants born via cesarean section lose more weight, with 25% of these babies losing more than 10% by 72 hours. Of them, 76% return to birth weight by 14 days and 92% by 21 days. By contrast, vaginally born infants regain weight faster, with 86% returning to their birth weight by 14 days and 95% by the 21st day.¹

Here, the infant was term and healthy, but we are not told some important details. Was she breast fed or bottle fed? Was she born by cesarean section or vaginally? We do know she was discharged on August 24th, her mother called the hotline on the 25th, and she was seen by the pediatrician on the 26th—at which point the infant had not stooled in 3 days. The mother called the physician’s office again on August 29th and was sent to the ED. We are told only that each feeding lasted an hour and the infant hadn’t stooled.

Continue to: Regarding stool...

Regarding stool—we have all had discussions with patients regarding hypervigilant concerns about stool color. We know there are some big things to look for with stool color (eg, black tarry reveals upper GI bleeding, while clay-colored or pale may reveal the absence of bile). Yet, patients’ expectations of the color-coded diagnostic abilities of their stool knows no bounds. Patients are convinced that we have some color wheel in our jacket pocket corresponding to stool color—and that the nuances between shades have important medical implications. If you ask, “Would you say it is more marigold, butterscotch yellow, or Tuscan sun?” … your patient will have an answer.

Patients reveal stool color hesitantly, reservedly, with nervous expectation. They wait for your response in quivering anticipation that the coming reply will include words to the effect that a boysenberry-purple stool is equivalent to a Death tarot card. A subconjunctival hemorrhage is the only thing that approaches the anxiety level of the oddly hued stool (Oddly Hued Stool Anxiety). Woe be the patient with both. For a patient bearing a subconjunctival hemorrhage who has also passed a jungle-green stool in the past 24 hours fully expects to explode within the next 60 minutes.

I’ve been rather facetious for a reason. My purpose is to acknowledge and to help you recognize that most discussions regarding stooling will not be (forgive me) productive. They are not productive because most stool coloration issues are nonentities—yet they produce patient anxiety that takes some time to address, leaving a busy clinician prone to curtly dismiss such discussions out of hand. Because many patient-initiated stool discussions aren’t productive, there is the risk for stool tune-out. As gross and unproductive as they can be, don’t tune out all stool discussions.

In this case, the appropriate frequency of stooling should have been at least once per day. For newborns, a stool color question is helpful; stool should not be white, pale, or clay-colored, which is suggestive of acholic stools from biliary atresia. Here, despite the absence of stool over a 3-day period, the defendant concluded the feeding problem was resolved and set a return visit for 2 weeks later. The plaintiff’s expert contended that the weight loss and absence of stooling was evidence of inadequate intake and warranted a return check the next day. Rather than risk the case going to trial, the defendant settled for $1,375,000.

IN SUM

Newborn nutrition is important. Understand that parents will be anxious about newborn feeding, although often there is no major medical concern. However, do not be dismissive of feeding concerns because of this expected anxiety. Listen to the parents fully, paying particular attention to quantifying feeding difficulty and stooling frequency matters. Don’t let patients’ rainbow parade of needless stool concerns blind you to considering important information. In other words, don’t be a stool fool.

[embed:render:related:node:211164]

[embed:render:related:node:208697]

[embed:render:related:node:207071]

On August 22, 2014, a baby girl was born healthy and at full term. She was discharged on August 24 after a routine hospital stay. A day later, the infant’s mother called the pediatrician’s emergency after-hours hotline, in distress. She was concerned because the infant had not had a bowel movement since August 23. She was also concerned that each feeding was lasting an hour. A nurse told the mother that her concerns would be discussed in a routine follow-up appointment scheduled for the next morning.

At the appointment, the pediatrician noted the infant was having feeding problems and had lost 11% of her at-birth weight. The pediatrician also noted a high respiratory rate and abnormal skin coloring. However, the pediatrician concluded that the infant’s feeding problems had resolved, reassured the parents she was healthy, and discharged her, telling her parents to return in 2 weeks.

On August 29, the mother again called the pediatrician’s office, this time with concerns over a decrease in the infant’s feeding. A nurse told her to bring the infant to the emergency department (ED). At the ED, the infant was found to have lost 12% of her weight since birth and to be severely dehydrated. Due to hypovolemia, health care providers could not complete lab tests on the infant until aggressive resuscitation had been performed for 4 hours. The infant’s lab values showed she had hypernatremia, which put her at risk for brain injury through a decrease in cellular hydration, increased vascular permeability, or elevated intracranial pressure.

The infant did sustain a permanent brain injury from the condition: right-side paralysis. Her multi-organ failure from dehydration also caused significant damage to her left kidney, which stopped functioning altogether in 2017.

The infant sued her pediatrician and his office. Plaintiff’s counsel stated that the infant’s early weight loss was a red flag and that the standard of care required the pediatrician to order in-office follow-up within 24 hours to confirm if the loss had been corrected. Plaintiff’s counsel also alleged the baby’s respiratory rate and poor coloring were also red flags for dehydration. He further alleged that if the infant had returned to the office, her weight loss would have prompted supplementation before the dehydration caused her brain injury.

VERDICT

The case was settled for $1,375,000.

COMMENTARY

This case merits discussion because it involves a type of patient many clinicians see in practice. Complaints of newborn and infant feeding problems are common. Most cases require reassurance and troubleshooting about common feeding problems—but the clinician must be on the lookout for serious issues. Thus, it is helpful to revisit expected newborn feeding, stooling, and weight status.

Continue to: With regard to feeding...

With regard to feeding, breastfed infants should receive between 8-12 feeds per day during the newborn hospitalization.¹ Bottlefed infants should be fed 20 kcal per 30 mL of iron-containing formula. Infants are fed on demand, and the duration of the feeding should not exceed 4 hours. The volume of the feed for the first few days of life should be 15-30 mL per feed.

For breastfed infants, clinicians should be attentive to issues that can impact nutrition, including latching difficulties, pain, mastitis, blocked duct, and engorgement. These can limit nutrition and be extremely upsetting to the mother.

Stooling frequency for newborns varies and depends on whether the infant is bottle fed or breast fed. During the first week of life, infants pass a mean of 4 stools per day.² Breastfed infants may have as few as one stool per day, increasing as mother’s milk production increases.²

With regard to weight loss, term infants may lose up to 10% of their birth weight in the first few days of life, which is typically regained in 10 to 14 days.¹ Infants born via cesarean section lose more weight, with 25% of these babies losing more than 10% by 72 hours. Of them, 76% return to birth weight by 14 days and 92% by 21 days. By contrast, vaginally born infants regain weight faster, with 86% returning to their birth weight by 14 days and 95% by the 21st day.¹

Here, the infant was term and healthy, but we are not told some important details. Was she breast fed or bottle fed? Was she born by cesarean section or vaginally? We do know she was discharged on August 24th, her mother called the hotline on the 25th, and she was seen by the pediatrician on the 26th—at which point the infant had not stooled in 3 days. The mother called the physician’s office again on August 29th and was sent to the ED. We are told only that each feeding lasted an hour and the infant hadn’t stooled.

Continue to: Regarding stool...

Regarding stool—we have all had discussions with patients regarding hypervigilant concerns about stool color. We know there are some big things to look for with stool color (eg, black tarry reveals upper GI bleeding, while clay-colored or pale may reveal the absence of bile). Yet, patients’ expectations of the color-coded diagnostic abilities of their stool knows no bounds. Patients are convinced that we have some color wheel in our jacket pocket corresponding to stool color—and that the nuances between shades have important medical implications. If you ask, “Would you say it is more marigold, butterscotch yellow, or Tuscan sun?” … your patient will have an answer.

Patients reveal stool color hesitantly, reservedly, with nervous expectation. They wait for your response in quivering anticipation that the coming reply will include words to the effect that a boysenberry-purple stool is equivalent to a Death tarot card. A subconjunctival hemorrhage is the only thing that approaches the anxiety level of the oddly hued stool (Oddly Hued Stool Anxiety). Woe be the patient with both. For a patient bearing a subconjunctival hemorrhage who has also passed a jungle-green stool in the past 24 hours fully expects to explode within the next 60 minutes.

I’ve been rather facetious for a reason. My purpose is to acknowledge and to help you recognize that most discussions regarding stooling will not be (forgive me) productive. They are not productive because most stool coloration issues are nonentities—yet they produce patient anxiety that takes some time to address, leaving a busy clinician prone to curtly dismiss such discussions out of hand. Because many patient-initiated stool discussions aren’t productive, there is the risk for stool tune-out. As gross and unproductive as they can be, don’t tune out all stool discussions.

In this case, the appropriate frequency of stooling should have been at least once per day. For newborns, a stool color question is helpful; stool should not be white, pale, or clay-colored, which is suggestive of acholic stools from biliary atresia. Here, despite the absence of stool over a 3-day period, the defendant concluded the feeding problem was resolved and set a return visit for 2 weeks later. The plaintiff’s expert contended that the weight loss and absence of stooling was evidence of inadequate intake and warranted a return check the next day. Rather than risk the case going to trial, the defendant settled for $1,375,000.

IN SUM

Newborn nutrition is important. Understand that parents will be anxious about newborn feeding, although often there is no major medical concern. However, do not be dismissive of feeding concerns because of this expected anxiety. Listen to the parents fully, paying particular attention to quantifying feeding difficulty and stooling frequency matters. Don’t let patients’ rainbow parade of needless stool concerns blind you to considering important information. In other words, don’t be a stool fool.

[embed:render:related:node:211164]

[embed:render:related:node:208697]

[embed:render:related:node:207071]

On August 22, 2014, a baby girl was born healthy and at full term. She was discharged on August 24 after a routine hospital stay. A day later, the infant’s mother called the pediatrician’s emergency after-hours hotline, in distress. She was concerned because the infant had not had a bowel movement since August 23. She was also concerned that each feeding was lasting an hour. A nurse told the mother that her concerns would be discussed in a routine follow-up appointment scheduled for the next morning.

At the appointment, the pediatrician noted the infant was having feeding problems and had lost 11% of her at-birth weight. The pediatrician also noted a high respiratory rate and abnormal skin coloring. However, the pediatrician concluded that the infant’s feeding problems had resolved, reassured the parents she was healthy, and discharged her, telling her parents to return in 2 weeks.

On August 29, the mother again called the pediatrician’s office, this time with concerns over a decrease in the infant’s feeding. A nurse told her to bring the infant to the emergency department (ED). At the ED, the infant was found to have lost 12% of her weight since birth and to be severely dehydrated. Due to hypovolemia, health care providers could not complete lab tests on the infant until aggressive resuscitation had been performed for 4 hours. The infant’s lab values showed she had hypernatremia, which put her at risk for brain injury through a decrease in cellular hydration, increased vascular permeability, or elevated intracranial pressure.

The infant did sustain a permanent brain injury from the condition: right-side paralysis. Her multi-organ failure from dehydration also caused significant damage to her left kidney, which stopped functioning altogether in 2017.

The infant sued her pediatrician and his office. Plaintiff’s counsel stated that the infant’s early weight loss was a red flag and that the standard of care required the pediatrician to order in-office follow-up within 24 hours to confirm if the loss had been corrected. Plaintiff’s counsel also alleged the baby’s respiratory rate and poor coloring were also red flags for dehydration. He further alleged that if the infant had returned to the office, her weight loss would have prompted supplementation before the dehydration caused her brain injury.

VERDICT

The case was settled for $1,375,000.

COMMENTARY

This case merits discussion because it involves a type of patient many clinicians see in practice. Complaints of newborn and infant feeding problems are common. Most cases require reassurance and troubleshooting about common feeding problems—but the clinician must be on the lookout for serious issues. Thus, it is helpful to revisit expected newborn feeding, stooling, and weight status.

Continue to: With regard to feeding...

With regard to feeding, breastfed infants should receive between 8-12 feeds per day during the newborn hospitalization.¹ Bottlefed infants should be fed 20 kcal per 30 mL of iron-containing formula. Infants are fed on demand, and the duration of the feeding should not exceed 4 hours. The volume of the feed for the first few days of life should be 15-30 mL per feed.

For breastfed infants, clinicians should be attentive to issues that can impact nutrition, including latching difficulties, pain, mastitis, blocked duct, and engorgement. These can limit nutrition and be extremely upsetting to the mother.

Stooling frequency for newborns varies and depends on whether the infant is bottle fed or breast fed. During the first week of life, infants pass a mean of 4 stools per day.² Breastfed infants may have as few as one stool per day, increasing as mother’s milk production increases.²

With regard to weight loss, term infants may lose up to 10% of their birth weight in the first few days of life, which is typically regained in 10 to 14 days.¹ Infants born via cesarean section lose more weight, with 25% of these babies losing more than 10% by 72 hours. Of them, 76% return to birth weight by 14 days and 92% by 21 days. By contrast, vaginally born infants regain weight faster, with 86% returning to their birth weight by 14 days and 95% by the 21st day.¹

Here, the infant was term and healthy, but we are not told some important details. Was she breast fed or bottle fed? Was she born by cesarean section or vaginally? We do know she was discharged on August 24th, her mother called the hotline on the 25th, and she was seen by the pediatrician on the 26th—at which point the infant had not stooled in 3 days. The mother called the physician’s office again on August 29th and was sent to the ED. We are told only that each feeding lasted an hour and the infant hadn’t stooled.

Continue to: Regarding stool...

Regarding stool—we have all had discussions with patients regarding hypervigilant concerns about stool color. We know there are some big things to look for with stool color (eg, black tarry reveals upper GI bleeding, while clay-colored or pale may reveal the absence of bile). Yet, patients’ expectations of the color-coded diagnostic abilities of their stool knows no bounds. Patients are convinced that we have some color wheel in our jacket pocket corresponding to stool color—and that the nuances between shades have important medical implications. If you ask, “Would you say it is more marigold, butterscotch yellow, or Tuscan sun?” … your patient will have an answer.

Patients reveal stool color hesitantly, reservedly, with nervous expectation. They wait for your response in quivering anticipation that the coming reply will include words to the effect that a boysenberry-purple stool is equivalent to a Death tarot card. A subconjunctival hemorrhage is the only thing that approaches the anxiety level of the oddly hued stool (Oddly Hued Stool Anxiety). Woe be the patient with both. For a patient bearing a subconjunctival hemorrhage who has also passed a jungle-green stool in the past 24 hours fully expects to explode within the next 60 minutes.

I’ve been rather facetious for a reason. My purpose is to acknowledge and to help you recognize that most discussions regarding stooling will not be (forgive me) productive. They are not productive because most stool coloration issues are nonentities—yet they produce patient anxiety that takes some time to address, leaving a busy clinician prone to curtly dismiss such discussions out of hand. Because many patient-initiated stool discussions aren’t productive, there is the risk for stool tune-out. As gross and unproductive as they can be, don’t tune out all stool discussions.

In this case, the appropriate frequency of stooling should have been at least once per day. For newborns, a stool color question is helpful; stool should not be white, pale, or clay-colored, which is suggestive of acholic stools from biliary atresia. Here, despite the absence of stool over a 3-day period, the defendant concluded the feeding problem was resolved and set a return visit for 2 weeks later. The plaintiff’s expert contended that the weight loss and absence of stooling was evidence of inadequate intake and warranted a return check the next day. Rather than risk the case going to trial, the defendant settled for $1,375,000.

IN SUM

Newborn nutrition is important. Understand that parents will be anxious about newborn feeding, although often there is no major medical concern. However, do not be dismissive of feeding concerns because of this expected anxiety. Listen to the parents fully, paying particular attention to quantifying feeding difficulty and stooling frequency matters. Don’t let patients’ rainbow parade of needless stool concerns blind you to considering important information. In other words, don’t be a stool fool.

[embed:render:related:node:211164]

[embed:render:related:node:208697]

[embed:render:related:node:207071]

Question: Which one of the following statements is incorrect?

A. Office of Inspector General (OIG) is a federal agency of Department of Health & Human Services (HHS) that investigates statutory violations of health care fraud and abuse.

B. The three main legal minefields for physicians are false claims, kickbacks, and self-referrals.

C. Jail terms are part of the penalties provided by law.

D. OIG is also responsible for excluding violators from participating in Medicare/Medicaid programs, as well as curtailing a physician’s license to practice.

E. A private citizen can file a qui tam lawsuit against an errant practitioner or health care entity for fraud and abuse.



Answer: D. Health care fraud, waste, and abuse consume some 10% of federal health expenditures despite well-established laws that attempt to prevent and reduce such losses. The three key fraud and abuse laws that affect physicians are the False Claims Act (FCA), Anti-Kickback Statute (AKS), and Physician Self-Referral Law (Stark law). The Department of Health & Human Services (HHS) Office of Inspector General, as well as the Department of Justice and the Centers for Medicare & Medicaid Services are charged with enforcing these and other laws like the Emergency Medical Treatment and Labor Act. Their web pages, referenced throughout this article, contain a wealth of information for the practitioner.

The term “Office of Inspector General” (OIG) refers to the oversight division of a federal or state agency charged with identifying and investigating fraud, waste, abuse, and mismanagement within that department or agency. There are currently 73 separate federal offices of inspectors general, which employ armed and unarmed criminal investigators, auditors, forensic auditors called “audigators,” and a variety of other specialists. An Act of Congress in 1976 established the first OIG under HHS. Besides being the first, HHS-OIG is also the largest, with a staff of approximately 1,600. A majority of resources goes toward the oversight of Medicare and Medicaid, as well as programs under other HHS institutions such as the Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration.¹

HHS-OIG has the authority to seek civil monetary penalties, assessments, and exclusion against an individual or entity based on a wide variety of prohibited conduct affecting federal health care programs. Stiff penalties are regularly assessed against violators, and jail terms are not uncommon; however, it has no direct jurisdictions over physician licensure or nonfederal programs. The government maintains a pictorial list of its most wanted health care fugitives2 and provides an excellent set of Physician Education Training Materials on its website.³
 

False Claims Act (FCA)

In the health care arena, violation of FCA (31 U.S.C. §§3729-3733) is the foremost infraction. False claims by physicians can include billing for noncovered services such as experimental treatments, double billing, billing the government as the primary payer, or regularly waiving deductibles and copayments, as well as quality of care issues and unnecessary services. Wrongdoing also includes knowingly using another patient’s name for purposes of, say, federal drug coverage, billing for no-shows, and misrepresenting the diagnosis to justify services, as well as other claims. In the modern doctor’s office, the EMR enables easy check-offs on a preprinted form as documentation of actual work done. However, fraud is implicated if the information is deliberately misleading such as for purposes of upcoding. Importantly, physicians are liable for the actions of their office staff, so it is prudent to oversee and supervise all such activities. Naturally, one should document all claims that are sent and know the rules for allowable and excluded services.

Tan_Siang_Yong_web.jpg

FCA is an old law that was first enacted in 1863. It imposes liability for submitting a payment demand to the federal government where there is actual or constructive knowledge that the claim is false. Intent to defraud is not a required element but knowing or showing reckless disregard of the truth is. However, an error that is negligently committed is insufficient to constitute a violation. Penalties include treble damages, costs and attorney fees, and fines of $11,000 per false claim, as well as possible imprisonment and criminal fines. A so-called whistle-blower may file a lawsuit on behalf of the government and is entitled to a percentage of any recoveries. Whistle-blowers may be current or ex-business partners, hospital or office staff, patients, or competitors. The fact that a claim results from a kickback or is made in violation of the Stark law (discussed below) may also render it fraudulent, thus creating additional liability under FCA.

HHS-OIG, as well as the Department of Justice, discloses named cases of statutory violations on their websites. A few random 2019 examples include a New York licensed doctor was convicted of nine counts in connection with Oxycodone and Fentanyl diversion scheme; a Newton, Mass., geriatrician agreed to pay $680,000 to resolve allegations that he violated the False Claims Act by submitting inflated claims to Medicare and the Massachusetts Medicaid program (MassHealth) for care rendered to nursing home patients; and two Clermont, Fla., ophthalmologists agreed to pay a combined total of $157,312.32 to resolve allegations that they violated FCA by knowingly billing the government for mutually exclusive eyelid repair surgeries.
 

Anti-Kickback Statute (AKS)

AKS (42 U.S.C. § 1320a-7b[b]) is a criminal law that prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by federal health care programs. Remuneration includes anything of value and can take many forms besides cash, such as free rent, lavish travel, and excessive compensation for medical directorships or consultancies. Rewarding a referral source may be acceptable in some industries, but is a crime in federal health care programs.

Moreover, the statute covers both the payers of kickbacks (those who offer or pay remuneration) and the recipients of kickbacks. Each party’s intent is a key element of their liability under AKS. Physicians who pay or accept kickbacks face penalties of up to $50,000 per kickback plus three times the amount of the remuneration and criminal prosecution. As an example, a Tulsa, Okla., doctor earlier this year agreed to pay the government $84,666.42 for allegedly accepting illegal kickback payments from a pharmacy, and in another case, a marketer agreed to pay nearly $340,000 for receiving kickbacks in exchange for prescription referrals.

A physician is an attractive target for kickback schemes. The kickback prohibition applies to all sources, even patients. For example, where the Medicare and Medicaid programs require patients to be responsible for copays for services, the health care provider is generally required to collect that money from the patients. Advertising the forgiveness of copayments or routinely waiving these copays would violate AKS. However, one may waive a copayment when a patient cannot afford to pay one or is uninsured. AKS also imposes civil monetary penalties on physicians who offer remuneration to Medicare and Medicaid beneficiaries to influence them to use their services. Note that the government does not need to prove patient harm or financial loss to show that a violation has occurred, and physicians can be guilty even if they rendered services that are medically necessary.

There are so-called safe harbors that protect certain payment and business practices from running afoul of AKS. The rules and requirements are complex, and require full understanding and strict adherence.⁴
 

Physician Self-Referral Law

The Physician Self-Referral Law (42 U.S.C. § 1395nn), commonly referred to as the Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. Financial relationships include both ownership/investment interests and compensation arrangements. A partial list of “designated health services” includes services related to clinical laboratory, physical therapy, radiology, parenteral and enteral supplies, prosthetic devices and supplies, home health care outpatient prescription drugs, and inpatient and outpatient hospital services. This list is not meant to be an exhaustive one.

Stark is a strict liability statute, which means proof of specific intent to violate the law is not required. The law prohibits the submission, or causing the submission, of claims in violation of the law’s restrictions on referrals. Penalties for physicians who violate the Stark law include fines, as well as exclusion from participation in federal health care programs. Like AKS, Stark law features its own safe harbors.
 

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some materials may have been discussed in earlier columns. For additional information, readers may contact the author at siang@hawaii.edu.
 

References

1. HHS Office of Inspector General. About OIG. https://oig.hhs.gov/about-oig/about-us/index.asp

2. HHS Office of Inspector General. OIG most wanted fugitives.

3. HHS Office of Inspector General. “Physician education training materials.” A roadmap for new physicians: Avoiding Medicare and Medicaid fraud and abuse.

4. HHS Office of Inspector General. Safe harbor regulations.
 

Question: Which one of the following statements is incorrect?

A. Office of Inspector General (OIG) is a federal agency of Department of Health & Human Services (HHS) that investigates statutory violations of health care fraud and abuse.

B. The three main legal minefields for physicians are false claims, kickbacks, and self-referrals.

C. Jail terms are part of the penalties provided by law.

D. OIG is also responsible for excluding violators from participating in Medicare/Medicaid programs, as well as curtailing a physician’s license to practice.

E. A private citizen can file a qui tam lawsuit against an errant practitioner or health care entity for fraud and abuse.



Answer: D. Health care fraud, waste, and abuse consume some 10% of federal health expenditures despite well-established laws that attempt to prevent and reduce such losses. The three key fraud and abuse laws that affect physicians are the False Claims Act (FCA), Anti-Kickback Statute (AKS), and Physician Self-Referral Law (Stark law). The Department of Health & Human Services (HHS) Office of Inspector General, as well as the Department of Justice and the Centers for Medicare & Medicaid Services are charged with enforcing these and other laws like the Emergency Medical Treatment and Labor Act. Their web pages, referenced throughout this article, contain a wealth of information for the practitioner.

The term “Office of Inspector General” (OIG) refers to the oversight division of a federal or state agency charged with identifying and investigating fraud, waste, abuse, and mismanagement within that department or agency. There are currently 73 separate federal offices of inspectors general, which employ armed and unarmed criminal investigators, auditors, forensic auditors called “audigators,” and a variety of other specialists. An Act of Congress in 1976 established the first OIG under HHS. Besides being the first, HHS-OIG is also the largest, with a staff of approximately 1,600. A majority of resources goes toward the oversight of Medicare and Medicaid, as well as programs under other HHS institutions such as the Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration.¹

HHS-OIG has the authority to seek civil monetary penalties, assessments, and exclusion against an individual or entity based on a wide variety of prohibited conduct affecting federal health care programs. Stiff penalties are regularly assessed against violators, and jail terms are not uncommon; however, it has no direct jurisdictions over physician licensure or nonfederal programs. The government maintains a pictorial list of its most wanted health care fugitives2 and provides an excellent set of Physician Education Training Materials on its website.³
 

False Claims Act (FCA)

In the health care arena, violation of FCA (31 U.S.C. §§3729-3733) is the foremost infraction. False claims by physicians can include billing for noncovered services such as experimental treatments, double billing, billing the government as the primary payer, or regularly waiving deductibles and copayments, as well as quality of care issues and unnecessary services. Wrongdoing also includes knowingly using another patient’s name for purposes of, say, federal drug coverage, billing for no-shows, and misrepresenting the diagnosis to justify services, as well as other claims. In the modern doctor’s office, the EMR enables easy check-offs on a preprinted form as documentation of actual work done. However, fraud is implicated if the information is deliberately misleading such as for purposes of upcoding. Importantly, physicians are liable for the actions of their office staff, so it is prudent to oversee and supervise all such activities. Naturally, one should document all claims that are sent and know the rules for allowable and excluded services.

Tan_Siang_Yong_web.jpg

FCA is an old law that was first enacted in 1863. It imposes liability for submitting a payment demand to the federal government where there is actual or constructive knowledge that the claim is false. Intent to defraud is not a required element but knowing or showing reckless disregard of the truth is. However, an error that is negligently committed is insufficient to constitute a violation. Penalties include treble damages, costs and attorney fees, and fines of $11,000 per false claim, as well as possible imprisonment and criminal fines. A so-called whistle-blower may file a lawsuit on behalf of the government and is entitled to a percentage of any recoveries. Whistle-blowers may be current or ex-business partners, hospital or office staff, patients, or competitors. The fact that a claim results from a kickback or is made in violation of the Stark law (discussed below) may also render it fraudulent, thus creating additional liability under FCA.

HHS-OIG, as well as the Department of Justice, discloses named cases of statutory violations on their websites. A few random 2019 examples include a New York licensed doctor was convicted of nine counts in connection with Oxycodone and Fentanyl diversion scheme; a Newton, Mass., geriatrician agreed to pay $680,000 to resolve allegations that he violated the False Claims Act by submitting inflated claims to Medicare and the Massachusetts Medicaid program (MassHealth) for care rendered to nursing home patients; and two Clermont, Fla., ophthalmologists agreed to pay a combined total of $157,312.32 to resolve allegations that they violated FCA by knowingly billing the government for mutually exclusive eyelid repair surgeries.
 

Anti-Kickback Statute (AKS)

AKS (42 U.S.C. § 1320a-7b[b]) is a criminal law that prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by federal health care programs. Remuneration includes anything of value and can take many forms besides cash, such as free rent, lavish travel, and excessive compensation for medical directorships or consultancies. Rewarding a referral source may be acceptable in some industries, but is a crime in federal health care programs.

Moreover, the statute covers both the payers of kickbacks (those who offer or pay remuneration) and the recipients of kickbacks. Each party’s intent is a key element of their liability under AKS. Physicians who pay or accept kickbacks face penalties of up to $50,000 per kickback plus three times the amount of the remuneration and criminal prosecution. As an example, a Tulsa, Okla., doctor earlier this year agreed to pay the government $84,666.42 for allegedly accepting illegal kickback payments from a pharmacy, and in another case, a marketer agreed to pay nearly $340,000 for receiving kickbacks in exchange for prescription referrals.

A physician is an attractive target for kickback schemes. The kickback prohibition applies to all sources, even patients. For example, where the Medicare and Medicaid programs require patients to be responsible for copays for services, the health care provider is generally required to collect that money from the patients. Advertising the forgiveness of copayments or routinely waiving these copays would violate AKS. However, one may waive a copayment when a patient cannot afford to pay one or is uninsured. AKS also imposes civil monetary penalties on physicians who offer remuneration to Medicare and Medicaid beneficiaries to influence them to use their services. Note that the government does not need to prove patient harm or financial loss to show that a violation has occurred, and physicians can be guilty even if they rendered services that are medically necessary.

There are so-called safe harbors that protect certain payment and business practices from running afoul of AKS. The rules and requirements are complex, and require full understanding and strict adherence.⁴
 

Physician Self-Referral Law

The Physician Self-Referral Law (42 U.S.C. § 1395nn), commonly referred to as the Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. Financial relationships include both ownership/investment interests and compensation arrangements. A partial list of “designated health services” includes services related to clinical laboratory, physical therapy, radiology, parenteral and enteral supplies, prosthetic devices and supplies, home health care outpatient prescription drugs, and inpatient and outpatient hospital services. This list is not meant to be an exhaustive one.

Stark is a strict liability statute, which means proof of specific intent to violate the law is not required. The law prohibits the submission, or causing the submission, of claims in violation of the law’s restrictions on referrals. Penalties for physicians who violate the Stark law include fines, as well as exclusion from participation in federal health care programs. Like AKS, Stark law features its own safe harbors.
 

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some materials may have been discussed in earlier columns. For additional information, readers may contact the author at siang@hawaii.edu.
 

References

1. HHS Office of Inspector General. About OIG. https://oig.hhs.gov/about-oig/about-us/index.asp

2. HHS Office of Inspector General. OIG most wanted fugitives.

3. HHS Office of Inspector General. “Physician education training materials.” A roadmap for new physicians: Avoiding Medicare and Medicaid fraud and abuse.

4. HHS Office of Inspector General. Safe harbor regulations.
 

Question: Which one of the following statements is incorrect?

A. Office of Inspector General (OIG) is a federal agency of Department of Health & Human Services (HHS) that investigates statutory violations of health care fraud and abuse.

B. The three main legal minefields for physicians are false claims, kickbacks, and self-referrals.

C. Jail terms are part of the penalties provided by law.

D. OIG is also responsible for excluding violators from participating in Medicare/Medicaid programs, as well as curtailing a physician’s license to practice.

E. A private citizen can file a qui tam lawsuit against an errant practitioner or health care entity for fraud and abuse.



Answer: D. Health care fraud, waste, and abuse consume some 10% of federal health expenditures despite well-established laws that attempt to prevent and reduce such losses. The three key fraud and abuse laws that affect physicians are the False Claims Act (FCA), Anti-Kickback Statute (AKS), and Physician Self-Referral Law (Stark law). The Department of Health & Human Services (HHS) Office of Inspector General, as well as the Department of Justice and the Centers for Medicare & Medicaid Services are charged with enforcing these and other laws like the Emergency Medical Treatment and Labor Act. Their web pages, referenced throughout this article, contain a wealth of information for the practitioner.

The term “Office of Inspector General” (OIG) refers to the oversight division of a federal or state agency charged with identifying and investigating fraud, waste, abuse, and mismanagement within that department or agency. There are currently 73 separate federal offices of inspectors general, which employ armed and unarmed criminal investigators, auditors, forensic auditors called “audigators,” and a variety of other specialists. An Act of Congress in 1976 established the first OIG under HHS. Besides being the first, HHS-OIG is also the largest, with a staff of approximately 1,600. A majority of resources goes toward the oversight of Medicare and Medicaid, as well as programs under other HHS institutions such as the Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration.¹

HHS-OIG has the authority to seek civil monetary penalties, assessments, and exclusion against an individual or entity based on a wide variety of prohibited conduct affecting federal health care programs. Stiff penalties are regularly assessed against violators, and jail terms are not uncommon; however, it has no direct jurisdictions over physician licensure or nonfederal programs. The government maintains a pictorial list of its most wanted health care fugitives2 and provides an excellent set of Physician Education Training Materials on its website.³
 

False Claims Act (FCA)

In the health care arena, violation of FCA (31 U.S.C. §§3729-3733) is the foremost infraction. False claims by physicians can include billing for noncovered services such as experimental treatments, double billing, billing the government as the primary payer, or regularly waiving deductibles and copayments, as well as quality of care issues and unnecessary services. Wrongdoing also includes knowingly using another patient’s name for purposes of, say, federal drug coverage, billing for no-shows, and misrepresenting the diagnosis to justify services, as well as other claims. In the modern doctor’s office, the EMR enables easy check-offs on a preprinted form as documentation of actual work done. However, fraud is implicated if the information is deliberately misleading such as for purposes of upcoding. Importantly, physicians are liable for the actions of their office staff, so it is prudent to oversee and supervise all such activities. Naturally, one should document all claims that are sent and know the rules for allowable and excluded services.

Tan_Siang_Yong_web.jpg

FCA is an old law that was first enacted in 1863. It imposes liability for submitting a payment demand to the federal government where there is actual or constructive knowledge that the claim is false. Intent to defraud is not a required element but knowing or showing reckless disregard of the truth is. However, an error that is negligently committed is insufficient to constitute a violation. Penalties include treble damages, costs and attorney fees, and fines of $11,000 per false claim, as well as possible imprisonment and criminal fines. A so-called whistle-blower may file a lawsuit on behalf of the government and is entitled to a percentage of any recoveries. Whistle-blowers may be current or ex-business partners, hospital or office staff, patients, or competitors. The fact that a claim results from a kickback or is made in violation of the Stark law (discussed below) may also render it fraudulent, thus creating additional liability under FCA.

HHS-OIG, as well as the Department of Justice, discloses named cases of statutory violations on their websites. A few random 2019 examples include a New York licensed doctor was convicted of nine counts in connection with Oxycodone and Fentanyl diversion scheme; a Newton, Mass., geriatrician agreed to pay $680,000 to resolve allegations that he violated the False Claims Act by submitting inflated claims to Medicare and the Massachusetts Medicaid program (MassHealth) for care rendered to nursing home patients; and two Clermont, Fla., ophthalmologists agreed to pay a combined total of $157,312.32 to resolve allegations that they violated FCA by knowingly billing the government for mutually exclusive eyelid repair surgeries.
 

Anti-Kickback Statute (AKS)

AKS (42 U.S.C. § 1320a-7b[b]) is a criminal law that prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by federal health care programs. Remuneration includes anything of value and can take many forms besides cash, such as free rent, lavish travel, and excessive compensation for medical directorships or consultancies. Rewarding a referral source may be acceptable in some industries, but is a crime in federal health care programs.

Moreover, the statute covers both the payers of kickbacks (those who offer or pay remuneration) and the recipients of kickbacks. Each party’s intent is a key element of their liability under AKS. Physicians who pay or accept kickbacks face penalties of up to $50,000 per kickback plus three times the amount of the remuneration and criminal prosecution. As an example, a Tulsa, Okla., doctor earlier this year agreed to pay the government $84,666.42 for allegedly accepting illegal kickback payments from a pharmacy, and in another case, a marketer agreed to pay nearly $340,000 for receiving kickbacks in exchange for prescription referrals.

A physician is an attractive target for kickback schemes. The kickback prohibition applies to all sources, even patients. For example, where the Medicare and Medicaid programs require patients to be responsible for copays for services, the health care provider is generally required to collect that money from the patients. Advertising the forgiveness of copayments or routinely waiving these copays would violate AKS. However, one may waive a copayment when a patient cannot afford to pay one or is uninsured. AKS also imposes civil monetary penalties on physicians who offer remuneration to Medicare and Medicaid beneficiaries to influence them to use their services. Note that the government does not need to prove patient harm or financial loss to show that a violation has occurred, and physicians can be guilty even if they rendered services that are medically necessary.

There are so-called safe harbors that protect certain payment and business practices from running afoul of AKS. The rules and requirements are complex, and require full understanding and strict adherence.⁴
 

Physician Self-Referral Law

The Physician Self-Referral Law (42 U.S.C. § 1395nn), commonly referred to as the Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. Financial relationships include both ownership/investment interests and compensation arrangements. A partial list of “designated health services” includes services related to clinical laboratory, physical therapy, radiology, parenteral and enteral supplies, prosthetic devices and supplies, home health care outpatient prescription drugs, and inpatient and outpatient hospital services. This list is not meant to be an exhaustive one.

Stark is a strict liability statute, which means proof of specific intent to violate the law is not required. The law prohibits the submission, or causing the submission, of claims in violation of the law’s restrictions on referrals. Penalties for physicians who violate the Stark law include fines, as well as exclusion from participation in federal health care programs. Like AKS, Stark law features its own safe harbors.
 

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some materials may have been discussed in earlier columns. For additional information, readers may contact the author at siang@hawaii.edu.
 

References

1. HHS Office of Inspector General. About OIG. https://oig.hhs.gov/about-oig/about-us/index.asp

2. HHS Office of Inspector General. OIG most wanted fugitives.

3. HHS Office of Inspector General. “Physician education training materials.” A roadmap for new physicians: Avoiding Medicare and Medicaid fraud and abuse.

4. HHS Office of Inspector General. Safe harbor regulations.
 

On May 24, 2011, a 53-year-old woman presented to a Wisconsin hospital emergency ­department (ED) with complaints of severe abdominal pain, a rapid heartbeat, and a fever of 101.3°F. During her 9-hour visit, she was treated by a PA and his supervising physician. She was seen by the physician for a total of 6 minutes; the rest of her care was provided by the PA. The patient was discharged around midnight with instructions to contact her gynecologist in the morning for management of uterine fibroids. At the time of discharge, her temperature was 102.9°F.

The following day, May 25, the patient collapsed in her home and was transported to another hospital. She was treated for septic shock from a group A streptococcus infection. Although the infection was halted, the patient sustained ischemic damage to her extremities and a month later required amputation of her 4 limbs.The plaintiff claimed that the supervising physician was negligent in failing to diagnose the strep A infection, which, left undetected, led to septic shock. She also alleged that the PA should have recognized the potential for her condition’s severity to quickly escalate. She maintained that the supervising physician should have been more involved in her case because of its complexity.

Plaintiff’s counsel also argued that the PA should have provided “alternative medical diagnoses,” which would have prompted consideration of other treatment options. The plaintiff contended that under Wisconsin’s informed consent law, both the PA and the physician failed to disclose enough information about her condition and failed to inform her of any choices for treatment.

The defense argued that the plaintiff received proper treatment based on the information available to the providers at the time.

VERDICT

The jury found for the plaintiff and apportioned 65% liability to the physician and 35% liability to the PA. A total of $25,342,096 was awarded to the plaintiff.

COMMENTARY

This is a huge verdict. Cases involving group A strep or necrotizing fasciitis frequently give rise to large medical malpractice verdicts, because everything about them is difficult to defend: Although there is typically trivial to no trauma involved, the wounds from these infections provide explicit images of damage, intra­operatively and postoperatively. Vasopressors required for hemodynamic support or sepsis itself frequently result in limb ischemia, gangrene, and amputation. In this case, the plaintiff, as a quadruple amputee, was a sympathetic and impressive courtroom presence—the personal toll was evident to anyone in the room.

Two providers—a PA and a physician—saw the patient. We are told only that she complained of severe abdominal pain, rapid heartbeat, and fever, which increased at some point during her ED stay. We aren’t given specifics on the rest of the patient’s vital signs or examination details. However, we can infer that the exam and lab findings were not impressive, because they weren’t mentioned in the case report. But as a result of the failure to catch the group A strep infection, the plaintiff suffered what one judge hearing the case described as a harrowing and unimaginable ordeal: the life-changing amputation of 4 limbs.¹ While the jury did not find the PA or physician negligent, they still found the clinicians liable and awarded a staggering verdict.

Continue to: How could this happen?

How could this happen? The answer is the theory of recovery: The jury found that the physician and the PA failed to provide the patient with informed consent in the form of “alternative medical diagnoses.”² The plaintiff’s attorney argued that the patient was never told a life-threatening bacterial infection was one possible diagnosis and claimed that if she had known, the patient would have pursued other treatment.

As in many malpractice cases, the plaintiff alleged failure to diagnose and failure to provide informed consent. Depending on state law, there are 3 standards for informed consent: subjective patient, reasonable patient, and reasonable physician.³ About half of the states have a physician-focused standard, while the other half have a patient-focused standard.³

Under the subjective patient standard, we would ask, “What would this patient need to know and understand to make an informed decision?”⁴ The subjective standard requires the clinician to essentially “get in the head” of a specific patient to determine what he or she would want to know when making a medical decision. This standard is problematic because it requires the clinician to have an intimate familiarity with the patient’s belief system and medical decision-making process—a daunting requirement for many clinicians, particularly in the absence of a longstanding clinician-patient relationship, as is the case in most emergency settings. Thankfully, the subjective patient standard is not followed by most states that have a patient-focused standard.

Under the objective reasonable patient standard, we would ask “What would the average patient need to know to be an informed participant in the decision?”⁴ One could argue that this standard more adequately allows the patient to be an active participant in shared decision-making. However, the drawback is that what is “reasonable” often falls on a spectrum, which would require the clinician to gauge the volume and type of information a patient cohort would want to have when making a medical decision. Under this standard, the plaintiff must prove that the clinician omitted information that a reasonable patient would want to know. Therefore, these standards are more friendly to the plaintiff, whereas the reasonable physician standard is more defendant friendly.

To meet the standard of care under a reasonable physician standard, information must be provided to the patient that a “reasonably prudent practitioner in the same field of practice or specialty” would provide to a patient.⁵ For a plaintiff to successfully sue under this standard, the plaintiff’s expert must testify that a reasonably prudent physician would have disclosed the omitted information.⁶ The reasonable physician standard is obviously better for malpractice defendants.

Continue to: While reasonable clinicians...

While reasonable clinicians can disagree (as can reasonable patients), clinicians are more likely to be closer in opinion. Clinicians are a smaller group whose opinions are underpinned by similar education, training, and experience. By contrast, among the general population, beliefs held by one hypothetical “reasonable person” are much less settled, and in some cases, wildly divergent from another’s. For example, vaccine skepticism would probably be considered unreasonable in the majority of jury pools but absolutely reasonable in some. The large size of the general population, coupled with opinions untethered to any definable discipline, make the reasonable patient standard hard to predict.

Additionally, the reasonable physician standard forces the plaintiff to prove his or her case by producing an expert witness (clinician) to specifically testify that the standard of care required the defendant clinician to disclose certain specific information, and that disclosure was lacking. That is an important requirement. Under patient-focused standards, the plaintiff doesn’t need a medical expert on this point and can simply argue to the jury that a reasonable patient would require an exhaustive discussion of each possibility in the differential diagnosis. Therefore, I would argue that the reasonable physician standard is more predictable and workable and should be followed.

At the time of this case, Wisconsin’s informed consent law was based on the reasonable patient standard. As a result of this case, Wisconsin lawmakers changed the law to a “reasonable physician standard,” which states “any physician who treats a patient shall inform the patient about the availability of reasonable alternate medical modes of treatment and about the benefits and risks of these treatments.”⁷ However, the law stipulates that this duty to inform does not require disclosure of (among others):

• Detailed technical information that in all probability a patient would not understand
• Risks apparent or known to the patient
• Extremely remote possibilities that might falsely or detrimentally alarm the patient
• Information about alternate medical modes of treatment for any condition the physician has not included in his or her diagnosis at the time the physician informs the patient.⁷

Finally, this case involved an extremely high verdict of more than $25 million. It may surprise you to learn that many states have caps for medical malpractice awards for noneconomic damages, such as pain and suffering. If you’re having a holiday dinner with friends or family members who are plaintiff’s attorneys and you’re itching for a good argument, skip current politics and go all-in: How about liability caps, Uncle Jim? Get ready for a lively debate.

Of the $25 million verdict, $16.5 million was awarded for pain and suffering—the jury was obviously shocked by the extent of the life-changing nature of the plaintiff’s injuries. At the time of this case, Wisconsin had a cap of $750,000 for noneconomic damages.⁸ However, plaintiffs may challenge state constitutionality of these caps when they feel they have the right case, which the plaintiff and her attorney felt they did. Two lower courts found the state cap unconstitutional and gave the plaintiff the full award. But the state Supreme Court later reversed that decision, upholding the cap.¹ The court decided that the legislature had a rational basis for making the law and changes to it should occur through the legislature, not the courts. The dissenting justices argued that there was no rational basis for the $750,000 cap, because there was no evidence that clinicians would flee the state fearing malpractice liability, or practice more defensive medicine, or suffer runaway malpractice insurance premiums without the cap. As a result of this case, the cap was upheld, and there was a “lively debate” on this issue at the highest levels of government.

Continue to: IN SUM

Become familiar with your state’s informed consent laws. Involve patients in decision-making, and convey information related to reasonable treatment options and risks. Document all of these discussions. Lastly, state-level political discussions on issues of tort reform, caps, and malpractice matters are ongoing—so take notice.

[embed:render:related:node:208697]

[embed:render:related:node:207071]

[embed:render:related:node:205585]

On May 24, 2011, a 53-year-old woman presented to a Wisconsin hospital emergency ­department (ED) with complaints of severe abdominal pain, a rapid heartbeat, and a fever of 101.3°F. During her 9-hour visit, she was treated by a PA and his supervising physician. She was seen by the physician for a total of 6 minutes; the rest of her care was provided by the PA. The patient was discharged around midnight with instructions to contact her gynecologist in the morning for management of uterine fibroids. At the time of discharge, her temperature was 102.9°F.

The following day, May 25, the patient collapsed in her home and was transported to another hospital. She was treated for septic shock from a group A streptococcus infection. Although the infection was halted, the patient sustained ischemic damage to her extremities and a month later required amputation of her 4 limbs.The plaintiff claimed that the supervising physician was negligent in failing to diagnose the strep A infection, which, left undetected, led to septic shock. She also alleged that the PA should have recognized the potential for her condition’s severity to quickly escalate. She maintained that the supervising physician should have been more involved in her case because of its complexity.

Plaintiff’s counsel also argued that the PA should have provided “alternative medical diagnoses,” which would have prompted consideration of other treatment options. The plaintiff contended that under Wisconsin’s informed consent law, both the PA and the physician failed to disclose enough information about her condition and failed to inform her of any choices for treatment.

The defense argued that the plaintiff received proper treatment based on the information available to the providers at the time.

VERDICT

The jury found for the plaintiff and apportioned 65% liability to the physician and 35% liability to the PA. A total of $25,342,096 was awarded to the plaintiff.

COMMENTARY

This is a huge verdict. Cases involving group A strep or necrotizing fasciitis frequently give rise to large medical malpractice verdicts, because everything about them is difficult to defend: Although there is typically trivial to no trauma involved, the wounds from these infections provide explicit images of damage, intra­operatively and postoperatively. Vasopressors required for hemodynamic support or sepsis itself frequently result in limb ischemia, gangrene, and amputation. In this case, the plaintiff, as a quadruple amputee, was a sympathetic and impressive courtroom presence—the personal toll was evident to anyone in the room.

Two providers—a PA and a physician—saw the patient. We are told only that she complained of severe abdominal pain, rapid heartbeat, and fever, which increased at some point during her ED stay. We aren’t given specifics on the rest of the patient’s vital signs or examination details. However, we can infer that the exam and lab findings were not impressive, because they weren’t mentioned in the case report. But as a result of the failure to catch the group A strep infection, the plaintiff suffered what one judge hearing the case described as a harrowing and unimaginable ordeal: the life-changing amputation of 4 limbs.¹ While the jury did not find the PA or physician negligent, they still found the clinicians liable and awarded a staggering verdict.

Continue to: How could this happen?

How could this happen? The answer is the theory of recovery: The jury found that the physician and the PA failed to provide the patient with informed consent in the form of “alternative medical diagnoses.”² The plaintiff’s attorney argued that the patient was never told a life-threatening bacterial infection was one possible diagnosis and claimed that if she had known, the patient would have pursued other treatment.

As in many malpractice cases, the plaintiff alleged failure to diagnose and failure to provide informed consent. Depending on state law, there are 3 standards for informed consent: subjective patient, reasonable patient, and reasonable physician.³ About half of the states have a physician-focused standard, while the other half have a patient-focused standard.³

Under the subjective patient standard, we would ask, “What would this patient need to know and understand to make an informed decision?”⁴ The subjective standard requires the clinician to essentially “get in the head” of a specific patient to determine what he or she would want to know when making a medical decision. This standard is problematic because it requires the clinician to have an intimate familiarity with the patient’s belief system and medical decision-making process—a daunting requirement for many clinicians, particularly in the absence of a longstanding clinician-patient relationship, as is the case in most emergency settings. Thankfully, the subjective patient standard is not followed by most states that have a patient-focused standard.

Under the objective reasonable patient standard, we would ask “What would the average patient need to know to be an informed participant in the decision?”⁴ One could argue that this standard more adequately allows the patient to be an active participant in shared decision-making. However, the drawback is that what is “reasonable” often falls on a spectrum, which would require the clinician to gauge the volume and type of information a patient cohort would want to have when making a medical decision. Under this standard, the plaintiff must prove that the clinician omitted information that a reasonable patient would want to know. Therefore, these standards are more friendly to the plaintiff, whereas the reasonable physician standard is more defendant friendly.

To meet the standard of care under a reasonable physician standard, information must be provided to the patient that a “reasonably prudent practitioner in the same field of practice or specialty” would provide to a patient.⁵ For a plaintiff to successfully sue under this standard, the plaintiff’s expert must testify that a reasonably prudent physician would have disclosed the omitted information.⁶ The reasonable physician standard is obviously better for malpractice defendants.

Continue to: While reasonable clinicians...

While reasonable clinicians can disagree (as can reasonable patients), clinicians are more likely to be closer in opinion. Clinicians are a smaller group whose opinions are underpinned by similar education, training, and experience. By contrast, among the general population, beliefs held by one hypothetical “reasonable person” are much less settled, and in some cases, wildly divergent from another’s. For example, vaccine skepticism would probably be considered unreasonable in the majority of jury pools but absolutely reasonable in some. The large size of the general population, coupled with opinions untethered to any definable discipline, make the reasonable patient standard hard to predict.

Additionally, the reasonable physician standard forces the plaintiff to prove his or her case by producing an expert witness (clinician) to specifically testify that the standard of care required the defendant clinician to disclose certain specific information, and that disclosure was lacking. That is an important requirement. Under patient-focused standards, the plaintiff doesn’t need a medical expert on this point and can simply argue to the jury that a reasonable patient would require an exhaustive discussion of each possibility in the differential diagnosis. Therefore, I would argue that the reasonable physician standard is more predictable and workable and should be followed.

At the time of this case, Wisconsin’s informed consent law was based on the reasonable patient standard. As a result of this case, Wisconsin lawmakers changed the law to a “reasonable physician standard,” which states “any physician who treats a patient shall inform the patient about the availability of reasonable alternate medical modes of treatment and about the benefits and risks of these treatments.”⁷ However, the law stipulates that this duty to inform does not require disclosure of (among others):

• Detailed technical information that in all probability a patient would not understand
• Risks apparent or known to the patient
• Extremely remote possibilities that might falsely or detrimentally alarm the patient
• Information about alternate medical modes of treatment for any condition the physician has not included in his or her diagnosis at the time the physician informs the patient.⁷

Finally, this case involved an extremely high verdict of more than $25 million. It may surprise you to learn that many states have caps for medical malpractice awards for noneconomic damages, such as pain and suffering. If you’re having a holiday dinner with friends or family members who are plaintiff’s attorneys and you’re itching for a good argument, skip current politics and go all-in: How about liability caps, Uncle Jim? Get ready for a lively debate.

Of the $25 million verdict, $16.5 million was awarded for pain and suffering—the jury was obviously shocked by the extent of the life-changing nature of the plaintiff’s injuries. At the time of this case, Wisconsin had a cap of $750,000 for noneconomic damages.⁸ However, plaintiffs may challenge state constitutionality of these caps when they feel they have the right case, which the plaintiff and her attorney felt they did. Two lower courts found the state cap unconstitutional and gave the plaintiff the full award. But the state Supreme Court later reversed that decision, upholding the cap.¹ The court decided that the legislature had a rational basis for making the law and changes to it should occur through the legislature, not the courts. The dissenting justices argued that there was no rational basis for the $750,000 cap, because there was no evidence that clinicians would flee the state fearing malpractice liability, or practice more defensive medicine, or suffer runaway malpractice insurance premiums without the cap. As a result of this case, the cap was upheld, and there was a “lively debate” on this issue at the highest levels of government.

Continue to: IN SUM

Become familiar with your state’s informed consent laws. Involve patients in decision-making, and convey information related to reasonable treatment options and risks. Document all of these discussions. Lastly, state-level political discussions on issues of tort reform, caps, and malpractice matters are ongoing—so take notice.

[embed:render:related:node:208697]

[embed:render:related:node:207071]

[embed:render:related:node:205585]

On May 24, 2011, a 53-year-old woman presented to a Wisconsin hospital emergency ­department (ED) with complaints of severe abdominal pain, a rapid heartbeat, and a fever of 101.3°F. During her 9-hour visit, she was treated by a PA and his supervising physician. She was seen by the physician for a total of 6 minutes; the rest of her care was provided by the PA. The patient was discharged around midnight with instructions to contact her gynecologist in the morning for management of uterine fibroids. At the time of discharge, her temperature was 102.9°F.

The following day, May 25, the patient collapsed in her home and was transported to another hospital. She was treated for septic shock from a group A streptococcus infection. Although the infection was halted, the patient sustained ischemic damage to her extremities and a month later required amputation of her 4 limbs.The plaintiff claimed that the supervising physician was negligent in failing to diagnose the strep A infection, which, left undetected, led to septic shock. She also alleged that the PA should have recognized the potential for her condition’s severity to quickly escalate. She maintained that the supervising physician should have been more involved in her case because of its complexity.

Plaintiff’s counsel also argued that the PA should have provided “alternative medical diagnoses,” which would have prompted consideration of other treatment options. The plaintiff contended that under Wisconsin’s informed consent law, both the PA and the physician failed to disclose enough information about her condition and failed to inform her of any choices for treatment.

The defense argued that the plaintiff received proper treatment based on the information available to the providers at the time.

VERDICT

The jury found for the plaintiff and apportioned 65% liability to the physician and 35% liability to the PA. A total of $25,342,096 was awarded to the plaintiff.

COMMENTARY

This is a huge verdict. Cases involving group A strep or necrotizing fasciitis frequently give rise to large medical malpractice verdicts, because everything about them is difficult to defend: Although there is typically trivial to no trauma involved, the wounds from these infections provide explicit images of damage, intra­operatively and postoperatively. Vasopressors required for hemodynamic support or sepsis itself frequently result in limb ischemia, gangrene, and amputation. In this case, the plaintiff, as a quadruple amputee, was a sympathetic and impressive courtroom presence—the personal toll was evident to anyone in the room.

Two providers—a PA and a physician—saw the patient. We are told only that she complained of severe abdominal pain, rapid heartbeat, and fever, which increased at some point during her ED stay. We aren’t given specifics on the rest of the patient’s vital signs or examination details. However, we can infer that the exam and lab findings were not impressive, because they weren’t mentioned in the case report. But as a result of the failure to catch the group A strep infection, the plaintiff suffered what one judge hearing the case described as a harrowing and unimaginable ordeal: the life-changing amputation of 4 limbs.¹ While the jury did not find the PA or physician negligent, they still found the clinicians liable and awarded a staggering verdict.

Continue to: How could this happen?

How could this happen? The answer is the theory of recovery: The jury found that the physician and the PA failed to provide the patient with informed consent in the form of “alternative medical diagnoses.”² The plaintiff’s attorney argued that the patient was never told a life-threatening bacterial infection was one possible diagnosis and claimed that if she had known, the patient would have pursued other treatment.

As in many malpractice cases, the plaintiff alleged failure to diagnose and failure to provide informed consent. Depending on state law, there are 3 standards for informed consent: subjective patient, reasonable patient, and reasonable physician.³ About half of the states have a physician-focused standard, while the other half have a patient-focused standard.³

Under the subjective patient standard, we would ask, “What would this patient need to know and understand to make an informed decision?”⁴ The subjective standard requires the clinician to essentially “get in the head” of a specific patient to determine what he or she would want to know when making a medical decision. This standard is problematic because it requires the clinician to have an intimate familiarity with the patient’s belief system and medical decision-making process—a daunting requirement for many clinicians, particularly in the absence of a longstanding clinician-patient relationship, as is the case in most emergency settings. Thankfully, the subjective patient standard is not followed by most states that have a patient-focused standard.

Under the objective reasonable patient standard, we would ask “What would the average patient need to know to be an informed participant in the decision?”⁴ One could argue that this standard more adequately allows the patient to be an active participant in shared decision-making. However, the drawback is that what is “reasonable” often falls on a spectrum, which would require the clinician to gauge the volume and type of information a patient cohort would want to have when making a medical decision. Under this standard, the plaintiff must prove that the clinician omitted information that a reasonable patient would want to know. Therefore, these standards are more friendly to the plaintiff, whereas the reasonable physician standard is more defendant friendly.

To meet the standard of care under a reasonable physician standard, information must be provided to the patient that a “reasonably prudent practitioner in the same field of practice or specialty” would provide to a patient.⁵ For a plaintiff to successfully sue under this standard, the plaintiff’s expert must testify that a reasonably prudent physician would have disclosed the omitted information.⁶ The reasonable physician standard is obviously better for malpractice defendants.

Continue to: While reasonable clinicians...

While reasonable clinicians can disagree (as can reasonable patients), clinicians are more likely to be closer in opinion. Clinicians are a smaller group whose opinions are underpinned by similar education, training, and experience. By contrast, among the general population, beliefs held by one hypothetical “reasonable person” are much less settled, and in some cases, wildly divergent from another’s. For example, vaccine skepticism would probably be considered unreasonable in the majority of jury pools but absolutely reasonable in some. The large size of the general population, coupled with opinions untethered to any definable discipline, make the reasonable patient standard hard to predict.

Additionally, the reasonable physician standard forces the plaintiff to prove his or her case by producing an expert witness (clinician) to specifically testify that the standard of care required the defendant clinician to disclose certain specific information, and that disclosure was lacking. That is an important requirement. Under patient-focused standards, the plaintiff doesn’t need a medical expert on this point and can simply argue to the jury that a reasonable patient would require an exhaustive discussion of each possibility in the differential diagnosis. Therefore, I would argue that the reasonable physician standard is more predictable and workable and should be followed.

At the time of this case, Wisconsin’s informed consent law was based on the reasonable patient standard. As a result of this case, Wisconsin lawmakers changed the law to a “reasonable physician standard,” which states “any physician who treats a patient shall inform the patient about the availability of reasonable alternate medical modes of treatment and about the benefits and risks of these treatments.”⁷ However, the law stipulates that this duty to inform does not require disclosure of (among others):

• Detailed technical information that in all probability a patient would not understand
• Risks apparent or known to the patient
• Extremely remote possibilities that might falsely or detrimentally alarm the patient
• Information about alternate medical modes of treatment for any condition the physician has not included in his or her diagnosis at the time the physician informs the patient.⁷

Finally, this case involved an extremely high verdict of more than $25 million. It may surprise you to learn that many states have caps for medical malpractice awards for noneconomic damages, such as pain and suffering. If you’re having a holiday dinner with friends or family members who are plaintiff’s attorneys and you’re itching for a good argument, skip current politics and go all-in: How about liability caps, Uncle Jim? Get ready for a lively debate.

Of the $25 million verdict, $16.5 million was awarded for pain and suffering—the jury was obviously shocked by the extent of the life-changing nature of the plaintiff’s injuries. At the time of this case, Wisconsin had a cap of $750,000 for noneconomic damages.⁸ However, plaintiffs may challenge state constitutionality of these caps when they feel they have the right case, which the plaintiff and her attorney felt they did. Two lower courts found the state cap unconstitutional and gave the plaintiff the full award. But the state Supreme Court later reversed that decision, upholding the cap.¹ The court decided that the legislature had a rational basis for making the law and changes to it should occur through the legislature, not the courts. The dissenting justices argued that there was no rational basis for the $750,000 cap, because there was no evidence that clinicians would flee the state fearing malpractice liability, or practice more defensive medicine, or suffer runaway malpractice insurance premiums without the cap. As a result of this case, the cap was upheld, and there was a “lively debate” on this issue at the highest levels of government.

Continue to: IN SUM

Become familiar with your state’s informed consent laws. Involve patients in decision-making, and convey information related to reasonable treatment options and risks. Document all of these discussions. Lastly, state-level political discussions on issues of tort reform, caps, and malpractice matters are ongoing—so take notice.

[embed:render:related:node:208697]

[embed:render:related:node:207071]

[embed:render:related:node:205585]