Health Policy

In a “significant modernization effort,” the VA has removed nearly 8 million paper files from 60 locations in under 22 months. The files are scanned into the electronic claims process system, which means faster claims decisions, the VA says.

According to the VA, it is a milestone in a years-long project to improve the veteran experience and streamline claims processes. The project began in 2013 when the VA began removing paper records from its regional offices to save space and money. It then expanded in 2016 when the VA launched the File Bank Extraction initiative, which removed more than 1.7 million paper claims files. In 2017, the agency began extracting 6.1 million paper records held in the Records Control Division (RCD) in St. Louis.

The records are temporarily stored in a secure facility certified by the National Archives and Records Administration, where they are inventoried, prioritized, and sent to VA vendors for scanning into the VA’s Veterans Benefits Management System.

The VA is negotiating to return the RCD’s leased warehouse space to the General Services Administration, estimating the move will save roughly $1.8 million per year.

Source:
VA achieves major milestone in effort to modernize claims processing [news release]. Washington, DC: U.S. Department of Veteran Affairs Office of Public Affairs and Media Relations; October 23,2018.  https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5131. Accessed October 31, 2018.

In a “significant modernization effort,” the VA has removed nearly 8 million paper files from 60 locations in under 22 months. The files are scanned into the electronic claims process system, which means faster claims decisions, the VA says.

According to the VA, it is a milestone in a years-long project to improve the veteran experience and streamline claims processes. The project began in 2013 when the VA began removing paper records from its regional offices to save space and money. It then expanded in 2016 when the VA launched the File Bank Extraction initiative, which removed more than 1.7 million paper claims files. In 2017, the agency began extracting 6.1 million paper records held in the Records Control Division (RCD) in St. Louis.

The records are temporarily stored in a secure facility certified by the National Archives and Records Administration, where they are inventoried, prioritized, and sent to VA vendors for scanning into the VA’s Veterans Benefits Management System.

The VA is negotiating to return the RCD’s leased warehouse space to the General Services Administration, estimating the move will save roughly $1.8 million per year.

Source:
VA achieves major milestone in effort to modernize claims processing [news release]. Washington, DC: U.S. Department of Veteran Affairs Office of Public Affairs and Media Relations; October 23,2018.  https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5131. Accessed October 31, 2018.

In a “significant modernization effort,” the VA has removed nearly 8 million paper files from 60 locations in under 22 months. The files are scanned into the electronic claims process system, which means faster claims decisions, the VA says.

According to the VA, it is a milestone in a years-long project to improve the veteran experience and streamline claims processes. The project began in 2013 when the VA began removing paper records from its regional offices to save space and money. It then expanded in 2016 when the VA launched the File Bank Extraction initiative, which removed more than 1.7 million paper claims files. In 2017, the agency began extracting 6.1 million paper records held in the Records Control Division (RCD) in St. Louis.

The records are temporarily stored in a secure facility certified by the National Archives and Records Administration, where they are inventoried, prioritized, and sent to VA vendors for scanning into the VA’s Veterans Benefits Management System.

The VA is negotiating to return the RCD’s leased warehouse space to the General Services Administration, estimating the move will save roughly $1.8 million per year.

Source:
VA achieves major milestone in effort to modernize claims processing [news release]. Washington, DC: U.S. Department of Veteran Affairs Office of Public Affairs and Media Relations; October 23,2018.  https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5131. Accessed October 31, 2018.

Hospital costs for children with firearm-related injuries rose from 2006 to 2014, while the incidence of emergency department visits declined over the same period, according to the first national study of such visits in children.

Median charges were $2,445 for an ED visit and $44,966 for inpatient management of individuals under 18 years of age for the entire study period, with both increasing over time and all data adjusted to 2018 dollars. The median charge for an ED visit rose from over $2,100 in 2006 to under $2,900 in 2014, while the inpatient median increased from approximately $43,000 to about $59,000. Total charges for firearm-related injuries in children were $2.5 billion during 2006-2014, with a mean of $270 million a year, Faiz Gani, MBBS, and Joseph K. Canner, MHS, said in JAMA Pediatrics.

The overall incidence of ED visits was 11.3/100,000 children under 18 years of age for the study period, with a steady decline seen from 2006, when incidence was about 15 visits/100,000, to 10/100,000 in 2014. The rate had dropped to about 7.5 visits/100,000 in 2013 before increasing in 2014, Dr. Gani and Mr. Canner of Johns Hopkins University, Baltimore, said based on data for 75,086 visits from the Nationwide Emergency Medicine Sample.

A trend observed throughout the course of the study was the higher incidence of ED visits among males, which was consistently more than five times higher than that of females. The highest incidence by age group was 85.9/100,000 for males aged 15-17 years. The most common intent of injury was assault at 49%, with unintentional injury next at 39% and suicide at 2%, the investigators reported.

This “first and largest nationally representative study” demonstrates the “substantial clinical and financial burden associated with firearm-related injuries among pediatric patients. Moving forward, additional resources and funds should be allocated to the study of firearm-related injuries. Only through further understanding of the social, political, and health-related risk factors for these injuries can we develop and implement effective policies to address this public health concern, wrote Dr. Gani and Mr. Canner, who reported no conflicts of interest.

[email protected]

SOURCE: JAMA Pediatr. 2018 Oct 29. doi: 10.1001/jamapediatrics.2018.3091.

Hospital costs for children with firearm-related injuries rose from 2006 to 2014, while the incidence of emergency department visits declined over the same period, according to the first national study of such visits in children.

Median charges were $2,445 for an ED visit and $44,966 for inpatient management of individuals under 18 years of age for the entire study period, with both increasing over time and all data adjusted to 2018 dollars. The median charge for an ED visit rose from over $2,100 in 2006 to under $2,900 in 2014, while the inpatient median increased from approximately $43,000 to about $59,000. Total charges for firearm-related injuries in children were $2.5 billion during 2006-2014, with a mean of $270 million a year, Faiz Gani, MBBS, and Joseph K. Canner, MHS, said in JAMA Pediatrics.

The overall incidence of ED visits was 11.3/100,000 children under 18 years of age for the study period, with a steady decline seen from 2006, when incidence was about 15 visits/100,000, to 10/100,000 in 2014. The rate had dropped to about 7.5 visits/100,000 in 2013 before increasing in 2014, Dr. Gani and Mr. Canner of Johns Hopkins University, Baltimore, said based on data for 75,086 visits from the Nationwide Emergency Medicine Sample.

A trend observed throughout the course of the study was the higher incidence of ED visits among males, which was consistently more than five times higher than that of females. The highest incidence by age group was 85.9/100,000 for males aged 15-17 years. The most common intent of injury was assault at 49%, with unintentional injury next at 39% and suicide at 2%, the investigators reported.

This “first and largest nationally representative study” demonstrates the “substantial clinical and financial burden associated with firearm-related injuries among pediatric patients. Moving forward, additional resources and funds should be allocated to the study of firearm-related injuries. Only through further understanding of the social, political, and health-related risk factors for these injuries can we develop and implement effective policies to address this public health concern, wrote Dr. Gani and Mr. Canner, who reported no conflicts of interest.

[email protected]

SOURCE: JAMA Pediatr. 2018 Oct 29. doi: 10.1001/jamapediatrics.2018.3091.

Hospital costs for children with firearm-related injuries rose from 2006 to 2014, while the incidence of emergency department visits declined over the same period, according to the first national study of such visits in children.

Median charges were $2,445 for an ED visit and $44,966 for inpatient management of individuals under 18 years of age for the entire study period, with both increasing over time and all data adjusted to 2018 dollars. The median charge for an ED visit rose from over $2,100 in 2006 to under $2,900 in 2014, while the inpatient median increased from approximately $43,000 to about $59,000. Total charges for firearm-related injuries in children were $2.5 billion during 2006-2014, with a mean of $270 million a year, Faiz Gani, MBBS, and Joseph K. Canner, MHS, said in JAMA Pediatrics.

The overall incidence of ED visits was 11.3/100,000 children under 18 years of age for the study period, with a steady decline seen from 2006, when incidence was about 15 visits/100,000, to 10/100,000 in 2014. The rate had dropped to about 7.5 visits/100,000 in 2013 before increasing in 2014, Dr. Gani and Mr. Canner of Johns Hopkins University, Baltimore, said based on data for 75,086 visits from the Nationwide Emergency Medicine Sample.

A trend observed throughout the course of the study was the higher incidence of ED visits among males, which was consistently more than five times higher than that of females. The highest incidence by age group was 85.9/100,000 for males aged 15-17 years. The most common intent of injury was assault at 49%, with unintentional injury next at 39% and suicide at 2%, the investigators reported.

This “first and largest nationally representative study” demonstrates the “substantial clinical and financial burden associated with firearm-related injuries among pediatric patients. Moving forward, additional resources and funds should be allocated to the study of firearm-related injuries. Only through further understanding of the social, political, and health-related risk factors for these injuries can we develop and implement effective policies to address this public health concern, wrote Dr. Gani and Mr. Canner, who reported no conflicts of interest.

[email protected]

SOURCE: JAMA Pediatr. 2018 Oct 29. doi: 10.1001/jamapediatrics.2018.3091.

An initial report from the Endocrine Society has raised concerns about bisphenol A use in products such as food and drink containers, toys, and medical devices, citing recent data that show the synthetic compound is linked to reproductive, behavioral, and metabolic disorders.

Although the Food and Drug Administration classifies bisphenol A (BPA) as safe to use in food containers, there have been hundreds of studies tying BPA to health problems such as “neurological outcomes, abnormal metabolism, reproductive effects as well as growth and development effects,” according to Laura N. Vandenberg, PhD, an Endocrine Society spokesperson, who spoke at a press briefing held on Oct. 23. Dr. Vandenberg explained the FDA’s 2014 position on BPA safety comes from a small subset of publicly available data, but these are not all the data on BPA, as some academic data are still under review.

The Endocrine Society recently held the news conference because they are concerned the FDA has “jumped the gun” before all the research has been published. “Even considering the fact that the data that have been presented by FDA have been interpreted by FDA as suggesting that BPA is safe, scientists still disagree,” Dr. Vandenberg said.

However, the Endocrine Society noted there is an issue with the current literature, which can be used to interpret and report different results. Heather Patisaul, PhD, cited a joint report from the Food and Agriculture Organization of the United Nations and World Health Organization, as well as a report from the National Toxicology Program (NTP), to illustrate this problem. Both reports expressed concern about BPA safety but took different approaches and a wider viewpoint, and came to different conclusions, she said.

“These two documents both concluded that there was some concern about bisphenol A and behavior, but they identified there was a big problem with trying to pool all this literature together because the experimental protocols were different, the animals were different, the dosing was different,” she said. “It was not a very harmonious literature.”

To combat this issue, the National Institute of Environmental Health Sciences and the FDA have funded the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) study. Dr. Patisaul said CLARITY-BPA is “the most ambitious project that’s ever been done” to study the health effects of a chemical, bringing together scientists from academic institutions, the NTP, and the FDA to help create data for risk assessment.

“The goal was to create this culture of partnership and communication between the agencies that have to make these decisions about safety and the scientists who are producing the data that’s trying to inform those assessments,” Dr. Patisaul said.

Dr. Vandenberg and Dr. Patisaul presented results from the CLARITY-BPA Core Study, which studied the effects of continuous doses of BPA in rats starting from 6 days of pregnancy; after birth, the rat offspring were fed doses of BPA for 1 year and 2 years. A second group of rats in a stop-dose group were fed BPA from early development, where the mothers were fed BPA at day 6 of pregnancy and the offspring fed BPA from birth until puberty (21 days) and followed for 1 year or 2 years. The researchers also examined 2.5 mcg/kg, 25 mcg/kg, 250 mcg/kg, 2,500 mcg/kg, and 25,000 mcg/kg doses of BPA exposure as well as continuous ethinyl estradiol exposure as a positive control.

In the FDA Core Study, there was a significantly increased incidence of mammary adenocarcinoma in the stop dose group and inflammation of the dorsal and lateral lobes of the prostate in the continuous dose group at a dose of 2.5 mcg/kg. In addition, kidney nephropathy and increased body weight in female rats in the continuous group were also seen at the 2.5 mcg/kg dose, Dr. Vandenberg noted.

“I think one of the reasons why FDA is dismissing those low-dose effects is that there’s an expectation with increasing dose, there should be an increase in an effect,” Dr. Vandenberg said.

In the low-dose range, BPA could be acting as a hormone such as estrogen, but also could be acting through other hormone receptors or as a toxicant at the high-dose range, she explained.

Dr. Patisaul also presented results of BPA-related effects on the brain and behavior in the existing literature from the TEDX Low-dose Bisphenol A project, which is a comparison of 391 in vivo and in vitro studies of BPA prior to 2009. The results showed brain and behavior was “heavily impacted” by BPA, as were organ systems such as the heart, which supports the results from the CLARITY-BPA study, Dr. Patisaul noted.

“When you think about reproducibility in the broadest sense, and you look at the effects that the FDA found at low dose, you look at the effects the CLARITY investigators found at low dose, and you go back and look at the existing literature, you see a very clear picture of BPA-produced effects on brain and behavior, female reproductive systems, and the cardiovascular system,” she said.

Dr. Patisaul is a study investigator for CLARITY-BPA.

An initial report from the Endocrine Society has raised concerns about bisphenol A use in products such as food and drink containers, toys, and medical devices, citing recent data that show the synthetic compound is linked to reproductive, behavioral, and metabolic disorders.

Although the Food and Drug Administration classifies bisphenol A (BPA) as safe to use in food containers, there have been hundreds of studies tying BPA to health problems such as “neurological outcomes, abnormal metabolism, reproductive effects as well as growth and development effects,” according to Laura N. Vandenberg, PhD, an Endocrine Society spokesperson, who spoke at a press briefing held on Oct. 23. Dr. Vandenberg explained the FDA’s 2014 position on BPA safety comes from a small subset of publicly available data, but these are not all the data on BPA, as some academic data are still under review.

The Endocrine Society recently held the news conference because they are concerned the FDA has “jumped the gun” before all the research has been published. “Even considering the fact that the data that have been presented by FDA have been interpreted by FDA as suggesting that BPA is safe, scientists still disagree,” Dr. Vandenberg said.

However, the Endocrine Society noted there is an issue with the current literature, which can be used to interpret and report different results. Heather Patisaul, PhD, cited a joint report from the Food and Agriculture Organization of the United Nations and World Health Organization, as well as a report from the National Toxicology Program (NTP), to illustrate this problem. Both reports expressed concern about BPA safety but took different approaches and a wider viewpoint, and came to different conclusions, she said.

“These two documents both concluded that there was some concern about bisphenol A and behavior, but they identified there was a big problem with trying to pool all this literature together because the experimental protocols were different, the animals were different, the dosing was different,” she said. “It was not a very harmonious literature.”

To combat this issue, the National Institute of Environmental Health Sciences and the FDA have funded the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) study. Dr. Patisaul said CLARITY-BPA is “the most ambitious project that’s ever been done” to study the health effects of a chemical, bringing together scientists from academic institutions, the NTP, and the FDA to help create data for risk assessment.

“The goal was to create this culture of partnership and communication between the agencies that have to make these decisions about safety and the scientists who are producing the data that’s trying to inform those assessments,” Dr. Patisaul said.

Dr. Vandenberg and Dr. Patisaul presented results from the CLARITY-BPA Core Study, which studied the effects of continuous doses of BPA in rats starting from 6 days of pregnancy; after birth, the rat offspring were fed doses of BPA for 1 year and 2 years. A second group of rats in a stop-dose group were fed BPA from early development, where the mothers were fed BPA at day 6 of pregnancy and the offspring fed BPA from birth until puberty (21 days) and followed for 1 year or 2 years. The researchers also examined 2.5 mcg/kg, 25 mcg/kg, 250 mcg/kg, 2,500 mcg/kg, and 25,000 mcg/kg doses of BPA exposure as well as continuous ethinyl estradiol exposure as a positive control.

In the FDA Core Study, there was a significantly increased incidence of mammary adenocarcinoma in the stop dose group and inflammation of the dorsal and lateral lobes of the prostate in the continuous dose group at a dose of 2.5 mcg/kg. In addition, kidney nephropathy and increased body weight in female rats in the continuous group were also seen at the 2.5 mcg/kg dose, Dr. Vandenberg noted.

“I think one of the reasons why FDA is dismissing those low-dose effects is that there’s an expectation with increasing dose, there should be an increase in an effect,” Dr. Vandenberg said.

In the low-dose range, BPA could be acting as a hormone such as estrogen, but also could be acting through other hormone receptors or as a toxicant at the high-dose range, she explained.

Dr. Patisaul also presented results of BPA-related effects on the brain and behavior in the existing literature from the TEDX Low-dose Bisphenol A project, which is a comparison of 391 in vivo and in vitro studies of BPA prior to 2009. The results showed brain and behavior was “heavily impacted” by BPA, as were organ systems such as the heart, which supports the results from the CLARITY-BPA study, Dr. Patisaul noted.

“When you think about reproducibility in the broadest sense, and you look at the effects that the FDA found at low dose, you look at the effects the CLARITY investigators found at low dose, and you go back and look at the existing literature, you see a very clear picture of BPA-produced effects on brain and behavior, female reproductive systems, and the cardiovascular system,” she said.

Dr. Patisaul is a study investigator for CLARITY-BPA.

An initial report from the Endocrine Society has raised concerns about bisphenol A use in products such as food and drink containers, toys, and medical devices, citing recent data that show the synthetic compound is linked to reproductive, behavioral, and metabolic disorders.

Although the Food and Drug Administration classifies bisphenol A (BPA) as safe to use in food containers, there have been hundreds of studies tying BPA to health problems such as “neurological outcomes, abnormal metabolism, reproductive effects as well as growth and development effects,” according to Laura N. Vandenberg, PhD, an Endocrine Society spokesperson, who spoke at a press briefing held on Oct. 23. Dr. Vandenberg explained the FDA’s 2014 position on BPA safety comes from a small subset of publicly available data, but these are not all the data on BPA, as some academic data are still under review.

The Endocrine Society recently held the news conference because they are concerned the FDA has “jumped the gun” before all the research has been published. “Even considering the fact that the data that have been presented by FDA have been interpreted by FDA as suggesting that BPA is safe, scientists still disagree,” Dr. Vandenberg said.

However, the Endocrine Society noted there is an issue with the current literature, which can be used to interpret and report different results. Heather Patisaul, PhD, cited a joint report from the Food and Agriculture Organization of the United Nations and World Health Organization, as well as a report from the National Toxicology Program (NTP), to illustrate this problem. Both reports expressed concern about BPA safety but took different approaches and a wider viewpoint, and came to different conclusions, she said.

“These two documents both concluded that there was some concern about bisphenol A and behavior, but they identified there was a big problem with trying to pool all this literature together because the experimental protocols were different, the animals were different, the dosing was different,” she said. “It was not a very harmonious literature.”

To combat this issue, the National Institute of Environmental Health Sciences and the FDA have funded the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) study. Dr. Patisaul said CLARITY-BPA is “the most ambitious project that’s ever been done” to study the health effects of a chemical, bringing together scientists from academic institutions, the NTP, and the FDA to help create data for risk assessment.

“The goal was to create this culture of partnership and communication between the agencies that have to make these decisions about safety and the scientists who are producing the data that’s trying to inform those assessments,” Dr. Patisaul said.

Dr. Vandenberg and Dr. Patisaul presented results from the CLARITY-BPA Core Study, which studied the effects of continuous doses of BPA in rats starting from 6 days of pregnancy; after birth, the rat offspring were fed doses of BPA for 1 year and 2 years. A second group of rats in a stop-dose group were fed BPA from early development, where the mothers were fed BPA at day 6 of pregnancy and the offspring fed BPA from birth until puberty (21 days) and followed for 1 year or 2 years. The researchers also examined 2.5 mcg/kg, 25 mcg/kg, 250 mcg/kg, 2,500 mcg/kg, and 25,000 mcg/kg doses of BPA exposure as well as continuous ethinyl estradiol exposure as a positive control.

In the FDA Core Study, there was a significantly increased incidence of mammary adenocarcinoma in the stop dose group and inflammation of the dorsal and lateral lobes of the prostate in the continuous dose group at a dose of 2.5 mcg/kg. In addition, kidney nephropathy and increased body weight in female rats in the continuous group were also seen at the 2.5 mcg/kg dose, Dr. Vandenberg noted.

“I think one of the reasons why FDA is dismissing those low-dose effects is that there’s an expectation with increasing dose, there should be an increase in an effect,” Dr. Vandenberg said.

In the low-dose range, BPA could be acting as a hormone such as estrogen, but also could be acting through other hormone receptors or as a toxicant at the high-dose range, she explained.

Dr. Patisaul also presented results of BPA-related effects on the brain and behavior in the existing literature from the TEDX Low-dose Bisphenol A project, which is a comparison of 391 in vivo and in vitro studies of BPA prior to 2009. The results showed brain and behavior was “heavily impacted” by BPA, as were organ systems such as the heart, which supports the results from the CLARITY-BPA study, Dr. Patisaul noted.

“When you think about reproducibility in the broadest sense, and you look at the effects that the FDA found at low dose, you look at the effects the CLARITY investigators found at low dose, and you go back and look at the existing literature, you see a very clear picture of BPA-produced effects on brain and behavior, female reproductive systems, and the cardiovascular system,” she said.

Dr. Patisaul is a study investigator for CLARITY-BPA.

SAN DIEGO – Between 2002 and April 2018, about one in five civil monetary penalty payments linked to Emergency Medical Treatment and Labor Act (EMTALA) violations involved psychiatric emergencies, an analysis of national data found.

“Penalties were twice as high for psychiatric cases as for nonpsychiatric cases, with failure to stabilize being more common,” Sophie Terp, MD, MPH, said at the annual meeting of the American College of Emergency Physicians. “Recent large penalties suggest the need to improve care for psychiatric emergencies.”

In an effort to characterize U.S. Office of Inspector General (OIG) penalties resulting from EMTALA violations involving psychiatric emergencies, Dr. Terp, of the department of emergency medicine at the University of Southern California, Los Angeles, and her colleagues reviewed all OIG penalties between 2002 and April 2018. Characteristics of penalties involving psychiatric emergencies were described and compared with other penalties.

Of the 229 civil monetary penalties levied during the study period, 44 (19%) were related to psychiatric emergencies and the average fine was $85,488, which was significantly higher than the average fine of $32,042 for nonpsychiatric-related civil monetary penalties (P = .004). The three largest penalties during the study period were all related to psychiatric emergencies, including one for $360,000 in 2012, one for $1,295,000 in 2017, and one for $200,000 in 2018.


“Settlements have been particularly high in recent years,” Dr. Terp said. By comparison, the largest civil monetary penalty for a nonpsychiatric case was $170,000.

Failure to provide a medical screening exam was the most common reason for civil monetary settlements in both psychiatric and nonpsychiatric cases (84% vs. 74%; P = .147), but “failure to stabilize” occurred in a significantly greater proportion of psychiatric versus nonpsychiatric cases (68% vs. 51%; P = .041). About one-third of all psychiatric cases occurred in Centers for Medicare & Medicaid Services Region 4, “which is a region known to have a very high rate of EMTALA enforcement overall,” Dr. Terp said. “About half of those cases occurred in Florida, and another 20% occurred in South Carolina. About 20% occurred in CMS Region 6, and about half of those were in Texas. But the overall proportions of psychiatric versus nonpsychiatric cases that distributed over the CMS regions did not significantly differ.”

Dr. Terp reported having no financial disclosures.

[email protected]

SOURCE: Terp S et al. ACEP18, Abstract 46.

SAN DIEGO – Between 2002 and April 2018, about one in five civil monetary penalty payments linked to Emergency Medical Treatment and Labor Act (EMTALA) violations involved psychiatric emergencies, an analysis of national data found.

“Penalties were twice as high for psychiatric cases as for nonpsychiatric cases, with failure to stabilize being more common,” Sophie Terp, MD, MPH, said at the annual meeting of the American College of Emergency Physicians. “Recent large penalties suggest the need to improve care for psychiatric emergencies.”

In an effort to characterize U.S. Office of Inspector General (OIG) penalties resulting from EMTALA violations involving psychiatric emergencies, Dr. Terp, of the department of emergency medicine at the University of Southern California, Los Angeles, and her colleagues reviewed all OIG penalties between 2002 and April 2018. Characteristics of penalties involving psychiatric emergencies were described and compared with other penalties.

Of the 229 civil monetary penalties levied during the study period, 44 (19%) were related to psychiatric emergencies and the average fine was $85,488, which was significantly higher than the average fine of $32,042 for nonpsychiatric-related civil monetary penalties (P = .004). The three largest penalties during the study period were all related to psychiatric emergencies, including one for $360,000 in 2012, one for $1,295,000 in 2017, and one for $200,000 in 2018.


“Settlements have been particularly high in recent years,” Dr. Terp said. By comparison, the largest civil monetary penalty for a nonpsychiatric case was $170,000.

Failure to provide a medical screening exam was the most common reason for civil monetary settlements in both psychiatric and nonpsychiatric cases (84% vs. 74%; P = .147), but “failure to stabilize” occurred in a significantly greater proportion of psychiatric versus nonpsychiatric cases (68% vs. 51%; P = .041). About one-third of all psychiatric cases occurred in Centers for Medicare & Medicaid Services Region 4, “which is a region known to have a very high rate of EMTALA enforcement overall,” Dr. Terp said. “About half of those cases occurred in Florida, and another 20% occurred in South Carolina. About 20% occurred in CMS Region 6, and about half of those were in Texas. But the overall proportions of psychiatric versus nonpsychiatric cases that distributed over the CMS regions did not significantly differ.”

Dr. Terp reported having no financial disclosures.

[email protected]

SOURCE: Terp S et al. ACEP18, Abstract 46.

SAN DIEGO – Between 2002 and April 2018, about one in five civil monetary penalty payments linked to Emergency Medical Treatment and Labor Act (EMTALA) violations involved psychiatric emergencies, an analysis of national data found.

“Penalties were twice as high for psychiatric cases as for nonpsychiatric cases, with failure to stabilize being more common,” Sophie Terp, MD, MPH, said at the annual meeting of the American College of Emergency Physicians. “Recent large penalties suggest the need to improve care for psychiatric emergencies.”

In an effort to characterize U.S. Office of Inspector General (OIG) penalties resulting from EMTALA violations involving psychiatric emergencies, Dr. Terp, of the department of emergency medicine at the University of Southern California, Los Angeles, and her colleagues reviewed all OIG penalties between 2002 and April 2018. Characteristics of penalties involving psychiatric emergencies were described and compared with other penalties.

Of the 229 civil monetary penalties levied during the study period, 44 (19%) were related to psychiatric emergencies and the average fine was $85,488, which was significantly higher than the average fine of $32,042 for nonpsychiatric-related civil monetary penalties (P = .004). The three largest penalties during the study period were all related to psychiatric emergencies, including one for $360,000 in 2012, one for $1,295,000 in 2017, and one for $200,000 in 2018.


“Settlements have been particularly high in recent years,” Dr. Terp said. By comparison, the largest civil monetary penalty for a nonpsychiatric case was $170,000.

Failure to provide a medical screening exam was the most common reason for civil monetary settlements in both psychiatric and nonpsychiatric cases (84% vs. 74%; P = .147), but “failure to stabilize” occurred in a significantly greater proportion of psychiatric versus nonpsychiatric cases (68% vs. 51%; P = .041). About one-third of all psychiatric cases occurred in Centers for Medicare & Medicaid Services Region 4, “which is a region known to have a very high rate of EMTALA enforcement overall,” Dr. Terp said. “About half of those cases occurred in Florida, and another 20% occurred in South Carolina. About 20% occurred in CMS Region 6, and about half of those were in Texas. But the overall proportions of psychiatric versus nonpsychiatric cases that distributed over the CMS regions did not significantly differ.”

Dr. Terp reported having no financial disclosures.

[email protected]

SOURCE: Terp S et al. ACEP18, Abstract 46.

You may recall that in mid-2013, the government launched the Physician Payment Sunshine Act bureaucracy, as mandated by the Affordable Care Act of 2010. The intent was to make relationships between pharmaceutical manufacturers and health care providers more transparent, by requiring the manufacturers to report to the Centers for Medicare & Medicaid Services all payments and other “transfers of value” provided to physicians and teaching hospitals.

Since the CMS has been collecting this information (and publishing it online each September) for 5 years now, I thought I would have a look at what has been learned to date, and what may have changed as a result.

Not much, apparently. In 2014, I predicted that attorneys, activists, and the occasional investigative reporter might peruse the data for their own purposes, but the general public would have little curiosity or use for the information. That appears to be the case thus far; there is no evidence that significant numbers of ordinary citizens have looked at the data or drawn any conclusions from it, perhaps because of the difficulty in accessing it (the website was widely panned when it debuted, although improvements have since been made); or perhaps because neither the CMS nor anyone else has offered the public any assistance in interpreting the raw data. Whether patients think less of doctors who accept an occasional industry-sponsored lunch for their employees, or think more (or less) of those who educate other providers or conduct clinical research, remain open questions.

One measurable – and probably unintended – consequence has been the increasing reluctance of physicians to provide legitimate feedback, or otherwise interact at all with industry, probably out of fear that they might one day have to explain a payment that could be construed by someone with an ax to grind as a conflict of interest. This is a shame, since there is no better way to develop new therapies, or to design solutions to the huge problems facing modern health care, than to actively involve doctors.

Furthermore, it is not clear how well the industry has complied with the law, or how effectively the government is enforcing it. The law authorizes fines of up to $150,000 annually, rising to $1 million for intentional violations; and while Vermont announced in late 2013 that it had levied 25 fines totaling $61,250 for violations of its somewhat stricter version of the statute, I could find no evidence of any similar enforcement by the CMS or any of the other states with standalone conflict of interest laws.*

All of that said, the law’s questionable impact and apparent lack of enforcement do not mean you can ignore it. Increased transparency and scrutiny of physician financial interests apparently are here to stay. The data are still being collected and displayed for anyone to see, so you still want to be certain that what is reported about you is accurate. This means keeping your own records of any money, food, or supplies that you receive from any pharmaceutical company, and making certain that it is in fact your information – and not someone else’s – that is published. (The CMS initially released a free smartphone application to facilitate that independent record-keeping process, but the app apparently is no longer available.)

Since all data must be reported to the CMS by March 31 annually, you need to set aside some time each April or May to review this information. If you have many (or complex) industry relationships, you should probably contact each manufacturer in January or February and ask to see the information before it is submitted. Then, review it again after the CMS gets it, to be sure that nothing has changed. You do have 2 years after the data go live to pursue corrections, but in the interim, the incorrect information remains online; so it’s best to fix it in advance of publication.

If you don’t see drug reps, accept office lunches, attend industry dinners, or give sponsored talks, don’t assume that you are not included in the database. Check anyway; you might be indirectly involved in a compensation that you were not aware of, or you may have been reported in error.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

*California, Colorado, Maine, Massachusetts, Minnesota, Vermont, West Virginia, and the District of Columbia had their own laws in place addressing industry relationships with providers before the ACA was enacted. Maine repealed its law in 2011.

You may recall that in mid-2013, the government launched the Physician Payment Sunshine Act bureaucracy, as mandated by the Affordable Care Act of 2010. The intent was to make relationships between pharmaceutical manufacturers and health care providers more transparent, by requiring the manufacturers to report to the Centers for Medicare & Medicaid Services all payments and other “transfers of value” provided to physicians and teaching hospitals.

Since the CMS has been collecting this information (and publishing it online each September) for 5 years now, I thought I would have a look at what has been learned to date, and what may have changed as a result.

Not much, apparently. In 2014, I predicted that attorneys, activists, and the occasional investigative reporter might peruse the data for their own purposes, but the general public would have little curiosity or use for the information. That appears to be the case thus far; there is no evidence that significant numbers of ordinary citizens have looked at the data or drawn any conclusions from it, perhaps because of the difficulty in accessing it (the website was widely panned when it debuted, although improvements have since been made); or perhaps because neither the CMS nor anyone else has offered the public any assistance in interpreting the raw data. Whether patients think less of doctors who accept an occasional industry-sponsored lunch for their employees, or think more (or less) of those who educate other providers or conduct clinical research, remain open questions.

One measurable – and probably unintended – consequence has been the increasing reluctance of physicians to provide legitimate feedback, or otherwise interact at all with industry, probably out of fear that they might one day have to explain a payment that could be construed by someone with an ax to grind as a conflict of interest. This is a shame, since there is no better way to develop new therapies, or to design solutions to the huge problems facing modern health care, than to actively involve doctors.

Furthermore, it is not clear how well the industry has complied with the law, or how effectively the government is enforcing it. The law authorizes fines of up to $150,000 annually, rising to $1 million for intentional violations; and while Vermont announced in late 2013 that it had levied 25 fines totaling $61,250 for violations of its somewhat stricter version of the statute, I could find no evidence of any similar enforcement by the CMS or any of the other states with standalone conflict of interest laws.*

All of that said, the law’s questionable impact and apparent lack of enforcement do not mean you can ignore it. Increased transparency and scrutiny of physician financial interests apparently are here to stay. The data are still being collected and displayed for anyone to see, so you still want to be certain that what is reported about you is accurate. This means keeping your own records of any money, food, or supplies that you receive from any pharmaceutical company, and making certain that it is in fact your information – and not someone else’s – that is published. (The CMS initially released a free smartphone application to facilitate that independent record-keeping process, but the app apparently is no longer available.)

Since all data must be reported to the CMS by March 31 annually, you need to set aside some time each April or May to review this information. If you have many (or complex) industry relationships, you should probably contact each manufacturer in January or February and ask to see the information before it is submitted. Then, review it again after the CMS gets it, to be sure that nothing has changed. You do have 2 years after the data go live to pursue corrections, but in the interim, the incorrect information remains online; so it’s best to fix it in advance of publication.

If you don’t see drug reps, accept office lunches, attend industry dinners, or give sponsored talks, don’t assume that you are not included in the database. Check anyway; you might be indirectly involved in a compensation that you were not aware of, or you may have been reported in error.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

*California, Colorado, Maine, Massachusetts, Minnesota, Vermont, West Virginia, and the District of Columbia had their own laws in place addressing industry relationships with providers before the ACA was enacted. Maine repealed its law in 2011.

You may recall that in mid-2013, the government launched the Physician Payment Sunshine Act bureaucracy, as mandated by the Affordable Care Act of 2010. The intent was to make relationships between pharmaceutical manufacturers and health care providers more transparent, by requiring the manufacturers to report to the Centers for Medicare & Medicaid Services all payments and other “transfers of value” provided to physicians and teaching hospitals.

Since the CMS has been collecting this information (and publishing it online each September) for 5 years now, I thought I would have a look at what has been learned to date, and what may have changed as a result.

Not much, apparently. In 2014, I predicted that attorneys, activists, and the occasional investigative reporter might peruse the data for their own purposes, but the general public would have little curiosity or use for the information. That appears to be the case thus far; there is no evidence that significant numbers of ordinary citizens have looked at the data or drawn any conclusions from it, perhaps because of the difficulty in accessing it (the website was widely panned when it debuted, although improvements have since been made); or perhaps because neither the CMS nor anyone else has offered the public any assistance in interpreting the raw data. Whether patients think less of doctors who accept an occasional industry-sponsored lunch for their employees, or think more (or less) of those who educate other providers or conduct clinical research, remain open questions.

One measurable – and probably unintended – consequence has been the increasing reluctance of physicians to provide legitimate feedback, or otherwise interact at all with industry, probably out of fear that they might one day have to explain a payment that could be construed by someone with an ax to grind as a conflict of interest. This is a shame, since there is no better way to develop new therapies, or to design solutions to the huge problems facing modern health care, than to actively involve doctors.

Furthermore, it is not clear how well the industry has complied with the law, or how effectively the government is enforcing it. The law authorizes fines of up to $150,000 annually, rising to $1 million for intentional violations; and while Vermont announced in late 2013 that it had levied 25 fines totaling $61,250 for violations of its somewhat stricter version of the statute, I could find no evidence of any similar enforcement by the CMS or any of the other states with standalone conflict of interest laws.*

All of that said, the law’s questionable impact and apparent lack of enforcement do not mean you can ignore it. Increased transparency and scrutiny of physician financial interests apparently are here to stay. The data are still being collected and displayed for anyone to see, so you still want to be certain that what is reported about you is accurate. This means keeping your own records of any money, food, or supplies that you receive from any pharmaceutical company, and making certain that it is in fact your information – and not someone else’s – that is published. (The CMS initially released a free smartphone application to facilitate that independent record-keeping process, but the app apparently is no longer available.)

Since all data must be reported to the CMS by March 31 annually, you need to set aside some time each April or May to review this information. If you have many (or complex) industry relationships, you should probably contact each manufacturer in January or February and ask to see the information before it is submitted. Then, review it again after the CMS gets it, to be sure that nothing has changed. You do have 2 years after the data go live to pursue corrections, but in the interim, the incorrect information remains online; so it’s best to fix it in advance of publication.

If you don’t see drug reps, accept office lunches, attend industry dinners, or give sponsored talks, don’t assume that you are not included in the database. Check anyway; you might be indirectly involved in a compensation that you were not aware of, or you may have been reported in error.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

*California, Colorado, Maine, Massachusetts, Minnesota, Vermont, West Virginia, and the District of Columbia had their own laws in place addressing industry relationships with providers before the ACA was enacted. Maine repealed its law in 2011.

Chronic diseases affect a substantial proportion of the US population, with 25% of adults diagnosed with 2 or more chronic health conditions.¹ In 2010, 2 chronic diseases, heart disease and cancer, accounted for nearly 48% of deaths.² Due to the significant public heath burden, strategies to improve chronic disease management have attracted a great deal of focus.^3,4 Within increasingly complex health care delivery systems, policy makers are promoting care coordination (CC) as a tool to reduce fragmented care for patients with multiple comorbidities, improve patient experience and quality of care, and decrease costs and risks for error.^3-8

Background

The Agency for Healthcare Research and Quality (AHRQ) defines care coordination as “deliberately organizing patient care activities and sharing information among all of the participants concerned with a patient’s care to achieve safer and more effective care.”⁵ Nationally, large scale investments have expanded health care models that provide team-based CC, such as patient-centered medical homes, known as patient-aligned care teams (PACTs) within the Department of Veterans Affairs (VA), accountable care organizations, and other complex care management programs.^9-12 Additionally, incentives that reimburse for CC, such as Medicare’s chronic care management and transition care management billing codes, also are emerging.^13,14

While there is significant interest and investment in promoting CC, little data about the specific activities and time required to provide necessary CC exist, which limits the ability of health care teams to optimize CC delivery.⁶ Understanding the components of CC has implications for human resource allocation, labor mapping, reimbursement, staff training, and optimizing collaborative networks for health care systems, which may improve the quality of CC and health outcomes for patients. To date, few tools exist that can be used to identify and track the CC services delivered by interdisciplinary teams within and outside of the health care setting. 

This article describes the development and preliminary results of the implementation of a CC Template that was created in the VA Computerized Patient Record System (CPRS) to identify and track the components of CC services, delivered by a multidisciplinary team, as part of a quality improvement (QI) pilot project. Through use of the template, the team sought a formative understanding of the following questions: (1) Is it feasible to use the CC Template during routine workflow? (2) What specific types of CC services are provided by the team? (3) How much time does it take to perform these activities? (4) Who is the team collaborating with inside and outside of the health care setting and how are they communicating? (5) Given new reimbursement incentives, can the provision of CC be standardized and documented for broad applicability?

In complex systems, where coordination is needed among primary, specialty, hospital, emergency, and nonclinical care settings, a tool such as the CC Template offers a sustainable and replicable way to standardize documentation and knowledge about CC components. This foundational information can be used to optimize team structure, training, and resource allocation, to improve the quality of CC and to link elements of CC with clinical and operational outcomes.

Pact Intensive Management

Despite the implementation of PACT within VA, patients with complex medical conditions combined with socioeconomic stressors, mental health comorbidities, and low health literacy are at high risk for preventable hospitalizations and acute care utilization.^17,18 Due to unmet needs that are beyond what PACTs are able to deliver, these high-risk patients may benefit from additional services to coordinate care within and outside the VA health care system, as suggest by the Extended Chronic Care Model.^19-21

In 2014, the Office of Primary Care Services sponsored a QI initiative at 5 VA demonstration sites to develop PACT Intensive Management (PIM) interventions targeting patients at high risk for hospitalization and acute care utilization within VA. The PIM program design is based on work described previously, with patients identified for enrollment based on 90-day hospitalization risk ≥ 90th percentile, based on a VA risk modeling tool, and an acute care episode in the previous 6 months. ¹⁹ A common component of all PIM programs is the provision of intensive care management and CC by an interdisciplinary team working in conjunction with PACT. The CC Template was developed to assist in documenting and rigorously understanding the implementation of CC by the PIM team.

Local Setting

The Atlanta VA Medical Center (AVAMC) was chosen as one of the PIM demonstration sites. The Atlanta PIM team identified and enrolled a random sample of eligible, high-risk patients from 1 community-based outpatient clinic (CBOC) in an urban location with 7,524 unique patients. Between September 2014 and September 2016, 300 patients were identified, and 86 patients agreed to participate in the PIM program.

In the CC Template pilot, the Atlanta PIM team included 2 nurse practitioners (NP), 2 social workers (SW), and 1 telehealth registered nurse (RN). Upon enrollment, members of the PIM team conducted comprehensive home assessments and offered intensive care management for medical, social, and behavioral needs. The main pillars of care management offered to high-risk patients were based on previous work done both inside and outside VA and included home visits, telephone-based disease management, co-attending appointments with patients, transition care management, and interdisciplinary team meetings with a focus on care coordination between PACT and all services required by patients.^11,19

The Atlanta PIM team performed a variety of tasks to coordinate care for enrolled patients that included simple, 1-step tasks, such as chart reviews, and multistep, complex tasks that required the expertise of multiple team members (Figure 1). 

Additionally, inconsistency in delivery of CC between PIM team members was noted. For example, there was significant variability in CC services provided by different team members in the provision of transition care management (TCM) and coordinating care from hospitalization back to home. Some PIM staff coordinated care and communicated with the patient, hospital team, home-care service, and primary-care team, while other staff only reviewed the chart and placed orders in CPRS. Additionally, much of the CC work was documented in administrative notes that did not trigger workload credit. This made it difficult to show how to appropriately labor map PIM staff or how staff were spending their time caring for patients.

In order to standardize documentation of the interdisciplinary CC activities performed by the PIM team and account for staff time, the Atlanta PIM team decided to develop a CPRS CC Template. The objective of the CC Template was to facilitate documentation of CC activities in the EHR, describe the types of CC activities performed by PIM team members, and track the time to perform these activities for patients with various chronic diseases.

Template Design and Implementation

The original design of the template was informed by the Atlanta PIM team after several informal focus groups and process mapping of CC pathways in the fall of 2015. The participants were all members of the Atlanta PIM team, 2 primary care physicians working with PIM, an AVAMC documentation specialist and a clinical applications coordinator (CAC) assigned to work with PIM. The major themes that arose during the brainstorming discussion were that the template should: (1) be feasible to use during their daily clinic workflow; (2) improve documentation of CC; and (3) have value for spread to other VA sites. Discussion centered on creating a CC Template versatile enough to:

• Decrease the number of steps for documenting CC;
• Consist only of check boxes, with very little need for free text, with the option to enter narrative free text after template completion;
• Document time spent in aggregate for completing complex CC encounters;
• Document various types of CC work and modes of communication;
• Allow for use by all PIM staff;
• Identify all team members that participated in the CC encounter to reduce redundant documentation by multiple staff;
• Adapt to different clinic sites based on the varied disciplines participating in other locations;
• Use evidence-based checklists to help standardize delivery of CC for certain activities such as TCM; and
• Extract data without extensive chart reviews to inform current CC and future QI work.

Following the brainstorming sessions, the authors performed a literature review to identify and integrate CC best practices. The AHRQ Care Coordination Atlas served as the main resource in the design of the logic model that depicted the delivery and subsequent documentation of high-quality, evidence-based CC in the CC Template (Figure 2).⁶ 

After reaching consensus about the key components of the CC Template, the CAC created a pilot version (Figure 3). All of the elements within the CC Template allowed for data abstraction from the VA Corporate Data Warehouse (CDW) via discrete data elements known as health factors. 

Over the course of implementation, the team became more enthusiastic about using the CC template to document previously unrecognized CC workload. Because the CC Template only was used to document CC workload and excluded encounters for clinical evaluation and management, specific notes were created and linked with the CC Template for optimal capture of encounters.

All components of the template were mandatory to eliminate the possibility of missing data. The Atlanta PIM site principal investigator developed a multicomponent training designed to increase support for the template by describing its value and to mitigate the potential for variability in how data are captured. Training included a face-to-face session with the team to review the template and work through sample CC cases. Additionally, a training manual with clear operational definitions and examples of how to complete each element of the CC Template was disseminated. The training was subsequently conducted with the San Francisco VA Medical Center PIM team, a spread site, via video conference. The spread site offered significant feedback on clarifying the training documents and adapting the CC template for their distinct care team structure. This feedback was incorporated into the final CC Template design to increase adaptability.

Implementation Evaluation

The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance)framework served as the basis for evaluation of CC Template implementation. The RE-AIM framework is well established and able to evaluate the implementation and potential successful spread of new programs.^23,24 Using RE-AIM, the authors planned to analyze data to explore the reach effectiveness, adoption, implementation, and maintenance of the CC Template use while providing complex care management for high-risk patients.

All data for the evaluation was extracted from the CDW by a data analyst and stored on a secure server. A statistical process control (SPC) chart was used to analyze the implementation process to assess variation in template use.

Results

After implementation, 35 weeks of CC Template pilot data were analyzed from June 1, 2015 to January 5, 2016. The PIM team completed 393 CC Templates over this collection period. After week 23, the CC template was linked to specific CC notes automatically. From weeks 23 to 35 an average of 20.3 CC Templates were completed per week by the team. The RE-AIM was used to assess the implementation of the CC Template.

Reach was determined by the number of patients enrolled in PIM with CC Template documentation. Of patients enrolled in Atlanta PIM, 90.1% had ≥ 1 CC encounter documented by the CC Template; 74.4% of Atlanta PIM patients had ≥ 1 CC encounter documented; 15.5% of patients had > 10 CC encounters documented; and 1 patient had > 25 CC encounters documented by the CC template.

Effectiveness for describing CC activities was captured through data from CC Template. The CC Template documentation by the PIM team showed that 79.4% of CC encounters were < 20 minutes, and 9.9% of encounters were > 61 minutes. Telephone communication was involved in 50.4% of CC encounters, and 24% required multiple modes of communication such as face-to-face, instant messenger, chart-based communication. Care coordination during hospitalization and discharge accounted for 5.9% of template use. Of the CC encounters documenting hospital transitions, 94.4% documented communication with the inpatient team, 58.3% documented coordination with social support, and only 11.1% documented communication with primary care teams. Improving communication with PACT teams after hospital discharge was identified as a future QI project based on these data. The PIM team initiated 83.2% of CC encounters.

Adoption was determined by the use of the CC Template by the team. All 5 team members used the CC template to document at least 1 CC encounter.

Implementation allowed for improvement based on feedback from the PIM team. Mean completion of CC Templates rose from 10.9 per week to 20.3 per week after automatically linking the CC Template to specific CC notes. (Figure 4)

Maintenance was monitored over the course of the pilot. Consistent use of the CC Template over 35 full work weeks of data collection was seen, and mean utilization per week nearly doubled in the latter half of the pilot period.

Because several elements were added to the CC Template over the course of the pilot period, our ability to analyze the data for descriptive statistics about the types of CC services, related diagnoses, collaborators, and PIM staff involved in CC encounters was limited.

Discussion

Though all components of CC encounters could not be assessed during the pilot phase due to continuous improvement of the CC Template, the authors showed that it is feasible to use this tool to document and describe granular details about team-based CC. Pilot data from AVAMC show that the use of the CC Template standardized team CC documentation in a busy clinic setting provided data about the complexity of coordination activities and duration of CC activities. It also informed future CC QI projects, such as improving communication with primary care during the hospital discharge process.

Future evaluation of CC Template data can be used to (1) describe types of CC activities for high-risk PIM patients; (2) quantify the time required to complete CC activities to assist with staff labor mapping; (3) describe staff roles and referrals needed to complete specific CC activities inside and outside VA; (4) describe modes of communication between PIM and collaborators; (5) relate patient demographics and associated diagnoses with quantity of CC encounters; and (6) quantify frequency and time frame of CC after hospitalizations and ED care and subsequent impact on repeat hospitalizations and ED visits. Future research also can explore the link between CC activities and effort with clinical and patient-reported outcomes.

Social network analysis could be used with CC Template data to understand the network of referrals and collaborators involved in the care of a CC team’s patients. This type of analysis would assist teams to strengthen and formalize ties with collaborators as appropriate. For example, if data show that the team frequently collaborates with the cardiology clinic for a large subset of its patients, they may consider creating a CC agreement with formalized modes of communication that would streamline collaboration.

In order to improve the quality of the CC Template and to assess factors that may lead to sustainable use in clinical practice, qualitative assessment through survey, interview, or usability testing with staff would be beneficial to identify strategies to increase its adoption among clinical providers. This type of assessment will add knowledge about the CC Template implementation process, including contextual barriers or facilitators, feasibility of use during day-to-day operations, versatility of template use within construct of team-based care, and overall satisfaction with the template.

Limitations

Though the CC Template offers a large amount of data about the components of CC delivery, the information is based on self-report by staff. Training to ensure that all team members are documenting in the same manner is crucial to maintain the internal validity of the data. The template is limited to the fields currently developed, and future research could explore additional data elements that are critical to include based on feedback from VA staff.

Conclusion

To our knowledge, this VA medical center CC Template is the first tool described in the literature that standardizes and captures data about CC components in the EHR. This pilot data show that the template is feasible for use in a busy clinic setting and can streamline the process for capturing CC data that may otherwise not be documented.

During the pilot phase, the CC template allowed the PIM team to identify a small subset of patients within the PIM complex management who have a high level of CC needs. By identifying these patients, further work can be done to understand the specific needs of these higher utilizers and the types of CC activities required to assist them so that resources can be directed appropriately to that smaller subset. Telephone CC accounted for a large proportion of delivery, which has implications for ensuring that staff have access to mobile phones and EHR capability to document this additional workload. The PIM staff maintained use of the template throughout the pilot period and increased documentation when the CC Template was easily accessible and already linked to their CPRS notes, suggesting that in future implementation, ensuring that the template is linked to notes in use by the care team will be important for successful spread.

Additionally, CC Template data identified gaps in high-quality, evidence-based CC that can be addressed in real time, for example during the discharge process. Data from the CC Template showed that only 11.1% of CC encounters had documentation of communication between the PIM and primary care teams during transitions from hospital to home. Improving communication with PACT teams after hospital discharge was identified as a future PIM QI project based on these data. By improving documentation of CC in the EHR, the resulting information is foundational for future work that can improve the quality of team-based CC; plan staffing, team composition, and labor mapping; determine the cost of CC activities and improve reimbursement in certain settings; and assess outcomes of CC.

This tool has potential for application beyond the PIM team in the VA. The CC Template and training manual is scalable to any setting with team-based CC, including PACT, homeless programs, palliative care, Mental Health Intensive Case Management (MHICM) programs, nurse navigator programs, and other complex care delivery models involving care coordinators. Future study of its implementation and data may inform initiatives to develop ongoing team-based care coordination programs.

Acknowledgments
The authors thank the following colleagues for their input and support: Florence Longchamp, RN, Clinical Applications Coordinator at the Atlanta VA Medical Center without whom the CC Template would not have been created; the Atlanta and San Francisco VA PIM teams for their thoughtful comments and enthusiastic embrace of the CC Template; and the PIM National Evaluation Center for their support of this QI project. PACT Intensive Management demonstration sites are funded by the VA Office of Patient Care Services. During the implementation of the CC Template pilot and the preparation of this paper, the primary author was supported by the Department of Veterans Affairs, Veterans Health Administration, Office of Academic Affiliations, Advanced Fellowships, VA Quality Scholars Program.

Chronic diseases affect a substantial proportion of the US population, with 25% of adults diagnosed with 2 or more chronic health conditions.¹ In 2010, 2 chronic diseases, heart disease and cancer, accounted for nearly 48% of deaths.² Due to the significant public heath burden, strategies to improve chronic disease management have attracted a great deal of focus.^3,4 Within increasingly complex health care delivery systems, policy makers are promoting care coordination (CC) as a tool to reduce fragmented care for patients with multiple comorbidities, improve patient experience and quality of care, and decrease costs and risks for error.^3-8

Background

The Agency for Healthcare Research and Quality (AHRQ) defines care coordination as “deliberately organizing patient care activities and sharing information among all of the participants concerned with a patient’s care to achieve safer and more effective care.”⁵ Nationally, large scale investments have expanded health care models that provide team-based CC, such as patient-centered medical homes, known as patient-aligned care teams (PACTs) within the Department of Veterans Affairs (VA), accountable care organizations, and other complex care management programs.^9-12 Additionally, incentives that reimburse for CC, such as Medicare’s chronic care management and transition care management billing codes, also are emerging.^13,14

While there is significant interest and investment in promoting CC, little data about the specific activities and time required to provide necessary CC exist, which limits the ability of health care teams to optimize CC delivery.⁶ Understanding the components of CC has implications for human resource allocation, labor mapping, reimbursement, staff training, and optimizing collaborative networks for health care systems, which may improve the quality of CC and health outcomes for patients. To date, few tools exist that can be used to identify and track the CC services delivered by interdisciplinary teams within and outside of the health care setting. 

This article describes the development and preliminary results of the implementation of a CC Template that was created in the VA Computerized Patient Record System (CPRS) to identify and track the components of CC services, delivered by a multidisciplinary team, as part of a quality improvement (QI) pilot project. Through use of the template, the team sought a formative understanding of the following questions: (1) Is it feasible to use the CC Template during routine workflow? (2) What specific types of CC services are provided by the team? (3) How much time does it take to perform these activities? (4) Who is the team collaborating with inside and outside of the health care setting and how are they communicating? (5) Given new reimbursement incentives, can the provision of CC be standardized and documented for broad applicability?

In complex systems, where coordination is needed among primary, specialty, hospital, emergency, and nonclinical care settings, a tool such as the CC Template offers a sustainable and replicable way to standardize documentation and knowledge about CC components. This foundational information can be used to optimize team structure, training, and resource allocation, to improve the quality of CC and to link elements of CC with clinical and operational outcomes.

Pact Intensive Management

Despite the implementation of PACT within VA, patients with complex medical conditions combined with socioeconomic stressors, mental health comorbidities, and low health literacy are at high risk for preventable hospitalizations and acute care utilization.^17,18 Due to unmet needs that are beyond what PACTs are able to deliver, these high-risk patients may benefit from additional services to coordinate care within and outside the VA health care system, as suggest by the Extended Chronic Care Model.^19-21

In 2014, the Office of Primary Care Services sponsored a QI initiative at 5 VA demonstration sites to develop PACT Intensive Management (PIM) interventions targeting patients at high risk for hospitalization and acute care utilization within VA. The PIM program design is based on work described previously, with patients identified for enrollment based on 90-day hospitalization risk ≥ 90th percentile, based on a VA risk modeling tool, and an acute care episode in the previous 6 months. ¹⁹ A common component of all PIM programs is the provision of intensive care management and CC by an interdisciplinary team working in conjunction with PACT. The CC Template was developed to assist in documenting and rigorously understanding the implementation of CC by the PIM team.

Local Setting

The Atlanta VA Medical Center (AVAMC) was chosen as one of the PIM demonstration sites. The Atlanta PIM team identified and enrolled a random sample of eligible, high-risk patients from 1 community-based outpatient clinic (CBOC) in an urban location with 7,524 unique patients. Between September 2014 and September 2016, 300 patients were identified, and 86 patients agreed to participate in the PIM program.

In the CC Template pilot, the Atlanta PIM team included 2 nurse practitioners (NP), 2 social workers (SW), and 1 telehealth registered nurse (RN). Upon enrollment, members of the PIM team conducted comprehensive home assessments and offered intensive care management for medical, social, and behavioral needs. The main pillars of care management offered to high-risk patients were based on previous work done both inside and outside VA and included home visits, telephone-based disease management, co-attending appointments with patients, transition care management, and interdisciplinary team meetings with a focus on care coordination between PACT and all services required by patients.^11,19

The Atlanta PIM team performed a variety of tasks to coordinate care for enrolled patients that included simple, 1-step tasks, such as chart reviews, and multistep, complex tasks that required the expertise of multiple team members (Figure 1). 

Additionally, inconsistency in delivery of CC between PIM team members was noted. For example, there was significant variability in CC services provided by different team members in the provision of transition care management (TCM) and coordinating care from hospitalization back to home. Some PIM staff coordinated care and communicated with the patient, hospital team, home-care service, and primary-care team, while other staff only reviewed the chart and placed orders in CPRS. Additionally, much of the CC work was documented in administrative notes that did not trigger workload credit. This made it difficult to show how to appropriately labor map PIM staff or how staff were spending their time caring for patients.

In order to standardize documentation of the interdisciplinary CC activities performed by the PIM team and account for staff time, the Atlanta PIM team decided to develop a CPRS CC Template. The objective of the CC Template was to facilitate documentation of CC activities in the EHR, describe the types of CC activities performed by PIM team members, and track the time to perform these activities for patients with various chronic diseases.

Template Design and Implementation

The original design of the template was informed by the Atlanta PIM team after several informal focus groups and process mapping of CC pathways in the fall of 2015. The participants were all members of the Atlanta PIM team, 2 primary care physicians working with PIM, an AVAMC documentation specialist and a clinical applications coordinator (CAC) assigned to work with PIM. The major themes that arose during the brainstorming discussion were that the template should: (1) be feasible to use during their daily clinic workflow; (2) improve documentation of CC; and (3) have value for spread to other VA sites. Discussion centered on creating a CC Template versatile enough to:

• Decrease the number of steps for documenting CC;
• Consist only of check boxes, with very little need for free text, with the option to enter narrative free text after template completion;
• Document time spent in aggregate for completing complex CC encounters;
• Document various types of CC work and modes of communication;
• Allow for use by all PIM staff;
• Identify all team members that participated in the CC encounter to reduce redundant documentation by multiple staff;
• Adapt to different clinic sites based on the varied disciplines participating in other locations;
• Use evidence-based checklists to help standardize delivery of CC for certain activities such as TCM; and
• Extract data without extensive chart reviews to inform current CC and future QI work.

Following the brainstorming sessions, the authors performed a literature review to identify and integrate CC best practices. The AHRQ Care Coordination Atlas served as the main resource in the design of the logic model that depicted the delivery and subsequent documentation of high-quality, evidence-based CC in the CC Template (Figure 2).⁶ 

After reaching consensus about the key components of the CC Template, the CAC created a pilot version (Figure 3). All of the elements within the CC Template allowed for data abstraction from the VA Corporate Data Warehouse (CDW) via discrete data elements known as health factors. 

Over the course of implementation, the team became more enthusiastic about using the CC template to document previously unrecognized CC workload. Because the CC Template only was used to document CC workload and excluded encounters for clinical evaluation and management, specific notes were created and linked with the CC Template for optimal capture of encounters.

All components of the template were mandatory to eliminate the possibility of missing data. The Atlanta PIM site principal investigator developed a multicomponent training designed to increase support for the template by describing its value and to mitigate the potential for variability in how data are captured. Training included a face-to-face session with the team to review the template and work through sample CC cases. Additionally, a training manual with clear operational definitions and examples of how to complete each element of the CC Template was disseminated. The training was subsequently conducted with the San Francisco VA Medical Center PIM team, a spread site, via video conference. The spread site offered significant feedback on clarifying the training documents and adapting the CC template for their distinct care team structure. This feedback was incorporated into the final CC Template design to increase adaptability.

Implementation Evaluation

The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance)framework served as the basis for evaluation of CC Template implementation. The RE-AIM framework is well established and able to evaluate the implementation and potential successful spread of new programs.^23,24 Using RE-AIM, the authors planned to analyze data to explore the reach effectiveness, adoption, implementation, and maintenance of the CC Template use while providing complex care management for high-risk patients.

All data for the evaluation was extracted from the CDW by a data analyst and stored on a secure server. A statistical process control (SPC) chart was used to analyze the implementation process to assess variation in template use.

Results

After implementation, 35 weeks of CC Template pilot data were analyzed from June 1, 2015 to January 5, 2016. The PIM team completed 393 CC Templates over this collection period. After week 23, the CC template was linked to specific CC notes automatically. From weeks 23 to 35 an average of 20.3 CC Templates were completed per week by the team. The RE-AIM was used to assess the implementation of the CC Template.

Reach was determined by the number of patients enrolled in PIM with CC Template documentation. Of patients enrolled in Atlanta PIM, 90.1% had ≥ 1 CC encounter documented by the CC Template; 74.4% of Atlanta PIM patients had ≥ 1 CC encounter documented; 15.5% of patients had > 10 CC encounters documented; and 1 patient had > 25 CC encounters documented by the CC template.

Effectiveness for describing CC activities was captured through data from CC Template. The CC Template documentation by the PIM team showed that 79.4% of CC encounters were < 20 minutes, and 9.9% of encounters were > 61 minutes. Telephone communication was involved in 50.4% of CC encounters, and 24% required multiple modes of communication such as face-to-face, instant messenger, chart-based communication. Care coordination during hospitalization and discharge accounted for 5.9% of template use. Of the CC encounters documenting hospital transitions, 94.4% documented communication with the inpatient team, 58.3% documented coordination with social support, and only 11.1% documented communication with primary care teams. Improving communication with PACT teams after hospital discharge was identified as a future QI project based on these data. The PIM team initiated 83.2% of CC encounters.

Adoption was determined by the use of the CC Template by the team. All 5 team members used the CC template to document at least 1 CC encounter.

Implementation allowed for improvement based on feedback from the PIM team. Mean completion of CC Templates rose from 10.9 per week to 20.3 per week after automatically linking the CC Template to specific CC notes. (Figure 4)

Maintenance was monitored over the course of the pilot. Consistent use of the CC Template over 35 full work weeks of data collection was seen, and mean utilization per week nearly doubled in the latter half of the pilot period.

Because several elements were added to the CC Template over the course of the pilot period, our ability to analyze the data for descriptive statistics about the types of CC services, related diagnoses, collaborators, and PIM staff involved in CC encounters was limited.

Discussion

Though all components of CC encounters could not be assessed during the pilot phase due to continuous improvement of the CC Template, the authors showed that it is feasible to use this tool to document and describe granular details about team-based CC. Pilot data from AVAMC show that the use of the CC Template standardized team CC documentation in a busy clinic setting provided data about the complexity of coordination activities and duration of CC activities. It also informed future CC QI projects, such as improving communication with primary care during the hospital discharge process.

Future evaluation of CC Template data can be used to (1) describe types of CC activities for high-risk PIM patients; (2) quantify the time required to complete CC activities to assist with staff labor mapping; (3) describe staff roles and referrals needed to complete specific CC activities inside and outside VA; (4) describe modes of communication between PIM and collaborators; (5) relate patient demographics and associated diagnoses with quantity of CC encounters; and (6) quantify frequency and time frame of CC after hospitalizations and ED care and subsequent impact on repeat hospitalizations and ED visits. Future research also can explore the link between CC activities and effort with clinical and patient-reported outcomes.

Social network analysis could be used with CC Template data to understand the network of referrals and collaborators involved in the care of a CC team’s patients. This type of analysis would assist teams to strengthen and formalize ties with collaborators as appropriate. For example, if data show that the team frequently collaborates with the cardiology clinic for a large subset of its patients, they may consider creating a CC agreement with formalized modes of communication that would streamline collaboration.

In order to improve the quality of the CC Template and to assess factors that may lead to sustainable use in clinical practice, qualitative assessment through survey, interview, or usability testing with staff would be beneficial to identify strategies to increase its adoption among clinical providers. This type of assessment will add knowledge about the CC Template implementation process, including contextual barriers or facilitators, feasibility of use during day-to-day operations, versatility of template use within construct of team-based care, and overall satisfaction with the template.

Limitations

Though the CC Template offers a large amount of data about the components of CC delivery, the information is based on self-report by staff. Training to ensure that all team members are documenting in the same manner is crucial to maintain the internal validity of the data. The template is limited to the fields currently developed, and future research could explore additional data elements that are critical to include based on feedback from VA staff.

Conclusion

To our knowledge, this VA medical center CC Template is the first tool described in the literature that standardizes and captures data about CC components in the EHR. This pilot data show that the template is feasible for use in a busy clinic setting and can streamline the process for capturing CC data that may otherwise not be documented.

During the pilot phase, the CC template allowed the PIM team to identify a small subset of patients within the PIM complex management who have a high level of CC needs. By identifying these patients, further work can be done to understand the specific needs of these higher utilizers and the types of CC activities required to assist them so that resources can be directed appropriately to that smaller subset. Telephone CC accounted for a large proportion of delivery, which has implications for ensuring that staff have access to mobile phones and EHR capability to document this additional workload. The PIM staff maintained use of the template throughout the pilot period and increased documentation when the CC Template was easily accessible and already linked to their CPRS notes, suggesting that in future implementation, ensuring that the template is linked to notes in use by the care team will be important for successful spread.

Additionally, CC Template data identified gaps in high-quality, evidence-based CC that can be addressed in real time, for example during the discharge process. Data from the CC Template showed that only 11.1% of CC encounters had documentation of communication between the PIM and primary care teams during transitions from hospital to home. Improving communication with PACT teams after hospital discharge was identified as a future PIM QI project based on these data. By improving documentation of CC in the EHR, the resulting information is foundational for future work that can improve the quality of team-based CC; plan staffing, team composition, and labor mapping; determine the cost of CC activities and improve reimbursement in certain settings; and assess outcomes of CC.

This tool has potential for application beyond the PIM team in the VA. The CC Template and training manual is scalable to any setting with team-based CC, including PACT, homeless programs, palliative care, Mental Health Intensive Case Management (MHICM) programs, nurse navigator programs, and other complex care delivery models involving care coordinators. Future study of its implementation and data may inform initiatives to develop ongoing team-based care coordination programs.

Acknowledgments
The authors thank the following colleagues for their input and support: Florence Longchamp, RN, Clinical Applications Coordinator at the Atlanta VA Medical Center without whom the CC Template would not have been created; the Atlanta and San Francisco VA PIM teams for their thoughtful comments and enthusiastic embrace of the CC Template; and the PIM National Evaluation Center for their support of this QI project. PACT Intensive Management demonstration sites are funded by the VA Office of Patient Care Services. During the implementation of the CC Template pilot and the preparation of this paper, the primary author was supported by the Department of Veterans Affairs, Veterans Health Administration, Office of Academic Affiliations, Advanced Fellowships, VA Quality Scholars Program.

Chronic diseases affect a substantial proportion of the US population, with 25% of adults diagnosed with 2 or more chronic health conditions.¹ In 2010, 2 chronic diseases, heart disease and cancer, accounted for nearly 48% of deaths.² Due to the significant public heath burden, strategies to improve chronic disease management have attracted a great deal of focus.^3,4 Within increasingly complex health care delivery systems, policy makers are promoting care coordination (CC) as a tool to reduce fragmented care for patients with multiple comorbidities, improve patient experience and quality of care, and decrease costs and risks for error.^3-8

Background

The Agency for Healthcare Research and Quality (AHRQ) defines care coordination as “deliberately organizing patient care activities and sharing information among all of the participants concerned with a patient’s care to achieve safer and more effective care.”⁵ Nationally, large scale investments have expanded health care models that provide team-based CC, such as patient-centered medical homes, known as patient-aligned care teams (PACTs) within the Department of Veterans Affairs (VA), accountable care organizations, and other complex care management programs.^9-12 Additionally, incentives that reimburse for CC, such as Medicare’s chronic care management and transition care management billing codes, also are emerging.^13,14

While there is significant interest and investment in promoting CC, little data about the specific activities and time required to provide necessary CC exist, which limits the ability of health care teams to optimize CC delivery.⁶ Understanding the components of CC has implications for human resource allocation, labor mapping, reimbursement, staff training, and optimizing collaborative networks for health care systems, which may improve the quality of CC and health outcomes for patients. To date, few tools exist that can be used to identify and track the CC services delivered by interdisciplinary teams within and outside of the health care setting. 

This article describes the development and preliminary results of the implementation of a CC Template that was created in the VA Computerized Patient Record System (CPRS) to identify and track the components of CC services, delivered by a multidisciplinary team, as part of a quality improvement (QI) pilot project. Through use of the template, the team sought a formative understanding of the following questions: (1) Is it feasible to use the CC Template during routine workflow? (2) What specific types of CC services are provided by the team? (3) How much time does it take to perform these activities? (4) Who is the team collaborating with inside and outside of the health care setting and how are they communicating? (5) Given new reimbursement incentives, can the provision of CC be standardized and documented for broad applicability?

In complex systems, where coordination is needed among primary, specialty, hospital, emergency, and nonclinical care settings, a tool such as the CC Template offers a sustainable and replicable way to standardize documentation and knowledge about CC components. This foundational information can be used to optimize team structure, training, and resource allocation, to improve the quality of CC and to link elements of CC with clinical and operational outcomes.

Pact Intensive Management

Despite the implementation of PACT within VA, patients with complex medical conditions combined with socioeconomic stressors, mental health comorbidities, and low health literacy are at high risk for preventable hospitalizations and acute care utilization.^17,18 Due to unmet needs that are beyond what PACTs are able to deliver, these high-risk patients may benefit from additional services to coordinate care within and outside the VA health care system, as suggest by the Extended Chronic Care Model.^19-21

In 2014, the Office of Primary Care Services sponsored a QI initiative at 5 VA demonstration sites to develop PACT Intensive Management (PIM) interventions targeting patients at high risk for hospitalization and acute care utilization within VA. The PIM program design is based on work described previously, with patients identified for enrollment based on 90-day hospitalization risk ≥ 90th percentile, based on a VA risk modeling tool, and an acute care episode in the previous 6 months. ¹⁹ A common component of all PIM programs is the provision of intensive care management and CC by an interdisciplinary team working in conjunction with PACT. The CC Template was developed to assist in documenting and rigorously understanding the implementation of CC by the PIM team.

Local Setting

The Atlanta VA Medical Center (AVAMC) was chosen as one of the PIM demonstration sites. The Atlanta PIM team identified and enrolled a random sample of eligible, high-risk patients from 1 community-based outpatient clinic (CBOC) in an urban location with 7,524 unique patients. Between September 2014 and September 2016, 300 patients were identified, and 86 patients agreed to participate in the PIM program.

In the CC Template pilot, the Atlanta PIM team included 2 nurse practitioners (NP), 2 social workers (SW), and 1 telehealth registered nurse (RN). Upon enrollment, members of the PIM team conducted comprehensive home assessments and offered intensive care management for medical, social, and behavioral needs. The main pillars of care management offered to high-risk patients were based on previous work done both inside and outside VA and included home visits, telephone-based disease management, co-attending appointments with patients, transition care management, and interdisciplinary team meetings with a focus on care coordination between PACT and all services required by patients.^11,19

The Atlanta PIM team performed a variety of tasks to coordinate care for enrolled patients that included simple, 1-step tasks, such as chart reviews, and multistep, complex tasks that required the expertise of multiple team members (Figure 1). 

Additionally, inconsistency in delivery of CC between PIM team members was noted. For example, there was significant variability in CC services provided by different team members in the provision of transition care management (TCM) and coordinating care from hospitalization back to home. Some PIM staff coordinated care and communicated with the patient, hospital team, home-care service, and primary-care team, while other staff only reviewed the chart and placed orders in CPRS. Additionally, much of the CC work was documented in administrative notes that did not trigger workload credit. This made it difficult to show how to appropriately labor map PIM staff or how staff were spending their time caring for patients.

In order to standardize documentation of the interdisciplinary CC activities performed by the PIM team and account for staff time, the Atlanta PIM team decided to develop a CPRS CC Template. The objective of the CC Template was to facilitate documentation of CC activities in the EHR, describe the types of CC activities performed by PIM team members, and track the time to perform these activities for patients with various chronic diseases.

Template Design and Implementation

The original design of the template was informed by the Atlanta PIM team after several informal focus groups and process mapping of CC pathways in the fall of 2015. The participants were all members of the Atlanta PIM team, 2 primary care physicians working with PIM, an AVAMC documentation specialist and a clinical applications coordinator (CAC) assigned to work with PIM. The major themes that arose during the brainstorming discussion were that the template should: (1) be feasible to use during their daily clinic workflow; (2) improve documentation of CC; and (3) have value for spread to other VA sites. Discussion centered on creating a CC Template versatile enough to:

• Decrease the number of steps for documenting CC;
• Consist only of check boxes, with very little need for free text, with the option to enter narrative free text after template completion;
• Document time spent in aggregate for completing complex CC encounters;
• Document various types of CC work and modes of communication;
• Allow for use by all PIM staff;
• Identify all team members that participated in the CC encounter to reduce redundant documentation by multiple staff;
• Adapt to different clinic sites based on the varied disciplines participating in other locations;
• Use evidence-based checklists to help standardize delivery of CC for certain activities such as TCM; and
• Extract data without extensive chart reviews to inform current CC and future QI work.

Following the brainstorming sessions, the authors performed a literature review to identify and integrate CC best practices. The AHRQ Care Coordination Atlas served as the main resource in the design of the logic model that depicted the delivery and subsequent documentation of high-quality, evidence-based CC in the CC Template (Figure 2).⁶ 

After reaching consensus about the key components of the CC Template, the CAC created a pilot version (Figure 3). All of the elements within the CC Template allowed for data abstraction from the VA Corporate Data Warehouse (CDW) via discrete data elements known as health factors. 

Over the course of implementation, the team became more enthusiastic about using the CC template to document previously unrecognized CC workload. Because the CC Template only was used to document CC workload and excluded encounters for clinical evaluation and management, specific notes were created and linked with the CC Template for optimal capture of encounters.

All components of the template were mandatory to eliminate the possibility of missing data. The Atlanta PIM site principal investigator developed a multicomponent training designed to increase support for the template by describing its value and to mitigate the potential for variability in how data are captured. Training included a face-to-face session with the team to review the template and work through sample CC cases. Additionally, a training manual with clear operational definitions and examples of how to complete each element of the CC Template was disseminated. The training was subsequently conducted with the San Francisco VA Medical Center PIM team, a spread site, via video conference. The spread site offered significant feedback on clarifying the training documents and adapting the CC template for their distinct care team structure. This feedback was incorporated into the final CC Template design to increase adaptability.

Implementation Evaluation

The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance)framework served as the basis for evaluation of CC Template implementation. The RE-AIM framework is well established and able to evaluate the implementation and potential successful spread of new programs.^23,24 Using RE-AIM, the authors planned to analyze data to explore the reach effectiveness, adoption, implementation, and maintenance of the CC Template use while providing complex care management for high-risk patients.

All data for the evaluation was extracted from the CDW by a data analyst and stored on a secure server. A statistical process control (SPC) chart was used to analyze the implementation process to assess variation in template use.

Results

After implementation, 35 weeks of CC Template pilot data were analyzed from June 1, 2015 to January 5, 2016. The PIM team completed 393 CC Templates over this collection period. After week 23, the CC template was linked to specific CC notes automatically. From weeks 23 to 35 an average of 20.3 CC Templates were completed per week by the team. The RE-AIM was used to assess the implementation of the CC Template.

Reach was determined by the number of patients enrolled in PIM with CC Template documentation. Of patients enrolled in Atlanta PIM, 90.1% had ≥ 1 CC encounter documented by the CC Template; 74.4% of Atlanta PIM patients had ≥ 1 CC encounter documented; 15.5% of patients had > 10 CC encounters documented; and 1 patient had > 25 CC encounters documented by the CC template.

Effectiveness for describing CC activities was captured through data from CC Template. The CC Template documentation by the PIM team showed that 79.4% of CC encounters were < 20 minutes, and 9.9% of encounters were > 61 minutes. Telephone communication was involved in 50.4% of CC encounters, and 24% required multiple modes of communication such as face-to-face, instant messenger, chart-based communication. Care coordination during hospitalization and discharge accounted for 5.9% of template use. Of the CC encounters documenting hospital transitions, 94.4% documented communication with the inpatient team, 58.3% documented coordination with social support, and only 11.1% documented communication with primary care teams. Improving communication with PACT teams after hospital discharge was identified as a future QI project based on these data. The PIM team initiated 83.2% of CC encounters.

Adoption was determined by the use of the CC Template by the team. All 5 team members used the CC template to document at least 1 CC encounter.

Implementation allowed for improvement based on feedback from the PIM team. Mean completion of CC Templates rose from 10.9 per week to 20.3 per week after automatically linking the CC Template to specific CC notes. (Figure 4)

Maintenance was monitored over the course of the pilot. Consistent use of the CC Template over 35 full work weeks of data collection was seen, and mean utilization per week nearly doubled in the latter half of the pilot period.

Because several elements were added to the CC Template over the course of the pilot period, our ability to analyze the data for descriptive statistics about the types of CC services, related diagnoses, collaborators, and PIM staff involved in CC encounters was limited.

Discussion

Though all components of CC encounters could not be assessed during the pilot phase due to continuous improvement of the CC Template, the authors showed that it is feasible to use this tool to document and describe granular details about team-based CC. Pilot data from AVAMC show that the use of the CC Template standardized team CC documentation in a busy clinic setting provided data about the complexity of coordination activities and duration of CC activities. It also informed future CC QI projects, such as improving communication with primary care during the hospital discharge process.

Future evaluation of CC Template data can be used to (1) describe types of CC activities for high-risk PIM patients; (2) quantify the time required to complete CC activities to assist with staff labor mapping; (3) describe staff roles and referrals needed to complete specific CC activities inside and outside VA; (4) describe modes of communication between PIM and collaborators; (5) relate patient demographics and associated diagnoses with quantity of CC encounters; and (6) quantify frequency and time frame of CC after hospitalizations and ED care and subsequent impact on repeat hospitalizations and ED visits. Future research also can explore the link between CC activities and effort with clinical and patient-reported outcomes.

Social network analysis could be used with CC Template data to understand the network of referrals and collaborators involved in the care of a CC team’s patients. This type of analysis would assist teams to strengthen and formalize ties with collaborators as appropriate. For example, if data show that the team frequently collaborates with the cardiology clinic for a large subset of its patients, they may consider creating a CC agreement with formalized modes of communication that would streamline collaboration.

In order to improve the quality of the CC Template and to assess factors that may lead to sustainable use in clinical practice, qualitative assessment through survey, interview, or usability testing with staff would be beneficial to identify strategies to increase its adoption among clinical providers. This type of assessment will add knowledge about the CC Template implementation process, including contextual barriers or facilitators, feasibility of use during day-to-day operations, versatility of template use within construct of team-based care, and overall satisfaction with the template.

Limitations

Though the CC Template offers a large amount of data about the components of CC delivery, the information is based on self-report by staff. Training to ensure that all team members are documenting in the same manner is crucial to maintain the internal validity of the data. The template is limited to the fields currently developed, and future research could explore additional data elements that are critical to include based on feedback from VA staff.

Conclusion

To our knowledge, this VA medical center CC Template is the first tool described in the literature that standardizes and captures data about CC components in the EHR. This pilot data show that the template is feasible for use in a busy clinic setting and can streamline the process for capturing CC data that may otherwise not be documented.

During the pilot phase, the CC template allowed the PIM team to identify a small subset of patients within the PIM complex management who have a high level of CC needs. By identifying these patients, further work can be done to understand the specific needs of these higher utilizers and the types of CC activities required to assist them so that resources can be directed appropriately to that smaller subset. Telephone CC accounted for a large proportion of delivery, which has implications for ensuring that staff have access to mobile phones and EHR capability to document this additional workload. The PIM staff maintained use of the template throughout the pilot period and increased documentation when the CC Template was easily accessible and already linked to their CPRS notes, suggesting that in future implementation, ensuring that the template is linked to notes in use by the care team will be important for successful spread.

Additionally, CC Template data identified gaps in high-quality, evidence-based CC that can be addressed in real time, for example during the discharge process. Data from the CC Template showed that only 11.1% of CC encounters had documentation of communication between the PIM and primary care teams during transitions from hospital to home. Improving communication with PACT teams after hospital discharge was identified as a future PIM QI project based on these data. By improving documentation of CC in the EHR, the resulting information is foundational for future work that can improve the quality of team-based CC; plan staffing, team composition, and labor mapping; determine the cost of CC activities and improve reimbursement in certain settings; and assess outcomes of CC.

This tool has potential for application beyond the PIM team in the VA. The CC Template and training manual is scalable to any setting with team-based CC, including PACT, homeless programs, palliative care, Mental Health Intensive Case Management (MHICM) programs, nurse navigator programs, and other complex care delivery models involving care coordinators. Future study of its implementation and data may inform initiatives to develop ongoing team-based care coordination programs.

Acknowledgments
The authors thank the following colleagues for their input and support: Florence Longchamp, RN, Clinical Applications Coordinator at the Atlanta VA Medical Center without whom the CC Template would not have been created; the Atlanta and San Francisco VA PIM teams for their thoughtful comments and enthusiastic embrace of the CC Template; and the PIM National Evaluation Center for their support of this QI project. PACT Intensive Management demonstration sites are funded by the VA Office of Patient Care Services. During the implementation of the CC Template pilot and the preparation of this paper, the primary author was supported by the Department of Veterans Affairs, Veterans Health Administration, Office of Academic Affiliations, Advanced Fellowships, VA Quality Scholars Program.

Question: Which of the following regarding medical trainee liability is best?

A. Trainees are commonly named as codefendants with their attending physician in a medical malpractice lawsuit.

B. “From a culture of blame to a culture of safety” is a rallying cry against poor work conditions.

C. House officers are always judged by a lower standard, because they are not fully qualified.

D. A, B, and C are correct.

E. A and C are correct.

Answer: A. A recent case of trainee liability in the United Kingdom resulted in criminal prosecution followed by the trainee being struck off the medical register.¹ Dr. Hadiza Bawa-Garba, a pediatric trainee in the U.K. National Health Service, was prosecuted in a court of law and found guilty of manslaughter by gross negligence for the septic death of a 6-year-old boy with Down syndrome. The General Medical Council (GMC), the U.K. medical regulatory agency, voted to take away her license. The decision aroused the ire of physicians worldwide, who noted the poor supervision and undue pressures she was under.

In August 2018, the U.K. Court of Appeal noted that the general clinical competency of Dr. Bawa-Garba was never at issue, and that “the risk of her clinical practice suddenly and without explanation falling below the standards expected on any given day is no higher than for any other reasonably competent doctor.” It reversed the expulsion order and reinstated the 1-year suspension recommended by the Medical Practitioners Tribunal.

Even as the GMC accepted this appellate decision and had convened a commission to look into criminal negligence, it nonetheless received heavy criticism for having overreacted – and for its failure to speak out more forcefully to support those practicing under oppressive conditions.

For example, the Doctors’ Association UK said the GMC had shown it could not be trusted to be objective and nonpunitive. The case, it noted, had “united the medical profession in fear and outrage,” whereby “a pediatrician in training ... a highly regarded doctor, with a previously unblemished record, [was] convicted of [the criminal offence of] gross negligence manslaughter for judgments made whilst doing the jobs of several doctors at once, covering six wards across four floors, responding to numerous pediatric emergencies, without a functioning IT system, and in the absence of a consultant [senior physician], all when just returning from 14 months of maternity leave.”

The Royal College of Pediatrics and Child Health said it had “previously flagged the importance of fostering a culture of supporting doctors to learn from their mistakes, rather than one which seeks to blame.” And the British Medical Association said, “lessons must be learned from this case, which raises wider issues about the multiple factors that affect patient safety in an NHS under extreme pressure, rather than narrowly focusing only on individuals.”²

The fiasco surrounding the Dr. Bawa-Garba case will hopefully result in action similar to that following the seminal report that medical errors account for nearly 100,000 annual hospital deaths in the United States. That study was not restricted to house staff mistakes, but involved multiple hospitals and hospital staff members. It spawned a nationwide reappraisal of how to approach medical errors, and it spurred the Institute of Medicine to recommend that the profession shift “from a culture of blame to a culture of safety.”³

Criminal prosecution in the United States is decidedly rare in death or injury occurring during the course of patient care – for either trainees or attending physicians. A malpractice lawsuit would have been a far more likely outcome had the Dr. Bawa-Garba case taken place in the United States.

Lawsuits against U.S. house staff are not rare, and resident physicians are regularly joined as codefendants with their supervisors, who may be medical school faculty or community practitioners admitting to “team care.” Regulatory actions are typically directed against fully licensed physicians, rather than the trainees. Instead, the director of the training program itself would take corrective action against an errant resident, if warranted, which can range from a warning to outright dismissal from the program.

How is negligence law applied to a trainee? Should it demand the same standard of care as it would a fully qualified attending physician?⁴ Surprisingly, the courts are split on this question. Some have favored using a dual standard of conduct, with trainees being held to a lower standard.

This was articulated in Rush v. Akron General Hospital, which involved a patient who had fallen through a glass door. The patient suffered several lacerations to his shoulder, which the intern treated. However, when two remaining pieces of glass were later discovered in the area of injury, the patient sued the intern for negligence.

The court dismissed the claim, finding that the intern had practiced with the skill and care of his peers of similar training. “It would be unreasonable to exact from an intern, doing emergency work in a hospital, that high degree of skill which is impliedly possessed by a physician and surgeon in the general practice of his profession, with an extensive and constant practice in hospitals and the community,” the court noted.⁵

However, not all courts have embraced this dual standard of review. The New Jersey Superior Court held that licensed residents should be judged by a standard applicable to a general practitioner, because any reduction in the standard of care would set a problematic precedent.⁶ In that case, the residents allegedly failed to reinsert a nasogastric tube, which caused the patient to aspirate.

And in Pratt v. Stein, a second-year resident was judged by an even higher standard – that of a specialist – after he had allegedly administered a toxic dose of neomycin to a postoperative patient, which resulted in deafness. Although the lower court had ruled that the resident should be held to the standard of an ordinary physician, the Pennsylvania appellate court disagreed, reasoning that “a resident should be held to the standard of a specialist when the resident is acting within his field of specialty. In our estimation, this is a sound conclusion. A resident is already a physician who has chosen to specialize, and thus possesses a higher degree of knowledge and skill in the chosen specialty than does the nonspecialist.”⁷

However, a subsequent decision from the same jurisdiction suggests a retreat from this unrealistic standard.

An orthopedic resident allegedly applied a cast with insufficient padding to the broken wrist of a patient. The plaintiff claimed this led to soft-tissue infection with Staphylococcus aureus, with complicating septicemia, staphylococcal endocarditis, and eventual death.

The court held that the resident’s standard of care should be “higher than that for general practitioners but less than that for fully trained orthopedic specialists. ... To require a resident to meet the same standard of care as fully trained specialists would be unrealistic. A resident may have had only days or weeks of training in the specialized residency program; a specialist, on the other hand, will have completed the residency program and may also have had years of experience in the specialized field. If we were to require the resident to exercise the same degree of skill and training as the specialist, we would, in effect, be requiring the resident to do the impossible.”⁸
 

Dr. Tan is emeritus professor 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. For additional information, readers may contact the author at [email protected].

References

1. Saurabh Jha, “To Err Is Homicide in Britain: The Case of Hadiza Bawa-Garba.” The Health Care Blog, Jan. 30, 2018.

2. “‘Lessons Must Be Learned’: UK Societies on Bawa-Garba Ruling.” Medscape, Aug. 14, 2018.

3. “To Err is Human: Building a Safer Health System.” Institute of Medicine, National Academies Press, Washington D.C., 1999.

4. JAMA. 2004 Sep 1;292(9):1051-6.

5. Rush v. Akron General Hospital, 171 N.E.2d 378 (Ohio Ct. App. 1987).

6. Clark v. University Hospital, 914 A.2d 838 (N.J. Super. 2006).

7. Pratt v. Stein, 444 A.2d 674 (Pa. Super. 1980).

8. Jistarri v. Nappi, 549 A.2d 210 (Pa. Super. 1988).

Question: Which of the following regarding medical trainee liability is best?

A. Trainees are commonly named as codefendants with their attending physician in a medical malpractice lawsuit.

B. “From a culture of blame to a culture of safety” is a rallying cry against poor work conditions.

C. House officers are always judged by a lower standard, because they are not fully qualified.

D. A, B, and C are correct.

E. A and C are correct.

Answer: A. A recent case of trainee liability in the United Kingdom resulted in criminal prosecution followed by the trainee being struck off the medical register.¹ Dr. Hadiza Bawa-Garba, a pediatric trainee in the U.K. National Health Service, was prosecuted in a court of law and found guilty of manslaughter by gross negligence for the septic death of a 6-year-old boy with Down syndrome. The General Medical Council (GMC), the U.K. medical regulatory agency, voted to take away her license. The decision aroused the ire of physicians worldwide, who noted the poor supervision and undue pressures she was under.

In August 2018, the U.K. Court of Appeal noted that the general clinical competency of Dr. Bawa-Garba was never at issue, and that “the risk of her clinical practice suddenly and without explanation falling below the standards expected on any given day is no higher than for any other reasonably competent doctor.” It reversed the expulsion order and reinstated the 1-year suspension recommended by the Medical Practitioners Tribunal.

Even as the GMC accepted this appellate decision and had convened a commission to look into criminal negligence, it nonetheless received heavy criticism for having overreacted – and for its failure to speak out more forcefully to support those practicing under oppressive conditions.

For example, the Doctors’ Association UK said the GMC had shown it could not be trusted to be objective and nonpunitive. The case, it noted, had “united the medical profession in fear and outrage,” whereby “a pediatrician in training ... a highly regarded doctor, with a previously unblemished record, [was] convicted of [the criminal offence of] gross negligence manslaughter for judgments made whilst doing the jobs of several doctors at once, covering six wards across four floors, responding to numerous pediatric emergencies, without a functioning IT system, and in the absence of a consultant [senior physician], all when just returning from 14 months of maternity leave.”

The Royal College of Pediatrics and Child Health said it had “previously flagged the importance of fostering a culture of supporting doctors to learn from their mistakes, rather than one which seeks to blame.” And the British Medical Association said, “lessons must be learned from this case, which raises wider issues about the multiple factors that affect patient safety in an NHS under extreme pressure, rather than narrowly focusing only on individuals.”²

The fiasco surrounding the Dr. Bawa-Garba case will hopefully result in action similar to that following the seminal report that medical errors account for nearly 100,000 annual hospital deaths in the United States. That study was not restricted to house staff mistakes, but involved multiple hospitals and hospital staff members. It spawned a nationwide reappraisal of how to approach medical errors, and it spurred the Institute of Medicine to recommend that the profession shift “from a culture of blame to a culture of safety.”³

Criminal prosecution in the United States is decidedly rare in death or injury occurring during the course of patient care – for either trainees or attending physicians. A malpractice lawsuit would have been a far more likely outcome had the Dr. Bawa-Garba case taken place in the United States.

Lawsuits against U.S. house staff are not rare, and resident physicians are regularly joined as codefendants with their supervisors, who may be medical school faculty or community practitioners admitting to “team care.” Regulatory actions are typically directed against fully licensed physicians, rather than the trainees. Instead, the director of the training program itself would take corrective action against an errant resident, if warranted, which can range from a warning to outright dismissal from the program.

How is negligence law applied to a trainee? Should it demand the same standard of care as it would a fully qualified attending physician?⁴ Surprisingly, the courts are split on this question. Some have favored using a dual standard of conduct, with trainees being held to a lower standard.

This was articulated in Rush v. Akron General Hospital, which involved a patient who had fallen through a glass door. The patient suffered several lacerations to his shoulder, which the intern treated. However, when two remaining pieces of glass were later discovered in the area of injury, the patient sued the intern for negligence.

The court dismissed the claim, finding that the intern had practiced with the skill and care of his peers of similar training. “It would be unreasonable to exact from an intern, doing emergency work in a hospital, that high degree of skill which is impliedly possessed by a physician and surgeon in the general practice of his profession, with an extensive and constant practice in hospitals and the community,” the court noted.⁵

However, not all courts have embraced this dual standard of review. The New Jersey Superior Court held that licensed residents should be judged by a standard applicable to a general practitioner, because any reduction in the standard of care would set a problematic precedent.⁶ In that case, the residents allegedly failed to reinsert a nasogastric tube, which caused the patient to aspirate.

And in Pratt v. Stein, a second-year resident was judged by an even higher standard – that of a specialist – after he had allegedly administered a toxic dose of neomycin to a postoperative patient, which resulted in deafness. Although the lower court had ruled that the resident should be held to the standard of an ordinary physician, the Pennsylvania appellate court disagreed, reasoning that “a resident should be held to the standard of a specialist when the resident is acting within his field of specialty. In our estimation, this is a sound conclusion. A resident is already a physician who has chosen to specialize, and thus possesses a higher degree of knowledge and skill in the chosen specialty than does the nonspecialist.”⁷

However, a subsequent decision from the same jurisdiction suggests a retreat from this unrealistic standard.

An orthopedic resident allegedly applied a cast with insufficient padding to the broken wrist of a patient. The plaintiff claimed this led to soft-tissue infection with Staphylococcus aureus, with complicating septicemia, staphylococcal endocarditis, and eventual death.

The court held that the resident’s standard of care should be “higher than that for general practitioners but less than that for fully trained orthopedic specialists. ... To require a resident to meet the same standard of care as fully trained specialists would be unrealistic. A resident may have had only days or weeks of training in the specialized residency program; a specialist, on the other hand, will have completed the residency program and may also have had years of experience in the specialized field. If we were to require the resident to exercise the same degree of skill and training as the specialist, we would, in effect, be requiring the resident to do the impossible.”⁸
 

Dr. Tan is emeritus professor 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. For additional information, readers may contact the author at [email protected].

References

1. Saurabh Jha, “To Err Is Homicide in Britain: The Case of Hadiza Bawa-Garba.” The Health Care Blog, Jan. 30, 2018.

2. “‘Lessons Must Be Learned’: UK Societies on Bawa-Garba Ruling.” Medscape, Aug. 14, 2018.

3. “To Err is Human: Building a Safer Health System.” Institute of Medicine, National Academies Press, Washington D.C., 1999.

4. JAMA. 2004 Sep 1;292(9):1051-6.

5. Rush v. Akron General Hospital, 171 N.E.2d 378 (Ohio Ct. App. 1987).

6. Clark v. University Hospital, 914 A.2d 838 (N.J. Super. 2006).

7. Pratt v. Stein, 444 A.2d 674 (Pa. Super. 1980).

8. Jistarri v. Nappi, 549 A.2d 210 (Pa. Super. 1988).

Question: Which of the following regarding medical trainee liability is best?

A. Trainees are commonly named as codefendants with their attending physician in a medical malpractice lawsuit.

B. “From a culture of blame to a culture of safety” is a rallying cry against poor work conditions.

C. House officers are always judged by a lower standard, because they are not fully qualified.

D. A, B, and C are correct.

E. A and C are correct.

Answer: A. A recent case of trainee liability in the United Kingdom resulted in criminal prosecution followed by the trainee being struck off the medical register.¹ Dr. Hadiza Bawa-Garba, a pediatric trainee in the U.K. National Health Service, was prosecuted in a court of law and found guilty of manslaughter by gross negligence for the septic death of a 6-year-old boy with Down syndrome. The General Medical Council (GMC), the U.K. medical regulatory agency, voted to take away her license. The decision aroused the ire of physicians worldwide, who noted the poor supervision and undue pressures she was under.

In August 2018, the U.K. Court of Appeal noted that the general clinical competency of Dr. Bawa-Garba was never at issue, and that “the risk of her clinical practice suddenly and without explanation falling below the standards expected on any given day is no higher than for any other reasonably competent doctor.” It reversed the expulsion order and reinstated the 1-year suspension recommended by the Medical Practitioners Tribunal.

Even as the GMC accepted this appellate decision and had convened a commission to look into criminal negligence, it nonetheless received heavy criticism for having overreacted – and for its failure to speak out more forcefully to support those practicing under oppressive conditions.

For example, the Doctors’ Association UK said the GMC had shown it could not be trusted to be objective and nonpunitive. The case, it noted, had “united the medical profession in fear and outrage,” whereby “a pediatrician in training ... a highly regarded doctor, with a previously unblemished record, [was] convicted of [the criminal offence of] gross negligence manslaughter for judgments made whilst doing the jobs of several doctors at once, covering six wards across four floors, responding to numerous pediatric emergencies, without a functioning IT system, and in the absence of a consultant [senior physician], all when just returning from 14 months of maternity leave.”

The Royal College of Pediatrics and Child Health said it had “previously flagged the importance of fostering a culture of supporting doctors to learn from their mistakes, rather than one which seeks to blame.” And the British Medical Association said, “lessons must be learned from this case, which raises wider issues about the multiple factors that affect patient safety in an NHS under extreme pressure, rather than narrowly focusing only on individuals.”²

The fiasco surrounding the Dr. Bawa-Garba case will hopefully result in action similar to that following the seminal report that medical errors account for nearly 100,000 annual hospital deaths in the United States. That study was not restricted to house staff mistakes, but involved multiple hospitals and hospital staff members. It spawned a nationwide reappraisal of how to approach medical errors, and it spurred the Institute of Medicine to recommend that the profession shift “from a culture of blame to a culture of safety.”³

Criminal prosecution in the United States is decidedly rare in death or injury occurring during the course of patient care – for either trainees or attending physicians. A malpractice lawsuit would have been a far more likely outcome had the Dr. Bawa-Garba case taken place in the United States.

Lawsuits against U.S. house staff are not rare, and resident physicians are regularly joined as codefendants with their supervisors, who may be medical school faculty or community practitioners admitting to “team care.” Regulatory actions are typically directed against fully licensed physicians, rather than the trainees. Instead, the director of the training program itself would take corrective action against an errant resident, if warranted, which can range from a warning to outright dismissal from the program.

How is negligence law applied to a trainee? Should it demand the same standard of care as it would a fully qualified attending physician?⁴ Surprisingly, the courts are split on this question. Some have favored using a dual standard of conduct, with trainees being held to a lower standard.

This was articulated in Rush v. Akron General Hospital, which involved a patient who had fallen through a glass door. The patient suffered several lacerations to his shoulder, which the intern treated. However, when two remaining pieces of glass were later discovered in the area of injury, the patient sued the intern for negligence.

The court dismissed the claim, finding that the intern had practiced with the skill and care of his peers of similar training. “It would be unreasonable to exact from an intern, doing emergency work in a hospital, that high degree of skill which is impliedly possessed by a physician and surgeon in the general practice of his profession, with an extensive and constant practice in hospitals and the community,” the court noted.⁵

However, not all courts have embraced this dual standard of review. The New Jersey Superior Court held that licensed residents should be judged by a standard applicable to a general practitioner, because any reduction in the standard of care would set a problematic precedent.⁶ In that case, the residents allegedly failed to reinsert a nasogastric tube, which caused the patient to aspirate.

And in Pratt v. Stein, a second-year resident was judged by an even higher standard – that of a specialist – after he had allegedly administered a toxic dose of neomycin to a postoperative patient, which resulted in deafness. Although the lower court had ruled that the resident should be held to the standard of an ordinary physician, the Pennsylvania appellate court disagreed, reasoning that “a resident should be held to the standard of a specialist when the resident is acting within his field of specialty. In our estimation, this is a sound conclusion. A resident is already a physician who has chosen to specialize, and thus possesses a higher degree of knowledge and skill in the chosen specialty than does the nonspecialist.”⁷

However, a subsequent decision from the same jurisdiction suggests a retreat from this unrealistic standard.

An orthopedic resident allegedly applied a cast with insufficient padding to the broken wrist of a patient. The plaintiff claimed this led to soft-tissue infection with Staphylococcus aureus, with complicating septicemia, staphylococcal endocarditis, and eventual death.

The court held that the resident’s standard of care should be “higher than that for general practitioners but less than that for fully trained orthopedic specialists. ... To require a resident to meet the same standard of care as fully trained specialists would be unrealistic. A resident may have had only days or weeks of training in the specialized residency program; a specialist, on the other hand, will have completed the residency program and may also have had years of experience in the specialized field. If we were to require the resident to exercise the same degree of skill and training as the specialist, we would, in effect, be requiring the resident to do the impossible.”⁸
 

Dr. Tan is emeritus professor 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. For additional information, readers may contact the author at [email protected].

References

1. Saurabh Jha, “To Err Is Homicide in Britain: The Case of Hadiza Bawa-Garba.” The Health Care Blog, Jan. 30, 2018.

2. “‘Lessons Must Be Learned’: UK Societies on Bawa-Garba Ruling.” Medscape, Aug. 14, 2018.

3. “To Err is Human: Building a Safer Health System.” Institute of Medicine, National Academies Press, Washington D.C., 1999.

4. JAMA. 2004 Sep 1;292(9):1051-6.

5. Rush v. Akron General Hospital, 171 N.E.2d 378 (Ohio Ct. App. 1987).

6. Clark v. University Hospital, 914 A.2d 838 (N.J. Super. 2006).

7. Pratt v. Stein, 444 A.2d 674 (Pa. Super. 1980).

8. Jistarri v. Nappi, 549 A.2d 210 (Pa. Super. 1988).

People using the federal healthcare.gov marketplace to buy health insurance in 2019 will see lower premiums for silver plans, the second-lowest cost option – the first such decline since the marketplace’s start in 2014 under the Affordable Care Act.

Mary Ellen Schneider/MDedge News

The Centers for Medicare & Medicaid Services reported that premiums will drop 1.5% on average, after an average increase of 25.4% in 2017 and an increase of 36.9% in 2018.

Tennessee saw the greatest reduction for the 2019 plan year, dropping 26.2%. North Dakota was at the opposite end, seeing premiums increase by 20.2%. CMS provided a state-by-state breakdown of premium changes for states in the federally facilitated marketplace.

CMS Administrator Seema Verma credits the decline to market stabilization actions taken by the agency.

“Despite predictions that our actions would increase rates and destabilize the markets, the opposite has happened,” she said in a statement. “The drop in benchmark plan premiums for plan year 2019 and the increased choices for Americans seeking insurance on the exchanges is proof positive that our actions are working.”

While the agency is “encouraged by this progress, we aren’t satisfied,” Ms. Verma added. “Even with this reduction, average rates are still too high. If we are going to truly offer affordable, high-quality health care, ultimately, the law needs to change.”

Some experts, however, were quick to dismiss Ms. Verma’s assertions that federal government action caused the decline.

In fact, the trend is more of a market correction, said Sara Collins, PhD, vice president of health coverage and access at the Commonwealth Fund, New York. It follows 2 years of premium increases by insurers anticipating government actions to intentionally destabilize the market.

“We saw a correction in premiums in 2017, which reflected the phase-out of the reinsurance program, so insurers adjusted their premiums to reflect that,” Dr. Collins said. “Also, insurers are getting to know their risk pools better. So, the prediction was that the markets would stabilize in the out-years of implementation.”

The individual market “is weathering very well the attempts by the Trump administration and Congress over the past year to weaken it,” Dr. Collins added. Those include repealing the individual mandate penalties, ending federal cost-sharing reduction payments, and promoting the sale of short-term, limited-duration health policies.

Efforts at the state level also have been helpful in stabilizing the marketplace, she noted, particularly in those states that implemented reinsurance plans. CMS noted its role in approving reinsurance waivers in seven states as a reason for the overall decline.

Matthew Fiedler, PhD, a fellow at the Brookings Institution, Washington, concurred that the reduction was more of a market correction than anything else.

It “is not that the repeal of the individual mandate and various other policy changes implemented by the administration haven’t hurt rates,” he said. “It’s that rates were far higher than they needed to be in 2018. Even with the headwind of those policy games, rates are declining this year. Without those policy changes, rates would be declining by more in 2018.”

[email protected]

People using the federal healthcare.gov marketplace to buy health insurance in 2019 will see lower premiums for silver plans, the second-lowest cost option – the first such decline since the marketplace’s start in 2014 under the Affordable Care Act.

Mary Ellen Schneider/MDedge News

The Centers for Medicare & Medicaid Services reported that premiums will drop 1.5% on average, after an average increase of 25.4% in 2017 and an increase of 36.9% in 2018.

Tennessee saw the greatest reduction for the 2019 plan year, dropping 26.2%. North Dakota was at the opposite end, seeing premiums increase by 20.2%. CMS provided a state-by-state breakdown of premium changes for states in the federally facilitated marketplace.

CMS Administrator Seema Verma credits the decline to market stabilization actions taken by the agency.

“Despite predictions that our actions would increase rates and destabilize the markets, the opposite has happened,” she said in a statement. “The drop in benchmark plan premiums for plan year 2019 and the increased choices for Americans seeking insurance on the exchanges is proof positive that our actions are working.”

While the agency is “encouraged by this progress, we aren’t satisfied,” Ms. Verma added. “Even with this reduction, average rates are still too high. If we are going to truly offer affordable, high-quality health care, ultimately, the law needs to change.”

Some experts, however, were quick to dismiss Ms. Verma’s assertions that federal government action caused the decline.

In fact, the trend is more of a market correction, said Sara Collins, PhD, vice president of health coverage and access at the Commonwealth Fund, New York. It follows 2 years of premium increases by insurers anticipating government actions to intentionally destabilize the market.

“We saw a correction in premiums in 2017, which reflected the phase-out of the reinsurance program, so insurers adjusted their premiums to reflect that,” Dr. Collins said. “Also, insurers are getting to know their risk pools better. So, the prediction was that the markets would stabilize in the out-years of implementation.”

The individual market “is weathering very well the attempts by the Trump administration and Congress over the past year to weaken it,” Dr. Collins added. Those include repealing the individual mandate penalties, ending federal cost-sharing reduction payments, and promoting the sale of short-term, limited-duration health policies.

Efforts at the state level also have been helpful in stabilizing the marketplace, she noted, particularly in those states that implemented reinsurance plans. CMS noted its role in approving reinsurance waivers in seven states as a reason for the overall decline.

Matthew Fiedler, PhD, a fellow at the Brookings Institution, Washington, concurred that the reduction was more of a market correction than anything else.

It “is not that the repeal of the individual mandate and various other policy changes implemented by the administration haven’t hurt rates,” he said. “It’s that rates were far higher than they needed to be in 2018. Even with the headwind of those policy games, rates are declining this year. Without those policy changes, rates would be declining by more in 2018.”

[email protected]

People using the federal healthcare.gov marketplace to buy health insurance in 2019 will see lower premiums for silver plans, the second-lowest cost option – the first such decline since the marketplace’s start in 2014 under the Affordable Care Act.

Mary Ellen Schneider/MDedge News

The Centers for Medicare & Medicaid Services reported that premiums will drop 1.5% on average, after an average increase of 25.4% in 2017 and an increase of 36.9% in 2018.

Tennessee saw the greatest reduction for the 2019 plan year, dropping 26.2%. North Dakota was at the opposite end, seeing premiums increase by 20.2%. CMS provided a state-by-state breakdown of premium changes for states in the federally facilitated marketplace.

CMS Administrator Seema Verma credits the decline to market stabilization actions taken by the agency.

“Despite predictions that our actions would increase rates and destabilize the markets, the opposite has happened,” she said in a statement. “The drop in benchmark plan premiums for plan year 2019 and the increased choices for Americans seeking insurance on the exchanges is proof positive that our actions are working.”

While the agency is “encouraged by this progress, we aren’t satisfied,” Ms. Verma added. “Even with this reduction, average rates are still too high. If we are going to truly offer affordable, high-quality health care, ultimately, the law needs to change.”

Some experts, however, were quick to dismiss Ms. Verma’s assertions that federal government action caused the decline.

In fact, the trend is more of a market correction, said Sara Collins, PhD, vice president of health coverage and access at the Commonwealth Fund, New York. It follows 2 years of premium increases by insurers anticipating government actions to intentionally destabilize the market.

“We saw a correction in premiums in 2017, which reflected the phase-out of the reinsurance program, so insurers adjusted their premiums to reflect that,” Dr. Collins said. “Also, insurers are getting to know their risk pools better. So, the prediction was that the markets would stabilize in the out-years of implementation.”

The individual market “is weathering very well the attempts by the Trump administration and Congress over the past year to weaken it,” Dr. Collins added. Those include repealing the individual mandate penalties, ending federal cost-sharing reduction payments, and promoting the sale of short-term, limited-duration health policies.

Efforts at the state level also have been helpful in stabilizing the marketplace, she noted, particularly in those states that implemented reinsurance plans. CMS noted its role in approving reinsurance waivers in seven states as a reason for the overall decline.

Matthew Fiedler, PhD, a fellow at the Brookings Institution, Washington, concurred that the reduction was more of a market correction than anything else.

It “is not that the repeal of the individual mandate and various other policy changes implemented by the administration haven’t hurt rates,” he said. “It’s that rates were far higher than they needed to be in 2018. Even with the headwind of those policy games, rates are declining this year. Without those policy changes, rates would be declining by more in 2018.”

[email protected]

The American College of Obstetricians and Gynecologists (ACOG) and specifically the Junior Fellow College Advisory Council (JFCAC) are rolling out steps to help you make your voice heard. Starting October 1, head to acog.org/advocacy to check out the ACOG Physician Advocacy video to get inspired. (Or watch it here!) Whether you are a seasoned advocate or just getting started, ACOG and women across the country are counting on you!

Week 1 (October 1–7): Why I advocate

The focus of this week is on delving into topics that interest you, learning why advocacy is critically important, and developing your own message to advocate for women’s health.

• View advocacy videos here to understand what advocacy is and why it is so important.
• See ACOG’s 2018 list of legislative priorities here to find topics that inspire you.

Week 2 (October 8–14): Use your voice

Explore the multitude of platforms available today for amplifying your message. Learn to use social media smartly, get advice for how to write op-eds for local outlets, add your name to support current legislative efforts, and find out who your representatives are to schedule sit-down meetings.

• For tips on communicating with elected officials, click here.
• Connect with ACOG and your district on social media, and remember to use social media responsibly to advocate effectively. See this link for more information!
• Don’t forget to include #JFadvoMonth in your posts while highlighting your advocacy work on social media!

Continued to: Week 3 (October 15–19): Empower your patients

As a physician, advocating for your patient extends into the clinic itself. Access toolkits, patient websites, handouts, and resources available through ACOG.

• Familiarize yourself with the Patient Page for videos, infographics, and FAQs that are useful resources for your patients.
• Toolkits for providers are available here—use these to enhance your practice and empower your patients!

Week 4 (October 22–28): Take it forward

Advocacy happens year-round. Be sure you are actively involved in ACOG’s efforts. Participate in calls to action and remember on November 6 to GET OUT THE VOTE!

• Participate in the annual Congressional Leadership Conference (March 10–12, 2019) in Washington, DC. Descend on Washington with hundreds of fellow ObGyns to advocate to Congress on important issues. For more information, click here.
• Donate to the Ob-GynPAC, ACOG’s political action committee dedicated to electing officials who support our specialty.
• Run for office! ACOG has resources to support you. Be on the lookout for opportunities to attend candidate workshops sponsored by the Ob-GynPAC!

Get active now!

We are at a critical moment for women’s health and the future of our specialty. Key issues nationally include advocating to Congress to move forward with bills in the Senate (S 1112) and House (HR 1318) to support efforts to reduce maternal mortality. (See this article for background information on these bills.)

To find your elected officials and take action now, click here and tell Congress to help prevent maternal mortality, defend patient protections, and improve access and quality of maternity care.

You can be an advocate for your patients and your profession. Your voice matters. Now is the time to be heard.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The American College of Obstetricians and Gynecologists (ACOG) and specifically the Junior Fellow College Advisory Council (JFCAC) are rolling out steps to help you make your voice heard. Starting October 1, head to acog.org/advocacy to check out the ACOG Physician Advocacy video to get inspired. (Or watch it here!) Whether you are a seasoned advocate or just getting started, ACOG and women across the country are counting on you!

Week 1 (October 1–7): Why I advocate

The focus of this week is on delving into topics that interest you, learning why advocacy is critically important, and developing your own message to advocate for women’s health.

• View advocacy videos here to understand what advocacy is and why it is so important.
• See ACOG’s 2018 list of legislative priorities here to find topics that inspire you.

Week 2 (October 8–14): Use your voice

Explore the multitude of platforms available today for amplifying your message. Learn to use social media smartly, get advice for how to write op-eds for local outlets, add your name to support current legislative efforts, and find out who your representatives are to schedule sit-down meetings.

• For tips on communicating with elected officials, click here.
• Connect with ACOG and your district on social media, and remember to use social media responsibly to advocate effectively. See this link for more information!
• Don’t forget to include #JFadvoMonth in your posts while highlighting your advocacy work on social media!

Continued to: Week 3 (October 15–19): Empower your patients

As a physician, advocating for your patient extends into the clinic itself. Access toolkits, patient websites, handouts, and resources available through ACOG.

• Familiarize yourself with the Patient Page for videos, infographics, and FAQs that are useful resources for your patients.
• Toolkits for providers are available here—use these to enhance your practice and empower your patients!

Week 4 (October 22–28): Take it forward

Advocacy happens year-round. Be sure you are actively involved in ACOG’s efforts. Participate in calls to action and remember on November 6 to GET OUT THE VOTE!

• Participate in the annual Congressional Leadership Conference (March 10–12, 2019) in Washington, DC. Descend on Washington with hundreds of fellow ObGyns to advocate to Congress on important issues. For more information, click here.
• Donate to the Ob-GynPAC, ACOG’s political action committee dedicated to electing officials who support our specialty.
• Run for office! ACOG has resources to support you. Be on the lookout for opportunities to attend candidate workshops sponsored by the Ob-GynPAC!

Get active now!

We are at a critical moment for women’s health and the future of our specialty. Key issues nationally include advocating to Congress to move forward with bills in the Senate (S 1112) and House (HR 1318) to support efforts to reduce maternal mortality. (See this article for background information on these bills.)

To find your elected officials and take action now, click here and tell Congress to help prevent maternal mortality, defend patient protections, and improve access and quality of maternity care.

You can be an advocate for your patients and your profession. Your voice matters. Now is the time to be heard.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The American College of Obstetricians and Gynecologists (ACOG) and specifically the Junior Fellow College Advisory Council (JFCAC) are rolling out steps to help you make your voice heard. Starting October 1, head to acog.org/advocacy to check out the ACOG Physician Advocacy video to get inspired. (Or watch it here!) Whether you are a seasoned advocate or just getting started, ACOG and women across the country are counting on you!

Week 1 (October 1–7): Why I advocate

The focus of this week is on delving into topics that interest you, learning why advocacy is critically important, and developing your own message to advocate for women’s health.

• View advocacy videos here to understand what advocacy is and why it is so important.
• See ACOG’s 2018 list of legislative priorities here to find topics that inspire you.

Week 2 (October 8–14): Use your voice

Explore the multitude of platforms available today for amplifying your message. Learn to use social media smartly, get advice for how to write op-eds for local outlets, add your name to support current legislative efforts, and find out who your representatives are to schedule sit-down meetings.

• For tips on communicating with elected officials, click here.
• Connect with ACOG and your district on social media, and remember to use social media responsibly to advocate effectively. See this link for more information!
• Don’t forget to include #JFadvoMonth in your posts while highlighting your advocacy work on social media!

Continued to: Week 3 (October 15–19): Empower your patients

As a physician, advocating for your patient extends into the clinic itself. Access toolkits, patient websites, handouts, and resources available through ACOG.

• Familiarize yourself with the Patient Page for videos, infographics, and FAQs that are useful resources for your patients.
• Toolkits for providers are available here—use these to enhance your practice and empower your patients!

Week 4 (October 22–28): Take it forward

Advocacy happens year-round. Be sure you are actively involved in ACOG’s efforts. Participate in calls to action and remember on November 6 to GET OUT THE VOTE!

• Participate in the annual Congressional Leadership Conference (March 10–12, 2019) in Washington, DC. Descend on Washington with hundreds of fellow ObGyns to advocate to Congress on important issues. For more information, click here.
• Donate to the Ob-GynPAC, ACOG’s political action committee dedicated to electing officials who support our specialty.
• Run for office! ACOG has resources to support you. Be on the lookout for opportunities to attend candidate workshops sponsored by the Ob-GynPAC!

Get active now!

We are at a critical moment for women’s health and the future of our specialty. Key issues nationally include advocating to Congress to move forward with bills in the Senate (S 1112) and House (HR 1318) to support efforts to reduce maternal mortality. (See this article for background information on these bills.)

To find your elected officials and take action now, click here and tell Congress to help prevent maternal mortality, defend patient protections, and improve access and quality of maternity care.

You can be an advocate for your patients and your profession. Your voice matters. Now is the time to be heard.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The 2017−2018 term of the Supreme Court of the United States (SCOTUS) was momentous. Justice Anthony Kennedy, who had been the deciding vote in most of the 5 to 4 cases for a generation, announced his retirement as of July 31, 2018. In addition, the Court decided a number of cases of interest to ObGyns. In this article we review some of those cases, as well as consider the future of the Court without Justice Kennedy. In selecting cases, we have given special attention to those in which national medical organizations filed amicus briefs. These “amicus curiae” or “friend of the court” briefs are filed by an entity who is not party to a case but wants to provide information or views to the court.

1. Abortion rulings

The Court decided 2 abortion cases and rejected a request to hear a third.

National Institute of Family and Life Advocates v Becerra

In this case,¹ the Court struck down a California law that required pregnancy crisis centers not offering abortions (generally operated by pro-life groups) to provide special notices to clients.²

At stake. These notices would inform clients that California provides free or low-cost services, including abortions, and provide a phone number to call for those services.

There were many amicus briefs filed in this case, including those by the American College of Obstetricians and Gynecologists (ACOG) and other specialty boards,³ as well as the American Association of Pro-Life Obstetricians and Gynecologists and other pro-life organizations.⁴ ACOG’s brief argued that the California-required notice facilitates the goal of allowing women to receive medical services without harmful delay.

Final ruling. The Court held that the law required clinics to engage in speech with which the clinics disagreed (known as “compelled speech”). It also noted that California disclosure requirements were “wildly underinclusive” because they apply only to some clinics. The majority felt that there was no strong state interest in compelling this speech because there were other alternatives for the state to provide information about the availability of abortion and other services. The Court found that the clinics were likely to succeed on the merits of their claims of a First Amendment (free speech) violation.

Right to abortion for illegal immigrants in custody

A very unusual abortion case involved “Jane Doe,” a minor who was at 8 weeks’ gestation when she illegally crossed the border into the United States.⁵ She was placed in a federally-funded shelter where she requested an abortion. The facility denied that request.

At stake. Legal argument ensued about releasing her to another facility for an abortion, as the argument was made that pregnant minors who are apprehended crossing into the United States illegally and placed into the custody of federal officials should have abortion access. A lower Court of Appeals ruled against the Trump Administration’s policy of denying abortions to undocumented minors in federal custody. During the process of the federal government taking the case to the Supreme Court, the attorneys for Doe moved appointments around and, without notice, the abortion was performed. Government attorneys said that Doe’s attorneys made “what appear to be material misrepresentations and omissions” designed to “thwart [the Supreme Court’s] review” of the case.⁵ The government requested that the Court vacate the order of the Court of Appeals so that it could not be used as precedent.

Final ruling. The Court granted the governments request to vacate the lower court’s order because the minor was no longer pregnant and the order was therefore moot. The basic issue in this case (the right of in-custody minors to access abortions) remains unresolved. It is likely to appear before the Court in the future.

Continue to: Access to medical abortions

An Arkansas law requires that a physician administering medical abortions contract with a physician who has admitting privileges at a hospital (a “contracted physician”).

At stake. Planned Parenthood filed suit challenging the requirement as unnecessary and harmful because it would result in the closure of 2 of the 3 abortion providers in Arkansas. ACOG filed an amicus brief urging the Supreme Court to consider the case.⁶ (Technically this was a petition for a Writ of Certiorari, the procedure by which the Court accepts cases. It accepts only about 1% of applications.) ACOG argued that there was no medical reason for the contracted physician requirement, and noted the harm it would do to women who would not have access to abortions.

Final ruling. On May 29, 2018, the Court declined to hear the case. This case is still active in the lower courts and may eventually return to the Supreme Court.

2. The patent system

The medical profession depends on the patent system to encourage the discovery of new patents efficiently and effectively. In 2012, Congress passed the America Invents Act⁷ that authorizes a petition by anyone other than the patent holder to the Patent and Trademark Office (PTO) for an “inter partes review” to assess a challenge to the patent’s legitimacy. If the PTO determines that there may be merit to the claim, the Patent Trial and Appeal Board undertakes a trial-like review process that may validate, invalidate, or amend the patent. The Board’s decision is subject to appellate court review.

At stake. This term, the inter partes review was challenged as unconstitutional on technical bases.⁸

Final ruling. The Court rejected this claim and approved the current administrative inter partes review process. The Court determined that once the Patent Office takes a petition challenging a patent, it must decide all of the claims against the patent, not pick and choose which elements of the challenge to evaluate.⁹ The Court’s decision upheld patent-review reform, but will require the Patent Office to tweak its procedures.

3. The travel ban

ACOG, the American Medical Association (AMA), the Association of American Medical Colleges, and more than 30 other health care and specialty associations filed an amicus brief regarding one of the most anticipated cases of the term—the “travel ban.”¹⁰

At stake. The essential argument of these organizations was that the US health care system depends on professionals from other countries. An efficient and fair immigration program is, therefore, important to advance the nation’s “health security.” During the 2016−2017 term, the Court considered but then removed the issue from its calendar when the Trump Administration issued a revised travel ban.¹¹

In September 2017, President Trump’s proclamation imposed a range of entry restrictions on the citizens of 8 countries, most (but not all) of which are predominantly Muslim. The government indicated that, in a study by Homeland Security and the State Department, these countries were identified as having especially deficient information-sharing practices and presented national security concerns. Trump v Hawaii¹² challenged this proclamation.

Final ruling. The majority of the Court upheld the travel ban. For the 5-Justice majority led by Chief Justice Roberts, the case came down to 3 things:

1. The Constitution and the laws passed by Congress of necessity give the President great authority to engage in foreign policy, including policies regarding entry into the country.
2. The courts are very reluctant to get into the substance of foreign affairs—they are not equipped to know in detail what the facts are, and things change very fast.
3. If courts start tinkering with foreign policy and things turn bad, it will appear that the courts are to blame and were interfering in an area about which they are not competent.

Continue to: 4. Did a credit card case add risk to health insurance markets?

It was just a credit card case, but one in which the AMA saw a real risk to regulation of the health insurance markets.

At stake. Technically, Ohio v American Express concerned a claim that American Express (AmEx) violated antitrust laws when it prohibited merchants taking its credit card from “steering” customers to cards with lower fees.¹³ AmEx maintained that, because credit cards were a special kind of “2-sided” market (connecting merchants on one side and customers on the other), antitrust laws should not be strictly enforced.

The AMA noticed that special rules regarding 2-sided markets might apply to health insurance, and it submitted an amicus brief¹⁴ that noted: “dominant health insurance networks … have imposed and could further impose rules or effectively erect barriers that prohibit physicians from referring patients to certain specialists, particularly out-of-network specialists, for innovative and even necessary medical tests.”¹⁴ It concluded that the antitrust rule AmEx was suggesting would make it nearly impossible to challenge these unfair provisions in health insurance arrangements.

Final ruling. The Court, however, accepted the AmEx position, making it very difficult to develop an antitrust case against 2-sided markets. It remains to be seen the degree to which the AMA concern about health insurance markets will be realized.

5. Gay wedding and a bakeshop

At stake. In Masterpiece Cakeshop v Colorado, a cakemaker declined to design a cake for a gay wedding and had been disciplined under Colorado law for discriminating against the couple based on sexual orientation.¹⁵

Final ruling. The Court, however, found that the Colorado regulators had, ironically, shown such religious animus in the way they treated the baker that the regulators themselves had discriminated on the basis of religion. As a result, the Court reversed the sanctions against the baker.

This decision was fairly narrow. It does not, for example, stand for the proposition that there may be a general religious exception to antidiscrimination laws. The question of broader religious or free-speech objections to antidiscrimination laws remains for another time.

Amicus brief. It was interesting that the American College of Pediatricians, American Association of Pro-Life Obstetricians and Gynecologists, and others, filed an amicus brief to report with concern the “demands that individual medical professionals must perform, assist with, or facilitate abortions, without regard to the teachings of their own faiths, consciences, and convictions.”¹⁶ The brief also noted that “issues in the present case implicate the fundamental rights of health care professionals, and to respectfully urge that the Court should by no means permit any weakening or qualification of well-established protections against compelled speech, and of free exercise” of religion.¹⁶

Clues to the future

During the term that ran from October 2, 2017, through June 27, 2018, the Court issued 72 decisions. An unusually high proportion of cases (26%; 19 cases) were decided on a 5 to 4 vote. Last term, the rate of 5 to 4 decisions was 10%; the 6-year average was 18%. The unanimous decision rate was 39% this term, compared with 59% last term, and 50% on average.

The rate of 5 to 4 cases provides a clue about the Court’s general direction. The number of times each Justice was in the majority in those nineteen 5 to 4 decisions included: Chief Justice Roberts, 17; and Justices Kennedy, 16; Gorsuch, 16; Thomas, 15; and Alito, 15; compared with Justices Ginsburg, 5; Breyer, 4; Sotomayor, 4; and Kagan, 3.

The Court convened on October 1, 2018. At this writing, whether the new term starts with 8 or 9 justices remains a question. President Trump nominated Brett Kavanaugh, JD, to take Justice Kennedy’s place on the Court. His professional qualifications and experience appear to make him qualified for a position on the Court, but as we have seen, there are many other elements that go into confirming a Justice’s nomination.

Next term, the Court is scheduled to hear cases regarding pharmaceutical liability, double jeopardy, sex-offender registration, expert witnesses, Social Security disability benefits, and the Age Discrimination in Employment Act. There will be at least 3 arbitration cases. Health care and reproductive rights will continue to be an important part of the Court’s docket.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The 2017−2018 term of the Supreme Court of the United States (SCOTUS) was momentous. Justice Anthony Kennedy, who had been the deciding vote in most of the 5 to 4 cases for a generation, announced his retirement as of July 31, 2018. In addition, the Court decided a number of cases of interest to ObGyns. In this article we review some of those cases, as well as consider the future of the Court without Justice Kennedy. In selecting cases, we have given special attention to those in which national medical organizations filed amicus briefs. These “amicus curiae” or “friend of the court” briefs are filed by an entity who is not party to a case but wants to provide information or views to the court.

1. Abortion rulings

The Court decided 2 abortion cases and rejected a request to hear a third.

National Institute of Family and Life Advocates v Becerra

In this case,¹ the Court struck down a California law that required pregnancy crisis centers not offering abortions (generally operated by pro-life groups) to provide special notices to clients.²

At stake. These notices would inform clients that California provides free or low-cost services, including abortions, and provide a phone number to call for those services.

There were many amicus briefs filed in this case, including those by the American College of Obstetricians and Gynecologists (ACOG) and other specialty boards,³ as well as the American Association of Pro-Life Obstetricians and Gynecologists and other pro-life organizations.⁴ ACOG’s brief argued that the California-required notice facilitates the goal of allowing women to receive medical services without harmful delay.

Final ruling. The Court held that the law required clinics to engage in speech with which the clinics disagreed (known as “compelled speech”). It also noted that California disclosure requirements were “wildly underinclusive” because they apply only to some clinics. The majority felt that there was no strong state interest in compelling this speech because there were other alternatives for the state to provide information about the availability of abortion and other services. The Court found that the clinics were likely to succeed on the merits of their claims of a First Amendment (free speech) violation.

Right to abortion for illegal immigrants in custody

A very unusual abortion case involved “Jane Doe,” a minor who was at 8 weeks’ gestation when she illegally crossed the border into the United States.⁵ She was placed in a federally-funded shelter where she requested an abortion. The facility denied that request.

At stake. Legal argument ensued about releasing her to another facility for an abortion, as the argument was made that pregnant minors who are apprehended crossing into the United States illegally and placed into the custody of federal officials should have abortion access. A lower Court of Appeals ruled against the Trump Administration’s policy of denying abortions to undocumented minors in federal custody. During the process of the federal government taking the case to the Supreme Court, the attorneys for Doe moved appointments around and, without notice, the abortion was performed. Government attorneys said that Doe’s attorneys made “what appear to be material misrepresentations and omissions” designed to “thwart [the Supreme Court’s] review” of the case.⁵ The government requested that the Court vacate the order of the Court of Appeals so that it could not be used as precedent.

Final ruling. The Court granted the governments request to vacate the lower court’s order because the minor was no longer pregnant and the order was therefore moot. The basic issue in this case (the right of in-custody minors to access abortions) remains unresolved. It is likely to appear before the Court in the future.

Continue to: Access to medical abortions

An Arkansas law requires that a physician administering medical abortions contract with a physician who has admitting privileges at a hospital (a “contracted physician”).

At stake. Planned Parenthood filed suit challenging the requirement as unnecessary and harmful because it would result in the closure of 2 of the 3 abortion providers in Arkansas. ACOG filed an amicus brief urging the Supreme Court to consider the case.⁶ (Technically this was a petition for a Writ of Certiorari, the procedure by which the Court accepts cases. It accepts only about 1% of applications.) ACOG argued that there was no medical reason for the contracted physician requirement, and noted the harm it would do to women who would not have access to abortions.

Final ruling. On May 29, 2018, the Court declined to hear the case. This case is still active in the lower courts and may eventually return to the Supreme Court.

2. The patent system

The medical profession depends on the patent system to encourage the discovery of new patents efficiently and effectively. In 2012, Congress passed the America Invents Act⁷ that authorizes a petition by anyone other than the patent holder to the Patent and Trademark Office (PTO) for an “inter partes review” to assess a challenge to the patent’s legitimacy. If the PTO determines that there may be merit to the claim, the Patent Trial and Appeal Board undertakes a trial-like review process that may validate, invalidate, or amend the patent. The Board’s decision is subject to appellate court review.

At stake. This term, the inter partes review was challenged as unconstitutional on technical bases.⁸

Final ruling. The Court rejected this claim and approved the current administrative inter partes review process. The Court determined that once the Patent Office takes a petition challenging a patent, it must decide all of the claims against the patent, not pick and choose which elements of the challenge to evaluate.⁹ The Court’s decision upheld patent-review reform, but will require the Patent Office to tweak its procedures.

3. The travel ban

ACOG, the American Medical Association (AMA), the Association of American Medical Colleges, and more than 30 other health care and specialty associations filed an amicus brief regarding one of the most anticipated cases of the term—the “travel ban.”¹⁰

At stake. The essential argument of these organizations was that the US health care system depends on professionals from other countries. An efficient and fair immigration program is, therefore, important to advance the nation’s “health security.” During the 2016−2017 term, the Court considered but then removed the issue from its calendar when the Trump Administration issued a revised travel ban.¹¹

In September 2017, President Trump’s proclamation imposed a range of entry restrictions on the citizens of 8 countries, most (but not all) of which are predominantly Muslim. The government indicated that, in a study by Homeland Security and the State Department, these countries were identified as having especially deficient information-sharing practices and presented national security concerns. Trump v Hawaii¹² challenged this proclamation.

Final ruling. The majority of the Court upheld the travel ban. For the 5-Justice majority led by Chief Justice Roberts, the case came down to 3 things:

1. The Constitution and the laws passed by Congress of necessity give the President great authority to engage in foreign policy, including policies regarding entry into the country.
2. The courts are very reluctant to get into the substance of foreign affairs—they are not equipped to know in detail what the facts are, and things change very fast.
3. If courts start tinkering with foreign policy and things turn bad, it will appear that the courts are to blame and were interfering in an area about which they are not competent.

Continue to: 4. Did a credit card case add risk to health insurance markets?

It was just a credit card case, but one in which the AMA saw a real risk to regulation of the health insurance markets.

At stake. Technically, Ohio v American Express concerned a claim that American Express (AmEx) violated antitrust laws when it prohibited merchants taking its credit card from “steering” customers to cards with lower fees.¹³ AmEx maintained that, because credit cards were a special kind of “2-sided” market (connecting merchants on one side and customers on the other), antitrust laws should not be strictly enforced.

The AMA noticed that special rules regarding 2-sided markets might apply to health insurance, and it submitted an amicus brief¹⁴ that noted: “dominant health insurance networks … have imposed and could further impose rules or effectively erect barriers that prohibit physicians from referring patients to certain specialists, particularly out-of-network specialists, for innovative and even necessary medical tests.”¹⁴ It concluded that the antitrust rule AmEx was suggesting would make it nearly impossible to challenge these unfair provisions in health insurance arrangements.

Final ruling. The Court, however, accepted the AmEx position, making it very difficult to develop an antitrust case against 2-sided markets. It remains to be seen the degree to which the AMA concern about health insurance markets will be realized.

5. Gay wedding and a bakeshop

At stake. In Masterpiece Cakeshop v Colorado, a cakemaker declined to design a cake for a gay wedding and had been disciplined under Colorado law for discriminating against the couple based on sexual orientation.¹⁵

Final ruling. The Court, however, found that the Colorado regulators had, ironically, shown such religious animus in the way they treated the baker that the regulators themselves had discriminated on the basis of religion. As a result, the Court reversed the sanctions against the baker.

This decision was fairly narrow. It does not, for example, stand for the proposition that there may be a general religious exception to antidiscrimination laws. The question of broader religious or free-speech objections to antidiscrimination laws remains for another time.

Amicus brief. It was interesting that the American College of Pediatricians, American Association of Pro-Life Obstetricians and Gynecologists, and others, filed an amicus brief to report with concern the “demands that individual medical professionals must perform, assist with, or facilitate abortions, without regard to the teachings of their own faiths, consciences, and convictions.”¹⁶ The brief also noted that “issues in the present case implicate the fundamental rights of health care professionals, and to respectfully urge that the Court should by no means permit any weakening or qualification of well-established protections against compelled speech, and of free exercise” of religion.¹⁶

Clues to the future

During the term that ran from October 2, 2017, through June 27, 2018, the Court issued 72 decisions. An unusually high proportion of cases (26%; 19 cases) were decided on a 5 to 4 vote. Last term, the rate of 5 to 4 decisions was 10%; the 6-year average was 18%. The unanimous decision rate was 39% this term, compared with 59% last term, and 50% on average.

The rate of 5 to 4 cases provides a clue about the Court’s general direction. The number of times each Justice was in the majority in those nineteen 5 to 4 decisions included: Chief Justice Roberts, 17; and Justices Kennedy, 16; Gorsuch, 16; Thomas, 15; and Alito, 15; compared with Justices Ginsburg, 5; Breyer, 4; Sotomayor, 4; and Kagan, 3.

The Court convened on October 1, 2018. At this writing, whether the new term starts with 8 or 9 justices remains a question. President Trump nominated Brett Kavanaugh, JD, to take Justice Kennedy’s place on the Court. His professional qualifications and experience appear to make him qualified for a position on the Court, but as we have seen, there are many other elements that go into confirming a Justice’s nomination.

Next term, the Court is scheduled to hear cases regarding pharmaceutical liability, double jeopardy, sex-offender registration, expert witnesses, Social Security disability benefits, and the Age Discrimination in Employment Act. There will be at least 3 arbitration cases. Health care and reproductive rights will continue to be an important part of the Court’s docket.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The 2017−2018 term of the Supreme Court of the United States (SCOTUS) was momentous. Justice Anthony Kennedy, who had been the deciding vote in most of the 5 to 4 cases for a generation, announced his retirement as of July 31, 2018. In addition, the Court decided a number of cases of interest to ObGyns. In this article we review some of those cases, as well as consider the future of the Court without Justice Kennedy. In selecting cases, we have given special attention to those in which national medical organizations filed amicus briefs. These “amicus curiae” or “friend of the court” briefs are filed by an entity who is not party to a case but wants to provide information or views to the court.

1. Abortion rulings

The Court decided 2 abortion cases and rejected a request to hear a third.

National Institute of Family and Life Advocates v Becerra

In this case,¹ the Court struck down a California law that required pregnancy crisis centers not offering abortions (generally operated by pro-life groups) to provide special notices to clients.²

At stake. These notices would inform clients that California provides free or low-cost services, including abortions, and provide a phone number to call for those services.

There were many amicus briefs filed in this case, including those by the American College of Obstetricians and Gynecologists (ACOG) and other specialty boards,³ as well as the American Association of Pro-Life Obstetricians and Gynecologists and other pro-life organizations.⁴ ACOG’s brief argued that the California-required notice facilitates the goal of allowing women to receive medical services without harmful delay.

Final ruling. The Court held that the law required clinics to engage in speech with which the clinics disagreed (known as “compelled speech”). It also noted that California disclosure requirements were “wildly underinclusive” because they apply only to some clinics. The majority felt that there was no strong state interest in compelling this speech because there were other alternatives for the state to provide information about the availability of abortion and other services. The Court found that the clinics were likely to succeed on the merits of their claims of a First Amendment (free speech) violation.

Right to abortion for illegal immigrants in custody

A very unusual abortion case involved “Jane Doe,” a minor who was at 8 weeks’ gestation when she illegally crossed the border into the United States.⁵ She was placed in a federally-funded shelter where she requested an abortion. The facility denied that request.

At stake. Legal argument ensued about releasing her to another facility for an abortion, as the argument was made that pregnant minors who are apprehended crossing into the United States illegally and placed into the custody of federal officials should have abortion access. A lower Court of Appeals ruled against the Trump Administration’s policy of denying abortions to undocumented minors in federal custody. During the process of the federal government taking the case to the Supreme Court, the attorneys for Doe moved appointments around and, without notice, the abortion was performed. Government attorneys said that Doe’s attorneys made “what appear to be material misrepresentations and omissions” designed to “thwart [the Supreme Court’s] review” of the case.⁵ The government requested that the Court vacate the order of the Court of Appeals so that it could not be used as precedent.

Final ruling. The Court granted the governments request to vacate the lower court’s order because the minor was no longer pregnant and the order was therefore moot. The basic issue in this case (the right of in-custody minors to access abortions) remains unresolved. It is likely to appear before the Court in the future.

Continue to: Access to medical abortions

An Arkansas law requires that a physician administering medical abortions contract with a physician who has admitting privileges at a hospital (a “contracted physician”).

At stake. Planned Parenthood filed suit challenging the requirement as unnecessary and harmful because it would result in the closure of 2 of the 3 abortion providers in Arkansas. ACOG filed an amicus brief urging the Supreme Court to consider the case.⁶ (Technically this was a petition for a Writ of Certiorari, the procedure by which the Court accepts cases. It accepts only about 1% of applications.) ACOG argued that there was no medical reason for the contracted physician requirement, and noted the harm it would do to women who would not have access to abortions.

Final ruling. On May 29, 2018, the Court declined to hear the case. This case is still active in the lower courts and may eventually return to the Supreme Court.

2. The patent system

The medical profession depends on the patent system to encourage the discovery of new patents efficiently and effectively. In 2012, Congress passed the America Invents Act⁷ that authorizes a petition by anyone other than the patent holder to the Patent and Trademark Office (PTO) for an “inter partes review” to assess a challenge to the patent’s legitimacy. If the PTO determines that there may be merit to the claim, the Patent Trial and Appeal Board undertakes a trial-like review process that may validate, invalidate, or amend the patent. The Board’s decision is subject to appellate court review.

At stake. This term, the inter partes review was challenged as unconstitutional on technical bases.⁸

Final ruling. The Court rejected this claim and approved the current administrative inter partes review process. The Court determined that once the Patent Office takes a petition challenging a patent, it must decide all of the claims against the patent, not pick and choose which elements of the challenge to evaluate.⁹ The Court’s decision upheld patent-review reform, but will require the Patent Office to tweak its procedures.

3. The travel ban

ACOG, the American Medical Association (AMA), the Association of American Medical Colleges, and more than 30 other health care and specialty associations filed an amicus brief regarding one of the most anticipated cases of the term—the “travel ban.”¹⁰

At stake. The essential argument of these organizations was that the US health care system depends on professionals from other countries. An efficient and fair immigration program is, therefore, important to advance the nation’s “health security.” During the 2016−2017 term, the Court considered but then removed the issue from its calendar when the Trump Administration issued a revised travel ban.¹¹

In September 2017, President Trump’s proclamation imposed a range of entry restrictions on the citizens of 8 countries, most (but not all) of which are predominantly Muslim. The government indicated that, in a study by Homeland Security and the State Department, these countries were identified as having especially deficient information-sharing practices and presented national security concerns. Trump v Hawaii¹² challenged this proclamation.

Final ruling. The majority of the Court upheld the travel ban. For the 5-Justice majority led by Chief Justice Roberts, the case came down to 3 things:

1. The Constitution and the laws passed by Congress of necessity give the President great authority to engage in foreign policy, including policies regarding entry into the country.
2. The courts are very reluctant to get into the substance of foreign affairs—they are not equipped to know in detail what the facts are, and things change very fast.
3. If courts start tinkering with foreign policy and things turn bad, it will appear that the courts are to blame and were interfering in an area about which they are not competent.

Continue to: 4. Did a credit card case add risk to health insurance markets?

It was just a credit card case, but one in which the AMA saw a real risk to regulation of the health insurance markets.

At stake. Technically, Ohio v American Express concerned a claim that American Express (AmEx) violated antitrust laws when it prohibited merchants taking its credit card from “steering” customers to cards with lower fees.¹³ AmEx maintained that, because credit cards were a special kind of “2-sided” market (connecting merchants on one side and customers on the other), antitrust laws should not be strictly enforced.

The AMA noticed that special rules regarding 2-sided markets might apply to health insurance, and it submitted an amicus brief¹⁴ that noted: “dominant health insurance networks … have imposed and could further impose rules or effectively erect barriers that prohibit physicians from referring patients to certain specialists, particularly out-of-network specialists, for innovative and even necessary medical tests.”¹⁴ It concluded that the antitrust rule AmEx was suggesting would make it nearly impossible to challenge these unfair provisions in health insurance arrangements.

Final ruling. The Court, however, accepted the AmEx position, making it very difficult to develop an antitrust case against 2-sided markets. It remains to be seen the degree to which the AMA concern about health insurance markets will be realized.

5. Gay wedding and a bakeshop

At stake. In Masterpiece Cakeshop v Colorado, a cakemaker declined to design a cake for a gay wedding and had been disciplined under Colorado law for discriminating against the couple based on sexual orientation.¹⁵

Final ruling. The Court, however, found that the Colorado regulators had, ironically, shown such religious animus in the way they treated the baker that the regulators themselves had discriminated on the basis of religion. As a result, the Court reversed the sanctions against the baker.

This decision was fairly narrow. It does not, for example, stand for the proposition that there may be a general religious exception to antidiscrimination laws. The question of broader religious or free-speech objections to antidiscrimination laws remains for another time.

Amicus brief. It was interesting that the American College of Pediatricians, American Association of Pro-Life Obstetricians and Gynecologists, and others, filed an amicus brief to report with concern the “demands that individual medical professionals must perform, assist with, or facilitate abortions, without regard to the teachings of their own faiths, consciences, and convictions.”¹⁶ The brief also noted that “issues in the present case implicate the fundamental rights of health care professionals, and to respectfully urge that the Court should by no means permit any weakening or qualification of well-established protections against compelled speech, and of free exercise” of religion.¹⁶

Clues to the future

During the term that ran from October 2, 2017, through June 27, 2018, the Court issued 72 decisions. An unusually high proportion of cases (26%; 19 cases) were decided on a 5 to 4 vote. Last term, the rate of 5 to 4 decisions was 10%; the 6-year average was 18%. The unanimous decision rate was 39% this term, compared with 59% last term, and 50% on average.

The rate of 5 to 4 cases provides a clue about the Court’s general direction. The number of times each Justice was in the majority in those nineteen 5 to 4 decisions included: Chief Justice Roberts, 17; and Justices Kennedy, 16; Gorsuch, 16; Thomas, 15; and Alito, 15; compared with Justices Ginsburg, 5; Breyer, 4; Sotomayor, 4; and Kagan, 3.

The Court convened on October 1, 2018. At this writing, whether the new term starts with 8 or 9 justices remains a question. President Trump nominated Brett Kavanaugh, JD, to take Justice Kennedy’s place on the Court. His professional qualifications and experience appear to make him qualified for a position on the Court, but as we have seen, there are many other elements that go into confirming a Justice’s nomination.

Next term, the Court is scheduled to hear cases regarding pharmaceutical liability, double jeopardy, sex-offender registration, expert witnesses, Social Security disability benefits, and the Age Discrimination in Employment Act. There will be at least 3 arbitration cases. Health care and reproductive rights will continue to be an important part of the Court’s docket.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.