Health Policy

To the Editor: We read with interest the editorial on the clinical use of intranasal esketamine in treatment-resistant depression by Editor-in-Chief Cynthia Geppert in the October 2019 issue of Federal Practitioner.¹ A recent case report published in your journal illustrated the success of IV ketamine in alleviating refractory chronic pain caused by a rare disease.² Ketamine has been well established as an appropriate adjuvant as well as an alternative to opioids in attenuating acute postoperative pain and in certain chronic pain syndromes.³ We write out of concern for the rapidity of adoption of intranasal esketamine without considering the merits of IV ketamine.

When adopting new treatments or extending established drugs for newer indications, clinicians must balance beneficence and nonmaleficence. There is an urgent need for better treatment options for depression, suicidality, posttraumatic stress disorder (PTSD), and chronic pain in the veteran population. However, one must proceed with caution before wide adoption of a treatment that lacks real-world data on sustained or long-term benefits.⁴ Enthusiasm for this drug must also be tempered by the documented adverse effect (AE) of hepatic injury and the lack of data tracking this AE from repeated, long-term use.⁵ With these considerations in mind, reliable dosing and predictable pharmacokinetics are of great importance.

In addition to outpatient esketamine, outpatient IV administration of racemic ketamine remains an advantageous option with unique benefits compared with esketamine. Pharmacokinetically, IV ketamine is superior to intranasal esketamine. The bioavailability of intranasal esketamine is likely to be variable. A patient with a poor intranasal application or poor absorption might be falsely labeled an esketamine nonresponder. Increasing intranasal esketamine dosage to avoid false nonresponders may place other patients at risk for overdose and undesired AEs, including dysphoria and hallucinations. The variable bioavailability of intranasal ketamine adds complexity to the examination of its clinical effectiveness. IV ketamine should provide a predictable drug level and more reliable data. One might retort that esketamine is not the same as ketamine. True, esketamine is the S-enantiomer of ketamine, whereas ketamine is a racemic mixture of S- and R-ketamine. However, there is no clear evidence of clinically relevant differences between these formulations.⁵

Psychomimetic effects and cardiovascular changes are the most common short-term AEs resulting from ketamine.⁵ An IV infusion allows the treating physician to slowly titrate the administered ketamine to reach an effective concentration at the target site. Unlike an all-or-none intranasal administration, an infusion can be stopped at the first appearance of an AE. Psychomimetic effects, such as hallucinations, visual disturbances, and dysphoria are thought to occur in a dose-dependent fashion and remit once a ketamine infusion is stopped.⁵ Furthermore, cardiovascular AEs, such as hypertension and tachycardia, are commonly in patients with a body mass index > 30, with IV administration on a mg/kg basis. This suggests that calculated ideal body weight is a safer denominator, and reliable dosing is important to mitigating AEs.⁶

We urge caution with the widespread adoption of intranasal esketamine and suggest the advantages of the IV route, which offers predictability of AEs and titratability of dose. Questions remain regarding the appropriate dose and formulation of ketamine, rate of infusion, and route of administration for chronic pain and psychiatric indications.^5,7 It is our responsibility to further study the long-term safety profile of ketamine and determine an appropriate dose of ketamine. The IV route allows many veterans to be helped in a safe and controllable manner.

Eugene Raggi, MD; and Srikantha L. Rao, MD, MS, FAS

To the Editor: We read with interest the editorial on the clinical use of intranasal esketamine in treatment-resistant depression by Editor-in-Chief Cynthia Geppert in the October 2019 issue of Federal Practitioner.¹ A recent case report published in your journal illustrated the success of IV ketamine in alleviating refractory chronic pain caused by a rare disease.² Ketamine has been well established as an appropriate adjuvant as well as an alternative to opioids in attenuating acute postoperative pain and in certain chronic pain syndromes.³ We write out of concern for the rapidity of adoption of intranasal esketamine without considering the merits of IV ketamine.

When adopting new treatments or extending established drugs for newer indications, clinicians must balance beneficence and nonmaleficence. There is an urgent need for better treatment options for depression, suicidality, posttraumatic stress disorder (PTSD), and chronic pain in the veteran population. However, one must proceed with caution before wide adoption of a treatment that lacks real-world data on sustained or long-term benefits.⁴ Enthusiasm for this drug must also be tempered by the documented adverse effect (AE) of hepatic injury and the lack of data tracking this AE from repeated, long-term use.⁵ With these considerations in mind, reliable dosing and predictable pharmacokinetics are of great importance.

In addition to outpatient esketamine, outpatient IV administration of racemic ketamine remains an advantageous option with unique benefits compared with esketamine. Pharmacokinetically, IV ketamine is superior to intranasal esketamine. The bioavailability of intranasal esketamine is likely to be variable. A patient with a poor intranasal application or poor absorption might be falsely labeled an esketamine nonresponder. Increasing intranasal esketamine dosage to avoid false nonresponders may place other patients at risk for overdose and undesired AEs, including dysphoria and hallucinations. The variable bioavailability of intranasal ketamine adds complexity to the examination of its clinical effectiveness. IV ketamine should provide a predictable drug level and more reliable data. One might retort that esketamine is not the same as ketamine. True, esketamine is the S-enantiomer of ketamine, whereas ketamine is a racemic mixture of S- and R-ketamine. However, there is no clear evidence of clinically relevant differences between these formulations.⁵

Psychomimetic effects and cardiovascular changes are the most common short-term AEs resulting from ketamine.⁵ An IV infusion allows the treating physician to slowly titrate the administered ketamine to reach an effective concentration at the target site. Unlike an all-or-none intranasal administration, an infusion can be stopped at the first appearance of an AE. Psychomimetic effects, such as hallucinations, visual disturbances, and dysphoria are thought to occur in a dose-dependent fashion and remit once a ketamine infusion is stopped.⁵ Furthermore, cardiovascular AEs, such as hypertension and tachycardia, are commonly in patients with a body mass index > 30, with IV administration on a mg/kg basis. This suggests that calculated ideal body weight is a safer denominator, and reliable dosing is important to mitigating AEs.⁶

We urge caution with the widespread adoption of intranasal esketamine and suggest the advantages of the IV route, which offers predictability of AEs and titratability of dose. Questions remain regarding the appropriate dose and formulation of ketamine, rate of infusion, and route of administration for chronic pain and psychiatric indications.^5,7 It is our responsibility to further study the long-term safety profile of ketamine and determine an appropriate dose of ketamine. The IV route allows many veterans to be helped in a safe and controllable manner.

Eugene Raggi, MD; and Srikantha L. Rao, MD, MS, FAS

To the Editor: We read with interest the editorial on the clinical use of intranasal esketamine in treatment-resistant depression by Editor-in-Chief Cynthia Geppert in the October 2019 issue of Federal Practitioner.¹ A recent case report published in your journal illustrated the success of IV ketamine in alleviating refractory chronic pain caused by a rare disease.² Ketamine has been well established as an appropriate adjuvant as well as an alternative to opioids in attenuating acute postoperative pain and in certain chronic pain syndromes.³ We write out of concern for the rapidity of adoption of intranasal esketamine without considering the merits of IV ketamine.

When adopting new treatments or extending established drugs for newer indications, clinicians must balance beneficence and nonmaleficence. There is an urgent need for better treatment options for depression, suicidality, posttraumatic stress disorder (PTSD), and chronic pain in the veteran population. However, one must proceed with caution before wide adoption of a treatment that lacks real-world data on sustained or long-term benefits.⁴ Enthusiasm for this drug must also be tempered by the documented adverse effect (AE) of hepatic injury and the lack of data tracking this AE from repeated, long-term use.⁵ With these considerations in mind, reliable dosing and predictable pharmacokinetics are of great importance.

In addition to outpatient esketamine, outpatient IV administration of racemic ketamine remains an advantageous option with unique benefits compared with esketamine. Pharmacokinetically, IV ketamine is superior to intranasal esketamine. The bioavailability of intranasal esketamine is likely to be variable. A patient with a poor intranasal application or poor absorption might be falsely labeled an esketamine nonresponder. Increasing intranasal esketamine dosage to avoid false nonresponders may place other patients at risk for overdose and undesired AEs, including dysphoria and hallucinations. The variable bioavailability of intranasal ketamine adds complexity to the examination of its clinical effectiveness. IV ketamine should provide a predictable drug level and more reliable data. One might retort that esketamine is not the same as ketamine. True, esketamine is the S-enantiomer of ketamine, whereas ketamine is a racemic mixture of S- and R-ketamine. However, there is no clear evidence of clinically relevant differences between these formulations.⁵

Psychomimetic effects and cardiovascular changes are the most common short-term AEs resulting from ketamine.⁵ An IV infusion allows the treating physician to slowly titrate the administered ketamine to reach an effective concentration at the target site. Unlike an all-or-none intranasal administration, an infusion can be stopped at the first appearance of an AE. Psychomimetic effects, such as hallucinations, visual disturbances, and dysphoria are thought to occur in a dose-dependent fashion and remit once a ketamine infusion is stopped.⁵ Furthermore, cardiovascular AEs, such as hypertension and tachycardia, are commonly in patients with a body mass index > 30, with IV administration on a mg/kg basis. This suggests that calculated ideal body weight is a safer denominator, and reliable dosing is important to mitigating AEs.⁶

We urge caution with the widespread adoption of intranasal esketamine and suggest the advantages of the IV route, which offers predictability of AEs and titratability of dose. Questions remain regarding the appropriate dose and formulation of ketamine, rate of infusion, and route of administration for chronic pain and psychiatric indications.^5,7 It is our responsibility to further study the long-term safety profile of ketamine and determine an appropriate dose of ketamine. The IV route allows many veterans to be helped in a safe and controllable manner.

Eugene Raggi, MD; and Srikantha L. Rao, MD, MS, FAS

NATIONAL HARBOR, MD–The US Department of Veterans Affairs (VA) is in the midst of a significant change in the way it will deliver care to veterans. Agency officials remain optimistic that the change will be for the better, and early indications are positive.

The change is being driven by the VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (Mission) Act of 2018, a bill that opens health services options for veterans and integrates VA-administered care and care from community-based providers.

“This is change that is enhancing their experience in the system, and this is enhancing their options and the quality of the options in the system,” Jennifer MacDonald, MD, chief consultant to the principal deputy undersecretary for health at the VA, said during a December 3 session at the AMSUS 2019 annual meeting. “We need also for our workforce to understand how important they are to us across this degree of change.”

Dr. MacDonald highlighted integration with community-based care, including a community urgent care provision that allows veterans to access urgent care facilities and receive care without the need for prior authorization.

“The important piece about that is that we are also looking at the way this care has been accessed,” she said. “By and large, what we have seen from the data is that veterans are indeed seeking community urgent care at a site close to home. This may be CVS or Walgreens. It may be a stand-alone urgent care with a bit more functionality than those Minute Clinics tend to have. We are seeing veterans typically access care through those sites for those minor concerns and illnesses.”

However, she noted that this type of access does not alter the role the VA plays in administration of health care services.

“We are seeing them come back to VA for the majority of their care and for their core care–when there are serious issues, when insulin needs to be adjusted for diabetes, when there are heart disease medications that need to be refilled–we are seeing veterans not seek out urgent care, but come to us, and that is exactly what we want,” she said. “We want the continuity of care to continue and we want to help guide people to the right care, right place, right time.”

Dr. MacDonald also highlighted the expansion of a program that provides a stipend to caregivers that allows veterans to avoid institutionalization and remain within the community under that caregiver’s (a family or friend) supervision. This will expand by year’s end to Vietnam War-era veterans and within 2 years, to veterans that fall between the Vietnam War-era and the September 11, 2001, terrorist attacks.

“We wanted to do this equitably across all eras of veterans,” she said. “This now gives us that opportunity.”

Telehealth also plays a key role.

“For the first time ever, VA now has what we term ‘anywhere-to-anywhere’ telehealth under the Mission Act, an enormous opportunity for us,” she said. “Since we stretch … from New York City to Guam, we need the opportunity to provide care where it may be difficult to recruit and retain providers wherever veterans choose to live,” she said. “We believe that we should be able to meet people where they are regardless of where they choose to live. That’s an aspirational vision, but it is one we believe is exceptionally important and indeed we are moving toward that.”

These are just the beginning; the full implementation of the act goes out to 2034.

According to Dr. MacDonald, the agency is working hard to engage both veterans and the workforce to keep tabs on how the implementation is going.

“It’s a fundamental change in the day-to-day business that they’ve been doing, sometimes for years, and so extremely important across this change is that we have set up processes and now a joint operations center and a number of forums to hear directly from our front line and make sure that their issues are our issues in central office, in DC here, and that they feel heard and that they know that when they have needs, those needs are actioned,” she said.

The VA, under the Mission Act, is also working hard to engage health care providers in the community, including making VA training to community partners, including training on opioid use, suicide prevent and military culture.

However, all these change are for naught if the veterans are not on board. But so far, Dr. MacDonald said the early feedback is very positive.

She cited a VFW survey that asked a question about the Mission Act changes so far and whether they would recommend the VA to other veterans. Ninety percent of the respondents answered they would.

“That’s our marker that we are getting somewhere with these changes and the way we do business,” she said. “That is what we want to see continue to increase.”

NATIONAL HARBOR, MD–The US Department of Veterans Affairs (VA) is in the midst of a significant change in the way it will deliver care to veterans. Agency officials remain optimistic that the change will be for the better, and early indications are positive.

The change is being driven by the VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (Mission) Act of 2018, a bill that opens health services options for veterans and integrates VA-administered care and care from community-based providers.

“This is change that is enhancing their experience in the system, and this is enhancing their options and the quality of the options in the system,” Jennifer MacDonald, MD, chief consultant to the principal deputy undersecretary for health at the VA, said during a December 3 session at the AMSUS 2019 annual meeting. “We need also for our workforce to understand how important they are to us across this degree of change.”

Dr. MacDonald highlighted integration with community-based care, including a community urgent care provision that allows veterans to access urgent care facilities and receive care without the need for prior authorization.

“The important piece about that is that we are also looking at the way this care has been accessed,” she said. “By and large, what we have seen from the data is that veterans are indeed seeking community urgent care at a site close to home. This may be CVS or Walgreens. It may be a stand-alone urgent care with a bit more functionality than those Minute Clinics tend to have. We are seeing veterans typically access care through those sites for those minor concerns and illnesses.”

However, she noted that this type of access does not alter the role the VA plays in administration of health care services.

“We are seeing them come back to VA for the majority of their care and for their core care–when there are serious issues, when insulin needs to be adjusted for diabetes, when there are heart disease medications that need to be refilled–we are seeing veterans not seek out urgent care, but come to us, and that is exactly what we want,” she said. “We want the continuity of care to continue and we want to help guide people to the right care, right place, right time.”

Dr. MacDonald also highlighted the expansion of a program that provides a stipend to caregivers that allows veterans to avoid institutionalization and remain within the community under that caregiver’s (a family or friend) supervision. This will expand by year’s end to Vietnam War-era veterans and within 2 years, to veterans that fall between the Vietnam War-era and the September 11, 2001, terrorist attacks.

“We wanted to do this equitably across all eras of veterans,” she said. “This now gives us that opportunity.”

Telehealth also plays a key role.

“For the first time ever, VA now has what we term ‘anywhere-to-anywhere’ telehealth under the Mission Act, an enormous opportunity for us,” she said. “Since we stretch … from New York City to Guam, we need the opportunity to provide care where it may be difficult to recruit and retain providers wherever veterans choose to live,” she said. “We believe that we should be able to meet people where they are regardless of where they choose to live. That’s an aspirational vision, but it is one we believe is exceptionally important and indeed we are moving toward that.”

These are just the beginning; the full implementation of the act goes out to 2034.

According to Dr. MacDonald, the agency is working hard to engage both veterans and the workforce to keep tabs on how the implementation is going.

“It’s a fundamental change in the day-to-day business that they’ve been doing, sometimes for years, and so extremely important across this change is that we have set up processes and now a joint operations center and a number of forums to hear directly from our front line and make sure that their issues are our issues in central office, in DC here, and that they feel heard and that they know that when they have needs, those needs are actioned,” she said.

The VA, under the Mission Act, is also working hard to engage health care providers in the community, including making VA training to community partners, including training on opioid use, suicide prevent and military culture.

However, all these change are for naught if the veterans are not on board. But so far, Dr. MacDonald said the early feedback is very positive.

She cited a VFW survey that asked a question about the Mission Act changes so far and whether they would recommend the VA to other veterans. Ninety percent of the respondents answered they would.

“That’s our marker that we are getting somewhere with these changes and the way we do business,” she said. “That is what we want to see continue to increase.”

NATIONAL HARBOR, MD–The US Department of Veterans Affairs (VA) is in the midst of a significant change in the way it will deliver care to veterans. Agency officials remain optimistic that the change will be for the better, and early indications are positive.

The change is being driven by the VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (Mission) Act of 2018, a bill that opens health services options for veterans and integrates VA-administered care and care from community-based providers.

“This is change that is enhancing their experience in the system, and this is enhancing their options and the quality of the options in the system,” Jennifer MacDonald, MD, chief consultant to the principal deputy undersecretary for health at the VA, said during a December 3 session at the AMSUS 2019 annual meeting. “We need also for our workforce to understand how important they are to us across this degree of change.”

Dr. MacDonald highlighted integration with community-based care, including a community urgent care provision that allows veterans to access urgent care facilities and receive care without the need for prior authorization.

“The important piece about that is that we are also looking at the way this care has been accessed,” she said. “By and large, what we have seen from the data is that veterans are indeed seeking community urgent care at a site close to home. This may be CVS or Walgreens. It may be a stand-alone urgent care with a bit more functionality than those Minute Clinics tend to have. We are seeing veterans typically access care through those sites for those minor concerns and illnesses.”

However, she noted that this type of access does not alter the role the VA plays in administration of health care services.

“We are seeing them come back to VA for the majority of their care and for their core care–when there are serious issues, when insulin needs to be adjusted for diabetes, when there are heart disease medications that need to be refilled–we are seeing veterans not seek out urgent care, but come to us, and that is exactly what we want,” she said. “We want the continuity of care to continue and we want to help guide people to the right care, right place, right time.”

Dr. MacDonald also highlighted the expansion of a program that provides a stipend to caregivers that allows veterans to avoid institutionalization and remain within the community under that caregiver’s (a family or friend) supervision. This will expand by year’s end to Vietnam War-era veterans and within 2 years, to veterans that fall between the Vietnam War-era and the September 11, 2001, terrorist attacks.

“We wanted to do this equitably across all eras of veterans,” she said. “This now gives us that opportunity.”

Telehealth also plays a key role.

“For the first time ever, VA now has what we term ‘anywhere-to-anywhere’ telehealth under the Mission Act, an enormous opportunity for us,” she said. “Since we stretch … from New York City to Guam, we need the opportunity to provide care where it may be difficult to recruit and retain providers wherever veterans choose to live,” she said. “We believe that we should be able to meet people where they are regardless of where they choose to live. That’s an aspirational vision, but it is one we believe is exceptionally important and indeed we are moving toward that.”

These are just the beginning; the full implementation of the act goes out to 2034.

According to Dr. MacDonald, the agency is working hard to engage both veterans and the workforce to keep tabs on how the implementation is going.

“It’s a fundamental change in the day-to-day business that they’ve been doing, sometimes for years, and so extremely important across this change is that we have set up processes and now a joint operations center and a number of forums to hear directly from our front line and make sure that their issues are our issues in central office, in DC here, and that they feel heard and that they know that when they have needs, those needs are actioned,” she said.

The VA, under the Mission Act, is also working hard to engage health care providers in the community, including making VA training to community partners, including training on opioid use, suicide prevent and military culture.

However, all these change are for naught if the veterans are not on board. But so far, Dr. MacDonald said the early feedback is very positive.

She cited a VFW survey that asked a question about the Mission Act changes so far and whether they would recommend the VA to other veterans. Ninety percent of the respondents answered they would.

“That’s our marker that we are getting somewhere with these changes and the way we do business,” she said. “That is what we want to see continue to increase.”

A new American College of Obstetricians and Gynecologists (ACOG) committee opinion addresses how contraception access can be improved through over-the-counter (OTC) hormonal contraception for people of all ages—including oral contraceptive pills (OCPs), progesterone-only pills, the patch, vaginal rings, and depot medroxyprogesterone acetate (DMPA). Although ACOG endorses OTC contraception, some health care providers may be hesitant to support the increase in accessibility for a variety of reasons. We are hopeful that we address these concerns and that all clinicians can move to support ACOG’s position.

Easing access to hormonal contraception is a first step

OCPs are the most widely used contraception among teens and women of reproductive age in the United States.¹ Although the Affordable Care Act (ACA) mandated health insurance coverage for contraception, many barriers continue to exist, including obtaining a prescription. Only 13 states have made it legal to obtain hormonal contraception through a pharmacist.² There also has been an increase in the number of telemedicine and online services that deliver contraceptives to individuals’ homes. While these efforts have helped to decrease barriers to hormonal contraception access for some patients, they only reach a small segment of the population. As clinicians, we should strive to make contraception universally accessible and affordable to everyone who desires to use it. OTC provision can bring us closer to this goal.

Addressing the misconceptions about contraception

Adverse events with hormonal contraception are rarer than one may think. There are few risks associated with hormonal contraception. Venous thromboembolus (VTE) is a serious, although rare, adverse effect (AE) of hormonal contraception. The rate of VTE with combined oral contraception is estimated at 3 to 8 events per 10,000 patient-years, and VTE is even less common with progestin-only contraception (1 to 5 per 10,000 patient-years). For both types of hormonal contraception, the risk of VTE is smaller than with pregnancy, which is 5 to 20 per 10,000 patient-years.³ There are comorbidities that increase the risk of VTE and other AEs of hormonal contraception. In the setting of OTC hormonal contraception, individuals would self-screen for contraindications in order to reduce these complications.

Patients have the aptitude to self-screen for contraindications. Studies looking at the ability of patients over the age of 18 to self-screen for contraindications to hormonal contraception have found that patients do appropriately screen themselves. In fact, they are often more conservative than a physician in avoiding hormonal contraceptive methods.⁴ Patients younger than age 18 rarely have contraindications to hormonal contraception, but limited studies have shown that they too are able to successfully self-screen.⁵ ACOG recommends self-screening tools be provided with all OTC combined hormonal contraceptive methods to aid an individual’s contraceptive choice.

Most patients continue their well person care. Some opponents to ACOG’s position also have expressed concern that people who access their contraception OTC will forego their annual exam with their provider. However, studies have shown that the majority of people will continue to make their preventative health care visits.^6,7

We need to invest in preventing unplanned pregnancy

Currently, hormonal contraception is covered by health insurance under the ACA, with some caveats. Without a prescription, patients may have to pay full price for their contraception. However, one can find generic OCPs for less than $10 per pack out of pocket. Any cost can be prohibitive to many patients; thus, transition to OTC access to contraception also should ensure limiting the cost to the patient. One possible solution to mitigate costs is to require insurance companies to cover the cost of OTC hormonal contraceptives. (See action item below.)

Reduction in unplanned pregnancies improves public health and public expense, and broadening access to effective forms of contraception is imperative in reducing unplanned pregnancies. Every $1 invested in contraception access realizes $7.09 in savings.⁸ By making hormonal contraception widely available OTC, access could be improved dramatically—although pharmacist provision of hormonal contraception may be a necessary intermediate step. ACOG’s most recent committee opinion encourages all reproductive health care providers to be strong advocates for this improvement in access. As women’s health providers, we should work to decrease access barriers for our patients; working toward OTC contraception is a critical step in equal access to birth control methods for all of our patients.

Action items

Remember, before a pill can move to OTC access, the manufacturing (pharmaceutical) company must submit an application to the US Food and Drug Administration to obtain this status. Once submitted, the process may take 3 to 4 years to be completed. Currently, no company has submitted an OTC application and no hormonal birth control is available OTC. Find resources for OTC birth control access here: http://ocsotc.org/ and www.freethepill.org.

• Talk to your state representatives about why both OTC birth control access and direct pharmacy availability are important to increasing access and decreasing disparities in reproductive health care. Find your local and federal representatives here and check the status of OCP access in your state here.
• Representative Ayanna Pressley (D-MA) and Senator Patty Murray (D-WA) both have introduced legislation—the Affordability is Access Act (HR 3296/S1847)—to ensure insurance coverage for OTC contraception. Call your representative and ask them to cosponsor this legislation.
• Be mindful of legislation that promotes OTC OCPs but limits access to some populations (minors) and increases cost sharing to the patient. This type of legislation can create harmful barriers to access for some of our patients

A new American College of Obstetricians and Gynecologists (ACOG) committee opinion addresses how contraception access can be improved through over-the-counter (OTC) hormonal contraception for people of all ages—including oral contraceptive pills (OCPs), progesterone-only pills, the patch, vaginal rings, and depot medroxyprogesterone acetate (DMPA). Although ACOG endorses OTC contraception, some health care providers may be hesitant to support the increase in accessibility for a variety of reasons. We are hopeful that we address these concerns and that all clinicians can move to support ACOG’s position.

Easing access to hormonal contraception is a first step

OCPs are the most widely used contraception among teens and women of reproductive age in the United States.¹ Although the Affordable Care Act (ACA) mandated health insurance coverage for contraception, many barriers continue to exist, including obtaining a prescription. Only 13 states have made it legal to obtain hormonal contraception through a pharmacist.² There also has been an increase in the number of telemedicine and online services that deliver contraceptives to individuals’ homes. While these efforts have helped to decrease barriers to hormonal contraception access for some patients, they only reach a small segment of the population. As clinicians, we should strive to make contraception universally accessible and affordable to everyone who desires to use it. OTC provision can bring us closer to this goal.

Addressing the misconceptions about contraception

Adverse events with hormonal contraception are rarer than one may think. There are few risks associated with hormonal contraception. Venous thromboembolus (VTE) is a serious, although rare, adverse effect (AE) of hormonal contraception. The rate of VTE with combined oral contraception is estimated at 3 to 8 events per 10,000 patient-years, and VTE is even less common with progestin-only contraception (1 to 5 per 10,000 patient-years). For both types of hormonal contraception, the risk of VTE is smaller than with pregnancy, which is 5 to 20 per 10,000 patient-years.³ There are comorbidities that increase the risk of VTE and other AEs of hormonal contraception. In the setting of OTC hormonal contraception, individuals would self-screen for contraindications in order to reduce these complications.

Patients have the aptitude to self-screen for contraindications. Studies looking at the ability of patients over the age of 18 to self-screen for contraindications to hormonal contraception have found that patients do appropriately screen themselves. In fact, they are often more conservative than a physician in avoiding hormonal contraceptive methods.⁴ Patients younger than age 18 rarely have contraindications to hormonal contraception, but limited studies have shown that they too are able to successfully self-screen.⁵ ACOG recommends self-screening tools be provided with all OTC combined hormonal contraceptive methods to aid an individual’s contraceptive choice.

Most patients continue their well person care. Some opponents to ACOG’s position also have expressed concern that people who access their contraception OTC will forego their annual exam with their provider. However, studies have shown that the majority of people will continue to make their preventative health care visits.^6,7

We need to invest in preventing unplanned pregnancy

Currently, hormonal contraception is covered by health insurance under the ACA, with some caveats. Without a prescription, patients may have to pay full price for their contraception. However, one can find generic OCPs for less than $10 per pack out of pocket. Any cost can be prohibitive to many patients; thus, transition to OTC access to contraception also should ensure limiting the cost to the patient. One possible solution to mitigate costs is to require insurance companies to cover the cost of OTC hormonal contraceptives. (See action item below.)

Reduction in unplanned pregnancies improves public health and public expense, and broadening access to effective forms of contraception is imperative in reducing unplanned pregnancies. Every $1 invested in contraception access realizes $7.09 in savings.⁸ By making hormonal contraception widely available OTC, access could be improved dramatically—although pharmacist provision of hormonal contraception may be a necessary intermediate step. ACOG’s most recent committee opinion encourages all reproductive health care providers to be strong advocates for this improvement in access. As women’s health providers, we should work to decrease access barriers for our patients; working toward OTC contraception is a critical step in equal access to birth control methods for all of our patients.

Action items

Remember, before a pill can move to OTC access, the manufacturing (pharmaceutical) company must submit an application to the US Food and Drug Administration to obtain this status. Once submitted, the process may take 3 to 4 years to be completed. Currently, no company has submitted an OTC application and no hormonal birth control is available OTC. Find resources for OTC birth control access here: http://ocsotc.org/ and www.freethepill.org.

• Talk to your state representatives about why both OTC birth control access and direct pharmacy availability are important to increasing access and decreasing disparities in reproductive health care. Find your local and federal representatives here and check the status of OCP access in your state here.
• Representative Ayanna Pressley (D-MA) and Senator Patty Murray (D-WA) both have introduced legislation—the Affordability is Access Act (HR 3296/S1847)—to ensure insurance coverage for OTC contraception. Call your representative and ask them to cosponsor this legislation.
• Be mindful of legislation that promotes OTC OCPs but limits access to some populations (minors) and increases cost sharing to the patient. This type of legislation can create harmful barriers to access for some of our patients

A new American College of Obstetricians and Gynecologists (ACOG) committee opinion addresses how contraception access can be improved through over-the-counter (OTC) hormonal contraception for people of all ages—including oral contraceptive pills (OCPs), progesterone-only pills, the patch, vaginal rings, and depot medroxyprogesterone acetate (DMPA). Although ACOG endorses OTC contraception, some health care providers may be hesitant to support the increase in accessibility for a variety of reasons. We are hopeful that we address these concerns and that all clinicians can move to support ACOG’s position.

Easing access to hormonal contraception is a first step

OCPs are the most widely used contraception among teens and women of reproductive age in the United States.¹ Although the Affordable Care Act (ACA) mandated health insurance coverage for contraception, many barriers continue to exist, including obtaining a prescription. Only 13 states have made it legal to obtain hormonal contraception through a pharmacist.² There also has been an increase in the number of telemedicine and online services that deliver contraceptives to individuals’ homes. While these efforts have helped to decrease barriers to hormonal contraception access for some patients, they only reach a small segment of the population. As clinicians, we should strive to make contraception universally accessible and affordable to everyone who desires to use it. OTC provision can bring us closer to this goal.

Addressing the misconceptions about contraception

Adverse events with hormonal contraception are rarer than one may think. There are few risks associated with hormonal contraception. Venous thromboembolus (VTE) is a serious, although rare, adverse effect (AE) of hormonal contraception. The rate of VTE with combined oral contraception is estimated at 3 to 8 events per 10,000 patient-years, and VTE is even less common with progestin-only contraception (1 to 5 per 10,000 patient-years). For both types of hormonal contraception, the risk of VTE is smaller than with pregnancy, which is 5 to 20 per 10,000 patient-years.³ There are comorbidities that increase the risk of VTE and other AEs of hormonal contraception. In the setting of OTC hormonal contraception, individuals would self-screen for contraindications in order to reduce these complications.

Patients have the aptitude to self-screen for contraindications. Studies looking at the ability of patients over the age of 18 to self-screen for contraindications to hormonal contraception have found that patients do appropriately screen themselves. In fact, they are often more conservative than a physician in avoiding hormonal contraceptive methods.⁴ Patients younger than age 18 rarely have contraindications to hormonal contraception, but limited studies have shown that they too are able to successfully self-screen.⁵ ACOG recommends self-screening tools be provided with all OTC combined hormonal contraceptive methods to aid an individual’s contraceptive choice.

Most patients continue their well person care. Some opponents to ACOG’s position also have expressed concern that people who access their contraception OTC will forego their annual exam with their provider. However, studies have shown that the majority of people will continue to make their preventative health care visits.^6,7

We need to invest in preventing unplanned pregnancy

Currently, hormonal contraception is covered by health insurance under the ACA, with some caveats. Without a prescription, patients may have to pay full price for their contraception. However, one can find generic OCPs for less than $10 per pack out of pocket. Any cost can be prohibitive to many patients; thus, transition to OTC access to contraception also should ensure limiting the cost to the patient. One possible solution to mitigate costs is to require insurance companies to cover the cost of OTC hormonal contraceptives. (See action item below.)

Reduction in unplanned pregnancies improves public health and public expense, and broadening access to effective forms of contraception is imperative in reducing unplanned pregnancies. Every $1 invested in contraception access realizes $7.09 in savings.⁸ By making hormonal contraception widely available OTC, access could be improved dramatically—although pharmacist provision of hormonal contraception may be a necessary intermediate step. ACOG’s most recent committee opinion encourages all reproductive health care providers to be strong advocates for this improvement in access. As women’s health providers, we should work to decrease access barriers for our patients; working toward OTC contraception is a critical step in equal access to birth control methods for all of our patients.

Action items

Remember, before a pill can move to OTC access, the manufacturing (pharmaceutical) company must submit an application to the US Food and Drug Administration to obtain this status. Once submitted, the process may take 3 to 4 years to be completed. Currently, no company has submitted an OTC application and no hormonal birth control is available OTC. Find resources for OTC birth control access here: http://ocsotc.org/ and www.freethepill.org.

• Talk to your state representatives about why both OTC birth control access and direct pharmacy availability are important to increasing access and decreasing disparities in reproductive health care. Find your local and federal representatives here and check the status of OCP access in your state here.
• Representative Ayanna Pressley (D-MA) and Senator Patty Murray (D-WA) both have introduced legislation—the Affordability is Access Act (HR 3296/S1847)—to ensure insurance coverage for OTC contraception. Call your representative and ask them to cosponsor this legislation.
• Be mindful of legislation that promotes OTC OCPs but limits access to some populations (minors) and increases cost sharing to the patient. This type of legislation can create harmful barriers to access for some of our patients

A federal court has struck down a Trump administration rule that would have allowed clinicians to refuse to provide medical care to patients for religious or moral reasons.

In a Nov. 6 decision, the U.S. District Court for the Southern District of New York vacated President Trump’s rule in its entirety, concluding that the rule had no justification and that its provisions were arbitrary and capricious. In his 147-page opinion, District Judge Paul Engelmayer wrote that the U.S. Department of Health & Human Services did not have the authority to enact such an expansive rule and that the measure conflicts with the Administrative Procedure Act, Title VII of the Civil Rights Act, and the Emergency Medical Treatment & Labor Act, among other laws.

“Had the court found only narrow parts of the rule infirm, a remedy tailoring the vacatur to only the problematic provision might well have been viable,” Judge Engelmayer wrote. “The [Administrative Procedure Act] violations that the court has found, however, are numerous, fundamental, and far reaching ... In these circumstances, a decision to leave standing isolated shards of the rule that have not been found specifically infirm would ignore the big picture: that the rulemaking exercise here was sufficiently shot through with glaring legal defects as to not justify a search for survivors [and] leaving stray nonsubstantive provisions intact would not serve a useful purpose.”

At press time, the Trump administration had not indicated whether they plan to file an appeal.

Clare Coleman, president & CEO for the National Family Planning & Reproductive Health Association, a plaintiff in the case, said the organization was heartened by the ruling and that the judge’s decision protects health care for millions of Americans.

“The court safeguarded the public’s health by striking down the Trump administration’s health care refusal rule,” Ms. Coleman said in a statement. “This unlawful rule is an outright attack on the health and wellness of millions of people across the country, and the court heard clear and compelling arguments about the harm communities face when our health care system is distorted to the point in which a patient’s health care needs are not paramount.”

The conscience rule, finalized in May 2019 by HHS, would have allowed clinicians to refuse care to patients if they deemed that care was in conflict with their religious or moral beliefs. The provisions principally – although not exclusively – addressed objections to abortion, sterilization, and assisted suicide, as well as counseling and referrals associated with these services.

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0

According to HHS, the final rule fulfills President Trump’s promise to promote and protect rights of conscience and religious liberty. “This rule ensures that health care entities and professionals won’t be bullied out of the health care field because they decline to participate in actions that violate their conscience, including the taking of human life,” Roger Severino, director of the Office for Civil Rights, said in a statement. “Protecting conscience and religious freedom not only fosters greater diversity in health care, it’s the law.”

The judge’s order invalidating the rule consolidated three legal challenges against HHS over the rule. Plaintiffs included more than 15 states, Planned Parenthood Federation of America, and the National Family Planning & Reproductive Health Association, among others. The plaintiffs argued that the rule, scheduled to take effect on Nov. 22, would have threatened the ability of clinicians to provide essential, potentially life-saving medical care and would have exacerbated health disparities.

Stephanie Taub, senior counsel at the First Liberty Institute, an organization that represents religious freedom cases, said the court’s decision leaves health care professionals across America vulnerable to being forced “to perform, facilitate, or refer for procedures that violate their conscience.”

“The Trump administration’s HHS protections would ensure that health care professionals are free to work consistent with their religious beliefs while providing the best care to their patients,” Ms. Taub said in a statement.

The court’s decision comes less than a week after another district judge temporarily blocked an order by President Trump that would make having health insurance, or the ability to pay for medical care, a requirement for immigrants seeking U.S. visas. In that case, the judge said there are serious questions about whether President Trump’s immigration rule was arbitrary and capricious and, therefore, a violation of the Administrative Procedure Act. The order is on hold while the case continues through the courts.

[email protected]

A federal court has struck down a Trump administration rule that would have allowed clinicians to refuse to provide medical care to patients for religious or moral reasons.

In a Nov. 6 decision, the U.S. District Court for the Southern District of New York vacated President Trump’s rule in its entirety, concluding that the rule had no justification and that its provisions were arbitrary and capricious. In his 147-page opinion, District Judge Paul Engelmayer wrote that the U.S. Department of Health & Human Services did not have the authority to enact such an expansive rule and that the measure conflicts with the Administrative Procedure Act, Title VII of the Civil Rights Act, and the Emergency Medical Treatment & Labor Act, among other laws.

“Had the court found only narrow parts of the rule infirm, a remedy tailoring the vacatur to only the problematic provision might well have been viable,” Judge Engelmayer wrote. “The [Administrative Procedure Act] violations that the court has found, however, are numerous, fundamental, and far reaching ... In these circumstances, a decision to leave standing isolated shards of the rule that have not been found specifically infirm would ignore the big picture: that the rulemaking exercise here was sufficiently shot through with glaring legal defects as to not justify a search for survivors [and] leaving stray nonsubstantive provisions intact would not serve a useful purpose.”

At press time, the Trump administration had not indicated whether they plan to file an appeal.

Clare Coleman, president & CEO for the National Family Planning & Reproductive Health Association, a plaintiff in the case, said the organization was heartened by the ruling and that the judge’s decision protects health care for millions of Americans.

“The court safeguarded the public’s health by striking down the Trump administration’s health care refusal rule,” Ms. Coleman said in a statement. “This unlawful rule is an outright attack on the health and wellness of millions of people across the country, and the court heard clear and compelling arguments about the harm communities face when our health care system is distorted to the point in which a patient’s health care needs are not paramount.”

The conscience rule, finalized in May 2019 by HHS, would have allowed clinicians to refuse care to patients if they deemed that care was in conflict with their religious or moral beliefs. The provisions principally – although not exclusively – addressed objections to abortion, sterilization, and assisted suicide, as well as counseling and referrals associated with these services.

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0

According to HHS, the final rule fulfills President Trump’s promise to promote and protect rights of conscience and religious liberty. “This rule ensures that health care entities and professionals won’t be bullied out of the health care field because they decline to participate in actions that violate their conscience, including the taking of human life,” Roger Severino, director of the Office for Civil Rights, said in a statement. “Protecting conscience and religious freedom not only fosters greater diversity in health care, it’s the law.”

The judge’s order invalidating the rule consolidated three legal challenges against HHS over the rule. Plaintiffs included more than 15 states, Planned Parenthood Federation of America, and the National Family Planning & Reproductive Health Association, among others. The plaintiffs argued that the rule, scheduled to take effect on Nov. 22, would have threatened the ability of clinicians to provide essential, potentially life-saving medical care and would have exacerbated health disparities.

Stephanie Taub, senior counsel at the First Liberty Institute, an organization that represents religious freedom cases, said the court’s decision leaves health care professionals across America vulnerable to being forced “to perform, facilitate, or refer for procedures that violate their conscience.”

“The Trump administration’s HHS protections would ensure that health care professionals are free to work consistent with their religious beliefs while providing the best care to their patients,” Ms. Taub said in a statement.

The court’s decision comes less than a week after another district judge temporarily blocked an order by President Trump that would make having health insurance, or the ability to pay for medical care, a requirement for immigrants seeking U.S. visas. In that case, the judge said there are serious questions about whether President Trump’s immigration rule was arbitrary and capricious and, therefore, a violation of the Administrative Procedure Act. The order is on hold while the case continues through the courts.

[email protected]

A federal court has struck down a Trump administration rule that would have allowed clinicians to refuse to provide medical care to patients for religious or moral reasons.

In a Nov. 6 decision, the U.S. District Court for the Southern District of New York vacated President Trump’s rule in its entirety, concluding that the rule had no justification and that its provisions were arbitrary and capricious. In his 147-page opinion, District Judge Paul Engelmayer wrote that the U.S. Department of Health & Human Services did not have the authority to enact such an expansive rule and that the measure conflicts with the Administrative Procedure Act, Title VII of the Civil Rights Act, and the Emergency Medical Treatment & Labor Act, among other laws.

“Had the court found only narrow parts of the rule infirm, a remedy tailoring the vacatur to only the problematic provision might well have been viable,” Judge Engelmayer wrote. “The [Administrative Procedure Act] violations that the court has found, however, are numerous, fundamental, and far reaching ... In these circumstances, a decision to leave standing isolated shards of the rule that have not been found specifically infirm would ignore the big picture: that the rulemaking exercise here was sufficiently shot through with glaring legal defects as to not justify a search for survivors [and] leaving stray nonsubstantive provisions intact would not serve a useful purpose.”

At press time, the Trump administration had not indicated whether they plan to file an appeal.

Clare Coleman, president & CEO for the National Family Planning & Reproductive Health Association, a plaintiff in the case, said the organization was heartened by the ruling and that the judge’s decision protects health care for millions of Americans.

“The court safeguarded the public’s health by striking down the Trump administration’s health care refusal rule,” Ms. Coleman said in a statement. “This unlawful rule is an outright attack on the health and wellness of millions of people across the country, and the court heard clear and compelling arguments about the harm communities face when our health care system is distorted to the point in which a patient’s health care needs are not paramount.”

The conscience rule, finalized in May 2019 by HHS, would have allowed clinicians to refuse care to patients if they deemed that care was in conflict with their religious or moral beliefs. The provisions principally – although not exclusively – addressed objections to abortion, sterilization, and assisted suicide, as well as counseling and referrals associated with these services.

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0

According to HHS, the final rule fulfills President Trump’s promise to promote and protect rights of conscience and religious liberty. “This rule ensures that health care entities and professionals won’t be bullied out of the health care field because they decline to participate in actions that violate their conscience, including the taking of human life,” Roger Severino, director of the Office for Civil Rights, said in a statement. “Protecting conscience and religious freedom not only fosters greater diversity in health care, it’s the law.”

The judge’s order invalidating the rule consolidated three legal challenges against HHS over the rule. Plaintiffs included more than 15 states, Planned Parenthood Federation of America, and the National Family Planning & Reproductive Health Association, among others. The plaintiffs argued that the rule, scheduled to take effect on Nov. 22, would have threatened the ability of clinicians to provide essential, potentially life-saving medical care and would have exacerbated health disparities.

Stephanie Taub, senior counsel at the First Liberty Institute, an organization that represents religious freedom cases, said the court’s decision leaves health care professionals across America vulnerable to being forced “to perform, facilitate, or refer for procedures that violate their conscience.”

“The Trump administration’s HHS protections would ensure that health care professionals are free to work consistent with their religious beliefs while providing the best care to their patients,” Ms. Taub said in a statement.

The court’s decision comes less than a week after another district judge temporarily blocked an order by President Trump that would make having health insurance, or the ability to pay for medical care, a requirement for immigrants seeking U.S. visas. In that case, the judge said there are serious questions about whether President Trump’s immigration rule was arbitrary and capricious and, therefore, a violation of the Administrative Procedure Act. The order is on hold while the case continues through the courts.

[email protected]

Digitalization of patient-specific information over the past 2 decades has dramatically altered health care delivery. Nonetheless, this technology has yet to live up to its promise of improving patient outcomes, in part due to data storage challenges as well as the emphasis on data entry to support administrative and financial goals of the institution.^1-4 Substantially less emphasis has been placed on the retrieval of information required for accurate diagnosis.

A new search engine, Voogle, is now available through Microsoft Internet Explorer (Redmond, WA) to all providers in the US Department of Veterans Affairs (VA) on any intranet-enabled computer behind the VA firewall. Voogle facilitates rapid query-based search and retrieval of patient-specific data in the VA Corporate Data Warehouse (CDW).

Case Example

A veteran presented requesting consideration for implantation of a new device for obstructive sleep apnea. Guidelines for implantation of the new device specify a narrow therapeutic window, so determination of his apnea-hypopnea index (AHI) was critical. The patient had received care at more than 20 VA facilities and knew the approximate year the test had been performed at a non-VA facility.

A health care provider (HCP) using Voogle from his VA computer indexed all Veterans Information Systems and Technology Architecture (VistA) notes for the desired date range. The indexing of > 200 notes was completed in seconds. The HCP opened the indexed records with Voogle and entered a query for “sleep apnea,” which displayed multiple instances of the term within the patient record notes. A VA HCP had previously entered the data from the outside sleep study into a note shortly after the study.

This information was found immediately by sorting the indexed notes by date. The total time required by Voogle to find and display the critical information from the sleep study entered at a different VA more than a dozen years earlier was about 1 minute. These data provided the information needed for decision making at the time of the current patient encounter, without which repeat (and unnecessary) testing would have been required.

Information Overload

Electronic health records (EHRs) such as VistA, upload, store, collate, and present data in near real-time across multiple locations. Although the availability of these data can potentially reduce the risk of error due to missing critical information, its sheer volume limits its utility for point-of-care decision making. Much patient-specific text data found in clinical notes are recorded for administrative, financial, and business purposes rather than to support patient care decision making.^1-3 The majority of data documents processes of care rather than HCP observations, assessment of current status, or plans for care. Much of this text is inserted into templates, consists of imported structured data elements, and may contain repeated copy-and-paste free text.

Data uploaded to the CDW are aggregated from multiple hospitals, each with its own “instance” of VistA. Often the CDW contains thousands of text notes for a single patient. This volume of text may conceal critical historical information needed for patient care mixed with a plethora of duplicated or extraneous text entered to satisfy administrative requirements. The effects of information overload and poor system usability have been studied extensively in other disciplines, but this science has largely not been incorporated into EHR design.^1,3,4

A position paper published recently by the American College of Physicians notes that physician cognitive work is adversely impacted by the incorporation of nonclinical information into the EHR for use by other administrative and financial functions.²

Information Chaos

Beasley and colleagues noted that information in an EHR needed for optimal care may be unavailable, inadequate, scattered, conflicting, lost, or inaccurate, a condition they term information chaos.⁵ Smith and colleagues reported that decision making in 1 of 7 primary care visits was impaired by missing critical information. Surveyed HCPs estimated that 44% of patients with missing information may receive compromised care as a result, including delayed or erroneous diagnosis and increased costs due to duplication of diagnostic testing.⁶

Even when technically available, the usability of patient-specific data needed for accurate diagnosis is compromised if the HCP cannot find the information. In most systems data storage paradigms mirror database design rather than provider cognitive models. Ultimately, the design of current EHR interaction paradigms squanders precious cognitive resources and time, particularly during patient encounters, leaving little available for the cognitive tasks necessary for accurate diagnosis and treatment decisions.^1,3,4,7

VA Corporate Data Warehouse

VistA was implemented as a decentralized system with 130 instances, each of which is a freestanding EHR. However, as all systems share common data structures, the data can be combined from multiple instances when needed. The VA established a CDW more than 15 years ago in order to collate information from multiple sites to support operations as well as to seek new insights. The CDW currently updates nightly from all 130 EHR instances and is the only location in which patient information from all treating sites is combined. Voogle can access the CDW through the Veterans Informatics and Computing Infrastructure (VINCI), which is a mirror of the CDW databases and was established as a secure research environment.

The CDW contains information on 25 million veterans, with about 15 terabytes of text data. Approximately 4 billion data points, including 1 million text notes, are accrued nightly. The Integrated Control Number (ICN), a unique patient identifier, is assigned to each CDW record and is cross-indexed in the master patient index. All CDW data are tied to the ICN, facilitating access to and attribution of all patient data from all VA sites. Voogle relies on this identifier to build indexed files, or domains (which are document collections), of requested specific patient information to support its search algorithm.

Structured Data

Most of the data accrued in an EHR are structured data (such as laboratory test results and vital signs) and stored in a defined database framework. Voogle uses iFind (Intersystems Inc, Cambridge, MA) to index, count, and then search for requested information within structured data fields.

Unstructured Text

In contrast to structured data, text notes are stored as documents that are retrievable by patient, author, date, clinic, as well as numerous other fields. Unstructured (free) text notes are more information rich than either structured data or templated notes since their narrative format more closely parallels providers’ cognitive processes.^1,7 The value of the narrative becomes even more critical in understanding complex clinical scenarios with multiple interacting disease processes. Narratives emphasize important details, reducing cognitive overload by reducing the salience of detail the author deems to be less critical. Narrative notes simultaneously assure availability through the use of unstandardized language, often including specialty and disease-specific abbreviations.¹ Information needed for decision making in the illustrative case in this report was present only in HCP-entered free-text notes, as the structured data from which the free text was derived were not available.

Search

The introduction of search engines can be considered one of the major technologic disruptors of the 21st century.⁸ However, this advance has not yet made significant inroads into health care, despite advances in other domains. As of 2019, EHR users are still required to be familiar with the system’s data and menu structure in order to find needed information (or enter orders, code visits, or any of a number of tasks). Anecdotally, one of the authors (David Eibling) observed that the most common question from his trainees is “How do you . . .?” referring not to the care of the patient but rather to interaction with the EHR.

What is needed is a simple query-based application that finds the data on request. In addition to Voogle, other advances are being made in this arena such as the EMERSE, medical record search engine (project-emerse.org). Voogle was released to VA providers in 2017 and is available through the Internet Explorer browser on VA computers with VA intranet access. The goal of Voogle is to reduce HCP cognitive load by reducing the time and effort needed to seek relevant information for the care of a specific patient.

Natural Language Processing

Linguistic analysis of text seeking to understand its meaning constitutes a rapidly expanding field, with current heavy emphasis on the role of artificial intelligence and machine learning.¹ Advances in processing both structured data and free-text notes in the health care domain is in its infancy, despite the investment of considerable resources. Undoubtedly, advances in this arena will dramatically change provider cognitive work in the next decades.

VistA is coded in MUMPS (Massachusetts General Hospital Utility Multi-Programming System, also known as M), which has been in use for more than 50 years. Voogle employs iKnow, a novel natural language processing (NLP) application that resides in Caché (Intersystems, Boston, MA), the vendor-supported MUMPS infrastructure VistA uses to perform text analysis. iKnow does not attempt to interpret the meaning of text as do other common NLP applications, but instead relies on the expert user to interpret the meaning of the analyzed text. iKnow initially divides sentences into relations (usually verbs) and concepts, and then generates an index of these entities. The efficiency of iKnow results in very rapid indexing—often several thousand notes (not an uncommon number) can be indexed in 20 to 30 seconds. iKnow responds to a user query by searching for specific terms or similar terms within the indexed text, and then displays these terms within the original source documents, similar to well-known commercial search engines. Structured data are indexed by the iFind program simultaneously with free-text indexing (Figure 1).

Security

Maintaining high levels of security of Health Insurance Portability and Accountability (HIPAA)-compliant information in an online application such as Voogle is critical to ensure trust of veterans and HCPs. All patient data accessed by Voogle reside within the secure firewall-protected VINCI environment. All moving information is protected with high-level encryption protocols (transport layer security [TLS]), and data at rest are also encrypted. As the application is online, no data are stored on the accessing device. Voogle uses a secure Microsoft Windows logon using VA Active Directory coupled with VistA authorization to regulate who can see the data and use the application. All access is audited, not only for “sensitive patients,” but also for specific data types. Users are reminded of this Voogle attribute on the home screen.

Accessing Voogle

Voogle is available on the VA intranet to all authorized users at https://voogle.vha.med.va.gov/voogle. To assure high-level security the application can only be accessed with the Internet Explorer browser using established user identification protocols to avoid unauthorized access or duplicative log-in tasks.

Indexing

Indexing is user-driven and is required prior to patient selection and term query. The user is prompted for a patient identifier and a date range. The CDW unique patient identifier is used for all internal processing. However, a social security number look-up table is incorporated to facilitate patient selection. The date field defaults to 3 years but can be extended to approximately the year 2000.

Queries

Entering the patient name in Lastname, Firstname (no space) format will yield a list of indexed patients. All access is audited in order to deter unauthorized queries. Data from a demonstration patient are displayed in Figures 2, 3, 4, 5,
and 6.

Structured Data Searches

Structured data categories that contain the queried term, as well as a term count, are displayed after the “Structured Data” toggle is selected (Figure 2). After the desired category (Figure 2: “Outpatient Rx”) is selected, Voogle accesses the data file and displays it as a grid (medication list, Figure 3). Filter and sort functions enable display of specific medications, drug classes, or date ranges (Figure 4).

Display of Terms Within Text Notes

Selecting a term from the drop-down list (Figure 5) opens a grid with the term highlighted in a snippet of text (Figure 6). Opening the document displays the context of the term, along with negation terms (ie, not, denies, no, etc) in red font if present. Voogle, unlike other NLP tools that attempt to interpret medical notes, relies on interpretation by the HCP user. Duplicate note fragments will be displayed in multiple notes, often across multiple screens, vividly demonstrating the pervasive use of the copy-and-paste text-entry strategy. Voogle satisfies 2 of the 4 recommendations of the recent report on copy-and-paste by Tsou and colleagues.⁹ The Voogle text display grid identifies copy-and-pasted text as well as establishes the provenance of the text (by sorting on the date column). Text can be copied from Voogle into an active Computerized Patient Record System (CPRS) note if needed for active patient care. Reindexing the following day and then repeating the search will demonstrate the newly copied-and-pasted text appended to the sequence.

Limitations

Voogle is unable to access all VA patient data currently. There are a dozen or so clinical domains that are indexed by Voogle that include prescriptions, problem lists, health factors, and others. More domains can be added with minimal effort and would then be available for fast search. The most critical deficiency is its inability to access, index, or query text reports stored as images within VistA Imaging. This includes nearly all reports from outside HCPs, emergency department visits or discharge summaries from unlinked hospitals, anesthesia reports, intensive care unit flow sheets, electrocardiograms, as well as numerous other text reports such as pulmonary function reports or sleep studies. Information that is transcribed by the provider into VistA as text (as in the case presented) is available within the CDW and can be found and displayed by Voogle search.

Voogle requires that the user initiates the indexing process prior to initiating the search process. Although Voogle defaults to 3 years prior to the current date, the user can specify a start date extending to close to the year 2000. The volume of data flowing into the CDW precludes automatic indexing of all patient data, as well as automatic updating of previously indexed data. We have explored the feasibility of queueing scheduled appointments for the following day, and although the strategy shows some promise, avoiding conflict with user-requested on-demand indexing remains challenging.

The current VA network architecture updates the CDW every night, resulting in up to a 24-hour delay in data availability. However, this delay should be reduced to several minutes after implementation of real-time data feeds accompanying the coming transition to a new EHR platform.

Conclusions

The recent introduction of the Joint Legacy Viewer (JLV) to the VA EHR desktop has enhanced the breadth of patient-specific information available to any VHA clinician, with recent enhancements providing access to some community care notes from outside HCPs. Voogle builds on this capability by enabling rapid search of text notes and structured data from multiple VA sites, over an extended time frame, and perhaps entered by hundreds of authors, as demonstrated in the case example. Formal usability and workload studies have not been performed; however, anecdotal reports indicate the application dramatically reduces the time required to search for critical information needed for care of complex patients who have been treated in multiple different VA hospitals and clinics.

The Voogle paradigm of leveraging patient information stored within a large enterprise-wide data warehouse through NLP techniques may be applicable to other systems as well, and warrants exploration. We believe that replacing traditional data search paradigms that require knowledge of data structure with a true query-based paradigm is a potential game changer for health information systems. Ultimately this strategy may help provide an antidote for the information chaos impacting HCP cognition. Moreover, reducing HCP cognitive load and time on task may lessen overall health care costs, reduce provider burn-out, and improve the quality of care received by patients.

Near real-time data feeds and adding additional clinical domains will potentially provide other benefits to patient care. For example, the authors plan to investigate whether sampling incoming data may assist with behind-the-scenes continuous monitoring of indicators of patient status to facilitate early warning of impending physiologic collapse.¹⁰ Other possible applications could include real-time scans for biosurveillance or other population screening requirements.

Acknowledgments
The authors express their sincere appreciation to Leslie DeYoung for documentation and Justin Wilson who constructed much of the graphical user interface for the Voogle application and design. Without their expertise, passion, and commitment the application would not be available as it is now.

Digitalization of patient-specific information over the past 2 decades has dramatically altered health care delivery. Nonetheless, this technology has yet to live up to its promise of improving patient outcomes, in part due to data storage challenges as well as the emphasis on data entry to support administrative and financial goals of the institution.^1-4 Substantially less emphasis has been placed on the retrieval of information required for accurate diagnosis.

A new search engine, Voogle, is now available through Microsoft Internet Explorer (Redmond, WA) to all providers in the US Department of Veterans Affairs (VA) on any intranet-enabled computer behind the VA firewall. Voogle facilitates rapid query-based search and retrieval of patient-specific data in the VA Corporate Data Warehouse (CDW).

Case Example

A veteran presented requesting consideration for implantation of a new device for obstructive sleep apnea. Guidelines for implantation of the new device specify a narrow therapeutic window, so determination of his apnea-hypopnea index (AHI) was critical. The patient had received care at more than 20 VA facilities and knew the approximate year the test had been performed at a non-VA facility.

A health care provider (HCP) using Voogle from his VA computer indexed all Veterans Information Systems and Technology Architecture (VistA) notes for the desired date range. The indexing of > 200 notes was completed in seconds. The HCP opened the indexed records with Voogle and entered a query for “sleep apnea,” which displayed multiple instances of the term within the patient record notes. A VA HCP had previously entered the data from the outside sleep study into a note shortly after the study.

This information was found immediately by sorting the indexed notes by date. The total time required by Voogle to find and display the critical information from the sleep study entered at a different VA more than a dozen years earlier was about 1 minute. These data provided the information needed for decision making at the time of the current patient encounter, without which repeat (and unnecessary) testing would have been required.

Information Overload

Electronic health records (EHRs) such as VistA, upload, store, collate, and present data in near real-time across multiple locations. Although the availability of these data can potentially reduce the risk of error due to missing critical information, its sheer volume limits its utility for point-of-care decision making. Much patient-specific text data found in clinical notes are recorded for administrative, financial, and business purposes rather than to support patient care decision making.^1-3 The majority of data documents processes of care rather than HCP observations, assessment of current status, or plans for care. Much of this text is inserted into templates, consists of imported structured data elements, and may contain repeated copy-and-paste free text.

Data uploaded to the CDW are aggregated from multiple hospitals, each with its own “instance” of VistA. Often the CDW contains thousands of text notes for a single patient. This volume of text may conceal critical historical information needed for patient care mixed with a plethora of duplicated or extraneous text entered to satisfy administrative requirements. The effects of information overload and poor system usability have been studied extensively in other disciplines, but this science has largely not been incorporated into EHR design.^1,3,4

A position paper published recently by the American College of Physicians notes that physician cognitive work is adversely impacted by the incorporation of nonclinical information into the EHR for use by other administrative and financial functions.²

Information Chaos

Beasley and colleagues noted that information in an EHR needed for optimal care may be unavailable, inadequate, scattered, conflicting, lost, or inaccurate, a condition they term information chaos.⁵ Smith and colleagues reported that decision making in 1 of 7 primary care visits was impaired by missing critical information. Surveyed HCPs estimated that 44% of patients with missing information may receive compromised care as a result, including delayed or erroneous diagnosis and increased costs due to duplication of diagnostic testing.⁶

Even when technically available, the usability of patient-specific data needed for accurate diagnosis is compromised if the HCP cannot find the information. In most systems data storage paradigms mirror database design rather than provider cognitive models. Ultimately, the design of current EHR interaction paradigms squanders precious cognitive resources and time, particularly during patient encounters, leaving little available for the cognitive tasks necessary for accurate diagnosis and treatment decisions.^1,3,4,7

VA Corporate Data Warehouse

VistA was implemented as a decentralized system with 130 instances, each of which is a freestanding EHR. However, as all systems share common data structures, the data can be combined from multiple instances when needed. The VA established a CDW more than 15 years ago in order to collate information from multiple sites to support operations as well as to seek new insights. The CDW currently updates nightly from all 130 EHR instances and is the only location in which patient information from all treating sites is combined. Voogle can access the CDW through the Veterans Informatics and Computing Infrastructure (VINCI), which is a mirror of the CDW databases and was established as a secure research environment.

The CDW contains information on 25 million veterans, with about 15 terabytes of text data. Approximately 4 billion data points, including 1 million text notes, are accrued nightly. The Integrated Control Number (ICN), a unique patient identifier, is assigned to each CDW record and is cross-indexed in the master patient index. All CDW data are tied to the ICN, facilitating access to and attribution of all patient data from all VA sites. Voogle relies on this identifier to build indexed files, or domains (which are document collections), of requested specific patient information to support its search algorithm.

Structured Data

Most of the data accrued in an EHR are structured data (such as laboratory test results and vital signs) and stored in a defined database framework. Voogle uses iFind (Intersystems Inc, Cambridge, MA) to index, count, and then search for requested information within structured data fields.

Unstructured Text

In contrast to structured data, text notes are stored as documents that are retrievable by patient, author, date, clinic, as well as numerous other fields. Unstructured (free) text notes are more information rich than either structured data or templated notes since their narrative format more closely parallels providers’ cognitive processes.^1,7 The value of the narrative becomes even more critical in understanding complex clinical scenarios with multiple interacting disease processes. Narratives emphasize important details, reducing cognitive overload by reducing the salience of detail the author deems to be less critical. Narrative notes simultaneously assure availability through the use of unstandardized language, often including specialty and disease-specific abbreviations.¹ Information needed for decision making in the illustrative case in this report was present only in HCP-entered free-text notes, as the structured data from which the free text was derived were not available.

Search

The introduction of search engines can be considered one of the major technologic disruptors of the 21st century.⁸ However, this advance has not yet made significant inroads into health care, despite advances in other domains. As of 2019, EHR users are still required to be familiar with the system’s data and menu structure in order to find needed information (or enter orders, code visits, or any of a number of tasks). Anecdotally, one of the authors (David Eibling) observed that the most common question from his trainees is “How do you . . .?” referring not to the care of the patient but rather to interaction with the EHR.

What is needed is a simple query-based application that finds the data on request. In addition to Voogle, other advances are being made in this arena such as the EMERSE, medical record search engine (project-emerse.org). Voogle was released to VA providers in 2017 and is available through the Internet Explorer browser on VA computers with VA intranet access. The goal of Voogle is to reduce HCP cognitive load by reducing the time and effort needed to seek relevant information for the care of a specific patient.

Natural Language Processing

Linguistic analysis of text seeking to understand its meaning constitutes a rapidly expanding field, with current heavy emphasis on the role of artificial intelligence and machine learning.¹ Advances in processing both structured data and free-text notes in the health care domain is in its infancy, despite the investment of considerable resources. Undoubtedly, advances in this arena will dramatically change provider cognitive work in the next decades.

VistA is coded in MUMPS (Massachusetts General Hospital Utility Multi-Programming System, also known as M), which has been in use for more than 50 years. Voogle employs iKnow, a novel natural language processing (NLP) application that resides in Caché (Intersystems, Boston, MA), the vendor-supported MUMPS infrastructure VistA uses to perform text analysis. iKnow does not attempt to interpret the meaning of text as do other common NLP applications, but instead relies on the expert user to interpret the meaning of the analyzed text. iKnow initially divides sentences into relations (usually verbs) and concepts, and then generates an index of these entities. The efficiency of iKnow results in very rapid indexing—often several thousand notes (not an uncommon number) can be indexed in 20 to 30 seconds. iKnow responds to a user query by searching for specific terms or similar terms within the indexed text, and then displays these terms within the original source documents, similar to well-known commercial search engines. Structured data are indexed by the iFind program simultaneously with free-text indexing (Figure 1).

Security

Maintaining high levels of security of Health Insurance Portability and Accountability (HIPAA)-compliant information in an online application such as Voogle is critical to ensure trust of veterans and HCPs. All patient data accessed by Voogle reside within the secure firewall-protected VINCI environment. All moving information is protected with high-level encryption protocols (transport layer security [TLS]), and data at rest are also encrypted. As the application is online, no data are stored on the accessing device. Voogle uses a secure Microsoft Windows logon using VA Active Directory coupled with VistA authorization to regulate who can see the data and use the application. All access is audited, not only for “sensitive patients,” but also for specific data types. Users are reminded of this Voogle attribute on the home screen.

Accessing Voogle

Voogle is available on the VA intranet to all authorized users at https://voogle.vha.med.va.gov/voogle. To assure high-level security the application can only be accessed with the Internet Explorer browser using established user identification protocols to avoid unauthorized access or duplicative log-in tasks.

Indexing

Indexing is user-driven and is required prior to patient selection and term query. The user is prompted for a patient identifier and a date range. The CDW unique patient identifier is used for all internal processing. However, a social security number look-up table is incorporated to facilitate patient selection. The date field defaults to 3 years but can be extended to approximately the year 2000.

Queries

Entering the patient name in Lastname, Firstname (no space) format will yield a list of indexed patients. All access is audited in order to deter unauthorized queries. Data from a demonstration patient are displayed in Figures 2, 3, 4, 5,
and 6.

Structured Data Searches

Structured data categories that contain the queried term, as well as a term count, are displayed after the “Structured Data” toggle is selected (Figure 2). After the desired category (Figure 2: “Outpatient Rx”) is selected, Voogle accesses the data file and displays it as a grid (medication list, Figure 3). Filter and sort functions enable display of specific medications, drug classes, or date ranges (Figure 4).

Display of Terms Within Text Notes

Selecting a term from the drop-down list (Figure 5) opens a grid with the term highlighted in a snippet of text (Figure 6). Opening the document displays the context of the term, along with negation terms (ie, not, denies, no, etc) in red font if present. Voogle, unlike other NLP tools that attempt to interpret medical notes, relies on interpretation by the HCP user. Duplicate note fragments will be displayed in multiple notes, often across multiple screens, vividly demonstrating the pervasive use of the copy-and-paste text-entry strategy. Voogle satisfies 2 of the 4 recommendations of the recent report on copy-and-paste by Tsou and colleagues.⁹ The Voogle text display grid identifies copy-and-pasted text as well as establishes the provenance of the text (by sorting on the date column). Text can be copied from Voogle into an active Computerized Patient Record System (CPRS) note if needed for active patient care. Reindexing the following day and then repeating the search will demonstrate the newly copied-and-pasted text appended to the sequence.

Limitations

Voogle is unable to access all VA patient data currently. There are a dozen or so clinical domains that are indexed by Voogle that include prescriptions, problem lists, health factors, and others. More domains can be added with minimal effort and would then be available for fast search. The most critical deficiency is its inability to access, index, or query text reports stored as images within VistA Imaging. This includes nearly all reports from outside HCPs, emergency department visits or discharge summaries from unlinked hospitals, anesthesia reports, intensive care unit flow sheets, electrocardiograms, as well as numerous other text reports such as pulmonary function reports or sleep studies. Information that is transcribed by the provider into VistA as text (as in the case presented) is available within the CDW and can be found and displayed by Voogle search.

Voogle requires that the user initiates the indexing process prior to initiating the search process. Although Voogle defaults to 3 years prior to the current date, the user can specify a start date extending to close to the year 2000. The volume of data flowing into the CDW precludes automatic indexing of all patient data, as well as automatic updating of previously indexed data. We have explored the feasibility of queueing scheduled appointments for the following day, and although the strategy shows some promise, avoiding conflict with user-requested on-demand indexing remains challenging.

The current VA network architecture updates the CDW every night, resulting in up to a 24-hour delay in data availability. However, this delay should be reduced to several minutes after implementation of real-time data feeds accompanying the coming transition to a new EHR platform.

Conclusions

The recent introduction of the Joint Legacy Viewer (JLV) to the VA EHR desktop has enhanced the breadth of patient-specific information available to any VHA clinician, with recent enhancements providing access to some community care notes from outside HCPs. Voogle builds on this capability by enabling rapid search of text notes and structured data from multiple VA sites, over an extended time frame, and perhaps entered by hundreds of authors, as demonstrated in the case example. Formal usability and workload studies have not been performed; however, anecdotal reports indicate the application dramatically reduces the time required to search for critical information needed for care of complex patients who have been treated in multiple different VA hospitals and clinics.

The Voogle paradigm of leveraging patient information stored within a large enterprise-wide data warehouse through NLP techniques may be applicable to other systems as well, and warrants exploration. We believe that replacing traditional data search paradigms that require knowledge of data structure with a true query-based paradigm is a potential game changer for health information systems. Ultimately this strategy may help provide an antidote for the information chaos impacting HCP cognition. Moreover, reducing HCP cognitive load and time on task may lessen overall health care costs, reduce provider burn-out, and improve the quality of care received by patients.

Near real-time data feeds and adding additional clinical domains will potentially provide other benefits to patient care. For example, the authors plan to investigate whether sampling incoming data may assist with behind-the-scenes continuous monitoring of indicators of patient status to facilitate early warning of impending physiologic collapse.¹⁰ Other possible applications could include real-time scans for biosurveillance or other population screening requirements.

Acknowledgments
The authors express their sincere appreciation to Leslie DeYoung for documentation and Justin Wilson who constructed much of the graphical user interface for the Voogle application and design. Without their expertise, passion, and commitment the application would not be available as it is now.

Digitalization of patient-specific information over the past 2 decades has dramatically altered health care delivery. Nonetheless, this technology has yet to live up to its promise of improving patient outcomes, in part due to data storage challenges as well as the emphasis on data entry to support administrative and financial goals of the institution.^1-4 Substantially less emphasis has been placed on the retrieval of information required for accurate diagnosis.

A new search engine, Voogle, is now available through Microsoft Internet Explorer (Redmond, WA) to all providers in the US Department of Veterans Affairs (VA) on any intranet-enabled computer behind the VA firewall. Voogle facilitates rapid query-based search and retrieval of patient-specific data in the VA Corporate Data Warehouse (CDW).

Case Example

A veteran presented requesting consideration for implantation of a new device for obstructive sleep apnea. Guidelines for implantation of the new device specify a narrow therapeutic window, so determination of his apnea-hypopnea index (AHI) was critical. The patient had received care at more than 20 VA facilities and knew the approximate year the test had been performed at a non-VA facility.

A health care provider (HCP) using Voogle from his VA computer indexed all Veterans Information Systems and Technology Architecture (VistA) notes for the desired date range. The indexing of > 200 notes was completed in seconds. The HCP opened the indexed records with Voogle and entered a query for “sleep apnea,” which displayed multiple instances of the term within the patient record notes. A VA HCP had previously entered the data from the outside sleep study into a note shortly after the study.

This information was found immediately by sorting the indexed notes by date. The total time required by Voogle to find and display the critical information from the sleep study entered at a different VA more than a dozen years earlier was about 1 minute. These data provided the information needed for decision making at the time of the current patient encounter, without which repeat (and unnecessary) testing would have been required.

Information Overload

Electronic health records (EHRs) such as VistA, upload, store, collate, and present data in near real-time across multiple locations. Although the availability of these data can potentially reduce the risk of error due to missing critical information, its sheer volume limits its utility for point-of-care decision making. Much patient-specific text data found in clinical notes are recorded for administrative, financial, and business purposes rather than to support patient care decision making.^1-3 The majority of data documents processes of care rather than HCP observations, assessment of current status, or plans for care. Much of this text is inserted into templates, consists of imported structured data elements, and may contain repeated copy-and-paste free text.

Data uploaded to the CDW are aggregated from multiple hospitals, each with its own “instance” of VistA. Often the CDW contains thousands of text notes for a single patient. This volume of text may conceal critical historical information needed for patient care mixed with a plethora of duplicated or extraneous text entered to satisfy administrative requirements. The effects of information overload and poor system usability have been studied extensively in other disciplines, but this science has largely not been incorporated into EHR design.^1,3,4

A position paper published recently by the American College of Physicians notes that physician cognitive work is adversely impacted by the incorporation of nonclinical information into the EHR for use by other administrative and financial functions.²

Information Chaos

Beasley and colleagues noted that information in an EHR needed for optimal care may be unavailable, inadequate, scattered, conflicting, lost, or inaccurate, a condition they term information chaos.⁵ Smith and colleagues reported that decision making in 1 of 7 primary care visits was impaired by missing critical information. Surveyed HCPs estimated that 44% of patients with missing information may receive compromised care as a result, including delayed or erroneous diagnosis and increased costs due to duplication of diagnostic testing.⁶

Even when technically available, the usability of patient-specific data needed for accurate diagnosis is compromised if the HCP cannot find the information. In most systems data storage paradigms mirror database design rather than provider cognitive models. Ultimately, the design of current EHR interaction paradigms squanders precious cognitive resources and time, particularly during patient encounters, leaving little available for the cognitive tasks necessary for accurate diagnosis and treatment decisions.^1,3,4,7

VA Corporate Data Warehouse

VistA was implemented as a decentralized system with 130 instances, each of which is a freestanding EHR. However, as all systems share common data structures, the data can be combined from multiple instances when needed. The VA established a CDW more than 15 years ago in order to collate information from multiple sites to support operations as well as to seek new insights. The CDW currently updates nightly from all 130 EHR instances and is the only location in which patient information from all treating sites is combined. Voogle can access the CDW through the Veterans Informatics and Computing Infrastructure (VINCI), which is a mirror of the CDW databases and was established as a secure research environment.

The CDW contains information on 25 million veterans, with about 15 terabytes of text data. Approximately 4 billion data points, including 1 million text notes, are accrued nightly. The Integrated Control Number (ICN), a unique patient identifier, is assigned to each CDW record and is cross-indexed in the master patient index. All CDW data are tied to the ICN, facilitating access to and attribution of all patient data from all VA sites. Voogle relies on this identifier to build indexed files, or domains (which are document collections), of requested specific patient information to support its search algorithm.

Structured Data

Most of the data accrued in an EHR are structured data (such as laboratory test results and vital signs) and stored in a defined database framework. Voogle uses iFind (Intersystems Inc, Cambridge, MA) to index, count, and then search for requested information within structured data fields.

Unstructured Text

In contrast to structured data, text notes are stored as documents that are retrievable by patient, author, date, clinic, as well as numerous other fields. Unstructured (free) text notes are more information rich than either structured data or templated notes since their narrative format more closely parallels providers’ cognitive processes.^1,7 The value of the narrative becomes even more critical in understanding complex clinical scenarios with multiple interacting disease processes. Narratives emphasize important details, reducing cognitive overload by reducing the salience of detail the author deems to be less critical. Narrative notes simultaneously assure availability through the use of unstandardized language, often including specialty and disease-specific abbreviations.¹ Information needed for decision making in the illustrative case in this report was present only in HCP-entered free-text notes, as the structured data from which the free text was derived were not available.

Search

The introduction of search engines can be considered one of the major technologic disruptors of the 21st century.⁸ However, this advance has not yet made significant inroads into health care, despite advances in other domains. As of 2019, EHR users are still required to be familiar with the system’s data and menu structure in order to find needed information (or enter orders, code visits, or any of a number of tasks). Anecdotally, one of the authors (David Eibling) observed that the most common question from his trainees is “How do you . . .?” referring not to the care of the patient but rather to interaction with the EHR.

What is needed is a simple query-based application that finds the data on request. In addition to Voogle, other advances are being made in this arena such as the EMERSE, medical record search engine (project-emerse.org). Voogle was released to VA providers in 2017 and is available through the Internet Explorer browser on VA computers with VA intranet access. The goal of Voogle is to reduce HCP cognitive load by reducing the time and effort needed to seek relevant information for the care of a specific patient.

Natural Language Processing

Linguistic analysis of text seeking to understand its meaning constitutes a rapidly expanding field, with current heavy emphasis on the role of artificial intelligence and machine learning.¹ Advances in processing both structured data and free-text notes in the health care domain is in its infancy, despite the investment of considerable resources. Undoubtedly, advances in this arena will dramatically change provider cognitive work in the next decades.

VistA is coded in MUMPS (Massachusetts General Hospital Utility Multi-Programming System, also known as M), which has been in use for more than 50 years. Voogle employs iKnow, a novel natural language processing (NLP) application that resides in Caché (Intersystems, Boston, MA), the vendor-supported MUMPS infrastructure VistA uses to perform text analysis. iKnow does not attempt to interpret the meaning of text as do other common NLP applications, but instead relies on the expert user to interpret the meaning of the analyzed text. iKnow initially divides sentences into relations (usually verbs) and concepts, and then generates an index of these entities. The efficiency of iKnow results in very rapid indexing—often several thousand notes (not an uncommon number) can be indexed in 20 to 30 seconds. iKnow responds to a user query by searching for specific terms or similar terms within the indexed text, and then displays these terms within the original source documents, similar to well-known commercial search engines. Structured data are indexed by the iFind program simultaneously with free-text indexing (Figure 1).

Security

Maintaining high levels of security of Health Insurance Portability and Accountability (HIPAA)-compliant information in an online application such as Voogle is critical to ensure trust of veterans and HCPs. All patient data accessed by Voogle reside within the secure firewall-protected VINCI environment. All moving information is protected with high-level encryption protocols (transport layer security [TLS]), and data at rest are also encrypted. As the application is online, no data are stored on the accessing device. Voogle uses a secure Microsoft Windows logon using VA Active Directory coupled with VistA authorization to regulate who can see the data and use the application. All access is audited, not only for “sensitive patients,” but also for specific data types. Users are reminded of this Voogle attribute on the home screen.

Accessing Voogle

Voogle is available on the VA intranet to all authorized users at https://voogle.vha.med.va.gov/voogle. To assure high-level security the application can only be accessed with the Internet Explorer browser using established user identification protocols to avoid unauthorized access or duplicative log-in tasks.

Indexing

Indexing is user-driven and is required prior to patient selection and term query. The user is prompted for a patient identifier and a date range. The CDW unique patient identifier is used for all internal processing. However, a social security number look-up table is incorporated to facilitate patient selection. The date field defaults to 3 years but can be extended to approximately the year 2000.

Queries

Entering the patient name in Lastname, Firstname (no space) format will yield a list of indexed patients. All access is audited in order to deter unauthorized queries. Data from a demonstration patient are displayed in Figures 2, 3, 4, 5,
and 6.

Structured Data Searches

Structured data categories that contain the queried term, as well as a term count, are displayed after the “Structured Data” toggle is selected (Figure 2). After the desired category (Figure 2: “Outpatient Rx”) is selected, Voogle accesses the data file and displays it as a grid (medication list, Figure 3). Filter and sort functions enable display of specific medications, drug classes, or date ranges (Figure 4).

Display of Terms Within Text Notes

Selecting a term from the drop-down list (Figure 5) opens a grid with the term highlighted in a snippet of text (Figure 6). Opening the document displays the context of the term, along with negation terms (ie, not, denies, no, etc) in red font if present. Voogle, unlike other NLP tools that attempt to interpret medical notes, relies on interpretation by the HCP user. Duplicate note fragments will be displayed in multiple notes, often across multiple screens, vividly demonstrating the pervasive use of the copy-and-paste text-entry strategy. Voogle satisfies 2 of the 4 recommendations of the recent report on copy-and-paste by Tsou and colleagues.⁹ The Voogle text display grid identifies copy-and-pasted text as well as establishes the provenance of the text (by sorting on the date column). Text can be copied from Voogle into an active Computerized Patient Record System (CPRS) note if needed for active patient care. Reindexing the following day and then repeating the search will demonstrate the newly copied-and-pasted text appended to the sequence.

Limitations

Voogle is unable to access all VA patient data currently. There are a dozen or so clinical domains that are indexed by Voogle that include prescriptions, problem lists, health factors, and others. More domains can be added with minimal effort and would then be available for fast search. The most critical deficiency is its inability to access, index, or query text reports stored as images within VistA Imaging. This includes nearly all reports from outside HCPs, emergency department visits or discharge summaries from unlinked hospitals, anesthesia reports, intensive care unit flow sheets, electrocardiograms, as well as numerous other text reports such as pulmonary function reports or sleep studies. Information that is transcribed by the provider into VistA as text (as in the case presented) is available within the CDW and can be found and displayed by Voogle search.

Voogle requires that the user initiates the indexing process prior to initiating the search process. Although Voogle defaults to 3 years prior to the current date, the user can specify a start date extending to close to the year 2000. The volume of data flowing into the CDW precludes automatic indexing of all patient data, as well as automatic updating of previously indexed data. We have explored the feasibility of queueing scheduled appointments for the following day, and although the strategy shows some promise, avoiding conflict with user-requested on-demand indexing remains challenging.

The current VA network architecture updates the CDW every night, resulting in up to a 24-hour delay in data availability. However, this delay should be reduced to several minutes after implementation of real-time data feeds accompanying the coming transition to a new EHR platform.

Conclusions

The recent introduction of the Joint Legacy Viewer (JLV) to the VA EHR desktop has enhanced the breadth of patient-specific information available to any VHA clinician, with recent enhancements providing access to some community care notes from outside HCPs. Voogle builds on this capability by enabling rapid search of text notes and structured data from multiple VA sites, over an extended time frame, and perhaps entered by hundreds of authors, as demonstrated in the case example. Formal usability and workload studies have not been performed; however, anecdotal reports indicate the application dramatically reduces the time required to search for critical information needed for care of complex patients who have been treated in multiple different VA hospitals and clinics.

The Voogle paradigm of leveraging patient information stored within a large enterprise-wide data warehouse through NLP techniques may be applicable to other systems as well, and warrants exploration. We believe that replacing traditional data search paradigms that require knowledge of data structure with a true query-based paradigm is a potential game changer for health information systems. Ultimately this strategy may help provide an antidote for the information chaos impacting HCP cognition. Moreover, reducing HCP cognitive load and time on task may lessen overall health care costs, reduce provider burn-out, and improve the quality of care received by patients.

Near real-time data feeds and adding additional clinical domains will potentially provide other benefits to patient care. For example, the authors plan to investigate whether sampling incoming data may assist with behind-the-scenes continuous monitoring of indicators of patient status to facilitate early warning of impending physiologic collapse.¹⁰ Other possible applications could include real-time scans for biosurveillance or other population screening requirements.

Acknowledgments
The authors express their sincere appreciation to Leslie DeYoung for documentation and Justin Wilson who constructed much of the graphical user interface for the Voogle application and design. Without their expertise, passion, and commitment the application would not be available as it is now.

The relationship between the Kingdom of Morocco and the US began just after the US declared its own independence. It is one of the oldest of US partnerships with a foreign country, and since the end of the First Barbary War in 1805 it has remained one of the most stable. The Utah National Guard (UTNG) has an active state partnership program (SPP) with Morocco, which helps maintain that stability and fosters the relationship. The SPP provides the Kingdom of Morocco assistance in the areas of disaster medicine, prehospital medicine, and rural access to health care.

The objective of this review is to highlight the role the SPP plays in ensuring Morocco’s continued stability, enhancing its role as a leader among African nations, aiding its medically vulnerable rural populations to prevent recruitment by terrorist organizations, and maintaining its long-term relationship with the US.

Background

The Kingdom of Morocco resides in a geologically and politically unstable part of the world, yet it has been a stable constitutional monarchy. Like California, Morocco has a long coastline of more than 1,000 miles. It sits along an active earthquake fault line with a disaster response program that is only in its infancy. The Kingdom has a high youth unemployment rate and lacks adequate public education opportunities, which exacerbate feelings of government indifference. Morocco’s medical system is highly centralized, and large parts of the rural population lack access to basic medical care—potentially alienating the population. The Moroccan current disaster plan ORSEC (plan d’ Organization des Secours) was established in 1966 and updated in 2005 but does not provide a comprehensive, unified disaster response. The ORSEC plan is of French derivation and is not a list of actions but a general plan of organization and supply. ¹

When governments fail to provide basic services—health care being just one—those services may be filled by groups seeking to influence the government and population by threatening acts of violence to achieve political, religious, and ideologic gain; for example, the Taliban in Afghanistan, the Muslim brotherhood in Egypt and in the West Bank, and the Islamic State in Iraq and Syria (ISIS) in Syria.^2-5 These groups gain a foothold and legitimacy by providing mosques, youth groups, clinics, hospitals, and schools. ^2-5

Identified Needs

Morocco is at risk of experiencing an earthquake and possible subsequent tsunami. In 1755, Morocco was impacted by the Great Lisbon earthquake and tsunami. Witnesses reported 15-meter waves with 24-meter crests.⁶ Building codes and architecture laws have changed little since the 1960 Agadir earthquake, which killed 12,000 people. The disaster response program—although improved since the 1960s—is still in the early stages of development, and another earthquake and possible subsequent tsunami would result in a disaster that could overwhelm the medical community of Morocco.

Perceived Government Indifference

The Moroccan constitutional monarchy is more stable than are the governments of its North African neighbors. King Mohammed VI presides over the government, and regular elections are held for members of Parliament, which names a prime minister. However, in August 2019, overall unemployment was at 8.5%, and youth unemployment was 22.3%.⁷ A United Nations report in August 2019 stated that literacy rates for Morocco were 71.7%. These data were from a 2015 census, the last year data were collected.⁸ These deficits in employment and education can foster anger toward the Moroccan government for not adequately providing these services and possibly introduce radicalization as a result of the population’s perceived government indifference and lack of economic mobility.

Access to Medical Care

Morocco has a 2-tiered medical system for providing services: urban and rural. In 2018 the Legatum Prosperity Index ranked Morocco 103 of 149 countries in health care. The prosperity index measures health variables, which include but were not limited to basic physical and mental health, health infrastructure, and preventive care.⁹ Outside the metropolitan areas, emergency medical care is nonexistent, primary care is sporadic, and there is little modern technology available.

Despite humanitarian efforts over many years, there is little to no medical care in the rural “medical desert.” A 2017 study from the University of Washington Institute for Health Metrics and Evaluation compared the global burden of disease in similar countries. The study found that Morocco was significantly higher than the mean in the prevalence of ischemic heart disease and Alzheimer disease, lower than the mean in the areas of neonatal disorders, lower respiratory infections, and tuberculosis, and statistically indistinct from the mean in stroke, congenital defects, road injuries, diabetes mellitus, and hypertensive heart disease compared with the disease prevalence of other countries of similar size and economic measures.¹⁰ The study also found a particularly acute disparity in access to health care in rural areas. In 2016, the Oxford Business Group reported staff shortages and disproportionate distribution of resources in the Moroccan health care system.¹¹

Additionally, the lack of trained health care personnel has added to an already overstressed health care system. A chief stressor in a health care system is an insufficient replacement rate. Health employees working for the Moroccan Ministry of Health retire at a rate of 1,500 per year.^10,11 These shortages may serve to further the feelings of frustration and government indifference. This frustration is momentarily decreased by humanitarian efforts that have taken place in the African continent in the past decades, but this band-aid approach to assisting the population that is medically underserved has done little to alleviate the long-term problem of access to care. And feelings of government abandonment can sow the seeds of discontent in the rural population, creating fertile ground for recruitment by terrorist organizations.^2,3

Lack of Health Care and Radicalism

It has been postulated that there is a link between radicalization and lack of medical care. Depression and perceived government indifference are considered contributors to radicalization.^12-16 In 2005, Victoroff suggested that there are certain psychological traits characteristic of “typical" terrorists: these include high affective valence regarding an ideologic issue, a personal stake (perceived oppression, persecution or humiliation, need for identity, glory, or vengeance), low cognitive ability, low tolerance for ambiguity, and a capacity to suppress instinctive and learned moral constraints against harming innocents.¹⁵ In 2009, Lafree and Ackerman suggested that terrorism feeds on the ability of groups to portray governments and their agents as illegitimate.¹⁶ It is possible that part of the illegitimacy campaign of radicalization and terrorist recruitment may be identification of the lack of health care by the government thus magnifying feelings of government abandonment in a vulnerable population.

In 2011, the new Moroccan constitution identified access to basic health care as a right of the Moroccan people.¹⁷ Additionally, in 2013, a government white paper was produced outlining the need to increase access to health care, particularly in rural areas, including a focus on infant and maternal mortality, diabetes mellitus (DM), heart disease, and respiratory problems.^17,18

Proposed Solutions, A Beginning

A health outreach program with a regional health professional training center in a relatively stable country within the African Union (AU) would be a step toward delivering health care to Morocco and interested AU members. Interested nations have been and will continue to be invited to train at the Moroccan center and return to their countries and start training programs. This idea was echoed by the World Bank in a 2015 loan proposal to Morocco, which suggested that addressing disparities in access to health care is a social justice issue, with other benefits such as increased productivity, employment, lower out-of-pocket expenditures, and promotion of good governance.¹⁷

In 2012, Buhi reported that a positive regard for authorities and healthier influences seemed to be a protective factor against radicalization. He also suggested a public health approach to understanding and preventing violent radicalization.¹⁹ The solutions are complex, especially in rural areas and in vulnerable nations common to Africa.

Medical training efforts by the US Department of Defense (DoD), Medical Readiness Training Institute (DMRT), and international health specialists working with the military and civilian entities in neighboring African countries have improved response to regional disasters. However, to address the broader issues, a more permanent, cooperative possible solution may begin with the establishment in Morocco of a regional education center for disaster preparedness and for health care providers (HCPs). This would serve as a training program for disaster first responders. Graduates of the program would receive additional training to become HCPs similar to physician assistant (PA) and nurse practitioner (NP) programs in the US. Morocco is uniquely positioned to accomplish this due to its location, political stability, and ties with other African nations.

The goal of the Moroccan regional education center (within the King Mohammed V Hospital) is to bring together global health experts and increase the intellectual infrastructure of not only Morocco, but also offer this training program to interested countries within the AU. Advancement of the regional education center will require legislative changes to expand prescriptive privileges and scope of practice within each country. The medical element of the SPP as presently constituted without the regional education center will continue its humanitarian goals, but the proposed creation of the regional education center will educate participants to serve the rural communities within each participating country. Eventually the entire educational program will be the responsibility of the Moroccan military and the AU participants. This will require reprioritizing resources from the provision of humanitarian health care services to an HCP education approach.

Disaster Response

Deficits in disaster response capabilities have been identified by members of the Moroccan military with the assistance of the UTNG. The most glaring deficit identified was the disparity in training between military and civilian first responders. Thus, a training program was initiated by the Moroccan military and the UTNG that combined internationally recognized, durable, robust emergency training programs. These programs consisted of, but were not limited to, parts or entire programs of the following: basic disaster life support, advanced disaster life support, disaster casualty care, and advanced trauma life support. The goal of this training was to improve communication, reduce mortality, and create strike teams, which can quickly provide health care independent of a hospital during a disaster.

Patients can overwhelm hospitals in a disaster when need exceeds resources. In 1996, Mallonee reported that at least 67% of the patients who sought care at a hospital during the Oklahoma City bombing disaster did not need advanced medical treatment.²⁰ Such patients could be seen at an identified casualty collection point by a strike team and treated and released rather than traveling to the hospital and using staff and resources that could be used more judiciously for the more seriously injured.²¹ These teams consist of trained first responders with an experienced HCP (physician, PA, NP) and a nurse and are trained to operate for up to 72 hours in a predetermined location and serve as a “filter” for the hospital. Their role is to treat and release the less severely injured and refer only the more severely injured to the hospital after basic stabilization, thus preserving precious resources necessary for the more seriously injured.

This disaster response training program was offered to the Moroccan military, ministry of health and ministry of tourism, and quickly turned into an Africa-wide interest. A regional training center was proposed. This was assisted with the cooperation of Weber State University in Ogden Utah, Utah Valley University in Orem, and private interests in a public/private/military state partnership. Program supplies and didactic instruction were and will be provided by the UTNG and supplemented through the DoD Africa command. Instruction will be a cooperative effort agreed on between the UTNG and the Moroccan military medical specialists within their specific area of expertise.

Underserved Communities

Finally, from this pool of interested strike team members, a health care provider school will be formed to educate, certify, and service the needs of the underserved communities in Morocco and interested AU countries. This program will be similar to the PA and NP programs in the US and will be geared to those graduates from the previous programs with intense classroom instruction for one year followed by a year of one-on-one preceptorship with an experienced physician. The goal of the program is to prepare individuals with patient care experience to fulfill a bigger role in health care in an underserved (usually austere, rural) area that currently has minimal health care presence. This fills a need identified by the World Bank in 2015 that the Moroccan government needs to respond to the demand for improved access to and quality of health care services—particularly to the rural poor.¹⁷

The Moroccan military has a presence in many medically underserved areas. The logical fit for the HCP program will be drawn from a pool of active-duty military individuals who express an interest and qualify through attendance in all phases of the training.

Conclusion

This program of disaster medical education, strike teams, and HCPs is currently training more than 200 students a year throughout Morocco. The proposed direction of this cooperative program to produce HCPs in rural areas will increase access to health care for the Moroccan people who are now underserved. Morocco, as a health care training hub in Africa, will increase access to health care for interested African countries. The goal politically will be to reduce feelings of government indifference in vulnerable populations and reduce recruitment into radical ideologies.

The relationship between the Kingdom of Morocco and the US began just after the US declared its own independence. It is one of the oldest of US partnerships with a foreign country, and since the end of the First Barbary War in 1805 it has remained one of the most stable. The Utah National Guard (UTNG) has an active state partnership program (SPP) with Morocco, which helps maintain that stability and fosters the relationship. The SPP provides the Kingdom of Morocco assistance in the areas of disaster medicine, prehospital medicine, and rural access to health care.

The objective of this review is to highlight the role the SPP plays in ensuring Morocco’s continued stability, enhancing its role as a leader among African nations, aiding its medically vulnerable rural populations to prevent recruitment by terrorist organizations, and maintaining its long-term relationship with the US.

Background

The Kingdom of Morocco resides in a geologically and politically unstable part of the world, yet it has been a stable constitutional monarchy. Like California, Morocco has a long coastline of more than 1,000 miles. It sits along an active earthquake fault line with a disaster response program that is only in its infancy. The Kingdom has a high youth unemployment rate and lacks adequate public education opportunities, which exacerbate feelings of government indifference. Morocco’s medical system is highly centralized, and large parts of the rural population lack access to basic medical care—potentially alienating the population. The Moroccan current disaster plan ORSEC (plan d’ Organization des Secours) was established in 1966 and updated in 2005 but does not provide a comprehensive, unified disaster response. The ORSEC plan is of French derivation and is not a list of actions but a general plan of organization and supply. ¹

When governments fail to provide basic services—health care being just one—those services may be filled by groups seeking to influence the government and population by threatening acts of violence to achieve political, religious, and ideologic gain; for example, the Taliban in Afghanistan, the Muslim brotherhood in Egypt and in the West Bank, and the Islamic State in Iraq and Syria (ISIS) in Syria.^2-5 These groups gain a foothold and legitimacy by providing mosques, youth groups, clinics, hospitals, and schools. ^2-5

Identified Needs

Morocco is at risk of experiencing an earthquake and possible subsequent tsunami. In 1755, Morocco was impacted by the Great Lisbon earthquake and tsunami. Witnesses reported 15-meter waves with 24-meter crests.⁶ Building codes and architecture laws have changed little since the 1960 Agadir earthquake, which killed 12,000 people. The disaster response program—although improved since the 1960s—is still in the early stages of development, and another earthquake and possible subsequent tsunami would result in a disaster that could overwhelm the medical community of Morocco.

Perceived Government Indifference

The Moroccan constitutional monarchy is more stable than are the governments of its North African neighbors. King Mohammed VI presides over the government, and regular elections are held for members of Parliament, which names a prime minister. However, in August 2019, overall unemployment was at 8.5%, and youth unemployment was 22.3%.⁷ A United Nations report in August 2019 stated that literacy rates for Morocco were 71.7%. These data were from a 2015 census, the last year data were collected.⁸ These deficits in employment and education can foster anger toward the Moroccan government for not adequately providing these services and possibly introduce radicalization as a result of the population’s perceived government indifference and lack of economic mobility.

Access to Medical Care

Morocco has a 2-tiered medical system for providing services: urban and rural. In 2018 the Legatum Prosperity Index ranked Morocco 103 of 149 countries in health care. The prosperity index measures health variables, which include but were not limited to basic physical and mental health, health infrastructure, and preventive care.⁹ Outside the metropolitan areas, emergency medical care is nonexistent, primary care is sporadic, and there is little modern technology available.

Despite humanitarian efforts over many years, there is little to no medical care in the rural “medical desert.” A 2017 study from the University of Washington Institute for Health Metrics and Evaluation compared the global burden of disease in similar countries. The study found that Morocco was significantly higher than the mean in the prevalence of ischemic heart disease and Alzheimer disease, lower than the mean in the areas of neonatal disorders, lower respiratory infections, and tuberculosis, and statistically indistinct from the mean in stroke, congenital defects, road injuries, diabetes mellitus, and hypertensive heart disease compared with the disease prevalence of other countries of similar size and economic measures.¹⁰ The study also found a particularly acute disparity in access to health care in rural areas. In 2016, the Oxford Business Group reported staff shortages and disproportionate distribution of resources in the Moroccan health care system.¹¹

Additionally, the lack of trained health care personnel has added to an already overstressed health care system. A chief stressor in a health care system is an insufficient replacement rate. Health employees working for the Moroccan Ministry of Health retire at a rate of 1,500 per year.^10,11 These shortages may serve to further the feelings of frustration and government indifference. This frustration is momentarily decreased by humanitarian efforts that have taken place in the African continent in the past decades, but this band-aid approach to assisting the population that is medically underserved has done little to alleviate the long-term problem of access to care. And feelings of government abandonment can sow the seeds of discontent in the rural population, creating fertile ground for recruitment by terrorist organizations.^2,3

Lack of Health Care and Radicalism

It has been postulated that there is a link between radicalization and lack of medical care. Depression and perceived government indifference are considered contributors to radicalization.^12-16 In 2005, Victoroff suggested that there are certain psychological traits characteristic of “typical" terrorists: these include high affective valence regarding an ideologic issue, a personal stake (perceived oppression, persecution or humiliation, need for identity, glory, or vengeance), low cognitive ability, low tolerance for ambiguity, and a capacity to suppress instinctive and learned moral constraints against harming innocents.¹⁵ In 2009, Lafree and Ackerman suggested that terrorism feeds on the ability of groups to portray governments and their agents as illegitimate.¹⁶ It is possible that part of the illegitimacy campaign of radicalization and terrorist recruitment may be identification of the lack of health care by the government thus magnifying feelings of government abandonment in a vulnerable population.

In 2011, the new Moroccan constitution identified access to basic health care as a right of the Moroccan people.¹⁷ Additionally, in 2013, a government white paper was produced outlining the need to increase access to health care, particularly in rural areas, including a focus on infant and maternal mortality, diabetes mellitus (DM), heart disease, and respiratory problems.^17,18

Proposed Solutions, A Beginning

A health outreach program with a regional health professional training center in a relatively stable country within the African Union (AU) would be a step toward delivering health care to Morocco and interested AU members. Interested nations have been and will continue to be invited to train at the Moroccan center and return to their countries and start training programs. This idea was echoed by the World Bank in a 2015 loan proposal to Morocco, which suggested that addressing disparities in access to health care is a social justice issue, with other benefits such as increased productivity, employment, lower out-of-pocket expenditures, and promotion of good governance.¹⁷

In 2012, Buhi reported that a positive regard for authorities and healthier influences seemed to be a protective factor against radicalization. He also suggested a public health approach to understanding and preventing violent radicalization.¹⁹ The solutions are complex, especially in rural areas and in vulnerable nations common to Africa.

Medical training efforts by the US Department of Defense (DoD), Medical Readiness Training Institute (DMRT), and international health specialists working with the military and civilian entities in neighboring African countries have improved response to regional disasters. However, to address the broader issues, a more permanent, cooperative possible solution may begin with the establishment in Morocco of a regional education center for disaster preparedness and for health care providers (HCPs). This would serve as a training program for disaster first responders. Graduates of the program would receive additional training to become HCPs similar to physician assistant (PA) and nurse practitioner (NP) programs in the US. Morocco is uniquely positioned to accomplish this due to its location, political stability, and ties with other African nations.

The goal of the Moroccan regional education center (within the King Mohammed V Hospital) is to bring together global health experts and increase the intellectual infrastructure of not only Morocco, but also offer this training program to interested countries within the AU. Advancement of the regional education center will require legislative changes to expand prescriptive privileges and scope of practice within each country. The medical element of the SPP as presently constituted without the regional education center will continue its humanitarian goals, but the proposed creation of the regional education center will educate participants to serve the rural communities within each participating country. Eventually the entire educational program will be the responsibility of the Moroccan military and the AU participants. This will require reprioritizing resources from the provision of humanitarian health care services to an HCP education approach.

Disaster Response

Deficits in disaster response capabilities have been identified by members of the Moroccan military with the assistance of the UTNG. The most glaring deficit identified was the disparity in training between military and civilian first responders. Thus, a training program was initiated by the Moroccan military and the UTNG that combined internationally recognized, durable, robust emergency training programs. These programs consisted of, but were not limited to, parts or entire programs of the following: basic disaster life support, advanced disaster life support, disaster casualty care, and advanced trauma life support. The goal of this training was to improve communication, reduce mortality, and create strike teams, which can quickly provide health care independent of a hospital during a disaster.

Patients can overwhelm hospitals in a disaster when need exceeds resources. In 1996, Mallonee reported that at least 67% of the patients who sought care at a hospital during the Oklahoma City bombing disaster did not need advanced medical treatment.²⁰ Such patients could be seen at an identified casualty collection point by a strike team and treated and released rather than traveling to the hospital and using staff and resources that could be used more judiciously for the more seriously injured.²¹ These teams consist of trained first responders with an experienced HCP (physician, PA, NP) and a nurse and are trained to operate for up to 72 hours in a predetermined location and serve as a “filter” for the hospital. Their role is to treat and release the less severely injured and refer only the more severely injured to the hospital after basic stabilization, thus preserving precious resources necessary for the more seriously injured.

This disaster response training program was offered to the Moroccan military, ministry of health and ministry of tourism, and quickly turned into an Africa-wide interest. A regional training center was proposed. This was assisted with the cooperation of Weber State University in Ogden Utah, Utah Valley University in Orem, and private interests in a public/private/military state partnership. Program supplies and didactic instruction were and will be provided by the UTNG and supplemented through the DoD Africa command. Instruction will be a cooperative effort agreed on between the UTNG and the Moroccan military medical specialists within their specific area of expertise.

Underserved Communities

Finally, from this pool of interested strike team members, a health care provider school will be formed to educate, certify, and service the needs of the underserved communities in Morocco and interested AU countries. This program will be similar to the PA and NP programs in the US and will be geared to those graduates from the previous programs with intense classroom instruction for one year followed by a year of one-on-one preceptorship with an experienced physician. The goal of the program is to prepare individuals with patient care experience to fulfill a bigger role in health care in an underserved (usually austere, rural) area that currently has minimal health care presence. This fills a need identified by the World Bank in 2015 that the Moroccan government needs to respond to the demand for improved access to and quality of health care services—particularly to the rural poor.¹⁷

The Moroccan military has a presence in many medically underserved areas. The logical fit for the HCP program will be drawn from a pool of active-duty military individuals who express an interest and qualify through attendance in all phases of the training.

Conclusion

This program of disaster medical education, strike teams, and HCPs is currently training more than 200 students a year throughout Morocco. The proposed direction of this cooperative program to produce HCPs in rural areas will increase access to health care for the Moroccan people who are now underserved. Morocco, as a health care training hub in Africa, will increase access to health care for interested African countries. The goal politically will be to reduce feelings of government indifference in vulnerable populations and reduce recruitment into radical ideologies.

The relationship between the Kingdom of Morocco and the US began just after the US declared its own independence. It is one of the oldest of US partnerships with a foreign country, and since the end of the First Barbary War in 1805 it has remained one of the most stable. The Utah National Guard (UTNG) has an active state partnership program (SPP) with Morocco, which helps maintain that stability and fosters the relationship. The SPP provides the Kingdom of Morocco assistance in the areas of disaster medicine, prehospital medicine, and rural access to health care.

The objective of this review is to highlight the role the SPP plays in ensuring Morocco’s continued stability, enhancing its role as a leader among African nations, aiding its medically vulnerable rural populations to prevent recruitment by terrorist organizations, and maintaining its long-term relationship with the US.

Background

The Kingdom of Morocco resides in a geologically and politically unstable part of the world, yet it has been a stable constitutional monarchy. Like California, Morocco has a long coastline of more than 1,000 miles. It sits along an active earthquake fault line with a disaster response program that is only in its infancy. The Kingdom has a high youth unemployment rate and lacks adequate public education opportunities, which exacerbate feelings of government indifference. Morocco’s medical system is highly centralized, and large parts of the rural population lack access to basic medical care—potentially alienating the population. The Moroccan current disaster plan ORSEC (plan d’ Organization des Secours) was established in 1966 and updated in 2005 but does not provide a comprehensive, unified disaster response. The ORSEC plan is of French derivation and is not a list of actions but a general plan of organization and supply. ¹

When governments fail to provide basic services—health care being just one—those services may be filled by groups seeking to influence the government and population by threatening acts of violence to achieve political, religious, and ideologic gain; for example, the Taliban in Afghanistan, the Muslim brotherhood in Egypt and in the West Bank, and the Islamic State in Iraq and Syria (ISIS) in Syria.^2-5 These groups gain a foothold and legitimacy by providing mosques, youth groups, clinics, hospitals, and schools. ^2-5

Identified Needs

Morocco is at risk of experiencing an earthquake and possible subsequent tsunami. In 1755, Morocco was impacted by the Great Lisbon earthquake and tsunami. Witnesses reported 15-meter waves with 24-meter crests.⁶ Building codes and architecture laws have changed little since the 1960 Agadir earthquake, which killed 12,000 people. The disaster response program—although improved since the 1960s—is still in the early stages of development, and another earthquake and possible subsequent tsunami would result in a disaster that could overwhelm the medical community of Morocco.

Perceived Government Indifference

The Moroccan constitutional monarchy is more stable than are the governments of its North African neighbors. King Mohammed VI presides over the government, and regular elections are held for members of Parliament, which names a prime minister. However, in August 2019, overall unemployment was at 8.5%, and youth unemployment was 22.3%.⁷ A United Nations report in August 2019 stated that literacy rates for Morocco were 71.7%. These data were from a 2015 census, the last year data were collected.⁸ These deficits in employment and education can foster anger toward the Moroccan government for not adequately providing these services and possibly introduce radicalization as a result of the population’s perceived government indifference and lack of economic mobility.

Access to Medical Care

Morocco has a 2-tiered medical system for providing services: urban and rural. In 2018 the Legatum Prosperity Index ranked Morocco 103 of 149 countries in health care. The prosperity index measures health variables, which include but were not limited to basic physical and mental health, health infrastructure, and preventive care.⁹ Outside the metropolitan areas, emergency medical care is nonexistent, primary care is sporadic, and there is little modern technology available.

Despite humanitarian efforts over many years, there is little to no medical care in the rural “medical desert.” A 2017 study from the University of Washington Institute for Health Metrics and Evaluation compared the global burden of disease in similar countries. The study found that Morocco was significantly higher than the mean in the prevalence of ischemic heart disease and Alzheimer disease, lower than the mean in the areas of neonatal disorders, lower respiratory infections, and tuberculosis, and statistically indistinct from the mean in stroke, congenital defects, road injuries, diabetes mellitus, and hypertensive heart disease compared with the disease prevalence of other countries of similar size and economic measures.¹⁰ The study also found a particularly acute disparity in access to health care in rural areas. In 2016, the Oxford Business Group reported staff shortages and disproportionate distribution of resources in the Moroccan health care system.¹¹

Additionally, the lack of trained health care personnel has added to an already overstressed health care system. A chief stressor in a health care system is an insufficient replacement rate. Health employees working for the Moroccan Ministry of Health retire at a rate of 1,500 per year.^10,11 These shortages may serve to further the feelings of frustration and government indifference. This frustration is momentarily decreased by humanitarian efforts that have taken place in the African continent in the past decades, but this band-aid approach to assisting the population that is medically underserved has done little to alleviate the long-term problem of access to care. And feelings of government abandonment can sow the seeds of discontent in the rural population, creating fertile ground for recruitment by terrorist organizations.^2,3

Lack of Health Care and Radicalism

It has been postulated that there is a link between radicalization and lack of medical care. Depression and perceived government indifference are considered contributors to radicalization.^12-16 In 2005, Victoroff suggested that there are certain psychological traits characteristic of “typical" terrorists: these include high affective valence regarding an ideologic issue, a personal stake (perceived oppression, persecution or humiliation, need for identity, glory, or vengeance), low cognitive ability, low tolerance for ambiguity, and a capacity to suppress instinctive and learned moral constraints against harming innocents.¹⁵ In 2009, Lafree and Ackerman suggested that terrorism feeds on the ability of groups to portray governments and their agents as illegitimate.¹⁶ It is possible that part of the illegitimacy campaign of radicalization and terrorist recruitment may be identification of the lack of health care by the government thus magnifying feelings of government abandonment in a vulnerable population.

In 2011, the new Moroccan constitution identified access to basic health care as a right of the Moroccan people.¹⁷ Additionally, in 2013, a government white paper was produced outlining the need to increase access to health care, particularly in rural areas, including a focus on infant and maternal mortality, diabetes mellitus (DM), heart disease, and respiratory problems.^17,18

Proposed Solutions, A Beginning

A health outreach program with a regional health professional training center in a relatively stable country within the African Union (AU) would be a step toward delivering health care to Morocco and interested AU members. Interested nations have been and will continue to be invited to train at the Moroccan center and return to their countries and start training programs. This idea was echoed by the World Bank in a 2015 loan proposal to Morocco, which suggested that addressing disparities in access to health care is a social justice issue, with other benefits such as increased productivity, employment, lower out-of-pocket expenditures, and promotion of good governance.¹⁷

In 2012, Buhi reported that a positive regard for authorities and healthier influences seemed to be a protective factor against radicalization. He also suggested a public health approach to understanding and preventing violent radicalization.¹⁹ The solutions are complex, especially in rural areas and in vulnerable nations common to Africa.

Medical training efforts by the US Department of Defense (DoD), Medical Readiness Training Institute (DMRT), and international health specialists working with the military and civilian entities in neighboring African countries have improved response to regional disasters. However, to address the broader issues, a more permanent, cooperative possible solution may begin with the establishment in Morocco of a regional education center for disaster preparedness and for health care providers (HCPs). This would serve as a training program for disaster first responders. Graduates of the program would receive additional training to become HCPs similar to physician assistant (PA) and nurse practitioner (NP) programs in the US. Morocco is uniquely positioned to accomplish this due to its location, political stability, and ties with other African nations.

The goal of the Moroccan regional education center (within the King Mohammed V Hospital) is to bring together global health experts and increase the intellectual infrastructure of not only Morocco, but also offer this training program to interested countries within the AU. Advancement of the regional education center will require legislative changes to expand prescriptive privileges and scope of practice within each country. The medical element of the SPP as presently constituted without the regional education center will continue its humanitarian goals, but the proposed creation of the regional education center will educate participants to serve the rural communities within each participating country. Eventually the entire educational program will be the responsibility of the Moroccan military and the AU participants. This will require reprioritizing resources from the provision of humanitarian health care services to an HCP education approach.

Disaster Response

Deficits in disaster response capabilities have been identified by members of the Moroccan military with the assistance of the UTNG. The most glaring deficit identified was the disparity in training between military and civilian first responders. Thus, a training program was initiated by the Moroccan military and the UTNG that combined internationally recognized, durable, robust emergency training programs. These programs consisted of, but were not limited to, parts or entire programs of the following: basic disaster life support, advanced disaster life support, disaster casualty care, and advanced trauma life support. The goal of this training was to improve communication, reduce mortality, and create strike teams, which can quickly provide health care independent of a hospital during a disaster.

Patients can overwhelm hospitals in a disaster when need exceeds resources. In 1996, Mallonee reported that at least 67% of the patients who sought care at a hospital during the Oklahoma City bombing disaster did not need advanced medical treatment.²⁰ Such patients could be seen at an identified casualty collection point by a strike team and treated and released rather than traveling to the hospital and using staff and resources that could be used more judiciously for the more seriously injured.²¹ These teams consist of trained first responders with an experienced HCP (physician, PA, NP) and a nurse and are trained to operate for up to 72 hours in a predetermined location and serve as a “filter” for the hospital. Their role is to treat and release the less severely injured and refer only the more severely injured to the hospital after basic stabilization, thus preserving precious resources necessary for the more seriously injured.

This disaster response training program was offered to the Moroccan military, ministry of health and ministry of tourism, and quickly turned into an Africa-wide interest. A regional training center was proposed. This was assisted with the cooperation of Weber State University in Ogden Utah, Utah Valley University in Orem, and private interests in a public/private/military state partnership. Program supplies and didactic instruction were and will be provided by the UTNG and supplemented through the DoD Africa command. Instruction will be a cooperative effort agreed on between the UTNG and the Moroccan military medical specialists within their specific area of expertise.

Underserved Communities

Finally, from this pool of interested strike team members, a health care provider school will be formed to educate, certify, and service the needs of the underserved communities in Morocco and interested AU countries. This program will be similar to the PA and NP programs in the US and will be geared to those graduates from the previous programs with intense classroom instruction for one year followed by a year of one-on-one preceptorship with an experienced physician. The goal of the program is to prepare individuals with patient care experience to fulfill a bigger role in health care in an underserved (usually austere, rural) area that currently has minimal health care presence. This fills a need identified by the World Bank in 2015 that the Moroccan government needs to respond to the demand for improved access to and quality of health care services—particularly to the rural poor.¹⁷

The Moroccan military has a presence in many medically underserved areas. The logical fit for the HCP program will be drawn from a pool of active-duty military individuals who express an interest and qualify through attendance in all phases of the training.

Conclusion

This program of disaster medical education, strike teams, and HCPs is currently training more than 200 students a year throughout Morocco. The proposed direction of this cooperative program to produce HCPs in rural areas will increase access to health care for the Moroccan people who are now underserved. Morocco, as a health care training hub in Africa, will increase access to health care for interested African countries. The goal politically will be to reduce feelings of government indifference in vulnerable populations and reduce recruitment into radical ideologies.

The most recently concluded term of the US Supreme Court, which began on October 1, 2018, yielded a number of decisions of interest to health care professionals and to ObGyns in particular. Although the term was viewed by some observers as less consequential than other recent terms, a review of the cases decided paints a picture of a more important term than some commentators expected.

When the term began, the Court had only 8 justices—1 short of a full bench: Judge Brett Kavanaugh had not yet been confirmed by the Senate. He was confirmed on October 6, by a 50-48 vote, and Justice Kavanaugh immediately joined the Court and began to hear and decide cases.

Increasingly, important decisions affect medical practice

From the nature of practice (abortion), to payment for service (Medicare reimbursement), resolution of disputes (arbitration), and fraud and abuse (the federal False Claims Act), the decisions of the Court will have an impact on many areas of medical practice. Organized medicine increasingly has recognized the significance of the work of the Court; nowhere has this been more clearly demonstrated than with amicus curiae (friend of the court) briefs filed by medical organizations.

Amicus curiae briefs. These briefs are filed by persons or organizations not a party to a case the Court is hearing. Their legitimate purpose is to inform the Court of 1) special information within the expertise of the amicus (or amici, plural) or 2) consequences of the decision that might not be apparent from arguments made by the parties to the case. Sometimes, the Court cites amicus briefs for having provided important information about the case.

Filing amicus briefs is time-consuming and expensive; organizations do not file them for trivial reasons. Organizations frequently join together to file a joint brief, to share expenses and express to the Court a stronger position.

Three categories of health professionals file amicus briefs in ObGyn-related cases:

• Major national organizations, often representing broad interests of health care professions or institutions (the American Medical Association [AMA], the Association of American Medical Colleges, and the American Hospital Association [AHA]), have filed a number of amicus briefs over the years.
• Specialty boards increasingly file amicus briefs. For example, the American College of Obstetricians and Gynecologists (ACOG) and the American Society for Reproductive Medicine have filed briefs related to abortion issues.
• In reproductive issues, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, and the Christian Medical & Dental Associations have been active amicus filers—frequently taking positions different than, even inconsistent with, amicus briefs filed by major specialty boards.

Amicus briefs filed by medical associations provide strong clues to what is important to clinicians. We have looked at such briefs to help us identify topics and cases from the just-concluded term that can be of particular interest to you.

Continue to: Surveying the shadow docket...

Surveying the shadow docket. As part of our review of the past term, we also looked at the so-called shadow docket, which includes decisions regarding writs of certiorari (which cases it agrees to hear); stays (usually delaying implementation of a law); or denials of stays. (Persuading the Court to hear a case is not easy: It hears approximately 70 cases per year out of as many as 7,000 applications to be heard.)

Abortion ruling

At stake. A number of states recently enacted a variety of provisions that might make an abortion more difficult to obtain. Some of the cases challenging these restrictions are making their way through lower courts, and one day might be argued before the Supreme Court. However, the Court has not (yet) agreed to hear the substance of many new abortion-related provisions.

Box v Planned Parenthood of Indiana and Kentucky, Inc.

The Court decided only 1 abortion restriction case this term.¹ The Indiana law in question included 2 provisions that the Court considered:

Disposal of remains. The law regulated the manner in which abortion providers can dispose of fetal remains (ie, they cannot be treated as “infectious and pathologic waste”).

Motivation for seeking abortion. The Indiana law makes it illegal for an abortion provider to perform an abortion when the provider knows that the mother is seeking that abortion “solely” because of the fetus’s race, sex, diagnosis of Down syndrome, disability, or related characteristics.

Final rulings. The Court held that the disposal-of-remains provision is constitutional. The provision is “rationally related to the state’s interest in proper disposal of fetal remains.”² Planned Parenthood had not raised the issue of whether the law might impose an undue burden on a woman’s right to obtain an abortion, so the Court did not decide that issue.

The Court did not consider the constitutionality of the part of the law proscribing certain reasons for seeking an otherwise legal abortion; instead, it awaits lower courts’ review of the issue. Justice Clarence Thomas wrote an extensive concurring opinion suggesting that this law is intended to avoid abortion to achieve eugenic goals.³

Key developments from the shadow docket

The Court issued a stay preventing a Louisiana statute that requires physicians who perform abortions to have admitting privileges at a nearby hospital from going into effect, pending the outcome of litigation about that law.⁴ Four dissenters noted that all 4 physicians who perform abortions in Louisiana have such privileges. Chief Justice Roberts was the fifth vote to grant the stay. This case likely will make its way back to the Court, as will a number of other state laws being adopted. The issue may be back as soon as the term just starting.

The Court is also considering whether to take another Indiana case, Box v Planned Parenthood of Indiana and Kentucky, Inc. (Box II). This case involves an Indiana ultrasonography viewing option as part of the abortion consent process.⁵

The Court declined to hear cases from Louisiana and Kansas in which the states had cut off Medicaid funding to Planned Parenthood. Lower courts had stopped the implementation of those laws.⁶ The legal issue was whether private parties, as opposed to the federal government, had standing to bring the case. For now, the decision of the lower courts to stop implementation of the funding cutoff is in effect. There is a split in the Circuit Courts on the issue, however, making it likely that the Supreme Court will have to resolve it sooner or later.

Health care organizations have filed a number of amicus briefs in these and other cases involving new abortion regulations. ACOG and others filed a brief opposing a Louisiana law that requires abortion providers to have admitting privileges at a nearby facility,⁷ and a brief opposing a similar Oklahoma law.⁸ The Association of Pro-Life Obstetricians and Gynecologists and others filed amicus curiae briefs in Box II⁹ and in an Alabama case involving so-called dismemberment abortion.¹⁰

Continue to: Medicare payments...

Medicare payments

Azar, Secretary of Health and Human Services v Allina Health Services, et al¹¹

This case drew interest—and many amicus briefs—from health care providers, including the AMA and the AHA.^12,13 There was good reason for their interest: First, the case involved more than $3 billion in reimbursements; second, it represented a potentially important precedent about the rights of providers and patients to comment on Medicare reimbursement changes. The question involved the technical calculation of additional payments made to institutions that serve a disproportionate number of low-income patients (known as Medicare Fractions).

At stake. The issue was a statutory requirement for a 60-day public notice and comment period for rules that “change a substantive legal standard” governing the scope of benefits, eligibility, or payment for services.¹⁴ In 2014, the Secretary of the Department of Health and Human Services (HHS) in the Obama administration posted a spreadsheet announcing Medicare fractions rates for hospitals (for 2012)—without formal notice or comment regarding the formula used. (The spreadsheet listed what each qualifying institution would receive, but it was based on a formula that, as noted, had not been subject to public notice and comment.) The AMA and AHA briefs emphasized the importance of a notice and comment period, especially when Medicare reimbursement is involved.

Final ruling. The Court held that the HHS process violated the notice and comment provision, thereby invalidating the policy underlying the so-called spreadsheet reimbursement. The decision was significant: This was a careful statutory interpretation of the 60-day notice and comment period, not the reimbursement policy itself. Presumably, had the HHS Secretary provided for sufficient notice and comment, the formula used would have met the requirements for issuing reimbursement formulas.

Key points. Hospitals will collectively receive $3 or $4 billion as a consequence of the ruling. Perhaps more importantly, the decision signals that HHS is going to have to take seriously the requirement that it publish Medicare-related reimbursement policies for the 60-day period.

Liability under the False Claims Act

The False Claims Act (FCA) protects the federal government from fraudulent claims for payment and for shoddy goods and services. It incentivizes (by a percentage of recovery) private parties to bring cases to enforce the law.¹⁵ (Of course, the federal government also enforces the Act.)

At stake. The FCA has been of considerable concern to the AHA, the Association of American Medical Colleges, and other health care organizations—understandably so.¹⁶ As the AHA informed the Court in an amicus brief, “The prevalence of [FCA] cases has ballooned over the past three decades.... These suits disproportionately target healthcare entities.... Of the 767 new FCA cases filed in 2018, for example, 506 involved healthcare defendants.”¹⁷

Final ruling. The Court considered an ambiguity in the statute of limitations for these actions and the Court unanimously ruled to permit an extended time in which qui tam actions (private actions under the law) can be filed.¹⁸

Key points. As long a period as 10 years can pass between the time an FCA violation occurs and an action is brought. This decision is likely to increase the number of FCA actions against health care providers because the case can be filed many years after the conduct that gave rise to the complaint.

Continue to: Registering sex offenders...

Registering sex offenders

The Court upheld the constitutionality of the federal Sex Offender Registration and Notification Act (SORNA).¹⁹ Sex offenders must register and periodically report, in person, to law enforcement in every state in which the offender works, studies, or resides.

At stake. The case involved the applicability of SORNA registration obligations to those convicted of sex offenses before SORNA was adopted (pre-Act offenders).²⁰ The court upheld registration requirements for pre-Act offenders.

Arbitration

The Court continued its practice of deciding at least one case each term that emphasizes that federal law requires that courts rather strictly enforce agreements to arbitrate (instead of to litigate) future disputes.²¹ In another case, the Court ruled that there can be “class” or “joint” arbitration only if the agreement to arbitrate a dispute clearly permits such class arbitration.²²

Pharma’s liability regarding product risk

The Court somewhat limited the liability of pharmaceutical companies for failing to provide adequate warning about the risk that their products pose. The case against Merck involved 500 patients who took denosumab (Fosamax) and suffered atypical femoral fractures.²³

At stake. Because prescribing information (in which warnings are provided) must be approved by the US Food and Drug Administration (FDA), the legal test is: Would the FDA have refused to approve a change in the warning if Merck had “fully informed the FDA of the justifications for the warning” required by state law to avoid liability?^24,25 Lower-court judges (not juries) will be expected to apply this test in the future.

The doctor and the death penalty

The Court has established a rule that, when a prisoner facing capital punishment objects to a form of execution because it is too painful, he has to propose an alternative that is reasonably available. In one case,²⁶ a physician, an expert witness for the prisoner, did not answer some essential relative-pain questions (ie, would one procedure be more painful than another?).

At stake. The AMA filed an amicus brief in this case, indicating that it is unethical for physicians to participate in an execution. The brief noted that “testimony used to determine which method of execution would reduce physical suffering would constitute physician participation in capital punishment and would be unethical.”²⁷

The expert witness’s failure to answer the question on relative pain had the unfortunate result of reducing the likelihood that the prisoner would prevail in his request for an alternative method of execution.

Analysis

Despite obvious disagreements about big issues (notably, abortion and the death penalty) the Court maintained a courteous and civil demeanor—something not always seen nowadays in other branches of government. Here are facts about the Court’s term just concluded:

• The Court issued 72 merits opinions (about average).
• Only 39% of decisions were unanimous (compared with the average of 49% in recent terms).
• On the other hand, 26% of decisions were split 5 to 4 (compared with a 10% recent average).
• In those 5 to 4 decisions, Justices were in the majority as follows²⁸: Justice Gorsuch, 65%; Justice Kavanaugh, 61%; Justice Thomas, 60%; Chief Justice Roberts and Justices Ginsburg and Alito, each 55%; Justice Breyer, 50%; and Justices Sotomayor and Kagan each at 45%.
• There were 57 dissenting opinions—up from 48 in the previous term.
• What is referred to as “the liberal-conservative split” might seem more profound than it really is: “Every conservative member of the court at some point voted to form a majority with the liberal justices. And every liberal at least once left behind all of his or her usual voting partners to join the conservatives.”²⁹

Continue to: Last, it was a year of personal health issues for...

Last, it was a year of personal health issues for the Court: Justice Ginsburg had a diagnosis of lung cancer and was absent, following surgery, in January. Of retired Justices, Sandra Day O’Connor suffers from dementia and former Justice John Paul Stevens died.

In closing

The Court has accepted approximately 50 cases for the current term, which began on October 7. The first 2 days of the term were spent on arguments about, first, whether a state can abolish the insanity defense and, second, whether nondiscrimination laws (“based on sex”) prohibit discrimination based on sexual orientation or transgender status. Cases also will deal with Patient Protection and Affordable Care Act payments to providers; the Deferred Action for Childhood Arrivals, or DACA; the death penalty; and international child custody disputes. The Court will be accepting more cases for several months. It promises to be a very interesting term.

The most recently concluded term of the US Supreme Court, which began on October 1, 2018, yielded a number of decisions of interest to health care professionals and to ObGyns in particular. Although the term was viewed by some observers as less consequential than other recent terms, a review of the cases decided paints a picture of a more important term than some commentators expected.

When the term began, the Court had only 8 justices—1 short of a full bench: Judge Brett Kavanaugh had not yet been confirmed by the Senate. He was confirmed on October 6, by a 50-48 vote, and Justice Kavanaugh immediately joined the Court and began to hear and decide cases.

Increasingly, important decisions affect medical practice

From the nature of practice (abortion), to payment for service (Medicare reimbursement), resolution of disputes (arbitration), and fraud and abuse (the federal False Claims Act), the decisions of the Court will have an impact on many areas of medical practice. Organized medicine increasingly has recognized the significance of the work of the Court; nowhere has this been more clearly demonstrated than with amicus curiae (friend of the court) briefs filed by medical organizations.

Amicus curiae briefs. These briefs are filed by persons or organizations not a party to a case the Court is hearing. Their legitimate purpose is to inform the Court of 1) special information within the expertise of the amicus (or amici, plural) or 2) consequences of the decision that might not be apparent from arguments made by the parties to the case. Sometimes, the Court cites amicus briefs for having provided important information about the case.

Filing amicus briefs is time-consuming and expensive; organizations do not file them for trivial reasons. Organizations frequently join together to file a joint brief, to share expenses and express to the Court a stronger position.

Three categories of health professionals file amicus briefs in ObGyn-related cases:

• Major national organizations, often representing broad interests of health care professions or institutions (the American Medical Association [AMA], the Association of American Medical Colleges, and the American Hospital Association [AHA]), have filed a number of amicus briefs over the years.
• Specialty boards increasingly file amicus briefs. For example, the American College of Obstetricians and Gynecologists (ACOG) and the American Society for Reproductive Medicine have filed briefs related to abortion issues.
• In reproductive issues, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, and the Christian Medical & Dental Associations have been active amicus filers—frequently taking positions different than, even inconsistent with, amicus briefs filed by major specialty boards.

Amicus briefs filed by medical associations provide strong clues to what is important to clinicians. We have looked at such briefs to help us identify topics and cases from the just-concluded term that can be of particular interest to you.

Continue to: Surveying the shadow docket...

Surveying the shadow docket. As part of our review of the past term, we also looked at the so-called shadow docket, which includes decisions regarding writs of certiorari (which cases it agrees to hear); stays (usually delaying implementation of a law); or denials of stays. (Persuading the Court to hear a case is not easy: It hears approximately 70 cases per year out of as many as 7,000 applications to be heard.)

Abortion ruling

At stake. A number of states recently enacted a variety of provisions that might make an abortion more difficult to obtain. Some of the cases challenging these restrictions are making their way through lower courts, and one day might be argued before the Supreme Court. However, the Court has not (yet) agreed to hear the substance of many new abortion-related provisions.

Box v Planned Parenthood of Indiana and Kentucky, Inc.

The Court decided only 1 abortion restriction case this term.¹ The Indiana law in question included 2 provisions that the Court considered:

Disposal of remains. The law regulated the manner in which abortion providers can dispose of fetal remains (ie, they cannot be treated as “infectious and pathologic waste”).

Motivation for seeking abortion. The Indiana law makes it illegal for an abortion provider to perform an abortion when the provider knows that the mother is seeking that abortion “solely” because of the fetus’s race, sex, diagnosis of Down syndrome, disability, or related characteristics.

Final rulings. The Court held that the disposal-of-remains provision is constitutional. The provision is “rationally related to the state’s interest in proper disposal of fetal remains.”² Planned Parenthood had not raised the issue of whether the law might impose an undue burden on a woman’s right to obtain an abortion, so the Court did not decide that issue.

The Court did not consider the constitutionality of the part of the law proscribing certain reasons for seeking an otherwise legal abortion; instead, it awaits lower courts’ review of the issue. Justice Clarence Thomas wrote an extensive concurring opinion suggesting that this law is intended to avoid abortion to achieve eugenic goals.³

Key developments from the shadow docket

The Court issued a stay preventing a Louisiana statute that requires physicians who perform abortions to have admitting privileges at a nearby hospital from going into effect, pending the outcome of litigation about that law.⁴ Four dissenters noted that all 4 physicians who perform abortions in Louisiana have such privileges. Chief Justice Roberts was the fifth vote to grant the stay. This case likely will make its way back to the Court, as will a number of other state laws being adopted. The issue may be back as soon as the term just starting.

The Court is also considering whether to take another Indiana case, Box v Planned Parenthood of Indiana and Kentucky, Inc. (Box II). This case involves an Indiana ultrasonography viewing option as part of the abortion consent process.⁵

The Court declined to hear cases from Louisiana and Kansas in which the states had cut off Medicaid funding to Planned Parenthood. Lower courts had stopped the implementation of those laws.⁶ The legal issue was whether private parties, as opposed to the federal government, had standing to bring the case. For now, the decision of the lower courts to stop implementation of the funding cutoff is in effect. There is a split in the Circuit Courts on the issue, however, making it likely that the Supreme Court will have to resolve it sooner or later.

Health care organizations have filed a number of amicus briefs in these and other cases involving new abortion regulations. ACOG and others filed a brief opposing a Louisiana law that requires abortion providers to have admitting privileges at a nearby facility,⁷ and a brief opposing a similar Oklahoma law.⁸ The Association of Pro-Life Obstetricians and Gynecologists and others filed amicus curiae briefs in Box II⁹ and in an Alabama case involving so-called dismemberment abortion.¹⁰

Continue to: Medicare payments...

Medicare payments

Azar, Secretary of Health and Human Services v Allina Health Services, et al¹¹

This case drew interest—and many amicus briefs—from health care providers, including the AMA and the AHA.^12,13 There was good reason for their interest: First, the case involved more than $3 billion in reimbursements; second, it represented a potentially important precedent about the rights of providers and patients to comment on Medicare reimbursement changes. The question involved the technical calculation of additional payments made to institutions that serve a disproportionate number of low-income patients (known as Medicare Fractions).

At stake. The issue was a statutory requirement for a 60-day public notice and comment period for rules that “change a substantive legal standard” governing the scope of benefits, eligibility, or payment for services.¹⁴ In 2014, the Secretary of the Department of Health and Human Services (HHS) in the Obama administration posted a spreadsheet announcing Medicare fractions rates for hospitals (for 2012)—without formal notice or comment regarding the formula used. (The spreadsheet listed what each qualifying institution would receive, but it was based on a formula that, as noted, had not been subject to public notice and comment.) The AMA and AHA briefs emphasized the importance of a notice and comment period, especially when Medicare reimbursement is involved.

Final ruling. The Court held that the HHS process violated the notice and comment provision, thereby invalidating the policy underlying the so-called spreadsheet reimbursement. The decision was significant: This was a careful statutory interpretation of the 60-day notice and comment period, not the reimbursement policy itself. Presumably, had the HHS Secretary provided for sufficient notice and comment, the formula used would have met the requirements for issuing reimbursement formulas.

Key points. Hospitals will collectively receive $3 or $4 billion as a consequence of the ruling. Perhaps more importantly, the decision signals that HHS is going to have to take seriously the requirement that it publish Medicare-related reimbursement policies for the 60-day period.

Liability under the False Claims Act

The False Claims Act (FCA) protects the federal government from fraudulent claims for payment and for shoddy goods and services. It incentivizes (by a percentage of recovery) private parties to bring cases to enforce the law.¹⁵ (Of course, the federal government also enforces the Act.)

At stake. The FCA has been of considerable concern to the AHA, the Association of American Medical Colleges, and other health care organizations—understandably so.¹⁶ As the AHA informed the Court in an amicus brief, “The prevalence of [FCA] cases has ballooned over the past three decades.... These suits disproportionately target healthcare entities.... Of the 767 new FCA cases filed in 2018, for example, 506 involved healthcare defendants.”¹⁷

Final ruling. The Court considered an ambiguity in the statute of limitations for these actions and the Court unanimously ruled to permit an extended time in which qui tam actions (private actions under the law) can be filed.¹⁸

Key points. As long a period as 10 years can pass between the time an FCA violation occurs and an action is brought. This decision is likely to increase the number of FCA actions against health care providers because the case can be filed many years after the conduct that gave rise to the complaint.

Continue to: Registering sex offenders...

Registering sex offenders

The Court upheld the constitutionality of the federal Sex Offender Registration and Notification Act (SORNA).¹⁹ Sex offenders must register and periodically report, in person, to law enforcement in every state in which the offender works, studies, or resides.

At stake. The case involved the applicability of SORNA registration obligations to those convicted of sex offenses before SORNA was adopted (pre-Act offenders).²⁰ The court upheld registration requirements for pre-Act offenders.

Arbitration

The Court continued its practice of deciding at least one case each term that emphasizes that federal law requires that courts rather strictly enforce agreements to arbitrate (instead of to litigate) future disputes.²¹ In another case, the Court ruled that there can be “class” or “joint” arbitration only if the agreement to arbitrate a dispute clearly permits such class arbitration.²²

Pharma’s liability regarding product risk

The Court somewhat limited the liability of pharmaceutical companies for failing to provide adequate warning about the risk that their products pose. The case against Merck involved 500 patients who took denosumab (Fosamax) and suffered atypical femoral fractures.²³

At stake. Because prescribing information (in which warnings are provided) must be approved by the US Food and Drug Administration (FDA), the legal test is: Would the FDA have refused to approve a change in the warning if Merck had “fully informed the FDA of the justifications for the warning” required by state law to avoid liability?^24,25 Lower-court judges (not juries) will be expected to apply this test in the future.

The doctor and the death penalty

The Court has established a rule that, when a prisoner facing capital punishment objects to a form of execution because it is too painful, he has to propose an alternative that is reasonably available. In one case,²⁶ a physician, an expert witness for the prisoner, did not answer some essential relative-pain questions (ie, would one procedure be more painful than another?).

At stake. The AMA filed an amicus brief in this case, indicating that it is unethical for physicians to participate in an execution. The brief noted that “testimony used to determine which method of execution would reduce physical suffering would constitute physician participation in capital punishment and would be unethical.”²⁷

The expert witness’s failure to answer the question on relative pain had the unfortunate result of reducing the likelihood that the prisoner would prevail in his request for an alternative method of execution.

Analysis

Despite obvious disagreements about big issues (notably, abortion and the death penalty) the Court maintained a courteous and civil demeanor—something not always seen nowadays in other branches of government. Here are facts about the Court’s term just concluded:

• The Court issued 72 merits opinions (about average).
• Only 39% of decisions were unanimous (compared with the average of 49% in recent terms).
• On the other hand, 26% of decisions were split 5 to 4 (compared with a 10% recent average).
• In those 5 to 4 decisions, Justices were in the majority as follows²⁸: Justice Gorsuch, 65%; Justice Kavanaugh, 61%; Justice Thomas, 60%; Chief Justice Roberts and Justices Ginsburg and Alito, each 55%; Justice Breyer, 50%; and Justices Sotomayor and Kagan each at 45%.
• There were 57 dissenting opinions—up from 48 in the previous term.
• What is referred to as “the liberal-conservative split” might seem more profound than it really is: “Every conservative member of the court at some point voted to form a majority with the liberal justices. And every liberal at least once left behind all of his or her usual voting partners to join the conservatives.”²⁹

Continue to: Last, it was a year of personal health issues for...

Last, it was a year of personal health issues for the Court: Justice Ginsburg had a diagnosis of lung cancer and was absent, following surgery, in January. Of retired Justices, Sandra Day O’Connor suffers from dementia and former Justice John Paul Stevens died.

In closing

The Court has accepted approximately 50 cases for the current term, which began on October 7. The first 2 days of the term were spent on arguments about, first, whether a state can abolish the insanity defense and, second, whether nondiscrimination laws (“based on sex”) prohibit discrimination based on sexual orientation or transgender status. Cases also will deal with Patient Protection and Affordable Care Act payments to providers; the Deferred Action for Childhood Arrivals, or DACA; the death penalty; and international child custody disputes. The Court will be accepting more cases for several months. It promises to be a very interesting term.

The most recently concluded term of the US Supreme Court, which began on October 1, 2018, yielded a number of decisions of interest to health care professionals and to ObGyns in particular. Although the term was viewed by some observers as less consequential than other recent terms, a review of the cases decided paints a picture of a more important term than some commentators expected.

When the term began, the Court had only 8 justices—1 short of a full bench: Judge Brett Kavanaugh had not yet been confirmed by the Senate. He was confirmed on October 6, by a 50-48 vote, and Justice Kavanaugh immediately joined the Court and began to hear and decide cases.

Increasingly, important decisions affect medical practice

From the nature of practice (abortion), to payment for service (Medicare reimbursement), resolution of disputes (arbitration), and fraud and abuse (the federal False Claims Act), the decisions of the Court will have an impact on many areas of medical practice. Organized medicine increasingly has recognized the significance of the work of the Court; nowhere has this been more clearly demonstrated than with amicus curiae (friend of the court) briefs filed by medical organizations.

Amicus curiae briefs. These briefs are filed by persons or organizations not a party to a case the Court is hearing. Their legitimate purpose is to inform the Court of 1) special information within the expertise of the amicus (or amici, plural) or 2) consequences of the decision that might not be apparent from arguments made by the parties to the case. Sometimes, the Court cites amicus briefs for having provided important information about the case.

Filing amicus briefs is time-consuming and expensive; organizations do not file them for trivial reasons. Organizations frequently join together to file a joint brief, to share expenses and express to the Court a stronger position.

Three categories of health professionals file amicus briefs in ObGyn-related cases:

• Major national organizations, often representing broad interests of health care professions or institutions (the American Medical Association [AMA], the Association of American Medical Colleges, and the American Hospital Association [AHA]), have filed a number of amicus briefs over the years.
• Specialty boards increasingly file amicus briefs. For example, the American College of Obstetricians and Gynecologists (ACOG) and the American Society for Reproductive Medicine have filed briefs related to abortion issues.
• In reproductive issues, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, and the Christian Medical & Dental Associations have been active amicus filers—frequently taking positions different than, even inconsistent with, amicus briefs filed by major specialty boards.

Amicus briefs filed by medical associations provide strong clues to what is important to clinicians. We have looked at such briefs to help us identify topics and cases from the just-concluded term that can be of particular interest to you.

Continue to: Surveying the shadow docket...

Surveying the shadow docket. As part of our review of the past term, we also looked at the so-called shadow docket, which includes decisions regarding writs of certiorari (which cases it agrees to hear); stays (usually delaying implementation of a law); or denials of stays. (Persuading the Court to hear a case is not easy: It hears approximately 70 cases per year out of as many as 7,000 applications to be heard.)

Abortion ruling

At stake. A number of states recently enacted a variety of provisions that might make an abortion more difficult to obtain. Some of the cases challenging these restrictions are making their way through lower courts, and one day might be argued before the Supreme Court. However, the Court has not (yet) agreed to hear the substance of many new abortion-related provisions.

Box v Planned Parenthood of Indiana and Kentucky, Inc.

The Court decided only 1 abortion restriction case this term.¹ The Indiana law in question included 2 provisions that the Court considered:

Disposal of remains. The law regulated the manner in which abortion providers can dispose of fetal remains (ie, they cannot be treated as “infectious and pathologic waste”).

Motivation for seeking abortion. The Indiana law makes it illegal for an abortion provider to perform an abortion when the provider knows that the mother is seeking that abortion “solely” because of the fetus’s race, sex, diagnosis of Down syndrome, disability, or related characteristics.

Final rulings. The Court held that the disposal-of-remains provision is constitutional. The provision is “rationally related to the state’s interest in proper disposal of fetal remains.”² Planned Parenthood had not raised the issue of whether the law might impose an undue burden on a woman’s right to obtain an abortion, so the Court did not decide that issue.

The Court did not consider the constitutionality of the part of the law proscribing certain reasons for seeking an otherwise legal abortion; instead, it awaits lower courts’ review of the issue. Justice Clarence Thomas wrote an extensive concurring opinion suggesting that this law is intended to avoid abortion to achieve eugenic goals.³

Key developments from the shadow docket

The Court issued a stay preventing a Louisiana statute that requires physicians who perform abortions to have admitting privileges at a nearby hospital from going into effect, pending the outcome of litigation about that law.⁴ Four dissenters noted that all 4 physicians who perform abortions in Louisiana have such privileges. Chief Justice Roberts was the fifth vote to grant the stay. This case likely will make its way back to the Court, as will a number of other state laws being adopted. The issue may be back as soon as the term just starting.

The Court is also considering whether to take another Indiana case, Box v Planned Parenthood of Indiana and Kentucky, Inc. (Box II). This case involves an Indiana ultrasonography viewing option as part of the abortion consent process.⁵

The Court declined to hear cases from Louisiana and Kansas in which the states had cut off Medicaid funding to Planned Parenthood. Lower courts had stopped the implementation of those laws.⁶ The legal issue was whether private parties, as opposed to the federal government, had standing to bring the case. For now, the decision of the lower courts to stop implementation of the funding cutoff is in effect. There is a split in the Circuit Courts on the issue, however, making it likely that the Supreme Court will have to resolve it sooner or later.

Health care organizations have filed a number of amicus briefs in these and other cases involving new abortion regulations. ACOG and others filed a brief opposing a Louisiana law that requires abortion providers to have admitting privileges at a nearby facility,⁷ and a brief opposing a similar Oklahoma law.⁸ The Association of Pro-Life Obstetricians and Gynecologists and others filed amicus curiae briefs in Box II⁹ and in an Alabama case involving so-called dismemberment abortion.¹⁰

Continue to: Medicare payments...

Medicare payments

Azar, Secretary of Health and Human Services v Allina Health Services, et al¹¹

This case drew interest—and many amicus briefs—from health care providers, including the AMA and the AHA.^12,13 There was good reason for their interest: First, the case involved more than $3 billion in reimbursements; second, it represented a potentially important precedent about the rights of providers and patients to comment on Medicare reimbursement changes. The question involved the technical calculation of additional payments made to institutions that serve a disproportionate number of low-income patients (known as Medicare Fractions).

At stake. The issue was a statutory requirement for a 60-day public notice and comment period for rules that “change a substantive legal standard” governing the scope of benefits, eligibility, or payment for services.¹⁴ In 2014, the Secretary of the Department of Health and Human Services (HHS) in the Obama administration posted a spreadsheet announcing Medicare fractions rates for hospitals (for 2012)—without formal notice or comment regarding the formula used. (The spreadsheet listed what each qualifying institution would receive, but it was based on a formula that, as noted, had not been subject to public notice and comment.) The AMA and AHA briefs emphasized the importance of a notice and comment period, especially when Medicare reimbursement is involved.

Final ruling. The Court held that the HHS process violated the notice and comment provision, thereby invalidating the policy underlying the so-called spreadsheet reimbursement. The decision was significant: This was a careful statutory interpretation of the 60-day notice and comment period, not the reimbursement policy itself. Presumably, had the HHS Secretary provided for sufficient notice and comment, the formula used would have met the requirements for issuing reimbursement formulas.

Key points. Hospitals will collectively receive $3 or $4 billion as a consequence of the ruling. Perhaps more importantly, the decision signals that HHS is going to have to take seriously the requirement that it publish Medicare-related reimbursement policies for the 60-day period.

Liability under the False Claims Act

The False Claims Act (FCA) protects the federal government from fraudulent claims for payment and for shoddy goods and services. It incentivizes (by a percentage of recovery) private parties to bring cases to enforce the law.¹⁵ (Of course, the federal government also enforces the Act.)

At stake. The FCA has been of considerable concern to the AHA, the Association of American Medical Colleges, and other health care organizations—understandably so.¹⁶ As the AHA informed the Court in an amicus brief, “The prevalence of [FCA] cases has ballooned over the past three decades.... These suits disproportionately target healthcare entities.... Of the 767 new FCA cases filed in 2018, for example, 506 involved healthcare defendants.”¹⁷

Final ruling. The Court considered an ambiguity in the statute of limitations for these actions and the Court unanimously ruled to permit an extended time in which qui tam actions (private actions under the law) can be filed.¹⁸

Key points. As long a period as 10 years can pass between the time an FCA violation occurs and an action is brought. This decision is likely to increase the number of FCA actions against health care providers because the case can be filed many years after the conduct that gave rise to the complaint.

Continue to: Registering sex offenders...

Registering sex offenders

The Court upheld the constitutionality of the federal Sex Offender Registration and Notification Act (SORNA).¹⁹ Sex offenders must register and periodically report, in person, to law enforcement in every state in which the offender works, studies, or resides.

At stake. The case involved the applicability of SORNA registration obligations to those convicted of sex offenses before SORNA was adopted (pre-Act offenders).²⁰ The court upheld registration requirements for pre-Act offenders.

Arbitration

The Court continued its practice of deciding at least one case each term that emphasizes that federal law requires that courts rather strictly enforce agreements to arbitrate (instead of to litigate) future disputes.²¹ In another case, the Court ruled that there can be “class” or “joint” arbitration only if the agreement to arbitrate a dispute clearly permits such class arbitration.²²

Pharma’s liability regarding product risk

The Court somewhat limited the liability of pharmaceutical companies for failing to provide adequate warning about the risk that their products pose. The case against Merck involved 500 patients who took denosumab (Fosamax) and suffered atypical femoral fractures.²³

At stake. Because prescribing information (in which warnings are provided) must be approved by the US Food and Drug Administration (FDA), the legal test is: Would the FDA have refused to approve a change in the warning if Merck had “fully informed the FDA of the justifications for the warning” required by state law to avoid liability?^24,25 Lower-court judges (not juries) will be expected to apply this test in the future.

The doctor and the death penalty

The Court has established a rule that, when a prisoner facing capital punishment objects to a form of execution because it is too painful, he has to propose an alternative that is reasonably available. In one case,²⁶ a physician, an expert witness for the prisoner, did not answer some essential relative-pain questions (ie, would one procedure be more painful than another?).

At stake. The AMA filed an amicus brief in this case, indicating that it is unethical for physicians to participate in an execution. The brief noted that “testimony used to determine which method of execution would reduce physical suffering would constitute physician participation in capital punishment and would be unethical.”²⁷

The expert witness’s failure to answer the question on relative pain had the unfortunate result of reducing the likelihood that the prisoner would prevail in his request for an alternative method of execution.

Analysis

Despite obvious disagreements about big issues (notably, abortion and the death penalty) the Court maintained a courteous and civil demeanor—something not always seen nowadays in other branches of government. Here are facts about the Court’s term just concluded:

• The Court issued 72 merits opinions (about average).
• Only 39% of decisions were unanimous (compared with the average of 49% in recent terms).
• On the other hand, 26% of decisions were split 5 to 4 (compared with a 10% recent average).
• In those 5 to 4 decisions, Justices were in the majority as follows²⁸: Justice Gorsuch, 65%; Justice Kavanaugh, 61%; Justice Thomas, 60%; Chief Justice Roberts and Justices Ginsburg and Alito, each 55%; Justice Breyer, 50%; and Justices Sotomayor and Kagan each at 45%.
• There were 57 dissenting opinions—up from 48 in the previous term.
• What is referred to as “the liberal-conservative split” might seem more profound than it really is: “Every conservative member of the court at some point voted to form a majority with the liberal justices. And every liberal at least once left behind all of his or her usual voting partners to join the conservatives.”²⁹

Continue to: Last, it was a year of personal health issues for...

Last, it was a year of personal health issues for the Court: Justice Ginsburg had a diagnosis of lung cancer and was absent, following surgery, in January. Of retired Justices, Sandra Day O’Connor suffers from dementia and former Justice John Paul Stevens died.

In closing

The Court has accepted approximately 50 cases for the current term, which began on October 7. The first 2 days of the term were spent on arguments about, first, whether a state can abolish the insanity defense and, second, whether nondiscrimination laws (“based on sex”) prohibit discrimination based on sexual orientation or transgender status. Cases also will deal with Patient Protection and Affordable Care Act payments to providers; the Deferred Action for Childhood Arrivals, or DACA; the death penalty; and international child custody disputes. The Court will be accepting more cases for several months. It promises to be a very interesting term.

In the current health care environment, hospitals are constantly challenged to improve quality metrics and deliver better health care outcomes. One means to achieving quality improvement is through the use of order sets, groups of related orders that a health care provider (HCP) can place with either a few keystrokes or mouse clicks.¹

Historically, design of order sets has largely focused on clicking checkboxes containing evidence-based practices. According to Bates and colleagues and the Institute for Safe Medication Practices, incorporating evidence-based medicine (EBM) into order sets is not by itself sufficient.^2,3Execution of proper design coupled with simplicity and provider efficiency is paramount to HCP buy-in, increased likelihood of order set adherence, and to potentially better outcomes.

In this article, we outline advancements in order set design. These improvements increase provider efficiency and ease of use; incorporate human factors engineering (HFE); apply failure mode and effects analysis; and include EBM.

Methods

An inpatient nicotine replacement therapy (NRT) order was developed as part of a multifaceted solution to improve tobacco cessation care at the James A. Haley Veterans’ Hospital (JAHVH) in Tampa, Florida, a complexity level 1a facility. This NRT order set used the 4-step order set design framework the authors’ developed (for additional information about the NRT order set, contact the authors). We distinguish order set design technique between 2 different inpatient NRT order sets. The first order set in the comparison (Figure 1) is an inpatient NRT order set of unknown origin—it is common for US Department of Veterans Affairs (VA) medical facilities to share order sets and other resources. The second order set (Figure 2) is an inpatient NRT order set we designed using our 4-step process for comparison in this article. No institutional review board approval was required as this work met criteria for operational improvement activities exempt from ethics review.

Justin Iannello, DO, MBA, was the team leader and developer of the 4-step order set design technique. The intervention team consisted of 4 internal medicine physicians with expertise in quality improvement and patient safety: 1 certified professional in patient safety and certified as a Lean Six Sigma Black Belt; 2 physicians certified as Lean Six Sigma Black Belts; and 1 physician certified as a Lean Six Sigma Green Belt. Two inpatient clinical pharmacists and 1 quality management specialist also were involved in its development.

Development of a new NRT order set was felt to be an integral part of the tobacco cessation care delivery process. An NRT order set perceived by users as value-added required a solution that merged EBM with standardization and applied quality improvement principles. The result was an approach to order set design that focused on 4 key questions: Is the order set efficient and easy to use/navigate? Is human factors engineering incorporated? Is failure mode and effects analysis applied? Are evidence-based practices included?

Ease of Use and Navigation

Implementing an order set that is efficient and easy to use or navigate seems straightforward but can be difficult to execute. Figure 1 shows many detailed options consisting of different combinations of nicotine patches, lozenges, and gum. Also included are oral tobacco cessation options (bupropion and varenicline). Although more options may seem better, confusion about appropriate medication selection can occur.

According to Heath and Heath, too many options can result in lack of action.⁴ For example, Heath and Heath discuss a food store that offered 6 free samples of different jams on one day and 24 jams the following day. The customers who sampled 6 different types of jam were 10 times more likely to buy jam. The authors concluded that the more options available, the more difficulty a potential buyer has in deciding on a course of action.⁴

In clinical situations where a HCP is using an order set, the number of options can mean the difference between use vs avoidance if the choices are overwhelming. HCPs process layers of detail every day when creating differential diagnoses and treatment plans. While that level of detail is necessary clinically, that same level of detail included in orders sets can create challenges for HCPs.

Figure 2 advances the order set in Figure 1 by providing a simpler and cleaner design, so HCPs can more easily review and process the information. This order set design minimizes the number of options available to help users make the right decision, focusing on value for the appropriate setting and audience. In other words, order sets should not be a “one size fits all” approach.

Order sets should be tailored to the appropriate clinical setting (eg, inpatient acute care, outpatient clinic setting, etc) and HCP (eg, hospitalist, tobacco cessation specialist, etc). We are comparing NRT order sets designed for HCPs who do not routinely prescribe oral tobacco cessation products in the inpatient setting. When possible, autogenerated bundle orders should also be used according to evidence-based recommendations (such as nicotine patch tapers) for ease of use and further simplification of order sets.

Finally, usability testing known as “evaluating a product or service by testing it with representative users” helps further refine an order set.⁵Usability testing should be applied during all phases of order set development with end user(s) as it helps identify problems with order set design prior to implementation. By applying usability testing, the order set becomes more meaningful and valued by the user.

Human Factors Engineering

HFE is “the study of all the factors that make it easier to do the work in the right way.”⁶ HFE seeks to identify, align, and apply processes for people and the world within which they live and work to promote safe and efficient practices, especially in relation to the technology and physical design features in their work environment.⁶

The average American adult makes about 35,000 decisions per day.⁷ Thus, there is potential for error at any moment. Design that does not take HFE into account can be dangerous. For example, when tube feed and IV line connectors look similar and are compatible, patients may inadvertently receive food administered directly into their bloodstream.⁸

HFE can and should be applied to order sets. Everything from the look, feel, and verbiage of an order set affects potential outcomes. For example, consider the impact even seemingly minor modifications can have on outcomes simply by guiding users in a different way: Figure 1 provides NRT options based on cigarette use per day, whereas Figure 2 conveys pack use per day in relation to the equivalent number of cigarettes used daily. These differences may seem small; however, it helps guide users to the right choice when considering that health care providers have been historically trained on social history gathering that emphasizes packs per day and pack-years.

Failure Mode and Effects Analysis

Failure mode and effects analysis (FMEA) is “a structured way to identify and address potential problems, or failures and their resulting effects on the system or process before an adverse event occurs.”⁹ The benefit of an order set must be weighed against the risk during development. FMEA should be applied during order set design to assess and limit risk just as with any other clinical care process.

FMEA examines both level of risk and frequency of risk occurrence associated with a new proposed process. For example, let’s evaluate an order set designed for pain control after surgery that consists of multiple high-risk opioids along with antihistamine medications for as-needed itch relief (a non-life-threatening adverse event (AE) of opioids well known by the medical community). An interdisciplinary FMEA team consisting of subject matter experts may examine how the process should flow in step-by-step detail and then discuss the benefit of a process and risk for potential error. A FMEA team would then analyze what could go wrong with each part of the process and assign a level of risk and risk frequency for various steps in the process, and then decide that certain steps should be modified or eliminated. Perhaps after FMEA, a facility might conclude that the risk of serious complications is high when you combine opioid use with antihistamine medications. The facility could decide to remove antihistamine medications from an order set if it is determined that risks outweigh benefits. While a root cause analysis might identify the cause of an AE after order set use, these situations can be prevented with FMEA.

When applying FMEA to Figure 1, while bupropion is known as an evidence-based oral tobacco cessation option, there is the possibility that bupropion could be inadvertently prescribed from the order set in a hospitalized patient with alcohol withdrawal and withdrawal seizure history. These potentially dangerous situations can be avoided with FMEA. Thus, although bupropion may be evidence-based for NRT, decisions regarding order set design using EBM alone are insufficient.

The practitioner must consider possible unintended consequences within order sets and target treatment options to the appropriate setting and audience. Although Figure 1 may appear to be more inclusive, the interdisciplinary committee designing the inpatient NRT order set felt there was heightened risk with introducing bupropion in Figure 1 and decided the risk would be lowered by removing bupropion from the redesigned NRT order set (Figure 2). In addition to the goal of balancing availability of NRT options with acceptable risk, Figure 2 also focused on building an NRT order set most applicable to the inpatient setting.

Including Evidence-Based Practices

EBM has become a routine part of clinical decision making. Therefore, including EBM in order set design is vital. EBM for NRT has demonstrated that combination therapy is more effective than is monotherapy to help tobacco users quit. Incremental doses of NRT are recommended for patients who use tobacco more frequently.¹⁰

As shown in Figures 1 and 2, both order set designs incorporate EBM for NRT. Although the importance of implementing EBM is evident, critical factors, such as HFE and FMEA make a difference with well-designed order sets.

Results

The 4-step order set design technique was used during development of an inpatient NRT order set at the JAHVH. Results for the inpatient Joint Commission Tobacco Treatment Measures were obtained from the Veterans Health Administration quality metric reporting system known as Strategic Analytics for Improvement and Learning (SAIL). SAIL performance measure outcomes, which include the inpatient Joint Commission Tobacco Treatment Measures, are derived from chart reviews conducted by the External Peer Review Program. Outcomes demonstrated that TOB-2 and TOB-3 (2 inpatient Joint Commission Tobacco Treatment Measures) known as tob20 and tob40, respectively, within SAIL improved by more than 300% after development of an NRT order set using the 4-step order set design framework along with implementation of a multifaceted tobacco cessation care delivery system at JAHVH.

Discussion

While the overall tobacco cessation care delivery system contributed to improved outcomes with the inpatient Joint Commission Tobacco Treatment Measures at JAHVH, the NRT order set was a cornerstone of the design. Although using our order set design technique does not necessarily guarantee successful outcomes, we believe using the 4-step order set design process increases the value of order sets and has potential to improve quality outcomes.

Limitations

Although improved outcomes following implementation of our NRT order set suggest correlation, causation cannot be proven. Also while the NRT order set is believed to have helped tremendously with outcomes, the entire tobacco cessation care delivery system at JAHVH contributed to the results. In addition, the inpatient Joint Commission Tobacco Treatment Measures help improve processes for tobacco cessation care. However, we are uncertain whether the results of our improvement efforts helped patients stop tobacco use. Further studies are needed to determine impact on population health. Finally, our results were based on improvement work done at a single center. Further studies are necessary to see whether results are reproducible.

Conclusion

There was significant improvement with the inpatient Joint Commission Tobacco Treatment Measures outcomes following development of a tobacco cessation care delivery system that included design of an inpatient NRT order set using a 4-step process we developed. This 4-step structure includes emphasis on efficiency and ease of use; human factors engineering; failure mode and effects analysis; and incorporation of evidence-based medicine (Box.) Postimplementation results showed improvement of the inpatient Joint Commission Tobacco Treatment Measures by greater than 3-fold at a single hospital.

The next steps for this initiative include testing the 4-step order set design process in multiple clinical settings to determine the effectiveness of this approach in other areas of clinical care.

In the current health care environment, hospitals are constantly challenged to improve quality metrics and deliver better health care outcomes. One means to achieving quality improvement is through the use of order sets, groups of related orders that a health care provider (HCP) can place with either a few keystrokes or mouse clicks.¹

Historically, design of order sets has largely focused on clicking checkboxes containing evidence-based practices. According to Bates and colleagues and the Institute for Safe Medication Practices, incorporating evidence-based medicine (EBM) into order sets is not by itself sufficient.^2,3Execution of proper design coupled with simplicity and provider efficiency is paramount to HCP buy-in, increased likelihood of order set adherence, and to potentially better outcomes.

In this article, we outline advancements in order set design. These improvements increase provider efficiency and ease of use; incorporate human factors engineering (HFE); apply failure mode and effects analysis; and include EBM.

Methods

An inpatient nicotine replacement therapy (NRT) order was developed as part of a multifaceted solution to improve tobacco cessation care at the James A. Haley Veterans’ Hospital (JAHVH) in Tampa, Florida, a complexity level 1a facility. This NRT order set used the 4-step order set design framework the authors’ developed (for additional information about the NRT order set, contact the authors). We distinguish order set design technique between 2 different inpatient NRT order sets. The first order set in the comparison (Figure 1) is an inpatient NRT order set of unknown origin—it is common for US Department of Veterans Affairs (VA) medical facilities to share order sets and other resources. The second order set (Figure 2) is an inpatient NRT order set we designed using our 4-step process for comparison in this article. No institutional review board approval was required as this work met criteria for operational improvement activities exempt from ethics review.

Justin Iannello, DO, MBA, was the team leader and developer of the 4-step order set design technique. The intervention team consisted of 4 internal medicine physicians with expertise in quality improvement and patient safety: 1 certified professional in patient safety and certified as a Lean Six Sigma Black Belt; 2 physicians certified as Lean Six Sigma Black Belts; and 1 physician certified as a Lean Six Sigma Green Belt. Two inpatient clinical pharmacists and 1 quality management specialist also were involved in its development.

Development of a new NRT order set was felt to be an integral part of the tobacco cessation care delivery process. An NRT order set perceived by users as value-added required a solution that merged EBM with standardization and applied quality improvement principles. The result was an approach to order set design that focused on 4 key questions: Is the order set efficient and easy to use/navigate? Is human factors engineering incorporated? Is failure mode and effects analysis applied? Are evidence-based practices included?

Ease of Use and Navigation

Implementing an order set that is efficient and easy to use or navigate seems straightforward but can be difficult to execute. Figure 1 shows many detailed options consisting of different combinations of nicotine patches, lozenges, and gum. Also included are oral tobacco cessation options (bupropion and varenicline). Although more options may seem better, confusion about appropriate medication selection can occur.

According to Heath and Heath, too many options can result in lack of action.⁴ For example, Heath and Heath discuss a food store that offered 6 free samples of different jams on one day and 24 jams the following day. The customers who sampled 6 different types of jam were 10 times more likely to buy jam. The authors concluded that the more options available, the more difficulty a potential buyer has in deciding on a course of action.⁴

In clinical situations where a HCP is using an order set, the number of options can mean the difference between use vs avoidance if the choices are overwhelming. HCPs process layers of detail every day when creating differential diagnoses and treatment plans. While that level of detail is necessary clinically, that same level of detail included in orders sets can create challenges for HCPs.

Figure 2 advances the order set in Figure 1 by providing a simpler and cleaner design, so HCPs can more easily review and process the information. This order set design minimizes the number of options available to help users make the right decision, focusing on value for the appropriate setting and audience. In other words, order sets should not be a “one size fits all” approach.

Order sets should be tailored to the appropriate clinical setting (eg, inpatient acute care, outpatient clinic setting, etc) and HCP (eg, hospitalist, tobacco cessation specialist, etc). We are comparing NRT order sets designed for HCPs who do not routinely prescribe oral tobacco cessation products in the inpatient setting. When possible, autogenerated bundle orders should also be used according to evidence-based recommendations (such as nicotine patch tapers) for ease of use and further simplification of order sets.

Finally, usability testing known as “evaluating a product or service by testing it with representative users” helps further refine an order set.⁵Usability testing should be applied during all phases of order set development with end user(s) as it helps identify problems with order set design prior to implementation. By applying usability testing, the order set becomes more meaningful and valued by the user.

Human Factors Engineering

HFE is “the study of all the factors that make it easier to do the work in the right way.”⁶ HFE seeks to identify, align, and apply processes for people and the world within which they live and work to promote safe and efficient practices, especially in relation to the technology and physical design features in their work environment.⁶

The average American adult makes about 35,000 decisions per day.⁷ Thus, there is potential for error at any moment. Design that does not take HFE into account can be dangerous. For example, when tube feed and IV line connectors look similar and are compatible, patients may inadvertently receive food administered directly into their bloodstream.⁸

HFE can and should be applied to order sets. Everything from the look, feel, and verbiage of an order set affects potential outcomes. For example, consider the impact even seemingly minor modifications can have on outcomes simply by guiding users in a different way: Figure 1 provides NRT options based on cigarette use per day, whereas Figure 2 conveys pack use per day in relation to the equivalent number of cigarettes used daily. These differences may seem small; however, it helps guide users to the right choice when considering that health care providers have been historically trained on social history gathering that emphasizes packs per day and pack-years.

Failure Mode and Effects Analysis

Failure mode and effects analysis (FMEA) is “a structured way to identify and address potential problems, or failures and their resulting effects on the system or process before an adverse event occurs.”⁹ The benefit of an order set must be weighed against the risk during development. FMEA should be applied during order set design to assess and limit risk just as with any other clinical care process.

FMEA examines both level of risk and frequency of risk occurrence associated with a new proposed process. For example, let’s evaluate an order set designed for pain control after surgery that consists of multiple high-risk opioids along with antihistamine medications for as-needed itch relief (a non-life-threatening adverse event (AE) of opioids well known by the medical community). An interdisciplinary FMEA team consisting of subject matter experts may examine how the process should flow in step-by-step detail and then discuss the benefit of a process and risk for potential error. A FMEA team would then analyze what could go wrong with each part of the process and assign a level of risk and risk frequency for various steps in the process, and then decide that certain steps should be modified or eliminated. Perhaps after FMEA, a facility might conclude that the risk of serious complications is high when you combine opioid use with antihistamine medications. The facility could decide to remove antihistamine medications from an order set if it is determined that risks outweigh benefits. While a root cause analysis might identify the cause of an AE after order set use, these situations can be prevented with FMEA.

When applying FMEA to Figure 1, while bupropion is known as an evidence-based oral tobacco cessation option, there is the possibility that bupropion could be inadvertently prescribed from the order set in a hospitalized patient with alcohol withdrawal and withdrawal seizure history. These potentially dangerous situations can be avoided with FMEA. Thus, although bupropion may be evidence-based for NRT, decisions regarding order set design using EBM alone are insufficient.

The practitioner must consider possible unintended consequences within order sets and target treatment options to the appropriate setting and audience. Although Figure 1 may appear to be more inclusive, the interdisciplinary committee designing the inpatient NRT order set felt there was heightened risk with introducing bupropion in Figure 1 and decided the risk would be lowered by removing bupropion from the redesigned NRT order set (Figure 2). In addition to the goal of balancing availability of NRT options with acceptable risk, Figure 2 also focused on building an NRT order set most applicable to the inpatient setting.

Including Evidence-Based Practices

EBM has become a routine part of clinical decision making. Therefore, including EBM in order set design is vital. EBM for NRT has demonstrated that combination therapy is more effective than is monotherapy to help tobacco users quit. Incremental doses of NRT are recommended for patients who use tobacco more frequently.¹⁰

As shown in Figures 1 and 2, both order set designs incorporate EBM for NRT. Although the importance of implementing EBM is evident, critical factors, such as HFE and FMEA make a difference with well-designed order sets.

Results

The 4-step order set design technique was used during development of an inpatient NRT order set at the JAHVH. Results for the inpatient Joint Commission Tobacco Treatment Measures were obtained from the Veterans Health Administration quality metric reporting system known as Strategic Analytics for Improvement and Learning (SAIL). SAIL performance measure outcomes, which include the inpatient Joint Commission Tobacco Treatment Measures, are derived from chart reviews conducted by the External Peer Review Program. Outcomes demonstrated that TOB-2 and TOB-3 (2 inpatient Joint Commission Tobacco Treatment Measures) known as tob20 and tob40, respectively, within SAIL improved by more than 300% after development of an NRT order set using the 4-step order set design framework along with implementation of a multifaceted tobacco cessation care delivery system at JAHVH.

Discussion

While the overall tobacco cessation care delivery system contributed to improved outcomes with the inpatient Joint Commission Tobacco Treatment Measures at JAHVH, the NRT order set was a cornerstone of the design. Although using our order set design technique does not necessarily guarantee successful outcomes, we believe using the 4-step order set design process increases the value of order sets and has potential to improve quality outcomes.

Limitations

Although improved outcomes following implementation of our NRT order set suggest correlation, causation cannot be proven. Also while the NRT order set is believed to have helped tremendously with outcomes, the entire tobacco cessation care delivery system at JAHVH contributed to the results. In addition, the inpatient Joint Commission Tobacco Treatment Measures help improve processes for tobacco cessation care. However, we are uncertain whether the results of our improvement efforts helped patients stop tobacco use. Further studies are needed to determine impact on population health. Finally, our results were based on improvement work done at a single center. Further studies are necessary to see whether results are reproducible.

Conclusion

There was significant improvement with the inpatient Joint Commission Tobacco Treatment Measures outcomes following development of a tobacco cessation care delivery system that included design of an inpatient NRT order set using a 4-step process we developed. This 4-step structure includes emphasis on efficiency and ease of use; human factors engineering; failure mode and effects analysis; and incorporation of evidence-based medicine (Box.) Postimplementation results showed improvement of the inpatient Joint Commission Tobacco Treatment Measures by greater than 3-fold at a single hospital.

The next steps for this initiative include testing the 4-step order set design process in multiple clinical settings to determine the effectiveness of this approach in other areas of clinical care.

In the current health care environment, hospitals are constantly challenged to improve quality metrics and deliver better health care outcomes. One means to achieving quality improvement is through the use of order sets, groups of related orders that a health care provider (HCP) can place with either a few keystrokes or mouse clicks.¹

Historically, design of order sets has largely focused on clicking checkboxes containing evidence-based practices. According to Bates and colleagues and the Institute for Safe Medication Practices, incorporating evidence-based medicine (EBM) into order sets is not by itself sufficient.^2,3Execution of proper design coupled with simplicity and provider efficiency is paramount to HCP buy-in, increased likelihood of order set adherence, and to potentially better outcomes.

In this article, we outline advancements in order set design. These improvements increase provider efficiency and ease of use; incorporate human factors engineering (HFE); apply failure mode and effects analysis; and include EBM.

Methods

An inpatient nicotine replacement therapy (NRT) order was developed as part of a multifaceted solution to improve tobacco cessation care at the James A. Haley Veterans’ Hospital (JAHVH) in Tampa, Florida, a complexity level 1a facility. This NRT order set used the 4-step order set design framework the authors’ developed (for additional information about the NRT order set, contact the authors). We distinguish order set design technique between 2 different inpatient NRT order sets. The first order set in the comparison (Figure 1) is an inpatient NRT order set of unknown origin—it is common for US Department of Veterans Affairs (VA) medical facilities to share order sets and other resources. The second order set (Figure 2) is an inpatient NRT order set we designed using our 4-step process for comparison in this article. No institutional review board approval was required as this work met criteria for operational improvement activities exempt from ethics review.

Justin Iannello, DO, MBA, was the team leader and developer of the 4-step order set design technique. The intervention team consisted of 4 internal medicine physicians with expertise in quality improvement and patient safety: 1 certified professional in patient safety and certified as a Lean Six Sigma Black Belt; 2 physicians certified as Lean Six Sigma Black Belts; and 1 physician certified as a Lean Six Sigma Green Belt. Two inpatient clinical pharmacists and 1 quality management specialist also were involved in its development.

Development of a new NRT order set was felt to be an integral part of the tobacco cessation care delivery process. An NRT order set perceived by users as value-added required a solution that merged EBM with standardization and applied quality improvement principles. The result was an approach to order set design that focused on 4 key questions: Is the order set efficient and easy to use/navigate? Is human factors engineering incorporated? Is failure mode and effects analysis applied? Are evidence-based practices included?

Ease of Use and Navigation

Implementing an order set that is efficient and easy to use or navigate seems straightforward but can be difficult to execute. Figure 1 shows many detailed options consisting of different combinations of nicotine patches, lozenges, and gum. Also included are oral tobacco cessation options (bupropion and varenicline). Although more options may seem better, confusion about appropriate medication selection can occur.

According to Heath and Heath, too many options can result in lack of action.⁴ For example, Heath and Heath discuss a food store that offered 6 free samples of different jams on one day and 24 jams the following day. The customers who sampled 6 different types of jam were 10 times more likely to buy jam. The authors concluded that the more options available, the more difficulty a potential buyer has in deciding on a course of action.⁴

In clinical situations where a HCP is using an order set, the number of options can mean the difference between use vs avoidance if the choices are overwhelming. HCPs process layers of detail every day when creating differential diagnoses and treatment plans. While that level of detail is necessary clinically, that same level of detail included in orders sets can create challenges for HCPs.

Figure 2 advances the order set in Figure 1 by providing a simpler and cleaner design, so HCPs can more easily review and process the information. This order set design minimizes the number of options available to help users make the right decision, focusing on value for the appropriate setting and audience. In other words, order sets should not be a “one size fits all” approach.

Order sets should be tailored to the appropriate clinical setting (eg, inpatient acute care, outpatient clinic setting, etc) and HCP (eg, hospitalist, tobacco cessation specialist, etc). We are comparing NRT order sets designed for HCPs who do not routinely prescribe oral tobacco cessation products in the inpatient setting. When possible, autogenerated bundle orders should also be used according to evidence-based recommendations (such as nicotine patch tapers) for ease of use and further simplification of order sets.

Finally, usability testing known as “evaluating a product or service by testing it with representative users” helps further refine an order set.⁵Usability testing should be applied during all phases of order set development with end user(s) as it helps identify problems with order set design prior to implementation. By applying usability testing, the order set becomes more meaningful and valued by the user.

Human Factors Engineering

HFE is “the study of all the factors that make it easier to do the work in the right way.”⁶ HFE seeks to identify, align, and apply processes for people and the world within which they live and work to promote safe and efficient practices, especially in relation to the technology and physical design features in their work environment.⁶

The average American adult makes about 35,000 decisions per day.⁷ Thus, there is potential for error at any moment. Design that does not take HFE into account can be dangerous. For example, when tube feed and IV line connectors look similar and are compatible, patients may inadvertently receive food administered directly into their bloodstream.⁸

HFE can and should be applied to order sets. Everything from the look, feel, and verbiage of an order set affects potential outcomes. For example, consider the impact even seemingly minor modifications can have on outcomes simply by guiding users in a different way: Figure 1 provides NRT options based on cigarette use per day, whereas Figure 2 conveys pack use per day in relation to the equivalent number of cigarettes used daily. These differences may seem small; however, it helps guide users to the right choice when considering that health care providers have been historically trained on social history gathering that emphasizes packs per day and pack-years.

Failure Mode and Effects Analysis

Failure mode and effects analysis (FMEA) is “a structured way to identify and address potential problems, or failures and their resulting effects on the system or process before an adverse event occurs.”⁹ The benefit of an order set must be weighed against the risk during development. FMEA should be applied during order set design to assess and limit risk just as with any other clinical care process.

FMEA examines both level of risk and frequency of risk occurrence associated with a new proposed process. For example, let’s evaluate an order set designed for pain control after surgery that consists of multiple high-risk opioids along with antihistamine medications for as-needed itch relief (a non-life-threatening adverse event (AE) of opioids well known by the medical community). An interdisciplinary FMEA team consisting of subject matter experts may examine how the process should flow in step-by-step detail and then discuss the benefit of a process and risk for potential error. A FMEA team would then analyze what could go wrong with each part of the process and assign a level of risk and risk frequency for various steps in the process, and then decide that certain steps should be modified or eliminated. Perhaps after FMEA, a facility might conclude that the risk of serious complications is high when you combine opioid use with antihistamine medications. The facility could decide to remove antihistamine medications from an order set if it is determined that risks outweigh benefits. While a root cause analysis might identify the cause of an AE after order set use, these situations can be prevented with FMEA.

When applying FMEA to Figure 1, while bupropion is known as an evidence-based oral tobacco cessation option, there is the possibility that bupropion could be inadvertently prescribed from the order set in a hospitalized patient with alcohol withdrawal and withdrawal seizure history. These potentially dangerous situations can be avoided with FMEA. Thus, although bupropion may be evidence-based for NRT, decisions regarding order set design using EBM alone are insufficient.

The practitioner must consider possible unintended consequences within order sets and target treatment options to the appropriate setting and audience. Although Figure 1 may appear to be more inclusive, the interdisciplinary committee designing the inpatient NRT order set felt there was heightened risk with introducing bupropion in Figure 1 and decided the risk would be lowered by removing bupropion from the redesigned NRT order set (Figure 2). In addition to the goal of balancing availability of NRT options with acceptable risk, Figure 2 also focused on building an NRT order set most applicable to the inpatient setting.

Including Evidence-Based Practices

EBM has become a routine part of clinical decision making. Therefore, including EBM in order set design is vital. EBM for NRT has demonstrated that combination therapy is more effective than is monotherapy to help tobacco users quit. Incremental doses of NRT are recommended for patients who use tobacco more frequently.¹⁰

As shown in Figures 1 and 2, both order set designs incorporate EBM for NRT. Although the importance of implementing EBM is evident, critical factors, such as HFE and FMEA make a difference with well-designed order sets.

Results

The 4-step order set design technique was used during development of an inpatient NRT order set at the JAHVH. Results for the inpatient Joint Commission Tobacco Treatment Measures were obtained from the Veterans Health Administration quality metric reporting system known as Strategic Analytics for Improvement and Learning (SAIL). SAIL performance measure outcomes, which include the inpatient Joint Commission Tobacco Treatment Measures, are derived from chart reviews conducted by the External Peer Review Program. Outcomes demonstrated that TOB-2 and TOB-3 (2 inpatient Joint Commission Tobacco Treatment Measures) known as tob20 and tob40, respectively, within SAIL improved by more than 300% after development of an NRT order set using the 4-step order set design framework along with implementation of a multifaceted tobacco cessation care delivery system at JAHVH.

Discussion

While the overall tobacco cessation care delivery system contributed to improved outcomes with the inpatient Joint Commission Tobacco Treatment Measures at JAHVH, the NRT order set was a cornerstone of the design. Although using our order set design technique does not necessarily guarantee successful outcomes, we believe using the 4-step order set design process increases the value of order sets and has potential to improve quality outcomes.

Limitations

Although improved outcomes following implementation of our NRT order set suggest correlation, causation cannot be proven. Also while the NRT order set is believed to have helped tremendously with outcomes, the entire tobacco cessation care delivery system at JAHVH contributed to the results. In addition, the inpatient Joint Commission Tobacco Treatment Measures help improve processes for tobacco cessation care. However, we are uncertain whether the results of our improvement efforts helped patients stop tobacco use. Further studies are needed to determine impact on population health. Finally, our results were based on improvement work done at a single center. Further studies are necessary to see whether results are reproducible.

Conclusion

There was significant improvement with the inpatient Joint Commission Tobacco Treatment Measures outcomes following development of a tobacco cessation care delivery system that included design of an inpatient NRT order set using a 4-step process we developed. This 4-step structure includes emphasis on efficiency and ease of use; human factors engineering; failure mode and effects analysis; and incorporation of evidence-based medicine (Box.) Postimplementation results showed improvement of the inpatient Joint Commission Tobacco Treatment Measures by greater than 3-fold at a single hospital.

The next steps for this initiative include testing the 4-step order set design process in multiple clinical settings to determine the effectiveness of this approach in other areas of clinical care.

"Extreme remedies are very appropriate for extreme diseases"
- Hippocrates Aphorisms

On March 5, 2019, the US Food and Drug Administration (FDA) approved a nasal spray formulation of the drug ketamine, an old anesthetic that has been put to a new use over the past 10 years as therapy for treatment-resistant severe depression. Ketamine, known on the street as Special K, has long been known to cause dissociation, hallucinations, and other hallucinogenic effects. In many randomized controlled trials, subanesthetic doses administered intravenously have demonstrated rapid and often dramatic relief of depressive symptoms.

Neuroscientists have heralded ketamine as the paradigm of the glutamatergic modifying drug class, which represents the first real breakthrough in the pharmaceutical treatment of depression in decades.¹ There have been 2 major pharmacologic limitations attached to this promising new treatment: the IV form of the drug and the short duration of its antidepressant effect. Pharmaceutical companies and neuroscientists predictably have been engaging in a fast and furious race to successfully overcome these obstacles, hoping to win fame and fortune and bring hope and help to the millions of patients who have failed to fully respond to or been unable to tolerate existing therapies for mood disorders.²

When the FDA approved Spravato (esketamine), a nasal administration of ketamine, many people hoped that researchers had succeeded in overcoming these barriers. The risks of serious adverse events (AEs) as well as the potential for abuse and diversion led the FDA to limit prescriptions under a Risk Evaluation and Mitigation Strategy (REMS).³ Patients self-administer the nasal spray but only in a certified medical facility under the observation of a health care practitioner. Patients also must agree to remain on site for 2 hours after administration of the drug to ensure their safety. The FDA recommends the drug be given twice a week for 4 weeks along with a conventional monoamine-acting antidepressant.When the US Department of Veterans Affairs (VA) cleared the way for use of esketamine, less than 2 weeks after the FDA approval, it also launched a series of controversies over how to use the drug in its massive health care system, which is the subject of this editorial. On March 19, 2019, the VA announced that VA practitioners would be able to prescribe the nasal spray for patients who were determined to have treatment-resistant depression but only after appropriate clinical assessment and in accordance with their patients’ preferences.

A number of controversies have emerged surrounding the VA adoption of esketamine, including its cost/benefit/risk ratio and who should be able to access the medication. Each of these issues has onion layers of political, regulatory, and ethical concerns that can only be superficially noted here and warrant fuller unpeeling. In June The New York Times featured a story alleging that in response to the tragic tide of ever-increasing veteran suicides, the VA sanctioned esketamine prescribing despite its cost and the serious questions experts raised about the data the FDA cited to establish its safety and efficacy. Although the cost to the VA of Spravato is unclear, it is much higher than generic IV ketamine.⁴

The access controversy is almost the ethical inverse of the first. In June 2019, a Veterans Health Administration advisory panel voted against allowing general use of esketamine, limiting it to individual cases of patients who are preapproved and have failed 2 antidepressant trials. Esketamine will not be on the VA formulary for widespread use. Congressional and public advocacy groups have noted that the formulary decision came in the wake of ongoing attention to the role of the pharmaceutical industry in the VA’s rapid adoption of the drug.^5,6 For the thousands of veterans for whom the data show conventional antidepressants even in combination with other psychotropic medications and evidence-based psychotherapies resulted in AEs or only partial remission of depression symptoms, the VA’s restriction will likely seem unfair and even uncaring.⁷

As a practicing VA psychiatrist, I know firsthand how desperately we need new, more effective, and better-tolerated treatments for severe unipolar and bipolar depression. Although I have not prescribed ketamine or esketamine, several of my most respected colleagues do. I have seen patients with chronic, severe, depression respond and even recover in ways that seem just a little short of miraculous when compared with other therapies. Yet as a longtime student of the history of psychiatry, I have also seen that often the treatments that initially seem so auspicious, in time, turn out to have a dark side. Families, communities, the country, VA, and the US Department of Defense and its practitioners in and out of mental health cannot in any moral universe abide by the fact that 20 plus men and women who served take their lives every day.⁸

As the epigraph to this column notes, we must often try radical therapies for grave cases in drastic crises. Yet we must also in making serious public health decisions fraught with unseen consequences take all due and considered diligence that we do not violate the even more fundamental dictum of the Hippocratic School, “at least do not harm.” That means trying to balance safety and availability while VA conducts its own research in a precarious way that leaves almost no stakeholder completely happy.

"Extreme remedies are very appropriate for extreme diseases"
- Hippocrates Aphorisms

On March 5, 2019, the US Food and Drug Administration (FDA) approved a nasal spray formulation of the drug ketamine, an old anesthetic that has been put to a new use over the past 10 years as therapy for treatment-resistant severe depression. Ketamine, known on the street as Special K, has long been known to cause dissociation, hallucinations, and other hallucinogenic effects. In many randomized controlled trials, subanesthetic doses administered intravenously have demonstrated rapid and often dramatic relief of depressive symptoms.

Neuroscientists have heralded ketamine as the paradigm of the glutamatergic modifying drug class, which represents the first real breakthrough in the pharmaceutical treatment of depression in decades.¹ There have been 2 major pharmacologic limitations attached to this promising new treatment: the IV form of the drug and the short duration of its antidepressant effect. Pharmaceutical companies and neuroscientists predictably have been engaging in a fast and furious race to successfully overcome these obstacles, hoping to win fame and fortune and bring hope and help to the millions of patients who have failed to fully respond to or been unable to tolerate existing therapies for mood disorders.²

When the FDA approved Spravato (esketamine), a nasal administration of ketamine, many people hoped that researchers had succeeded in overcoming these barriers. The risks of serious adverse events (AEs) as well as the potential for abuse and diversion led the FDA to limit prescriptions under a Risk Evaluation and Mitigation Strategy (REMS).³ Patients self-administer the nasal spray but only in a certified medical facility under the observation of a health care practitioner. Patients also must agree to remain on site for 2 hours after administration of the drug to ensure their safety. The FDA recommends the drug be given twice a week for 4 weeks along with a conventional monoamine-acting antidepressant.When the US Department of Veterans Affairs (VA) cleared the way for use of esketamine, less than 2 weeks after the FDA approval, it also launched a series of controversies over how to use the drug in its massive health care system, which is the subject of this editorial. On March 19, 2019, the VA announced that VA practitioners would be able to prescribe the nasal spray for patients who were determined to have treatment-resistant depression but only after appropriate clinical assessment and in accordance with their patients’ preferences.

A number of controversies have emerged surrounding the VA adoption of esketamine, including its cost/benefit/risk ratio and who should be able to access the medication. Each of these issues has onion layers of political, regulatory, and ethical concerns that can only be superficially noted here and warrant fuller unpeeling. In June The New York Times featured a story alleging that in response to the tragic tide of ever-increasing veteran suicides, the VA sanctioned esketamine prescribing despite its cost and the serious questions experts raised about the data the FDA cited to establish its safety and efficacy. Although the cost to the VA of Spravato is unclear, it is much higher than generic IV ketamine.⁴

The access controversy is almost the ethical inverse of the first. In June 2019, a Veterans Health Administration advisory panel voted against allowing general use of esketamine, limiting it to individual cases of patients who are preapproved and have failed 2 antidepressant trials. Esketamine will not be on the VA formulary for widespread use. Congressional and public advocacy groups have noted that the formulary decision came in the wake of ongoing attention to the role of the pharmaceutical industry in the VA’s rapid adoption of the drug.^5,6 For the thousands of veterans for whom the data show conventional antidepressants even in combination with other psychotropic medications and evidence-based psychotherapies resulted in AEs or only partial remission of depression symptoms, the VA’s restriction will likely seem unfair and even uncaring.⁷

As a practicing VA psychiatrist, I know firsthand how desperately we need new, more effective, and better-tolerated treatments for severe unipolar and bipolar depression. Although I have not prescribed ketamine or esketamine, several of my most respected colleagues do. I have seen patients with chronic, severe, depression respond and even recover in ways that seem just a little short of miraculous when compared with other therapies. Yet as a longtime student of the history of psychiatry, I have also seen that often the treatments that initially seem so auspicious, in time, turn out to have a dark side. Families, communities, the country, VA, and the US Department of Defense and its practitioners in and out of mental health cannot in any moral universe abide by the fact that 20 plus men and women who served take their lives every day.⁸

As the epigraph to this column notes, we must often try radical therapies for grave cases in drastic crises. Yet we must also in making serious public health decisions fraught with unseen consequences take all due and considered diligence that we do not violate the even more fundamental dictum of the Hippocratic School, “at least do not harm.” That means trying to balance safety and availability while VA conducts its own research in a precarious way that leaves almost no stakeholder completely happy.

"Extreme remedies are very appropriate for extreme diseases"
- Hippocrates Aphorisms

On March 5, 2019, the US Food and Drug Administration (FDA) approved a nasal spray formulation of the drug ketamine, an old anesthetic that has been put to a new use over the past 10 years as therapy for treatment-resistant severe depression. Ketamine, known on the street as Special K, has long been known to cause dissociation, hallucinations, and other hallucinogenic effects. In many randomized controlled trials, subanesthetic doses administered intravenously have demonstrated rapid and often dramatic relief of depressive symptoms.

Neuroscientists have heralded ketamine as the paradigm of the glutamatergic modifying drug class, which represents the first real breakthrough in the pharmaceutical treatment of depression in decades.¹ There have been 2 major pharmacologic limitations attached to this promising new treatment: the IV form of the drug and the short duration of its antidepressant effect. Pharmaceutical companies and neuroscientists predictably have been engaging in a fast and furious race to successfully overcome these obstacles, hoping to win fame and fortune and bring hope and help to the millions of patients who have failed to fully respond to or been unable to tolerate existing therapies for mood disorders.²

When the FDA approved Spravato (esketamine), a nasal administration of ketamine, many people hoped that researchers had succeeded in overcoming these barriers. The risks of serious adverse events (AEs) as well as the potential for abuse and diversion led the FDA to limit prescriptions under a Risk Evaluation and Mitigation Strategy (REMS).³ Patients self-administer the nasal spray but only in a certified medical facility under the observation of a health care practitioner. Patients also must agree to remain on site for 2 hours after administration of the drug to ensure their safety. The FDA recommends the drug be given twice a week for 4 weeks along with a conventional monoamine-acting antidepressant.When the US Department of Veterans Affairs (VA) cleared the way for use of esketamine, less than 2 weeks after the FDA approval, it also launched a series of controversies over how to use the drug in its massive health care system, which is the subject of this editorial. On March 19, 2019, the VA announced that VA practitioners would be able to prescribe the nasal spray for patients who were determined to have treatment-resistant depression but only after appropriate clinical assessment and in accordance with their patients’ preferences.

A number of controversies have emerged surrounding the VA adoption of esketamine, including its cost/benefit/risk ratio and who should be able to access the medication. Each of these issues has onion layers of political, regulatory, and ethical concerns that can only be superficially noted here and warrant fuller unpeeling. In June The New York Times featured a story alleging that in response to the tragic tide of ever-increasing veteran suicides, the VA sanctioned esketamine prescribing despite its cost and the serious questions experts raised about the data the FDA cited to establish its safety and efficacy. Although the cost to the VA of Spravato is unclear, it is much higher than generic IV ketamine.⁴

The access controversy is almost the ethical inverse of the first. In June 2019, a Veterans Health Administration advisory panel voted against allowing general use of esketamine, limiting it to individual cases of patients who are preapproved and have failed 2 antidepressant trials. Esketamine will not be on the VA formulary for widespread use. Congressional and public advocacy groups have noted that the formulary decision came in the wake of ongoing attention to the role of the pharmaceutical industry in the VA’s rapid adoption of the drug.^5,6 For the thousands of veterans for whom the data show conventional antidepressants even in combination with other psychotropic medications and evidence-based psychotherapies resulted in AEs or only partial remission of depression symptoms, the VA’s restriction will likely seem unfair and even uncaring.⁷

As a practicing VA psychiatrist, I know firsthand how desperately we need new, more effective, and better-tolerated treatments for severe unipolar and bipolar depression. Although I have not prescribed ketamine or esketamine, several of my most respected colleagues do. I have seen patients with chronic, severe, depression respond and even recover in ways that seem just a little short of miraculous when compared with other therapies. Yet as a longtime student of the history of psychiatry, I have also seen that often the treatments that initially seem so auspicious, in time, turn out to have a dark side. Families, communities, the country, VA, and the US Department of Defense and its practitioners in and out of mental health cannot in any moral universe abide by the fact that 20 plus men and women who served take their lives every day.⁸

As the epigraph to this column notes, we must often try radical therapies for grave cases in drastic crises. Yet we must also in making serious public health decisions fraught with unseen consequences take all due and considered diligence that we do not violate the even more fundamental dictum of the Hippocratic School, “at least do not harm.” That means trying to balance safety and availability while VA conducts its own research in a precarious way that leaves almost no stakeholder completely happy.