Surgical trainees have a large, potentially unmanageable debt burden and are in need of long-term financial education to help better navigate the growing cost of medical education, according to new research.

“Surgical residents are highly leveraged financially and have minimal financial training,” Sarah E. Tevis, MD, of the University of Texas MD Anderson Cancer Center, Houston, and her colleagues wrote in a study in the Journal of the American College of Surgeons. “This places residents in a volatile financial situation as they complete their training and start accumulating debt liabilities, such as mortgages and child care, in the face of tremendous amounts of educational and other debt liabilities.”

Studies of resident debt load typically account for medical education debt, but not for other debts such as undergraduate loans, consumer debt, and mortgages. Residents’ actual debt burden may be considerably higher than has been reported.

The researchers sent surveys to all surgical residents at the University of Wisconsin, Madison, in 2015, with 105 responding (an 80% response rate). Of those responding, 38% reported having more than $200,000 in educational debt, and 82% had a moderate- or high-risk debt-to-asset ratio.

“We found that surgical residents are dangerously overleveraged, with 70% of residents found to have high debt-to-asset ratios,” Dr. Tevis and her colleagues wrote, with the addition of mortgages and vehicle debt on top of educational debt being the key factors of moving residents into the high-risk debt-to-asset category.

The debt-to-asset ratio was calculated as the sum of student loan debt + nonstudent loan debt + credit card balance + mortgage debt + vehicle debt divided by the value of home and other real estate + value of household vehicles + amount in savings + value of retirement investment. A debt-to-asset ratio of 0.5 to 0.9 was considered moderate risk, with a ratio greater than or equal to 0.9 considered high risk.

The debt-to-income ratio was calculated as the sum of student loan debt + nonstudent loan debt + credit card balance + mortgage debt + vehicle debt divided by total household income. A high-risk ratio defined as being greater than 0.4, the line at which surgical trainees might be restricted from obtaining a traditional mortgage.

Total household income included personal income, domestic partner income, military income, and any income from moonlighting, rental properties, and other sources of revenue. Assets included home and second home purchase prices when applicable, value of vehicles, amount in savings, value of retirement accounts, and value of investments. Contributors to debt included student loan, nonstudent loan, mortgage, vehicle financing, and credit card balances.

Salary data for U.S. residents, which strictly tracked U.S. inflation, was calculated over a 15-year period (2000-2015) using data from the Association of American Medical Colleges for comparison.

In examining debt-to-income, researchers found that “83% of residents have a high-risk debt-to-income ratio [greater than 0.4],” the authors wrote. “We found that the majority of residents were classified in the high financial risk exposure cohort when comprehensive total debt liabilities were considered. In this group of highly leveraged residents, over 80% of residents were dangerously unable to manage regular monthly liabilities with their current level of income.”

No statistically significant association between sex, residency year, residency program, or who manages finances and risk debt-to-asset ratios were found in this study.

The authors noted that, although this study did not look at the psychological impact of significant debt load and lack of training on how to manage finances, these factors have been shown in other studies to correlate with resident burnout and psychological stress.

Bruce A. Harms, MD, FACS, coauthor of the study said in an interview, “We are in an evolving era in surgery and in health care in general and financial resources are being stretched. We don’t know for sure that the rising educational debt and overall debt burden as residents enter their prime years will drive the next generation of physicians to certain career choices. It may even perhaps drive a given fully trained young surgeon away from a practice that is more exposed to an underserved population. Excessive financial debt induced stress may influence a resident’s decision on what they do with their skill set but to what degree is largely unknown.”

Dr. Harms added that residents may assume that when they eventually enter practice, they will have a pathway and the means to deal with educational debt. “They would be correct in that starting salaries are keeping pace with inflation. However, in many instances, they are also entering a time in their lives when they will be taking on additional debt in the form of home mortgage, family, and child care costs. I believe, in most instances, residents are focused almost totally on their residency training and many other financial considerations take a back seat and ‘we’ll deal with our debt problem in the future’ attitude. Residents for the most part don’t have the financial means and resources to deal with debt anyway during the course of their lengthy residency training. The exception would be having a secondary income from a spouse or partner that would allow for a more robust debt-attrition strategy. Also, residents are likely not focused on or considering a strategy for the best return on investment of their time, additional expense, and career delay from their prolonged pathway to becoming a fully trained surgeon.”

The bottom line is that basic financial educational is not included in core surgical training even though most surgical residents would like some degree of financial education. That is the basic problem and shortcoming of existing residency training programs, Dr. Tevis and her colleagues wrote.

Given the financial burdens that education and other factors are placing on surgical residents, Dr. Tevis and her colleagues proposed “that formal training in the business of medicine and personal finance for surgical residents be strongly considered at the training program level or in partnership with other organizations, such as the American College of Surgeons, in an effort to improve the financial status of residents and prepare them for their careers, both personally and professionally.”

Dr. Harms noted, “It is probable that in most cases, educational loan debt principal is not being paid down to any significant degree given the current residency salary structure. We can only hope that residents are given some degree of good information on strategies for managing educational loan debt, which may include federally sponsored loan repayment programs such as [those offered] through NIH-sponsored research or federal loan forgiveness programs that residents may qualify for. In most cases, federal loan forgiveness programs require a minimum monthly payment that is calculated based upon current income. As an absolute minimum, interest payments should be made as additional interest debt will add significantly to the overall debt burden as interest will continue to accrue.”

Getting that financial training early could have significant benefits on the back end. The study authors noted that salary data from the Association of American Medical Colleges showed assistant professor salaries mirrored inflation metrics, but even better, surgeon salaries continued to exceed inflation-indexed targets and continued upward trends even through recession periods.

“Therefore, the financial pathway, built on increases in surgeon starting salaries exceeding annual inflation, presently still exists for deleveraging of critical debt exposure if personal finances are optimally managed,” the authors stated.

The study did have its limitations. It did not include certain variable expenses such as utilities, food, and other shopping habits, although that may have been captured as the survey asked respondents to list other “major” sources of income and debt. It also was limited to surgical residents at a single institution and may not be applicable to other specialties or geographic locations. It did not assess whether residents with mortgage payments were able to make educational loan payments beyond the minimum.

The investigators reported no conflicts.

[email protected]

SOURCE: Tevis SE et al. J Am Coll Surg. 2018 May 31. doi: 10.1016/j.jamcollsurg.2018.05.002.

Surgical trainees have a large, potentially unmanageable debt burden and are in need of long-term financial education to help better navigate the growing cost of medical education, according to new research.

“Surgical residents are highly leveraged financially and have minimal financial training,” Sarah E. Tevis, MD, of the University of Texas MD Anderson Cancer Center, Houston, and her colleagues wrote in a study in the Journal of the American College of Surgeons. “This places residents in a volatile financial situation as they complete their training and start accumulating debt liabilities, such as mortgages and child care, in the face of tremendous amounts of educational and other debt liabilities.”

Studies of resident debt load typically account for medical education debt, but not for other debts such as undergraduate loans, consumer debt, and mortgages. Residents’ actual debt burden may be considerably higher than has been reported.

The researchers sent surveys to all surgical residents at the University of Wisconsin, Madison, in 2015, with 105 responding (an 80% response rate). Of those responding, 38% reported having more than $200,000 in educational debt, and 82% had a moderate- or high-risk debt-to-asset ratio.

“We found that surgical residents are dangerously overleveraged, with 70% of residents found to have high debt-to-asset ratios,” Dr. Tevis and her colleagues wrote, with the addition of mortgages and vehicle debt on top of educational debt being the key factors of moving residents into the high-risk debt-to-asset category.

The debt-to-asset ratio was calculated as the sum of student loan debt + nonstudent loan debt + credit card balance + mortgage debt + vehicle debt divided by the value of home and other real estate + value of household vehicles + amount in savings + value of retirement investment. A debt-to-asset ratio of 0.5 to 0.9 was considered moderate risk, with a ratio greater than or equal to 0.9 considered high risk.

The debt-to-income ratio was calculated as the sum of student loan debt + nonstudent loan debt + credit card balance + mortgage debt + vehicle debt divided by total household income. A high-risk ratio defined as being greater than 0.4, the line at which surgical trainees might be restricted from obtaining a traditional mortgage.

Total household income included personal income, domestic partner income, military income, and any income from moonlighting, rental properties, and other sources of revenue. Assets included home and second home purchase prices when applicable, value of vehicles, amount in savings, value of retirement accounts, and value of investments. Contributors to debt included student loan, nonstudent loan, mortgage, vehicle financing, and credit card balances.

Salary data for U.S. residents, which strictly tracked U.S. inflation, was calculated over a 15-year period (2000-2015) using data from the Association of American Medical Colleges for comparison.

In examining debt-to-income, researchers found that “83% of residents have a high-risk debt-to-income ratio [greater than 0.4],” the authors wrote. “We found that the majority of residents were classified in the high financial risk exposure cohort when comprehensive total debt liabilities were considered. In this group of highly leveraged residents, over 80% of residents were dangerously unable to manage regular monthly liabilities with their current level of income.”

No statistically significant association between sex, residency year, residency program, or who manages finances and risk debt-to-asset ratios were found in this study.

The authors noted that, although this study did not look at the psychological impact of significant debt load and lack of training on how to manage finances, these factors have been shown in other studies to correlate with resident burnout and psychological stress.

Bruce A. Harms, MD, FACS, coauthor of the study said in an interview, “We are in an evolving era in surgery and in health care in general and financial resources are being stretched. We don’t know for sure that the rising educational debt and overall debt burden as residents enter their prime years will drive the next generation of physicians to certain career choices. It may even perhaps drive a given fully trained young surgeon away from a practice that is more exposed to an underserved population. Excessive financial debt induced stress may influence a resident’s decision on what they do with their skill set but to what degree is largely unknown.”

Dr. Harms added that residents may assume that when they eventually enter practice, they will have a pathway and the means to deal with educational debt. “They would be correct in that starting salaries are keeping pace with inflation. However, in many instances, they are also entering a time in their lives when they will be taking on additional debt in the form of home mortgage, family, and child care costs. I believe, in most instances, residents are focused almost totally on their residency training and many other financial considerations take a back seat and ‘we’ll deal with our debt problem in the future’ attitude. Residents for the most part don’t have the financial means and resources to deal with debt anyway during the course of their lengthy residency training. The exception would be having a secondary income from a spouse or partner that would allow for a more robust debt-attrition strategy. Also, residents are likely not focused on or considering a strategy for the best return on investment of their time, additional expense, and career delay from their prolonged pathway to becoming a fully trained surgeon.”

The bottom line is that basic financial educational is not included in core surgical training even though most surgical residents would like some degree of financial education. That is the basic problem and shortcoming of existing residency training programs, Dr. Tevis and her colleagues wrote.

Given the financial burdens that education and other factors are placing on surgical residents, Dr. Tevis and her colleagues proposed “that formal training in the business of medicine and personal finance for surgical residents be strongly considered at the training program level or in partnership with other organizations, such as the American College of Surgeons, in an effort to improve the financial status of residents and prepare them for their careers, both personally and professionally.”

Dr. Harms noted, “It is probable that in most cases, educational loan debt principal is not being paid down to any significant degree given the current residency salary structure. We can only hope that residents are given some degree of good information on strategies for managing educational loan debt, which may include federally sponsored loan repayment programs such as [those offered] through NIH-sponsored research or federal loan forgiveness programs that residents may qualify for. In most cases, federal loan forgiveness programs require a minimum monthly payment that is calculated based upon current income. As an absolute minimum, interest payments should be made as additional interest debt will add significantly to the overall debt burden as interest will continue to accrue.”

Getting that financial training early could have significant benefits on the back end. The study authors noted that salary data from the Association of American Medical Colleges showed assistant professor salaries mirrored inflation metrics, but even better, surgeon salaries continued to exceed inflation-indexed targets and continued upward trends even through recession periods.

“Therefore, the financial pathway, built on increases in surgeon starting salaries exceeding annual inflation, presently still exists for deleveraging of critical debt exposure if personal finances are optimally managed,” the authors stated.

The study did have its limitations. It did not include certain variable expenses such as utilities, food, and other shopping habits, although that may have been captured as the survey asked respondents to list other “major” sources of income and debt. It also was limited to surgical residents at a single institution and may not be applicable to other specialties or geographic locations. It did not assess whether residents with mortgage payments were able to make educational loan payments beyond the minimum.

The investigators reported no conflicts.

[email protected]

SOURCE: Tevis SE et al. J Am Coll Surg. 2018 May 31. doi: 10.1016/j.jamcollsurg.2018.05.002.

Surgical trainees have a large, potentially unmanageable debt burden and are in need of long-term financial education to help better navigate the growing cost of medical education, according to new research.

“Surgical residents are highly leveraged financially and have minimal financial training,” Sarah E. Tevis, MD, of the University of Texas MD Anderson Cancer Center, Houston, and her colleagues wrote in a study in the Journal of the American College of Surgeons. “This places residents in a volatile financial situation as they complete their training and start accumulating debt liabilities, such as mortgages and child care, in the face of tremendous amounts of educational and other debt liabilities.”

Studies of resident debt load typically account for medical education debt, but not for other debts such as undergraduate loans, consumer debt, and mortgages. Residents’ actual debt burden may be considerably higher than has been reported.

The researchers sent surveys to all surgical residents at the University of Wisconsin, Madison, in 2015, with 105 responding (an 80% response rate). Of those responding, 38% reported having more than $200,000 in educational debt, and 82% had a moderate- or high-risk debt-to-asset ratio.

“We found that surgical residents are dangerously overleveraged, with 70% of residents found to have high debt-to-asset ratios,” Dr. Tevis and her colleagues wrote, with the addition of mortgages and vehicle debt on top of educational debt being the key factors of moving residents into the high-risk debt-to-asset category.

The debt-to-asset ratio was calculated as the sum of student loan debt + nonstudent loan debt + credit card balance + mortgage debt + vehicle debt divided by the value of home and other real estate + value of household vehicles + amount in savings + value of retirement investment. A debt-to-asset ratio of 0.5 to 0.9 was considered moderate risk, with a ratio greater than or equal to 0.9 considered high risk.

The debt-to-income ratio was calculated as the sum of student loan debt + nonstudent loan debt + credit card balance + mortgage debt + vehicle debt divided by total household income. A high-risk ratio defined as being greater than 0.4, the line at which surgical trainees might be restricted from obtaining a traditional mortgage.

Total household income included personal income, domestic partner income, military income, and any income from moonlighting, rental properties, and other sources of revenue. Assets included home and second home purchase prices when applicable, value of vehicles, amount in savings, value of retirement accounts, and value of investments. Contributors to debt included student loan, nonstudent loan, mortgage, vehicle financing, and credit card balances.

Salary data for U.S. residents, which strictly tracked U.S. inflation, was calculated over a 15-year period (2000-2015) using data from the Association of American Medical Colleges for comparison.

In examining debt-to-income, researchers found that “83% of residents have a high-risk debt-to-income ratio [greater than 0.4],” the authors wrote. “We found that the majority of residents were classified in the high financial risk exposure cohort when comprehensive total debt liabilities were considered. In this group of highly leveraged residents, over 80% of residents were dangerously unable to manage regular monthly liabilities with their current level of income.”

No statistically significant association between sex, residency year, residency program, or who manages finances and risk debt-to-asset ratios were found in this study.

The authors noted that, although this study did not look at the psychological impact of significant debt load and lack of training on how to manage finances, these factors have been shown in other studies to correlate with resident burnout and psychological stress.

Bruce A. Harms, MD, FACS, coauthor of the study said in an interview, “We are in an evolving era in surgery and in health care in general and financial resources are being stretched. We don’t know for sure that the rising educational debt and overall debt burden as residents enter their prime years will drive the next generation of physicians to certain career choices. It may even perhaps drive a given fully trained young surgeon away from a practice that is more exposed to an underserved population. Excessive financial debt induced stress may influence a resident’s decision on what they do with their skill set but to what degree is largely unknown.”

Dr. Harms added that residents may assume that when they eventually enter practice, they will have a pathway and the means to deal with educational debt. “They would be correct in that starting salaries are keeping pace with inflation. However, in many instances, they are also entering a time in their lives when they will be taking on additional debt in the form of home mortgage, family, and child care costs. I believe, in most instances, residents are focused almost totally on their residency training and many other financial considerations take a back seat and ‘we’ll deal with our debt problem in the future’ attitude. Residents for the most part don’t have the financial means and resources to deal with debt anyway during the course of their lengthy residency training. The exception would be having a secondary income from a spouse or partner that would allow for a more robust debt-attrition strategy. Also, residents are likely not focused on or considering a strategy for the best return on investment of their time, additional expense, and career delay from their prolonged pathway to becoming a fully trained surgeon.”

The bottom line is that basic financial educational is not included in core surgical training even though most surgical residents would like some degree of financial education. That is the basic problem and shortcoming of existing residency training programs, Dr. Tevis and her colleagues wrote.

Given the financial burdens that education and other factors are placing on surgical residents, Dr. Tevis and her colleagues proposed “that formal training in the business of medicine and personal finance for surgical residents be strongly considered at the training program level or in partnership with other organizations, such as the American College of Surgeons, in an effort to improve the financial status of residents and prepare them for their careers, both personally and professionally.”

Dr. Harms noted, “It is probable that in most cases, educational loan debt principal is not being paid down to any significant degree given the current residency salary structure. We can only hope that residents are given some degree of good information on strategies for managing educational loan debt, which may include federally sponsored loan repayment programs such as [those offered] through NIH-sponsored research or federal loan forgiveness programs that residents may qualify for. In most cases, federal loan forgiveness programs require a minimum monthly payment that is calculated based upon current income. As an absolute minimum, interest payments should be made as additional interest debt will add significantly to the overall debt burden as interest will continue to accrue.”

Getting that financial training early could have significant benefits on the back end. The study authors noted that salary data from the Association of American Medical Colleges showed assistant professor salaries mirrored inflation metrics, but even better, surgeon salaries continued to exceed inflation-indexed targets and continued upward trends even through recession periods.

“Therefore, the financial pathway, built on increases in surgeon starting salaries exceeding annual inflation, presently still exists for deleveraging of critical debt exposure if personal finances are optimally managed,” the authors stated.

The study did have its limitations. It did not include certain variable expenses such as utilities, food, and other shopping habits, although that may have been captured as the survey asked respondents to list other “major” sources of income and debt. It also was limited to surgical residents at a single institution and may not be applicable to other specialties or geographic locations. It did not assess whether residents with mortgage payments were able to make educational loan payments beyond the minimum.

The investigators reported no conflicts.

[email protected]

SOURCE: Tevis SE et al. J Am Coll Surg. 2018 May 31. doi: 10.1016/j.jamcollsurg.2018.05.002.

Dr. James Griffith and Dr. Lorenzo Norris finish their conversation on resilience in the third and final part of this Psychcast series.

Dr. James Griffith and Dr. Lorenzo Norris finish their conversation on resilience in the third and final part of this Psychcast series.

Dr. James Griffith and Dr. Lorenzo Norris finish their conversation on resilience in the third and final part of this Psychcast series.

The Trump administration seeks to reorganize several federal agencies as part of a sweeping reform proposal, issued June 21. Although the plans hits many parts of federal health care, the most dramatic change is a proposed reduction of the Public Health Service (PHS) Commissioned Corps from more than 6,000 officers to no more than 4,500.

“Government in the 21st century is fundamentally a services business, and modern information technology should be at the heart of the U.S. government service delivery model,” according to the administration’s reform proposal. “And yet, today’s Executive branch is still aligned to the stove-piped organizational constructs of the 20th century, which in many cases have grown inefficient and out of date. Consequently, the public and our workforce are frustrated with government’s ability to deliver its mission in an effective, efficient, and secure way.”

tupungato/Thinkstock

If implemented, changes to the Commissioned Corp would be dramatic. The plan directs the Department of Health and Human Services (HHS) to “civilianize officers who do not provide critical public health services” and to ensure that the Corps is deployed at least once every 3 years to positions that either are difficult to fill or respond to a public health emergency. Instead the Commissioned Corps would be replaced with a Reserve Corps. Similar to the armed forces reserves, this group “would consist of Government employees and private citizens who agree to be deployed and serve in times of national need.”  In addition, the plan would change the way federal agencies pay for the retirement benefits of Commissioned Corps members, potentially eliminating one of the fiscal benefits that agencies receive for hiring Commissioned Corps members. 

In addition, under the proposal, nutrition assistance programs currently run out of the U.S. Department of Agriculture (USDA) including the Supplemental Nutrition Assistance Program (SNAP) and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) would move to the Department of Health and Human Services, which would be rebranded the Department of Health and Public Welfare.

Moving these programs “would allow for better and easier coordination across programs that serve similar populations, ensuring consistent policies and a single point of administration for the major public assistance programs,” according to the proposal. “This single point of administration would lead to reduced duplication in state reporting requirements and other administrative burdens, and a more streamlined process for issuing guidance, writing regulations, and approving waivers.”

Food oversight functions would move from the Food and Drug Administration to the USDA; FDA would be rebranded the Federal Drug Administration and focus on drugs, devices, biologics, tobacco, dietary supplements, and cosmetics.

The administration also proposed to create a Council on Public Assistance comprised of “all federal agencies that administer public benefits, with a statutory authority to set cross-cutting program policies, including uniform work requirements.”

Other functions of the council would include approving service plans and waivers by states under Welfare-to-Work projects; resolving disputes when multiple agencies disagree on a particular policy; and recommending policy changes to eliminate barriers at the federal, state, and local level to getting welfare beneficiaries to work.

The proposal also calls for a restructuring of the National Institutes of Health “to ensure operations are effective and efficient,” with no detail provided. It would also place the Agency for Healthcare Research and Quality under the auspices of NIH.

The Strategic National Stockpile would be managed by the Assistant Secretary for Preparedness and Response “to consolidate strategic decision making around the development and procurement of medical countermeasures, and streamline operational decisions during responses to public health and other emergencies to improve responsiveness.”

Senator Patty Murray (D-WA), the ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, was quick to dismiss the plan, labeling it as “futile” and an “attempt to make government work worse for the people it serves.”

This article originally appeared at Internal Medicine News. It has been edited for Federal Practitioner and includes additional reporting by Reid Paul.

[email protected]

The Trump administration seeks to reorganize several federal agencies as part of a sweeping reform proposal, issued June 21. Although the plans hits many parts of federal health care, the most dramatic change is a proposed reduction of the Public Health Service (PHS) Commissioned Corps from more than 6,000 officers to no more than 4,500.

“Government in the 21st century is fundamentally a services business, and modern information technology should be at the heart of the U.S. government service delivery model,” according to the administration’s reform proposal. “And yet, today’s Executive branch is still aligned to the stove-piped organizational constructs of the 20th century, which in many cases have grown inefficient and out of date. Consequently, the public and our workforce are frustrated with government’s ability to deliver its mission in an effective, efficient, and secure way.”

tupungato/Thinkstock

If implemented, changes to the Commissioned Corp would be dramatic. The plan directs the Department of Health and Human Services (HHS) to “civilianize officers who do not provide critical public health services” and to ensure that the Corps is deployed at least once every 3 years to positions that either are difficult to fill or respond to a public health emergency. Instead the Commissioned Corps would be replaced with a Reserve Corps. Similar to the armed forces reserves, this group “would consist of Government employees and private citizens who agree to be deployed and serve in times of national need.”  In addition, the plan would change the way federal agencies pay for the retirement benefits of Commissioned Corps members, potentially eliminating one of the fiscal benefits that agencies receive for hiring Commissioned Corps members. 

In addition, under the proposal, nutrition assistance programs currently run out of the U.S. Department of Agriculture (USDA) including the Supplemental Nutrition Assistance Program (SNAP) and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) would move to the Department of Health and Human Services, which would be rebranded the Department of Health and Public Welfare.

Moving these programs “would allow for better and easier coordination across programs that serve similar populations, ensuring consistent policies and a single point of administration for the major public assistance programs,” according to the proposal. “This single point of administration would lead to reduced duplication in state reporting requirements and other administrative burdens, and a more streamlined process for issuing guidance, writing regulations, and approving waivers.”

Food oversight functions would move from the Food and Drug Administration to the USDA; FDA would be rebranded the Federal Drug Administration and focus on drugs, devices, biologics, tobacco, dietary supplements, and cosmetics.

The administration also proposed to create a Council on Public Assistance comprised of “all federal agencies that administer public benefits, with a statutory authority to set cross-cutting program policies, including uniform work requirements.”

Other functions of the council would include approving service plans and waivers by states under Welfare-to-Work projects; resolving disputes when multiple agencies disagree on a particular policy; and recommending policy changes to eliminate barriers at the federal, state, and local level to getting welfare beneficiaries to work.

The proposal also calls for a restructuring of the National Institutes of Health “to ensure operations are effective and efficient,” with no detail provided. It would also place the Agency for Healthcare Research and Quality under the auspices of NIH.

The Strategic National Stockpile would be managed by the Assistant Secretary for Preparedness and Response “to consolidate strategic decision making around the development and procurement of medical countermeasures, and streamline operational decisions during responses to public health and other emergencies to improve responsiveness.”

Senator Patty Murray (D-WA), the ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, was quick to dismiss the plan, labeling it as “futile” and an “attempt to make government work worse for the people it serves.”

This article originally appeared at Internal Medicine News. It has been edited for Federal Practitioner and includes additional reporting by Reid Paul.

[email protected]

The Trump administration seeks to reorganize several federal agencies as part of a sweeping reform proposal, issued June 21. Although the plans hits many parts of federal health care, the most dramatic change is a proposed reduction of the Public Health Service (PHS) Commissioned Corps from more than 6,000 officers to no more than 4,500.

“Government in the 21st century is fundamentally a services business, and modern information technology should be at the heart of the U.S. government service delivery model,” according to the administration’s reform proposal. “And yet, today’s Executive branch is still aligned to the stove-piped organizational constructs of the 20th century, which in many cases have grown inefficient and out of date. Consequently, the public and our workforce are frustrated with government’s ability to deliver its mission in an effective, efficient, and secure way.”

tupungato/Thinkstock

If implemented, changes to the Commissioned Corp would be dramatic. The plan directs the Department of Health and Human Services (HHS) to “civilianize officers who do not provide critical public health services” and to ensure that the Corps is deployed at least once every 3 years to positions that either are difficult to fill or respond to a public health emergency. Instead the Commissioned Corps would be replaced with a Reserve Corps. Similar to the armed forces reserves, this group “would consist of Government employees and private citizens who agree to be deployed and serve in times of national need.”  In addition, the plan would change the way federal agencies pay for the retirement benefits of Commissioned Corps members, potentially eliminating one of the fiscal benefits that agencies receive for hiring Commissioned Corps members. 

In addition, under the proposal, nutrition assistance programs currently run out of the U.S. Department of Agriculture (USDA) including the Supplemental Nutrition Assistance Program (SNAP) and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) would move to the Department of Health and Human Services, which would be rebranded the Department of Health and Public Welfare.

Moving these programs “would allow for better and easier coordination across programs that serve similar populations, ensuring consistent policies and a single point of administration for the major public assistance programs,” according to the proposal. “This single point of administration would lead to reduced duplication in state reporting requirements and other administrative burdens, and a more streamlined process for issuing guidance, writing regulations, and approving waivers.”

Food oversight functions would move from the Food and Drug Administration to the USDA; FDA would be rebranded the Federal Drug Administration and focus on drugs, devices, biologics, tobacco, dietary supplements, and cosmetics.

The administration also proposed to create a Council on Public Assistance comprised of “all federal agencies that administer public benefits, with a statutory authority to set cross-cutting program policies, including uniform work requirements.”

Other functions of the council would include approving service plans and waivers by states under Welfare-to-Work projects; resolving disputes when multiple agencies disagree on a particular policy; and recommending policy changes to eliminate barriers at the federal, state, and local level to getting welfare beneficiaries to work.

The proposal also calls for a restructuring of the National Institutes of Health “to ensure operations are effective and efficient,” with no detail provided. It would also place the Agency for Healthcare Research and Quality under the auspices of NIH.

The Strategic National Stockpile would be managed by the Assistant Secretary for Preparedness and Response “to consolidate strategic decision making around the development and procurement of medical countermeasures, and streamline operational decisions during responses to public health and other emergencies to improve responsiveness.”

Senator Patty Murray (D-WA), the ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, was quick to dismiss the plan, labeling it as “futile” and an “attempt to make government work worse for the people it serves.”

This article originally appeared at Internal Medicine News. It has been edited for Federal Practitioner and includes additional reporting by Reid Paul.

[email protected]

The FDA’s MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. These and other label changes are searchable in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats. Boxed warnings are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefi t from the drug that it is essential that it be considered in assessing the risks and benefi ts of using the drug; or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. For complete FDA Drug Safety Labeling changes, please visit http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges.

VIDEX AND VIDEX EC (DIDANOSINE):

• Edited boxed warning, January 2018

WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS

Coadministration of VIDEX or VIDEX EC and stavudine is contraindicated because of increased risk of serious and/or life-threatening events. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occurs.

ZYDELIG (IDELALISIB):

• Edited boxed warning, January 2018

WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION

Fatal and/or serious hepatotoxicity occurred in 16% to 18% of Zydelig-treated patients…

Fatal and/or serious and severe diarrhea or colitis occurred in 14% to 20% of Zydelig-treated patients…

Fatal and/or serious infections occurred in 21% to 48% of Zydelig-treated patients…

AQUAMEPHYTON (PHYTONADIONE):

• Edited boxed warning, March 2018

WARNING: HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE

Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of Aqua-MEPHYTON. Reactions have occurred despite dilution to avoid rapid infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified.

FERAHEME (FERUMOXYTOL):

• Edited boxed warning, February 2018

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving feraheme. Initial symptoms may
include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.

Only administer feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

METHADONE HYDROCHLORIDE, METHADOSE (METHADONE HYDROCHLORIDE):

• Edited boxed warning, February 2018

RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Concomitant use with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, is a risk factor for respiratory depression and death.

Reserve concomitant prescribing of benzodiazepines or other CNS depressants for use in patients for whom alternatives to benzodiazepines or other CNS depressants are inadequate.

Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of sedation, and consider delaying or omitting daily methadone dosing.

DOLOPHINE HYDROCHLORIDE (METHADONE HYDROCHLORIDE):

• Edited boxed warning, February 2018

RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing of DOLOPHINE Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternatives to benzodiazepines or other CNS depressants are inadequate.

Limit dosages and durations to the minimum required for patients being treated for pain.

Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of sedation, and consider delaying or omitting the daily methadone dose.

PARNATE (TRANYLCYPROMINE SULFATE):

• Edited boxed warning, January 2018

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS AND HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE

SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. PARNATE is not approved for use in pediatric patients.

HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE
Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with PARNATE or after PARNATE discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of PARNATE and interacting drugs. Instruct patients to avoid ingestion of foods and beverages with high tyramine content.

OCALIVA (OBETICHOLIC ACID):

• New boxed warning/Newly added section, February 2018

WARNING: HEPATIC DECOMPENSATION AND FAILURE IN INCORRECTLY DOSED PBC PATIENTS WITH CHILD-PUGH CLASS B OR C OR DECOMPENSATED CIRRHOSIS

In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with primary biliary cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed more frequently than recommended.

The recommended starting dosage of OCALIVA is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event.

The FDA’s MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. These and other label changes are searchable in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats. Boxed warnings are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefi t from the drug that it is essential that it be considered in assessing the risks and benefi ts of using the drug; or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. For complete FDA Drug Safety Labeling changes, please visit http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges.

VIDEX AND VIDEX EC (DIDANOSINE):

• Edited boxed warning, January 2018

WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS

Coadministration of VIDEX or VIDEX EC and stavudine is contraindicated because of increased risk of serious and/or life-threatening events. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occurs.

ZYDELIG (IDELALISIB):

• Edited boxed warning, January 2018

WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION

Fatal and/or serious hepatotoxicity occurred in 16% to 18% of Zydelig-treated patients…

Fatal and/or serious and severe diarrhea or colitis occurred in 14% to 20% of Zydelig-treated patients…

Fatal and/or serious infections occurred in 21% to 48% of Zydelig-treated patients…

AQUAMEPHYTON (PHYTONADIONE):

• Edited boxed warning, March 2018

WARNING: HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE

Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of Aqua-MEPHYTON. Reactions have occurred despite dilution to avoid rapid infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified.

FERAHEME (FERUMOXYTOL):

• Edited boxed warning, February 2018

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving feraheme. Initial symptoms may
include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.

Only administer feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

METHADONE HYDROCHLORIDE, METHADOSE (METHADONE HYDROCHLORIDE):

• Edited boxed warning, February 2018

RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Concomitant use with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, is a risk factor for respiratory depression and death.

Reserve concomitant prescribing of benzodiazepines or other CNS depressants for use in patients for whom alternatives to benzodiazepines or other CNS depressants are inadequate.

Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of sedation, and consider delaying or omitting daily methadone dosing.

DOLOPHINE HYDROCHLORIDE (METHADONE HYDROCHLORIDE):

• Edited boxed warning, February 2018

RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing of DOLOPHINE Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternatives to benzodiazepines or other CNS depressants are inadequate.

Limit dosages and durations to the minimum required for patients being treated for pain.

Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of sedation, and consider delaying or omitting the daily methadone dose.

PARNATE (TRANYLCYPROMINE SULFATE):

• Edited boxed warning, January 2018

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS AND HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE

SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. PARNATE is not approved for use in pediatric patients.

HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE
Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with PARNATE or after PARNATE discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of PARNATE and interacting drugs. Instruct patients to avoid ingestion of foods and beverages with high tyramine content.

OCALIVA (OBETICHOLIC ACID):

• New boxed warning/Newly added section, February 2018

WARNING: HEPATIC DECOMPENSATION AND FAILURE IN INCORRECTLY DOSED PBC PATIENTS WITH CHILD-PUGH CLASS B OR C OR DECOMPENSATED CIRRHOSIS

In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with primary biliary cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed more frequently than recommended.

The recommended starting dosage of OCALIVA is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event.

The FDA’s MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. These and other label changes are searchable in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats. Boxed warnings are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefi t from the drug that it is essential that it be considered in assessing the risks and benefi ts of using the drug; or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. For complete FDA Drug Safety Labeling changes, please visit http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges.

VIDEX AND VIDEX EC (DIDANOSINE):

• Edited boxed warning, January 2018

WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS

Coadministration of VIDEX or VIDEX EC and stavudine is contraindicated because of increased risk of serious and/or life-threatening events. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occurs.

ZYDELIG (IDELALISIB):

• Edited boxed warning, January 2018

WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION

Fatal and/or serious hepatotoxicity occurred in 16% to 18% of Zydelig-treated patients…

Fatal and/or serious and severe diarrhea or colitis occurred in 14% to 20% of Zydelig-treated patients…

Fatal and/or serious infections occurred in 21% to 48% of Zydelig-treated patients…

AQUAMEPHYTON (PHYTONADIONE):

• Edited boxed warning, March 2018

WARNING: HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE

Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of Aqua-MEPHYTON. Reactions have occurred despite dilution to avoid rapid infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified.

FERAHEME (FERUMOXYTOL):

• Edited boxed warning, February 2018

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving feraheme. Initial symptoms may
include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.

Only administer feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

METHADONE HYDROCHLORIDE, METHADOSE (METHADONE HYDROCHLORIDE):

• Edited boxed warning, February 2018

RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Concomitant use with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, is a risk factor for respiratory depression and death.

Reserve concomitant prescribing of benzodiazepines or other CNS depressants for use in patients for whom alternatives to benzodiazepines or other CNS depressants are inadequate.

Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of sedation, and consider delaying or omitting daily methadone dosing.

DOLOPHINE HYDROCHLORIDE (METHADONE HYDROCHLORIDE):

• Edited boxed warning, February 2018

RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing of DOLOPHINE Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternatives to benzodiazepines or other CNS depressants are inadequate.

Limit dosages and durations to the minimum required for patients being treated for pain.

Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of sedation, and consider delaying or omitting the daily methadone dose.

PARNATE (TRANYLCYPROMINE SULFATE):

• Edited boxed warning, January 2018

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS AND HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE

SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. PARNATE is not approved for use in pediatric patients.

HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE
Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with PARNATE or after PARNATE discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of PARNATE and interacting drugs. Instruct patients to avoid ingestion of foods and beverages with high tyramine content.

OCALIVA (OBETICHOLIC ACID):

• New boxed warning/Newly added section, February 2018

WARNING: HEPATIC DECOMPENSATION AND FAILURE IN INCORRECTLY DOSED PBC PATIENTS WITH CHILD-PUGH CLASS B OR C OR DECOMPENSATED CIRRHOSIS

In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with primary biliary cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed more frequently than recommended.

The recommended starting dosage of OCALIVA is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event.

Hepatitis C virus (HCV) infection is a major public health problem in the US. Following the 2010 report of the Institute of Medicine/National Academies of Sciences, Engineering, and Medicine (NASEM) on hepatitis and liver cancer, the US Department of Health and Human Services (HHS) released the first National Viral Hepatitis Action Plan in 2011 with subsequent action plan updates for 2014-2016 and 2017-2020.^1-3 A NASEM phase 2 report and the 2017-2020 HHS action plan outline a national strategy to prevent new viral hepatitis infections; reduce deaths and improve the health of people living with viral hepatitis; reduce viral hepatitis health disparities; and coordinate, monitor, and report on implementation of viral hepatitis activities.^3,4 The Department of Veterans Affairs (VA) is the single largest HCV care provider in the US with about 165,000 veterans in care diagnosed with HCV in the beginning of 2014 and is a national leader in the testing and treatment of HCV.^5,6

The VA’s recommendations for screening for HCV infection are in alignment with the United States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations to test all veterans born between 1945 and 1965 and anyone with risk factors such as injection drug use.7-9 As of January 1, 2018, the VA had screened more than 80% of veterans in care within this highest risk birth cohort. As of January 1, 2018, more than 100,000 veterans in VA care have initiated treatment for HCV with direct-acting antivirals (DAAs) (Figure 1). 

Several critical factors contributed to the VA success with HCV testing and treatment, including congressional appropriation of funding from fiscal year (FY) 2016 through FY 2018, unrestricted access to interferon-free DAA HCV treatments, and dedicated resources from the VA National Viral Hepatitis Program within the HIV, Hepatitis, and Related Conditions Programs (HHRC) in the Office of Specialty Care Services.⁵ In 2014, HHRC created and supported the Hepatitis Innovation Team (HIT) Collaborative, a VA process improvement initiative enabling
Veterans Integrated Service Network (VISN) -based, multidisciplinary teams to increase veterans’ access to HCV testing and treatment.

As the VA makes consistent progress toward eliminating HCV in veterans in VA care, it has become clear that achieving a cure is only a starting point in improving HCV care. Many patients with HCV infection also have advanced liver disease (ALD), or cirrhosis, which is a condition of permanent liver fibrosis that remains after the patient has been cured of HCV infection. In addition to hepatitis C, ALD also can be caused by excessive alcohol use, hepatitis B virus (HBV) infection, nonalcoholic fatty liver diseases, and several other inherited diseases. Advanced liver disease affects more than 80,000 veterans in VA care, and the HIT infrastructure provides an excellent framework to better understand and address facility-level and systemwide challenges in diagnosing, caring for, and treating veterans with ALD across the Veterans Health Administration (VHA) system.

This report will describe the elements that contributed to the success of the HIT Collaborative in redesigning care for patients affected by HCV in the VA and how these elements can be applied to improve the system of care for VHA ALD care.

Hepatitis Innovation Teams Collaborative Leadership

After the US Food and Drug Administration (FDA) approved new DAA medications to treat HCV, the VA recognized the need to mobilize the health care system quickly and allocate resources for these new, minimally toxic, and highly effective medications. Early in 2014, HHRC established the National Hepatitis C Resource Center (NHCRC), a successor program to the 4 regional hepatitis C resource centers that had addressed HCV care across the system.10 The NHCRC was charged with developing an operational strategy for VA to respond rapidly to the availability of DAAs. In collaboration with representatives from the Office of Strategic Integration | Veterans Engineering Resource Center (OSI|VERC), the NHCRC formed the HIT Collaborative Leadership Team (CLT).

The HIT CLT is responsible for executing the HIT Collaborative and uses a Lean process improvement framework focused on eliminating waste and maximizing value. Members of the CLT with expertise in facilitation, Lean process improvement, leadership, clinical knowledge, and population health management act as coaches for the VISN HITs. The CLT works to build and support the VISN HITs, identify opportunities for individual teams to improve and assist in finding the right local mix of “players” to be successful. The HIT CLT ensures all teams are functioning and working toward achieving their goals. The CLT obtains data from VA national databases, which are provided to the VISN HITs to inform and encourage continuous improvement of their strategies. Annual VA-wide aspirational goals are developed and disseminated to encourage a unified mission.

Catchment areas for each VISN include between 6 and 10 medical centers as well as outpatient and ambulatory care centers. Multidisciplinary HITs are composed of physicians, nurses, pharmacists, nurse practitioners, physician assistants, social workers, mental health and substance use providers, peer support specialists, administrators, information technology experts, and systems redesign professionals from medical centers within each VISN. Teams develop strong relationships across medical centers, implement context-specific strategies applicable to rural
and urban centers, and share expertise. In addition to intra-VISN process improvement, HITs collaborate monthly across VISNs via a virtual platform. They share strong practices, seek advice from one another, and compare outcomes on an established set of goals.

The HITs use process improvement tools to systematically assess the current steps involved in care. At the close of each year, the HITs analyze the current state of operations and set goals to improve over the following year guided by a target state map. Seed funding is provided to every VISN HIT annually to launch change initiatives. Many VISN HITs use these funds to support a VISN HIT coordinator, and HITs also use this financial support to conduct 2- to 3-day process improvement workshops and to purchase supplies, such as point-of-care testing kits. The HIT communication and work are predominantly executed virtually.

Each year, teams worked toward achieving goals set nationally. These included increasing HCV birth cohort testing and improving the percentage of patients who had SVR12 testing
(Table). 

The HITs also set specific local VISN and medical center goals, prioritizing projects that could have the greatest impact on local patient access and quality of care and build on existing strengths and address barriers. These projects encompass a wide range of areas that contribute to the overall national goals.

Focus on Lean

Lean process improvement is based on 2 key pillars: respect for people (those seeking service as customers and patients and those providing service as frontline staff and stakeholders) and continuous improvement. With Lean, personnel providing care should work to identify and eliminate waste in the system and to streamline care delivery to maximize process steps that are most valued by patients (eg, interaction with a clinical provider) and minimize those that are not valued (eg, time spent waiting to see a provider). With the knowledge that HHRC fully supports their work, HITs were encouraged to innovate based on local resources, context, and culture.

Teams receive basic training in Lean from the HIT CLT and local systems redesign specialists if available. The HITs apply the A3 structured approach to problem solving.¹¹ The HITs follow prescribed problemsolving steps that help identify where to focus process improvement efforts, including analyzing the current state of care, outlining the target state, and prioritizing solution
approaches based on what will have the highest impact for patients. 

Innovations

Over the course of the HIT Collaborative, numerous innovations have emerged to address and mitigate barriers to HCV screening and treatment. Examples of successful innovations include the following:

• To address transportation issues, several teams developed programs specific to patients with HCV in rural locations or with limited mobility. Mobile vans and units traditionally used as mobile cardiology clinics were transformed into HCV clinics, bringing testing and treatment services directly to veterans;
• Pharmacists and social workers developed outreach strategies to locate homeless veterans, provide point-of-care testing and utilize mobile technology to concurrently enroll and link veterans to care; and
• Many liver care teams partnered with inpatient and outpatient substance use treatment clinics to provide patient education and coordinate HCV treatment.

Inter-VISN working groups developed systemwide tools to address common needs. In the program’s first year, a few medical facilities across a handful of VISNs shared local population health management systems, programming, and best practices. Over time, this working group combined the virtual networking capacity of the HIT Collaborative with technical expertise to promote rapid dissemination and uptake of a population health management system. Providers at medical centers across VA use the tools to identify veterans who should be screened and treated for HCV with the ability to continuously update information, identifying patients who do not respond to treatment or patients overdue for SVR12 testing.

Providers with experience using telehepatology formed another inter-VISN working group. These subject matter experts provided guidance to care teams interested in implementing telehealth in areas where limited local resources or knowledge had prevented them from moving forward. The ability to build a strong coalition across content areas fostered a collaborative learning environment, adaptable to implementing new processes and technologies.

In 2017, the VA made significant efforts to reach out to veterans eligible for VA care who had not yet been screened or remained untreated. In May, Hepatitis Awareness Month, HITs held HCV testing and community outreach events and participated in veteran stand-downs and veteran service organization activities.

Evaluation

Since 2014, the VA has increased its HCV treatment and screening rates. To assess the components contributing to these achievements and the role of the HIT Collaborative in driving this success, a team of implementation scientists have been working with the CLT to conduct a HIT program evaluation. The goal of the evaluation is to establish the impact of the HIT Collaborative. The evaluation team catalogs the activities of the Collaborative and the HITs and assesses implementation strategies (use of specific techniques) to increase the uptake of evidence-based practices specifically related to HCV treatment.¹²

At the close of each FY, HCV providers and members of the HIT Collaborative are queried through an online survey to determine which strategies have been used to improve HCV care and how these strategies were associated with the HIT Collaborative. The use of more strategies was associated with more HCV treatment initiations.¹³ All utilized strategies were identified whether or not they were associated with treatment starts. These data are being used to understand which combinations of strategies are most effective at increasing treatment for HCV in the VA and to inform future initiatives.

Expanding the Scope

Inspired by the successful results of the HIT work in HCV and in the spirit of continuously improving health care delivery, HHRC expanded the scope of the HIT Collaborative in FY 2018 to include ALD. There are about 80,000 veterans in VA care with advanced scarring of the liver and between 10,000 to 15,000 new diagnoses each year. In addition to HCV as an etiology for ALD, cases of cirrhosis are projected to increase among veterans in care due to metabolic syndrome and alcohol use. A recent review of VA data from fiscal year 2016 found that 88.6% of ALD patients had been seen in primary care within the past 2 years, with about half (51%) seen in a gastroenterology (GI) or hepatology clinic (Personal communication, HIV, Hepatitis, and Related Conditions Program Office March 16, 2018). For patients in VA care with ALD, GI visits are associated with a lower 5-year mortality.14 Annual mortality for all ALD patients in VA is 6.2%, and of those with a hospital admission, mortality rises to 31%.15 In FY 2016, there were about 52,000 ALD-related discharges (more than 2 per patient). Of those discharges, 24% were readmitted within 30 days, with an average length of stay of 1.9 days and an estimated cost per patient of $47,000 over 3 years.¹⁶

Hepatologists from across the VA convened to identify critical opportunities for improvement for patients with ALD. Base on available evidence presented in the literature and their clinical expertise, these subject matter experts identified several areas for quality improvement, with the overarching goal to improve identification of patients with early cirrhosis and ensure appropriate linkage to care for all cirrhotic patients, thus improving quality of life and reducing mortality. Although not finalized, candidate improvement targets include consistent linkage to care and treatment for HCV and HBV, comprehensive case management, post-discharge patient follow-up, and adherence to evidence-based standards of care.

Conclusion

The VA has made great strides in nearly eliminating HCV among veterans in VA care. The national effort to redesign hepatitis care using Lean management strategies and develop local and regional teams and centralized support allowed VA to maximize available resources to achieve higher rates of HCV birth cohort testing and treatment of patients infected with HCV than has any other health care system in the US.

The HIT Collaborative has been a unique and innovative mechanism to promote directed, patient-outcome driven change in a large and dynamic health care system. It has allowed rural and urban providers to work together to develop and spread quality improvement innovations and as an integrated system to achieve national priorities. The focus of this foundational HIT structure is expanding to identifying, treat, and care for VA’s ALD population.

Hepatitis C virus (HCV) infection is a major public health problem in the US. Following the 2010 report of the Institute of Medicine/National Academies of Sciences, Engineering, and Medicine (NASEM) on hepatitis and liver cancer, the US Department of Health and Human Services (HHS) released the first National Viral Hepatitis Action Plan in 2011 with subsequent action plan updates for 2014-2016 and 2017-2020.^1-3 A NASEM phase 2 report and the 2017-2020 HHS action plan outline a national strategy to prevent new viral hepatitis infections; reduce deaths and improve the health of people living with viral hepatitis; reduce viral hepatitis health disparities; and coordinate, monitor, and report on implementation of viral hepatitis activities.^3,4 The Department of Veterans Affairs (VA) is the single largest HCV care provider in the US with about 165,000 veterans in care diagnosed with HCV in the beginning of 2014 and is a national leader in the testing and treatment of HCV.^5,6

The VA’s recommendations for screening for HCV infection are in alignment with the United States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations to test all veterans born between 1945 and 1965 and anyone with risk factors such as injection drug use.7-9 As of January 1, 2018, the VA had screened more than 80% of veterans in care within this highest risk birth cohort. As of January 1, 2018, more than 100,000 veterans in VA care have initiated treatment for HCV with direct-acting antivirals (DAAs) (Figure 1). 

Several critical factors contributed to the VA success with HCV testing and treatment, including congressional appropriation of funding from fiscal year (FY) 2016 through FY 2018, unrestricted access to interferon-free DAA HCV treatments, and dedicated resources from the VA National Viral Hepatitis Program within the HIV, Hepatitis, and Related Conditions Programs (HHRC) in the Office of Specialty Care Services.⁵ In 2014, HHRC created and supported the Hepatitis Innovation Team (HIT) Collaborative, a VA process improvement initiative enabling
Veterans Integrated Service Network (VISN) -based, multidisciplinary teams to increase veterans’ access to HCV testing and treatment.

As the VA makes consistent progress toward eliminating HCV in veterans in VA care, it has become clear that achieving a cure is only a starting point in improving HCV care. Many patients with HCV infection also have advanced liver disease (ALD), or cirrhosis, which is a condition of permanent liver fibrosis that remains after the patient has been cured of HCV infection. In addition to hepatitis C, ALD also can be caused by excessive alcohol use, hepatitis B virus (HBV) infection, nonalcoholic fatty liver diseases, and several other inherited diseases. Advanced liver disease affects more than 80,000 veterans in VA care, and the HIT infrastructure provides an excellent framework to better understand and address facility-level and systemwide challenges in diagnosing, caring for, and treating veterans with ALD across the Veterans Health Administration (VHA) system.

This report will describe the elements that contributed to the success of the HIT Collaborative in redesigning care for patients affected by HCV in the VA and how these elements can be applied to improve the system of care for VHA ALD care.

Hepatitis Innovation Teams Collaborative Leadership

After the US Food and Drug Administration (FDA) approved new DAA medications to treat HCV, the VA recognized the need to mobilize the health care system quickly and allocate resources for these new, minimally toxic, and highly effective medications. Early in 2014, HHRC established the National Hepatitis C Resource Center (NHCRC), a successor program to the 4 regional hepatitis C resource centers that had addressed HCV care across the system.10 The NHCRC was charged with developing an operational strategy for VA to respond rapidly to the availability of DAAs. In collaboration with representatives from the Office of Strategic Integration | Veterans Engineering Resource Center (OSI|VERC), the NHCRC formed the HIT Collaborative Leadership Team (CLT).

The HIT CLT is responsible for executing the HIT Collaborative and uses a Lean process improvement framework focused on eliminating waste and maximizing value. Members of the CLT with expertise in facilitation, Lean process improvement, leadership, clinical knowledge, and population health management act as coaches for the VISN HITs. The CLT works to build and support the VISN HITs, identify opportunities for individual teams to improve and assist in finding the right local mix of “players” to be successful. The HIT CLT ensures all teams are functioning and working toward achieving their goals. The CLT obtains data from VA national databases, which are provided to the VISN HITs to inform and encourage continuous improvement of their strategies. Annual VA-wide aspirational goals are developed and disseminated to encourage a unified mission.

Catchment areas for each VISN include between 6 and 10 medical centers as well as outpatient and ambulatory care centers. Multidisciplinary HITs are composed of physicians, nurses, pharmacists, nurse practitioners, physician assistants, social workers, mental health and substance use providers, peer support specialists, administrators, information technology experts, and systems redesign professionals from medical centers within each VISN. Teams develop strong relationships across medical centers, implement context-specific strategies applicable to rural
and urban centers, and share expertise. In addition to intra-VISN process improvement, HITs collaborate monthly across VISNs via a virtual platform. They share strong practices, seek advice from one another, and compare outcomes on an established set of goals.

The HITs use process improvement tools to systematically assess the current steps involved in care. At the close of each year, the HITs analyze the current state of operations and set goals to improve over the following year guided by a target state map. Seed funding is provided to every VISN HIT annually to launch change initiatives. Many VISN HITs use these funds to support a VISN HIT coordinator, and HITs also use this financial support to conduct 2- to 3-day process improvement workshops and to purchase supplies, such as point-of-care testing kits. The HIT communication and work are predominantly executed virtually.

Each year, teams worked toward achieving goals set nationally. These included increasing HCV birth cohort testing and improving the percentage of patients who had SVR12 testing
(Table). 

The HITs also set specific local VISN and medical center goals, prioritizing projects that could have the greatest impact on local patient access and quality of care and build on existing strengths and address barriers. These projects encompass a wide range of areas that contribute to the overall national goals.

Focus on Lean

Lean process improvement is based on 2 key pillars: respect for people (those seeking service as customers and patients and those providing service as frontline staff and stakeholders) and continuous improvement. With Lean, personnel providing care should work to identify and eliminate waste in the system and to streamline care delivery to maximize process steps that are most valued by patients (eg, interaction with a clinical provider) and minimize those that are not valued (eg, time spent waiting to see a provider). With the knowledge that HHRC fully supports their work, HITs were encouraged to innovate based on local resources, context, and culture.

Teams receive basic training in Lean from the HIT CLT and local systems redesign specialists if available. The HITs apply the A3 structured approach to problem solving.¹¹ The HITs follow prescribed problemsolving steps that help identify where to focus process improvement efforts, including analyzing the current state of care, outlining the target state, and prioritizing solution
approaches based on what will have the highest impact for patients. 

Innovations

Over the course of the HIT Collaborative, numerous innovations have emerged to address and mitigate barriers to HCV screening and treatment. Examples of successful innovations include the following:

• To address transportation issues, several teams developed programs specific to patients with HCV in rural locations or with limited mobility. Mobile vans and units traditionally used as mobile cardiology clinics were transformed into HCV clinics, bringing testing and treatment services directly to veterans;
• Pharmacists and social workers developed outreach strategies to locate homeless veterans, provide point-of-care testing and utilize mobile technology to concurrently enroll and link veterans to care; and
• Many liver care teams partnered with inpatient and outpatient substance use treatment clinics to provide patient education and coordinate HCV treatment.

Inter-VISN working groups developed systemwide tools to address common needs. In the program’s first year, a few medical facilities across a handful of VISNs shared local population health management systems, programming, and best practices. Over time, this working group combined the virtual networking capacity of the HIT Collaborative with technical expertise to promote rapid dissemination and uptake of a population health management system. Providers at medical centers across VA use the tools to identify veterans who should be screened and treated for HCV with the ability to continuously update information, identifying patients who do not respond to treatment or patients overdue for SVR12 testing.

Providers with experience using telehepatology formed another inter-VISN working group. These subject matter experts provided guidance to care teams interested in implementing telehealth in areas where limited local resources or knowledge had prevented them from moving forward. The ability to build a strong coalition across content areas fostered a collaborative learning environment, adaptable to implementing new processes and technologies.

In 2017, the VA made significant efforts to reach out to veterans eligible for VA care who had not yet been screened or remained untreated. In May, Hepatitis Awareness Month, HITs held HCV testing and community outreach events and participated in veteran stand-downs and veteran service organization activities.

Evaluation

Since 2014, the VA has increased its HCV treatment and screening rates. To assess the components contributing to these achievements and the role of the HIT Collaborative in driving this success, a team of implementation scientists have been working with the CLT to conduct a HIT program evaluation. The goal of the evaluation is to establish the impact of the HIT Collaborative. The evaluation team catalogs the activities of the Collaborative and the HITs and assesses implementation strategies (use of specific techniques) to increase the uptake of evidence-based practices specifically related to HCV treatment.¹²

At the close of each FY, HCV providers and members of the HIT Collaborative are queried through an online survey to determine which strategies have been used to improve HCV care and how these strategies were associated with the HIT Collaborative. The use of more strategies was associated with more HCV treatment initiations.¹³ All utilized strategies were identified whether or not they were associated with treatment starts. These data are being used to understand which combinations of strategies are most effective at increasing treatment for HCV in the VA and to inform future initiatives.

Expanding the Scope

Inspired by the successful results of the HIT work in HCV and in the spirit of continuously improving health care delivery, HHRC expanded the scope of the HIT Collaborative in FY 2018 to include ALD. There are about 80,000 veterans in VA care with advanced scarring of the liver and between 10,000 to 15,000 new diagnoses each year. In addition to HCV as an etiology for ALD, cases of cirrhosis are projected to increase among veterans in care due to metabolic syndrome and alcohol use. A recent review of VA data from fiscal year 2016 found that 88.6% of ALD patients had been seen in primary care within the past 2 years, with about half (51%) seen in a gastroenterology (GI) or hepatology clinic (Personal communication, HIV, Hepatitis, and Related Conditions Program Office March 16, 2018). For patients in VA care with ALD, GI visits are associated with a lower 5-year mortality.14 Annual mortality for all ALD patients in VA is 6.2%, and of those with a hospital admission, mortality rises to 31%.15 In FY 2016, there were about 52,000 ALD-related discharges (more than 2 per patient). Of those discharges, 24% were readmitted within 30 days, with an average length of stay of 1.9 days and an estimated cost per patient of $47,000 over 3 years.¹⁶

Hepatologists from across the VA convened to identify critical opportunities for improvement for patients with ALD. Base on available evidence presented in the literature and their clinical expertise, these subject matter experts identified several areas for quality improvement, with the overarching goal to improve identification of patients with early cirrhosis and ensure appropriate linkage to care for all cirrhotic patients, thus improving quality of life and reducing mortality. Although not finalized, candidate improvement targets include consistent linkage to care and treatment for HCV and HBV, comprehensive case management, post-discharge patient follow-up, and adherence to evidence-based standards of care.

Conclusion

The VA has made great strides in nearly eliminating HCV among veterans in VA care. The national effort to redesign hepatitis care using Lean management strategies and develop local and regional teams and centralized support allowed VA to maximize available resources to achieve higher rates of HCV birth cohort testing and treatment of patients infected with HCV than has any other health care system in the US.

The HIT Collaborative has been a unique and innovative mechanism to promote directed, patient-outcome driven change in a large and dynamic health care system. It has allowed rural and urban providers to work together to develop and spread quality improvement innovations and as an integrated system to achieve national priorities. The focus of this foundational HIT structure is expanding to identifying, treat, and care for VA’s ALD population.

Hepatitis C virus (HCV) infection is a major public health problem in the US. Following the 2010 report of the Institute of Medicine/National Academies of Sciences, Engineering, and Medicine (NASEM) on hepatitis and liver cancer, the US Department of Health and Human Services (HHS) released the first National Viral Hepatitis Action Plan in 2011 with subsequent action plan updates for 2014-2016 and 2017-2020.^1-3 A NASEM phase 2 report and the 2017-2020 HHS action plan outline a national strategy to prevent new viral hepatitis infections; reduce deaths and improve the health of people living with viral hepatitis; reduce viral hepatitis health disparities; and coordinate, monitor, and report on implementation of viral hepatitis activities.^3,4 The Department of Veterans Affairs (VA) is the single largest HCV care provider in the US with about 165,000 veterans in care diagnosed with HCV in the beginning of 2014 and is a national leader in the testing and treatment of HCV.^5,6

The VA’s recommendations for screening for HCV infection are in alignment with the United States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations to test all veterans born between 1945 and 1965 and anyone with risk factors such as injection drug use.7-9 As of January 1, 2018, the VA had screened more than 80% of veterans in care within this highest risk birth cohort. As of January 1, 2018, more than 100,000 veterans in VA care have initiated treatment for HCV with direct-acting antivirals (DAAs) (Figure 1). 

Several critical factors contributed to the VA success with HCV testing and treatment, including congressional appropriation of funding from fiscal year (FY) 2016 through FY 2018, unrestricted access to interferon-free DAA HCV treatments, and dedicated resources from the VA National Viral Hepatitis Program within the HIV, Hepatitis, and Related Conditions Programs (HHRC) in the Office of Specialty Care Services.⁵ In 2014, HHRC created and supported the Hepatitis Innovation Team (HIT) Collaborative, a VA process improvement initiative enabling
Veterans Integrated Service Network (VISN) -based, multidisciplinary teams to increase veterans’ access to HCV testing and treatment.

As the VA makes consistent progress toward eliminating HCV in veterans in VA care, it has become clear that achieving a cure is only a starting point in improving HCV care. Many patients with HCV infection also have advanced liver disease (ALD), or cirrhosis, which is a condition of permanent liver fibrosis that remains after the patient has been cured of HCV infection. In addition to hepatitis C, ALD also can be caused by excessive alcohol use, hepatitis B virus (HBV) infection, nonalcoholic fatty liver diseases, and several other inherited diseases. Advanced liver disease affects more than 80,000 veterans in VA care, and the HIT infrastructure provides an excellent framework to better understand and address facility-level and systemwide challenges in diagnosing, caring for, and treating veterans with ALD across the Veterans Health Administration (VHA) system.

This report will describe the elements that contributed to the success of the HIT Collaborative in redesigning care for patients affected by HCV in the VA and how these elements can be applied to improve the system of care for VHA ALD care.

Hepatitis Innovation Teams Collaborative Leadership

After the US Food and Drug Administration (FDA) approved new DAA medications to treat HCV, the VA recognized the need to mobilize the health care system quickly and allocate resources for these new, minimally toxic, and highly effective medications. Early in 2014, HHRC established the National Hepatitis C Resource Center (NHCRC), a successor program to the 4 regional hepatitis C resource centers that had addressed HCV care across the system.10 The NHCRC was charged with developing an operational strategy for VA to respond rapidly to the availability of DAAs. In collaboration with representatives from the Office of Strategic Integration | Veterans Engineering Resource Center (OSI|VERC), the NHCRC formed the HIT Collaborative Leadership Team (CLT).

The HIT CLT is responsible for executing the HIT Collaborative and uses a Lean process improvement framework focused on eliminating waste and maximizing value. Members of the CLT with expertise in facilitation, Lean process improvement, leadership, clinical knowledge, and population health management act as coaches for the VISN HITs. The CLT works to build and support the VISN HITs, identify opportunities for individual teams to improve and assist in finding the right local mix of “players” to be successful. The HIT CLT ensures all teams are functioning and working toward achieving their goals. The CLT obtains data from VA national databases, which are provided to the VISN HITs to inform and encourage continuous improvement of their strategies. Annual VA-wide aspirational goals are developed and disseminated to encourage a unified mission.

Catchment areas for each VISN include between 6 and 10 medical centers as well as outpatient and ambulatory care centers. Multidisciplinary HITs are composed of physicians, nurses, pharmacists, nurse practitioners, physician assistants, social workers, mental health and substance use providers, peer support specialists, administrators, information technology experts, and systems redesign professionals from medical centers within each VISN. Teams develop strong relationships across medical centers, implement context-specific strategies applicable to rural
and urban centers, and share expertise. In addition to intra-VISN process improvement, HITs collaborate monthly across VISNs via a virtual platform. They share strong practices, seek advice from one another, and compare outcomes on an established set of goals.

The HITs use process improvement tools to systematically assess the current steps involved in care. At the close of each year, the HITs analyze the current state of operations and set goals to improve over the following year guided by a target state map. Seed funding is provided to every VISN HIT annually to launch change initiatives. Many VISN HITs use these funds to support a VISN HIT coordinator, and HITs also use this financial support to conduct 2- to 3-day process improvement workshops and to purchase supplies, such as point-of-care testing kits. The HIT communication and work are predominantly executed virtually.

Each year, teams worked toward achieving goals set nationally. These included increasing HCV birth cohort testing and improving the percentage of patients who had SVR12 testing
(Table). 

The HITs also set specific local VISN and medical center goals, prioritizing projects that could have the greatest impact on local patient access and quality of care and build on existing strengths and address barriers. These projects encompass a wide range of areas that contribute to the overall national goals.

Focus on Lean

Lean process improvement is based on 2 key pillars: respect for people (those seeking service as customers and patients and those providing service as frontline staff and stakeholders) and continuous improvement. With Lean, personnel providing care should work to identify and eliminate waste in the system and to streamline care delivery to maximize process steps that are most valued by patients (eg, interaction with a clinical provider) and minimize those that are not valued (eg, time spent waiting to see a provider). With the knowledge that HHRC fully supports their work, HITs were encouraged to innovate based on local resources, context, and culture.

Teams receive basic training in Lean from the HIT CLT and local systems redesign specialists if available. The HITs apply the A3 structured approach to problem solving.¹¹ The HITs follow prescribed problemsolving steps that help identify where to focus process improvement efforts, including analyzing the current state of care, outlining the target state, and prioritizing solution
approaches based on what will have the highest impact for patients. 

Innovations

Over the course of the HIT Collaborative, numerous innovations have emerged to address and mitigate barriers to HCV screening and treatment. Examples of successful innovations include the following:

• To address transportation issues, several teams developed programs specific to patients with HCV in rural locations or with limited mobility. Mobile vans and units traditionally used as mobile cardiology clinics were transformed into HCV clinics, bringing testing and treatment services directly to veterans;
• Pharmacists and social workers developed outreach strategies to locate homeless veterans, provide point-of-care testing and utilize mobile technology to concurrently enroll and link veterans to care; and
• Many liver care teams partnered with inpatient and outpatient substance use treatment clinics to provide patient education and coordinate HCV treatment.

Inter-VISN working groups developed systemwide tools to address common needs. In the program’s first year, a few medical facilities across a handful of VISNs shared local population health management systems, programming, and best practices. Over time, this working group combined the virtual networking capacity of the HIT Collaborative with technical expertise to promote rapid dissemination and uptake of a population health management system. Providers at medical centers across VA use the tools to identify veterans who should be screened and treated for HCV with the ability to continuously update information, identifying patients who do not respond to treatment or patients overdue for SVR12 testing.

Providers with experience using telehepatology formed another inter-VISN working group. These subject matter experts provided guidance to care teams interested in implementing telehealth in areas where limited local resources or knowledge had prevented them from moving forward. The ability to build a strong coalition across content areas fostered a collaborative learning environment, adaptable to implementing new processes and technologies.

In 2017, the VA made significant efforts to reach out to veterans eligible for VA care who had not yet been screened or remained untreated. In May, Hepatitis Awareness Month, HITs held HCV testing and community outreach events and participated in veteran stand-downs and veteran service organization activities.

Evaluation

Since 2014, the VA has increased its HCV treatment and screening rates. To assess the components contributing to these achievements and the role of the HIT Collaborative in driving this success, a team of implementation scientists have been working with the CLT to conduct a HIT program evaluation. The goal of the evaluation is to establish the impact of the HIT Collaborative. The evaluation team catalogs the activities of the Collaborative and the HITs and assesses implementation strategies (use of specific techniques) to increase the uptake of evidence-based practices specifically related to HCV treatment.¹²

At the close of each FY, HCV providers and members of the HIT Collaborative are queried through an online survey to determine which strategies have been used to improve HCV care and how these strategies were associated with the HIT Collaborative. The use of more strategies was associated with more HCV treatment initiations.¹³ All utilized strategies were identified whether or not they were associated with treatment starts. These data are being used to understand which combinations of strategies are most effective at increasing treatment for HCV in the VA and to inform future initiatives.

Expanding the Scope

Inspired by the successful results of the HIT work in HCV and in the spirit of continuously improving health care delivery, HHRC expanded the scope of the HIT Collaborative in FY 2018 to include ALD. There are about 80,000 veterans in VA care with advanced scarring of the liver and between 10,000 to 15,000 new diagnoses each year. In addition to HCV as an etiology for ALD, cases of cirrhosis are projected to increase among veterans in care due to metabolic syndrome and alcohol use. A recent review of VA data from fiscal year 2016 found that 88.6% of ALD patients had been seen in primary care within the past 2 years, with about half (51%) seen in a gastroenterology (GI) or hepatology clinic (Personal communication, HIV, Hepatitis, and Related Conditions Program Office March 16, 2018). For patients in VA care with ALD, GI visits are associated with a lower 5-year mortality.14 Annual mortality for all ALD patients in VA is 6.2%, and of those with a hospital admission, mortality rises to 31%.15 In FY 2016, there were about 52,000 ALD-related discharges (more than 2 per patient). Of those discharges, 24% were readmitted within 30 days, with an average length of stay of 1.9 days and an estimated cost per patient of $47,000 over 3 years.¹⁶

Hepatologists from across the VA convened to identify critical opportunities for improvement for patients with ALD. Base on available evidence presented in the literature and their clinical expertise, these subject matter experts identified several areas for quality improvement, with the overarching goal to improve identification of patients with early cirrhosis and ensure appropriate linkage to care for all cirrhotic patients, thus improving quality of life and reducing mortality. Although not finalized, candidate improvement targets include consistent linkage to care and treatment for HCV and HBV, comprehensive case management, post-discharge patient follow-up, and adherence to evidence-based standards of care.

Conclusion

The VA has made great strides in nearly eliminating HCV among veterans in VA care. The national effort to redesign hepatitis care using Lean management strategies and develop local and regional teams and centralized support allowed VA to maximize available resources to achieve higher rates of HCV birth cohort testing and treatment of patients infected with HCV than has any other health care system in the US.

The HIT Collaborative has been a unique and innovative mechanism to promote directed, patient-outcome driven change in a large and dynamic health care system. It has allowed rural and urban providers to work together to develop and spread quality improvement innovations and as an integrated system to achieve national priorities. The focus of this foundational HIT structure is expanding to identifying, treat, and care for VA’s ALD population.

Daria Pagliara, MD, PhD

STOCKHOLM—Researchers have identified a “highly effective” transplant strategy for pediatric patients with primary immunodeficiencies who lack a suitable HLA-compatible donor, according to a speaker at the 23rd Congress of the European Hematology Association (EHA).

The strategy involves α/β T-cell- and B-cell-depleted haploidentical hematopoietic stem cell transplant (haplo-HSCT) followed by infusion of the T-cell product BPX-501.

Children treated with this strategy in a phase 1/2 trial had disease-free and overall survival rates that compared favorably with rates observed in recipients of matched, unrelated transplants.

In addition, the incidence of severe acute and chronic graft-versus-host disease (GHVD) was low in this trial.

Daria Pagliara, MD, PhD, of Ospedale Pediatrico Bambino Gesu in Rome, Italy, presented these results at the recent EHA Congress as abstract S871.

The research was sponsored by Bellicum Pharmaceuticals, Inc., the company developing BPX-501.

BPX-501 consists of genetically modified donor T cells incorporating the CaspaCIDe safety switch, which is designed to eliminate the T cells in the event of toxicity. Rimiducid is used to activate the CaspaCIDe safety switch, which consists of the CID-binding domain coupled to the signaling domain of caspase-9, an enzyme that is part of the apoptotic pathway.

Dr Pagliara explained that T cells are collected from donors via non-mobilized apheresis, the cells are modified to create the BPX-501 product, and the product is infused in HSCT recipients at day 14 after transplant (+/- 4 days).

The patients do not receive GVHD prophylaxis after transplant but are given rimiducid if they develop GVHD that does not respond to standard therapy.

Patients and transplant characteristics

Dr Pagliara reported results with BPX-501 in 59 patients. They had a median age of 1.85 years (range, 0.21 to 17.55), and 57.6% were male.

Patients had severe combined immune deficiency (32%), Wiskott–Aldrich syndrome (15%), chronic granulomatous disease (12%), hemophagocytic lymphohistiocytosis (10%), combined immunodeficiency disease (7%), major histocompatibility complex class II deficiency (5%), and “other” immunodeficiencies (19%).

The patients received BPX-501 after an α/β T-cell-depleted, B-cell-depleted haplo-HSCT. Most patients had a parent donor (94.9%), and 5.1% had a sibling donor. The median donor age was 34 (range, 21-52).

About half of patients (49.2%) received treosulfan-based conditioning, 39% received busulfan-based conditioning, and 11.9% received other conditioning.

The median CD34 dose was 22.0 x 10⁶/kg, and the median α/β T-cell dose was 0.4 x 10⁵/kg.

The median time to BPX-501 infusion was 15 days (range, 11-56). The median time to discharge was 40 days (range, 18-204).

The median follow-up was 536 days (range, 32-1252).

Engraftment and survival

The median time to neutrophil engraftment was 16 days, and the median time to platelet engraftment was 11 days.

Three patients had primary graft failure (5.1%), but 1 of these patients was successfully re-transplanted from the same donor.

The cumulative incidence of transplant-related mortality was 8.7%.

There were 5 cases of transplant-related mortality, which were due to graft failure/disseminated fungal infection, cytomegalovirus (CMV) encephalitis, worsening juvenile dermatomyositis/macrophage activation syndrome, bronchopulmonary hemorrhage, and CMV/adenovirus.

“I would like to underline that 3 of these 5 patients died of infectious complications that were present before the transplant—1 fungal invasive infection, 1 encephalitis due to CMV reactivation, and 1 pulmonary infection due to the presence of adenovirus and cytomegalovirus,” Dr Pagliara said.

The rate of disease-free survival and overall survival were both 87.6%.

GVHD and adverse events

Dr Pagliara said there were low rates of acute GVHD in the first 100 days.

The rate of grade 2-4 acute GVHD was 8.9%, and the rate of grade 3-4 acute GVHD was 1.8%. There were 4 cases of grade 2 GVHD—three stage 3 skin and one stage 1 upper gastrointestinal. There was a single case of grade 3 GVHD—stage 3 liver.

Of the 19 patients who developed acute GVHD, 7 received at least 1 dose of rimiducid. These patients had visceral involvement or GVHD that was not responsive to standard care.

Four patients had a complete response to rimiducid, and 1 had a partial response. One patient did not respond, and 1 was not evaluable. The non-evaluable patient was on corticosteroids and cyclosporine with controlled GVHD but was unable to be weaned off corticosteroids. Rimiducid was given in an attempt to wean the patient off corticosteroids.

“Most importantly, only 1 patient out of 59 developed chronic GVHD, with only mild involvement of the skin,” Dr Pagliara said. This patient did not receive rimiducid.

Nine patients (15.2%) had at least 1 adverse event (AE).

AEs occurring after BPX-501 administration were grade 1 or 2 in nature. They included diarrhea, vomiting, pyrexia, CMV viremia, rhinovirus infection, hypokalemia, pruritus, and rash.

There were no severe AEs attributed to BPX-501.

Daria Pagliara, MD, PhD

STOCKHOLM—Researchers have identified a “highly effective” transplant strategy for pediatric patients with primary immunodeficiencies who lack a suitable HLA-compatible donor, according to a speaker at the 23rd Congress of the European Hematology Association (EHA).

The strategy involves α/β T-cell- and B-cell-depleted haploidentical hematopoietic stem cell transplant (haplo-HSCT) followed by infusion of the T-cell product BPX-501.

Children treated with this strategy in a phase 1/2 trial had disease-free and overall survival rates that compared favorably with rates observed in recipients of matched, unrelated transplants.

In addition, the incidence of severe acute and chronic graft-versus-host disease (GHVD) was low in this trial.

Daria Pagliara, MD, PhD, of Ospedale Pediatrico Bambino Gesu in Rome, Italy, presented these results at the recent EHA Congress as abstract S871.

The research was sponsored by Bellicum Pharmaceuticals, Inc., the company developing BPX-501.

BPX-501 consists of genetically modified donor T cells incorporating the CaspaCIDe safety switch, which is designed to eliminate the T cells in the event of toxicity. Rimiducid is used to activate the CaspaCIDe safety switch, which consists of the CID-binding domain coupled to the signaling domain of caspase-9, an enzyme that is part of the apoptotic pathway.

Dr Pagliara explained that T cells are collected from donors via non-mobilized apheresis, the cells are modified to create the BPX-501 product, and the product is infused in HSCT recipients at day 14 after transplant (+/- 4 days).

The patients do not receive GVHD prophylaxis after transplant but are given rimiducid if they develop GVHD that does not respond to standard therapy.

Patients and transplant characteristics

Dr Pagliara reported results with BPX-501 in 59 patients. They had a median age of 1.85 years (range, 0.21 to 17.55), and 57.6% were male.

Patients had severe combined immune deficiency (32%), Wiskott–Aldrich syndrome (15%), chronic granulomatous disease (12%), hemophagocytic lymphohistiocytosis (10%), combined immunodeficiency disease (7%), major histocompatibility complex class II deficiency (5%), and “other” immunodeficiencies (19%).

The patients received BPX-501 after an α/β T-cell-depleted, B-cell-depleted haplo-HSCT. Most patients had a parent donor (94.9%), and 5.1% had a sibling donor. The median donor age was 34 (range, 21-52).

About half of patients (49.2%) received treosulfan-based conditioning, 39% received busulfan-based conditioning, and 11.9% received other conditioning.

The median CD34 dose was 22.0 x 10⁶/kg, and the median α/β T-cell dose was 0.4 x 10⁵/kg.

The median time to BPX-501 infusion was 15 days (range, 11-56). The median time to discharge was 40 days (range, 18-204).

The median follow-up was 536 days (range, 32-1252).

Engraftment and survival

The median time to neutrophil engraftment was 16 days, and the median time to platelet engraftment was 11 days.

Three patients had primary graft failure (5.1%), but 1 of these patients was successfully re-transplanted from the same donor.

The cumulative incidence of transplant-related mortality was 8.7%.

There were 5 cases of transplant-related mortality, which were due to graft failure/disseminated fungal infection, cytomegalovirus (CMV) encephalitis, worsening juvenile dermatomyositis/macrophage activation syndrome, bronchopulmonary hemorrhage, and CMV/adenovirus.

“I would like to underline that 3 of these 5 patients died of infectious complications that were present before the transplant—1 fungal invasive infection, 1 encephalitis due to CMV reactivation, and 1 pulmonary infection due to the presence of adenovirus and cytomegalovirus,” Dr Pagliara said.

The rate of disease-free survival and overall survival were both 87.6%.

GVHD and adverse events

Dr Pagliara said there were low rates of acute GVHD in the first 100 days.

The rate of grade 2-4 acute GVHD was 8.9%, and the rate of grade 3-4 acute GVHD was 1.8%. There were 4 cases of grade 2 GVHD—three stage 3 skin and one stage 1 upper gastrointestinal. There was a single case of grade 3 GVHD—stage 3 liver.

Of the 19 patients who developed acute GVHD, 7 received at least 1 dose of rimiducid. These patients had visceral involvement or GVHD that was not responsive to standard care.

Four patients had a complete response to rimiducid, and 1 had a partial response. One patient did not respond, and 1 was not evaluable. The non-evaluable patient was on corticosteroids and cyclosporine with controlled GVHD but was unable to be weaned off corticosteroids. Rimiducid was given in an attempt to wean the patient off corticosteroids.

“Most importantly, only 1 patient out of 59 developed chronic GVHD, with only mild involvement of the skin,” Dr Pagliara said. This patient did not receive rimiducid.

Nine patients (15.2%) had at least 1 adverse event (AE).

AEs occurring after BPX-501 administration were grade 1 or 2 in nature. They included diarrhea, vomiting, pyrexia, CMV viremia, rhinovirus infection, hypokalemia, pruritus, and rash.

There were no severe AEs attributed to BPX-501.

Daria Pagliara, MD, PhD

STOCKHOLM—Researchers have identified a “highly effective” transplant strategy for pediatric patients with primary immunodeficiencies who lack a suitable HLA-compatible donor, according to a speaker at the 23rd Congress of the European Hematology Association (EHA).

The strategy involves α/β T-cell- and B-cell-depleted haploidentical hematopoietic stem cell transplant (haplo-HSCT) followed by infusion of the T-cell product BPX-501.

Children treated with this strategy in a phase 1/2 trial had disease-free and overall survival rates that compared favorably with rates observed in recipients of matched, unrelated transplants.

In addition, the incidence of severe acute and chronic graft-versus-host disease (GHVD) was low in this trial.

Daria Pagliara, MD, PhD, of Ospedale Pediatrico Bambino Gesu in Rome, Italy, presented these results at the recent EHA Congress as abstract S871.

The research was sponsored by Bellicum Pharmaceuticals, Inc., the company developing BPX-501.

BPX-501 consists of genetically modified donor T cells incorporating the CaspaCIDe safety switch, which is designed to eliminate the T cells in the event of toxicity. Rimiducid is used to activate the CaspaCIDe safety switch, which consists of the CID-binding domain coupled to the signaling domain of caspase-9, an enzyme that is part of the apoptotic pathway.

Dr Pagliara explained that T cells are collected from donors via non-mobilized apheresis, the cells are modified to create the BPX-501 product, and the product is infused in HSCT recipients at day 14 after transplant (+/- 4 days).

The patients do not receive GVHD prophylaxis after transplant but are given rimiducid if they develop GVHD that does not respond to standard therapy.

Patients and transplant characteristics

Dr Pagliara reported results with BPX-501 in 59 patients. They had a median age of 1.85 years (range, 0.21 to 17.55), and 57.6% were male.

Patients had severe combined immune deficiency (32%), Wiskott–Aldrich syndrome (15%), chronic granulomatous disease (12%), hemophagocytic lymphohistiocytosis (10%), combined immunodeficiency disease (7%), major histocompatibility complex class II deficiency (5%), and “other” immunodeficiencies (19%).

The patients received BPX-501 after an α/β T-cell-depleted, B-cell-depleted haplo-HSCT. Most patients had a parent donor (94.9%), and 5.1% had a sibling donor. The median donor age was 34 (range, 21-52).

About half of patients (49.2%) received treosulfan-based conditioning, 39% received busulfan-based conditioning, and 11.9% received other conditioning.

The median CD34 dose was 22.0 x 10⁶/kg, and the median α/β T-cell dose was 0.4 x 10⁵/kg.

The median time to BPX-501 infusion was 15 days (range, 11-56). The median time to discharge was 40 days (range, 18-204).

The median follow-up was 536 days (range, 32-1252).

Engraftment and survival

The median time to neutrophil engraftment was 16 days, and the median time to platelet engraftment was 11 days.

Three patients had primary graft failure (5.1%), but 1 of these patients was successfully re-transplanted from the same donor.

The cumulative incidence of transplant-related mortality was 8.7%.

There were 5 cases of transplant-related mortality, which were due to graft failure/disseminated fungal infection, cytomegalovirus (CMV) encephalitis, worsening juvenile dermatomyositis/macrophage activation syndrome, bronchopulmonary hemorrhage, and CMV/adenovirus.

“I would like to underline that 3 of these 5 patients died of infectious complications that were present before the transplant—1 fungal invasive infection, 1 encephalitis due to CMV reactivation, and 1 pulmonary infection due to the presence of adenovirus and cytomegalovirus,” Dr Pagliara said.

The rate of disease-free survival and overall survival were both 87.6%.

GVHD and adverse events

Dr Pagliara said there were low rates of acute GVHD in the first 100 days.

The rate of grade 2-4 acute GVHD was 8.9%, and the rate of grade 3-4 acute GVHD was 1.8%. There were 4 cases of grade 2 GVHD—three stage 3 skin and one stage 1 upper gastrointestinal. There was a single case of grade 3 GVHD—stage 3 liver.

Of the 19 patients who developed acute GVHD, 7 received at least 1 dose of rimiducid. These patients had visceral involvement or GVHD that was not responsive to standard care.

Four patients had a complete response to rimiducid, and 1 had a partial response. One patient did not respond, and 1 was not evaluable. The non-evaluable patient was on corticosteroids and cyclosporine with controlled GVHD but was unable to be weaned off corticosteroids. Rimiducid was given in an attempt to wean the patient off corticosteroids.

“Most importantly, only 1 patient out of 59 developed chronic GVHD, with only mild involvement of the skin,” Dr Pagliara said. This patient did not receive rimiducid.

Nine patients (15.2%) had at least 1 adverse event (AE).

AEs occurring after BPX-501 administration were grade 1 or 2 in nature. They included diarrhea, vomiting, pyrexia, CMV viremia, rhinovirus infection, hypokalemia, pruritus, and rash.

There were no severe AEs attributed to BPX-501.

Photo from UAB Hospital

Patients who receive red blood cell (RBC) transfusions before, during, or immediately after surgery may have an increased risk of venous thromboembolism (VTE), a new study suggests.

In this retrospective study, transfusion recipients had twice the risk of VTE as patients who did not receive RBC transfusions during the perioperative period.

Investigators say these findings require validation, but they suggest a need for physicians to consider non-transfusion alternatives to treat anemia in patients undergoing surgery.

“These findings reinforce the importance of following rigorous perioperative patient blood management practices for transfusions,” said Ruchika Goel, MD, of Weill Cornell Medicine in New York, New York.

Dr Goel and her colleagues reported their findings in JAMA Surgery.

The investigators analyzed data on 750,937 patients who underwent surgery in 2014. In all, 6.3% (n=47,410) of patients received at least one RBC transfusion.

Within 30 days of surgery, 0.8% (n=6309) of all patients had a VTE. This included 0.6% (n=4336) with deep vein thrombosis (DVT), 0.3% (n=2514) with pulmonary embolism (PE), and 0.1% (n=541) with DVT and PE.

Analyses showed that patients who received RBC transfusions were twice as likely to develop VTE as those who did not receive transfusions (adjusted odds ratio [aOR]=2.1). This was true for both DVT (aOR=2.2) and PE (aOR=1.9).

“We also saw this risk across different surgical disciplines, ranging from neurosurgery to cardiac surgery,” said study author Aaron Tobian, MD, PhD, of Johns Hopkins University School of Medicine in Baltimore, Maryland.

Furthermore, VTE risk increased with the number of RBC transfusions a patient received. The aORs were 2.1 for 1 transfusion, 3.1 for 2 transfusions, and 4.5 for 3 or more transfusions (compared to patients who did not receive any transfusions).

“This retrospective study demonstrates that there may be additional risks to blood transfusion that are not generally recognized in the community,” Dr Tobian said. “While additional research is needed to confirm these results, the findings reinforce the need to limit blood transfusions to only when necessary.”

Photo from UAB Hospital

Patients who receive red blood cell (RBC) transfusions before, during, or immediately after surgery may have an increased risk of venous thromboembolism (VTE), a new study suggests.

In this retrospective study, transfusion recipients had twice the risk of VTE as patients who did not receive RBC transfusions during the perioperative period.

Investigators say these findings require validation, but they suggest a need for physicians to consider non-transfusion alternatives to treat anemia in patients undergoing surgery.

“These findings reinforce the importance of following rigorous perioperative patient blood management practices for transfusions,” said Ruchika Goel, MD, of Weill Cornell Medicine in New York, New York.

Dr Goel and her colleagues reported their findings in JAMA Surgery.

The investigators analyzed data on 750,937 patients who underwent surgery in 2014. In all, 6.3% (n=47,410) of patients received at least one RBC transfusion.

Within 30 days of surgery, 0.8% (n=6309) of all patients had a VTE. This included 0.6% (n=4336) with deep vein thrombosis (DVT), 0.3% (n=2514) with pulmonary embolism (PE), and 0.1% (n=541) with DVT and PE.

Analyses showed that patients who received RBC transfusions were twice as likely to develop VTE as those who did not receive transfusions (adjusted odds ratio [aOR]=2.1). This was true for both DVT (aOR=2.2) and PE (aOR=1.9).

“We also saw this risk across different surgical disciplines, ranging from neurosurgery to cardiac surgery,” said study author Aaron Tobian, MD, PhD, of Johns Hopkins University School of Medicine in Baltimore, Maryland.

Furthermore, VTE risk increased with the number of RBC transfusions a patient received. The aORs were 2.1 for 1 transfusion, 3.1 for 2 transfusions, and 4.5 for 3 or more transfusions (compared to patients who did not receive any transfusions).

“This retrospective study demonstrates that there may be additional risks to blood transfusion that are not generally recognized in the community,” Dr Tobian said. “While additional research is needed to confirm these results, the findings reinforce the need to limit blood transfusions to only when necessary.”

Photo from UAB Hospital

Patients who receive red blood cell (RBC) transfusions before, during, or immediately after surgery may have an increased risk of venous thromboembolism (VTE), a new study suggests.

In this retrospective study, transfusion recipients had twice the risk of VTE as patients who did not receive RBC transfusions during the perioperative period.

Investigators say these findings require validation, but they suggest a need for physicians to consider non-transfusion alternatives to treat anemia in patients undergoing surgery.

“These findings reinforce the importance of following rigorous perioperative patient blood management practices for transfusions,” said Ruchika Goel, MD, of Weill Cornell Medicine in New York, New York.

Dr Goel and her colleagues reported their findings in JAMA Surgery.

The investigators analyzed data on 750,937 patients who underwent surgery in 2014. In all, 6.3% (n=47,410) of patients received at least one RBC transfusion.

Within 30 days of surgery, 0.8% (n=6309) of all patients had a VTE. This included 0.6% (n=4336) with deep vein thrombosis (DVT), 0.3% (n=2514) with pulmonary embolism (PE), and 0.1% (n=541) with DVT and PE.

Analyses showed that patients who received RBC transfusions were twice as likely to develop VTE as those who did not receive transfusions (adjusted odds ratio [aOR]=2.1). This was true for both DVT (aOR=2.2) and PE (aOR=1.9).

“We also saw this risk across different surgical disciplines, ranging from neurosurgery to cardiac surgery,” said study author Aaron Tobian, MD, PhD, of Johns Hopkins University School of Medicine in Baltimore, Maryland.

Furthermore, VTE risk increased with the number of RBC transfusions a patient received. The aORs were 2.1 for 1 transfusion, 3.1 for 2 transfusions, and 4.5 for 3 or more transfusions (compared to patients who did not receive any transfusions).

“This retrospective study demonstrates that there may be additional risks to blood transfusion that are not generally recognized in the community,” Dr Tobian said. “While additional research is needed to confirm these results, the findings reinforce the need to limit blood transfusions to only when necessary.”

Red blood cells

Erytech Pharma said it plans to stop development of eryaspase for acute lymphoblastic leukemia (ALL).

This means withdrawal of the European marketing authorization application for eryaspase as a treatment for relapsed and refractory ALL.

However, Erytech will continue development of eryaspase as a treatment for certain solid tumor malignancies.

Eryaspase consists of L-asparaginase encapsulated inside donor-derived red blood cells. These enzyme-loaded red blood cells function as bioreactors to eliminate circulating asparagine and “starve” cancer cells, thereby inducing their death.

Erytech noted that eryaspase has produced favorable efficacy and safety results in ALL.

However, based on recent feedback from regulatory agencies in Europe and the US, the company believes significant additional investment would be required to seek regulatory approval of eryaspase for the treatment of ALL. Erytech also believes there would be a limited market opportunity for eryaspase in ALL.

Therefore, the company decided to cease further clinical development efforts in ALL. The resources that will become available as a result of this decision will be allocated to the development of eryaspase in solid tumors.

In 2017, Erytech announced results from a phase 2b clinical trial of eryaspase plus chemotherapy in patients with second-line metastatic pancreatic cancer. The company expects to begin enrollment in a phase 3 trial of this patient population in the third quarter of 2018.

In addition, Erytech is preparing for a pair of phase 2 proof-of-concept trials of eryaspase. One is in first-line pancreatic cancer, and the other is in metastatic triple-negative breast cancer. The company is also evaluating development options in additional solid tumor indications with high unmet medical need.

To ensure an adequate supply of eryaspase, Erytech is constructing a large-scale manufacturing facility in Princeton, New Jersey, and is expanding its manufacturing capacity in Lyon, France. The company expects both facilities to be operational for clinical production at the expanded capacity in the first quarter of 2019.

Red blood cells

Erytech Pharma said it plans to stop development of eryaspase for acute lymphoblastic leukemia (ALL).

This means withdrawal of the European marketing authorization application for eryaspase as a treatment for relapsed and refractory ALL.

However, Erytech will continue development of eryaspase as a treatment for certain solid tumor malignancies.

Eryaspase consists of L-asparaginase encapsulated inside donor-derived red blood cells. These enzyme-loaded red blood cells function as bioreactors to eliminate circulating asparagine and “starve” cancer cells, thereby inducing their death.

Erytech noted that eryaspase has produced favorable efficacy and safety results in ALL.

However, based on recent feedback from regulatory agencies in Europe and the US, the company believes significant additional investment would be required to seek regulatory approval of eryaspase for the treatment of ALL. Erytech also believes there would be a limited market opportunity for eryaspase in ALL.

Therefore, the company decided to cease further clinical development efforts in ALL. The resources that will become available as a result of this decision will be allocated to the development of eryaspase in solid tumors.

In 2017, Erytech announced results from a phase 2b clinical trial of eryaspase plus chemotherapy in patients with second-line metastatic pancreatic cancer. The company expects to begin enrollment in a phase 3 trial of this patient population in the third quarter of 2018.

In addition, Erytech is preparing for a pair of phase 2 proof-of-concept trials of eryaspase. One is in first-line pancreatic cancer, and the other is in metastatic triple-negative breast cancer. The company is also evaluating development options in additional solid tumor indications with high unmet medical need.

To ensure an adequate supply of eryaspase, Erytech is constructing a large-scale manufacturing facility in Princeton, New Jersey, and is expanding its manufacturing capacity in Lyon, France. The company expects both facilities to be operational for clinical production at the expanded capacity in the first quarter of 2019.

Red blood cells

Erytech Pharma said it plans to stop development of eryaspase for acute lymphoblastic leukemia (ALL).

This means withdrawal of the European marketing authorization application for eryaspase as a treatment for relapsed and refractory ALL.

However, Erytech will continue development of eryaspase as a treatment for certain solid tumor malignancies.

Eryaspase consists of L-asparaginase encapsulated inside donor-derived red blood cells. These enzyme-loaded red blood cells function as bioreactors to eliminate circulating asparagine and “starve” cancer cells, thereby inducing their death.

Erytech noted that eryaspase has produced favorable efficacy and safety results in ALL.

However, based on recent feedback from regulatory agencies in Europe and the US, the company believes significant additional investment would be required to seek regulatory approval of eryaspase for the treatment of ALL. Erytech also believes there would be a limited market opportunity for eryaspase in ALL.

Therefore, the company decided to cease further clinical development efforts in ALL. The resources that will become available as a result of this decision will be allocated to the development of eryaspase in solid tumors.

In 2017, Erytech announced results from a phase 2b clinical trial of eryaspase plus chemotherapy in patients with second-line metastatic pancreatic cancer. The company expects to begin enrollment in a phase 3 trial of this patient population in the third quarter of 2018.

In addition, Erytech is preparing for a pair of phase 2 proof-of-concept trials of eryaspase. One is in first-line pancreatic cancer, and the other is in metastatic triple-negative breast cancer. The company is also evaluating development options in additional solid tumor indications with high unmet medical need.

To ensure an adequate supply of eryaspase, Erytech is constructing a large-scale manufacturing facility in Princeton, New Jersey, and is expanding its manufacturing capacity in Lyon, France. The company expects both facilities to be operational for clinical production at the expanded capacity in the first quarter of 2019.

Hepatitis C virus infection often is associated with the accumulation of fat in hepatocytes, which shows a connection between the virus and the lipid metabolism of the liver, according to Sarah Hoffman, MD, of the Leibniz Institute for Experimental Virology, Hamburg, Germany, and her colleagues. “Our study provides a detailed analysis of the changes in the lipid composition in HCV-infected cells that revealed dependency on FA [fatty acid] elongation and desaturation for effective viral replication and virion production,” they reported.

Dr. Hoffman and her colleagues assessed lipid composition of infected cells in an in vitro study of cell lines, which were assessed 8-11 days post infection, according to the report published in BBA: Molecular and Cell Biology of Lipids. They determined the abundance of each major lipid class and compared the pattern of HCV-infected cells with that of controls.

The researchers found that HCV caused an accumulation of membrane phosopholipids but not neutral lipids and that cholesterol accumulated in the perinuclear region of HCV-infected cells. In addition, lipid species with longer fatty acyl chains were more abundant in HCV-infected cells and free polyunsaturated fatty acid (PUFA) levels were greatly increased.

In further confirmation of the critical role of lipid metabolism in HCV replication, they found that knockdown of fatty acid elongases and desaturases disrupted HCV replication, while overexpression of these enzymes showed a proviral effect.

“We identified several lipid-remodeling pathways that are required for distinct steps in viral infection. Future studies have to address the molecular function of longer fatty acyl chains in HCV RNA replication and why PUFAs are needed for HCV particle production,” the researchers concluded.

The authors reported government and institutional-only funding and no personal disclosures.

[email protected]

SOURCE: Hoffman S et al. Biochim Biophys Acta. 2018 Jun 6;1863(9):1041-56.

Hepatitis C virus infection often is associated with the accumulation of fat in hepatocytes, which shows a connection between the virus and the lipid metabolism of the liver, according to Sarah Hoffman, MD, of the Leibniz Institute for Experimental Virology, Hamburg, Germany, and her colleagues. “Our study provides a detailed analysis of the changes in the lipid composition in HCV-infected cells that revealed dependency on FA [fatty acid] elongation and desaturation for effective viral replication and virion production,” they reported.

Dr. Hoffman and her colleagues assessed lipid composition of infected cells in an in vitro study of cell lines, which were assessed 8-11 days post infection, according to the report published in BBA: Molecular and Cell Biology of Lipids. They determined the abundance of each major lipid class and compared the pattern of HCV-infected cells with that of controls.

The researchers found that HCV caused an accumulation of membrane phosopholipids but not neutral lipids and that cholesterol accumulated in the perinuclear region of HCV-infected cells. In addition, lipid species with longer fatty acyl chains were more abundant in HCV-infected cells and free polyunsaturated fatty acid (PUFA) levels were greatly increased.

In further confirmation of the critical role of lipid metabolism in HCV replication, they found that knockdown of fatty acid elongases and desaturases disrupted HCV replication, while overexpression of these enzymes showed a proviral effect.

“We identified several lipid-remodeling pathways that are required for distinct steps in viral infection. Future studies have to address the molecular function of longer fatty acyl chains in HCV RNA replication and why PUFAs are needed for HCV particle production,” the researchers concluded.

The authors reported government and institutional-only funding and no personal disclosures.

[email protected]

SOURCE: Hoffman S et al. Biochim Biophys Acta. 2018 Jun 6;1863(9):1041-56.

Hepatitis C virus infection often is associated with the accumulation of fat in hepatocytes, which shows a connection between the virus and the lipid metabolism of the liver, according to Sarah Hoffman, MD, of the Leibniz Institute for Experimental Virology, Hamburg, Germany, and her colleagues. “Our study provides a detailed analysis of the changes in the lipid composition in HCV-infected cells that revealed dependency on FA [fatty acid] elongation and desaturation for effective viral replication and virion production,” they reported.

Dr. Hoffman and her colleagues assessed lipid composition of infected cells in an in vitro study of cell lines, which were assessed 8-11 days post infection, according to the report published in BBA: Molecular and Cell Biology of Lipids. They determined the abundance of each major lipid class and compared the pattern of HCV-infected cells with that of controls.

The researchers found that HCV caused an accumulation of membrane phosopholipids but not neutral lipids and that cholesterol accumulated in the perinuclear region of HCV-infected cells. In addition, lipid species with longer fatty acyl chains were more abundant in HCV-infected cells and free polyunsaturated fatty acid (PUFA) levels were greatly increased.

In further confirmation of the critical role of lipid metabolism in HCV replication, they found that knockdown of fatty acid elongases and desaturases disrupted HCV replication, while overexpression of these enzymes showed a proviral effect.

“We identified several lipid-remodeling pathways that are required for distinct steps in viral infection. Future studies have to address the molecular function of longer fatty acyl chains in HCV RNA replication and why PUFAs are needed for HCV particle production,” the researchers concluded.

The authors reported government and institutional-only funding and no personal disclosures.

[email protected]

SOURCE: Hoffman S et al. Biochim Biophys Acta. 2018 Jun 6;1863(9):1041-56.

BALTIMORE – Continuous positive airway pressure (CPAP) may supersede supplemental oxygen and patient education for improving one key marker of cardiac electrophysiological autonomic function during sleep, but supplemental oxygen may have the upper hand in improving a second key electrophysiological biomarker, according to results of a multicenter, randomized clinical trial presented at the annual meeting of the Associated Professional Sleep Societies.

“Based on these findings, it appears that there are opposing alterations in both frequency and time domain in heart rate variability indices in the CPAP versus oxygen groups,” said Jenie George, MD, of the Cleveland Clinic.

The study evaluated 3-month outcomes of frequency-based heart rate variability (HRV) indices obtained with ECG from sleep studies in 203 patients with obstructive sleep apnea and increased cardiovascular risk in the Heart Biomarker Elevation in Apnea Treatment (HeartBEAT) trial. The interventions were either CPAP, supplemental oxygen, or healthy lifestyle education. Dr. George noted that HRV is a noninvasive tool to evaluate autonomic function by quantifying changes in intervals between sinus beats during sleep.

On the high-frequency power index, patients on CPAP had a 9% reduction versus a 19% increase for those on supplemental oxygen, Dr. George said. However for the low frequency to high frequency ratio, the CPAP group had a 4% increase, whereas the oxygen group had a 34% reduction.

The increase of low frequency to high frequency ratio in the CPAP group is a reflection of sympathovagal balance – the ratio between low-frequency and high-frequency powers – while the changes in high-frequency power in the CPAP patients reflect changes in sinoatrial node electrophysiological function, Dr. George said.

Strengths of the study were its use of data from a large clinical trial, careful preprocessing of ECG data, and consideration of the influence of oxygen in sleep apnea and of confounding influences, such as medications. Limitations of the study, Dr. George noted, include the absence of sleep-wake data and acknowledgment that HRV measures are accepted surrogates of autonomic imbalance but that they are not direct measures.

The next steps for the current research, Dr. George said, include an analysis of how respiratory events influence HRV indices in CPAP and supplemental oxygen. Future trials should be designed to examine how the two interventions affect direct measures of autonomic function and consider a longer follow-up duration, she said.

Dr. George had no financial relationships to disclose. The trial received support from the National Heart, Lung, and Blood Institute and the National Center for Research Resources.

SOURCE: George J et al. Sleep 2018, Abstract 0444.

BALTIMORE – Continuous positive airway pressure (CPAP) may supersede supplemental oxygen and patient education for improving one key marker of cardiac electrophysiological autonomic function during sleep, but supplemental oxygen may have the upper hand in improving a second key electrophysiological biomarker, according to results of a multicenter, randomized clinical trial presented at the annual meeting of the Associated Professional Sleep Societies.

“Based on these findings, it appears that there are opposing alterations in both frequency and time domain in heart rate variability indices in the CPAP versus oxygen groups,” said Jenie George, MD, of the Cleveland Clinic.

The study evaluated 3-month outcomes of frequency-based heart rate variability (HRV) indices obtained with ECG from sleep studies in 203 patients with obstructive sleep apnea and increased cardiovascular risk in the Heart Biomarker Elevation in Apnea Treatment (HeartBEAT) trial. The interventions were either CPAP, supplemental oxygen, or healthy lifestyle education. Dr. George noted that HRV is a noninvasive tool to evaluate autonomic function by quantifying changes in intervals between sinus beats during sleep.

On the high-frequency power index, patients on CPAP had a 9% reduction versus a 19% increase for those on supplemental oxygen, Dr. George said. However for the low frequency to high frequency ratio, the CPAP group had a 4% increase, whereas the oxygen group had a 34% reduction.

The increase of low frequency to high frequency ratio in the CPAP group is a reflection of sympathovagal balance – the ratio between low-frequency and high-frequency powers – while the changes in high-frequency power in the CPAP patients reflect changes in sinoatrial node electrophysiological function, Dr. George said.

Strengths of the study were its use of data from a large clinical trial, careful preprocessing of ECG data, and consideration of the influence of oxygen in sleep apnea and of confounding influences, such as medications. Limitations of the study, Dr. George noted, include the absence of sleep-wake data and acknowledgment that HRV measures are accepted surrogates of autonomic imbalance but that they are not direct measures.

The next steps for the current research, Dr. George said, include an analysis of how respiratory events influence HRV indices in CPAP and supplemental oxygen. Future trials should be designed to examine how the two interventions affect direct measures of autonomic function and consider a longer follow-up duration, she said.

Dr. George had no financial relationships to disclose. The trial received support from the National Heart, Lung, and Blood Institute and the National Center for Research Resources.

SOURCE: George J et al. Sleep 2018, Abstract 0444.

BALTIMORE – Continuous positive airway pressure (CPAP) may supersede supplemental oxygen and patient education for improving one key marker of cardiac electrophysiological autonomic function during sleep, but supplemental oxygen may have the upper hand in improving a second key electrophysiological biomarker, according to results of a multicenter, randomized clinical trial presented at the annual meeting of the Associated Professional Sleep Societies.

“Based on these findings, it appears that there are opposing alterations in both frequency and time domain in heart rate variability indices in the CPAP versus oxygen groups,” said Jenie George, MD, of the Cleveland Clinic.

The study evaluated 3-month outcomes of frequency-based heart rate variability (HRV) indices obtained with ECG from sleep studies in 203 patients with obstructive sleep apnea and increased cardiovascular risk in the Heart Biomarker Elevation in Apnea Treatment (HeartBEAT) trial. The interventions were either CPAP, supplemental oxygen, or healthy lifestyle education. Dr. George noted that HRV is a noninvasive tool to evaluate autonomic function by quantifying changes in intervals between sinus beats during sleep.

On the high-frequency power index, patients on CPAP had a 9% reduction versus a 19% increase for those on supplemental oxygen, Dr. George said. However for the low frequency to high frequency ratio, the CPAP group had a 4% increase, whereas the oxygen group had a 34% reduction.

The increase of low frequency to high frequency ratio in the CPAP group is a reflection of sympathovagal balance – the ratio between low-frequency and high-frequency powers – while the changes in high-frequency power in the CPAP patients reflect changes in sinoatrial node electrophysiological function, Dr. George said.

Strengths of the study were its use of data from a large clinical trial, careful preprocessing of ECG data, and consideration of the influence of oxygen in sleep apnea and of confounding influences, such as medications. Limitations of the study, Dr. George noted, include the absence of sleep-wake data and acknowledgment that HRV measures are accepted surrogates of autonomic imbalance but that they are not direct measures.

The next steps for the current research, Dr. George said, include an analysis of how respiratory events influence HRV indices in CPAP and supplemental oxygen. Future trials should be designed to examine how the two interventions affect direct measures of autonomic function and consider a longer follow-up duration, she said.

Dr. George had no financial relationships to disclose. The trial received support from the National Heart, Lung, and Blood Institute and the National Center for Research Resources.

SOURCE: George J et al. Sleep 2018, Abstract 0444.