Health Policy

In late February, a soldier stationed at Camp Carroll near Daegu, South Korea, was the first military member to test positive for the coronavirus (COVID-19). Before being diagnosed, he visited other areas, including Camp Walker in Daegu, according to a statement released by US Forces Korea. More than 75,000 troops are stationed in countries with virus outbreaks, including Japan, Italy, and Bahrain.

Military research laboratories are working “feverishly around the horn” to come up with a vaccine, Joint Chiefs of Staff Chairman Gen. Mark A. Milley said in a March 2, 2020, news conference. At the same conference, Defense Secretary Mark T. Esper, MD, said US Department of Defense (DoD) civilian and military leadership are working together to prepare for short-and long-term scenarios.

The US Northern Command is the “global integrator,” Esper said, with the DoD communicating regularly with operational commanders to assess how the virus might impact exercises and ongoing operations around the world. For example, a command post exercise in South Korea has been postponed; Exercise Cobra Gold in Thailand is continuing.

Commanders are taking all necessary precautions because the virus is unique to every situation and every location, Esper said: “We’re relying on them to make good judgments.”

He emphasized that commanders at all levels have the authority and guidance they need to operate. In a late February video teleconference, Esper had told commanders deployed overseas that he wanted them to give him a heads-up before making decisions related to protecting their troops, according to The New York Times.

The New York Times article cited an exchange in which Gen. Robert Abrams, commander of American forces in South Korea, where > 4,000 coronavirus cases have been confirmed, discussed his options to protect American military personnel against the virus. Esper said he wanted advance notice, according to an official briefed on the call and quoted in the Times article. Gen. Abrams said although he would try to give Sec. Esper advance warning, he might have to make urgent health decisions before receiving final approval from Washington.

In a statement responding to the Times article, Jonathan Hoffman, Assistant to the Secretary of Defense for Public Affairs, said the Secretary of Defense has given the Global Combatant Commanders the “clear and unequivocal authority” to take any and all actions necessary to ensure the health and safety of US service members, civilian DoD personnel, families, and dependents.

In the video teleconference, Hoffman said, Secretary Espers “directed commanders to take all force health protection measures, and to notify their chain of command when actions are taken so that DoD leadership can inform the interagency—including US Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC), the Department of Homeland Security, the State Department, and the White House—and the American people.” Esper “explicitly did not direct them to ‘clear’ their force health decisions in advance,” Hoffman said. “[T]hat is a dangerous and inaccurate mischaracterization.” 

In January, the Office of the Under Secretary of Defense released a memorandum on force health protection guidance for the coronavirus outbreak. The DoD, it says, will follow the CDC guidance and will “closely coordinate with interagency partners to ensure accurate and timely information is available.”

“An informed, common-sense approach minimizes the chances of getting sick,” military health officials say. But, “due to the dynamic nature of this outbreak,” people should frequently check the CDC website for additional updates. Related Military Health System information and links to the CDC are available at https://www.health.mil/News/In-the-Spotlight/Coronavirus.

The CDC provides a summary of its latest recommendations and DoD health care providers can access COVID-19–specific guidance, including information on evaluating “persons under investigation,” at https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html.

Sec. Esper, in the Monday news conference, said, “My number-one priority remains to protect our forces and their families; second is to safeguard our mission capabilities and third [is] to support the interagency whole-of-government’s approach. We will continue to take all necessary precautions to ensure that our people are safe and able to continue their very important mission.”

In late February, a soldier stationed at Camp Carroll near Daegu, South Korea, was the first military member to test positive for the coronavirus (COVID-19). Before being diagnosed, he visited other areas, including Camp Walker in Daegu, according to a statement released by US Forces Korea. More than 75,000 troops are stationed in countries with virus outbreaks, including Japan, Italy, and Bahrain.

Military research laboratories are working “feverishly around the horn” to come up with a vaccine, Joint Chiefs of Staff Chairman Gen. Mark A. Milley said in a March 2, 2020, news conference. At the same conference, Defense Secretary Mark T. Esper, MD, said US Department of Defense (DoD) civilian and military leadership are working together to prepare for short-and long-term scenarios.

The US Northern Command is the “global integrator,” Esper said, with the DoD communicating regularly with operational commanders to assess how the virus might impact exercises and ongoing operations around the world. For example, a command post exercise in South Korea has been postponed; Exercise Cobra Gold in Thailand is continuing.

Commanders are taking all necessary precautions because the virus is unique to every situation and every location, Esper said: “We’re relying on them to make good judgments.”

He emphasized that commanders at all levels have the authority and guidance they need to operate. In a late February video teleconference, Esper had told commanders deployed overseas that he wanted them to give him a heads-up before making decisions related to protecting their troops, according to The New York Times.

The New York Times article cited an exchange in which Gen. Robert Abrams, commander of American forces in South Korea, where > 4,000 coronavirus cases have been confirmed, discussed his options to protect American military personnel against the virus. Esper said he wanted advance notice, according to an official briefed on the call and quoted in the Times article. Gen. Abrams said although he would try to give Sec. Esper advance warning, he might have to make urgent health decisions before receiving final approval from Washington.

In a statement responding to the Times article, Jonathan Hoffman, Assistant to the Secretary of Defense for Public Affairs, said the Secretary of Defense has given the Global Combatant Commanders the “clear and unequivocal authority” to take any and all actions necessary to ensure the health and safety of US service members, civilian DoD personnel, families, and dependents.

In the video teleconference, Hoffman said, Secretary Espers “directed commanders to take all force health protection measures, and to notify their chain of command when actions are taken so that DoD leadership can inform the interagency—including US Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC), the Department of Homeland Security, the State Department, and the White House—and the American people.” Esper “explicitly did not direct them to ‘clear’ their force health decisions in advance,” Hoffman said. “[T]hat is a dangerous and inaccurate mischaracterization.” 

In January, the Office of the Under Secretary of Defense released a memorandum on force health protection guidance for the coronavirus outbreak. The DoD, it says, will follow the CDC guidance and will “closely coordinate with interagency partners to ensure accurate and timely information is available.”

“An informed, common-sense approach minimizes the chances of getting sick,” military health officials say. But, “due to the dynamic nature of this outbreak,” people should frequently check the CDC website for additional updates. Related Military Health System information and links to the CDC are available at https://www.health.mil/News/In-the-Spotlight/Coronavirus.

The CDC provides a summary of its latest recommendations and DoD health care providers can access COVID-19–specific guidance, including information on evaluating “persons under investigation,” at https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html.

Sec. Esper, in the Monday news conference, said, “My number-one priority remains to protect our forces and their families; second is to safeguard our mission capabilities and third [is] to support the interagency whole-of-government’s approach. We will continue to take all necessary precautions to ensure that our people are safe and able to continue their very important mission.”

In late February, a soldier stationed at Camp Carroll near Daegu, South Korea, was the first military member to test positive for the coronavirus (COVID-19). Before being diagnosed, he visited other areas, including Camp Walker in Daegu, according to a statement released by US Forces Korea. More than 75,000 troops are stationed in countries with virus outbreaks, including Japan, Italy, and Bahrain.

Military research laboratories are working “feverishly around the horn” to come up with a vaccine, Joint Chiefs of Staff Chairman Gen. Mark A. Milley said in a March 2, 2020, news conference. At the same conference, Defense Secretary Mark T. Esper, MD, said US Department of Defense (DoD) civilian and military leadership are working together to prepare for short-and long-term scenarios.

The US Northern Command is the “global integrator,” Esper said, with the DoD communicating regularly with operational commanders to assess how the virus might impact exercises and ongoing operations around the world. For example, a command post exercise in South Korea has been postponed; Exercise Cobra Gold in Thailand is continuing.

Commanders are taking all necessary precautions because the virus is unique to every situation and every location, Esper said: “We’re relying on them to make good judgments.”

He emphasized that commanders at all levels have the authority and guidance they need to operate. In a late February video teleconference, Esper had told commanders deployed overseas that he wanted them to give him a heads-up before making decisions related to protecting their troops, according to The New York Times.

The New York Times article cited an exchange in which Gen. Robert Abrams, commander of American forces in South Korea, where > 4,000 coronavirus cases have been confirmed, discussed his options to protect American military personnel against the virus. Esper said he wanted advance notice, according to an official briefed on the call and quoted in the Times article. Gen. Abrams said although he would try to give Sec. Esper advance warning, he might have to make urgent health decisions before receiving final approval from Washington.

In a statement responding to the Times article, Jonathan Hoffman, Assistant to the Secretary of Defense for Public Affairs, said the Secretary of Defense has given the Global Combatant Commanders the “clear and unequivocal authority” to take any and all actions necessary to ensure the health and safety of US service members, civilian DoD personnel, families, and dependents.

In the video teleconference, Hoffman said, Secretary Espers “directed commanders to take all force health protection measures, and to notify their chain of command when actions are taken so that DoD leadership can inform the interagency—including US Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC), the Department of Homeland Security, the State Department, and the White House—and the American people.” Esper “explicitly did not direct them to ‘clear’ their force health decisions in advance,” Hoffman said. “[T]hat is a dangerous and inaccurate mischaracterization.” 

In January, the Office of the Under Secretary of Defense released a memorandum on force health protection guidance for the coronavirus outbreak. The DoD, it says, will follow the CDC guidance and will “closely coordinate with interagency partners to ensure accurate and timely information is available.”

“An informed, common-sense approach minimizes the chances of getting sick,” military health officials say. But, “due to the dynamic nature of this outbreak,” people should frequently check the CDC website for additional updates. Related Military Health System information and links to the CDC are available at https://www.health.mil/News/In-the-Spotlight/Coronavirus.

The CDC provides a summary of its latest recommendations and DoD health care providers can access COVID-19–specific guidance, including information on evaluating “persons under investigation,” at https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html.

Sec. Esper, in the Monday news conference, said, “My number-one priority remains to protect our forces and their families; second is to safeguard our mission capabilities and third [is] to support the interagency whole-of-government’s approach. We will continue to take all necessary precautions to ensure that our people are safe and able to continue their very important mission.”

The White House Coronavirus Task Force appeared at a press briefing March 2 to provide updates about testing strategies and public health coordination to address the current outbreak of the coronavirus COVID-19. Speaking at the briefing, led by Vice President Mike Pence, Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said, “Working with our public health partners we continue to be able to identify new community cases and use our public health efforts to aggressively confirm, isolate, and do contact tracking.” Calling state, local, tribal, and territorial public health departments “the backbone of the public health system in our country,” Dr. Redfield noted that he expected many more confirmed COVID-19 cases to emerge.

At least some of the expected increase in confirmed cases of COVID-19 will occur because of expanded testing capacity, noted several of the task force members. On Feb. 29, the Food and Drug Administration issued a new policy to expedite the process for some laboratories to develop new diagnostic tests for SARS-CoV2, the virus that is causing the current outbreak of COVID-19.

Highly qualified laboratories, including both those run by public agencies and private labs, are now authorized to begin using their own validated test for the virus as long as they submit an Emergency Use Authorization (EUA) to the Food and Drug Administration within 15 days of notifying the agency of validation.

“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care,” the agency wrote in a press announcement of the expedited test expansion.

On Feb. 4, the Secretary of the Department of Health & Human Services declared a coronavirus public health emergency. The FDA was then authorized to allow individual laboratories with validated coronavirus tests to begin testing samples immediately. The goal is a more rapid and expanded testing capacity in the United States.

“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said in the press release.

The new guidance that permits the immediate use of clinical tests after individual development and validation, said the FDA, only applies to labs already certified to perform high complexity testing under Clinical Laboratory Improvement Amendments. Many governmental, academic, and private laboratories fall into this category, however.

“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation,” he added in the press release.

“By the end of this week, close to a million tests will be available,” FDA Commissioner Stephen M. Hahn, MD, said during the March 2 briefing.*

Updated criteria

The CDC is maintaining updated criteria for the virus testing on its website. Testing criteria are based both on clinical features and epidemiologic risk.

Individuals with less severe clinical features – those who have either fever or signs and symptoms of lower respiratory disease such as cough or shortness of breath, but who don’t require hospitalization – should be tested if they have high epidemiologic risk. “High risk” is defined by the CDC as any individual, including health care workers, who has had close contact with a person with confirmed COVID-19 within the past 2 weeks. For health care workers, testing can be considered even if they have relatively mild respiratory symptoms or have had contact with a person who is suspected, but not yet confirmed, to have coronavirus.

In its testing guidance, the CDC recognizes that defining close contact is difficult. General guidelines are that individuals are considered to have been in close contact with a person who has COVID-19 if they were within about six feet of the person for a prolonged period, or cared for or have spent a prolonged amount of time in the same room or house as a person with confirmed COVID-19.

Individuals who have both fever and signs or symptoms of lower respiratory illness who require hospitalization should be tested if they have a history of travel from any affected geographic area within 14 days of the onset of their symptoms. The CDC now defines “affected geographic area” as any country or region that has at least a CDC Level 2 Travel Health Notice for COVID-19, so that the testing criteria themselves don’t need to be updated when new geographic areas are included in these alerts. As of March 3, China, Iran, Italy, Japan, and South Korea all have Level 2 or 3 travel alerts.

The CDC now recommends that any patient who has severe acute lower respiratory illness that requires hospitalization and doesn’t have an alternative diagnosis should be tested, even without any identified source of exposure.

“Despite seeing these new cases, the risk to the American people is low,” said the CDC’s Dr. Redfield. In response to a question from the press about how fast the coronavirus will spread across the United States, Dr. Redfield said, “From the beginning we’ve anticipated seeing community cases pop up.” He added that as these cases arise, testing and public health strategies will focus on unearthing linkages and contacts to learn how the virus is spreading. “We’ll use the public health strategies that we can to limit that transmission,” he said.

koakes@mdedge.com

*An earlier version of this article misattributed this quote.

The White House Coronavirus Task Force appeared at a press briefing March 2 to provide updates about testing strategies and public health coordination to address the current outbreak of the coronavirus COVID-19. Speaking at the briefing, led by Vice President Mike Pence, Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said, “Working with our public health partners we continue to be able to identify new community cases and use our public health efforts to aggressively confirm, isolate, and do contact tracking.” Calling state, local, tribal, and territorial public health departments “the backbone of the public health system in our country,” Dr. Redfield noted that he expected many more confirmed COVID-19 cases to emerge.

At least some of the expected increase in confirmed cases of COVID-19 will occur because of expanded testing capacity, noted several of the task force members. On Feb. 29, the Food and Drug Administration issued a new policy to expedite the process for some laboratories to develop new diagnostic tests for SARS-CoV2, the virus that is causing the current outbreak of COVID-19.

Highly qualified laboratories, including both those run by public agencies and private labs, are now authorized to begin using their own validated test for the virus as long as they submit an Emergency Use Authorization (EUA) to the Food and Drug Administration within 15 days of notifying the agency of validation.

“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care,” the agency wrote in a press announcement of the expedited test expansion.

On Feb. 4, the Secretary of the Department of Health & Human Services declared a coronavirus public health emergency. The FDA was then authorized to allow individual laboratories with validated coronavirus tests to begin testing samples immediately. The goal is a more rapid and expanded testing capacity in the United States.

“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said in the press release.

The new guidance that permits the immediate use of clinical tests after individual development and validation, said the FDA, only applies to labs already certified to perform high complexity testing under Clinical Laboratory Improvement Amendments. Many governmental, academic, and private laboratories fall into this category, however.

“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation,” he added in the press release.

“By the end of this week, close to a million tests will be available,” FDA Commissioner Stephen M. Hahn, MD, said during the March 2 briefing.*

Updated criteria

The CDC is maintaining updated criteria for the virus testing on its website. Testing criteria are based both on clinical features and epidemiologic risk.

Individuals with less severe clinical features – those who have either fever or signs and symptoms of lower respiratory disease such as cough or shortness of breath, but who don’t require hospitalization – should be tested if they have high epidemiologic risk. “High risk” is defined by the CDC as any individual, including health care workers, who has had close contact with a person with confirmed COVID-19 within the past 2 weeks. For health care workers, testing can be considered even if they have relatively mild respiratory symptoms or have had contact with a person who is suspected, but not yet confirmed, to have coronavirus.

In its testing guidance, the CDC recognizes that defining close contact is difficult. General guidelines are that individuals are considered to have been in close contact with a person who has COVID-19 if they were within about six feet of the person for a prolonged period, or cared for or have spent a prolonged amount of time in the same room or house as a person with confirmed COVID-19.

Individuals who have both fever and signs or symptoms of lower respiratory illness who require hospitalization should be tested if they have a history of travel from any affected geographic area within 14 days of the onset of their symptoms. The CDC now defines “affected geographic area” as any country or region that has at least a CDC Level 2 Travel Health Notice for COVID-19, so that the testing criteria themselves don’t need to be updated when new geographic areas are included in these alerts. As of March 3, China, Iran, Italy, Japan, and South Korea all have Level 2 or 3 travel alerts.

The CDC now recommends that any patient who has severe acute lower respiratory illness that requires hospitalization and doesn’t have an alternative diagnosis should be tested, even without any identified source of exposure.

“Despite seeing these new cases, the risk to the American people is low,” said the CDC’s Dr. Redfield. In response to a question from the press about how fast the coronavirus will spread across the United States, Dr. Redfield said, “From the beginning we’ve anticipated seeing community cases pop up.” He added that as these cases arise, testing and public health strategies will focus on unearthing linkages and contacts to learn how the virus is spreading. “We’ll use the public health strategies that we can to limit that transmission,” he said.

koakes@mdedge.com

*An earlier version of this article misattributed this quote.

The White House Coronavirus Task Force appeared at a press briefing March 2 to provide updates about testing strategies and public health coordination to address the current outbreak of the coronavirus COVID-19. Speaking at the briefing, led by Vice President Mike Pence, Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said, “Working with our public health partners we continue to be able to identify new community cases and use our public health efforts to aggressively confirm, isolate, and do contact tracking.” Calling state, local, tribal, and territorial public health departments “the backbone of the public health system in our country,” Dr. Redfield noted that he expected many more confirmed COVID-19 cases to emerge.

At least some of the expected increase in confirmed cases of COVID-19 will occur because of expanded testing capacity, noted several of the task force members. On Feb. 29, the Food and Drug Administration issued a new policy to expedite the process for some laboratories to develop new diagnostic tests for SARS-CoV2, the virus that is causing the current outbreak of COVID-19.

Highly qualified laboratories, including both those run by public agencies and private labs, are now authorized to begin using their own validated test for the virus as long as they submit an Emergency Use Authorization (EUA) to the Food and Drug Administration within 15 days of notifying the agency of validation.

“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care,” the agency wrote in a press announcement of the expedited test expansion.

On Feb. 4, the Secretary of the Department of Health & Human Services declared a coronavirus public health emergency. The FDA was then authorized to allow individual laboratories with validated coronavirus tests to begin testing samples immediately. The goal is a more rapid and expanded testing capacity in the United States.

“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said in the press release.

The new guidance that permits the immediate use of clinical tests after individual development and validation, said the FDA, only applies to labs already certified to perform high complexity testing under Clinical Laboratory Improvement Amendments. Many governmental, academic, and private laboratories fall into this category, however.

“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation,” he added in the press release.

“By the end of this week, close to a million tests will be available,” FDA Commissioner Stephen M. Hahn, MD, said during the March 2 briefing.*

Updated criteria

The CDC is maintaining updated criteria for the virus testing on its website. Testing criteria are based both on clinical features and epidemiologic risk.

Individuals with less severe clinical features – those who have either fever or signs and symptoms of lower respiratory disease such as cough or shortness of breath, but who don’t require hospitalization – should be tested if they have high epidemiologic risk. “High risk” is defined by the CDC as any individual, including health care workers, who has had close contact with a person with confirmed COVID-19 within the past 2 weeks. For health care workers, testing can be considered even if they have relatively mild respiratory symptoms or have had contact with a person who is suspected, but not yet confirmed, to have coronavirus.

In its testing guidance, the CDC recognizes that defining close contact is difficult. General guidelines are that individuals are considered to have been in close contact with a person who has COVID-19 if they were within about six feet of the person for a prolonged period, or cared for or have spent a prolonged amount of time in the same room or house as a person with confirmed COVID-19.

Individuals who have both fever and signs or symptoms of lower respiratory illness who require hospitalization should be tested if they have a history of travel from any affected geographic area within 14 days of the onset of their symptoms. The CDC now defines “affected geographic area” as any country or region that has at least a CDC Level 2 Travel Health Notice for COVID-19, so that the testing criteria themselves don’t need to be updated when new geographic areas are included in these alerts. As of March 3, China, Iran, Italy, Japan, and South Korea all have Level 2 or 3 travel alerts.

The CDC now recommends that any patient who has severe acute lower respiratory illness that requires hospitalization and doesn’t have an alternative diagnosis should be tested, even without any identified source of exposure.

“Despite seeing these new cases, the risk to the American people is low,” said the CDC’s Dr. Redfield. In response to a question from the press about how fast the coronavirus will spread across the United States, Dr. Redfield said, “From the beginning we’ve anticipated seeing community cases pop up.” He added that as these cases arise, testing and public health strategies will focus on unearthing linkages and contacts to learn how the virus is spreading. “We’ll use the public health strategies that we can to limit that transmission,” he said.

koakes@mdedge.com

*An earlier version of this article misattributed this quote.

The VA has released an updated list of locations outside of Vietnam where tactical herbicides have been used, tested, or stored by the US military. The list, which includes the “rainbow” herbicides (Agents Orange, Pink, Green, Purple, Blue, and White), comes from the DoD, after a “thorough review” of research, reports, and government publications in response to a November 2018 US Government Accountability Office (GAO) report.

The GAO made 6 recommendations, including that the DoD develop a process for updating the list, and that the DoD and the VA develop a process for coordinating the communication of the information. The DoD concurred with 4 recommendations.

The VA, responding to the GAO report, said it was “concerned that the report conflates the terms commercial herbicides with tactical herbicides, which are distinct from one another.” Certain testing and storage locations (eg, Kelly Air Force Base), it noted, are added to the list based on the presence of commercial herbicides or “mere components” of Agent Orange or other rainbow agents.

The distinction is important for veterans applying for disability benefits. The impetus for creating the list of testing and storage sites, the VA says, was to carry out the administration of providing disability benefits in accordance with the applicable Agent Orange statute and regulations. Exposure to tactical herbicides (herbicides intended for military operations in Vietnam) is required for the VA to grant benefits on a presumptive basis for Agent Orange conditions outside of Vietnam. Thus, the VA concludes in its response, unless the commercial herbicides were the “same composition, forms, and mixtures” as the estimated 20 million gallons of rainbow agents specifically produced for operations in Vietnam, the “discussion is misleading.”

The VA also did not concur with the recommendation that it take the lead on developing “clear and transparent criteria” for what constitutes a location to be included on the list.

The DoD and VA did agree with the recommendation that the DoD should be the lead agency for producing and updating the list, while the VA will be the lead agency in providing information to veterans. The list will be updated as verifiable information becomes available, said Defense Secretary Mark Esper.

The full list of locations is available at https://www.publichealth.va.gov/docs/agentorange/dod_herbicides_outside_vietnam.pdf.
The GAO report is available at https://www.gao.gov/assets/gao-19-24.pdf.

The VA has released an updated list of locations outside of Vietnam where tactical herbicides have been used, tested, or stored by the US military. The list, which includes the “rainbow” herbicides (Agents Orange, Pink, Green, Purple, Blue, and White), comes from the DoD, after a “thorough review” of research, reports, and government publications in response to a November 2018 US Government Accountability Office (GAO) report.

The GAO made 6 recommendations, including that the DoD develop a process for updating the list, and that the DoD and the VA develop a process for coordinating the communication of the information. The DoD concurred with 4 recommendations.

The VA, responding to the GAO report, said it was “concerned that the report conflates the terms commercial herbicides with tactical herbicides, which are distinct from one another.” Certain testing and storage locations (eg, Kelly Air Force Base), it noted, are added to the list based on the presence of commercial herbicides or “mere components” of Agent Orange or other rainbow agents.

The distinction is important for veterans applying for disability benefits. The impetus for creating the list of testing and storage sites, the VA says, was to carry out the administration of providing disability benefits in accordance with the applicable Agent Orange statute and regulations. Exposure to tactical herbicides (herbicides intended for military operations in Vietnam) is required for the VA to grant benefits on a presumptive basis for Agent Orange conditions outside of Vietnam. Thus, the VA concludes in its response, unless the commercial herbicides were the “same composition, forms, and mixtures” as the estimated 20 million gallons of rainbow agents specifically produced for operations in Vietnam, the “discussion is misleading.”

The VA also did not concur with the recommendation that it take the lead on developing “clear and transparent criteria” for what constitutes a location to be included on the list.

The DoD and VA did agree with the recommendation that the DoD should be the lead agency for producing and updating the list, while the VA will be the lead agency in providing information to veterans. The list will be updated as verifiable information becomes available, said Defense Secretary Mark Esper.

The full list of locations is available at https://www.publichealth.va.gov/docs/agentorange/dod_herbicides_outside_vietnam.pdf.
The GAO report is available at https://www.gao.gov/assets/gao-19-24.pdf.

The VA has released an updated list of locations outside of Vietnam where tactical herbicides have been used, tested, or stored by the US military. The list, which includes the “rainbow” herbicides (Agents Orange, Pink, Green, Purple, Blue, and White), comes from the DoD, after a “thorough review” of research, reports, and government publications in response to a November 2018 US Government Accountability Office (GAO) report.

The GAO made 6 recommendations, including that the DoD develop a process for updating the list, and that the DoD and the VA develop a process for coordinating the communication of the information. The DoD concurred with 4 recommendations.

The VA, responding to the GAO report, said it was “concerned that the report conflates the terms commercial herbicides with tactical herbicides, which are distinct from one another.” Certain testing and storage locations (eg, Kelly Air Force Base), it noted, are added to the list based on the presence of commercial herbicides or “mere components” of Agent Orange or other rainbow agents.

The distinction is important for veterans applying for disability benefits. The impetus for creating the list of testing and storage sites, the VA says, was to carry out the administration of providing disability benefits in accordance with the applicable Agent Orange statute and regulations. Exposure to tactical herbicides (herbicides intended for military operations in Vietnam) is required for the VA to grant benefits on a presumptive basis for Agent Orange conditions outside of Vietnam. Thus, the VA concludes in its response, unless the commercial herbicides were the “same composition, forms, and mixtures” as the estimated 20 million gallons of rainbow agents specifically produced for operations in Vietnam, the “discussion is misleading.”

The VA also did not concur with the recommendation that it take the lead on developing “clear and transparent criteria” for what constitutes a location to be included on the list.

The DoD and VA did agree with the recommendation that the DoD should be the lead agency for producing and updating the list, while the VA will be the lead agency in providing information to veterans. The list will be updated as verifiable information becomes available, said Defense Secretary Mark Esper.

The full list of locations is available at https://www.publichealth.va.gov/docs/agentorange/dod_herbicides_outside_vietnam.pdf.
The GAO report is available at https://www.gao.gov/assets/gao-19-24.pdf.

The Trump administration can move forward with expanding a rule that makes it more difficult for immigrants to remain in the United States if they receive health care assistance, the U.S. Supreme Court ruled in a 5-4 vote.

Courtesy Fred Schilling, Collection of the Supreme Court of the United States

The Feb. 21 order allows the administration to broaden the so-called “public charge rule” while legal challenges against the expanded regulation continue in the lower courts. The Supreme Court’s decision, which lifts a preliminary injunction against the expansion, applies to enforcement only in Illinois, where a district court blocked the revised rule from moving forward in October 2019. The Supreme Court’s measure follows another 5-4 order in January, in which justices lifted a nationwide injunction against the revised rule.

Under the long-standing public charge rule, immigration officials can refuse to admit immigrants into the United States or can deny them permanent legal status if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid, the Supplemental Nutrition Assistance Program, and several housing programs. Use of these programs for more than 12 months in the aggregate during a 36-month period may result in a “public charge” designation and lead to green card denial.

Eight legal challenges were immediately filed against the rule changes, including a complaint issued by 14 states. At least five trial courts have since blocked the measure, while appeals courts have lifted some of the injunctions and upheld enforcement.

In its Jan. 27 order lifting the nationwide injunction, Associate Justice Neil M. Gorsuch wrote that nationwide injunctions are being overused by trial courts with negative consequences.

“The real problem here is the increasingly common practice of trial courts ordering relief that transcends the cases before them. Whether framed as injunctions of ‘nationwide,’ ‘universal,’ or ‘cosmic’ scope, these orders share the same basic flaw – they direct how the defendant must act toward persons who are not parties to the case,” he wrote. “It has become increasingly apparent that this court must, at some point, confront these important objections to this increasingly widespread practice. As the brief and furious history of the regulation before us illustrates, the routine issuance of universal injunctions is patently unworkable, sowing chaos for litigants, the government, courts, and all those affected by these conflicting decisions.”

In the court’s Feb. 21 order lifting the injunction in Illinois, justices gave no explanation for overturning the lower court’s injunction. However, Associate Justice Sonia Sotomayor issued a sharply-worded dissent, criticizing her fellow justices for allowing the rule to proceed.

“In sum, the government’s only claimed hardship is that it must enforce an existing interpretation of an immigration rule in one state – just as it has done for the past 20 years – while an updated version of the rule takes effect in the remaining 49,” she wrote. “The government has not quantified or explained any burdens that would arise from this state of the world.”

ACA cases still in limbo

Meanwhile, the Supreme Court still has not decided whether it will hear Texas v. United States, a case that could effectively dismantle the Affordable Care Act.

The high court was expected to announce whether it would take the high-profile case at a private Feb. 21 conference, but the justices have released no update. The case was relisted for consideration at the court’s Feb. 28 conference.

Texas v. United States stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Because the Trump administration declined to defend the law, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. The Democratic attorneys general and governors appealed the decision to the U.S. Supreme Court.

If the Supreme Court agrees to hear the challenge, the court could fast-track the case and schedule arguments for the current term or wait until its next term, which starts in October 2020. If justices decline to hear the case, the challenge will remain with the district court for more analysis about the law’s severability.

Another ACA-related case – Maine Community Health Options v. U.S. – also remains in limbo. Justices heard the case, which was consolidated with two similar challenges, on Dec. 10, 2019, but still have not issued a decision.

The consolidated challenges center on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law. The ACA’s risk corridor program required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them to the tune of $12 billion.

The Department of Justice counters that the government is not required to pay the insurers because of appropriations measures passed by Congress in 2014 and in later years that limited the funding available to compensate insurers for their losses.

The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.

A Supreme Court decision in the case could come as soon as Feb. 26.

Court to hear women’s health cases

Two closely watched reproductive health cases will go before the court this spring.

On March 4, justices will hear oral arguments in June Medical Services v. Russo, regarding the constitutionality of a Louisiana law that requires physicians performing abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, according to the state law, originally passed in 2014. Clinics that employ such doctors can also have their licenses revoked.

June Medical Services LLC, a women’s health clinic, sued over the law. A district court ruled in favor of the plaintiff, but the 5th U.S. Circuit Court of Appeals reversed and upheld Louisiana’s law. The clinic appealed to the U.S. Supreme Court. Louisiana officials argue the challenge should be dismissed, and the law allowed to proceed, because the plaintiffs lack standing.

The Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, justices struck down the measure as unconstitutional.

And on April 29, justices will hear arguments in Little Sisters of the Poor v. Pennsylvania, a consolidated case about whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraceptive mandate. Entities that object to providing contraception on the basis of religious beliefs can opt out of complying with the mandate, according to the 2018 regulations. Additionally, nonprofit organizations and small businesses that have nonreligious moral convictions against the mandate can skip compliance. A number of states and entities sued over the new rules.

A federal appeals court temporarily barred the regulations from moving forward, ruling the plaintiffs were likely to succeed in proving the Trump administration did not follow appropriate procedures when it promulgated the new rules and that the regulations were not authorized under the ACA.

Justices will decide whether the parties have standing in the case, whether the Trump administration followed correct rule-making procedures, and if the regulations can stand.

agallegos@mdedge.com

The Trump administration can move forward with expanding a rule that makes it more difficult for immigrants to remain in the United States if they receive health care assistance, the U.S. Supreme Court ruled in a 5-4 vote.

Courtesy Fred Schilling, Collection of the Supreme Court of the United States

The Feb. 21 order allows the administration to broaden the so-called “public charge rule” while legal challenges against the expanded regulation continue in the lower courts. The Supreme Court’s decision, which lifts a preliminary injunction against the expansion, applies to enforcement only in Illinois, where a district court blocked the revised rule from moving forward in October 2019. The Supreme Court’s measure follows another 5-4 order in January, in which justices lifted a nationwide injunction against the revised rule.

Under the long-standing public charge rule, immigration officials can refuse to admit immigrants into the United States or can deny them permanent legal status if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid, the Supplemental Nutrition Assistance Program, and several housing programs. Use of these programs for more than 12 months in the aggregate during a 36-month period may result in a “public charge” designation and lead to green card denial.

Eight legal challenges were immediately filed against the rule changes, including a complaint issued by 14 states. At least five trial courts have since blocked the measure, while appeals courts have lifted some of the injunctions and upheld enforcement.

In its Jan. 27 order lifting the nationwide injunction, Associate Justice Neil M. Gorsuch wrote that nationwide injunctions are being overused by trial courts with negative consequences.

“The real problem here is the increasingly common practice of trial courts ordering relief that transcends the cases before them. Whether framed as injunctions of ‘nationwide,’ ‘universal,’ or ‘cosmic’ scope, these orders share the same basic flaw – they direct how the defendant must act toward persons who are not parties to the case,” he wrote. “It has become increasingly apparent that this court must, at some point, confront these important objections to this increasingly widespread practice. As the brief and furious history of the regulation before us illustrates, the routine issuance of universal injunctions is patently unworkable, sowing chaos for litigants, the government, courts, and all those affected by these conflicting decisions.”

In the court’s Feb. 21 order lifting the injunction in Illinois, justices gave no explanation for overturning the lower court’s injunction. However, Associate Justice Sonia Sotomayor issued a sharply-worded dissent, criticizing her fellow justices for allowing the rule to proceed.

“In sum, the government’s only claimed hardship is that it must enforce an existing interpretation of an immigration rule in one state – just as it has done for the past 20 years – while an updated version of the rule takes effect in the remaining 49,” she wrote. “The government has not quantified or explained any burdens that would arise from this state of the world.”

ACA cases still in limbo

Meanwhile, the Supreme Court still has not decided whether it will hear Texas v. United States, a case that could effectively dismantle the Affordable Care Act.

The high court was expected to announce whether it would take the high-profile case at a private Feb. 21 conference, but the justices have released no update. The case was relisted for consideration at the court’s Feb. 28 conference.

Texas v. United States stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Because the Trump administration declined to defend the law, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. The Democratic attorneys general and governors appealed the decision to the U.S. Supreme Court.

If the Supreme Court agrees to hear the challenge, the court could fast-track the case and schedule arguments for the current term or wait until its next term, which starts in October 2020. If justices decline to hear the case, the challenge will remain with the district court for more analysis about the law’s severability.

Another ACA-related case – Maine Community Health Options v. U.S. – also remains in limbo. Justices heard the case, which was consolidated with two similar challenges, on Dec. 10, 2019, but still have not issued a decision.

The consolidated challenges center on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law. The ACA’s risk corridor program required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them to the tune of $12 billion.

The Department of Justice counters that the government is not required to pay the insurers because of appropriations measures passed by Congress in 2014 and in later years that limited the funding available to compensate insurers for their losses.

The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.

A Supreme Court decision in the case could come as soon as Feb. 26.

Court to hear women’s health cases

Two closely watched reproductive health cases will go before the court this spring.

On March 4, justices will hear oral arguments in June Medical Services v. Russo, regarding the constitutionality of a Louisiana law that requires physicians performing abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, according to the state law, originally passed in 2014. Clinics that employ such doctors can also have their licenses revoked.

June Medical Services LLC, a women’s health clinic, sued over the law. A district court ruled in favor of the plaintiff, but the 5th U.S. Circuit Court of Appeals reversed and upheld Louisiana’s law. The clinic appealed to the U.S. Supreme Court. Louisiana officials argue the challenge should be dismissed, and the law allowed to proceed, because the plaintiffs lack standing.

The Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, justices struck down the measure as unconstitutional.

And on April 29, justices will hear arguments in Little Sisters of the Poor v. Pennsylvania, a consolidated case about whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraceptive mandate. Entities that object to providing contraception on the basis of religious beliefs can opt out of complying with the mandate, according to the 2018 regulations. Additionally, nonprofit organizations and small businesses that have nonreligious moral convictions against the mandate can skip compliance. A number of states and entities sued over the new rules.

A federal appeals court temporarily barred the regulations from moving forward, ruling the plaintiffs were likely to succeed in proving the Trump administration did not follow appropriate procedures when it promulgated the new rules and that the regulations were not authorized under the ACA.

Justices will decide whether the parties have standing in the case, whether the Trump administration followed correct rule-making procedures, and if the regulations can stand.

agallegos@mdedge.com

The Trump administration can move forward with expanding a rule that makes it more difficult for immigrants to remain in the United States if they receive health care assistance, the U.S. Supreme Court ruled in a 5-4 vote.

Courtesy Fred Schilling, Collection of the Supreme Court of the United States

The Feb. 21 order allows the administration to broaden the so-called “public charge rule” while legal challenges against the expanded regulation continue in the lower courts. The Supreme Court’s decision, which lifts a preliminary injunction against the expansion, applies to enforcement only in Illinois, where a district court blocked the revised rule from moving forward in October 2019. The Supreme Court’s measure follows another 5-4 order in January, in which justices lifted a nationwide injunction against the revised rule.

Under the long-standing public charge rule, immigration officials can refuse to admit immigrants into the United States or can deny them permanent legal status if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid, the Supplemental Nutrition Assistance Program, and several housing programs. Use of these programs for more than 12 months in the aggregate during a 36-month period may result in a “public charge” designation and lead to green card denial.

Eight legal challenges were immediately filed against the rule changes, including a complaint issued by 14 states. At least five trial courts have since blocked the measure, while appeals courts have lifted some of the injunctions and upheld enforcement.

In its Jan. 27 order lifting the nationwide injunction, Associate Justice Neil M. Gorsuch wrote that nationwide injunctions are being overused by trial courts with negative consequences.

“The real problem here is the increasingly common practice of trial courts ordering relief that transcends the cases before them. Whether framed as injunctions of ‘nationwide,’ ‘universal,’ or ‘cosmic’ scope, these orders share the same basic flaw – they direct how the defendant must act toward persons who are not parties to the case,” he wrote. “It has become increasingly apparent that this court must, at some point, confront these important objections to this increasingly widespread practice. As the brief and furious history of the regulation before us illustrates, the routine issuance of universal injunctions is patently unworkable, sowing chaos for litigants, the government, courts, and all those affected by these conflicting decisions.”

In the court’s Feb. 21 order lifting the injunction in Illinois, justices gave no explanation for overturning the lower court’s injunction. However, Associate Justice Sonia Sotomayor issued a sharply-worded dissent, criticizing her fellow justices for allowing the rule to proceed.

“In sum, the government’s only claimed hardship is that it must enforce an existing interpretation of an immigration rule in one state – just as it has done for the past 20 years – while an updated version of the rule takes effect in the remaining 49,” she wrote. “The government has not quantified or explained any burdens that would arise from this state of the world.”

ACA cases still in limbo

Meanwhile, the Supreme Court still has not decided whether it will hear Texas v. United States, a case that could effectively dismantle the Affordable Care Act.

The high court was expected to announce whether it would take the high-profile case at a private Feb. 21 conference, but the justices have released no update. The case was relisted for consideration at the court’s Feb. 28 conference.

Texas v. United States stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Because the Trump administration declined to defend the law, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. The Democratic attorneys general and governors appealed the decision to the U.S. Supreme Court.

If the Supreme Court agrees to hear the challenge, the court could fast-track the case and schedule arguments for the current term or wait until its next term, which starts in October 2020. If justices decline to hear the case, the challenge will remain with the district court for more analysis about the law’s severability.

Another ACA-related case – Maine Community Health Options v. U.S. – also remains in limbo. Justices heard the case, which was consolidated with two similar challenges, on Dec. 10, 2019, but still have not issued a decision.

The consolidated challenges center on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law. The ACA’s risk corridor program required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them to the tune of $12 billion.

The Department of Justice counters that the government is not required to pay the insurers because of appropriations measures passed by Congress in 2014 and in later years that limited the funding available to compensate insurers for their losses.

The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.

A Supreme Court decision in the case could come as soon as Feb. 26.

Court to hear women’s health cases

Two closely watched reproductive health cases will go before the court this spring.

On March 4, justices will hear oral arguments in June Medical Services v. Russo, regarding the constitutionality of a Louisiana law that requires physicians performing abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, according to the state law, originally passed in 2014. Clinics that employ such doctors can also have their licenses revoked.

June Medical Services LLC, a women’s health clinic, sued over the law. A district court ruled in favor of the plaintiff, but the 5th U.S. Circuit Court of Appeals reversed and upheld Louisiana’s law. The clinic appealed to the U.S. Supreme Court. Louisiana officials argue the challenge should be dismissed, and the law allowed to proceed, because the plaintiffs lack standing.

The Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, justices struck down the measure as unconstitutional.

And on April 29, justices will hear arguments in Little Sisters of the Poor v. Pennsylvania, a consolidated case about whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraceptive mandate. Entities that object to providing contraception on the basis of religious beliefs can opt out of complying with the mandate, according to the 2018 regulations. Additionally, nonprofit organizations and small businesses that have nonreligious moral convictions against the mandate can skip compliance. A number of states and entities sued over the new rules.

A federal appeals court temporarily barred the regulations from moving forward, ruling the plaintiffs were likely to succeed in proving the Trump administration did not follow appropriate procedures when it promulgated the new rules and that the regulations were not authorized under the ACA.

Justices will decide whether the parties have standing in the case, whether the Trump administration followed correct rule-making procedures, and if the regulations can stand.

agallegos@mdedge.com

On March 4, 2020, the Supreme Court of the United States (SCOTUS) will hear opening arguments for June Medical Services v. Russo. (Please note that this case was originally referred to as June Medical Services v. Gee. However, Secretary Rebekah Gee resigned from her position on January 31, 2020, and was replaced by Interim Secretary Stephen Russo.) The case will examine a Louisiana law (Louisiana Act 620, or LA 620), originally passed in 2014, that requires physicians to have hospital admitting privileges within 30 miles of where they provide abortion services.¹ When LA 620 was signed into law in 2014, 5 of Louisiana’s 6 abortion clinics would not have met the standards created by this legislation and would have been forced to close, potentially leaving the vast majority of women in Louisiana without access to an abortion provider, and disproportionately impacting poor and rural women. Prior to enactment of this law, physicians at these 5 clinics attempted to obtain admitting privileges, and all were denied. The denials occurred due to two main reasons—because the providers admitted too few patients each year to qualify for hospital privileges or simply because they provided abortion care.² Shortly after this legislation was signed into law, the Center for Reproductive Rights (CRR) challenged the law, citing the undue burden it created for patients attempting to access abortion care.
 

Prior case also considered question of hospital privileges for abortion providers

Interestingly, SCOTUS already has ruled on this very question. In 1992, the Court ruled in Planned Parenthood of Southeastern Pennsylvania v. Casey that it is unconstitutional for a state to create an “undue burden” on a woman’s right to abortion prior to fetal viability.³ And in 2016, when considering whether or not requiring abortion providers to obtain hospital privileges creates an undue burden in Whole Women’s Health (WWH) v. Hellerstedt, the Supreme Court’s answer was yes, it does. WWH, with legal aid from CRR, challenged Texas House Bill 2 (H.B. 2), which similar to LA 620, required abortion providers to have local admitting privileges. Based largely on the precedent set in Casey, SCOTUS ruled 5-3 in favor of WWH.

The Louisiana law currently in question was written and challenged in district court simultaneous to the Supreme Court’s review of WWH. The district court declared LA 620 invalid and permanently enjoined its enforcement, finding the law would “drastically burden women’s right to choose abortions.”⁴ However, the US Court of Appeals for the Fifth Circuit reviewed the case and overturned the district court decision, finding the lower court’s analysis erroneous and stating, “no clinics will likely be forced to close on account of [LA 620].” The Fifth Circuit panel ruled that, despite the precedent of WWH, LA 620 did not create an undue burden because of state-level differences in admitting privileges, demographics, and geography. They also found that only 30% of the 2 million women living in Louisiana would be impacted by the law, predominantly via longer wait times, and argued that this does not represent significant burden. The plaintiffs filed for an emergency stay with SCOTUS, who granted the stay pending a full hearing. On March 4, the Supreme Court will hear arguments to determine if the Fifth Circuit was correct in drawing a distinction between LA 620 and the SCOTUS verdict in WWH.

Targeted restrictions on abortion providers

LA 620 joins a long series of laws meant to enact targeted restrictions on abortion providers, or “TRAP” laws. TRAP laws are written to limit access to abortion under the guise of improving patient safety, despite ample evidence to the contrary, and include such various regulations as admitting privileges, facilities requirements, waiting periods, and parental or partner notification. Many such laws have been enacted in the last decade, and many struck down based on judicial precedent.

How the Supreme Court has ruled in the past

When a case is appealed to the Supreme Court, the court can either decline to hear the case, thereby leaving the lower courts’ ruling in place, or choose to hear the case in full and either affirm or overturn the lower court’s decision. After issuing a ruling in WWH, the 2016-2017 Roberts Court declined to hear challenges from other states with similarly overturned laws, leaving the laws struck down. In electing to hear June Medical Services v. Russo, the court has the opportunity to uphold or overturn the Fifth Circuit Court’s decision. However, today’s Supreme Court differs greatly from the Supreme Court in 2016.

In 2016, the court ruled 5-3 to overturn H.B. 2 in WWH shortly after the death of Justice Antonin Scalia. Scalia was replaced by Justice Neil Gorsuch, a Constitutional originalist who has never directly ruled on an abortion case.⁵ In 2018, Justice Anthony Kennedy, who authored the court’s majority opinion on Casey and was among the majority on WWH, retired, and was replaced by Justice Brett Kavanaugh. Kavanaugh has ruled once on the right to abortion in Garza v. Hargan in 2017, where he argued that precedent states that the government has “permissible interests in favoring fetal life…and refraining from facilitating abortion,” and that significant delay in care did not constitute undue burden.⁶ In regard to the 5-4 stay issued by the court in June Medical Services, Kavanaugh joined Gorsuch in voting to deny the application for stay, and was the only justice to issue an opinion alongside the ruling, arguing that because the doctors in question had not applied for and been denied admitting privileges since the WWH ruling, the case hinges on theoretical rather than demonstrable undue burden.⁷ Appointed by President Donald Trump, both Gorsuch and Kavanaugh are widely considered to be conservative judges, and while neither has a strong judicial record on abortion rights, both are anticipated to side with the conservative majority on the court.

The Supreme Court rarely overturns its own precedent, but concerns are high

The question of precedent will be central in SCOTUS hearing June Medical Services v. Russo so quickly after the WWH decision. Additionally, in hearing this case, the court will have the opportunity to reexamine all relevant precedent, including the Planned Parenthood of Southeastern Pennsylvania v. Casey decision and even Roe v. Wade. With a conservative court and an increasingly charged political environment, reproductive rights advocates fear that the June Medical Services v. Russo ruling may be the first step toward dismantling judicial protection of abortion rights in the United States.

If SCOTUS rules against June Medical Services, stating that admitting privileges do not cause an undue burden for women seeking to access abortion care, other states likely will introduce and enact similar legislation. These TRAP laws have the potential to limit or eliminate access to abortion for 25 million people of reproductive age. Numerous studies have demonstrated that limiting access to abortion care does not decrease the number of abortions but can result in patients using unsafe means to obtain an abortion.⁸

The medical community recognizes the danger of enacting restrictive legislation. The American College of Obstetricians and Gynecologists (ACOG), along with the American Medical Association, the Society of Maternal-Fetal Medicine, the Association for Sexual and Reproductive Medicine, the American Association of Family Practitioners, and many others, filed an amicus curiae in support of the June Medical Services plaintiffs.⁹ These brief filings are critical to ensuring the courts hear physician voices in this important legal decision, and ACOG’s briefs have been quoted in several previous Supreme Court opinions, concurrences, and dissents.
 

Action items

• Although June Medical Services v. Russo’s decision will not be made until early summer 2020, we can continue to use our voices and expertise to speak out against laws designed to limit access to abortion—at the state and federal levels. As women’s health clinicians, we see the impact abortion restrictions have on our patients, especially our low income and rural patients. Sharing these stories with our legislators, testifying for or against legislation, and speaking out in our communities can have a powerful impact. Check with your local ACOG chapter or with ACOG’s state and government affairs office for more information.
• Follow along with this case at SCOTUS Blog.
• Lastly, make sure you are registered to vote. We are in an election year, and using our voices in and out of the ballot box is critical. You can register here.

On March 4, 2020, the Supreme Court of the United States (SCOTUS) will hear opening arguments for June Medical Services v. Russo. (Please note that this case was originally referred to as June Medical Services v. Gee. However, Secretary Rebekah Gee resigned from her position on January 31, 2020, and was replaced by Interim Secretary Stephen Russo.) The case will examine a Louisiana law (Louisiana Act 620, or LA 620), originally passed in 2014, that requires physicians to have hospital admitting privileges within 30 miles of where they provide abortion services.¹ When LA 620 was signed into law in 2014, 5 of Louisiana’s 6 abortion clinics would not have met the standards created by this legislation and would have been forced to close, potentially leaving the vast majority of women in Louisiana without access to an abortion provider, and disproportionately impacting poor and rural women. Prior to enactment of this law, physicians at these 5 clinics attempted to obtain admitting privileges, and all were denied. The denials occurred due to two main reasons—because the providers admitted too few patients each year to qualify for hospital privileges or simply because they provided abortion care.² Shortly after this legislation was signed into law, the Center for Reproductive Rights (CRR) challenged the law, citing the undue burden it created for patients attempting to access abortion care.
 

Prior case also considered question of hospital privileges for abortion providers

Interestingly, SCOTUS already has ruled on this very question. In 1992, the Court ruled in Planned Parenthood of Southeastern Pennsylvania v. Casey that it is unconstitutional for a state to create an “undue burden” on a woman’s right to abortion prior to fetal viability.³ And in 2016, when considering whether or not requiring abortion providers to obtain hospital privileges creates an undue burden in Whole Women’s Health (WWH) v. Hellerstedt, the Supreme Court’s answer was yes, it does. WWH, with legal aid from CRR, challenged Texas House Bill 2 (H.B. 2), which similar to LA 620, required abortion providers to have local admitting privileges. Based largely on the precedent set in Casey, SCOTUS ruled 5-3 in favor of WWH.

The Louisiana law currently in question was written and challenged in district court simultaneous to the Supreme Court’s review of WWH. The district court declared LA 620 invalid and permanently enjoined its enforcement, finding the law would “drastically burden women’s right to choose abortions.”⁴ However, the US Court of Appeals for the Fifth Circuit reviewed the case and overturned the district court decision, finding the lower court’s analysis erroneous and stating, “no clinics will likely be forced to close on account of [LA 620].” The Fifth Circuit panel ruled that, despite the precedent of WWH, LA 620 did not create an undue burden because of state-level differences in admitting privileges, demographics, and geography. They also found that only 30% of the 2 million women living in Louisiana would be impacted by the law, predominantly via longer wait times, and argued that this does not represent significant burden. The plaintiffs filed for an emergency stay with SCOTUS, who granted the stay pending a full hearing. On March 4, the Supreme Court will hear arguments to determine if the Fifth Circuit was correct in drawing a distinction between LA 620 and the SCOTUS verdict in WWH.

Targeted restrictions on abortion providers

LA 620 joins a long series of laws meant to enact targeted restrictions on abortion providers, or “TRAP” laws. TRAP laws are written to limit access to abortion under the guise of improving patient safety, despite ample evidence to the contrary, and include such various regulations as admitting privileges, facilities requirements, waiting periods, and parental or partner notification. Many such laws have been enacted in the last decade, and many struck down based on judicial precedent.

How the Supreme Court has ruled in the past

When a case is appealed to the Supreme Court, the court can either decline to hear the case, thereby leaving the lower courts’ ruling in place, or choose to hear the case in full and either affirm or overturn the lower court’s decision. After issuing a ruling in WWH, the 2016-2017 Roberts Court declined to hear challenges from other states with similarly overturned laws, leaving the laws struck down. In electing to hear June Medical Services v. Russo, the court has the opportunity to uphold or overturn the Fifth Circuit Court’s decision. However, today’s Supreme Court differs greatly from the Supreme Court in 2016.

In 2016, the court ruled 5-3 to overturn H.B. 2 in WWH shortly after the death of Justice Antonin Scalia. Scalia was replaced by Justice Neil Gorsuch, a Constitutional originalist who has never directly ruled on an abortion case.⁵ In 2018, Justice Anthony Kennedy, who authored the court’s majority opinion on Casey and was among the majority on WWH, retired, and was replaced by Justice Brett Kavanaugh. Kavanaugh has ruled once on the right to abortion in Garza v. Hargan in 2017, where he argued that precedent states that the government has “permissible interests in favoring fetal life…and refraining from facilitating abortion,” and that significant delay in care did not constitute undue burden.⁶ In regard to the 5-4 stay issued by the court in June Medical Services, Kavanaugh joined Gorsuch in voting to deny the application for stay, and was the only justice to issue an opinion alongside the ruling, arguing that because the doctors in question had not applied for and been denied admitting privileges since the WWH ruling, the case hinges on theoretical rather than demonstrable undue burden.⁷ Appointed by President Donald Trump, both Gorsuch and Kavanaugh are widely considered to be conservative judges, and while neither has a strong judicial record on abortion rights, both are anticipated to side with the conservative majority on the court.

The Supreme Court rarely overturns its own precedent, but concerns are high

The question of precedent will be central in SCOTUS hearing June Medical Services v. Russo so quickly after the WWH decision. Additionally, in hearing this case, the court will have the opportunity to reexamine all relevant precedent, including the Planned Parenthood of Southeastern Pennsylvania v. Casey decision and even Roe v. Wade. With a conservative court and an increasingly charged political environment, reproductive rights advocates fear that the June Medical Services v. Russo ruling may be the first step toward dismantling judicial protection of abortion rights in the United States.

If SCOTUS rules against June Medical Services, stating that admitting privileges do not cause an undue burden for women seeking to access abortion care, other states likely will introduce and enact similar legislation. These TRAP laws have the potential to limit or eliminate access to abortion for 25 million people of reproductive age. Numerous studies have demonstrated that limiting access to abortion care does not decrease the number of abortions but can result in patients using unsafe means to obtain an abortion.⁸

The medical community recognizes the danger of enacting restrictive legislation. The American College of Obstetricians and Gynecologists (ACOG), along with the American Medical Association, the Society of Maternal-Fetal Medicine, the Association for Sexual and Reproductive Medicine, the American Association of Family Practitioners, and many others, filed an amicus curiae in support of the June Medical Services plaintiffs.⁹ These brief filings are critical to ensuring the courts hear physician voices in this important legal decision, and ACOG’s briefs have been quoted in several previous Supreme Court opinions, concurrences, and dissents.
 

Action items

• Although June Medical Services v. Russo’s decision will not be made until early summer 2020, we can continue to use our voices and expertise to speak out against laws designed to limit access to abortion—at the state and federal levels. As women’s health clinicians, we see the impact abortion restrictions have on our patients, especially our low income and rural patients. Sharing these stories with our legislators, testifying for or against legislation, and speaking out in our communities can have a powerful impact. Check with your local ACOG chapter or with ACOG’s state and government affairs office for more information.
• Follow along with this case at SCOTUS Blog.
• Lastly, make sure you are registered to vote. We are in an election year, and using our voices in and out of the ballot box is critical. You can register here.

On March 4, 2020, the Supreme Court of the United States (SCOTUS) will hear opening arguments for June Medical Services v. Russo. (Please note that this case was originally referred to as June Medical Services v. Gee. However, Secretary Rebekah Gee resigned from her position on January 31, 2020, and was replaced by Interim Secretary Stephen Russo.) The case will examine a Louisiana law (Louisiana Act 620, or LA 620), originally passed in 2014, that requires physicians to have hospital admitting privileges within 30 miles of where they provide abortion services.¹ When LA 620 was signed into law in 2014, 5 of Louisiana’s 6 abortion clinics would not have met the standards created by this legislation and would have been forced to close, potentially leaving the vast majority of women in Louisiana without access to an abortion provider, and disproportionately impacting poor and rural women. Prior to enactment of this law, physicians at these 5 clinics attempted to obtain admitting privileges, and all were denied. The denials occurred due to two main reasons—because the providers admitted too few patients each year to qualify for hospital privileges or simply because they provided abortion care.² Shortly after this legislation was signed into law, the Center for Reproductive Rights (CRR) challenged the law, citing the undue burden it created for patients attempting to access abortion care.
 

Prior case also considered question of hospital privileges for abortion providers

Interestingly, SCOTUS already has ruled on this very question. In 1992, the Court ruled in Planned Parenthood of Southeastern Pennsylvania v. Casey that it is unconstitutional for a state to create an “undue burden” on a woman’s right to abortion prior to fetal viability.³ And in 2016, when considering whether or not requiring abortion providers to obtain hospital privileges creates an undue burden in Whole Women’s Health (WWH) v. Hellerstedt, the Supreme Court’s answer was yes, it does. WWH, with legal aid from CRR, challenged Texas House Bill 2 (H.B. 2), which similar to LA 620, required abortion providers to have local admitting privileges. Based largely on the precedent set in Casey, SCOTUS ruled 5-3 in favor of WWH.

The Louisiana law currently in question was written and challenged in district court simultaneous to the Supreme Court’s review of WWH. The district court declared LA 620 invalid and permanently enjoined its enforcement, finding the law would “drastically burden women’s right to choose abortions.”⁴ However, the US Court of Appeals for the Fifth Circuit reviewed the case and overturned the district court decision, finding the lower court’s analysis erroneous and stating, “no clinics will likely be forced to close on account of [LA 620].” The Fifth Circuit panel ruled that, despite the precedent of WWH, LA 620 did not create an undue burden because of state-level differences in admitting privileges, demographics, and geography. They also found that only 30% of the 2 million women living in Louisiana would be impacted by the law, predominantly via longer wait times, and argued that this does not represent significant burden. The plaintiffs filed for an emergency stay with SCOTUS, who granted the stay pending a full hearing. On March 4, the Supreme Court will hear arguments to determine if the Fifth Circuit was correct in drawing a distinction between LA 620 and the SCOTUS verdict in WWH.

Targeted restrictions on abortion providers

LA 620 joins a long series of laws meant to enact targeted restrictions on abortion providers, or “TRAP” laws. TRAP laws are written to limit access to abortion under the guise of improving patient safety, despite ample evidence to the contrary, and include such various regulations as admitting privileges, facilities requirements, waiting periods, and parental or partner notification. Many such laws have been enacted in the last decade, and many struck down based on judicial precedent.

How the Supreme Court has ruled in the past

When a case is appealed to the Supreme Court, the court can either decline to hear the case, thereby leaving the lower courts’ ruling in place, or choose to hear the case in full and either affirm or overturn the lower court’s decision. After issuing a ruling in WWH, the 2016-2017 Roberts Court declined to hear challenges from other states with similarly overturned laws, leaving the laws struck down. In electing to hear June Medical Services v. Russo, the court has the opportunity to uphold or overturn the Fifth Circuit Court’s decision. However, today’s Supreme Court differs greatly from the Supreme Court in 2016.

In 2016, the court ruled 5-3 to overturn H.B. 2 in WWH shortly after the death of Justice Antonin Scalia. Scalia was replaced by Justice Neil Gorsuch, a Constitutional originalist who has never directly ruled on an abortion case.⁵ In 2018, Justice Anthony Kennedy, who authored the court’s majority opinion on Casey and was among the majority on WWH, retired, and was replaced by Justice Brett Kavanaugh. Kavanaugh has ruled once on the right to abortion in Garza v. Hargan in 2017, where he argued that precedent states that the government has “permissible interests in favoring fetal life…and refraining from facilitating abortion,” and that significant delay in care did not constitute undue burden.⁶ In regard to the 5-4 stay issued by the court in June Medical Services, Kavanaugh joined Gorsuch in voting to deny the application for stay, and was the only justice to issue an opinion alongside the ruling, arguing that because the doctors in question had not applied for and been denied admitting privileges since the WWH ruling, the case hinges on theoretical rather than demonstrable undue burden.⁷ Appointed by President Donald Trump, both Gorsuch and Kavanaugh are widely considered to be conservative judges, and while neither has a strong judicial record on abortion rights, both are anticipated to side with the conservative majority on the court.

The Supreme Court rarely overturns its own precedent, but concerns are high

The question of precedent will be central in SCOTUS hearing June Medical Services v. Russo so quickly after the WWH decision. Additionally, in hearing this case, the court will have the opportunity to reexamine all relevant precedent, including the Planned Parenthood of Southeastern Pennsylvania v. Casey decision and even Roe v. Wade. With a conservative court and an increasingly charged political environment, reproductive rights advocates fear that the June Medical Services v. Russo ruling may be the first step toward dismantling judicial protection of abortion rights in the United States.

If SCOTUS rules against June Medical Services, stating that admitting privileges do not cause an undue burden for women seeking to access abortion care, other states likely will introduce and enact similar legislation. These TRAP laws have the potential to limit or eliminate access to abortion for 25 million people of reproductive age. Numerous studies have demonstrated that limiting access to abortion care does not decrease the number of abortions but can result in patients using unsafe means to obtain an abortion.⁸

The medical community recognizes the danger of enacting restrictive legislation. The American College of Obstetricians and Gynecologists (ACOG), along with the American Medical Association, the Society of Maternal-Fetal Medicine, the Association for Sexual and Reproductive Medicine, the American Association of Family Practitioners, and many others, filed an amicus curiae in support of the June Medical Services plaintiffs.⁹ These brief filings are critical to ensuring the courts hear physician voices in this important legal decision, and ACOG’s briefs have been quoted in several previous Supreme Court opinions, concurrences, and dissents.
 

Action items

• Although June Medical Services v. Russo’s decision will not be made until early summer 2020, we can continue to use our voices and expertise to speak out against laws designed to limit access to abortion—at the state and federal levels. As women’s health clinicians, we see the impact abortion restrictions have on our patients, especially our low income and rural patients. Sharing these stories with our legislators, testifying for or against legislation, and speaking out in our communities can have a powerful impact. Check with your local ACOG chapter or with ACOG’s state and government affairs office for more information.
• Follow along with this case at SCOTUS Blog.
• Lastly, make sure you are registered to vote. We are in an election year, and using our voices in and out of the ballot box is critical. You can register here.

Population studies show high prevalence of chronic hepatitis C virus (HCV) infection among veterans, especially Vietnam War era veterans.^1,2 The development of safe and efficacious direct-acting antiviral (DAA) medications to treat HCV infection made the majority of those infected eligible for treatment. However, the large number of veterans needing DAA treatment stressed the resources of the US Department of Veterans Affairs (VA) health care system. This occurred while Congress was focused on reducing wait times for veterans receiving care at the VA.

Congress passed the Veterans Access, Choice, and Accountability Act (Choice) on August 7, 2014, leading to the creation of the Veterans Choice Program. Legislators felt there were inappropriate delays in care at the VA, and the Choice program was meant to address this problem and provide an “apples-to-apples comparison [of the VA] with non-VA hospitals.”³

Congress acknowledged the importance of curing HCV in the veteran population and allocated $1.5 billion for fiscal year (FY) 2016 for DAAs. The VA Central Office (VACO) carefully monitored these resources. The first policy memorandum from VACO for HCV care, issued on May 21, 2015, recommended that the sickest patients who will benefit from the treatment “receive priority over those who are less ill.”^4,5 Those who met criteria for advanced liver disease were prioritized for treatment at the VA, while those who did not meet criteria were given the option of receiving treatment through Choice, or waiting for a change in policy.⁶ Over time, revisions to the guidelines relaxed the criteria for VA treatment eligibility, and on February 24, 2016, all restrictions on HCV treatment at the VA were lifted.^7,8

The aim of this study was to provide a comparison of VA and non-VA care, specifically to determine whether care provided through Choice was timelier and more cost effective than care provided by the VA, and whether there was a quality difference. The high prevalence among veterans, well-established standards of care, and finite treatment course with clear indicators of success and failure makes HCV treatment an ideal disease with which to make this comparison.

Methods

We retrospectively analyzed the VA electronic health records of all veterans seen in the VA Loma Linda Healthcare System (VALLHCS) Hepatology clinic for chronic HCV infection during FY 2016 who were referred to Choice for HCV treatment. One hundred veterans met these criteria, encompassing the Choice population; 71 were seen at least once by a non-VA (Choice) health care provider (HCP) and 61 completed a treatment regimen through Choice. Treatment completion was defined as cessation of medication after the planned duration of therapy, or early termination of medication without resumption by that HCP. The Choice population was matched to an equal number of veterans who received HCV treatment from VALLHCS HCPs.

Data collected included age, gender, HCV genotype, determinants of liver fibrosis, and treatment success (defined as sustained virologic response at 12 weeks after the last dose of medication [SVR12]). Determinants of liver fibrosis included documented cirrhosis or complications of cirrhosis, Fibrosis-4 score (Fib-4), and platelet count.

Treatment failures were categorized as nonresponse (defined as detectable HCV viral load at the end of treatment), relapse (defined as an undetectable HCV viral load at the end of treatment with a subsequent positive test), and early termination (defined as a failure to complete the planned treatment regimen). Documented patient nonadherence, medical comorbidities that affected the treatment protocol, mental health diagnoses, and active social issues (defined as active or history of heavy alcohol use, active or history of illicit drug use, lack of social support, and homelessness) were noted.

Timeliness of delivery of care was measured in days. For the VA group, the wait time was defined as the date the consult for HCV treatment was placed to the date of the initial appointment with the HCV treatment provider. For the Choice group, the wait time was defined as the date the referral to the Choice program was made to the date of the initial appointment with the Choice HCP. Treatment regimens were evaluated for appropriateness based on guidelines from VACO and the American Association for the Study of Liver Diseases.^9-11

Tests performed by Choice providers were evaluated for whether they were relevant to HCV care and whether similar data already were available from VALLHCS. Tests that were not indicated were identified as unnecessary costs incurred by the Choice program, as were tests that had to be repeated at the VA because of a lack of documentation from the Choice provider. All medications given inappropriately were considered added costs. Medicare reimbursement rates for the most applicable Current Procedural Terminology (CPT) code and VA national contract pricing for medications were used for calculations. This study was approved by the VALLHCS institutional review board.

Statistical Analysis

IBM (Armonk, NY) Statistical Package for Social Sciences software was used to evaluate for differences in Fib-4, platelet count, prevalence of cirrhosis, prevalence of medical comorbidities, prevalence of mental health comorbidities, prevalence of the social issues defined in the Methods section, time from referral to time of appointment date, and SVR12 rate between the VA and Choice groups.

Exclusions

There were 15 veterans in the VA group who had a wait time of > 100 days. Of these, 5 (33%) were initially Choice referrals, but due to negative interactions with the Choice provider, the veterans returned to VALLHCS for care. Two of the 15 (13%) did not keep appointments and were lost to follow up. Six of the 15 (40%) had medical comorbidities that required more immediate attention, so HCV treatment initiation was deliberately moved back. The final 2 veterans scheduled their appointments unusually far apart, artificially increasing their wait time. Given that these were unique situations and some of the veterans received care from both Choice and VA providers, a decision was made to exclude these individuals from the study.

It has been shown that platelet count correlates with degree of liver fibrosis, a concept that is the basis for the Fib-4 scoring system.¹² Studies have shown that platelet count is a survival predictor in those with cirrhosis, and thrombocytopenia is a negative predictor of HCV treatment success using peginterferon and ribavirin.^13,14 Therefore, the VA memorandum automatically assigned the sickest individuals to the VA for HCV treatment. The goal of this study was to compare the impact of factors other than stage of fibrosis on HCV treatment success, which is why the 12 veterans with platelet count < 100,000 in the VA group were excluded. There were no veterans with platelet count < 100,000 in the Choice group.

When comparing SVR12 rates between the VA and Choice groups, every veteran treated at VALLHCS in FY 2016 was included, increasing the number in the VA group from 100 to 320 and therefore the power of this comparison.

Results

A summary of the statistical analysis can be found in Table 1. The genotype distribution was consistent with epidemiological studies, including those specific to veterans.^15,16 There were statistically significant differences (P < .001) in mean Fib-4 and mean platelet count. The VA group had a higher Fib-4 and lower platelet count. Seventy-four percent of the VA population was defined as cirrhotic, while only 3% of the Choice population met similar criteria (P < .001). The VA and Choice groups were similar in terms of age, gender, and genotype distribution (Table 2).

The VA group was found to have a higher prevalence of comorbidities that affected HCV treatment. These conditions included but were not limited to: chronic kidney disease that precluded the use of certain medications, any condition that required medication with a known interaction with DAAs (ie, proton pump inhibitors, statins, and amiodarone), and cirrhosis if it impacted the treatment regimen. The difference in the prevalence of mental health comorbidities was not significant (P = .39), but there was a higher prevalence of social issues among the VA group (P = .002).

The mean wait time from referral to appointment was 28.6 days for the VA group and 42.3 days for the Choice group (P < .001), indicating that a Choice referral took longer to complete than a referral within the VA for HCV treatment. Thirty of the 71 (42%) veterans seen by a Choice provider accrued extraneous cost, with a mean additional cost of $8,561.40 per veteran. In the Choice group, 61 veterans completed a treatment regimen with the Choice HCP. Fifty-five veterans completed treatment and had available SVR12 data (6 were lost to follow up without SVR12 testing) and 50 (91%) had confirmed SVR12. The charts of the 5 treatment failures were reviewed to discern the cause for failure. Two cases involved early termination of therapy, 3 involved relapse and 2 failed to comply with medication instructions. There was 1 case of the Choice HCP not addressing simultaneous use of ledipasvir and a proton pump inhibitor, potentially causing an interaction, and 1 case where both the VA and Choice providers failed to recognize indicators of cirrhosis, which impacted the regimen used.

In the VALLHCS group, records of 320 veterans who completed treatment and had SVR12 testing were reviewed. While the Choice memorandum was active, veterans selected to be treated at VALLHCS had advanced liver fibrosis or cirrhosis, medical and mental health comorbidities that increased the risk of treatment complications or were considered to have difficulty adhering to the medication regimen. For this group, 296 (93%) had confirmed SVR12. Eighteen of the 24 (75%) treatment failures were complicated by nonadherence, including all 13 cases of early termination. One patient died from complications of decompensated cirrhosis before completing treatment, and 1 did not receive HCV medications during a hospital admission due to poor coordination of care between the VA inpatient and outpatient pharmacy services, leading to multiple missed doses.

The difference in SVR12 rates (ie, treatment failure rates), between the VA and Choice groups was not statistically significant (P = .61). None of the specific reasons for treatment failure had a statistically significant difference between groups. A treatment failure analysis is shown in Table 3, and Table 4 indicates the breakdown of treatment regimens.

Discussion

The Veterans Health Administration (VHA) is the largest integrated health care system in the US, consisting of 152 medical centers and > 1,700 sites of care. The VA has the potential to meet the health care needs of 21.6 million veterans. About 9 million veterans are enrolled in the VA system and 5.9 million received health care through VHA.¹⁷ However, every medical service cannot realistically be made available at every facility, and some veterans have difficulty gaining access to VHA care; distance and wait times have been well-publicized issues that need further exploration.^18,19 The Choice program is an attempt to meet gaps in VA coverage using non-VA HCPs.

HCV infection is a specific diagnosis with national treatment guidelines and well-studied treatments; it can be cured, with an evidence-based definition of cure. The VACO policy memorandum to refer less sick veterans to Choice while treating sicker veterans at the VA provided the opportunity to directly compare the quality of the 2 programs. The SVR12 rates of VALLHCS and Choice providers were comparable to the national average at the time, and while the difference in SVR12 rate was not significant, VALLHCS treated a significantly higher number of patients with cirrhosis because of the referral criteria.²⁰

The significant difference in medical comorbidities between the VA and Choice groups was not surprising, partly because of the referral criteria. Cirrhosis can impact the treatment regimen, especially in regard to use of ribavirin. Since the presence of mental health comorbidities did not affect selection into the Choice group, it makes sense that there was no significant difference in prevalence between the groups.

VACO allowed veterans with HCV treatment plans that VA HCPs felt were too complicated for the Choice program to be treated by VHA HCPs.⁹ VALLHCS exercised this right for veterans at risk for nonadherence, because in HCV treatment, nonadherence leads to treatment failure and development of drug resistant virus strains. Therefore, veterans who would have difficulty traveling to VALLHCS to pick up medications, those who lacked means of communication (such as those who were homeless), and those who had active substance abuse were treated at the VA, where closer monitoring and immediate access to a wide range of services was possible. Studies have confirmed the impact of these types of issues on HCV treatment adherence and success.²¹ This explains the higher prevalence of social issues in the VA group.

For an internal referral for HCV treatment at VALLHCS, the hepatology provider submits a consult request to the HCV treatment provider, who works in the same office, making direct communication simple. The main administrative limiting factor to minimizing wait times is the number of HCPs, which is dependent on hiring allowances.

When a veteran is referred to Choice, the VA provider places a consult for non-VA care, which the VA Office of Community Care processes by compiling relevant documents and sending the package to Triwest Healthcare Alliance, a private insurance processor contracted with the VA. Triwest selects the Choice provider, often without any input from the VA, and arranges the veteran’s initial appointment.²² Geographic distance to the veteran’s address is the main selection criteria for Triwest. Documents sent between the Choice and VA HCPs go through the Office of Community Care and Triwest. This significantly increases the potential for delays and failed communication. Triwest had a comprehensive list of providers deemed to be qualified to treat HCV within the geographic catchment of VALLHCS. This list was reviewed, and all veterans referred to Choice had HCPs near their home address; therefore, availability of Choice HCPs was not an issue.

The VA can provide guidance on management of the veteran in the form of bundle packages containing a list of services for which the Choice provider is authorized to provide, and ones the Choice provider is not authorized to provide. Some Choice HCPs ordered tests that were not authorized for HCV treatment such as esophagogastroduodenoscopy, colonoscopy, and liver biopsy. In all, 17 of 71 (24%) veterans seen by Choice HCPs had tests performed or ordered that VA HCPs would not have obtained for the purpose of HCV treatment (Table 5).

In order to prevent veterans from receiving unnecessary tests, a VALLHCS hepatologist asked to be notified by VA administrators overseeing Choice referrals whenever a secondary authorization request (SAR) was submitted by a Choice HCP. This strategy is not standard VA practice, therefore at many VA sites these requested tests would have been performed by the Choice HCP, which is why SARs were factored into cost analysis.

SVR12 test results that were drawn too early and had to be repeated at VALLHCS were a cost unique to the Choice program. Duplicate tests, particularly imaging studies and blood work, were extraneous costs. The largest extraneous costs were treatment regimens prescribed by Choice HCPs that did not follow standard of care and required VA provider intervention. Thirty of the 71 (42%) veterans seen by a Choice provider accrued a mean $8,561.40 in extra costs. As a result, the Choice program cost VHA $250,000 more to provide care for 30 veterans (enough to pay for a physician’s annual salary).

Some inappropriate treatment regimens were the result of Choice HCP error, such as 1 case in which a veteran was inadvertently switched from ledipasvir/sofosbuvir to ombitasvir/paritaprevir/ritonavir/dasabuvir after week 4. The veteran had to start therapy over but still achieved SVR12. Other cases saw veterans receive regimens for which they had clear contraindications, such as creatinine clearance < 30 mL/min/1.73m² for sofosbuvir or a positive resistance panel for specific medications. Eleven of 62 (18%) veterans who were started on HCV treatment by a Choice HCP received a regimen not consistent with VA guidelines—an alarming result.

Follow up for veterans referred to Choice was extremely labor intensive, and assessment of personnel requirements in a Choice-based VA system must take this into consideration. The Choice HCP has no obligation to communicate with the VA HCP. At the time of chart review, 57 of 71 (80%) Choice veterans had inadequate documentation to make a confident assessment of the treatment outcome. Multiple calls to the offices of the Choice HCP were needed to acquire records, and veterans had to be tracked down for additional tests. Veterans often would complete treatment and stop following up with the Choice provider before SVR12 confirmation. The VA hepatology provider reviewing Choice referrals served as clinician, case manager, and clerk in order to get veterans to an appropriate end point in their hepatitis C treatment, with mostly unmeasured hours of work.

Limitations

The study population size was limited by the number of veterans able to complete treatment through Choice. The parameters in the VACO policy memos automatically selected the VA and Choice groups but made them clinically distinct populations. New treatment medications were released during the study period, which impacted management strategy. Occasionally, VA and non-VA HCPs preferred different treatment regimens, leading to variation in the distribution of regimens used despite similar genotype distribution (Tables 2 and 4). In addition, a retrospective study is at risk for recall bias. A prospective study randomizing veterans to the Choice and VA groups is an important future endeavor. Comparing veteran satisfaction for Choice and VA services is also crucial.

Conclusions

This study demonstrates that the VA was able to provide more cost-effective and more timely care for HCV treatment to a relatively sicker population with no reduction in treatment success when compared with non-VA HCPs through the Choice program. While the Choice program can help veterans receive services they may otherwise not have access to and reduce travel time, the current system introduces inefficiencies that delay care and decrease cost-effectiveness. The Choice HCP selection process is based on proximity rather than quality, which may place the veteran at risk for receiving substandard care. Large-scale quality of care studies that compare efficiency measures, clinical outcomes, patient demographics, travel distance, cost efficacy and patient satisfaction for veterans receiving similar services at a VA facility and through Choice should be performed to ensure that veterans receive the best care available.

Population studies show high prevalence of chronic hepatitis C virus (HCV) infection among veterans, especially Vietnam War era veterans.^1,2 The development of safe and efficacious direct-acting antiviral (DAA) medications to treat HCV infection made the majority of those infected eligible for treatment. However, the large number of veterans needing DAA treatment stressed the resources of the US Department of Veterans Affairs (VA) health care system. This occurred while Congress was focused on reducing wait times for veterans receiving care at the VA.

Congress passed the Veterans Access, Choice, and Accountability Act (Choice) on August 7, 2014, leading to the creation of the Veterans Choice Program. Legislators felt there were inappropriate delays in care at the VA, and the Choice program was meant to address this problem and provide an “apples-to-apples comparison [of the VA] with non-VA hospitals.”³

Congress acknowledged the importance of curing HCV in the veteran population and allocated $1.5 billion for fiscal year (FY) 2016 for DAAs. The VA Central Office (VACO) carefully monitored these resources. The first policy memorandum from VACO for HCV care, issued on May 21, 2015, recommended that the sickest patients who will benefit from the treatment “receive priority over those who are less ill.”^4,5 Those who met criteria for advanced liver disease were prioritized for treatment at the VA, while those who did not meet criteria were given the option of receiving treatment through Choice, or waiting for a change in policy.⁶ Over time, revisions to the guidelines relaxed the criteria for VA treatment eligibility, and on February 24, 2016, all restrictions on HCV treatment at the VA were lifted.^7,8

The aim of this study was to provide a comparison of VA and non-VA care, specifically to determine whether care provided through Choice was timelier and more cost effective than care provided by the VA, and whether there was a quality difference. The high prevalence among veterans, well-established standards of care, and finite treatment course with clear indicators of success and failure makes HCV treatment an ideal disease with which to make this comparison.

Methods

We retrospectively analyzed the VA electronic health records of all veterans seen in the VA Loma Linda Healthcare System (VALLHCS) Hepatology clinic for chronic HCV infection during FY 2016 who were referred to Choice for HCV treatment. One hundred veterans met these criteria, encompassing the Choice population; 71 were seen at least once by a non-VA (Choice) health care provider (HCP) and 61 completed a treatment regimen through Choice. Treatment completion was defined as cessation of medication after the planned duration of therapy, or early termination of medication without resumption by that HCP. The Choice population was matched to an equal number of veterans who received HCV treatment from VALLHCS HCPs.

Data collected included age, gender, HCV genotype, determinants of liver fibrosis, and treatment success (defined as sustained virologic response at 12 weeks after the last dose of medication [SVR12]). Determinants of liver fibrosis included documented cirrhosis or complications of cirrhosis, Fibrosis-4 score (Fib-4), and platelet count.

Treatment failures were categorized as nonresponse (defined as detectable HCV viral load at the end of treatment), relapse (defined as an undetectable HCV viral load at the end of treatment with a subsequent positive test), and early termination (defined as a failure to complete the planned treatment regimen). Documented patient nonadherence, medical comorbidities that affected the treatment protocol, mental health diagnoses, and active social issues (defined as active or history of heavy alcohol use, active or history of illicit drug use, lack of social support, and homelessness) were noted.

Timeliness of delivery of care was measured in days. For the VA group, the wait time was defined as the date the consult for HCV treatment was placed to the date of the initial appointment with the HCV treatment provider. For the Choice group, the wait time was defined as the date the referral to the Choice program was made to the date of the initial appointment with the Choice HCP. Treatment regimens were evaluated for appropriateness based on guidelines from VACO and the American Association for the Study of Liver Diseases.^9-11

Tests performed by Choice providers were evaluated for whether they were relevant to HCV care and whether similar data already were available from VALLHCS. Tests that were not indicated were identified as unnecessary costs incurred by the Choice program, as were tests that had to be repeated at the VA because of a lack of documentation from the Choice provider. All medications given inappropriately were considered added costs. Medicare reimbursement rates for the most applicable Current Procedural Terminology (CPT) code and VA national contract pricing for medications were used for calculations. This study was approved by the VALLHCS institutional review board.

Statistical Analysis

IBM (Armonk, NY) Statistical Package for Social Sciences software was used to evaluate for differences in Fib-4, platelet count, prevalence of cirrhosis, prevalence of medical comorbidities, prevalence of mental health comorbidities, prevalence of the social issues defined in the Methods section, time from referral to time of appointment date, and SVR12 rate between the VA and Choice groups.

Exclusions

There were 15 veterans in the VA group who had a wait time of > 100 days. Of these, 5 (33%) were initially Choice referrals, but due to negative interactions with the Choice provider, the veterans returned to VALLHCS for care. Two of the 15 (13%) did not keep appointments and were lost to follow up. Six of the 15 (40%) had medical comorbidities that required more immediate attention, so HCV treatment initiation was deliberately moved back. The final 2 veterans scheduled their appointments unusually far apart, artificially increasing their wait time. Given that these were unique situations and some of the veterans received care from both Choice and VA providers, a decision was made to exclude these individuals from the study.

It has been shown that platelet count correlates with degree of liver fibrosis, a concept that is the basis for the Fib-4 scoring system.¹² Studies have shown that platelet count is a survival predictor in those with cirrhosis, and thrombocytopenia is a negative predictor of HCV treatment success using peginterferon and ribavirin.^13,14 Therefore, the VA memorandum automatically assigned the sickest individuals to the VA for HCV treatment. The goal of this study was to compare the impact of factors other than stage of fibrosis on HCV treatment success, which is why the 12 veterans with platelet count < 100,000 in the VA group were excluded. There were no veterans with platelet count < 100,000 in the Choice group.

When comparing SVR12 rates between the VA and Choice groups, every veteran treated at VALLHCS in FY 2016 was included, increasing the number in the VA group from 100 to 320 and therefore the power of this comparison.

Results

A summary of the statistical analysis can be found in Table 1. The genotype distribution was consistent with epidemiological studies, including those specific to veterans.^15,16 There were statistically significant differences (P < .001) in mean Fib-4 and mean platelet count. The VA group had a higher Fib-4 and lower platelet count. Seventy-four percent of the VA population was defined as cirrhotic, while only 3% of the Choice population met similar criteria (P < .001). The VA and Choice groups were similar in terms of age, gender, and genotype distribution (Table 2).

The VA group was found to have a higher prevalence of comorbidities that affected HCV treatment. These conditions included but were not limited to: chronic kidney disease that precluded the use of certain medications, any condition that required medication with a known interaction with DAAs (ie, proton pump inhibitors, statins, and amiodarone), and cirrhosis if it impacted the treatment regimen. The difference in the prevalence of mental health comorbidities was not significant (P = .39), but there was a higher prevalence of social issues among the VA group (P = .002).

The mean wait time from referral to appointment was 28.6 days for the VA group and 42.3 days for the Choice group (P < .001), indicating that a Choice referral took longer to complete than a referral within the VA for HCV treatment. Thirty of the 71 (42%) veterans seen by a Choice provider accrued extraneous cost, with a mean additional cost of $8,561.40 per veteran. In the Choice group, 61 veterans completed a treatment regimen with the Choice HCP. Fifty-five veterans completed treatment and had available SVR12 data (6 were lost to follow up without SVR12 testing) and 50 (91%) had confirmed SVR12. The charts of the 5 treatment failures were reviewed to discern the cause for failure. Two cases involved early termination of therapy, 3 involved relapse and 2 failed to comply with medication instructions. There was 1 case of the Choice HCP not addressing simultaneous use of ledipasvir and a proton pump inhibitor, potentially causing an interaction, and 1 case where both the VA and Choice providers failed to recognize indicators of cirrhosis, which impacted the regimen used.

In the VALLHCS group, records of 320 veterans who completed treatment and had SVR12 testing were reviewed. While the Choice memorandum was active, veterans selected to be treated at VALLHCS had advanced liver fibrosis or cirrhosis, medical and mental health comorbidities that increased the risk of treatment complications or were considered to have difficulty adhering to the medication regimen. For this group, 296 (93%) had confirmed SVR12. Eighteen of the 24 (75%) treatment failures were complicated by nonadherence, including all 13 cases of early termination. One patient died from complications of decompensated cirrhosis before completing treatment, and 1 did not receive HCV medications during a hospital admission due to poor coordination of care between the VA inpatient and outpatient pharmacy services, leading to multiple missed doses.

The difference in SVR12 rates (ie, treatment failure rates), between the VA and Choice groups was not statistically significant (P = .61). None of the specific reasons for treatment failure had a statistically significant difference between groups. A treatment failure analysis is shown in Table 3, and Table 4 indicates the breakdown of treatment regimens.

Discussion

The Veterans Health Administration (VHA) is the largest integrated health care system in the US, consisting of 152 medical centers and > 1,700 sites of care. The VA has the potential to meet the health care needs of 21.6 million veterans. About 9 million veterans are enrolled in the VA system and 5.9 million received health care through VHA.¹⁷ However, every medical service cannot realistically be made available at every facility, and some veterans have difficulty gaining access to VHA care; distance and wait times have been well-publicized issues that need further exploration.^18,19 The Choice program is an attempt to meet gaps in VA coverage using non-VA HCPs.

HCV infection is a specific diagnosis with national treatment guidelines and well-studied treatments; it can be cured, with an evidence-based definition of cure. The VACO policy memorandum to refer less sick veterans to Choice while treating sicker veterans at the VA provided the opportunity to directly compare the quality of the 2 programs. The SVR12 rates of VALLHCS and Choice providers were comparable to the national average at the time, and while the difference in SVR12 rate was not significant, VALLHCS treated a significantly higher number of patients with cirrhosis because of the referral criteria.²⁰

The significant difference in medical comorbidities between the VA and Choice groups was not surprising, partly because of the referral criteria. Cirrhosis can impact the treatment regimen, especially in regard to use of ribavirin. Since the presence of mental health comorbidities did not affect selection into the Choice group, it makes sense that there was no significant difference in prevalence between the groups.

VACO allowed veterans with HCV treatment plans that VA HCPs felt were too complicated for the Choice program to be treated by VHA HCPs.⁹ VALLHCS exercised this right for veterans at risk for nonadherence, because in HCV treatment, nonadherence leads to treatment failure and development of drug resistant virus strains. Therefore, veterans who would have difficulty traveling to VALLHCS to pick up medications, those who lacked means of communication (such as those who were homeless), and those who had active substance abuse were treated at the VA, where closer monitoring and immediate access to a wide range of services was possible. Studies have confirmed the impact of these types of issues on HCV treatment adherence and success.²¹ This explains the higher prevalence of social issues in the VA group.

For an internal referral for HCV treatment at VALLHCS, the hepatology provider submits a consult request to the HCV treatment provider, who works in the same office, making direct communication simple. The main administrative limiting factor to minimizing wait times is the number of HCPs, which is dependent on hiring allowances.

When a veteran is referred to Choice, the VA provider places a consult for non-VA care, which the VA Office of Community Care processes by compiling relevant documents and sending the package to Triwest Healthcare Alliance, a private insurance processor contracted with the VA. Triwest selects the Choice provider, often without any input from the VA, and arranges the veteran’s initial appointment.²² Geographic distance to the veteran’s address is the main selection criteria for Triwest. Documents sent between the Choice and VA HCPs go through the Office of Community Care and Triwest. This significantly increases the potential for delays and failed communication. Triwest had a comprehensive list of providers deemed to be qualified to treat HCV within the geographic catchment of VALLHCS. This list was reviewed, and all veterans referred to Choice had HCPs near their home address; therefore, availability of Choice HCPs was not an issue.

The VA can provide guidance on management of the veteran in the form of bundle packages containing a list of services for which the Choice provider is authorized to provide, and ones the Choice provider is not authorized to provide. Some Choice HCPs ordered tests that were not authorized for HCV treatment such as esophagogastroduodenoscopy, colonoscopy, and liver biopsy. In all, 17 of 71 (24%) veterans seen by Choice HCPs had tests performed or ordered that VA HCPs would not have obtained for the purpose of HCV treatment (Table 5).

In order to prevent veterans from receiving unnecessary tests, a VALLHCS hepatologist asked to be notified by VA administrators overseeing Choice referrals whenever a secondary authorization request (SAR) was submitted by a Choice HCP. This strategy is not standard VA practice, therefore at many VA sites these requested tests would have been performed by the Choice HCP, which is why SARs were factored into cost analysis.

SVR12 test results that were drawn too early and had to be repeated at VALLHCS were a cost unique to the Choice program. Duplicate tests, particularly imaging studies and blood work, were extraneous costs. The largest extraneous costs were treatment regimens prescribed by Choice HCPs that did not follow standard of care and required VA provider intervention. Thirty of the 71 (42%) veterans seen by a Choice provider accrued a mean $8,561.40 in extra costs. As a result, the Choice program cost VHA $250,000 more to provide care for 30 veterans (enough to pay for a physician’s annual salary).

Some inappropriate treatment regimens were the result of Choice HCP error, such as 1 case in which a veteran was inadvertently switched from ledipasvir/sofosbuvir to ombitasvir/paritaprevir/ritonavir/dasabuvir after week 4. The veteran had to start therapy over but still achieved SVR12. Other cases saw veterans receive regimens for which they had clear contraindications, such as creatinine clearance < 30 mL/min/1.73m² for sofosbuvir or a positive resistance panel for specific medications. Eleven of 62 (18%) veterans who were started on HCV treatment by a Choice HCP received a regimen not consistent with VA guidelines—an alarming result.

Follow up for veterans referred to Choice was extremely labor intensive, and assessment of personnel requirements in a Choice-based VA system must take this into consideration. The Choice HCP has no obligation to communicate with the VA HCP. At the time of chart review, 57 of 71 (80%) Choice veterans had inadequate documentation to make a confident assessment of the treatment outcome. Multiple calls to the offices of the Choice HCP were needed to acquire records, and veterans had to be tracked down for additional tests. Veterans often would complete treatment and stop following up with the Choice provider before SVR12 confirmation. The VA hepatology provider reviewing Choice referrals served as clinician, case manager, and clerk in order to get veterans to an appropriate end point in their hepatitis C treatment, with mostly unmeasured hours of work.

Limitations

The study population size was limited by the number of veterans able to complete treatment through Choice. The parameters in the VACO policy memos automatically selected the VA and Choice groups but made them clinically distinct populations. New treatment medications were released during the study period, which impacted management strategy. Occasionally, VA and non-VA HCPs preferred different treatment regimens, leading to variation in the distribution of regimens used despite similar genotype distribution (Tables 2 and 4). In addition, a retrospective study is at risk for recall bias. A prospective study randomizing veterans to the Choice and VA groups is an important future endeavor. Comparing veteran satisfaction for Choice and VA services is also crucial.

Conclusions

This study demonstrates that the VA was able to provide more cost-effective and more timely care for HCV treatment to a relatively sicker population with no reduction in treatment success when compared with non-VA HCPs through the Choice program. While the Choice program can help veterans receive services they may otherwise not have access to and reduce travel time, the current system introduces inefficiencies that delay care and decrease cost-effectiveness. The Choice HCP selection process is based on proximity rather than quality, which may place the veteran at risk for receiving substandard care. Large-scale quality of care studies that compare efficiency measures, clinical outcomes, patient demographics, travel distance, cost efficacy and patient satisfaction for veterans receiving similar services at a VA facility and through Choice should be performed to ensure that veterans receive the best care available.

Population studies show high prevalence of chronic hepatitis C virus (HCV) infection among veterans, especially Vietnam War era veterans.^1,2 The development of safe and efficacious direct-acting antiviral (DAA) medications to treat HCV infection made the majority of those infected eligible for treatment. However, the large number of veterans needing DAA treatment stressed the resources of the US Department of Veterans Affairs (VA) health care system. This occurred while Congress was focused on reducing wait times for veterans receiving care at the VA.

Congress passed the Veterans Access, Choice, and Accountability Act (Choice) on August 7, 2014, leading to the creation of the Veterans Choice Program. Legislators felt there were inappropriate delays in care at the VA, and the Choice program was meant to address this problem and provide an “apples-to-apples comparison [of the VA] with non-VA hospitals.”³

Congress acknowledged the importance of curing HCV in the veteran population and allocated $1.5 billion for fiscal year (FY) 2016 for DAAs. The VA Central Office (VACO) carefully monitored these resources. The first policy memorandum from VACO for HCV care, issued on May 21, 2015, recommended that the sickest patients who will benefit from the treatment “receive priority over those who are less ill.”^4,5 Those who met criteria for advanced liver disease were prioritized for treatment at the VA, while those who did not meet criteria were given the option of receiving treatment through Choice, or waiting for a change in policy.⁶ Over time, revisions to the guidelines relaxed the criteria for VA treatment eligibility, and on February 24, 2016, all restrictions on HCV treatment at the VA were lifted.^7,8

The aim of this study was to provide a comparison of VA and non-VA care, specifically to determine whether care provided through Choice was timelier and more cost effective than care provided by the VA, and whether there was a quality difference. The high prevalence among veterans, well-established standards of care, and finite treatment course with clear indicators of success and failure makes HCV treatment an ideal disease with which to make this comparison.

Methods

We retrospectively analyzed the VA electronic health records of all veterans seen in the VA Loma Linda Healthcare System (VALLHCS) Hepatology clinic for chronic HCV infection during FY 2016 who were referred to Choice for HCV treatment. One hundred veterans met these criteria, encompassing the Choice population; 71 were seen at least once by a non-VA (Choice) health care provider (HCP) and 61 completed a treatment regimen through Choice. Treatment completion was defined as cessation of medication after the planned duration of therapy, or early termination of medication without resumption by that HCP. The Choice population was matched to an equal number of veterans who received HCV treatment from VALLHCS HCPs.

Data collected included age, gender, HCV genotype, determinants of liver fibrosis, and treatment success (defined as sustained virologic response at 12 weeks after the last dose of medication [SVR12]). Determinants of liver fibrosis included documented cirrhosis or complications of cirrhosis, Fibrosis-4 score (Fib-4), and platelet count.

Treatment failures were categorized as nonresponse (defined as detectable HCV viral load at the end of treatment), relapse (defined as an undetectable HCV viral load at the end of treatment with a subsequent positive test), and early termination (defined as a failure to complete the planned treatment regimen). Documented patient nonadherence, medical comorbidities that affected the treatment protocol, mental health diagnoses, and active social issues (defined as active or history of heavy alcohol use, active or history of illicit drug use, lack of social support, and homelessness) were noted.

Timeliness of delivery of care was measured in days. For the VA group, the wait time was defined as the date the consult for HCV treatment was placed to the date of the initial appointment with the HCV treatment provider. For the Choice group, the wait time was defined as the date the referral to the Choice program was made to the date of the initial appointment with the Choice HCP. Treatment regimens were evaluated for appropriateness based on guidelines from VACO and the American Association for the Study of Liver Diseases.^9-11

Tests performed by Choice providers were evaluated for whether they were relevant to HCV care and whether similar data already were available from VALLHCS. Tests that were not indicated were identified as unnecessary costs incurred by the Choice program, as were tests that had to be repeated at the VA because of a lack of documentation from the Choice provider. All medications given inappropriately were considered added costs. Medicare reimbursement rates for the most applicable Current Procedural Terminology (CPT) code and VA national contract pricing for medications were used for calculations. This study was approved by the VALLHCS institutional review board.

Statistical Analysis

IBM (Armonk, NY) Statistical Package for Social Sciences software was used to evaluate for differences in Fib-4, platelet count, prevalence of cirrhosis, prevalence of medical comorbidities, prevalence of mental health comorbidities, prevalence of the social issues defined in the Methods section, time from referral to time of appointment date, and SVR12 rate between the VA and Choice groups.

Exclusions

There were 15 veterans in the VA group who had a wait time of > 100 days. Of these, 5 (33%) were initially Choice referrals, but due to negative interactions with the Choice provider, the veterans returned to VALLHCS for care. Two of the 15 (13%) did not keep appointments and were lost to follow up. Six of the 15 (40%) had medical comorbidities that required more immediate attention, so HCV treatment initiation was deliberately moved back. The final 2 veterans scheduled their appointments unusually far apart, artificially increasing their wait time. Given that these were unique situations and some of the veterans received care from both Choice and VA providers, a decision was made to exclude these individuals from the study.

It has been shown that platelet count correlates with degree of liver fibrosis, a concept that is the basis for the Fib-4 scoring system.¹² Studies have shown that platelet count is a survival predictor in those with cirrhosis, and thrombocytopenia is a negative predictor of HCV treatment success using peginterferon and ribavirin.^13,14 Therefore, the VA memorandum automatically assigned the sickest individuals to the VA for HCV treatment. The goal of this study was to compare the impact of factors other than stage of fibrosis on HCV treatment success, which is why the 12 veterans with platelet count < 100,000 in the VA group were excluded. There were no veterans with platelet count < 100,000 in the Choice group.

When comparing SVR12 rates between the VA and Choice groups, every veteran treated at VALLHCS in FY 2016 was included, increasing the number in the VA group from 100 to 320 and therefore the power of this comparison.

Results

A summary of the statistical analysis can be found in Table 1. The genotype distribution was consistent with epidemiological studies, including those specific to veterans.^15,16 There were statistically significant differences (P < .001) in mean Fib-4 and mean platelet count. The VA group had a higher Fib-4 and lower platelet count. Seventy-four percent of the VA population was defined as cirrhotic, while only 3% of the Choice population met similar criteria (P < .001). The VA and Choice groups were similar in terms of age, gender, and genotype distribution (Table 2).

The VA group was found to have a higher prevalence of comorbidities that affected HCV treatment. These conditions included but were not limited to: chronic kidney disease that precluded the use of certain medications, any condition that required medication with a known interaction with DAAs (ie, proton pump inhibitors, statins, and amiodarone), and cirrhosis if it impacted the treatment regimen. The difference in the prevalence of mental health comorbidities was not significant (P = .39), but there was a higher prevalence of social issues among the VA group (P = .002).

The mean wait time from referral to appointment was 28.6 days for the VA group and 42.3 days for the Choice group (P < .001), indicating that a Choice referral took longer to complete than a referral within the VA for HCV treatment. Thirty of the 71 (42%) veterans seen by a Choice provider accrued extraneous cost, with a mean additional cost of $8,561.40 per veteran. In the Choice group, 61 veterans completed a treatment regimen with the Choice HCP. Fifty-five veterans completed treatment and had available SVR12 data (6 were lost to follow up without SVR12 testing) and 50 (91%) had confirmed SVR12. The charts of the 5 treatment failures were reviewed to discern the cause for failure. Two cases involved early termination of therapy, 3 involved relapse and 2 failed to comply with medication instructions. There was 1 case of the Choice HCP not addressing simultaneous use of ledipasvir and a proton pump inhibitor, potentially causing an interaction, and 1 case where both the VA and Choice providers failed to recognize indicators of cirrhosis, which impacted the regimen used.

In the VALLHCS group, records of 320 veterans who completed treatment and had SVR12 testing were reviewed. While the Choice memorandum was active, veterans selected to be treated at VALLHCS had advanced liver fibrosis or cirrhosis, medical and mental health comorbidities that increased the risk of treatment complications or were considered to have difficulty adhering to the medication regimen. For this group, 296 (93%) had confirmed SVR12. Eighteen of the 24 (75%) treatment failures were complicated by nonadherence, including all 13 cases of early termination. One patient died from complications of decompensated cirrhosis before completing treatment, and 1 did not receive HCV medications during a hospital admission due to poor coordination of care between the VA inpatient and outpatient pharmacy services, leading to multiple missed doses.

The difference in SVR12 rates (ie, treatment failure rates), between the VA and Choice groups was not statistically significant (P = .61). None of the specific reasons for treatment failure had a statistically significant difference between groups. A treatment failure analysis is shown in Table 3, and Table 4 indicates the breakdown of treatment regimens.

Discussion

The Veterans Health Administration (VHA) is the largest integrated health care system in the US, consisting of 152 medical centers and > 1,700 sites of care. The VA has the potential to meet the health care needs of 21.6 million veterans. About 9 million veterans are enrolled in the VA system and 5.9 million received health care through VHA.¹⁷ However, every medical service cannot realistically be made available at every facility, and some veterans have difficulty gaining access to VHA care; distance and wait times have been well-publicized issues that need further exploration.^18,19 The Choice program is an attempt to meet gaps in VA coverage using non-VA HCPs.

HCV infection is a specific diagnosis with national treatment guidelines and well-studied treatments; it can be cured, with an evidence-based definition of cure. The VACO policy memorandum to refer less sick veterans to Choice while treating sicker veterans at the VA provided the opportunity to directly compare the quality of the 2 programs. The SVR12 rates of VALLHCS and Choice providers were comparable to the national average at the time, and while the difference in SVR12 rate was not significant, VALLHCS treated a significantly higher number of patients with cirrhosis because of the referral criteria.²⁰

The significant difference in medical comorbidities between the VA and Choice groups was not surprising, partly because of the referral criteria. Cirrhosis can impact the treatment regimen, especially in regard to use of ribavirin. Since the presence of mental health comorbidities did not affect selection into the Choice group, it makes sense that there was no significant difference in prevalence between the groups.

VACO allowed veterans with HCV treatment plans that VA HCPs felt were too complicated for the Choice program to be treated by VHA HCPs.⁹ VALLHCS exercised this right for veterans at risk for nonadherence, because in HCV treatment, nonadherence leads to treatment failure and development of drug resistant virus strains. Therefore, veterans who would have difficulty traveling to VALLHCS to pick up medications, those who lacked means of communication (such as those who were homeless), and those who had active substance abuse were treated at the VA, where closer monitoring and immediate access to a wide range of services was possible. Studies have confirmed the impact of these types of issues on HCV treatment adherence and success.²¹ This explains the higher prevalence of social issues in the VA group.

For an internal referral for HCV treatment at VALLHCS, the hepatology provider submits a consult request to the HCV treatment provider, who works in the same office, making direct communication simple. The main administrative limiting factor to minimizing wait times is the number of HCPs, which is dependent on hiring allowances.

When a veteran is referred to Choice, the VA provider places a consult for non-VA care, which the VA Office of Community Care processes by compiling relevant documents and sending the package to Triwest Healthcare Alliance, a private insurance processor contracted with the VA. Triwest selects the Choice provider, often without any input from the VA, and arranges the veteran’s initial appointment.²² Geographic distance to the veteran’s address is the main selection criteria for Triwest. Documents sent between the Choice and VA HCPs go through the Office of Community Care and Triwest. This significantly increases the potential for delays and failed communication. Triwest had a comprehensive list of providers deemed to be qualified to treat HCV within the geographic catchment of VALLHCS. This list was reviewed, and all veterans referred to Choice had HCPs near their home address; therefore, availability of Choice HCPs was not an issue.

The VA can provide guidance on management of the veteran in the form of bundle packages containing a list of services for which the Choice provider is authorized to provide, and ones the Choice provider is not authorized to provide. Some Choice HCPs ordered tests that were not authorized for HCV treatment such as esophagogastroduodenoscopy, colonoscopy, and liver biopsy. In all, 17 of 71 (24%) veterans seen by Choice HCPs had tests performed or ordered that VA HCPs would not have obtained for the purpose of HCV treatment (Table 5).

In order to prevent veterans from receiving unnecessary tests, a VALLHCS hepatologist asked to be notified by VA administrators overseeing Choice referrals whenever a secondary authorization request (SAR) was submitted by a Choice HCP. This strategy is not standard VA practice, therefore at many VA sites these requested tests would have been performed by the Choice HCP, which is why SARs were factored into cost analysis.

SVR12 test results that were drawn too early and had to be repeated at VALLHCS were a cost unique to the Choice program. Duplicate tests, particularly imaging studies and blood work, were extraneous costs. The largest extraneous costs were treatment regimens prescribed by Choice HCPs that did not follow standard of care and required VA provider intervention. Thirty of the 71 (42%) veterans seen by a Choice provider accrued a mean $8,561.40 in extra costs. As a result, the Choice program cost VHA $250,000 more to provide care for 30 veterans (enough to pay for a physician’s annual salary).

Some inappropriate treatment regimens were the result of Choice HCP error, such as 1 case in which a veteran was inadvertently switched from ledipasvir/sofosbuvir to ombitasvir/paritaprevir/ritonavir/dasabuvir after week 4. The veteran had to start therapy over but still achieved SVR12. Other cases saw veterans receive regimens for which they had clear contraindications, such as creatinine clearance < 30 mL/min/1.73m² for sofosbuvir or a positive resistance panel for specific medications. Eleven of 62 (18%) veterans who were started on HCV treatment by a Choice HCP received a regimen not consistent with VA guidelines—an alarming result.

Follow up for veterans referred to Choice was extremely labor intensive, and assessment of personnel requirements in a Choice-based VA system must take this into consideration. The Choice HCP has no obligation to communicate with the VA HCP. At the time of chart review, 57 of 71 (80%) Choice veterans had inadequate documentation to make a confident assessment of the treatment outcome. Multiple calls to the offices of the Choice HCP were needed to acquire records, and veterans had to be tracked down for additional tests. Veterans often would complete treatment and stop following up with the Choice provider before SVR12 confirmation. The VA hepatology provider reviewing Choice referrals served as clinician, case manager, and clerk in order to get veterans to an appropriate end point in their hepatitis C treatment, with mostly unmeasured hours of work.

Limitations

The study population size was limited by the number of veterans able to complete treatment through Choice. The parameters in the VACO policy memos automatically selected the VA and Choice groups but made them clinically distinct populations. New treatment medications were released during the study period, which impacted management strategy. Occasionally, VA and non-VA HCPs preferred different treatment regimens, leading to variation in the distribution of regimens used despite similar genotype distribution (Tables 2 and 4). In addition, a retrospective study is at risk for recall bias. A prospective study randomizing veterans to the Choice and VA groups is an important future endeavor. Comparing veteran satisfaction for Choice and VA services is also crucial.

Conclusions

This study demonstrates that the VA was able to provide more cost-effective and more timely care for HCV treatment to a relatively sicker population with no reduction in treatment success when compared with non-VA HCPs through the Choice program. While the Choice program can help veterans receive services they may otherwise not have access to and reduce travel time, the current system introduces inefficiencies that delay care and decrease cost-effectiveness. The Choice HCP selection process is based on proximity rather than quality, which may place the veteran at risk for receiving substandard care. Large-scale quality of care studies that compare efficiency measures, clinical outcomes, patient demographics, travel distance, cost efficacy and patient satisfaction for veterans receiving similar services at a VA facility and through Choice should be performed to ensure that veterans receive the best care available.

The Trump administration on Feb. 10 argued for cutting spending for a federal agency at the forefront of the efforts to combat the coronavirus, while also seeking to slow spending in certain parts of the Medicare and Medicaid programs.

President Donald Trump presented his fiscal 2021 request to Congress for refilling the coffers of federal agencies. In any administration, an annual budget serves only as a political blueprint, as the White House document itself makes no changes in federal spending.

In Mr. Trump’s case, several of his requests for agencies within the Department of Health & Human Services run counter to recent budget trends. Republicans and Democrats in Congress have worked together in recent years to increase budgets for major federal health agencies.

But Mr. Trump asked Congress to cut annual budget authority for the National Institute of Allergy and Infectious Diseases by $430 million to $5.446 billion for fiscal 2021. In contrast, Congress has raised the annual budget for NIAID, a key agency in combating the coronavirus, from $5.545 billion in fiscal 2019 to $5.876 billion in fiscal 2020, which began in October, according to an HHS summary of Mr. Trump’s request.

For the Centers for Disease Control and Prevention, which is central to the battle against the coronavirus, Mr. Trump proposed a drop in discretionary funding to $5.627 billion. In contrast, Congress raised the CDC budget from $6.544 billion in fiscal 2019 to $6.917 in fiscal 2020.

Mr. Trump also wants to cut $559 million from the budget of the National Cancer Institute, dropping it to $5.881 billion in fiscal 2021. In contrast, Congress raised NCI’s budget from $6.121 billion in fiscal 2019 to $6.440 billion in fiscal 2020.

Mr. Trump requested a $2.6 billion reduction in the National Institutes of Health’s total discretionary budget, seeking to drop it to $37.70 billion. In contrast, Congress raised NIH’s budget from $37.887 in fiscal 2019 to $40.304 billion in fiscal 2020.

Mr. Trump’s budget proposal also includes an estimate of $152 billion in savings over a decade for Medicaid through the implementation of what the administration calls “community engagement” requirements.

The Trump administration has been at odds with Democrats for years about whether work requirements should be attached to Medicaid. “Well-designed community engagement incentives have great potential to improve health and well-being while empowering beneficiaries to rise out of poverty,” HHS said in a budget document.

Yet researchers last year reported that Arkansas’ attempt to attach work requirements to Medicaid caused almost 17,000 adults to lose this health care coverage within the first 6 months, and there was no significant difference in employment.

The researchers say this loss of coverage was partly a result of bureaucratic obstacles and confusion about the new rules. In June 2018, Arkansas became the first state to implement work requirements for Medicaid, Benjamin D. Sommers, MD, PhD, of the Harvard T.H. Chan School of Public Health, Boston, and colleagues wrote in the New England Journal of Medicine (2019 Sep 12;381[11]:1073-82). 

Budget ‘would thwart’ progress

A few medical groups on Monday quickly criticized Mr. Trump’s proposals.

“In a time where our nation continues to face significant public health challenges — including 2019 novel coronavirus, climate change, gun violence, and costly chronic diseases such as heart disease and cancer – the administration should be investing more resources in better health, not cutting federal health budgets,” said Georges C. Benjamin, MD, executive director of the American Public Health Association, in a statement.

David J. Skorton, MD, chief executive and president of the Association of American Medical Colleges (AAMC) also urged increased investment in fighting disease.

“We must continue the bipartisan budget trajectory set forth by Congress over the last several years, not reverse course,” Dr. Skorton said in a statement.

Mr. Trump’s proposed cuts in medical research “would thwart scientific progress on strategies to prevent, diagnose, treat, and cure medical conditions that affect countless patients nationwide,” he said.

In total, the new 2021 appropriations for HHS would fall by $9.46 billion to $85.667 billion under Mr. Trump’s proposal. Appropriations, also called discretionary budget authority, represents the operating budgets for federal agencies. These are decided through annual spending bills.

Congress has separate sets of laws for handling payments the federal government makes through Medicare and Medicaid. These are known as mandatory spending.

‘Untenable cuts’

AAMC’s Dr. Skorton also objected to what he termed Mr. Trump’s bid “to reduce and consolidate Medicare, Medicaid, and children’s hospital graduate medical education into a single grant program.”

This would force teaching hospitals to absorb $52 billion in “untenable cuts,” he said.

“The proposal ignores the intent of the Medicare GME program, which is to ensure an adequate physician workforce to care for Medicare beneficiaries and support the critical patient care missions of America’s teaching hospitals,” Dr. Skorton said.

The budget also seeks cuts to Medicaid, which come in addition to the administration’s “recent proposals to scale back Medicaid coverage,” Dr. Skorton said.

“More than 26% of all Medicaid hospitalizations occur at AAMC-member teaching hospitals, even though these institutions represent only 5% of all hospitals,” Dr. Skorton said. “Each of the administration’s proposals on their own would be devastating for patients – and combined, they would be disastrous.”

Rick Pollack, the chief executive and president of the American Hospital Association, described Mr. Trump’s fiscal 2021 proposal as another bid to undermine medical care in the United States.

“Every year, we adapt to a constantly changing environment, but every year, the administration aims to gut our nation’s health care infrastructure,” Mr. Pollack said in a statement.

In it, he noted that about one in five people in America depend on Medicaid, with children accounting for a large proportion of those covered by the state-federal program.

“The budget’s proposal on Medicaid financing and service delivery would cut hundreds of billions of dollars from the Medicaid program annually,” Mr. Pollack said.

He also objected to “hundreds of billions of proposed reductions to Medicare” endorsed by Mr. Trump.

Medical malpractice overhaul

The Trump administration also offered many suggestions for changing federal laws to reduce health care spending. Among these was a proposed overhaul of the approach to medical malpractice cases.

The president’s budget proposal estimates $40 billion in savings over a decade from steps to limit medical liability, according to a report from the Office of Management and Budget (OMB).

“The current medical liability system does not work for patients or providers, nor does it promote high-quality, evidence-based care,” OMB said. “Providers practice with a threat of potentially frivolous lawsuits, and injured patients often do not receive just compensation for their injuries.”

Mr. Trump’s fiscal 2021 budget calls for a cap on noneconomic damage awards of $250,000, which would increase with inflation over time, and a 3-year statute of limitations. Under this plan, courts could also modify attorney’s fee arrangements. HHS could provide guidance to states on how to create expert panels and administrative health care tribunals to review medical liability.

These steps would lead to lower health care spending, with clinicians dropping “defensive medicine practices,” OMB said. That would benefit the Medicare and Medicaid programs as well as lowering costs of health insurance in general.

Mr. Trump’s fiscal 2021 budget also includes a series of proposals for Medicare that it estimates would, in aggregate, save $755.5 billion over a decade.

Site-neutral policy

A large chunk of the estimated Medicare savings in Mr. Trump’s fiscal 2021 health budget would come from lowering payments to hospitals for services provided in their outpatient and physician offices.

In the fiscal 2021 proposal, HHS noted that “Medicare generally pays on-campus hospital outpatient departments substantially more than physician offices for the same services.”

Mr. Trump’s budget proposal seeks a more expansive shift to what’s called a “site-neutral” payment for services delivered in hospital outpatient programs or physician offices. This would bring these payments more in line with those made to independent physician practices.

“This proposal would eliminate the often significant disparity between what Medicare pays in these different settings for the same services,” HHS said in the budget summary.

HHS estimated this change in policy would generate $117.2 billion in savings over a decade. Combined with saving from medical malpractice reforms, the Trump administration estimates these two moves combined could save about $164 billion over a decade.

The site-neutral policy has been a legal battleground, with hospital and physician groups winning a round last year. 

Another Medicare proposal included in Mr. Trump’s fiscal 2021 budget homes in on this issue for cases where a hospital owns a physician office. Medicare now pays most off-campus hospital outpatient departments higher rates than the program’s physician fee schedule dictates for the same services.

Switching to a site-neutral policy for these hospital-owned physician offices would result in $47.2 billion in savings over a decade, HHS said in the budget document.
 

This article first appeared on Medscape.com.

The Trump administration on Feb. 10 argued for cutting spending for a federal agency at the forefront of the efforts to combat the coronavirus, while also seeking to slow spending in certain parts of the Medicare and Medicaid programs.

President Donald Trump presented his fiscal 2021 request to Congress for refilling the coffers of federal agencies. In any administration, an annual budget serves only as a political blueprint, as the White House document itself makes no changes in federal spending.

In Mr. Trump’s case, several of his requests for agencies within the Department of Health & Human Services run counter to recent budget trends. Republicans and Democrats in Congress have worked together in recent years to increase budgets for major federal health agencies.

But Mr. Trump asked Congress to cut annual budget authority for the National Institute of Allergy and Infectious Diseases by $430 million to $5.446 billion for fiscal 2021. In contrast, Congress has raised the annual budget for NIAID, a key agency in combating the coronavirus, from $5.545 billion in fiscal 2019 to $5.876 billion in fiscal 2020, which began in October, according to an HHS summary of Mr. Trump’s request.

For the Centers for Disease Control and Prevention, which is central to the battle against the coronavirus, Mr. Trump proposed a drop in discretionary funding to $5.627 billion. In contrast, Congress raised the CDC budget from $6.544 billion in fiscal 2019 to $6.917 in fiscal 2020.

Mr. Trump also wants to cut $559 million from the budget of the National Cancer Institute, dropping it to $5.881 billion in fiscal 2021. In contrast, Congress raised NCI’s budget from $6.121 billion in fiscal 2019 to $6.440 billion in fiscal 2020.

Mr. Trump requested a $2.6 billion reduction in the National Institutes of Health’s total discretionary budget, seeking to drop it to $37.70 billion. In contrast, Congress raised NIH’s budget from $37.887 in fiscal 2019 to $40.304 billion in fiscal 2020.

Mr. Trump’s budget proposal also includes an estimate of $152 billion in savings over a decade for Medicaid through the implementation of what the administration calls “community engagement” requirements.

The Trump administration has been at odds with Democrats for years about whether work requirements should be attached to Medicaid. “Well-designed community engagement incentives have great potential to improve health and well-being while empowering beneficiaries to rise out of poverty,” HHS said in a budget document.

Yet researchers last year reported that Arkansas’ attempt to attach work requirements to Medicaid caused almost 17,000 adults to lose this health care coverage within the first 6 months, and there was no significant difference in employment.

The researchers say this loss of coverage was partly a result of bureaucratic obstacles and confusion about the new rules. In June 2018, Arkansas became the first state to implement work requirements for Medicaid, Benjamin D. Sommers, MD, PhD, of the Harvard T.H. Chan School of Public Health, Boston, and colleagues wrote in the New England Journal of Medicine (2019 Sep 12;381[11]:1073-82). 

Budget ‘would thwart’ progress

A few medical groups on Monday quickly criticized Mr. Trump’s proposals.

“In a time where our nation continues to face significant public health challenges — including 2019 novel coronavirus, climate change, gun violence, and costly chronic diseases such as heart disease and cancer – the administration should be investing more resources in better health, not cutting federal health budgets,” said Georges C. Benjamin, MD, executive director of the American Public Health Association, in a statement.

David J. Skorton, MD, chief executive and president of the Association of American Medical Colleges (AAMC) also urged increased investment in fighting disease.

“We must continue the bipartisan budget trajectory set forth by Congress over the last several years, not reverse course,” Dr. Skorton said in a statement.

Mr. Trump’s proposed cuts in medical research “would thwart scientific progress on strategies to prevent, diagnose, treat, and cure medical conditions that affect countless patients nationwide,” he said.

In total, the new 2021 appropriations for HHS would fall by $9.46 billion to $85.667 billion under Mr. Trump’s proposal. Appropriations, also called discretionary budget authority, represents the operating budgets for federal agencies. These are decided through annual spending bills.

Congress has separate sets of laws for handling payments the federal government makes through Medicare and Medicaid. These are known as mandatory spending.

‘Untenable cuts’

AAMC’s Dr. Skorton also objected to what he termed Mr. Trump’s bid “to reduce and consolidate Medicare, Medicaid, and children’s hospital graduate medical education into a single grant program.”

This would force teaching hospitals to absorb $52 billion in “untenable cuts,” he said.

“The proposal ignores the intent of the Medicare GME program, which is to ensure an adequate physician workforce to care for Medicare beneficiaries and support the critical patient care missions of America’s teaching hospitals,” Dr. Skorton said.

The budget also seeks cuts to Medicaid, which come in addition to the administration’s “recent proposals to scale back Medicaid coverage,” Dr. Skorton said.

“More than 26% of all Medicaid hospitalizations occur at AAMC-member teaching hospitals, even though these institutions represent only 5% of all hospitals,” Dr. Skorton said. “Each of the administration’s proposals on their own would be devastating for patients – and combined, they would be disastrous.”

Rick Pollack, the chief executive and president of the American Hospital Association, described Mr. Trump’s fiscal 2021 proposal as another bid to undermine medical care in the United States.

“Every year, we adapt to a constantly changing environment, but every year, the administration aims to gut our nation’s health care infrastructure,” Mr. Pollack said in a statement.

In it, he noted that about one in five people in America depend on Medicaid, with children accounting for a large proportion of those covered by the state-federal program.

“The budget’s proposal on Medicaid financing and service delivery would cut hundreds of billions of dollars from the Medicaid program annually,” Mr. Pollack said.

He also objected to “hundreds of billions of proposed reductions to Medicare” endorsed by Mr. Trump.

Medical malpractice overhaul

The Trump administration also offered many suggestions for changing federal laws to reduce health care spending. Among these was a proposed overhaul of the approach to medical malpractice cases.

The president’s budget proposal estimates $40 billion in savings over a decade from steps to limit medical liability, according to a report from the Office of Management and Budget (OMB).

“The current medical liability system does not work for patients or providers, nor does it promote high-quality, evidence-based care,” OMB said. “Providers practice with a threat of potentially frivolous lawsuits, and injured patients often do not receive just compensation for their injuries.”

Mr. Trump’s fiscal 2021 budget calls for a cap on noneconomic damage awards of $250,000, which would increase with inflation over time, and a 3-year statute of limitations. Under this plan, courts could also modify attorney’s fee arrangements. HHS could provide guidance to states on how to create expert panels and administrative health care tribunals to review medical liability.

These steps would lead to lower health care spending, with clinicians dropping “defensive medicine practices,” OMB said. That would benefit the Medicare and Medicaid programs as well as lowering costs of health insurance in general.

Mr. Trump’s fiscal 2021 budget also includes a series of proposals for Medicare that it estimates would, in aggregate, save $755.5 billion over a decade.

Site-neutral policy

A large chunk of the estimated Medicare savings in Mr. Trump’s fiscal 2021 health budget would come from lowering payments to hospitals for services provided in their outpatient and physician offices.

In the fiscal 2021 proposal, HHS noted that “Medicare generally pays on-campus hospital outpatient departments substantially more than physician offices for the same services.”

Mr. Trump’s budget proposal seeks a more expansive shift to what’s called a “site-neutral” payment for services delivered in hospital outpatient programs or physician offices. This would bring these payments more in line with those made to independent physician practices.

“This proposal would eliminate the often significant disparity between what Medicare pays in these different settings for the same services,” HHS said in the budget summary.

HHS estimated this change in policy would generate $117.2 billion in savings over a decade. Combined with saving from medical malpractice reforms, the Trump administration estimates these two moves combined could save about $164 billion over a decade.

The site-neutral policy has been a legal battleground, with hospital and physician groups winning a round last year. 

Another Medicare proposal included in Mr. Trump’s fiscal 2021 budget homes in on this issue for cases where a hospital owns a physician office. Medicare now pays most off-campus hospital outpatient departments higher rates than the program’s physician fee schedule dictates for the same services.

Switching to a site-neutral policy for these hospital-owned physician offices would result in $47.2 billion in savings over a decade, HHS said in the budget document.
 

This article first appeared on Medscape.com.

The Trump administration on Feb. 10 argued for cutting spending for a federal agency at the forefront of the efforts to combat the coronavirus, while also seeking to slow spending in certain parts of the Medicare and Medicaid programs.

President Donald Trump presented his fiscal 2021 request to Congress for refilling the coffers of federal agencies. In any administration, an annual budget serves only as a political blueprint, as the White House document itself makes no changes in federal spending.

In Mr. Trump’s case, several of his requests for agencies within the Department of Health & Human Services run counter to recent budget trends. Republicans and Democrats in Congress have worked together in recent years to increase budgets for major federal health agencies.

But Mr. Trump asked Congress to cut annual budget authority for the National Institute of Allergy and Infectious Diseases by $430 million to $5.446 billion for fiscal 2021. In contrast, Congress has raised the annual budget for NIAID, a key agency in combating the coronavirus, from $5.545 billion in fiscal 2019 to $5.876 billion in fiscal 2020, which began in October, according to an HHS summary of Mr. Trump’s request.

For the Centers for Disease Control and Prevention, which is central to the battle against the coronavirus, Mr. Trump proposed a drop in discretionary funding to $5.627 billion. In contrast, Congress raised the CDC budget from $6.544 billion in fiscal 2019 to $6.917 in fiscal 2020.

Mr. Trump also wants to cut $559 million from the budget of the National Cancer Institute, dropping it to $5.881 billion in fiscal 2021. In contrast, Congress raised NCI’s budget from $6.121 billion in fiscal 2019 to $6.440 billion in fiscal 2020.

Mr. Trump requested a $2.6 billion reduction in the National Institutes of Health’s total discretionary budget, seeking to drop it to $37.70 billion. In contrast, Congress raised NIH’s budget from $37.887 in fiscal 2019 to $40.304 billion in fiscal 2020.

Mr. Trump’s budget proposal also includes an estimate of $152 billion in savings over a decade for Medicaid through the implementation of what the administration calls “community engagement” requirements.

The Trump administration has been at odds with Democrats for years about whether work requirements should be attached to Medicaid. “Well-designed community engagement incentives have great potential to improve health and well-being while empowering beneficiaries to rise out of poverty,” HHS said in a budget document.

Yet researchers last year reported that Arkansas’ attempt to attach work requirements to Medicaid caused almost 17,000 adults to lose this health care coverage within the first 6 months, and there was no significant difference in employment.

The researchers say this loss of coverage was partly a result of bureaucratic obstacles and confusion about the new rules. In June 2018, Arkansas became the first state to implement work requirements for Medicaid, Benjamin D. Sommers, MD, PhD, of the Harvard T.H. Chan School of Public Health, Boston, and colleagues wrote in the New England Journal of Medicine (2019 Sep 12;381[11]:1073-82). 

Budget ‘would thwart’ progress

A few medical groups on Monday quickly criticized Mr. Trump’s proposals.

“In a time where our nation continues to face significant public health challenges — including 2019 novel coronavirus, climate change, gun violence, and costly chronic diseases such as heart disease and cancer – the administration should be investing more resources in better health, not cutting federal health budgets,” said Georges C. Benjamin, MD, executive director of the American Public Health Association, in a statement.

David J. Skorton, MD, chief executive and president of the Association of American Medical Colleges (AAMC) also urged increased investment in fighting disease.

“We must continue the bipartisan budget trajectory set forth by Congress over the last several years, not reverse course,” Dr. Skorton said in a statement.

Mr. Trump’s proposed cuts in medical research “would thwart scientific progress on strategies to prevent, diagnose, treat, and cure medical conditions that affect countless patients nationwide,” he said.

In total, the new 2021 appropriations for HHS would fall by $9.46 billion to $85.667 billion under Mr. Trump’s proposal. Appropriations, also called discretionary budget authority, represents the operating budgets for federal agencies. These are decided through annual spending bills.

Congress has separate sets of laws for handling payments the federal government makes through Medicare and Medicaid. These are known as mandatory spending.

‘Untenable cuts’

AAMC’s Dr. Skorton also objected to what he termed Mr. Trump’s bid “to reduce and consolidate Medicare, Medicaid, and children’s hospital graduate medical education into a single grant program.”

This would force teaching hospitals to absorb $52 billion in “untenable cuts,” he said.

“The proposal ignores the intent of the Medicare GME program, which is to ensure an adequate physician workforce to care for Medicare beneficiaries and support the critical patient care missions of America’s teaching hospitals,” Dr. Skorton said.

The budget also seeks cuts to Medicaid, which come in addition to the administration’s “recent proposals to scale back Medicaid coverage,” Dr. Skorton said.

“More than 26% of all Medicaid hospitalizations occur at AAMC-member teaching hospitals, even though these institutions represent only 5% of all hospitals,” Dr. Skorton said. “Each of the administration’s proposals on their own would be devastating for patients – and combined, they would be disastrous.”

Rick Pollack, the chief executive and president of the American Hospital Association, described Mr. Trump’s fiscal 2021 proposal as another bid to undermine medical care in the United States.

“Every year, we adapt to a constantly changing environment, but every year, the administration aims to gut our nation’s health care infrastructure,” Mr. Pollack said in a statement.

In it, he noted that about one in five people in America depend on Medicaid, with children accounting for a large proportion of those covered by the state-federal program.

“The budget’s proposal on Medicaid financing and service delivery would cut hundreds of billions of dollars from the Medicaid program annually,” Mr. Pollack said.

He also objected to “hundreds of billions of proposed reductions to Medicare” endorsed by Mr. Trump.

Medical malpractice overhaul

The Trump administration also offered many suggestions for changing federal laws to reduce health care spending. Among these was a proposed overhaul of the approach to medical malpractice cases.

The president’s budget proposal estimates $40 billion in savings over a decade from steps to limit medical liability, according to a report from the Office of Management and Budget (OMB).

“The current medical liability system does not work for patients or providers, nor does it promote high-quality, evidence-based care,” OMB said. “Providers practice with a threat of potentially frivolous lawsuits, and injured patients often do not receive just compensation for their injuries.”

Mr. Trump’s fiscal 2021 budget calls for a cap on noneconomic damage awards of $250,000, which would increase with inflation over time, and a 3-year statute of limitations. Under this plan, courts could also modify attorney’s fee arrangements. HHS could provide guidance to states on how to create expert panels and administrative health care tribunals to review medical liability.

These steps would lead to lower health care spending, with clinicians dropping “defensive medicine practices,” OMB said. That would benefit the Medicare and Medicaid programs as well as lowering costs of health insurance in general.

Mr. Trump’s fiscal 2021 budget also includes a series of proposals for Medicare that it estimates would, in aggregate, save $755.5 billion over a decade.

Site-neutral policy

A large chunk of the estimated Medicare savings in Mr. Trump’s fiscal 2021 health budget would come from lowering payments to hospitals for services provided in their outpatient and physician offices.

In the fiscal 2021 proposal, HHS noted that “Medicare generally pays on-campus hospital outpatient departments substantially more than physician offices for the same services.”

Mr. Trump’s budget proposal seeks a more expansive shift to what’s called a “site-neutral” payment for services delivered in hospital outpatient programs or physician offices. This would bring these payments more in line with those made to independent physician practices.

“This proposal would eliminate the often significant disparity between what Medicare pays in these different settings for the same services,” HHS said in the budget summary.

HHS estimated this change in policy would generate $117.2 billion in savings over a decade. Combined with saving from medical malpractice reforms, the Trump administration estimates these two moves combined could save about $164 billion over a decade.

The site-neutral policy has been a legal battleground, with hospital and physician groups winning a round last year. 

Another Medicare proposal included in Mr. Trump’s fiscal 2021 budget homes in on this issue for cases where a hospital owns a physician office. Medicare now pays most off-campus hospital outpatient departments higher rates than the program’s physician fee schedule dictates for the same services.

Switching to a site-neutral policy for these hospital-owned physician offices would result in $47.2 billion in savings over a decade, HHS said in the budget document.
 

This article first appeared on Medscape.com.

Candida auris (C. auris) infection was first detected in New York, in July 2016. As of June 2019, 801 patients have been identified in New York as having C auris—and of those, 3 had pan-resistant infection.

CDC researchers say C auris is “a globally emerging yeast.” Cases with resistance to all 3 classes of commonly prescribed antifungal drugs have been reported in multiple countries.

In New York, of the first 277 available clinical isolates, 276 were resistant to fluconazole and 170 were resistant to amphotericin B. None were resistant to echinocandins. Subsequent testing found 99.7% of 331 isolates from infected patients with susceptibilities were resistant to fluconazole, 63% were resistant to amphotericin B, and 4% were resistant to echinocandins. Three of the subsequent isolates were pan-resistant.

The first 2 of those 3 patients were > 50 years old and residents of long-term care facilities. Each had multiple medical conditions, including ventilator dependence and colonization with multidrug-resistant bacteria. Neither patient was known to have received antifungal medications before the diagnosis of C. auris infection, but both were treated with prolonged courses of echinocandins after the diagnosis. Cultures taken after echinocandin therapy showed resistance to fluconazole, amphotericin B, and echinocandins. Both patients died, but the role of C. auris in their deaths is unclear.

The researchers found no epidemiologic links between the 2 patients. They were residents at different health care facilities, neither had any known domestic or foreign travel. No pan-resistant isolates were identified among contacts or on environmental surfaces from their rooms or common equipment at the 3 facilities where they had been patients. Although C. auris was isolated from other patients, none was pan-resistant.

A retrospective review of all New York C. auris isolates turned up a third pan-resistant patient. The patient also was aged > 50 years old , had multiple comorbidities, and a prolonged hospital and long-term care stay. However, the patient received care at a third unique facility. This third patient, who died from underlying medical conditions, was also not known to have traveled recently, and had no known contact with the other 2 patients.

Isolates from all 3 patients were initially sensitive to echinocandins. Resistance was detected after treatment, indicating it emerged during treatment with the drugs. The researchers found no evidence of transmission.

Approximately 3 years after the beginning of the New York outbreak, the pan-resistant isolates still appear to be rare, the researchers say, but “their emergence is concerning.” They urge close monitoring for patients on antifungal treatment for C. auris, along with follow-up cultures and repeat susceptibility testing, especially in patients previously treated with echinocandins.

Candida auris (C. auris) infection was first detected in New York, in July 2016. As of June 2019, 801 patients have been identified in New York as having C auris—and of those, 3 had pan-resistant infection.

CDC researchers say C auris is “a globally emerging yeast.” Cases with resistance to all 3 classes of commonly prescribed antifungal drugs have been reported in multiple countries.

In New York, of the first 277 available clinical isolates, 276 were resistant to fluconazole and 170 were resistant to amphotericin B. None were resistant to echinocandins. Subsequent testing found 99.7% of 331 isolates from infected patients with susceptibilities were resistant to fluconazole, 63% were resistant to amphotericin B, and 4% were resistant to echinocandins. Three of the subsequent isolates were pan-resistant.

The first 2 of those 3 patients were > 50 years old and residents of long-term care facilities. Each had multiple medical conditions, including ventilator dependence and colonization with multidrug-resistant bacteria. Neither patient was known to have received antifungal medications before the diagnosis of C. auris infection, but both were treated with prolonged courses of echinocandins after the diagnosis. Cultures taken after echinocandin therapy showed resistance to fluconazole, amphotericin B, and echinocandins. Both patients died, but the role of C. auris in their deaths is unclear.

The researchers found no epidemiologic links between the 2 patients. They were residents at different health care facilities, neither had any known domestic or foreign travel. No pan-resistant isolates were identified among contacts or on environmental surfaces from their rooms or common equipment at the 3 facilities where they had been patients. Although C. auris was isolated from other patients, none was pan-resistant.

A retrospective review of all New York C. auris isolates turned up a third pan-resistant patient. The patient also was aged > 50 years old , had multiple comorbidities, and a prolonged hospital and long-term care stay. However, the patient received care at a third unique facility. This third patient, who died from underlying medical conditions, was also not known to have traveled recently, and had no known contact with the other 2 patients.

Isolates from all 3 patients were initially sensitive to echinocandins. Resistance was detected after treatment, indicating it emerged during treatment with the drugs. The researchers found no evidence of transmission.

Approximately 3 years after the beginning of the New York outbreak, the pan-resistant isolates still appear to be rare, the researchers say, but “their emergence is concerning.” They urge close monitoring for patients on antifungal treatment for C. auris, along with follow-up cultures and repeat susceptibility testing, especially in patients previously treated with echinocandins.

Candida auris (C. auris) infection was first detected in New York, in July 2016. As of June 2019, 801 patients have been identified in New York as having C auris—and of those, 3 had pan-resistant infection.

CDC researchers say C auris is “a globally emerging yeast.” Cases with resistance to all 3 classes of commonly prescribed antifungal drugs have been reported in multiple countries.

In New York, of the first 277 available clinical isolates, 276 were resistant to fluconazole and 170 were resistant to amphotericin B. None were resistant to echinocandins. Subsequent testing found 99.7% of 331 isolates from infected patients with susceptibilities were resistant to fluconazole, 63% were resistant to amphotericin B, and 4% were resistant to echinocandins. Three of the subsequent isolates were pan-resistant.

The first 2 of those 3 patients were > 50 years old and residents of long-term care facilities. Each had multiple medical conditions, including ventilator dependence and colonization with multidrug-resistant bacteria. Neither patient was known to have received antifungal medications before the diagnosis of C. auris infection, but both were treated with prolonged courses of echinocandins after the diagnosis. Cultures taken after echinocandin therapy showed resistance to fluconazole, amphotericin B, and echinocandins. Both patients died, but the role of C. auris in their deaths is unclear.

The researchers found no epidemiologic links between the 2 patients. They were residents at different health care facilities, neither had any known domestic or foreign travel. No pan-resistant isolates were identified among contacts or on environmental surfaces from their rooms or common equipment at the 3 facilities where they had been patients. Although C. auris was isolated from other patients, none was pan-resistant.

A retrospective review of all New York C. auris isolates turned up a third pan-resistant patient. The patient also was aged > 50 years old , had multiple comorbidities, and a prolonged hospital and long-term care stay. However, the patient received care at a third unique facility. This third patient, who died from underlying medical conditions, was also not known to have traveled recently, and had no known contact with the other 2 patients.

Isolates from all 3 patients were initially sensitive to echinocandins. Resistance was detected after treatment, indicating it emerged during treatment with the drugs. The researchers found no evidence of transmission.

Approximately 3 years after the beginning of the New York outbreak, the pan-resistant isolates still appear to be rare, the researchers say, but “their emergence is concerning.” They urge close monitoring for patients on antifungal treatment for C. auris, along with follow-up cultures and repeat susceptibility testing, especially in patients previously treated with echinocandins.

Carbon monoxide (CO)—colorless, odorless, tasteless and highly toxic—is one of the most common causes of unintentional poisoning deaths in the US. Researchers who described their analysis of CO-related incidents in the military for the Medical Surveillance Monthly Report say military activities, materials, and settings pose “unique and potentially lethal sources of significant CO exposure.”

They reported on episodes of CO poisoning among members of the US Armed Forces between 2009 and 2019 and expanded on reports that dated back to 2001. Their analysis included reserve members and nonservice member beneficiaries.

Over the 10 years, there were 1,288 confirmed/probable cases of CO poisoning among active component service members, 366 among reserve component service members, and 4,754 among nonservice member beneficiaries. The highest number of active-duty members with CO confirmed/probable poisoning were reported at Fort Carson, Colorado (60) and NMC San Diego, California (52).

Of the confirmed/probable cases among active-duty members, 613 were classified as having unintentional intent, 538 undetermined intent, and 136 self-harm intent. One was due to assault. Most of the cases were related to work in repair/engineering occupations. Although the majority of sources were “other or unspecified,” motor vehicle exhaust accounted for 17% of the confirmed cases and all of the probable cases. Similarly, in the reserve component and among nonservice member beneficiaries, vehicle exhaust was the second-most common source.

The researchers found that CO poisoning-related injuries/diagnoses in the military often involved a single exposure that affected multiple personnel. For example, 21 soldiers showed symptoms during a multi-day exercise at the Yukon Training Center.

Excessive CO exposure is “entirely preventable,” the researchers say. Primary medical care providers—including unit medics and emergency medical technicians—should be knowledgeable about and sensitive to the “diverse and nonspecific” early clinical manifestations of CO intoxication, such as dizziness, headache, malaise, fatigue, disorientation, nausea, and vomiting. High CO exposure can cause more pronounced and severe symptoms, including syncope, seizures, acute stroke-like syndromes, and coma.

 It’s important to remember, the researchers add, that increased oxygen demand from muscular activity exacerbates the symptoms of CO exposure, but individuals at rest may experience no other symptoms before losing consciousness.

An editorial comment notes that the full impact of morbidity and mortality from CO poisoning is difficult to estimate. For one thing, because the symptoms can be so nonspecific, clinicians may not consider CO poisoning when patients present for care.

This study differs from previous ones in that it uses code data from both the Ninth and Tenth Revisions of the International Classification of Diseases. Such data, the editorial comment says, can be used at national and Military Health System–wide levels with relatively few resources, providing useful information on trends and risk factors that can be used in designing interventions

Carbon monoxide (CO)—colorless, odorless, tasteless and highly toxic—is one of the most common causes of unintentional poisoning deaths in the US. Researchers who described their analysis of CO-related incidents in the military for the Medical Surveillance Monthly Report say military activities, materials, and settings pose “unique and potentially lethal sources of significant CO exposure.”

They reported on episodes of CO poisoning among members of the US Armed Forces between 2009 and 2019 and expanded on reports that dated back to 2001. Their analysis included reserve members and nonservice member beneficiaries.

Over the 10 years, there were 1,288 confirmed/probable cases of CO poisoning among active component service members, 366 among reserve component service members, and 4,754 among nonservice member beneficiaries. The highest number of active-duty members with CO confirmed/probable poisoning were reported at Fort Carson, Colorado (60) and NMC San Diego, California (52).

Of the confirmed/probable cases among active-duty members, 613 were classified as having unintentional intent, 538 undetermined intent, and 136 self-harm intent. One was due to assault. Most of the cases were related to work in repair/engineering occupations. Although the majority of sources were “other or unspecified,” motor vehicle exhaust accounted for 17% of the confirmed cases and all of the probable cases. Similarly, in the reserve component and among nonservice member beneficiaries, vehicle exhaust was the second-most common source.

The researchers found that CO poisoning-related injuries/diagnoses in the military often involved a single exposure that affected multiple personnel. For example, 21 soldiers showed symptoms during a multi-day exercise at the Yukon Training Center.

Excessive CO exposure is “entirely preventable,” the researchers say. Primary medical care providers—including unit medics and emergency medical technicians—should be knowledgeable about and sensitive to the “diverse and nonspecific” early clinical manifestations of CO intoxication, such as dizziness, headache, malaise, fatigue, disorientation, nausea, and vomiting. High CO exposure can cause more pronounced and severe symptoms, including syncope, seizures, acute stroke-like syndromes, and coma.

 It’s important to remember, the researchers add, that increased oxygen demand from muscular activity exacerbates the symptoms of CO exposure, but individuals at rest may experience no other symptoms before losing consciousness.

An editorial comment notes that the full impact of morbidity and mortality from CO poisoning is difficult to estimate. For one thing, because the symptoms can be so nonspecific, clinicians may not consider CO poisoning when patients present for care.

This study differs from previous ones in that it uses code data from both the Ninth and Tenth Revisions of the International Classification of Diseases. Such data, the editorial comment says, can be used at national and Military Health System–wide levels with relatively few resources, providing useful information on trends and risk factors that can be used in designing interventions

Carbon monoxide (CO)—colorless, odorless, tasteless and highly toxic—is one of the most common causes of unintentional poisoning deaths in the US. Researchers who described their analysis of CO-related incidents in the military for the Medical Surveillance Monthly Report say military activities, materials, and settings pose “unique and potentially lethal sources of significant CO exposure.”

They reported on episodes of CO poisoning among members of the US Armed Forces between 2009 and 2019 and expanded on reports that dated back to 2001. Their analysis included reserve members and nonservice member beneficiaries.

Over the 10 years, there were 1,288 confirmed/probable cases of CO poisoning among active component service members, 366 among reserve component service members, and 4,754 among nonservice member beneficiaries. The highest number of active-duty members with CO confirmed/probable poisoning were reported at Fort Carson, Colorado (60) and NMC San Diego, California (52).

Of the confirmed/probable cases among active-duty members, 613 were classified as having unintentional intent, 538 undetermined intent, and 136 self-harm intent. One was due to assault. Most of the cases were related to work in repair/engineering occupations. Although the majority of sources were “other or unspecified,” motor vehicle exhaust accounted for 17% of the confirmed cases and all of the probable cases. Similarly, in the reserve component and among nonservice member beneficiaries, vehicle exhaust was the second-most common source.

The researchers found that CO poisoning-related injuries/diagnoses in the military often involved a single exposure that affected multiple personnel. For example, 21 soldiers showed symptoms during a multi-day exercise at the Yukon Training Center.

Excessive CO exposure is “entirely preventable,” the researchers say. Primary medical care providers—including unit medics and emergency medical technicians—should be knowledgeable about and sensitive to the “diverse and nonspecific” early clinical manifestations of CO intoxication, such as dizziness, headache, malaise, fatigue, disorientation, nausea, and vomiting. High CO exposure can cause more pronounced and severe symptoms, including syncope, seizures, acute stroke-like syndromes, and coma.

 It’s important to remember, the researchers add, that increased oxygen demand from muscular activity exacerbates the symptoms of CO exposure, but individuals at rest may experience no other symptoms before losing consciousness.

An editorial comment notes that the full impact of morbidity and mortality from CO poisoning is difficult to estimate. For one thing, because the symptoms can be so nonspecific, clinicians may not consider CO poisoning when patients present for care.

This study differs from previous ones in that it uses code data from both the Ninth and Tenth Revisions of the International Classification of Diseases. Such data, the editorial comment says, can be used at national and Military Health System–wide levels with relatively few resources, providing useful information on trends and risk factors that can be used in designing interventions

In this second in a series of 3 articles discussing medical malpractice and the ObGyn we look at the reasons for malpractice claims and liability, what happens to malpractice claims, and the direction and future of medical malpractice. The first article dealt with 2 sources of major malpractice damages: the “big verdict” and physicians with multiple malpractice paid claims. Next month we look at the place of apology in medicine, in cases in which error, including negligence, may have caused a patient injury.

CASE 1 Long-term brachial plexus injury

Right upper extremity injury occurs in the neonate at delivery with sequela of long-term brachial plexus injury (which is diagnosed around 6 months of age). Physical therapy and orthopedic assessment are rendered. Despite continued treatment, discrepancy in arm lengths (ie, affected side arm is noticeably shorter than opposite side) remains. The child cannot play basketball with his older brother and is the victim of ridicule, the plaintiff’s attorney emphasizes. He is unable to properly pronate or supinate the affected arm.

The defendant ObGyn maintains that there was “no shoulder dystocia [at delivery] and the shoulder did not get obstructed in the pelvis; shoulder was delivered 15 seconds after delivery of the head.” The nursing staff testifies that if shoulder dystocia had been the problem they would have launched upon a series of procedures to address such, in accord with the delivering obstetrician. The defense expert witness testifies that a brachial plexus injury can happen without shoulder dystocia.

A defense verdict is rendered by the Florida jury.¹
 

CASE 2 Shoulder dystocia

During delivery, the obstetrician notes a shoulder dystocia (“turtle sign”). After initial attempts to release the shoulder were unsuccessful, the physician applies traction several times to the head of the child, and the baby is delivered. There is permanent injury to the right brachial plexus. The defendant ObGyn says that traction was necessary to dislodge the shoulder, and that the injury was the result of the forces of labor (not the traction). The expert witness for the plaintiff testifies that the medical standard of care did not permit traction under these circumstances, and that the traction was the likely cause of the injury.

The Virginia jury awards $2.32 million in damages.²

Note: The above vignettes are drawn from actual cases but are only outlines of those cases and are not complete descriptions of the claims in the cases. Because the information comes from informal sources, not formal court records, the facts may be inaccurate and incomplete. They should be viewed as illustrations only.

The trend in malpractice

It has been clear for many years that medical malpractice claims are not randomly or evenly distributed among physicians. Notably, the variation among specialties has, and continues to be, substantial (FIGURE 1).³ Recent data suggest that, although paid claims per “1,000 physician-years” averages 14 paid claims per 1,000 physician years, it ranges from 4 or 5 in 1,000 (psychiatry and pediatrics) to 53 and 49 claims per 1,000 (neurology and plastic surgery, respectively). Obstetrics and gynecology has the fourth highest rate at 42.5 paid claims per 1,000 physician years.⁴ (These data are for the years 1992–2014.)

Continue to: The number of ObGyn paid malpractice claims has decreased over time...

The number of ObGyn paid malpractice claims has decreased over time. Although large verdicts and physicians with multiple paid malpractice claims receive a good deal of attention (as we noted in part 1 of our series), in fact, paid medical malpractice claims have trended downward in recent decades.⁵ When the data above are disaggregated by 5-year periods, for example, in obstetrics and gynecology, there has been a consistent reduction in paid malpractice claims from 1992 to 2014. Paid claims went from 58 per 1,000 physician-years in 1992–1996 to 25 per 1,000 in 2009–2014 (FIGURE 2).^4,6 In short, the rate dropped by half over approximately 20 years.⁴

It is reasonable to expect that such a decline in the cost of malpractice insurance premiums would follow. Robert L. Barbieri, MD, who practices in Boston, Massachusetts, in his excellent recent editorial in OBG Management⁶ reported that his professional liability insurance premiums decreased 18% from 2014 to 2019, and his colleague reported a 22% reduction during the same time period.⁶ An American Medical Association report of 7 states or metropolitan areas for 2008 to 2017 found considerable variance. The study looked at the rates and the trend of rates for malpractice insurance in several areas of the United States (FIGURE 3).⁷ For ObGyns, one of these jurisdictions experienced increased rates; in one other, rates stayed the same, and in 5 jurisdictions, the rates went down. The premiums varied across the country, however. In 2017, Los Angeles/Orange had an average rate of $49,804, and in Nassau and Suffolk counties, New York, the rate was $214,999. The median rate was approximately $170,000.⁷

Why have malpractice payouts declined overall?

Have medical errors declined?

It would be wonderful if the reduction in malpractice claims represented a significant decrease in medical errors. Attention to medical errors was driven by the first widely noticed study of medical error deaths. The Institute of Medicine (IOM) study in 2000, put the number of deaths annually at 44,000 to 98,000.⁸ There have been many efforts to reduce such errors, and it is possible that those efforts have indeed reduced errors somewhat.⁴ Barbieri provided a helpful digest of many of the error-reduction suggestions for ObGyn practice (TABLE 1).⁶ But the number of medical errors remains high. More recent studies have suggested that the IOM’s reported number of injuries may have been low.⁹ In 2013, one study suggested that 210,000 deaths annually were “associated with preventable harm” in hospitals. Because of how the data were gathered the authors estimated that the actual number of preventable deaths was closer to 400,000 annually. Serious harm to patients was estimated at 10 to 20 times the IOM rate.⁹

Therefore, a dramatic reduction in preventable medical errors does not appear to explain the reduction in malpractice claims. Some portion of it may be explained by malpractice reforms—see "The medical reform factor" section below.

The collective accountability factor

The way malpractice claims are paid (FIGURE 4),¹⁰ reported, and handled may explain some of the apparent reduction in overall paid claims. Perhaps the advent of “collective accountability,” in which patient care is rendered by teams and responsibility accepted at a team level, can alleviate a significant amount of individual physician medical malpractice claims.¹¹ This “enterprise liability” may shift the burden of medical error from physicians to health care organizations.¹² Collective accountability may, therefore, focus on institutional responsibility rather than individual physician negligence.^11,13 Institutions frequently hire multiple specialists and cover their medical malpractice costs as well as stand to be named in suits.

Continue to: The institutional involvement in malpractice cases also may affect...

The institutional involvement in malpractice cases also may affect apparent malpractice rates in another way. The National Practitioner Data Bank, which is the source of information for many malpractice studies, only requires reporting about individual physicians, not institutions.¹⁴ If, therefore, claims are settled on behalf of an institution, without implicating the physician, the number of physician malpractice cases may appear to decline without any real change in malpractice rates.¹⁴ In addition, institutions have taken the lead in informal resolution of injuries that occur in the institution, and these programs may reduce the direct malpractice claims against physicians. (These “disclosure, apology, and offer,” and similar programs, are discussed in the upcoming third part of this series.)

The medical reform factor

As noted, annual rates paid for medical malpractice in our specialty are trending downward. Many commentators look to malpractice reforms as the reason for the drop in malpractice rates.^15-17 Because medical malpractice is essentially a matter of state law, the medical malpractice reform has occurred primarily at the state level.¹⁸ There have been many different reforms tried—limits on expert witnesses, review panels, and a variety of procedural limitations.¹⁹ Perhaps the most effective reform has been caps being placed on noneconomic damages (generally pain and suffering).²⁰ These caps vary by state (FIGURE 5)^21,22 and, of course, affect the “big verdict” cases. (As we saw in the second case scenario above, Virginia is an example of a state with a cap on malpractice awards.) They also have the secondary effect of reducing the number of malpractice cases. They make malpractice cases less attractive to some attorneys because they reduce the opportunity of large contingency fees from large verdicts. (Virtually all medical malpractice cases in the United States are tried on a contingency-fee basis, meaning that the plaintiff does not pay the attorney handling the case but rather the attorney takes a percentage of any recovery—typically in the neighborhood of 35%.) The reform process continues, although, presently, there is less pressure to act on the malpractice crisis.

Medical malpractice cases are emotional and costly

Another reason for the relatively low rate of paid claims is that medical malpractice cases are difficult, emotionally challenging, time consuming, and expensive to pursue.²³ They typically drag on for years, require extensive and expensive expert consultants as well as witnesses, and face stiff defense (compared with many other torts). The settlement of medical malpractice cases, for example, is less likely than other kinds of personal injury cases.

The contingency-fee basis does mean that injured patients do not have to pay attorney fees up front; however, plaintiffs may have to pay substantial costs along the way. The other side of this coin is that lawyers can be reluctant to take malpractice cases in which the damages are likely to be small, or where the legal uncertainty reduces the odds of achieving any damages. Thus, many potential malpractice cases are never filed.

A word of caution

The news of a reduction in malpractice paid claims may not be permanent. The numbers can conceivably be cyclical, and political reforms achieved can be changed. In addition, new technology will likely bring new kinds of malpractice claims. That appears to be the case, for example, with electronic health records (EHRs). One insurer reports that EHR malpractice claims have increased over the last 8 years.²⁴ The most common injury in these claims was death (25%), as well as a magnitude of less serious injuries. EHR-related claims result from system failures, copy-paste inaccuracies, faulty drop-down menu use, and uncorrected “auto-populated” fields. Obstetrics is tied for fifth on the list of 14 specialties with claims related to EHRs, and gynecology is tied for eighth place.²⁴

Continue to: A federal court ruled that a hospital that changed from...

A federal court ruled that a hospital that changed from paper records to EHRs for test results had a duty to “‘implement a reasonable procedure during the transition phase’ to ensure the timely delivery of test results” to health care providers.²⁵ We will address this in a future “What’s the Verdict?”.

Rates of harm, malpractice cases, and the disposition of cases

There are many surprises when looking at medical malpractice claims data generally. The first surprise is how few claims are filed relative to the number of error-related injuries. Given the estimate of 210,000 to 400,000 deaths “associated with preventable harm” in hospitals, plus 10 to 20 times that number of serious injuries, it would be reasonable to expect claims of many hundreds of thousands per year. Compare the probability of a malpractice claim from an error-related injury, for example, with the probability of other personal injuries—eg, of traffic deaths associated with preventable harm.

The second key observation is how many of the claims filed are not successful—even when there was evidence in the record of errors associated with the injury. Studies slice the data in different ways but collectively suggest that only a small proportion of malpractice claims filed (a claim is generally regarded as some written demand for compensation for injuries) result in payments, either through settlement or by trial. A 2006 study by Studdert and colleagues determined that 63% of formal malpractice claims filed did involve injuries resulting from errors.²⁶ The study found that in 16% of the claims (not injuries) there was no payment even though there was error. In 10% of the claims there was payment, even in the absence of error.

Overall, in this study, 56% of the claims received some compensation.²⁶ That is higher than a more recent study by Jena and others, which found only 22% of claims resulted in compensation.³

How malpractice claims are decided is also interesting. Jena and colleagues found that only 55% of claims resulted in litigation.²⁷ Presumably, the other 45% may have resulted in the plaintiff dropping the case, or in some form of settlement. Of the claims that were litigated, 54% were dismissed by the court, and another 35% were settled before a trial verdict. The cases that went to trial (about 10%), overwhelmingly (80%) resulted in verdicts for the defense.^3,27 A different study found that only 9% of cases went to trial, and 87% were a defense verdict.²⁸ The high level of defense verdicts may suggest that malpractice defense lawyers, and their client physicians, do a good job of assessing cases they are likely to lose, and settling them before trial.

ObGyns generally have larger numbers of claims and among the largest payment amounts when there is payment. Fewer of their cases are dismissed by the courts, so more go to trial. At trial, however, ObGyns prevail at a remarkably high rate.²⁷ As for the probability of payment of a malpractice claim for ObGyns, one study suggested that there is approximately a 16% annual probability of a claim being filed, but only a 3% annual probability of a payment being made (suggesting about a 20% probability of payment per claim).³

Continue to: The purposes and effects of the medical malpractice system...

The purposes and effects of the medical malpractice system

The essential goals of tort law (including medical malpractice) include compensation for those who are injured and deterrence of future injuries (TABLE 2). What are the overall effects to the medical malpractice system? Unfortunately, the answer is that the law delivers disappointing results at best. It has a fairly high error rate. Many people who deserve some compensation for their injuries never seek compensation, and many deserving injured patients fail in efforts to receive compensation. At the same time, a few of the injured receive huge recoveries (even windfalls), and at least a small fraction receive compensation when there was no medical error. In addition to the high error rate, the system is inefficient and very expensive. Both defendants (through their insurance carriers) and plaintiffs spend a lot of money, years of time, and untold emotional pain dealing with these cases. The system also exacts high emotional and personal costs on plaintiffs and defendants.

Malpractice reform has not really addressed these issues—it has generally been focused on ways to reduce the cost of malpractice insurance. The most effective reform in reducing rates—caps—has had the effect of compensating the most seriously injured as though they were more modestly injured, and dissuading attorneys from taking the cases of those less seriously injured.

The medical and legal professions exist to help patients (the public). It does not seem that we have arrived at a system that does that very fairly or efficiently when a patient is injured because of preventable medical error.

Watch for the third and final article in this series next month, as we are going to look at “apology in medicine and a proactive response” to communication regarding a complication.

In this second in a series of 3 articles discussing medical malpractice and the ObGyn we look at the reasons for malpractice claims and liability, what happens to malpractice claims, and the direction and future of medical malpractice. The first article dealt with 2 sources of major malpractice damages: the “big verdict” and physicians with multiple malpractice paid claims. Next month we look at the place of apology in medicine, in cases in which error, including negligence, may have caused a patient injury.

CASE 1 Long-term brachial plexus injury

Right upper extremity injury occurs in the neonate at delivery with sequela of long-term brachial plexus injury (which is diagnosed around 6 months of age). Physical therapy and orthopedic assessment are rendered. Despite continued treatment, discrepancy in arm lengths (ie, affected side arm is noticeably shorter than opposite side) remains. The child cannot play basketball with his older brother and is the victim of ridicule, the plaintiff’s attorney emphasizes. He is unable to properly pronate or supinate the affected arm.

The defendant ObGyn maintains that there was “no shoulder dystocia [at delivery] and the shoulder did not get obstructed in the pelvis; shoulder was delivered 15 seconds after delivery of the head.” The nursing staff testifies that if shoulder dystocia had been the problem they would have launched upon a series of procedures to address such, in accord with the delivering obstetrician. The defense expert witness testifies that a brachial plexus injury can happen without shoulder dystocia.

A defense verdict is rendered by the Florida jury.¹
 

CASE 2 Shoulder dystocia

During delivery, the obstetrician notes a shoulder dystocia (“turtle sign”). After initial attempts to release the shoulder were unsuccessful, the physician applies traction several times to the head of the child, and the baby is delivered. There is permanent injury to the right brachial plexus. The defendant ObGyn says that traction was necessary to dislodge the shoulder, and that the injury was the result of the forces of labor (not the traction). The expert witness for the plaintiff testifies that the medical standard of care did not permit traction under these circumstances, and that the traction was the likely cause of the injury.

The Virginia jury awards $2.32 million in damages.²

Note: The above vignettes are drawn from actual cases but are only outlines of those cases and are not complete descriptions of the claims in the cases. Because the information comes from informal sources, not formal court records, the facts may be inaccurate and incomplete. They should be viewed as illustrations only.

The trend in malpractice

It has been clear for many years that medical malpractice claims are not randomly or evenly distributed among physicians. Notably, the variation among specialties has, and continues to be, substantial (FIGURE 1).³ Recent data suggest that, although paid claims per “1,000 physician-years” averages 14 paid claims per 1,000 physician years, it ranges from 4 or 5 in 1,000 (psychiatry and pediatrics) to 53 and 49 claims per 1,000 (neurology and plastic surgery, respectively). Obstetrics and gynecology has the fourth highest rate at 42.5 paid claims per 1,000 physician years.⁴ (These data are for the years 1992–2014.)

Continue to: The number of ObGyn paid malpractice claims has decreased over time...

The number of ObGyn paid malpractice claims has decreased over time. Although large verdicts and physicians with multiple paid malpractice claims receive a good deal of attention (as we noted in part 1 of our series), in fact, paid medical malpractice claims have trended downward in recent decades.⁵ When the data above are disaggregated by 5-year periods, for example, in obstetrics and gynecology, there has been a consistent reduction in paid malpractice claims from 1992 to 2014. Paid claims went from 58 per 1,000 physician-years in 1992–1996 to 25 per 1,000 in 2009–2014 (FIGURE 2).^4,6 In short, the rate dropped by half over approximately 20 years.⁴

It is reasonable to expect that such a decline in the cost of malpractice insurance premiums would follow. Robert L. Barbieri, MD, who practices in Boston, Massachusetts, in his excellent recent editorial in OBG Management⁶ reported that his professional liability insurance premiums decreased 18% from 2014 to 2019, and his colleague reported a 22% reduction during the same time period.⁶ An American Medical Association report of 7 states or metropolitan areas for 2008 to 2017 found considerable variance. The study looked at the rates and the trend of rates for malpractice insurance in several areas of the United States (FIGURE 3).⁷ For ObGyns, one of these jurisdictions experienced increased rates; in one other, rates stayed the same, and in 5 jurisdictions, the rates went down. The premiums varied across the country, however. In 2017, Los Angeles/Orange had an average rate of $49,804, and in Nassau and Suffolk counties, New York, the rate was $214,999. The median rate was approximately $170,000.⁷

Why have malpractice payouts declined overall?

Have medical errors declined?

It would be wonderful if the reduction in malpractice claims represented a significant decrease in medical errors. Attention to medical errors was driven by the first widely noticed study of medical error deaths. The Institute of Medicine (IOM) study in 2000, put the number of deaths annually at 44,000 to 98,000.⁸ There have been many efforts to reduce such errors, and it is possible that those efforts have indeed reduced errors somewhat.⁴ Barbieri provided a helpful digest of many of the error-reduction suggestions for ObGyn practice (TABLE 1).⁶ But the number of medical errors remains high. More recent studies have suggested that the IOM’s reported number of injuries may have been low.⁹ In 2013, one study suggested that 210,000 deaths annually were “associated with preventable harm” in hospitals. Because of how the data were gathered the authors estimated that the actual number of preventable deaths was closer to 400,000 annually. Serious harm to patients was estimated at 10 to 20 times the IOM rate.⁹

Therefore, a dramatic reduction in preventable medical errors does not appear to explain the reduction in malpractice claims. Some portion of it may be explained by malpractice reforms—see "The medical reform factor" section below.

The collective accountability factor

The way malpractice claims are paid (FIGURE 4),¹⁰ reported, and handled may explain some of the apparent reduction in overall paid claims. Perhaps the advent of “collective accountability,” in which patient care is rendered by teams and responsibility accepted at a team level, can alleviate a significant amount of individual physician medical malpractice claims.¹¹ This “enterprise liability” may shift the burden of medical error from physicians to health care organizations.¹² Collective accountability may, therefore, focus on institutional responsibility rather than individual physician negligence.^11,13 Institutions frequently hire multiple specialists and cover their medical malpractice costs as well as stand to be named in suits.

Continue to: The institutional involvement in malpractice cases also may affect...

The institutional involvement in malpractice cases also may affect apparent malpractice rates in another way. The National Practitioner Data Bank, which is the source of information for many malpractice studies, only requires reporting about individual physicians, not institutions.¹⁴ If, therefore, claims are settled on behalf of an institution, without implicating the physician, the number of physician malpractice cases may appear to decline without any real change in malpractice rates.¹⁴ In addition, institutions have taken the lead in informal resolution of injuries that occur in the institution, and these programs may reduce the direct malpractice claims against physicians. (These “disclosure, apology, and offer,” and similar programs, are discussed in the upcoming third part of this series.)

The medical reform factor

As noted, annual rates paid for medical malpractice in our specialty are trending downward. Many commentators look to malpractice reforms as the reason for the drop in malpractice rates.^15-17 Because medical malpractice is essentially a matter of state law, the medical malpractice reform has occurred primarily at the state level.¹⁸ There have been many different reforms tried—limits on expert witnesses, review panels, and a variety of procedural limitations.¹⁹ Perhaps the most effective reform has been caps being placed on noneconomic damages (generally pain and suffering).²⁰ These caps vary by state (FIGURE 5)^21,22 and, of course, affect the “big verdict” cases. (As we saw in the second case scenario above, Virginia is an example of a state with a cap on malpractice awards.) They also have the secondary effect of reducing the number of malpractice cases. They make malpractice cases less attractive to some attorneys because they reduce the opportunity of large contingency fees from large verdicts. (Virtually all medical malpractice cases in the United States are tried on a contingency-fee basis, meaning that the plaintiff does not pay the attorney handling the case but rather the attorney takes a percentage of any recovery—typically in the neighborhood of 35%.) The reform process continues, although, presently, there is less pressure to act on the malpractice crisis.

Medical malpractice cases are emotional and costly

Another reason for the relatively low rate of paid claims is that medical malpractice cases are difficult, emotionally challenging, time consuming, and expensive to pursue.²³ They typically drag on for years, require extensive and expensive expert consultants as well as witnesses, and face stiff defense (compared with many other torts). The settlement of medical malpractice cases, for example, is less likely than other kinds of personal injury cases.

The contingency-fee basis does mean that injured patients do not have to pay attorney fees up front; however, plaintiffs may have to pay substantial costs along the way. The other side of this coin is that lawyers can be reluctant to take malpractice cases in which the damages are likely to be small, or where the legal uncertainty reduces the odds of achieving any damages. Thus, many potential malpractice cases are never filed.

A word of caution

The news of a reduction in malpractice paid claims may not be permanent. The numbers can conceivably be cyclical, and political reforms achieved can be changed. In addition, new technology will likely bring new kinds of malpractice claims. That appears to be the case, for example, with electronic health records (EHRs). One insurer reports that EHR malpractice claims have increased over the last 8 years.²⁴ The most common injury in these claims was death (25%), as well as a magnitude of less serious injuries. EHR-related claims result from system failures, copy-paste inaccuracies, faulty drop-down menu use, and uncorrected “auto-populated” fields. Obstetrics is tied for fifth on the list of 14 specialties with claims related to EHRs, and gynecology is tied for eighth place.²⁴

Continue to: A federal court ruled that a hospital that changed from...

A federal court ruled that a hospital that changed from paper records to EHRs for test results had a duty to “‘implement a reasonable procedure during the transition phase’ to ensure the timely delivery of test results” to health care providers.²⁵ We will address this in a future “What’s the Verdict?”.

Rates of harm, malpractice cases, and the disposition of cases

There are many surprises when looking at medical malpractice claims data generally. The first surprise is how few claims are filed relative to the number of error-related injuries. Given the estimate of 210,000 to 400,000 deaths “associated with preventable harm” in hospitals, plus 10 to 20 times that number of serious injuries, it would be reasonable to expect claims of many hundreds of thousands per year. Compare the probability of a malpractice claim from an error-related injury, for example, with the probability of other personal injuries—eg, of traffic deaths associated with preventable harm.

The second key observation is how many of the claims filed are not successful—even when there was evidence in the record of errors associated with the injury. Studies slice the data in different ways but collectively suggest that only a small proportion of malpractice claims filed (a claim is generally regarded as some written demand for compensation for injuries) result in payments, either through settlement or by trial. A 2006 study by Studdert and colleagues determined that 63% of formal malpractice claims filed did involve injuries resulting from errors.²⁶ The study found that in 16% of the claims (not injuries) there was no payment even though there was error. In 10% of the claims there was payment, even in the absence of error.

Overall, in this study, 56% of the claims received some compensation.²⁶ That is higher than a more recent study by Jena and others, which found only 22% of claims resulted in compensation.³

How malpractice claims are decided is also interesting. Jena and colleagues found that only 55% of claims resulted in litigation.²⁷ Presumably, the other 45% may have resulted in the plaintiff dropping the case, or in some form of settlement. Of the claims that were litigated, 54% were dismissed by the court, and another 35% were settled before a trial verdict. The cases that went to trial (about 10%), overwhelmingly (80%) resulted in verdicts for the defense.^3,27 A different study found that only 9% of cases went to trial, and 87% were a defense verdict.²⁸ The high level of defense verdicts may suggest that malpractice defense lawyers, and their client physicians, do a good job of assessing cases they are likely to lose, and settling them before trial.

ObGyns generally have larger numbers of claims and among the largest payment amounts when there is payment. Fewer of their cases are dismissed by the courts, so more go to trial. At trial, however, ObGyns prevail at a remarkably high rate.²⁷ As for the probability of payment of a malpractice claim for ObGyns, one study suggested that there is approximately a 16% annual probability of a claim being filed, but only a 3% annual probability of a payment being made (suggesting about a 20% probability of payment per claim).³

Continue to: The purposes and effects of the medical malpractice system...

The purposes and effects of the medical malpractice system

The essential goals of tort law (including medical malpractice) include compensation for those who are injured and deterrence of future injuries (TABLE 2). What are the overall effects to the medical malpractice system? Unfortunately, the answer is that the law delivers disappointing results at best. It has a fairly high error rate. Many people who deserve some compensation for their injuries never seek compensation, and many deserving injured patients fail in efforts to receive compensation. At the same time, a few of the injured receive huge recoveries (even windfalls), and at least a small fraction receive compensation when there was no medical error. In addition to the high error rate, the system is inefficient and very expensive. Both defendants (through their insurance carriers) and plaintiffs spend a lot of money, years of time, and untold emotional pain dealing with these cases. The system also exacts high emotional and personal costs on plaintiffs and defendants.

Malpractice reform has not really addressed these issues—it has generally been focused on ways to reduce the cost of malpractice insurance. The most effective reform in reducing rates—caps—has had the effect of compensating the most seriously injured as though they were more modestly injured, and dissuading attorneys from taking the cases of those less seriously injured.

The medical and legal professions exist to help patients (the public). It does not seem that we have arrived at a system that does that very fairly or efficiently when a patient is injured because of preventable medical error.

Watch for the third and final article in this series next month, as we are going to look at “apology in medicine and a proactive response” to communication regarding a complication.

In this second in a series of 3 articles discussing medical malpractice and the ObGyn we look at the reasons for malpractice claims and liability, what happens to malpractice claims, and the direction and future of medical malpractice. The first article dealt with 2 sources of major malpractice damages: the “big verdict” and physicians with multiple malpractice paid claims. Next month we look at the place of apology in medicine, in cases in which error, including negligence, may have caused a patient injury.

CASE 1 Long-term brachial plexus injury

Right upper extremity injury occurs in the neonate at delivery with sequela of long-term brachial plexus injury (which is diagnosed around 6 months of age). Physical therapy and orthopedic assessment are rendered. Despite continued treatment, discrepancy in arm lengths (ie, affected side arm is noticeably shorter than opposite side) remains. The child cannot play basketball with his older brother and is the victim of ridicule, the plaintiff’s attorney emphasizes. He is unable to properly pronate or supinate the affected arm.

The defendant ObGyn maintains that there was “no shoulder dystocia [at delivery] and the shoulder did not get obstructed in the pelvis; shoulder was delivered 15 seconds after delivery of the head.” The nursing staff testifies that if shoulder dystocia had been the problem they would have launched upon a series of procedures to address such, in accord with the delivering obstetrician. The defense expert witness testifies that a brachial plexus injury can happen without shoulder dystocia.

A defense verdict is rendered by the Florida jury.¹
 

CASE 2 Shoulder dystocia

During delivery, the obstetrician notes a shoulder dystocia (“turtle sign”). After initial attempts to release the shoulder were unsuccessful, the physician applies traction several times to the head of the child, and the baby is delivered. There is permanent injury to the right brachial plexus. The defendant ObGyn says that traction was necessary to dislodge the shoulder, and that the injury was the result of the forces of labor (not the traction). The expert witness for the plaintiff testifies that the medical standard of care did not permit traction under these circumstances, and that the traction was the likely cause of the injury.

The Virginia jury awards $2.32 million in damages.²

Note: The above vignettes are drawn from actual cases but are only outlines of those cases and are not complete descriptions of the claims in the cases. Because the information comes from informal sources, not formal court records, the facts may be inaccurate and incomplete. They should be viewed as illustrations only.

The trend in malpractice

It has been clear for many years that medical malpractice claims are not randomly or evenly distributed among physicians. Notably, the variation among specialties has, and continues to be, substantial (FIGURE 1).³ Recent data suggest that, although paid claims per “1,000 physician-years” averages 14 paid claims per 1,000 physician years, it ranges from 4 or 5 in 1,000 (psychiatry and pediatrics) to 53 and 49 claims per 1,000 (neurology and plastic surgery, respectively). Obstetrics and gynecology has the fourth highest rate at 42.5 paid claims per 1,000 physician years.⁴ (These data are for the years 1992–2014.)

Continue to: The number of ObGyn paid malpractice claims has decreased over time...

The number of ObGyn paid malpractice claims has decreased over time. Although large verdicts and physicians with multiple paid malpractice claims receive a good deal of attention (as we noted in part 1 of our series), in fact, paid medical malpractice claims have trended downward in recent decades.⁵ When the data above are disaggregated by 5-year periods, for example, in obstetrics and gynecology, there has been a consistent reduction in paid malpractice claims from 1992 to 2014. Paid claims went from 58 per 1,000 physician-years in 1992–1996 to 25 per 1,000 in 2009–2014 (FIGURE 2).^4,6 In short, the rate dropped by half over approximately 20 years.⁴

It is reasonable to expect that such a decline in the cost of malpractice insurance premiums would follow. Robert L. Barbieri, MD, who practices in Boston, Massachusetts, in his excellent recent editorial in OBG Management⁶ reported that his professional liability insurance premiums decreased 18% from 2014 to 2019, and his colleague reported a 22% reduction during the same time period.⁶ An American Medical Association report of 7 states or metropolitan areas for 2008 to 2017 found considerable variance. The study looked at the rates and the trend of rates for malpractice insurance in several areas of the United States (FIGURE 3).⁷ For ObGyns, one of these jurisdictions experienced increased rates; in one other, rates stayed the same, and in 5 jurisdictions, the rates went down. The premiums varied across the country, however. In 2017, Los Angeles/Orange had an average rate of $49,804, and in Nassau and Suffolk counties, New York, the rate was $214,999. The median rate was approximately $170,000.⁷

Why have malpractice payouts declined overall?

Have medical errors declined?

It would be wonderful if the reduction in malpractice claims represented a significant decrease in medical errors. Attention to medical errors was driven by the first widely noticed study of medical error deaths. The Institute of Medicine (IOM) study in 2000, put the number of deaths annually at 44,000 to 98,000.⁸ There have been many efforts to reduce such errors, and it is possible that those efforts have indeed reduced errors somewhat.⁴ Barbieri provided a helpful digest of many of the error-reduction suggestions for ObGyn practice (TABLE 1).⁶ But the number of medical errors remains high. More recent studies have suggested that the IOM’s reported number of injuries may have been low.⁹ In 2013, one study suggested that 210,000 deaths annually were “associated with preventable harm” in hospitals. Because of how the data were gathered the authors estimated that the actual number of preventable deaths was closer to 400,000 annually. Serious harm to patients was estimated at 10 to 20 times the IOM rate.⁹

Therefore, a dramatic reduction in preventable medical errors does not appear to explain the reduction in malpractice claims. Some portion of it may be explained by malpractice reforms—see "The medical reform factor" section below.

The collective accountability factor

The way malpractice claims are paid (FIGURE 4),¹⁰ reported, and handled may explain some of the apparent reduction in overall paid claims. Perhaps the advent of “collective accountability,” in which patient care is rendered by teams and responsibility accepted at a team level, can alleviate a significant amount of individual physician medical malpractice claims.¹¹ This “enterprise liability” may shift the burden of medical error from physicians to health care organizations.¹² Collective accountability may, therefore, focus on institutional responsibility rather than individual physician negligence.^11,13 Institutions frequently hire multiple specialists and cover their medical malpractice costs as well as stand to be named in suits.

Continue to: The institutional involvement in malpractice cases also may affect...

The institutional involvement in malpractice cases also may affect apparent malpractice rates in another way. The National Practitioner Data Bank, which is the source of information for many malpractice studies, only requires reporting about individual physicians, not institutions.¹⁴ If, therefore, claims are settled on behalf of an institution, without implicating the physician, the number of physician malpractice cases may appear to decline without any real change in malpractice rates.¹⁴ In addition, institutions have taken the lead in informal resolution of injuries that occur in the institution, and these programs may reduce the direct malpractice claims against physicians. (These “disclosure, apology, and offer,” and similar programs, are discussed in the upcoming third part of this series.)

The medical reform factor

As noted, annual rates paid for medical malpractice in our specialty are trending downward. Many commentators look to malpractice reforms as the reason for the drop in malpractice rates.^15-17 Because medical malpractice is essentially a matter of state law, the medical malpractice reform has occurred primarily at the state level.¹⁸ There have been many different reforms tried—limits on expert witnesses, review panels, and a variety of procedural limitations.¹⁹ Perhaps the most effective reform has been caps being placed on noneconomic damages (generally pain and suffering).²⁰ These caps vary by state (FIGURE 5)^21,22 and, of course, affect the “big verdict” cases. (As we saw in the second case scenario above, Virginia is an example of a state with a cap on malpractice awards.) They also have the secondary effect of reducing the number of malpractice cases. They make malpractice cases less attractive to some attorneys because they reduce the opportunity of large contingency fees from large verdicts. (Virtually all medical malpractice cases in the United States are tried on a contingency-fee basis, meaning that the plaintiff does not pay the attorney handling the case but rather the attorney takes a percentage of any recovery—typically in the neighborhood of 35%.) The reform process continues, although, presently, there is less pressure to act on the malpractice crisis.

Medical malpractice cases are emotional and costly

Another reason for the relatively low rate of paid claims is that medical malpractice cases are difficult, emotionally challenging, time consuming, and expensive to pursue.²³ They typically drag on for years, require extensive and expensive expert consultants as well as witnesses, and face stiff defense (compared with many other torts). The settlement of medical malpractice cases, for example, is less likely than other kinds of personal injury cases.

The contingency-fee basis does mean that injured patients do not have to pay attorney fees up front; however, plaintiffs may have to pay substantial costs along the way. The other side of this coin is that lawyers can be reluctant to take malpractice cases in which the damages are likely to be small, or where the legal uncertainty reduces the odds of achieving any damages. Thus, many potential malpractice cases are never filed.

A word of caution

The news of a reduction in malpractice paid claims may not be permanent. The numbers can conceivably be cyclical, and political reforms achieved can be changed. In addition, new technology will likely bring new kinds of malpractice claims. That appears to be the case, for example, with electronic health records (EHRs). One insurer reports that EHR malpractice claims have increased over the last 8 years.²⁴ The most common injury in these claims was death (25%), as well as a magnitude of less serious injuries. EHR-related claims result from system failures, copy-paste inaccuracies, faulty drop-down menu use, and uncorrected “auto-populated” fields. Obstetrics is tied for fifth on the list of 14 specialties with claims related to EHRs, and gynecology is tied for eighth place.²⁴

Continue to: A federal court ruled that a hospital that changed from...

A federal court ruled that a hospital that changed from paper records to EHRs for test results had a duty to “‘implement a reasonable procedure during the transition phase’ to ensure the timely delivery of test results” to health care providers.²⁵ We will address this in a future “What’s the Verdict?”.

Rates of harm, malpractice cases, and the disposition of cases

There are many surprises when looking at medical malpractice claims data generally. The first surprise is how few claims are filed relative to the number of error-related injuries. Given the estimate of 210,000 to 400,000 deaths “associated with preventable harm” in hospitals, plus 10 to 20 times that number of serious injuries, it would be reasonable to expect claims of many hundreds of thousands per year. Compare the probability of a malpractice claim from an error-related injury, for example, with the probability of other personal injuries—eg, of traffic deaths associated with preventable harm.

The second key observation is how many of the claims filed are not successful—even when there was evidence in the record of errors associated with the injury. Studies slice the data in different ways but collectively suggest that only a small proportion of malpractice claims filed (a claim is generally regarded as some written demand for compensation for injuries) result in payments, either through settlement or by trial. A 2006 study by Studdert and colleagues determined that 63% of formal malpractice claims filed did involve injuries resulting from errors.²⁶ The study found that in 16% of the claims (not injuries) there was no payment even though there was error. In 10% of the claims there was payment, even in the absence of error.

Overall, in this study, 56% of the claims received some compensation.²⁶ That is higher than a more recent study by Jena and others, which found only 22% of claims resulted in compensation.³

How malpractice claims are decided is also interesting. Jena and colleagues found that only 55% of claims resulted in litigation.²⁷ Presumably, the other 45% may have resulted in the plaintiff dropping the case, or in some form of settlement. Of the claims that were litigated, 54% were dismissed by the court, and another 35% were settled before a trial verdict. The cases that went to trial (about 10%), overwhelmingly (80%) resulted in verdicts for the defense.^3,27 A different study found that only 9% of cases went to trial, and 87% were a defense verdict.²⁸ The high level of defense verdicts may suggest that malpractice defense lawyers, and their client physicians, do a good job of assessing cases they are likely to lose, and settling them before trial.

ObGyns generally have larger numbers of claims and among the largest payment amounts when there is payment. Fewer of their cases are dismissed by the courts, so more go to trial. At trial, however, ObGyns prevail at a remarkably high rate.²⁷ As for the probability of payment of a malpractice claim for ObGyns, one study suggested that there is approximately a 16% annual probability of a claim being filed, but only a 3% annual probability of a payment being made (suggesting about a 20% probability of payment per claim).³

Continue to: The purposes and effects of the medical malpractice system...

The purposes and effects of the medical malpractice system

The essential goals of tort law (including medical malpractice) include compensation for those who are injured and deterrence of future injuries (TABLE 2). What are the overall effects to the medical malpractice system? Unfortunately, the answer is that the law delivers disappointing results at best. It has a fairly high error rate. Many people who deserve some compensation for their injuries never seek compensation, and many deserving injured patients fail in efforts to receive compensation. At the same time, a few of the injured receive huge recoveries (even windfalls), and at least a small fraction receive compensation when there was no medical error. In addition to the high error rate, the system is inefficient and very expensive. Both defendants (through their insurance carriers) and plaintiffs spend a lot of money, years of time, and untold emotional pain dealing with these cases. The system also exacts high emotional and personal costs on plaintiffs and defendants.

Malpractice reform has not really addressed these issues—it has generally been focused on ways to reduce the cost of malpractice insurance. The most effective reform in reducing rates—caps—has had the effect of compensating the most seriously injured as though they were more modestly injured, and dissuading attorneys from taking the cases of those less seriously injured.

The medical and legal professions exist to help patients (the public). It does not seem that we have arrived at a system that does that very fairly or efficiently when a patient is injured because of preventable medical error.

Watch for the third and final article in this series next month, as we are going to look at “apology in medicine and a proactive response” to communication regarding a complication.