Health care has been dramatically transformed and influenced by medical and technological advances, insurance companies, state and federal legislation, and medical ethics. Amid these changes, including crises such as the ongoing coronavirus pandemic, earning the trust of patients to care for their mental and physical health remains a priority and a privilege.

It is troubling that federal health care agencies, in addition to hospitals, clinics, pharmacies, insurance companies, and administrators, often use the term provider when referring to clinicians on the multidisciplinary health care treatment team, which has become the predominant model for health care delivery. The word provider does not originate in the health care arena but from the world of commerce and contains no reference to professionalism or therapeutic relationships.¹ Therefore, it should be replaced with more appropriate terminology that acknowledges clinicians’ roles and expertise and values our unique relationship with patients.

Why Is Provider a Problem?

First, the origin of the term provider is deplorable. During its ascent to power in the 1930s, the Nazi Party promoted the devaluation and exclusion of Jews in German society, including the medical community. Due to its eugenics campaign, the Nazi Party first targeted pediatrics, a specialty in which nearly half of its practitioners were Jewish.² Beginning with female pediatricians, all Jewish physicians were redesignated as Behandler (provider) instead of Arzt (doctor).² This is the first documented demeaning of physicians as providers in modern history. Jewish doctors were soon restricted to treating only Jewish patients and were further persecuted during the Holocaust. Knowing this background, what health care organization would use a term once associated with Nazi ideology?³

Second, using provider changes the treatment relationship. The nomenclature shift in the United States also seems to have originated in political and legislative circles. Although the reasons for this shift are unclear, the terminology became more pervasive after the government first used the term provider in Title XIX of the 1965 Social Security Amendments that established Medicare and Medicaid. Paydarfar and Schwartz noted it was used “in the sense of a contractor being paid for delivering any health-related products and services.”⁴ Ironically, a 1967 medical student health organization grant proposal discussed the role of a patient advocate in facilitating communication between “health care provider and patient.”⁵ A journalist for the New York Times used the word to describe a 1970 New York Senate debate surrounding the sale of Medicaid bills to collection agencies, but it is unclear whether the senators themselves used the term.⁶ Provider was later used in the National Health Planning and Resource Development Act of 1974.⁷

Ultimately, the adaptation of this terminology led to medicine being thought of only as a business, a commoditization of care, and reinforced by referring to patients as consumers, clients, or customers.³ This terminology suggests that the clinician-patient relationship is a commercial transaction based on a market concept where patients are consumers to be serviced.^1,8 Emphasis is placed on following algorithms and treating symptoms rather than patients.⁹ Despite a goal of minimizing cost, a mismatched referral to a provider may actually compromise patient safety and cost-effectiveness due to missed diagnoses or excessive diagnostic testing.¹⁰

In addition to government, other nonclinical entities (eg, insurance companies, advocacy groups) and some clinicians may prefer the generic term provider. Besides health care commoditization, reasons may include convenience, simplifying health care nomenclature, or removing distinctions among health care professionals to reduce costs and/or increase autonomy.

However, our value as health care professionals is not simply what we can “provide.”¹¹ We seek to know patients as people, putting their needs ahead of ours.¹ We serve as confidants and advocates and not merely providers of medications, tests, or procedures.¹¹ This personalized nature of health care depends on trust and professionalism rather than dispassionate delivery of commoditized services.¹ Using traditional terminology acknowledges the true nature of the treatment relationship—one that is established not on market concepts but on medical ethics of autonomy, justice, beneficence, and nonmaleficence.

Third, provider is inaccurate and potentially disrespectful and harmful. The word doctor is derived from Latin doctus or docere, meaning to teach or instruct—a valued function in our interactions with patients, families, students, and colleagues.^12,13 In contrast, provider refers to commercial transactions or the provision of shelter, food, and love within families and communities.^1,14

Although there are no studies assessing the impact of this terminology on individual clinicians, the term provider may have a negative impact on both individual clinicians and on the health care system. Health care professionals may feel they are being disrespected by being portrayed as dispensers of services rather than as individuals.^13,15 Furthermore, provider does not acknowledge the specialized training and qualifications of multidisciplinary treatment team members. The historical and theoretical foundation, degrees awarded, and scopes of practice for physicians, physician assistants, nurse practitioners, dentists, psychologists, optometrists, physical therapists, or social workers are different yet valuable, and their expertise and accomplishment should be recognized.

The use of this term has potential for causing moral injury and reduced self-worth, sense of purpose, and meaning in our daily work; this could threaten satisfaction and commitment and lead to demoralization and burnout.^1,16 It may impair effective team dynamics, as it makes no reference to professional values and may lead patients and clinicians to place lower value on professionalism and conduct.¹⁰ It may negatively impact primary care specialties by propagating the connotation that primary care is simple care and promoting low compensation, lagging recruitment, and diminished respect.¹⁰ Finally, it is detrimental to patients by changing the nature of the relationship and failing to evoke the compassion and support that sick people (that is, patients) need and deserve.³

Last, use of this term can mislead patients. By law, a health care provider is defined as “a doctor of medicine or osteopathy who is authorized to practice medicine or surgery… or any other person determined by the Secretary [of Labor] to be capable of providing health care services,” which includes podiatrists, dentists, clinical psychologists, optometrists, chiropractors, nurse practitioners, nurse-midwives, clinical social workers, and physician assistants.¹⁷

When clinicians are categorized as providers rather than by their degrees and roles/responsibilities, patients may assume that all team members have equal training, interchangeable skills, and uniform expertise and knowledge and may conclude they can receive the same level of care from anyone.^8,10 Potential for confusion is increased by the nearly ubiquitous white laboratory coat in clinical settings and doctoral degrees attainable in different health care disciplines (eg, medicine, nursing, psychology, pharmacy, physical therapy). Patients deserve to know who does what on the team of professionals who care for them and may not be fully informed when requesting or receiving treatment if they are not provided important information, such as a clinician’s title, training, and scope of practice.^8,16

Reversing the Trend 

Increasing awareness among patients, their families, health professions students, and health care colleagues and administrators of the importance of traditional nomenclature is a first step in reversing this trend or mitigating its impact. If an overarching generic term is required, then health care professional, clinician, or practitioner are preferred.^10,12 Fifteen years ago, the Southern California Permanente Medical Group prohibited the use of the word provider to describe physicians, and its editorial style deemed it cold and institutional.¹⁶ Many, but not all, state, regional, or national medical associations and journals avoid provider in their names or titles.

I am encouraged that this journal—drawing its audience from several government health care agencies—is named Federal Practitioner rather than Federal Provider. This is reasonable and accurate, as practitioner refers to the practice of a profession, usually associated with health care.

I hope other professions can resist this trend. Lawyers are not considered legal aid providers, and teachers are not called knowledge providers.³ We do not refer to airline pilots as air transportation providers or musicians as instrument-playing melody providers. Many veterans likely would be offended if they were referred to as Constitution support and defense providers rather than by the military branch-specific titles that they earned through dedication, training, and sacrifice. The individuals in these examples demonstrate commitment to representing clients, educating students, flying passengers, playing instruments, or ensuring national defense. As health care professionals, our commitment to treating patients is equally important.⁴

Language matters when it comes to people feeling respected and achieving their full potential.¹ I encourage government health care agencies to stop referring to us as providers and resume using traditional nomenclature. This will demonstrate genuine respect for us, transparency for the patients we serve, and recognition that caring for the sick is a calling, not a commodity.

Dedication

The author dedicates this article to his father John E. Scarff, Jr, a physician and United States Army veteran.

Health care has been dramatically transformed and influenced by medical and technological advances, insurance companies, state and federal legislation, and medical ethics. Amid these changes, including crises such as the ongoing coronavirus pandemic, earning the trust of patients to care for their mental and physical health remains a priority and a privilege.

It is troubling that federal health care agencies, in addition to hospitals, clinics, pharmacies, insurance companies, and administrators, often use the term provider when referring to clinicians on the multidisciplinary health care treatment team, which has become the predominant model for health care delivery. The word provider does not originate in the health care arena but from the world of commerce and contains no reference to professionalism or therapeutic relationships.¹ Therefore, it should be replaced with more appropriate terminology that acknowledges clinicians’ roles and expertise and values our unique relationship with patients.

Why Is Provider a Problem?

First, the origin of the term provider is deplorable. During its ascent to power in the 1930s, the Nazi Party promoted the devaluation and exclusion of Jews in German society, including the medical community. Due to its eugenics campaign, the Nazi Party first targeted pediatrics, a specialty in which nearly half of its practitioners were Jewish.² Beginning with female pediatricians, all Jewish physicians were redesignated as Behandler (provider) instead of Arzt (doctor).² This is the first documented demeaning of physicians as providers in modern history. Jewish doctors were soon restricted to treating only Jewish patients and were further persecuted during the Holocaust. Knowing this background, what health care organization would use a term once associated with Nazi ideology?³

Second, using provider changes the treatment relationship. The nomenclature shift in the United States also seems to have originated in political and legislative circles. Although the reasons for this shift are unclear, the terminology became more pervasive after the government first used the term provider in Title XIX of the 1965 Social Security Amendments that established Medicare and Medicaid. Paydarfar and Schwartz noted it was used “in the sense of a contractor being paid for delivering any health-related products and services.”⁴ Ironically, a 1967 medical student health organization grant proposal discussed the role of a patient advocate in facilitating communication between “health care provider and patient.”⁵ A journalist for the New York Times used the word to describe a 1970 New York Senate debate surrounding the sale of Medicaid bills to collection agencies, but it is unclear whether the senators themselves used the term.⁶ Provider was later used in the National Health Planning and Resource Development Act of 1974.⁷

Ultimately, the adaptation of this terminology led to medicine being thought of only as a business, a commoditization of care, and reinforced by referring to patients as consumers, clients, or customers.³ This terminology suggests that the clinician-patient relationship is a commercial transaction based on a market concept where patients are consumers to be serviced.^1,8 Emphasis is placed on following algorithms and treating symptoms rather than patients.⁹ Despite a goal of minimizing cost, a mismatched referral to a provider may actually compromise patient safety and cost-effectiveness due to missed diagnoses or excessive diagnostic testing.¹⁰

In addition to government, other nonclinical entities (eg, insurance companies, advocacy groups) and some clinicians may prefer the generic term provider. Besides health care commoditization, reasons may include convenience, simplifying health care nomenclature, or removing distinctions among health care professionals to reduce costs and/or increase autonomy.

However, our value as health care professionals is not simply what we can “provide.”¹¹ We seek to know patients as people, putting their needs ahead of ours.¹ We serve as confidants and advocates and not merely providers of medications, tests, or procedures.¹¹ This personalized nature of health care depends on trust and professionalism rather than dispassionate delivery of commoditized services.¹ Using traditional terminology acknowledges the true nature of the treatment relationship—one that is established not on market concepts but on medical ethics of autonomy, justice, beneficence, and nonmaleficence.

Third, provider is inaccurate and potentially disrespectful and harmful. The word doctor is derived from Latin doctus or docere, meaning to teach or instruct—a valued function in our interactions with patients, families, students, and colleagues.^12,13 In contrast, provider refers to commercial transactions or the provision of shelter, food, and love within families and communities.^1,14

Although there are no studies assessing the impact of this terminology on individual clinicians, the term provider may have a negative impact on both individual clinicians and on the health care system. Health care professionals may feel they are being disrespected by being portrayed as dispensers of services rather than as individuals.^13,15 Furthermore, provider does not acknowledge the specialized training and qualifications of multidisciplinary treatment team members. The historical and theoretical foundation, degrees awarded, and scopes of practice for physicians, physician assistants, nurse practitioners, dentists, psychologists, optometrists, physical therapists, or social workers are different yet valuable, and their expertise and accomplishment should be recognized.

The use of this term has potential for causing moral injury and reduced self-worth, sense of purpose, and meaning in our daily work; this could threaten satisfaction and commitment and lead to demoralization and burnout.^1,16 It may impair effective team dynamics, as it makes no reference to professional values and may lead patients and clinicians to place lower value on professionalism and conduct.¹⁰ It may negatively impact primary care specialties by propagating the connotation that primary care is simple care and promoting low compensation, lagging recruitment, and diminished respect.¹⁰ Finally, it is detrimental to patients by changing the nature of the relationship and failing to evoke the compassion and support that sick people (that is, patients) need and deserve.³

Last, use of this term can mislead patients. By law, a health care provider is defined as “a doctor of medicine or osteopathy who is authorized to practice medicine or surgery… or any other person determined by the Secretary [of Labor] to be capable of providing health care services,” which includes podiatrists, dentists, clinical psychologists, optometrists, chiropractors, nurse practitioners, nurse-midwives, clinical social workers, and physician assistants.¹⁷

When clinicians are categorized as providers rather than by their degrees and roles/responsibilities, patients may assume that all team members have equal training, interchangeable skills, and uniform expertise and knowledge and may conclude they can receive the same level of care from anyone.^8,10 Potential for confusion is increased by the nearly ubiquitous white laboratory coat in clinical settings and doctoral degrees attainable in different health care disciplines (eg, medicine, nursing, psychology, pharmacy, physical therapy). Patients deserve to know who does what on the team of professionals who care for them and may not be fully informed when requesting or receiving treatment if they are not provided important information, such as a clinician’s title, training, and scope of practice.^8,16

Reversing the Trend 

Increasing awareness among patients, their families, health professions students, and health care colleagues and administrators of the importance of traditional nomenclature is a first step in reversing this trend or mitigating its impact. If an overarching generic term is required, then health care professional, clinician, or practitioner are preferred.^10,12 Fifteen years ago, the Southern California Permanente Medical Group prohibited the use of the word provider to describe physicians, and its editorial style deemed it cold and institutional.¹⁶ Many, but not all, state, regional, or national medical associations and journals avoid provider in their names or titles.

I am encouraged that this journal—drawing its audience from several government health care agencies—is named Federal Practitioner rather than Federal Provider. This is reasonable and accurate, as practitioner refers to the practice of a profession, usually associated with health care.

I hope other professions can resist this trend. Lawyers are not considered legal aid providers, and teachers are not called knowledge providers.³ We do not refer to airline pilots as air transportation providers or musicians as instrument-playing melody providers. Many veterans likely would be offended if they were referred to as Constitution support and defense providers rather than by the military branch-specific titles that they earned through dedication, training, and sacrifice. The individuals in these examples demonstrate commitment to representing clients, educating students, flying passengers, playing instruments, or ensuring national defense. As health care professionals, our commitment to treating patients is equally important.⁴

Language matters when it comes to people feeling respected and achieving their full potential.¹ I encourage government health care agencies to stop referring to us as providers and resume using traditional nomenclature. This will demonstrate genuine respect for us, transparency for the patients we serve, and recognition that caring for the sick is a calling, not a commodity.

Dedication

The author dedicates this article to his father John E. Scarff, Jr, a physician and United States Army veteran.

Health care has been dramatically transformed and influenced by medical and technological advances, insurance companies, state and federal legislation, and medical ethics. Amid these changes, including crises such as the ongoing coronavirus pandemic, earning the trust of patients to care for their mental and physical health remains a priority and a privilege.

It is troubling that federal health care agencies, in addition to hospitals, clinics, pharmacies, insurance companies, and administrators, often use the term provider when referring to clinicians on the multidisciplinary health care treatment team, which has become the predominant model for health care delivery. The word provider does not originate in the health care arena but from the world of commerce and contains no reference to professionalism or therapeutic relationships.¹ Therefore, it should be replaced with more appropriate terminology that acknowledges clinicians’ roles and expertise and values our unique relationship with patients.

Why Is Provider a Problem?

First, the origin of the term provider is deplorable. During its ascent to power in the 1930s, the Nazi Party promoted the devaluation and exclusion of Jews in German society, including the medical community. Due to its eugenics campaign, the Nazi Party first targeted pediatrics, a specialty in which nearly half of its practitioners were Jewish.² Beginning with female pediatricians, all Jewish physicians were redesignated as Behandler (provider) instead of Arzt (doctor).² This is the first documented demeaning of physicians as providers in modern history. Jewish doctors were soon restricted to treating only Jewish patients and were further persecuted during the Holocaust. Knowing this background, what health care organization would use a term once associated with Nazi ideology?³

Second, using provider changes the treatment relationship. The nomenclature shift in the United States also seems to have originated in political and legislative circles. Although the reasons for this shift are unclear, the terminology became more pervasive after the government first used the term provider in Title XIX of the 1965 Social Security Amendments that established Medicare and Medicaid. Paydarfar and Schwartz noted it was used “in the sense of a contractor being paid for delivering any health-related products and services.”⁴ Ironically, a 1967 medical student health organization grant proposal discussed the role of a patient advocate in facilitating communication between “health care provider and patient.”⁵ A journalist for the New York Times used the word to describe a 1970 New York Senate debate surrounding the sale of Medicaid bills to collection agencies, but it is unclear whether the senators themselves used the term.⁶ Provider was later used in the National Health Planning and Resource Development Act of 1974.⁷

Ultimately, the adaptation of this terminology led to medicine being thought of only as a business, a commoditization of care, and reinforced by referring to patients as consumers, clients, or customers.³ This terminology suggests that the clinician-patient relationship is a commercial transaction based on a market concept where patients are consumers to be serviced.^1,8 Emphasis is placed on following algorithms and treating symptoms rather than patients.⁹ Despite a goal of minimizing cost, a mismatched referral to a provider may actually compromise patient safety and cost-effectiveness due to missed diagnoses or excessive diagnostic testing.¹⁰

In addition to government, other nonclinical entities (eg, insurance companies, advocacy groups) and some clinicians may prefer the generic term provider. Besides health care commoditization, reasons may include convenience, simplifying health care nomenclature, or removing distinctions among health care professionals to reduce costs and/or increase autonomy.

However, our value as health care professionals is not simply what we can “provide.”¹¹ We seek to know patients as people, putting their needs ahead of ours.¹ We serve as confidants and advocates and not merely providers of medications, tests, or procedures.¹¹ This personalized nature of health care depends on trust and professionalism rather than dispassionate delivery of commoditized services.¹ Using traditional terminology acknowledges the true nature of the treatment relationship—one that is established not on market concepts but on medical ethics of autonomy, justice, beneficence, and nonmaleficence.

Third, provider is inaccurate and potentially disrespectful and harmful. The word doctor is derived from Latin doctus or docere, meaning to teach or instruct—a valued function in our interactions with patients, families, students, and colleagues.^12,13 In contrast, provider refers to commercial transactions or the provision of shelter, food, and love within families and communities.^1,14

Although there are no studies assessing the impact of this terminology on individual clinicians, the term provider may have a negative impact on both individual clinicians and on the health care system. Health care professionals may feel they are being disrespected by being portrayed as dispensers of services rather than as individuals.^13,15 Furthermore, provider does not acknowledge the specialized training and qualifications of multidisciplinary treatment team members. The historical and theoretical foundation, degrees awarded, and scopes of practice for physicians, physician assistants, nurse practitioners, dentists, psychologists, optometrists, physical therapists, or social workers are different yet valuable, and their expertise and accomplishment should be recognized.

The use of this term has potential for causing moral injury and reduced self-worth, sense of purpose, and meaning in our daily work; this could threaten satisfaction and commitment and lead to demoralization and burnout.^1,16 It may impair effective team dynamics, as it makes no reference to professional values and may lead patients and clinicians to place lower value on professionalism and conduct.¹⁰ It may negatively impact primary care specialties by propagating the connotation that primary care is simple care and promoting low compensation, lagging recruitment, and diminished respect.¹⁰ Finally, it is detrimental to patients by changing the nature of the relationship and failing to evoke the compassion and support that sick people (that is, patients) need and deserve.³

Last, use of this term can mislead patients. By law, a health care provider is defined as “a doctor of medicine or osteopathy who is authorized to practice medicine or surgery… or any other person determined by the Secretary [of Labor] to be capable of providing health care services,” which includes podiatrists, dentists, clinical psychologists, optometrists, chiropractors, nurse practitioners, nurse-midwives, clinical social workers, and physician assistants.¹⁷

When clinicians are categorized as providers rather than by their degrees and roles/responsibilities, patients may assume that all team members have equal training, interchangeable skills, and uniform expertise and knowledge and may conclude they can receive the same level of care from anyone.^8,10 Potential for confusion is increased by the nearly ubiquitous white laboratory coat in clinical settings and doctoral degrees attainable in different health care disciplines (eg, medicine, nursing, psychology, pharmacy, physical therapy). Patients deserve to know who does what on the team of professionals who care for them and may not be fully informed when requesting or receiving treatment if they are not provided important information, such as a clinician’s title, training, and scope of practice.^8,16

Reversing the Trend 

Increasing awareness among patients, their families, health professions students, and health care colleagues and administrators of the importance of traditional nomenclature is a first step in reversing this trend or mitigating its impact. If an overarching generic term is required, then health care professional, clinician, or practitioner are preferred.^10,12 Fifteen years ago, the Southern California Permanente Medical Group prohibited the use of the word provider to describe physicians, and its editorial style deemed it cold and institutional.¹⁶ Many, but not all, state, regional, or national medical associations and journals avoid provider in their names or titles.

I am encouraged that this journal—drawing its audience from several government health care agencies—is named Federal Practitioner rather than Federal Provider. This is reasonable and accurate, as practitioner refers to the practice of a profession, usually associated with health care.

I hope other professions can resist this trend. Lawyers are not considered legal aid providers, and teachers are not called knowledge providers.³ We do not refer to airline pilots as air transportation providers or musicians as instrument-playing melody providers. Many veterans likely would be offended if they were referred to as Constitution support and defense providers rather than by the military branch-specific titles that they earned through dedication, training, and sacrifice. The individuals in these examples demonstrate commitment to representing clients, educating students, flying passengers, playing instruments, or ensuring national defense. As health care professionals, our commitment to treating patients is equally important.⁴

Language matters when it comes to people feeling respected and achieving their full potential.¹ I encourage government health care agencies to stop referring to us as providers and resume using traditional nomenclature. This will demonstrate genuine respect for us, transparency for the patients we serve, and recognition that caring for the sick is a calling, not a commodity.

Dedication

The author dedicates this article to his father John E. Scarff, Jr, a physician and United States Army veteran.

In the United States, opioid use disorder (OUD) is a major public health challenge. In 2018 drug overdose deaths were 4 times higher than they were in 1999.¹ This increase highlights a critical need to expand treatment access. Medication for opioid use disorder (MOUD), including methadone, naltrexone, and buprenorphine, improves outcomes for patients retained in care.² Compared with the general population, veterans, particularly those with co-occurring posttraumatic stress disorder (PTSD) or depression, are more likely to receive higher dosages of opioid medications and experience opioid-related adverse outcomes (eg, overdose, OUD).^3,4 As a risk reduction strategy, patients receiving potentially dangerous full-dose agonist opioid medication who are unable to taper to safer dosages may be eligible to transition to buprenorphine.⁵

Buprenorphine and naltrexone can be prescribed in office-based settings or in addiction, primary care, mental health, and pain clinics. Office-based opioid treatment with buprenorphine (OBOT-B) expands access to patients who are not reached by addiction treatment programs.^6,7 This is particularly true in rural settings, where addiction care services are typically scarce.⁸ OBOT-B prevents relapse and maintains opioid-free days and may increase patient engagement by reducing stigma and providing treatment within an existing clinical care team.⁹ For many patients, OBOT-B results in good retention with just medical monitoring and minimal or no ancillary addiction counseling.^10,11

Successful implementation of OBOT-B has occurred through a variety of care models in selected community health care settings.^8,12,13 Historically in the Veterans Health Administration (VHA), MOUD has been prescribed in substance use disorder clinics by mental health practitioners. Currently, more than 44% of veterans with OUD are on MOUD.¹⁴

The VHA has invested significant resources to improve access to MOUD. In 2018, the Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative launched, with the aim to improve access within primary care, mental health, and pain clinics.¹⁵ SCOUTT emphasizes stepped-care treatment, with patients engaging in the step of care most appropriate to their needs. Step 0 is self-directed care/self-management, including mutual support groups; step-1 environments include office-based primary care, mental health, and pain clinics; and step-2 environments are specialty care settings. Through a series of remote webinars, an in-person national 2-day conference, and external facilitation, SCOUTT engaged 18 teams representing each Veterans Integrated Service Network (VISN) across the country to assist in implementing MOUD within 2 step-1 clinics. These teams have developed several models of providing step-1 care, including an interdisciplinary team-based primary care delivery model as well as a pharmacist care manager model.^{16, 17}

US Department of Veterans Affairs (VA) Connecticut Health Care System (VACHS), which delivers care to approximately 58,000 veterans, was chosen to be a phase 1 SCOUTT site. Though all patients in VACHS have access to specialty care step-2 clinics, including methadone and buprenorphine programs, there remained many patients not yet on MOUD who could benefit from it. Baseline data (fiscal year [FY] 2018 4th quarter), obtained through electronic health record (EHR) database dashboards indicated that 710 (56%) patients with an OUD diagnosis were not receiving MOUD. International Classification of Disease, 10th Revision codes are the foundation for VA population management dashboards, and based their data on codes for opioid abuse and opioid dependence. These tools are limited by the accuracy of coding in EHRs. Additionally, 366 patients receiving long-term opioid prescriptions were identified as moderate, high, or very high risk for overdose or death based on an algorithm that considered prescribed medications, sociodemographics, and comorbid conditions, as characterized in the VA EHR (Stratification Tool for Opioid Risk Mitigation [STORM] report).¹⁸

This article describes the VACHSquality-improvement effort to extend OBOT-B into step-1 primary care and general mental health clinics. Our objectives are to (1) outline the process for initiating SCOUTT within VACHS; (2) examine barriers to implementation and the SCOUTT team response; (3) review VACHS patient and prescriber data at baseline and 1 year after implementation; and (4) explore future implementation strategies.

SCOUTT Team

A VACHS interdisciplinary team was formed and attended the national SCOUTT kickoff conference in 2018.¹⁵ Similar to other SCOUTT teams, the team consisted of VISN leadership (in primary care, mental health, and addiction care), pharmacists, and a team of health care practitioners (HCPs) from step-2 clinics (including 2 addiction psychiatrists, and an advanced practice registered nurse, a registered nurse specializing in addiction care), and a team of HCPs from prospective step-1 clinics (including a clinical psychologist and 2 primary care physicians). An external facilitator was provided from outside the VISN who met remotely with the team to assist in facilitation. Our team met monthly, with the goal to identify local barriers and facilitators to OBOT-B and implement interventions to enhance prescribing in step-1 primary care and general mental health clinics.

Implementation Steps

The team identified multiple barriers to dissemination of OBOT-B in target clinics (Table). The 3 main barriers were limited leadership engagement in promoting OBOT-B in target clinics, inadequate number of HCPs with active X-waivered prescribing status in the targeted clinics, and the need for standardized processes and tools to facilitate prescribing and follow-up.

To address leadership engagement, the SCOUTT team held quarterly presentations of SCOUTT goals and progress on target clinic leadership calls (usually 15 minutes) and arranged a 90-minute multidisciplinary leadership summit with key leadership representation from primary care, general mental health, specialty addiction care, nursing, and pharmacy. To enhance X-waivered prescribers in target clinics, the SCOUTT team sent quarterly emails with brief education points on MOUD and links to waiver trainings. At the time of implementation, in order to prescribe buprenorphine and meet qualifications to treat OUD, prescribers were required to complete specialized training as necessitated by the Drug Addiction Treatment Act of 2000. X-waivered status can now be obtained without requiring training

The SCOUTT team advocated for X-waivered status to be incentivized by performance pay for primary care practitioners and held quarterly case-based education sessions during preexisting allotted time. The onboarding process for new waivered prescribers to navigate from waiver training to active prescribing within the EHR was standardized via development of a standard operating procedure (SOP).

The SCOUTT team also assisted in the development of standardized processes and tools for prescribing in target clinics, including implementation of a standard operating procedure regarding prescribing (both initiation of buprenorphine, and maintenance) in target clinics. This procedure specifies that target clinic HCPs prescribe for patients requiring less intensive management, and who are appropriate for office-based treatment based on specific criteria (eAppendix

Analysis

We examined changes in MOUD receipt and prescriber characteristics at baseline (FY 2018 4th quarter) and 1 year after implementation (FY 2019 4th quarter). Patient data were extracted from the VHA Corporate Data Warehouse (CDW), which contains data from all VHA EHRs. The VA STORM, is a CDW tool that automatically flags patients prescribed opioids who are at risk for overdose and suicide. Prescriber data were obtained from the Buprenorphine/X-Waivered Provider Report, a VA Academic Detailing Service database that provides details on HCP type, X-waivered status, and prescribing by location. χ² analyses were conducted on before and after measures when total values were available.

Results

There was a 4% increase in patients with an OUD diagnosis receiving MOUD, from 552 (44%) to 582 (48%) (P = .04), over this time. The number of waivered prescribers increased from 67 to 131, the number of prescribers of buprenorphine in a 6-month span increased from 35 to 52, and the percentage of HCPs capable of prescribing within the EHR increased from 75% to 89% (P =.01).

Initially, addiction HCPs prescribed to about 68% of patients on buprenorphine, with target clinic HCPs prescribing to 24% (with the remaining coming from other specialty HCPs). On follow-up, addiction professionals prescribed to 63%, with target clinic clincians prescribing to 32%.

Interpretation

SCOUTT team interventions succeeded in increasing the number of patients receiving MOUD, a substantial increase in waivered HCPs, an increase in the number of waivered HCPs prescribing MOUD, and an increase in the proportion of patients receiving MOUD in step-1 target clinics. It is important to note that within the quality-improvement framework and goals of our SCOUTT team that the data were not collected as part of a research study but to assess impact of our interventions. Within this framework, it is not possible to directly attribute the increase in eligible patients receiving MOUD solely to SCOUTT team interventions, as other factors may have contributed, including improved awareness of HCPs.

Summary and Future Directions

Since implementation of SCOUTT in August 2018, VACHS has identified several barriers to buprenorphine prescribing in step-1 clinics and implemented strategies to overcome them. Describing our approach will hopefully inform other large health care systems (VA or non-VA) on changes required in order to scale up implementation of OBOT-B. The VACHS SCOUTT team was successful at enhancing a ready workforce in step-1 clinics, though noted a delay in changing prescribing practice and culture.

We recommend utilizing academic detailing to work with clinics and individual HCPs to identify and overcome barriers to prescribing. Also, we recommend implementation of a nursing or clinical pharmacy collaborative care model in target step-1 clinics (rather than the HCP-driven model). A collaborative care model reflects the patient aligned care team (PACT) principle of team-based efficient care, and PACT nurses or clinical pharmacists should be able to provide the minimal quarterly follow-up of clinically stable patients on MOUD within the step-1 clinics. Templated notes for assessment, initiation, and follow-up of patients on MOUD are now available from the SCOUTT national program and should be broadly implemented to facilitate adoption of the collaborative model in target clinics. In order to accomplish a full collaborative model, the VHA would need to enhance appropriate staffing to support this model, broaden access to telehealth, and expand incentives to teams/clinicians who prescribe in these settings.

Acknowledgments/Funding

This material is based upon work supported by the US Department of Veterans Affairs (VA), Office of Mental Health and Suicide Prevention, Veterans Health Administration; the VA Health Services Research and Development (HSR&D) Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative (PEC) grants #19-001. Supporting organizations had no further role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the paper for publication.

In the United States, opioid use disorder (OUD) is a major public health challenge. In 2018 drug overdose deaths were 4 times higher than they were in 1999.¹ This increase highlights a critical need to expand treatment access. Medication for opioid use disorder (MOUD), including methadone, naltrexone, and buprenorphine, improves outcomes for patients retained in care.² Compared with the general population, veterans, particularly those with co-occurring posttraumatic stress disorder (PTSD) or depression, are more likely to receive higher dosages of opioid medications and experience opioid-related adverse outcomes (eg, overdose, OUD).^3,4 As a risk reduction strategy, patients receiving potentially dangerous full-dose agonist opioid medication who are unable to taper to safer dosages may be eligible to transition to buprenorphine.⁵

Buprenorphine and naltrexone can be prescribed in office-based settings or in addiction, primary care, mental health, and pain clinics. Office-based opioid treatment with buprenorphine (OBOT-B) expands access to patients who are not reached by addiction treatment programs.^6,7 This is particularly true in rural settings, where addiction care services are typically scarce.⁸ OBOT-B prevents relapse and maintains opioid-free days and may increase patient engagement by reducing stigma and providing treatment within an existing clinical care team.⁹ For many patients, OBOT-B results in good retention with just medical monitoring and minimal or no ancillary addiction counseling.^10,11

Successful implementation of OBOT-B has occurred through a variety of care models in selected community health care settings.^8,12,13 Historically in the Veterans Health Administration (VHA), MOUD has been prescribed in substance use disorder clinics by mental health practitioners. Currently, more than 44% of veterans with OUD are on MOUD.¹⁴

The VHA has invested significant resources to improve access to MOUD. In 2018, the Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative launched, with the aim to improve access within primary care, mental health, and pain clinics.¹⁵ SCOUTT emphasizes stepped-care treatment, with patients engaging in the step of care most appropriate to their needs. Step 0 is self-directed care/self-management, including mutual support groups; step-1 environments include office-based primary care, mental health, and pain clinics; and step-2 environments are specialty care settings. Through a series of remote webinars, an in-person national 2-day conference, and external facilitation, SCOUTT engaged 18 teams representing each Veterans Integrated Service Network (VISN) across the country to assist in implementing MOUD within 2 step-1 clinics. These teams have developed several models of providing step-1 care, including an interdisciplinary team-based primary care delivery model as well as a pharmacist care manager model.^{16, 17}

US Department of Veterans Affairs (VA) Connecticut Health Care System (VACHS), which delivers care to approximately 58,000 veterans, was chosen to be a phase 1 SCOUTT site. Though all patients in VACHS have access to specialty care step-2 clinics, including methadone and buprenorphine programs, there remained many patients not yet on MOUD who could benefit from it. Baseline data (fiscal year [FY] 2018 4th quarter), obtained through electronic health record (EHR) database dashboards indicated that 710 (56%) patients with an OUD diagnosis were not receiving MOUD. International Classification of Disease, 10th Revision codes are the foundation for VA population management dashboards, and based their data on codes for opioid abuse and opioid dependence. These tools are limited by the accuracy of coding in EHRs. Additionally, 366 patients receiving long-term opioid prescriptions were identified as moderate, high, or very high risk for overdose or death based on an algorithm that considered prescribed medications, sociodemographics, and comorbid conditions, as characterized in the VA EHR (Stratification Tool for Opioid Risk Mitigation [STORM] report).¹⁸

This article describes the VACHSquality-improvement effort to extend OBOT-B into step-1 primary care and general mental health clinics. Our objectives are to (1) outline the process for initiating SCOUTT within VACHS; (2) examine barriers to implementation and the SCOUTT team response; (3) review VACHS patient and prescriber data at baseline and 1 year after implementation; and (4) explore future implementation strategies.

SCOUTT Team

A VACHS interdisciplinary team was formed and attended the national SCOUTT kickoff conference in 2018.¹⁵ Similar to other SCOUTT teams, the team consisted of VISN leadership (in primary care, mental health, and addiction care), pharmacists, and a team of health care practitioners (HCPs) from step-2 clinics (including 2 addiction psychiatrists, and an advanced practice registered nurse, a registered nurse specializing in addiction care), and a team of HCPs from prospective step-1 clinics (including a clinical psychologist and 2 primary care physicians). An external facilitator was provided from outside the VISN who met remotely with the team to assist in facilitation. Our team met monthly, with the goal to identify local barriers and facilitators to OBOT-B and implement interventions to enhance prescribing in step-1 primary care and general mental health clinics.

Implementation Steps

The team identified multiple barriers to dissemination of OBOT-B in target clinics (Table). The 3 main barriers were limited leadership engagement in promoting OBOT-B in target clinics, inadequate number of HCPs with active X-waivered prescribing status in the targeted clinics, and the need for standardized processes and tools to facilitate prescribing and follow-up.

To address leadership engagement, the SCOUTT team held quarterly presentations of SCOUTT goals and progress on target clinic leadership calls (usually 15 minutes) and arranged a 90-minute multidisciplinary leadership summit with key leadership representation from primary care, general mental health, specialty addiction care, nursing, and pharmacy. To enhance X-waivered prescribers in target clinics, the SCOUTT team sent quarterly emails with brief education points on MOUD and links to waiver trainings. At the time of implementation, in order to prescribe buprenorphine and meet qualifications to treat OUD, prescribers were required to complete specialized training as necessitated by the Drug Addiction Treatment Act of 2000. X-waivered status can now be obtained without requiring training

The SCOUTT team advocated for X-waivered status to be incentivized by performance pay for primary care practitioners and held quarterly case-based education sessions during preexisting allotted time. The onboarding process for new waivered prescribers to navigate from waiver training to active prescribing within the EHR was standardized via development of a standard operating procedure (SOP).

The SCOUTT team also assisted in the development of standardized processes and tools for prescribing in target clinics, including implementation of a standard operating procedure regarding prescribing (both initiation of buprenorphine, and maintenance) in target clinics. This procedure specifies that target clinic HCPs prescribe for patients requiring less intensive management, and who are appropriate for office-based treatment based on specific criteria (eAppendix

Analysis

We examined changes in MOUD receipt and prescriber characteristics at baseline (FY 2018 4th quarter) and 1 year after implementation (FY 2019 4th quarter). Patient data were extracted from the VHA Corporate Data Warehouse (CDW), which contains data from all VHA EHRs. The VA STORM, is a CDW tool that automatically flags patients prescribed opioids who are at risk for overdose and suicide. Prescriber data were obtained from the Buprenorphine/X-Waivered Provider Report, a VA Academic Detailing Service database that provides details on HCP type, X-waivered status, and prescribing by location. χ² analyses were conducted on before and after measures when total values were available.

Results

There was a 4% increase in patients with an OUD diagnosis receiving MOUD, from 552 (44%) to 582 (48%) (P = .04), over this time. The number of waivered prescribers increased from 67 to 131, the number of prescribers of buprenorphine in a 6-month span increased from 35 to 52, and the percentage of HCPs capable of prescribing within the EHR increased from 75% to 89% (P =.01).

Initially, addiction HCPs prescribed to about 68% of patients on buprenorphine, with target clinic HCPs prescribing to 24% (with the remaining coming from other specialty HCPs). On follow-up, addiction professionals prescribed to 63%, with target clinic clincians prescribing to 32%.

Interpretation

SCOUTT team interventions succeeded in increasing the number of patients receiving MOUD, a substantial increase in waivered HCPs, an increase in the number of waivered HCPs prescribing MOUD, and an increase in the proportion of patients receiving MOUD in step-1 target clinics. It is important to note that within the quality-improvement framework and goals of our SCOUTT team that the data were not collected as part of a research study but to assess impact of our interventions. Within this framework, it is not possible to directly attribute the increase in eligible patients receiving MOUD solely to SCOUTT team interventions, as other factors may have contributed, including improved awareness of HCPs.

Summary and Future Directions

Since implementation of SCOUTT in August 2018, VACHS has identified several barriers to buprenorphine prescribing in step-1 clinics and implemented strategies to overcome them. Describing our approach will hopefully inform other large health care systems (VA or non-VA) on changes required in order to scale up implementation of OBOT-B. The VACHS SCOUTT team was successful at enhancing a ready workforce in step-1 clinics, though noted a delay in changing prescribing practice and culture.

We recommend utilizing academic detailing to work with clinics and individual HCPs to identify and overcome barriers to prescribing. Also, we recommend implementation of a nursing or clinical pharmacy collaborative care model in target step-1 clinics (rather than the HCP-driven model). A collaborative care model reflects the patient aligned care team (PACT) principle of team-based efficient care, and PACT nurses or clinical pharmacists should be able to provide the minimal quarterly follow-up of clinically stable patients on MOUD within the step-1 clinics. Templated notes for assessment, initiation, and follow-up of patients on MOUD are now available from the SCOUTT national program and should be broadly implemented to facilitate adoption of the collaborative model in target clinics. In order to accomplish a full collaborative model, the VHA would need to enhance appropriate staffing to support this model, broaden access to telehealth, and expand incentives to teams/clinicians who prescribe in these settings.

Acknowledgments/Funding

This material is based upon work supported by the US Department of Veterans Affairs (VA), Office of Mental Health and Suicide Prevention, Veterans Health Administration; the VA Health Services Research and Development (HSR&D) Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative (PEC) grants #19-001. Supporting organizations had no further role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the paper for publication.

In the United States, opioid use disorder (OUD) is a major public health challenge. In 2018 drug overdose deaths were 4 times higher than they were in 1999.¹ This increase highlights a critical need to expand treatment access. Medication for opioid use disorder (MOUD), including methadone, naltrexone, and buprenorphine, improves outcomes for patients retained in care.² Compared with the general population, veterans, particularly those with co-occurring posttraumatic stress disorder (PTSD) or depression, are more likely to receive higher dosages of opioid medications and experience opioid-related adverse outcomes (eg, overdose, OUD).^3,4 As a risk reduction strategy, patients receiving potentially dangerous full-dose agonist opioid medication who are unable to taper to safer dosages may be eligible to transition to buprenorphine.⁵

Buprenorphine and naltrexone can be prescribed in office-based settings or in addiction, primary care, mental health, and pain clinics. Office-based opioid treatment with buprenorphine (OBOT-B) expands access to patients who are not reached by addiction treatment programs.^6,7 This is particularly true in rural settings, where addiction care services are typically scarce.⁸ OBOT-B prevents relapse and maintains opioid-free days and may increase patient engagement by reducing stigma and providing treatment within an existing clinical care team.⁹ For many patients, OBOT-B results in good retention with just medical monitoring and minimal or no ancillary addiction counseling.^10,11

Successful implementation of OBOT-B has occurred through a variety of care models in selected community health care settings.^8,12,13 Historically in the Veterans Health Administration (VHA), MOUD has been prescribed in substance use disorder clinics by mental health practitioners. Currently, more than 44% of veterans with OUD are on MOUD.¹⁴

The VHA has invested significant resources to improve access to MOUD. In 2018, the Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative launched, with the aim to improve access within primary care, mental health, and pain clinics.¹⁵ SCOUTT emphasizes stepped-care treatment, with patients engaging in the step of care most appropriate to their needs. Step 0 is self-directed care/self-management, including mutual support groups; step-1 environments include office-based primary care, mental health, and pain clinics; and step-2 environments are specialty care settings. Through a series of remote webinars, an in-person national 2-day conference, and external facilitation, SCOUTT engaged 18 teams representing each Veterans Integrated Service Network (VISN) across the country to assist in implementing MOUD within 2 step-1 clinics. These teams have developed several models of providing step-1 care, including an interdisciplinary team-based primary care delivery model as well as a pharmacist care manager model.^{16, 17}

US Department of Veterans Affairs (VA) Connecticut Health Care System (VACHS), which delivers care to approximately 58,000 veterans, was chosen to be a phase 1 SCOUTT site. Though all patients in VACHS have access to specialty care step-2 clinics, including methadone and buprenorphine programs, there remained many patients not yet on MOUD who could benefit from it. Baseline data (fiscal year [FY] 2018 4th quarter), obtained through electronic health record (EHR) database dashboards indicated that 710 (56%) patients with an OUD diagnosis were not receiving MOUD. International Classification of Disease, 10th Revision codes are the foundation for VA population management dashboards, and based their data on codes for opioid abuse and opioid dependence. These tools are limited by the accuracy of coding in EHRs. Additionally, 366 patients receiving long-term opioid prescriptions were identified as moderate, high, or very high risk for overdose or death based on an algorithm that considered prescribed medications, sociodemographics, and comorbid conditions, as characterized in the VA EHR (Stratification Tool for Opioid Risk Mitigation [STORM] report).¹⁸

This article describes the VACHSquality-improvement effort to extend OBOT-B into step-1 primary care and general mental health clinics. Our objectives are to (1) outline the process for initiating SCOUTT within VACHS; (2) examine barriers to implementation and the SCOUTT team response; (3) review VACHS patient and prescriber data at baseline and 1 year after implementation; and (4) explore future implementation strategies.

SCOUTT Team

A VACHS interdisciplinary team was formed and attended the national SCOUTT kickoff conference in 2018.¹⁵ Similar to other SCOUTT teams, the team consisted of VISN leadership (in primary care, mental health, and addiction care), pharmacists, and a team of health care practitioners (HCPs) from step-2 clinics (including 2 addiction psychiatrists, and an advanced practice registered nurse, a registered nurse specializing in addiction care), and a team of HCPs from prospective step-1 clinics (including a clinical psychologist and 2 primary care physicians). An external facilitator was provided from outside the VISN who met remotely with the team to assist in facilitation. Our team met monthly, with the goal to identify local barriers and facilitators to OBOT-B and implement interventions to enhance prescribing in step-1 primary care and general mental health clinics.

Implementation Steps

The team identified multiple barriers to dissemination of OBOT-B in target clinics (Table). The 3 main barriers were limited leadership engagement in promoting OBOT-B in target clinics, inadequate number of HCPs with active X-waivered prescribing status in the targeted clinics, and the need for standardized processes and tools to facilitate prescribing and follow-up.

To address leadership engagement, the SCOUTT team held quarterly presentations of SCOUTT goals and progress on target clinic leadership calls (usually 15 minutes) and arranged a 90-minute multidisciplinary leadership summit with key leadership representation from primary care, general mental health, specialty addiction care, nursing, and pharmacy. To enhance X-waivered prescribers in target clinics, the SCOUTT team sent quarterly emails with brief education points on MOUD and links to waiver trainings. At the time of implementation, in order to prescribe buprenorphine and meet qualifications to treat OUD, prescribers were required to complete specialized training as necessitated by the Drug Addiction Treatment Act of 2000. X-waivered status can now be obtained without requiring training

The SCOUTT team advocated for X-waivered status to be incentivized by performance pay for primary care practitioners and held quarterly case-based education sessions during preexisting allotted time. The onboarding process for new waivered prescribers to navigate from waiver training to active prescribing within the EHR was standardized via development of a standard operating procedure (SOP).

The SCOUTT team also assisted in the development of standardized processes and tools for prescribing in target clinics, including implementation of a standard operating procedure regarding prescribing (both initiation of buprenorphine, and maintenance) in target clinics. This procedure specifies that target clinic HCPs prescribe for patients requiring less intensive management, and who are appropriate for office-based treatment based on specific criteria (eAppendix

Analysis

We examined changes in MOUD receipt and prescriber characteristics at baseline (FY 2018 4th quarter) and 1 year after implementation (FY 2019 4th quarter). Patient data were extracted from the VHA Corporate Data Warehouse (CDW), which contains data from all VHA EHRs. The VA STORM, is a CDW tool that automatically flags patients prescribed opioids who are at risk for overdose and suicide. Prescriber data were obtained from the Buprenorphine/X-Waivered Provider Report, a VA Academic Detailing Service database that provides details on HCP type, X-waivered status, and prescribing by location. χ² analyses were conducted on before and after measures when total values were available.

Results

There was a 4% increase in patients with an OUD diagnosis receiving MOUD, from 552 (44%) to 582 (48%) (P = .04), over this time. The number of waivered prescribers increased from 67 to 131, the number of prescribers of buprenorphine in a 6-month span increased from 35 to 52, and the percentage of HCPs capable of prescribing within the EHR increased from 75% to 89% (P =.01).

Initially, addiction HCPs prescribed to about 68% of patients on buprenorphine, with target clinic HCPs prescribing to 24% (with the remaining coming from other specialty HCPs). On follow-up, addiction professionals prescribed to 63%, with target clinic clincians prescribing to 32%.

Interpretation

SCOUTT team interventions succeeded in increasing the number of patients receiving MOUD, a substantial increase in waivered HCPs, an increase in the number of waivered HCPs prescribing MOUD, and an increase in the proportion of patients receiving MOUD in step-1 target clinics. It is important to note that within the quality-improvement framework and goals of our SCOUTT team that the data were not collected as part of a research study but to assess impact of our interventions. Within this framework, it is not possible to directly attribute the increase in eligible patients receiving MOUD solely to SCOUTT team interventions, as other factors may have contributed, including improved awareness of HCPs.

Summary and Future Directions

Since implementation of SCOUTT in August 2018, VACHS has identified several barriers to buprenorphine prescribing in step-1 clinics and implemented strategies to overcome them. Describing our approach will hopefully inform other large health care systems (VA or non-VA) on changes required in order to scale up implementation of OBOT-B. The VACHS SCOUTT team was successful at enhancing a ready workforce in step-1 clinics, though noted a delay in changing prescribing practice and culture.

We recommend utilizing academic detailing to work with clinics and individual HCPs to identify and overcome barriers to prescribing. Also, we recommend implementation of a nursing or clinical pharmacy collaborative care model in target step-1 clinics (rather than the HCP-driven model). A collaborative care model reflects the patient aligned care team (PACT) principle of team-based efficient care, and PACT nurses or clinical pharmacists should be able to provide the minimal quarterly follow-up of clinically stable patients on MOUD within the step-1 clinics. Templated notes for assessment, initiation, and follow-up of patients on MOUD are now available from the SCOUTT national program and should be broadly implemented to facilitate adoption of the collaborative model in target clinics. In order to accomplish a full collaborative model, the VHA would need to enhance appropriate staffing to support this model, broaden access to telehealth, and expand incentives to teams/clinicians who prescribe in these settings.

Acknowledgments/Funding

This material is based upon work supported by the US Department of Veterans Affairs (VA), Office of Mental Health and Suicide Prevention, Veterans Health Administration; the VA Health Services Research and Development (HSR&D) Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative (PEC) grants #19-001. Supporting organizations had no further role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the paper for publication.

It is a time of significant change as the Military Health System (MHS) transitions to the purview of the Defense Health Agency (DHA). Additionally, the landscape of combat is ever changing, and military medicine needs to evolve to ensure that the lessons learned are utilized to optimize care of the war fighters. The purpose of this review is to evaluate the available literature on existing operational medicine curriculums and make recommendations to restructure current military medicine training to produce operationally prepared clinicians who are informed in operationally focused research principles.

Operational Medicine

Before diving into the importance of creating a curriculum and investing in training for scholarly activity proficiency, operational medicine needs to be defined. It can be defined as medical care provided in an austere environment with limited resources and possibly under hostile conditions. Another way to look at operational medicine is as the evaluation of normal human physiology and pathology under abnormal conditions. The mission set of each of the services is unique. The Marines and Army may operate forward past the wire vulnerable to the environment, gunfire, and improvised explosive devices, remote from fixed medical facilities. The Navy has divers exposed to the risks of decompression sickness. The Air Force has pilots exposed to altitude changes and strains of G-forces during flight. Locations vary from cold high-altitude mountainous regions to high-temperature desolate deserts. Many times, medical practitioners may be remotely stationed, far from specialty or immediate definitive care. Patient care may consist of low-acuity management of individual patients in sick call to mass casualty events where patient numbers and morbidity may outstrip available resources, making the difficult task of triage necessary.

Despite the challenges of being a uniformed physician, the benefits of being embedded is a better understanding of the roles and capability of the unit. Military physicians need to have the unique knowledge of the type of injuries sustained in that particular theater of war, such as differentiating between the trauma pattern and care required for blast injuries vs high-velocity missiles. There are also chemical, biologic, radiologic, and nuclear threats that military physicians need to recognize. Much of what disables a military fighting force is not a direct relationship to combat-related injuries; however, entire units have been taken down by infectious diarrhea or trench foot. There is also a need for familiarity of the infections and parasitology endemic to the particular theater with the aim of implementation of prevention whenever possible.

Military medicine does not fit in any box. Military physicians need to know the job requirements of various specialties, including elements of occupational medicine, such as aircrew piloting high-performance fighters or ground troops fully loaded with body armor and 80-lb backpacks. There are musculoskeletal injuries from the stressors of various military occupations. Working around weaponry and contact with hostile forces will create scenarios requiring emergent and critical care. In addition to physical injuries, there is the mental strain of combat with the risk of imminent personal injury, the guilt of survivorship, dealing with the scars and permanent physical damage of combat, and prolonged separation from family and other support systems.

The National Defense Authorization Act 2017 mandated the establishment of a standardized process to oversee all military graduate medical education (GME) programs with the goal of ensuring medical operational readiness.¹ This is no small task with > 3000 residents in more than 70 specialties, comprising approximately 12% of US residents.^1,2 Presently, 26 to 32% of the medical corps is enrolled in full-time training compared with 12% of the total force.² With significant time and resources expended during this period, it is vital to maximize the potential of the training.

Literature Review

A literature review was performed, evaluating historical precedence of specialized military medical training and research as well as current operational curriculums. Literature search was conducted in the PubMed and Uniformed Services University (USU) Learning Resource databases using the terms “operational medicine curriculum,” “military medicine curriculum,” “operational medicine training,” “military medicine training,” “operational medicine research,” and “military medicine research,” and included all articles from 1997 to 2020. Inclusion criteria included studies that detailed military medicine training programs and/or outcomes. The source types used in this research project included peer-reviewed journal publications—both review articles and original research—from medical and military journals. The citations of these articles were also reviewed for additional usable publications. Secondary sources included official reports and studies by the RAND Corporation, the US Government Accountability Office, and the Institute for Defense Analysis (IDA). Due to lack of literature on the topic, other sources such as talking papers, letters, and formal presentations from subject matter experts were included to showcase the current state and gaps on this topic. Key findings from peer-reviewed publications are presented in Table 1.

Overall, the literature review showed that longitudinal deliberately mapped out curriculums can be well integrated into the existing medical curriculum.³ The military medicine course topics include environmental medicine, applied field medicine, combat casualty care, medical support planning, mass casualty incident preparation, and military-focused problem solving, decision making, and leadership.⁴

One 1997 study looked at the degree of implementation of military unique curriculum in 18 family medicine residencies. Only 30% of residents stated that their program had a specific operational medicine curriculum.5 Salerno and colleagues surveyed current residents and recently graduated internal medicine physicians at 14 facilities in the Army, Air Force, and Navy to determine confidence level with military medicine. More than half did not feel ready to practice deployment medicine; just 19% felt comfortable treating nuclear, biologic, and chemical warfare injuries; and 32% felt unfamiliar with the command and administrative duties. A subgroup analysis showed that USU graduates felt more prepared in these areas compared with civilian program graduates.6 Additional studies showed perceived smoother transition in the first active-duty tour after participation in an operational curriculum.⁷

In addition to in-program training, other options include operational rotations offsite and military courses conducted outside the GME program.¹² Some of these courses may include just-in-time training such as expeditionary medical support system training prior to scheduled deployments. Examples of experiential training are listed in Table 3.

Critical Analysis 

Current gaps were identified in the military medicine training pipeline’s operational medicine curriculum and research programs. The analysis looked at specific components that make the operational medicine curriculum and research unique as well as current readiness goals, to determine how to best align both to meet the mission requirements. Some factors considered included efficiency, cost, program portability, duplication minimization, retention, and sustainability.

Efficiency

A well-created curriculum that meets objectives will require more than an assigned rotation and a few lectures. The most successful ones in the literature review were the ones that were deliberately planned and longitudinal, such as the ones at USU that combined a mixture of classroom and field exercises over the course of 4 years.^4,8 In that way, the curriculum may not be considered time efficient, but if integrated well into the already existing medical training, the production of military physicians who are mission ready upon graduation—ready to serve as military medical leaders and deploy—will be invaluable.

Cost Comparison

Due to the associated overhead of running a training platform and the additional hours of operational training, military GME is more expensive initially compared with civilian outsourcing. In USU, for example, there is an additional 700 hours of operational curriculum alone. This cost difference more than doubles the cost of a USU education vs a Health Professional Scholarship Program (HPSP) scholarship at a civilian medical school. However, a causal analysis performed by the IDA to determine value basis noted that USU graduates deploy almost 3 times as much and serve 6 years longer on active duty.³

After graduating medical school through either accession source, physicians complete specialization training in a GME program. The IDA study noted an average $12,000 increased cost of military GME compared with civilian programs. The analysis included resident compensation and overhead costs of running the program as well as the net cost, which also accounted for resident productivity and workload by training in a military facility.³ Calculations due to mandated budget cuts estimated cost savings of closing the military medical school at < $100 million while significantly impacting the military physician pipeline and operational research output.³

Duplication of Effort

There are already established training programs such as Tactical Combat Casualty Care (TCCC) that could be incorporated into the curriculum to avoid expending additional resources to recreate the wheel. USU has a validated operational training curriculum and may be able to make opportunities available for outside trainees to participate in some of its military-unique training and leadership exercises. Other ways to decrease duplication of effort and improve cost efficiency include focusing on the creation of an academic health system (AHS) and consolidating similar programs to conserve resources. Increasing existing military program sizes will not only ensure the continuation of the military medicine pipeline, but will spread overhead costs over a larger cohort, decrease costs of civilian outsourcing, and ensure the less tangible benefits of military cultural exposure early in trainees’ careers. For example, increasing the class size of USU by 30 students actually reduces the cost per student to $239,000 per year from $253,000, while decreasing the need for HPSP accessions training in civilian programs, making the endeavor overall cost neutral.³

Program Portability

The operational medicine residency has proved that an operational curriculum can be remotely managed and reproduced at a variety of residency specialties.¹² Remote education could be developed and distributed throughout the MHS, such as the proposed USU course Military Medicine and Leadership course.3 Centralized training programs like Global Medicine and C-STARS could be scheduled TDYs during the medical training calendar.

Retention

The military medical school, USU, is the largest military medicine accession source. An IDA report notes that retention of USU graduates is 15.2 years compared with 9.2 years served by civilian trainees. Due to the longevity in service, USU graduates also make up more than 25% of military medical leadership.4 The long-term outcome study that looked at the past 40 years of USU graduates observed that over 70% of graduates served until retirement eligibility and are overrepresented in special operations units.3,13 While some of this longevity may be attributed to the longer USU service contracts, military GME graduates were still noted to be 4 times more likely to commit to a multiyear service contract.¹⁴ A RAND study on the retention of military physicians in the Army, Air Force, and Navy noted that overall retention increased throughout all the services for physicians who went through the military GME pipeline.¹⁵ Conversely, civilian GME training was associated with a 45% chance in leaving active duty.¹⁶

It is theorized that early military acculturation during training increases the likelihood of instilling a sense of mission. Being involved in military GME on the teaching side also showed increased retention rates for 63% of survey respondents.¹⁷ Reduced burnout and increased work satisfaction for those involved in military GME was noted on another faculty satisfaction survey.¹⁷

Sustainability

Programs like USU, which have been around for decades, and the newer operational residency program evolving since 2013 have shown sustainability.^4,11 Dissemination of proven curriculums as well as centralization of already validated training programs can help standardize operational medical training throughout the MHS. In order to flourish at individual programs, the faculty need to be well versed in a train the trainer model and have institutional support. The ability to engage with the line at individual locations may be a factor as well.¹⁸ In regard to research, once residents are taught the principles of scholarly activity, they will have the tools to continue operational medicine research advancements and mentoring students.

Discussion

The 2020 NDAA recommends the establishment of an AHS.3 This step will create a culture of military medical readiness from the top down as congressional mandates push reorganization of the MHS, including military GME programs. An overall restructuring of military medicine will require prioritization of resources toward operational requirements vs the historic significant division of attention to beneficiary care that has caused a lack of unity of effort and additional strain on an already heavily tasked medical force. The changes in military GME are just one aspect of that. It is vital to look at the restructuring with a comprehension of the unique challenges of combat health rather than only from an in-garrison, hospital-based aspect.¹⁹ Benefits of having a military medicine AHS include opportunities to share resources and successful business models as well as foster interdisciplinary teamwork and partnerships with civilian health care facilities and research institutions as a force multiplier.¹⁹

There has been recent discussion about budget cuts, including shutting down USU and military GME and transitioning all training to civilian programs to be cost-effective.⁴ If this were to happen, it would be a step backward from the goal of operational readiness. Maintaining US Department of Defense (DoD) control of the military medicine pipeline has innumerable benefits, including built-in mentorship from operationally-seasoned faculty, military leadership development, proficiency in MHS systems, open communication between GME programs and DoD, and curriculum control to ensure focus on readiness.²⁰ Military GME programs are also a significant production source of military-related scholarly activity. Over fiscal year 2017/2018, 63% of the publications out of the San Antonio Uniformed Services Health Education Consortium—the largest Air Force GME platform and second largest multiservice GME platform—involved military relevant medical topics.¹⁷ Much of the volume of operational research as well as the relevant skills learned and future innovations secondary to conducting this research would be lost if military GME did not exist.^17,21

Practically speaking, military GME provides the majority of the military medicine accessions. For example, a presentation by the Air Force Chief of Physician Education noted that the total military GME pipeline included 2875 students, but direct physician access averaged only 20 physicians a year.²² Even if the decision was made to defer to civilian education, capacity does not exist in civilian GME programs. This is worsened by the increased competitiveness of the GME match with the proliferation of medical schools without concurrent increase in residency spots. The 2018 National Resident Matching Program noted that there were more than 37,103 US and foreign applicants for only 33,000 residency positions, leaving many US applicants unmatched.¹⁷ It is doubtful that the civilian GME programs would be able to absorb the influx of military residents, affecting both the military and civilian medicine pipelines. As a secondary effect, the military treatment centers that house the military GME programs would have to close, with surrounding civilian medical facilities also likely unable to absorb the sudden influx of patients and residents losing the intangible benefits of caring for a military population.¹⁵ This was even recognized by the civilian president of the Accreditation Council for Graduate Medical Education:

Military physicians must be trained in the systems of care that are operative in military medicine, which is significantly unlike civilian medicine in many ways. It is often practiced in circumstances that are not seen in civilian medicine, within care structures that are not encountered in American medical practice… Military medicine has advanced research into the care of individuals suffering traumatic injury, critical care, rehabilitation medicine, prosthetics, psychiatric care of those traumatized, and closed head injury, to name a just a few. The sacrifices of our active military demand these advances, and the American Public benefit from these advances.²¹

Where deficiencies exist in military GME, it is possible to use the growing military-civilian training institution partnerships. Two prime examples are the just-in-time deployment training done with civilian trauma facilities by the Air Force Center for the Sustainment of Trauma Readiness Skills and the Air Force Special Operations Surgical Team-Special Operations Critical Care Evacuation Team being embedded in civilian facilities to maintain trauma, surgical, and emergency care skills. While military physicians can maintain competencies, at the same time, the civilian sector can benefit from the lessons learned in the military in regard to mass casualty and disaster responses. Fostering military and civilian training agreements can also enhance research opportunities.¹

Just as the realities of operational medicine frequently require the military physician to think outside the box, the most successful methods of instruction of military medicine tend to be nontraditional. Classroom education should be involved beyond lectures and can include other methods, such as case-based, role-playing, small group discussion, and computer-based teaching. Maintaining flexibility in live vs distance learning as well as synchronous vs asynchronous learning can expand the capacity of available instructors and standardize material over several sites.²³ Asking learners to consider operational concerns, such as whether certain medical conditions would be compatible with military duty in addition to the routine investigation is an easy way to incorporate military training in preexisting medical training.¹² The advancement of technology has made simulation one of the best ways to engage in hands-on learning, whether through computer simulations, animal models, standardized or moulaged patients, or mannequins that can realistically mimic medical or trauma-related conditions.²⁴ Many times, simulation can be combined with exercises in the field to create a realistic operational environment.²³

There are 3 pillars of an operational curriculum that should be integrated into the existing residency curriculum—operational medicine, leadership, and research principles (Appendix).

Conclusions

Judging by the continuing operational tempo and evolution of warfare, maintaining enhanced military medical readiness will remain a priority. Operational medicine is a unique field that requires specialized preparation. Studies have shown that longitudinal deliberately mapped out curriculums are able to be integrated well into the existing medical curriculum. The recommendation moving forward is increasing the access of existing operational training structures that have well established programs and modeling individual GME program curriculums after those that have shown proven success with a focus on the 3 pillars of operational training, leadership, and research.

Acknowledgments

Previously submitted in April 2020 in expanded form as part of graduation requirements for the Masters of Military Arts and Science degree program at Air University, Maxwell Air Force Base in Alabama.

It is a time of significant change as the Military Health System (MHS) transitions to the purview of the Defense Health Agency (DHA). Additionally, the landscape of combat is ever changing, and military medicine needs to evolve to ensure that the lessons learned are utilized to optimize care of the war fighters. The purpose of this review is to evaluate the available literature on existing operational medicine curriculums and make recommendations to restructure current military medicine training to produce operationally prepared clinicians who are informed in operationally focused research principles.

Operational Medicine

Before diving into the importance of creating a curriculum and investing in training for scholarly activity proficiency, operational medicine needs to be defined. It can be defined as medical care provided in an austere environment with limited resources and possibly under hostile conditions. Another way to look at operational medicine is as the evaluation of normal human physiology and pathology under abnormal conditions. The mission set of each of the services is unique. The Marines and Army may operate forward past the wire vulnerable to the environment, gunfire, and improvised explosive devices, remote from fixed medical facilities. The Navy has divers exposed to the risks of decompression sickness. The Air Force has pilots exposed to altitude changes and strains of G-forces during flight. Locations vary from cold high-altitude mountainous regions to high-temperature desolate deserts. Many times, medical practitioners may be remotely stationed, far from specialty or immediate definitive care. Patient care may consist of low-acuity management of individual patients in sick call to mass casualty events where patient numbers and morbidity may outstrip available resources, making the difficult task of triage necessary.

Despite the challenges of being a uniformed physician, the benefits of being embedded is a better understanding of the roles and capability of the unit. Military physicians need to have the unique knowledge of the type of injuries sustained in that particular theater of war, such as differentiating between the trauma pattern and care required for blast injuries vs high-velocity missiles. There are also chemical, biologic, radiologic, and nuclear threats that military physicians need to recognize. Much of what disables a military fighting force is not a direct relationship to combat-related injuries; however, entire units have been taken down by infectious diarrhea or trench foot. There is also a need for familiarity of the infections and parasitology endemic to the particular theater with the aim of implementation of prevention whenever possible.

Military medicine does not fit in any box. Military physicians need to know the job requirements of various specialties, including elements of occupational medicine, such as aircrew piloting high-performance fighters or ground troops fully loaded with body armor and 80-lb backpacks. There are musculoskeletal injuries from the stressors of various military occupations. Working around weaponry and contact with hostile forces will create scenarios requiring emergent and critical care. In addition to physical injuries, there is the mental strain of combat with the risk of imminent personal injury, the guilt of survivorship, dealing with the scars and permanent physical damage of combat, and prolonged separation from family and other support systems.

The National Defense Authorization Act 2017 mandated the establishment of a standardized process to oversee all military graduate medical education (GME) programs with the goal of ensuring medical operational readiness.¹ This is no small task with > 3000 residents in more than 70 specialties, comprising approximately 12% of US residents.^1,2 Presently, 26 to 32% of the medical corps is enrolled in full-time training compared with 12% of the total force.² With significant time and resources expended during this period, it is vital to maximize the potential of the training.

Literature Review

A literature review was performed, evaluating historical precedence of specialized military medical training and research as well as current operational curriculums. Literature search was conducted in the PubMed and Uniformed Services University (USU) Learning Resource databases using the terms “operational medicine curriculum,” “military medicine curriculum,” “operational medicine training,” “military medicine training,” “operational medicine research,” and “military medicine research,” and included all articles from 1997 to 2020. Inclusion criteria included studies that detailed military medicine training programs and/or outcomes. The source types used in this research project included peer-reviewed journal publications—both review articles and original research—from medical and military journals. The citations of these articles were also reviewed for additional usable publications. Secondary sources included official reports and studies by the RAND Corporation, the US Government Accountability Office, and the Institute for Defense Analysis (IDA). Due to lack of literature on the topic, other sources such as talking papers, letters, and formal presentations from subject matter experts were included to showcase the current state and gaps on this topic. Key findings from peer-reviewed publications are presented in Table 1.

Overall, the literature review showed that longitudinal deliberately mapped out curriculums can be well integrated into the existing medical curriculum.³ The military medicine course topics include environmental medicine, applied field medicine, combat casualty care, medical support planning, mass casualty incident preparation, and military-focused problem solving, decision making, and leadership.⁴

One 1997 study looked at the degree of implementation of military unique curriculum in 18 family medicine residencies. Only 30% of residents stated that their program had a specific operational medicine curriculum.5 Salerno and colleagues surveyed current residents and recently graduated internal medicine physicians at 14 facilities in the Army, Air Force, and Navy to determine confidence level with military medicine. More than half did not feel ready to practice deployment medicine; just 19% felt comfortable treating nuclear, biologic, and chemical warfare injuries; and 32% felt unfamiliar with the command and administrative duties. A subgroup analysis showed that USU graduates felt more prepared in these areas compared with civilian program graduates.6 Additional studies showed perceived smoother transition in the first active-duty tour after participation in an operational curriculum.⁷

In addition to in-program training, other options include operational rotations offsite and military courses conducted outside the GME program.¹² Some of these courses may include just-in-time training such as expeditionary medical support system training prior to scheduled deployments. Examples of experiential training are listed in Table 3.

Critical Analysis 

Current gaps were identified in the military medicine training pipeline’s operational medicine curriculum and research programs. The analysis looked at specific components that make the operational medicine curriculum and research unique as well as current readiness goals, to determine how to best align both to meet the mission requirements. Some factors considered included efficiency, cost, program portability, duplication minimization, retention, and sustainability.

Efficiency

A well-created curriculum that meets objectives will require more than an assigned rotation and a few lectures. The most successful ones in the literature review were the ones that were deliberately planned and longitudinal, such as the ones at USU that combined a mixture of classroom and field exercises over the course of 4 years.^4,8 In that way, the curriculum may not be considered time efficient, but if integrated well into the already existing medical training, the production of military physicians who are mission ready upon graduation—ready to serve as military medical leaders and deploy—will be invaluable.

Cost Comparison

Due to the associated overhead of running a training platform and the additional hours of operational training, military GME is more expensive initially compared with civilian outsourcing. In USU, for example, there is an additional 700 hours of operational curriculum alone. This cost difference more than doubles the cost of a USU education vs a Health Professional Scholarship Program (HPSP) scholarship at a civilian medical school. However, a causal analysis performed by the IDA to determine value basis noted that USU graduates deploy almost 3 times as much and serve 6 years longer on active duty.³

After graduating medical school through either accession source, physicians complete specialization training in a GME program. The IDA study noted an average $12,000 increased cost of military GME compared with civilian programs. The analysis included resident compensation and overhead costs of running the program as well as the net cost, which also accounted for resident productivity and workload by training in a military facility.³ Calculations due to mandated budget cuts estimated cost savings of closing the military medical school at < $100 million while significantly impacting the military physician pipeline and operational research output.³

Duplication of Effort

There are already established training programs such as Tactical Combat Casualty Care (TCCC) that could be incorporated into the curriculum to avoid expending additional resources to recreate the wheel. USU has a validated operational training curriculum and may be able to make opportunities available for outside trainees to participate in some of its military-unique training and leadership exercises. Other ways to decrease duplication of effort and improve cost efficiency include focusing on the creation of an academic health system (AHS) and consolidating similar programs to conserve resources. Increasing existing military program sizes will not only ensure the continuation of the military medicine pipeline, but will spread overhead costs over a larger cohort, decrease costs of civilian outsourcing, and ensure the less tangible benefits of military cultural exposure early in trainees’ careers. For example, increasing the class size of USU by 30 students actually reduces the cost per student to $239,000 per year from $253,000, while decreasing the need for HPSP accessions training in civilian programs, making the endeavor overall cost neutral.³

Program Portability

The operational medicine residency has proved that an operational curriculum can be remotely managed and reproduced at a variety of residency specialties.¹² Remote education could be developed and distributed throughout the MHS, such as the proposed USU course Military Medicine and Leadership course.3 Centralized training programs like Global Medicine and C-STARS could be scheduled TDYs during the medical training calendar.

Retention

The military medical school, USU, is the largest military medicine accession source. An IDA report notes that retention of USU graduates is 15.2 years compared with 9.2 years served by civilian trainees. Due to the longevity in service, USU graduates also make up more than 25% of military medical leadership.4 The long-term outcome study that looked at the past 40 years of USU graduates observed that over 70% of graduates served until retirement eligibility and are overrepresented in special operations units.3,13 While some of this longevity may be attributed to the longer USU service contracts, military GME graduates were still noted to be 4 times more likely to commit to a multiyear service contract.¹⁴ A RAND study on the retention of military physicians in the Army, Air Force, and Navy noted that overall retention increased throughout all the services for physicians who went through the military GME pipeline.¹⁵ Conversely, civilian GME training was associated with a 45% chance in leaving active duty.¹⁶

It is theorized that early military acculturation during training increases the likelihood of instilling a sense of mission. Being involved in military GME on the teaching side also showed increased retention rates for 63% of survey respondents.¹⁷ Reduced burnout and increased work satisfaction for those involved in military GME was noted on another faculty satisfaction survey.¹⁷

Sustainability

Programs like USU, which have been around for decades, and the newer operational residency program evolving since 2013 have shown sustainability.^4,11 Dissemination of proven curriculums as well as centralization of already validated training programs can help standardize operational medical training throughout the MHS. In order to flourish at individual programs, the faculty need to be well versed in a train the trainer model and have institutional support. The ability to engage with the line at individual locations may be a factor as well.¹⁸ In regard to research, once residents are taught the principles of scholarly activity, they will have the tools to continue operational medicine research advancements and mentoring students.

Discussion

The 2020 NDAA recommends the establishment of an AHS.3 This step will create a culture of military medical readiness from the top down as congressional mandates push reorganization of the MHS, including military GME programs. An overall restructuring of military medicine will require prioritization of resources toward operational requirements vs the historic significant division of attention to beneficiary care that has caused a lack of unity of effort and additional strain on an already heavily tasked medical force. The changes in military GME are just one aspect of that. It is vital to look at the restructuring with a comprehension of the unique challenges of combat health rather than only from an in-garrison, hospital-based aspect.¹⁹ Benefits of having a military medicine AHS include opportunities to share resources and successful business models as well as foster interdisciplinary teamwork and partnerships with civilian health care facilities and research institutions as a force multiplier.¹⁹

There has been recent discussion about budget cuts, including shutting down USU and military GME and transitioning all training to civilian programs to be cost-effective.⁴ If this were to happen, it would be a step backward from the goal of operational readiness. Maintaining US Department of Defense (DoD) control of the military medicine pipeline has innumerable benefits, including built-in mentorship from operationally-seasoned faculty, military leadership development, proficiency in MHS systems, open communication between GME programs and DoD, and curriculum control to ensure focus on readiness.²⁰ Military GME programs are also a significant production source of military-related scholarly activity. Over fiscal year 2017/2018, 63% of the publications out of the San Antonio Uniformed Services Health Education Consortium—the largest Air Force GME platform and second largest multiservice GME platform—involved military relevant medical topics.¹⁷ Much of the volume of operational research as well as the relevant skills learned and future innovations secondary to conducting this research would be lost if military GME did not exist.^17,21

Practically speaking, military GME provides the majority of the military medicine accessions. For example, a presentation by the Air Force Chief of Physician Education noted that the total military GME pipeline included 2875 students, but direct physician access averaged only 20 physicians a year.²² Even if the decision was made to defer to civilian education, capacity does not exist in civilian GME programs. This is worsened by the increased competitiveness of the GME match with the proliferation of medical schools without concurrent increase in residency spots. The 2018 National Resident Matching Program noted that there were more than 37,103 US and foreign applicants for only 33,000 residency positions, leaving many US applicants unmatched.¹⁷ It is doubtful that the civilian GME programs would be able to absorb the influx of military residents, affecting both the military and civilian medicine pipelines. As a secondary effect, the military treatment centers that house the military GME programs would have to close, with surrounding civilian medical facilities also likely unable to absorb the sudden influx of patients and residents losing the intangible benefits of caring for a military population.¹⁵ This was even recognized by the civilian president of the Accreditation Council for Graduate Medical Education:

Military physicians must be trained in the systems of care that are operative in military medicine, which is significantly unlike civilian medicine in many ways. It is often practiced in circumstances that are not seen in civilian medicine, within care structures that are not encountered in American medical practice… Military medicine has advanced research into the care of individuals suffering traumatic injury, critical care, rehabilitation medicine, prosthetics, psychiatric care of those traumatized, and closed head injury, to name a just a few. The sacrifices of our active military demand these advances, and the American Public benefit from these advances.²¹

Where deficiencies exist in military GME, it is possible to use the growing military-civilian training institution partnerships. Two prime examples are the just-in-time deployment training done with civilian trauma facilities by the Air Force Center for the Sustainment of Trauma Readiness Skills and the Air Force Special Operations Surgical Team-Special Operations Critical Care Evacuation Team being embedded in civilian facilities to maintain trauma, surgical, and emergency care skills. While military physicians can maintain competencies, at the same time, the civilian sector can benefit from the lessons learned in the military in regard to mass casualty and disaster responses. Fostering military and civilian training agreements can also enhance research opportunities.¹

Just as the realities of operational medicine frequently require the military physician to think outside the box, the most successful methods of instruction of military medicine tend to be nontraditional. Classroom education should be involved beyond lectures and can include other methods, such as case-based, role-playing, small group discussion, and computer-based teaching. Maintaining flexibility in live vs distance learning as well as synchronous vs asynchronous learning can expand the capacity of available instructors and standardize material over several sites.²³ Asking learners to consider operational concerns, such as whether certain medical conditions would be compatible with military duty in addition to the routine investigation is an easy way to incorporate military training in preexisting medical training.¹² The advancement of technology has made simulation one of the best ways to engage in hands-on learning, whether through computer simulations, animal models, standardized or moulaged patients, or mannequins that can realistically mimic medical or trauma-related conditions.²⁴ Many times, simulation can be combined with exercises in the field to create a realistic operational environment.²³

There are 3 pillars of an operational curriculum that should be integrated into the existing residency curriculum—operational medicine, leadership, and research principles (Appendix).

Conclusions

Judging by the continuing operational tempo and evolution of warfare, maintaining enhanced military medical readiness will remain a priority. Operational medicine is a unique field that requires specialized preparation. Studies have shown that longitudinal deliberately mapped out curriculums are able to be integrated well into the existing medical curriculum. The recommendation moving forward is increasing the access of existing operational training structures that have well established programs and modeling individual GME program curriculums after those that have shown proven success with a focus on the 3 pillars of operational training, leadership, and research.

Acknowledgments

Previously submitted in April 2020 in expanded form as part of graduation requirements for the Masters of Military Arts and Science degree program at Air University, Maxwell Air Force Base in Alabama.

It is a time of significant change as the Military Health System (MHS) transitions to the purview of the Defense Health Agency (DHA). Additionally, the landscape of combat is ever changing, and military medicine needs to evolve to ensure that the lessons learned are utilized to optimize care of the war fighters. The purpose of this review is to evaluate the available literature on existing operational medicine curriculums and make recommendations to restructure current military medicine training to produce operationally prepared clinicians who are informed in operationally focused research principles.

Operational Medicine

Before diving into the importance of creating a curriculum and investing in training for scholarly activity proficiency, operational medicine needs to be defined. It can be defined as medical care provided in an austere environment with limited resources and possibly under hostile conditions. Another way to look at operational medicine is as the evaluation of normal human physiology and pathology under abnormal conditions. The mission set of each of the services is unique. The Marines and Army may operate forward past the wire vulnerable to the environment, gunfire, and improvised explosive devices, remote from fixed medical facilities. The Navy has divers exposed to the risks of decompression sickness. The Air Force has pilots exposed to altitude changes and strains of G-forces during flight. Locations vary from cold high-altitude mountainous regions to high-temperature desolate deserts. Many times, medical practitioners may be remotely stationed, far from specialty or immediate definitive care. Patient care may consist of low-acuity management of individual patients in sick call to mass casualty events where patient numbers and morbidity may outstrip available resources, making the difficult task of triage necessary.

Despite the challenges of being a uniformed physician, the benefits of being embedded is a better understanding of the roles and capability of the unit. Military physicians need to have the unique knowledge of the type of injuries sustained in that particular theater of war, such as differentiating between the trauma pattern and care required for blast injuries vs high-velocity missiles. There are also chemical, biologic, radiologic, and nuclear threats that military physicians need to recognize. Much of what disables a military fighting force is not a direct relationship to combat-related injuries; however, entire units have been taken down by infectious diarrhea or trench foot. There is also a need for familiarity of the infections and parasitology endemic to the particular theater with the aim of implementation of prevention whenever possible.

Military medicine does not fit in any box. Military physicians need to know the job requirements of various specialties, including elements of occupational medicine, such as aircrew piloting high-performance fighters or ground troops fully loaded with body armor and 80-lb backpacks. There are musculoskeletal injuries from the stressors of various military occupations. Working around weaponry and contact with hostile forces will create scenarios requiring emergent and critical care. In addition to physical injuries, there is the mental strain of combat with the risk of imminent personal injury, the guilt of survivorship, dealing with the scars and permanent physical damage of combat, and prolonged separation from family and other support systems.

The National Defense Authorization Act 2017 mandated the establishment of a standardized process to oversee all military graduate medical education (GME) programs with the goal of ensuring medical operational readiness.¹ This is no small task with > 3000 residents in more than 70 specialties, comprising approximately 12% of US residents.^1,2 Presently, 26 to 32% of the medical corps is enrolled in full-time training compared with 12% of the total force.² With significant time and resources expended during this period, it is vital to maximize the potential of the training.

Literature Review

A literature review was performed, evaluating historical precedence of specialized military medical training and research as well as current operational curriculums. Literature search was conducted in the PubMed and Uniformed Services University (USU) Learning Resource databases using the terms “operational medicine curriculum,” “military medicine curriculum,” “operational medicine training,” “military medicine training,” “operational medicine research,” and “military medicine research,” and included all articles from 1997 to 2020. Inclusion criteria included studies that detailed military medicine training programs and/or outcomes. The source types used in this research project included peer-reviewed journal publications—both review articles and original research—from medical and military journals. The citations of these articles were also reviewed for additional usable publications. Secondary sources included official reports and studies by the RAND Corporation, the US Government Accountability Office, and the Institute for Defense Analysis (IDA). Due to lack of literature on the topic, other sources such as talking papers, letters, and formal presentations from subject matter experts were included to showcase the current state and gaps on this topic. Key findings from peer-reviewed publications are presented in Table 1.

Overall, the literature review showed that longitudinal deliberately mapped out curriculums can be well integrated into the existing medical curriculum.³ The military medicine course topics include environmental medicine, applied field medicine, combat casualty care, medical support planning, mass casualty incident preparation, and military-focused problem solving, decision making, and leadership.⁴

One 1997 study looked at the degree of implementation of military unique curriculum in 18 family medicine residencies. Only 30% of residents stated that their program had a specific operational medicine curriculum.5 Salerno and colleagues surveyed current residents and recently graduated internal medicine physicians at 14 facilities in the Army, Air Force, and Navy to determine confidence level with military medicine. More than half did not feel ready to practice deployment medicine; just 19% felt comfortable treating nuclear, biologic, and chemical warfare injuries; and 32% felt unfamiliar with the command and administrative duties. A subgroup analysis showed that USU graduates felt more prepared in these areas compared with civilian program graduates.6 Additional studies showed perceived smoother transition in the first active-duty tour after participation in an operational curriculum.⁷

In addition to in-program training, other options include operational rotations offsite and military courses conducted outside the GME program.¹² Some of these courses may include just-in-time training such as expeditionary medical support system training prior to scheduled deployments. Examples of experiential training are listed in Table 3.

Critical Analysis 

Current gaps were identified in the military medicine training pipeline’s operational medicine curriculum and research programs. The analysis looked at specific components that make the operational medicine curriculum and research unique as well as current readiness goals, to determine how to best align both to meet the mission requirements. Some factors considered included efficiency, cost, program portability, duplication minimization, retention, and sustainability.

Efficiency

A well-created curriculum that meets objectives will require more than an assigned rotation and a few lectures. The most successful ones in the literature review were the ones that were deliberately planned and longitudinal, such as the ones at USU that combined a mixture of classroom and field exercises over the course of 4 years.^4,8 In that way, the curriculum may not be considered time efficient, but if integrated well into the already existing medical training, the production of military physicians who are mission ready upon graduation—ready to serve as military medical leaders and deploy—will be invaluable.

Cost Comparison

Due to the associated overhead of running a training platform and the additional hours of operational training, military GME is more expensive initially compared with civilian outsourcing. In USU, for example, there is an additional 700 hours of operational curriculum alone. This cost difference more than doubles the cost of a USU education vs a Health Professional Scholarship Program (HPSP) scholarship at a civilian medical school. However, a causal analysis performed by the IDA to determine value basis noted that USU graduates deploy almost 3 times as much and serve 6 years longer on active duty.³

After graduating medical school through either accession source, physicians complete specialization training in a GME program. The IDA study noted an average $12,000 increased cost of military GME compared with civilian programs. The analysis included resident compensation and overhead costs of running the program as well as the net cost, which also accounted for resident productivity and workload by training in a military facility.³ Calculations due to mandated budget cuts estimated cost savings of closing the military medical school at < $100 million while significantly impacting the military physician pipeline and operational research output.³

Duplication of Effort

There are already established training programs such as Tactical Combat Casualty Care (TCCC) that could be incorporated into the curriculum to avoid expending additional resources to recreate the wheel. USU has a validated operational training curriculum and may be able to make opportunities available for outside trainees to participate in some of its military-unique training and leadership exercises. Other ways to decrease duplication of effort and improve cost efficiency include focusing on the creation of an academic health system (AHS) and consolidating similar programs to conserve resources. Increasing existing military program sizes will not only ensure the continuation of the military medicine pipeline, but will spread overhead costs over a larger cohort, decrease costs of civilian outsourcing, and ensure the less tangible benefits of military cultural exposure early in trainees’ careers. For example, increasing the class size of USU by 30 students actually reduces the cost per student to $239,000 per year from $253,000, while decreasing the need for HPSP accessions training in civilian programs, making the endeavor overall cost neutral.³

Program Portability

The operational medicine residency has proved that an operational curriculum can be remotely managed and reproduced at a variety of residency specialties.¹² Remote education could be developed and distributed throughout the MHS, such as the proposed USU course Military Medicine and Leadership course.3 Centralized training programs like Global Medicine and C-STARS could be scheduled TDYs during the medical training calendar.

Retention

The military medical school, USU, is the largest military medicine accession source. An IDA report notes that retention of USU graduates is 15.2 years compared with 9.2 years served by civilian trainees. Due to the longevity in service, USU graduates also make up more than 25% of military medical leadership.4 The long-term outcome study that looked at the past 40 years of USU graduates observed that over 70% of graduates served until retirement eligibility and are overrepresented in special operations units.3,13 While some of this longevity may be attributed to the longer USU service contracts, military GME graduates were still noted to be 4 times more likely to commit to a multiyear service contract.¹⁴ A RAND study on the retention of military physicians in the Army, Air Force, and Navy noted that overall retention increased throughout all the services for physicians who went through the military GME pipeline.¹⁵ Conversely, civilian GME training was associated with a 45% chance in leaving active duty.¹⁶

It is theorized that early military acculturation during training increases the likelihood of instilling a sense of mission. Being involved in military GME on the teaching side also showed increased retention rates for 63% of survey respondents.¹⁷ Reduced burnout and increased work satisfaction for those involved in military GME was noted on another faculty satisfaction survey.¹⁷

Sustainability

Programs like USU, which have been around for decades, and the newer operational residency program evolving since 2013 have shown sustainability.^4,11 Dissemination of proven curriculums as well as centralization of already validated training programs can help standardize operational medical training throughout the MHS. In order to flourish at individual programs, the faculty need to be well versed in a train the trainer model and have institutional support. The ability to engage with the line at individual locations may be a factor as well.¹⁸ In regard to research, once residents are taught the principles of scholarly activity, they will have the tools to continue operational medicine research advancements and mentoring students.

Discussion

The 2020 NDAA recommends the establishment of an AHS.3 This step will create a culture of military medical readiness from the top down as congressional mandates push reorganization of the MHS, including military GME programs. An overall restructuring of military medicine will require prioritization of resources toward operational requirements vs the historic significant division of attention to beneficiary care that has caused a lack of unity of effort and additional strain on an already heavily tasked medical force. The changes in military GME are just one aspect of that. It is vital to look at the restructuring with a comprehension of the unique challenges of combat health rather than only from an in-garrison, hospital-based aspect.¹⁹ Benefits of having a military medicine AHS include opportunities to share resources and successful business models as well as foster interdisciplinary teamwork and partnerships with civilian health care facilities and research institutions as a force multiplier.¹⁹

There has been recent discussion about budget cuts, including shutting down USU and military GME and transitioning all training to civilian programs to be cost-effective.⁴ If this were to happen, it would be a step backward from the goal of operational readiness. Maintaining US Department of Defense (DoD) control of the military medicine pipeline has innumerable benefits, including built-in mentorship from operationally-seasoned faculty, military leadership development, proficiency in MHS systems, open communication between GME programs and DoD, and curriculum control to ensure focus on readiness.²⁰ Military GME programs are also a significant production source of military-related scholarly activity. Over fiscal year 2017/2018, 63% of the publications out of the San Antonio Uniformed Services Health Education Consortium—the largest Air Force GME platform and second largest multiservice GME platform—involved military relevant medical topics.¹⁷ Much of the volume of operational research as well as the relevant skills learned and future innovations secondary to conducting this research would be lost if military GME did not exist.^17,21

Practically speaking, military GME provides the majority of the military medicine accessions. For example, a presentation by the Air Force Chief of Physician Education noted that the total military GME pipeline included 2875 students, but direct physician access averaged only 20 physicians a year.²² Even if the decision was made to defer to civilian education, capacity does not exist in civilian GME programs. This is worsened by the increased competitiveness of the GME match with the proliferation of medical schools without concurrent increase in residency spots. The 2018 National Resident Matching Program noted that there were more than 37,103 US and foreign applicants for only 33,000 residency positions, leaving many US applicants unmatched.¹⁷ It is doubtful that the civilian GME programs would be able to absorb the influx of military residents, affecting both the military and civilian medicine pipelines. As a secondary effect, the military treatment centers that house the military GME programs would have to close, with surrounding civilian medical facilities also likely unable to absorb the sudden influx of patients and residents losing the intangible benefits of caring for a military population.¹⁵ This was even recognized by the civilian president of the Accreditation Council for Graduate Medical Education:

Military physicians must be trained in the systems of care that are operative in military medicine, which is significantly unlike civilian medicine in many ways. It is often practiced in circumstances that are not seen in civilian medicine, within care structures that are not encountered in American medical practice… Military medicine has advanced research into the care of individuals suffering traumatic injury, critical care, rehabilitation medicine, prosthetics, psychiatric care of those traumatized, and closed head injury, to name a just a few. The sacrifices of our active military demand these advances, and the American Public benefit from these advances.²¹

Where deficiencies exist in military GME, it is possible to use the growing military-civilian training institution partnerships. Two prime examples are the just-in-time deployment training done with civilian trauma facilities by the Air Force Center for the Sustainment of Trauma Readiness Skills and the Air Force Special Operations Surgical Team-Special Operations Critical Care Evacuation Team being embedded in civilian facilities to maintain trauma, surgical, and emergency care skills. While military physicians can maintain competencies, at the same time, the civilian sector can benefit from the lessons learned in the military in regard to mass casualty and disaster responses. Fostering military and civilian training agreements can also enhance research opportunities.¹

Just as the realities of operational medicine frequently require the military physician to think outside the box, the most successful methods of instruction of military medicine tend to be nontraditional. Classroom education should be involved beyond lectures and can include other methods, such as case-based, role-playing, small group discussion, and computer-based teaching. Maintaining flexibility in live vs distance learning as well as synchronous vs asynchronous learning can expand the capacity of available instructors and standardize material over several sites.²³ Asking learners to consider operational concerns, such as whether certain medical conditions would be compatible with military duty in addition to the routine investigation is an easy way to incorporate military training in preexisting medical training.¹² The advancement of technology has made simulation one of the best ways to engage in hands-on learning, whether through computer simulations, animal models, standardized or moulaged patients, or mannequins that can realistically mimic medical or trauma-related conditions.²⁴ Many times, simulation can be combined with exercises in the field to create a realistic operational environment.²³

There are 3 pillars of an operational curriculum that should be integrated into the existing residency curriculum—operational medicine, leadership, and research principles (Appendix).

Conclusions

Judging by the continuing operational tempo and evolution of warfare, maintaining enhanced military medical readiness will remain a priority. Operational medicine is a unique field that requires specialized preparation. Studies have shown that longitudinal deliberately mapped out curriculums are able to be integrated well into the existing medical curriculum. The recommendation moving forward is increasing the access of existing operational training structures that have well established programs and modeling individual GME program curriculums after those that have shown proven success with a focus on the 3 pillars of operational training, leadership, and research.

Acknowledgments

Previously submitted in April 2020 in expanded form as part of graduation requirements for the Masters of Military Arts and Science degree program at Air University, Maxwell Air Force Base in Alabama.

To the Editor: September is National Suicide Prevention and Awareness month. In 2021, the US Department of Veterans Affairs (VA) Office of Mental Health and Suicide Prevention marked the month by demonstrating why it is the national visionary when it comes to preventing suicide. The office rolled out several public service announcements (PSAs) about creating “space between thought and trigger.”¹ These incredibly sensitive spots, the first of their kind, encourage safer storage and reduced access to firearms at points of heightened crises. The PSAs are timely, especially given the just released annual report showing that 69.2% of veteran suicide deaths are by firearm.² Wide PSA dissemination is vital.

But concerningly, the PSAs completely missed the importance of critical partnerships. As described in Federal Practitioner 2 years ago, VA forged a groundbreaking collaboration with the National Shooting Sports Foundation (NSSF), the firearms industry trade association, and the American Foundation for Suicide Prevention (AFSP).³ Having NSSF as a partner advanced VA’s effort to ensure that lethal means safety counseling is culturally relevant, comes from a trusted source, and contains no antifirearm bias. Since then, VA and NSSF cobranded billboards in 8 states, encouraging storing firearms responsibly to prevent suicide. They collectively developed an educational, training, and resource toolkit that guides communities through the process of building coalitions to raise awareness about securely storing firearms when not in use.⁴ VA and NSSF have cross-listed safe storage websites. In May 2020, the VA cosponsored a COVID-19 suicide prevention video with the NSSF, AFSP, and the US Concealed Carry Association, including ways that the firearm industry, gun owners, and their families can help.⁵

Yet when the VA launched its PSA campaign last month, NSSF’s name was conspicuously absent. That must be corrected going forward. Reaching vulnerable veterans who own firearms requires partnerships with individuals and groups who own firearms. Going it alone undercuts the essence of what VA has worked so hard to achieve in the past few years.

Russell B. Lemle, PhD
Veterans Healthcare
Policy Institute

To the Editor: September is National Suicide Prevention and Awareness month. In 2021, the US Department of Veterans Affairs (VA) Office of Mental Health and Suicide Prevention marked the month by demonstrating why it is the national visionary when it comes to preventing suicide. The office rolled out several public service announcements (PSAs) about creating “space between thought and trigger.”¹ These incredibly sensitive spots, the first of their kind, encourage safer storage and reduced access to firearms at points of heightened crises. The PSAs are timely, especially given the just released annual report showing that 69.2% of veteran suicide deaths are by firearm.² Wide PSA dissemination is vital.

But concerningly, the PSAs completely missed the importance of critical partnerships. As described in Federal Practitioner 2 years ago, VA forged a groundbreaking collaboration with the National Shooting Sports Foundation (NSSF), the firearms industry trade association, and the American Foundation for Suicide Prevention (AFSP).³ Having NSSF as a partner advanced VA’s effort to ensure that lethal means safety counseling is culturally relevant, comes from a trusted source, and contains no antifirearm bias. Since then, VA and NSSF cobranded billboards in 8 states, encouraging storing firearms responsibly to prevent suicide. They collectively developed an educational, training, and resource toolkit that guides communities through the process of building coalitions to raise awareness about securely storing firearms when not in use.⁴ VA and NSSF have cross-listed safe storage websites. In May 2020, the VA cosponsored a COVID-19 suicide prevention video with the NSSF, AFSP, and the US Concealed Carry Association, including ways that the firearm industry, gun owners, and their families can help.⁵

Yet when the VA launched its PSA campaign last month, NSSF’s name was conspicuously absent. That must be corrected going forward. Reaching vulnerable veterans who own firearms requires partnerships with individuals and groups who own firearms. Going it alone undercuts the essence of what VA has worked so hard to achieve in the past few years.

Russell B. Lemle, PhD
Veterans Healthcare
Policy Institute

To the Editor: September is National Suicide Prevention and Awareness month. In 2021, the US Department of Veterans Affairs (VA) Office of Mental Health and Suicide Prevention marked the month by demonstrating why it is the national visionary when it comes to preventing suicide. The office rolled out several public service announcements (PSAs) about creating “space between thought and trigger.”¹ These incredibly sensitive spots, the first of their kind, encourage safer storage and reduced access to firearms at points of heightened crises. The PSAs are timely, especially given the just released annual report showing that 69.2% of veteran suicide deaths are by firearm.² Wide PSA dissemination is vital.

But concerningly, the PSAs completely missed the importance of critical partnerships. As described in Federal Practitioner 2 years ago, VA forged a groundbreaking collaboration with the National Shooting Sports Foundation (NSSF), the firearms industry trade association, and the American Foundation for Suicide Prevention (AFSP).³ Having NSSF as a partner advanced VA’s effort to ensure that lethal means safety counseling is culturally relevant, comes from a trusted source, and contains no antifirearm bias. Since then, VA and NSSF cobranded billboards in 8 states, encouraging storing firearms responsibly to prevent suicide. They collectively developed an educational, training, and resource toolkit that guides communities through the process of building coalitions to raise awareness about securely storing firearms when not in use.⁴ VA and NSSF have cross-listed safe storage websites. In May 2020, the VA cosponsored a COVID-19 suicide prevention video with the NSSF, AFSP, and the US Concealed Carry Association, including ways that the firearm industry, gun owners, and their families can help.⁵

Yet when the VA launched its PSA campaign last month, NSSF’s name was conspicuously absent. That must be corrected going forward. Reaching vulnerable veterans who own firearms requires partnerships with individuals and groups who own firearms. Going it alone undercuts the essence of what VA has worked so hard to achieve in the past few years.

Russell B. Lemle, PhD
Veterans Healthcare
Policy Institute

A comparison of long-term survival between patients who either did or did not undergo permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) revealed no differences, according to results of the SWEDEHEART observational study.

The nationwide population-based cohort study included all patients who underwent transfemoral TAVR in Sweden from 2008 to 2018.
 

Most frequent complications

While newer-generation aortic valve prostheses are less likely to necessitate PPI, the need for PPI is higher after TAVR than after surgical aortic valve replacement (SAVR), and the need for PPI remains the most frequent complication after TAVR, the study authors noted. Use of self-expandable valves, deep prosthetic valve implantation, preprocedural conduction disturbances, older age, and a high number of comorbidities are among the risk factors for PPI following TAVR.

With prior studies producing conflicting results, the authors stated, the impact of PPI after TAVR remains unknown. Expanding use of TAVR to include younger and low-risk patients with a long life expectancy underscores the importance of gaining greater understand of the impact of PPI after TAVR. Accordingly, the study was conducted to investigate long-term, clinically important outcomes in this post-TAVR population.

Out of 4,750 patients who underwent TAVR in the study period, 3,420 patients in SWEDEHEART met study criteria, with 481 (14.1%) undergoing PPI within 30 days after TAVR, and 2,939 not receiving a pacemaker. PPI exposure was defined as implantation of a permanent pacemaker or implantable cardioverter-defibrillator. The study primary outcome was all-cause mortality, with cardiovascular death, heart failure, and endocarditis as secondary outcomes. It was reported in JACC: Cardiovascular Interventions.
 

Similar survival

Mean patient age was 81.3 years (50.4% female). The rate for all-cause mortality in those with no pacemaker was 11.4 per 100 patient years and 13.1 for those with a pacemaker (hazard ratio, 1.04; 95% confidence interval, 0.89-1.23). The cardiovascular death rate in the no-pacemaker group was 6.0 per 100 patient years and 7.1 per 100 patient years in the pacemaker group (HR, 0.96; 95% CI, 0.75-1.23). For heart failure the rates were 4.5 per 100 patient years in the no pacemaker group and 6.3 in the pacemaker group (HR, 1.22; 95% CI, 0.93-1.672). Endocarditis rates were 1.2 and 1.1 per 100 patient years in the no pacemaker and pacemaker groups, respectively (HR, 0.93; 95% CI, 0.51-1.71).

The authors pointed out that their prior study had found PPI after SAVR in almost 25,000 patients to be associated with increased all-cause mortality and heart failure rates. Patients who undergo TAVR, however, are older and have more comorbidities than patients who undergo SAVR.

It is thus likely that patients who undergo TAVR die of other causes before the negative effects of their pacemaker become clinically evident.

Also, the incidence of conduction abnormalities increases with age, making it more likely that beneficial effects of pacemakers occur in older patients rather than younger ones, counterbalancing the detrimental effects to a larger extent.
 

Reduce PPI rates after TAVR

The study authors also observed that, although they did not find increased mortality or heart failure in patients who underwent PPI, PPI is associated with risks, including lead- and pocket-related complications, other traumatic complications, longer hospital stays and higher societal costs. These factors justify the search for strategies to reduce PPI rates after TAVR.

“Our study adds important information about the prognosis in patients who received a permanent pacemaker implantation following TAVR,” study author Natalie Glaser, MD, PhD, said in an interview. “Increased knowledge about prognosis after TAVR in different patient populations has important implications for preoperative risk stratification and can help to optimize postoperative follow-up and treatment for these patients.” Future studies, Dr. Glaser added, should include younger and low-risk patients with longer follow-up to confirm the present findings. 
 

Balancing factors

In an accompanying editorial, Antonio J. Muñoz-García, MD, PhD, and Erika Muñoz-García, MD also noted factors potentially counterbalancing and masking adverse effects of PPI, echoing some mentioned by the study authors. Among those without PPI, 10%-50% develop new-onset left bundle branch block (LBBB) after TAVR. LBBB is a known marker of low long-term survival in TAVR populations, producing intraventricular dyssynchrony leading potentially to left ventricular dysfunction or development of complete atrioventricular block with higher mortality risk in those without pacemakers. PPI, as well, can be protective against unexpected death in those with advanced conduction disorders. Still, they point out, PPI can entail lead dysfunction, need for generator replacement, infection, and tricuspid valve regurgitation.

Commenting in an interview that an observed trend of a greater increase in events in the group of patients with pacemakers for the first 4 years is consistent with prior studies, Dr. Antonio Muñoz-García said: “This can be explained because long-term survival in the TAVI population is conditioned by comorbidities. It is true that the presence of a pacemaker can cause left ventricular ejection fraction to deteriorate and therefore condition heart failure and increased mortality. But the involvement of the pacemaker in left ventricular function in patients with TAVI is multifactorial and depends on the indication of the pacemaker, whether prophylactic or absolute, on the time-dependent pacing, whether or not the patients prior to TAVI present with alterations in atrioventricular conduction [and therefore could benefit from the implantation of pacemakers], as well as the forms of pacing optimization [resynchronization, hisian pacing, etc]. All of these are issues to be considered in clinical practice.”

The editorialists concluded: “To date, the impact of PPI on late clinical outcomes after TAVR remains controversial; however, this study to some extent helps clarify this controversy.” In accord with the study authors, they called for reductions in PPI rates and long-term clinical follow-up.

The study was funded by several Swedish research organizations. The study investigators and editorial authors declared having no disclosures.

A comparison of long-term survival between patients who either did or did not undergo permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) revealed no differences, according to results of the SWEDEHEART observational study.

The nationwide population-based cohort study included all patients who underwent transfemoral TAVR in Sweden from 2008 to 2018.
 

Most frequent complications

While newer-generation aortic valve prostheses are less likely to necessitate PPI, the need for PPI is higher after TAVR than after surgical aortic valve replacement (SAVR), and the need for PPI remains the most frequent complication after TAVR, the study authors noted. Use of self-expandable valves, deep prosthetic valve implantation, preprocedural conduction disturbances, older age, and a high number of comorbidities are among the risk factors for PPI following TAVR.

With prior studies producing conflicting results, the authors stated, the impact of PPI after TAVR remains unknown. Expanding use of TAVR to include younger and low-risk patients with a long life expectancy underscores the importance of gaining greater understand of the impact of PPI after TAVR. Accordingly, the study was conducted to investigate long-term, clinically important outcomes in this post-TAVR population.

Out of 4,750 patients who underwent TAVR in the study period, 3,420 patients in SWEDEHEART met study criteria, with 481 (14.1%) undergoing PPI within 30 days after TAVR, and 2,939 not receiving a pacemaker. PPI exposure was defined as implantation of a permanent pacemaker or implantable cardioverter-defibrillator. The study primary outcome was all-cause mortality, with cardiovascular death, heart failure, and endocarditis as secondary outcomes. It was reported in JACC: Cardiovascular Interventions.
 

Similar survival

Mean patient age was 81.3 years (50.4% female). The rate for all-cause mortality in those with no pacemaker was 11.4 per 100 patient years and 13.1 for those with a pacemaker (hazard ratio, 1.04; 95% confidence interval, 0.89-1.23). The cardiovascular death rate in the no-pacemaker group was 6.0 per 100 patient years and 7.1 per 100 patient years in the pacemaker group (HR, 0.96; 95% CI, 0.75-1.23). For heart failure the rates were 4.5 per 100 patient years in the no pacemaker group and 6.3 in the pacemaker group (HR, 1.22; 95% CI, 0.93-1.672). Endocarditis rates were 1.2 and 1.1 per 100 patient years in the no pacemaker and pacemaker groups, respectively (HR, 0.93; 95% CI, 0.51-1.71).

The authors pointed out that their prior study had found PPI after SAVR in almost 25,000 patients to be associated with increased all-cause mortality and heart failure rates. Patients who undergo TAVR, however, are older and have more comorbidities than patients who undergo SAVR.

It is thus likely that patients who undergo TAVR die of other causes before the negative effects of their pacemaker become clinically evident.

Also, the incidence of conduction abnormalities increases with age, making it more likely that beneficial effects of pacemakers occur in older patients rather than younger ones, counterbalancing the detrimental effects to a larger extent.
 

Reduce PPI rates after TAVR

The study authors also observed that, although they did not find increased mortality or heart failure in patients who underwent PPI, PPI is associated with risks, including lead- and pocket-related complications, other traumatic complications, longer hospital stays and higher societal costs. These factors justify the search for strategies to reduce PPI rates after TAVR.

“Our study adds important information about the prognosis in patients who received a permanent pacemaker implantation following TAVR,” study author Natalie Glaser, MD, PhD, said in an interview. “Increased knowledge about prognosis after TAVR in different patient populations has important implications for preoperative risk stratification and can help to optimize postoperative follow-up and treatment for these patients.” Future studies, Dr. Glaser added, should include younger and low-risk patients with longer follow-up to confirm the present findings. 
 

Balancing factors

In an accompanying editorial, Antonio J. Muñoz-García, MD, PhD, and Erika Muñoz-García, MD also noted factors potentially counterbalancing and masking adverse effects of PPI, echoing some mentioned by the study authors. Among those without PPI, 10%-50% develop new-onset left bundle branch block (LBBB) after TAVR. LBBB is a known marker of low long-term survival in TAVR populations, producing intraventricular dyssynchrony leading potentially to left ventricular dysfunction or development of complete atrioventricular block with higher mortality risk in those without pacemakers. PPI, as well, can be protective against unexpected death in those with advanced conduction disorders. Still, they point out, PPI can entail lead dysfunction, need for generator replacement, infection, and tricuspid valve regurgitation.

Commenting in an interview that an observed trend of a greater increase in events in the group of patients with pacemakers for the first 4 years is consistent with prior studies, Dr. Antonio Muñoz-García said: “This can be explained because long-term survival in the TAVI population is conditioned by comorbidities. It is true that the presence of a pacemaker can cause left ventricular ejection fraction to deteriorate and therefore condition heart failure and increased mortality. But the involvement of the pacemaker in left ventricular function in patients with TAVI is multifactorial and depends on the indication of the pacemaker, whether prophylactic or absolute, on the time-dependent pacing, whether or not the patients prior to TAVI present with alterations in atrioventricular conduction [and therefore could benefit from the implantation of pacemakers], as well as the forms of pacing optimization [resynchronization, hisian pacing, etc]. All of these are issues to be considered in clinical practice.”

The editorialists concluded: “To date, the impact of PPI on late clinical outcomes after TAVR remains controversial; however, this study to some extent helps clarify this controversy.” In accord with the study authors, they called for reductions in PPI rates and long-term clinical follow-up.

The study was funded by several Swedish research organizations. The study investigators and editorial authors declared having no disclosures.

A comparison of long-term survival between patients who either did or did not undergo permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) revealed no differences, according to results of the SWEDEHEART observational study.

The nationwide population-based cohort study included all patients who underwent transfemoral TAVR in Sweden from 2008 to 2018.
 

Most frequent complications

While newer-generation aortic valve prostheses are less likely to necessitate PPI, the need for PPI is higher after TAVR than after surgical aortic valve replacement (SAVR), and the need for PPI remains the most frequent complication after TAVR, the study authors noted. Use of self-expandable valves, deep prosthetic valve implantation, preprocedural conduction disturbances, older age, and a high number of comorbidities are among the risk factors for PPI following TAVR.

With prior studies producing conflicting results, the authors stated, the impact of PPI after TAVR remains unknown. Expanding use of TAVR to include younger and low-risk patients with a long life expectancy underscores the importance of gaining greater understand of the impact of PPI after TAVR. Accordingly, the study was conducted to investigate long-term, clinically important outcomes in this post-TAVR population.

Out of 4,750 patients who underwent TAVR in the study period, 3,420 patients in SWEDEHEART met study criteria, with 481 (14.1%) undergoing PPI within 30 days after TAVR, and 2,939 not receiving a pacemaker. PPI exposure was defined as implantation of a permanent pacemaker or implantable cardioverter-defibrillator. The study primary outcome was all-cause mortality, with cardiovascular death, heart failure, and endocarditis as secondary outcomes. It was reported in JACC: Cardiovascular Interventions.
 

Similar survival

Mean patient age was 81.3 years (50.4% female). The rate for all-cause mortality in those with no pacemaker was 11.4 per 100 patient years and 13.1 for those with a pacemaker (hazard ratio, 1.04; 95% confidence interval, 0.89-1.23). The cardiovascular death rate in the no-pacemaker group was 6.0 per 100 patient years and 7.1 per 100 patient years in the pacemaker group (HR, 0.96; 95% CI, 0.75-1.23). For heart failure the rates were 4.5 per 100 patient years in the no pacemaker group and 6.3 in the pacemaker group (HR, 1.22; 95% CI, 0.93-1.672). Endocarditis rates were 1.2 and 1.1 per 100 patient years in the no pacemaker and pacemaker groups, respectively (HR, 0.93; 95% CI, 0.51-1.71).

The authors pointed out that their prior study had found PPI after SAVR in almost 25,000 patients to be associated with increased all-cause mortality and heart failure rates. Patients who undergo TAVR, however, are older and have more comorbidities than patients who undergo SAVR.

It is thus likely that patients who undergo TAVR die of other causes before the negative effects of their pacemaker become clinically evident.

Also, the incidence of conduction abnormalities increases with age, making it more likely that beneficial effects of pacemakers occur in older patients rather than younger ones, counterbalancing the detrimental effects to a larger extent.
 

Reduce PPI rates after TAVR

The study authors also observed that, although they did not find increased mortality or heart failure in patients who underwent PPI, PPI is associated with risks, including lead- and pocket-related complications, other traumatic complications, longer hospital stays and higher societal costs. These factors justify the search for strategies to reduce PPI rates after TAVR.

“Our study adds important information about the prognosis in patients who received a permanent pacemaker implantation following TAVR,” study author Natalie Glaser, MD, PhD, said in an interview. “Increased knowledge about prognosis after TAVR in different patient populations has important implications for preoperative risk stratification and can help to optimize postoperative follow-up and treatment for these patients.” Future studies, Dr. Glaser added, should include younger and low-risk patients with longer follow-up to confirm the present findings. 
 

Balancing factors

In an accompanying editorial, Antonio J. Muñoz-García, MD, PhD, and Erika Muñoz-García, MD also noted factors potentially counterbalancing and masking adverse effects of PPI, echoing some mentioned by the study authors. Among those without PPI, 10%-50% develop new-onset left bundle branch block (LBBB) after TAVR. LBBB is a known marker of low long-term survival in TAVR populations, producing intraventricular dyssynchrony leading potentially to left ventricular dysfunction or development of complete atrioventricular block with higher mortality risk in those without pacemakers. PPI, as well, can be protective against unexpected death in those with advanced conduction disorders. Still, they point out, PPI can entail lead dysfunction, need for generator replacement, infection, and tricuspid valve regurgitation.

Commenting in an interview that an observed trend of a greater increase in events in the group of patients with pacemakers for the first 4 years is consistent with prior studies, Dr. Antonio Muñoz-García said: “This can be explained because long-term survival in the TAVI population is conditioned by comorbidities. It is true that the presence of a pacemaker can cause left ventricular ejection fraction to deteriorate and therefore condition heart failure and increased mortality. But the involvement of the pacemaker in left ventricular function in patients with TAVI is multifactorial and depends on the indication of the pacemaker, whether prophylactic or absolute, on the time-dependent pacing, whether or not the patients prior to TAVI present with alterations in atrioventricular conduction [and therefore could benefit from the implantation of pacemakers], as well as the forms of pacing optimization [resynchronization, hisian pacing, etc]. All of these are issues to be considered in clinical practice.”

The editorialists concluded: “To date, the impact of PPI on late clinical outcomes after TAVR remains controversial; however, this study to some extent helps clarify this controversy.” In accord with the study authors, they called for reductions in PPI rates and long-term clinical follow-up.

The study was funded by several Swedish research organizations. The study investigators and editorial authors declared having no disclosures.

Hot flashes affect three out of four women and can last 7-10 years, but the current standard of care treatment isn’t necessarily appropriate for all women who experience vasomotor symptoms, according to Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health Clinic in Jacksonville, Fla.

For the majority of women under age 60 who are within 10 years of menopause, hormone therapy currently remains the most effective management option for hot flashes where the benefits outweigh the risks, Dr. Faubion told attendees Sept. 25 during a plenary at the annual meeting of the North American Menopause Society. “But really, individualizing treatment is the goal, and there are some women who are going to need some other options.”

Contraindications for hormone therapy include having a history of breast cancer, coronary heart disease, active liver disease, unexplained vaginal bleeding, high-risk endometrial cancer, transient ischemic attack, and a previous venous thromboembolic event or stroke.

“Fortunately, we have things in development,” Dr. Faubion said. She reviewed a wide range of therapies that are not currently Food and Drug Administration approved for vasomotor symptoms but are either available off label or are in clinical trials.

One of these is oxybutynin, an antimuscarinic, anticholinergic agent currently used to treat overactive bladder and overactive sweating. In a 2016 trial, 73% of women taking 15 mg extended-release oxybutynin once daily rated their symptoms as “much better,” compared with 26% who received placebo. The women experienced reduced frequency and severity of hot flashes and better sleep.

Subsequent research found a 60% reduction in hot flash frequency with 2.5 mg twice a day and a 77% reduction with 5 mg twice a day, compared with a 27% reduction with placebo. The only reported side effect that occurred more often with oxybutynin was dry mouth, but there were no significant differences in reasons for discontinuation between the treatment and placebo groups.

There are, however, some potential long-term cognitive effects from oxybutynin, Dr. Faubion said. Some research has shown an increased risk of dementia from oxybutynin and from an overall higher cumulative use of anticholinergics.

“There’s some concern about that for long-term use,” she said, but it’s effective, it’s “probably not harmful [when] used short term in women with significant, bothersome hot flashes who are unwilling or unable to use hormone therapy, and the adverse effects are tolerable for most women.” Women with bladder symptoms would be especially ideal candidates since the drug already treats those.

Dr. Faubion then discussed a new estrogen called estetrol (E4), a naturally occurring estrogen with selection action in tissues that is produced by the fetal liver and crosses the placenta. It has a long half-life of 28-32 hours, and its potential mechanism may give it a different safety profile than estradiol (E2). “There may be a lower risk of drug-drug interactions; lower breast stimulation, pain or carcinogenic impact; lower impact on triglycerides; and a neutral impact on markers of coagulation,” she said.

Though estetrol was recently approved as an oral contraceptive under the name Estelle, it’s also under investigation as a postmenopausal regimen. Preliminary findings suggest it reduces vasomotor symptom severity by 44%, compared with 30% with placebo, at 15 mg, the apparent minimum effective dose. The safety profile showed no endometrial hyperplasia and no unexpected adverse events. In those taking 15 mg of estetrol, mean endometrial thickness increased from 2 to 6 mm but returned to baseline after progestin therapy.

“The 15-mg dose also positively influenced markers of bone turnover, increased HDL [cholesterol], improved glucose tolerance,” and had no effects on coagulation parameters or triglycerides, Dr. Faubion added.

Another group of potential agents being studied for hot flashes are NK3 antagonists, which aim to exploit the recent discovery that kisspeptin, neurokinin B, and dynorphin (KNDy) neurons may play an important role in the etiology of vasomotor symptoms. Development of one of these, MLE 4901, was halted despite a 45% reduction in hot flashes because 3 of 28 women developed transiently elevated liver function tests, about four to six times the upper limit of normal.

Two others, fezolinetant and NT-814, are in phase 2 trials and have shown a significant reduction in symptoms, compared with placebo. The most commonly reported adverse effect in the phase 2a trial was gastrointestinal effects, but none of the participants stopped the drug because of these, and no elevated liver tests occurred. In the larger phase 2b trial, the most commonly reported treatment-emergent adverse events included nausea, diarrhea, fatigue, urinary tract infection, sinusitis, upper respiratory infection, headache, and cough. Five women discontinued the drug because of elevated liver enzymes.

“Overall, NK3 inhibitors appear to be generally well tolerated,” Dr. Faubion said. “There does seem to be mild transaminase elevation,” though it’s not yet known if this is an effect from this class of drugs as a whole. She noted that follicle-stimulating hormone does not significantly increase, which is important because elevated FSH is associated with poor bone health, nor does estradiol significantly increase, which is clinically relevant for women at high risk of breast cancer.

“We don’t know the effects on the heart, the brain, the bone, mood, weight, or sexual health, so there’s a lot that is still not known,” Dr. Faubion said. “We still don’t know about long-term safety and efficacy with these chemical compounds,” but clinical trials of them are ongoing.

They “would be a welcome alternative to hormone therapy for those who can’t or prefer not to use a hormonal option,” Dr. Faubion said. “However, we may need broad education of clinicians to caution against widespread abandonment of hormone therapy, particularly in women with premature or early menopause.”

Donna Klassen, LCSW, the cofounder of Let’s Talk Menopause, asked whether any of these new therapies were being tested in women with breast cancer and whether anything was known about taking oxybutynin at the same time as letrozole.

“I suspect that most women with chronic diseases would have been excluded from these initial studies, but I can’t speak to that,” Dr. Faubion said, and she wasn’t aware of any data related to taking oxybutynin and letrozole concurrently.

James Simon, MD, medical director and founder of IntimMedicine and one of those who led the research on oxybutynin, responded that his trials excluded breast cancer survivors and anyone taking aromatase inhibitors.

“It will be unlikely that, in the very near future, that data will be available because all the clinical developments on these NK3s or KNDy neuron-modulating drugs exclude cancer patients,” Dr. Simon said.

However, another attendee, Lisa Larkin, MD, of Cincinnati, introduced herself as a breast cancer survivor who takes tamoxifen and said she feels “completely comfortable” prescribing oxybutynin to breast cancer survivors.

“In terms of side effects and effectiveness in patients on tamoxifen and aromatase inhibitors, I’ve had incredibly good luck with it, and I think it’s underutilized,” Dr. Larkin said. “The clinical pearl I would tell you is you can start really low, and the dry mouth really seems to improve with time.” She added that patients should be informed that it takes 2 weeks before it begins working, but the side effects eventually go away. “It becomes very tolerable, so I just encourage all of you to consider it as another great option.”

Dr. Faubion had no disclosures. Disclosure information was unavailable for Dr. Simon, Dr. Larkin, and Ms. Klassen.

Hot flashes affect three out of four women and can last 7-10 years, but the current standard of care treatment isn’t necessarily appropriate for all women who experience vasomotor symptoms, according to Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health Clinic in Jacksonville, Fla.

For the majority of women under age 60 who are within 10 years of menopause, hormone therapy currently remains the most effective management option for hot flashes where the benefits outweigh the risks, Dr. Faubion told attendees Sept. 25 during a plenary at the annual meeting of the North American Menopause Society. “But really, individualizing treatment is the goal, and there are some women who are going to need some other options.”

Contraindications for hormone therapy include having a history of breast cancer, coronary heart disease, active liver disease, unexplained vaginal bleeding, high-risk endometrial cancer, transient ischemic attack, and a previous venous thromboembolic event or stroke.

“Fortunately, we have things in development,” Dr. Faubion said. She reviewed a wide range of therapies that are not currently Food and Drug Administration approved for vasomotor symptoms but are either available off label or are in clinical trials.

One of these is oxybutynin, an antimuscarinic, anticholinergic agent currently used to treat overactive bladder and overactive sweating. In a 2016 trial, 73% of women taking 15 mg extended-release oxybutynin once daily rated their symptoms as “much better,” compared with 26% who received placebo. The women experienced reduced frequency and severity of hot flashes and better sleep.

Subsequent research found a 60% reduction in hot flash frequency with 2.5 mg twice a day and a 77% reduction with 5 mg twice a day, compared with a 27% reduction with placebo. The only reported side effect that occurred more often with oxybutynin was dry mouth, but there were no significant differences in reasons for discontinuation between the treatment and placebo groups.

There are, however, some potential long-term cognitive effects from oxybutynin, Dr. Faubion said. Some research has shown an increased risk of dementia from oxybutynin and from an overall higher cumulative use of anticholinergics.

“There’s some concern about that for long-term use,” she said, but it’s effective, it’s “probably not harmful [when] used short term in women with significant, bothersome hot flashes who are unwilling or unable to use hormone therapy, and the adverse effects are tolerable for most women.” Women with bladder symptoms would be especially ideal candidates since the drug already treats those.

Dr. Faubion then discussed a new estrogen called estetrol (E4), a naturally occurring estrogen with selection action in tissues that is produced by the fetal liver and crosses the placenta. It has a long half-life of 28-32 hours, and its potential mechanism may give it a different safety profile than estradiol (E2). “There may be a lower risk of drug-drug interactions; lower breast stimulation, pain or carcinogenic impact; lower impact on triglycerides; and a neutral impact on markers of coagulation,” she said.

Though estetrol was recently approved as an oral contraceptive under the name Estelle, it’s also under investigation as a postmenopausal regimen. Preliminary findings suggest it reduces vasomotor symptom severity by 44%, compared with 30% with placebo, at 15 mg, the apparent minimum effective dose. The safety profile showed no endometrial hyperplasia and no unexpected adverse events. In those taking 15 mg of estetrol, mean endometrial thickness increased from 2 to 6 mm but returned to baseline after progestin therapy.

“The 15-mg dose also positively influenced markers of bone turnover, increased HDL [cholesterol], improved glucose tolerance,” and had no effects on coagulation parameters or triglycerides, Dr. Faubion added.

Another group of potential agents being studied for hot flashes are NK3 antagonists, which aim to exploit the recent discovery that kisspeptin, neurokinin B, and dynorphin (KNDy) neurons may play an important role in the etiology of vasomotor symptoms. Development of one of these, MLE 4901, was halted despite a 45% reduction in hot flashes because 3 of 28 women developed transiently elevated liver function tests, about four to six times the upper limit of normal.

Two others, fezolinetant and NT-814, are in phase 2 trials and have shown a significant reduction in symptoms, compared with placebo. The most commonly reported adverse effect in the phase 2a trial was gastrointestinal effects, but none of the participants stopped the drug because of these, and no elevated liver tests occurred. In the larger phase 2b trial, the most commonly reported treatment-emergent adverse events included nausea, diarrhea, fatigue, urinary tract infection, sinusitis, upper respiratory infection, headache, and cough. Five women discontinued the drug because of elevated liver enzymes.

“Overall, NK3 inhibitors appear to be generally well tolerated,” Dr. Faubion said. “There does seem to be mild transaminase elevation,” though it’s not yet known if this is an effect from this class of drugs as a whole. She noted that follicle-stimulating hormone does not significantly increase, which is important because elevated FSH is associated with poor bone health, nor does estradiol significantly increase, which is clinically relevant for women at high risk of breast cancer.

“We don’t know the effects on the heart, the brain, the bone, mood, weight, or sexual health, so there’s a lot that is still not known,” Dr. Faubion said. “We still don’t know about long-term safety and efficacy with these chemical compounds,” but clinical trials of them are ongoing.

They “would be a welcome alternative to hormone therapy for those who can’t or prefer not to use a hormonal option,” Dr. Faubion said. “However, we may need broad education of clinicians to caution against widespread abandonment of hormone therapy, particularly in women with premature or early menopause.”

Donna Klassen, LCSW, the cofounder of Let’s Talk Menopause, asked whether any of these new therapies were being tested in women with breast cancer and whether anything was known about taking oxybutynin at the same time as letrozole.

“I suspect that most women with chronic diseases would have been excluded from these initial studies, but I can’t speak to that,” Dr. Faubion said, and she wasn’t aware of any data related to taking oxybutynin and letrozole concurrently.

James Simon, MD, medical director and founder of IntimMedicine and one of those who led the research on oxybutynin, responded that his trials excluded breast cancer survivors and anyone taking aromatase inhibitors.

“It will be unlikely that, in the very near future, that data will be available because all the clinical developments on these NK3s or KNDy neuron-modulating drugs exclude cancer patients,” Dr. Simon said.

However, another attendee, Lisa Larkin, MD, of Cincinnati, introduced herself as a breast cancer survivor who takes tamoxifen and said she feels “completely comfortable” prescribing oxybutynin to breast cancer survivors.

“In terms of side effects and effectiveness in patients on tamoxifen and aromatase inhibitors, I’ve had incredibly good luck with it, and I think it’s underutilized,” Dr. Larkin said. “The clinical pearl I would tell you is you can start really low, and the dry mouth really seems to improve with time.” She added that patients should be informed that it takes 2 weeks before it begins working, but the side effects eventually go away. “It becomes very tolerable, so I just encourage all of you to consider it as another great option.”

Dr. Faubion had no disclosures. Disclosure information was unavailable for Dr. Simon, Dr. Larkin, and Ms. Klassen.

Hot flashes affect three out of four women and can last 7-10 years, but the current standard of care treatment isn’t necessarily appropriate for all women who experience vasomotor symptoms, according to Stephanie Faubion, MD, MBA, director of the Mayo Clinic Women’s Health Clinic in Jacksonville, Fla.

For the majority of women under age 60 who are within 10 years of menopause, hormone therapy currently remains the most effective management option for hot flashes where the benefits outweigh the risks, Dr. Faubion told attendees Sept. 25 during a plenary at the annual meeting of the North American Menopause Society. “But really, individualizing treatment is the goal, and there are some women who are going to need some other options.”

Contraindications for hormone therapy include having a history of breast cancer, coronary heart disease, active liver disease, unexplained vaginal bleeding, high-risk endometrial cancer, transient ischemic attack, and a previous venous thromboembolic event or stroke.

“Fortunately, we have things in development,” Dr. Faubion said. She reviewed a wide range of therapies that are not currently Food and Drug Administration approved for vasomotor symptoms but are either available off label or are in clinical trials.

One of these is oxybutynin, an antimuscarinic, anticholinergic agent currently used to treat overactive bladder and overactive sweating. In a 2016 trial, 73% of women taking 15 mg extended-release oxybutynin once daily rated their symptoms as “much better,” compared with 26% who received placebo. The women experienced reduced frequency and severity of hot flashes and better sleep.

Subsequent research found a 60% reduction in hot flash frequency with 2.5 mg twice a day and a 77% reduction with 5 mg twice a day, compared with a 27% reduction with placebo. The only reported side effect that occurred more often with oxybutynin was dry mouth, but there were no significant differences in reasons for discontinuation between the treatment and placebo groups.

There are, however, some potential long-term cognitive effects from oxybutynin, Dr. Faubion said. Some research has shown an increased risk of dementia from oxybutynin and from an overall higher cumulative use of anticholinergics.

“There’s some concern about that for long-term use,” she said, but it’s effective, it’s “probably not harmful [when] used short term in women with significant, bothersome hot flashes who are unwilling or unable to use hormone therapy, and the adverse effects are tolerable for most women.” Women with bladder symptoms would be especially ideal candidates since the drug already treats those.

Dr. Faubion then discussed a new estrogen called estetrol (E4), a naturally occurring estrogen with selection action in tissues that is produced by the fetal liver and crosses the placenta. It has a long half-life of 28-32 hours, and its potential mechanism may give it a different safety profile than estradiol (E2). “There may be a lower risk of drug-drug interactions; lower breast stimulation, pain or carcinogenic impact; lower impact on triglycerides; and a neutral impact on markers of coagulation,” she said.

Though estetrol was recently approved as an oral contraceptive under the name Estelle, it’s also under investigation as a postmenopausal regimen. Preliminary findings suggest it reduces vasomotor symptom severity by 44%, compared with 30% with placebo, at 15 mg, the apparent minimum effective dose. The safety profile showed no endometrial hyperplasia and no unexpected adverse events. In those taking 15 mg of estetrol, mean endometrial thickness increased from 2 to 6 mm but returned to baseline after progestin therapy.

“The 15-mg dose also positively influenced markers of bone turnover, increased HDL [cholesterol], improved glucose tolerance,” and had no effects on coagulation parameters or triglycerides, Dr. Faubion added.

Another group of potential agents being studied for hot flashes are NK3 antagonists, which aim to exploit the recent discovery that kisspeptin, neurokinin B, and dynorphin (KNDy) neurons may play an important role in the etiology of vasomotor symptoms. Development of one of these, MLE 4901, was halted despite a 45% reduction in hot flashes because 3 of 28 women developed transiently elevated liver function tests, about four to six times the upper limit of normal.

Two others, fezolinetant and NT-814, are in phase 2 trials and have shown a significant reduction in symptoms, compared with placebo. The most commonly reported adverse effect in the phase 2a trial was gastrointestinal effects, but none of the participants stopped the drug because of these, and no elevated liver tests occurred. In the larger phase 2b trial, the most commonly reported treatment-emergent adverse events included nausea, diarrhea, fatigue, urinary tract infection, sinusitis, upper respiratory infection, headache, and cough. Five women discontinued the drug because of elevated liver enzymes.

“Overall, NK3 inhibitors appear to be generally well tolerated,” Dr. Faubion said. “There does seem to be mild transaminase elevation,” though it’s not yet known if this is an effect from this class of drugs as a whole. She noted that follicle-stimulating hormone does not significantly increase, which is important because elevated FSH is associated with poor bone health, nor does estradiol significantly increase, which is clinically relevant for women at high risk of breast cancer.

“We don’t know the effects on the heart, the brain, the bone, mood, weight, or sexual health, so there’s a lot that is still not known,” Dr. Faubion said. “We still don’t know about long-term safety and efficacy with these chemical compounds,” but clinical trials of them are ongoing.

They “would be a welcome alternative to hormone therapy for those who can’t or prefer not to use a hormonal option,” Dr. Faubion said. “However, we may need broad education of clinicians to caution against widespread abandonment of hormone therapy, particularly in women with premature or early menopause.”

Donna Klassen, LCSW, the cofounder of Let’s Talk Menopause, asked whether any of these new therapies were being tested in women with breast cancer and whether anything was known about taking oxybutynin at the same time as letrozole.

“I suspect that most women with chronic diseases would have been excluded from these initial studies, but I can’t speak to that,” Dr. Faubion said, and she wasn’t aware of any data related to taking oxybutynin and letrozole concurrently.

James Simon, MD, medical director and founder of IntimMedicine and one of those who led the research on oxybutynin, responded that his trials excluded breast cancer survivors and anyone taking aromatase inhibitors.

“It will be unlikely that, in the very near future, that data will be available because all the clinical developments on these NK3s or KNDy neuron-modulating drugs exclude cancer patients,” Dr. Simon said.

However, another attendee, Lisa Larkin, MD, of Cincinnati, introduced herself as a breast cancer survivor who takes tamoxifen and said she feels “completely comfortable” prescribing oxybutynin to breast cancer survivors.

“In terms of side effects and effectiveness in patients on tamoxifen and aromatase inhibitors, I’ve had incredibly good luck with it, and I think it’s underutilized,” Dr. Larkin said. “The clinical pearl I would tell you is you can start really low, and the dry mouth really seems to improve with time.” She added that patients should be informed that it takes 2 weeks before it begins working, but the side effects eventually go away. “It becomes very tolerable, so I just encourage all of you to consider it as another great option.”

Dr. Faubion had no disclosures. Disclosure information was unavailable for Dr. Simon, Dr. Larkin, and Ms. Klassen.

A year into the COVID-19 pandemic, the share of the U.S. adult population reporting symptoms of elevated depression had more than tripled from prepandemic levels and worsened significantly since restrictions went into effect, a study of more than 1,000 adults surveyed at the start of the pandemic and 1 year into it has reported.

The study also found that younger adults, people with lower incomes and savings, unmarried people, and those exposed to multiple stress factors were most vulnerable to elevated levels of depression through the first year of the pandemic.

“The pandemic has been an ongoing exposure,” lead author Catherine K. Ettman, a PhD candidate at Brown University, Providence, R.I., said in an interview. “Mental health is sensitive to economic and social conditions. While living conditions have improved for some people over the last 12 months, the pandemic has been disruptive to life and economic well-being for many,” said Ms. Ettman, who is also chief of staff and director of strategic initiatives in the office of the dean at Boston University. Her study was published in Lancet Regional Health – Americas.

Ms. Ettman and coauthors reported that 32.8% (95% confidence interval, 29.1%-36.8%) of surveyed adults had elevated depressive symptoms in 2021, compared with 27.8% (95% CI, 24.9%-30.9%) in the early months of the pandemic in 2020 (P = .0016). That compares with a rate of 8.5% before the pandemic, a figure based on a prepandemic sample of 5,065 patients from the National Health and Nutrition Examination Survey reported previously by Ms. Ettman and associates.

“The COVID-19 pandemic and its economic consequences have displaced social networks, created ongoing stressors, and reduced access to the resources that protect mental health,” Ms. Ettman said.
 

Four groups most affected

In this latest research, a longitudinal panel study of a nationally representative group of U.S. adults, the researchers surveyed participants in March and April 2020 (n = 1,414) and the same group again in March and April 2021 (n = 1,161). The participants completed the Patient Health Questionnaire–9 (PHQ-9) and were enrolled in the COVID-19 and Life Stressors Impact on Mental Health and Well-Being study.

The study found that elevated depressive symptoms were most prevalent in four groups:

• Younger patients, with 43.9% of patients aged 18-39 years self-reporting elevated depressive symptoms, compared with 32.4% of those aged 40-59, and 19.1% of patients aged 60 and older.
• People with lower incomes, with 58.1% of people making $19,999 or less reporting elevated symptoms, compared with 41.3% of those making $20,000-$44,999, 31.4% of people making $45,000-$74,999, and 14.1% of those making $75,000 or more.
• People with less than $5,000 in family savings, with a rate of 51.1%, compared with 24.2% of those with more than that.
• People never married, with a rate of 39.8% versus 37.7% of those living with a partner; 31.5% widowed, divorced, or separated; and 18.3% married.

The study also found correlations between the number of self-reported stressors and elevated depression symptoms: a rate of 51.1% in people with four or more stressors; 25.8% in those with two or three stressors; and 17% in people with one or no stressors.

Among the groups reporting the lowest rates of depressive symptoms in 2021 were people making more than $75,000 a year; those with one or no COVID-19 stressors; and non-Hispanic Asian persons.

“Stressors such as difficulties finding childcare, difficulties paying for housing, and job loss were associated with greater depression 12 months into the COVID-19 pandemic,” Ms. Ettman said. “Efforts to address stressors and improve access to childcare, housing, employment, and fair wages can improve mental health.”

The duration of the pandemic is another explanation for the significant rise in depressive symptoms, senior author Sandro Galea, MD, MPH, DrPH, said in an interview. “The COVID-19 pandemic is different from other traumatic events in its ongoing length, in its widespread reach, and in its inequities,” Dr. Galea added. “Unlike acute traumatic events, the COVID-19 pandemic has been ongoing.”

He said clinicians, public health officials, and policy makers need to be aware of the impact COVID-19 has had on mental health. “We can take steps as a society to treat and prevent depression and create conditions that allow all populations to be healthy,” said Dr. Galea, who is dean and a professor of family medicine at Boston University.
 

Age of sample cited as limitation

The study builds on existing evidence linking depression trends and the COVID-19 pandemic, David Puder, MD, a medical director at Loma Linda (Calif.) University, said in an interview. However, he noted it had some limitations. “The age range is only 18 and older, so we don’t get to see what is happening with a highly impacted group of students who have not been able to go to school and be with their friends during COVID,” said Dr. Puder, who also hosts the podcast “Psychiatry & Psychotherapy.” “Further, the PHQ-9 is often a screening tool for depression and is not best used for changes in mental health over time.”

At the same time, Dr. Puder said, one of the study’s strengths was that it showed how depressive symptoms increased during the COVID lockdown. “It shows certain groups are at higher risk, including those with less financial resources and those with higher amounts of stress,” Dr. Puder said.

Ms. Ettman, Dr. Galea, and Dr. Puder reported no relevant disclosures.

A year into the COVID-19 pandemic, the share of the U.S. adult population reporting symptoms of elevated depression had more than tripled from prepandemic levels and worsened significantly since restrictions went into effect, a study of more than 1,000 adults surveyed at the start of the pandemic and 1 year into it has reported.

The study also found that younger adults, people with lower incomes and savings, unmarried people, and those exposed to multiple stress factors were most vulnerable to elevated levels of depression through the first year of the pandemic.

“The pandemic has been an ongoing exposure,” lead author Catherine K. Ettman, a PhD candidate at Brown University, Providence, R.I., said in an interview. “Mental health is sensitive to economic and social conditions. While living conditions have improved for some people over the last 12 months, the pandemic has been disruptive to life and economic well-being for many,” said Ms. Ettman, who is also chief of staff and director of strategic initiatives in the office of the dean at Boston University. Her study was published in Lancet Regional Health – Americas.

Ms. Ettman and coauthors reported that 32.8% (95% confidence interval, 29.1%-36.8%) of surveyed adults had elevated depressive symptoms in 2021, compared with 27.8% (95% CI, 24.9%-30.9%) in the early months of the pandemic in 2020 (P = .0016). That compares with a rate of 8.5% before the pandemic, a figure based on a prepandemic sample of 5,065 patients from the National Health and Nutrition Examination Survey reported previously by Ms. Ettman and associates.

“The COVID-19 pandemic and its economic consequences have displaced social networks, created ongoing stressors, and reduced access to the resources that protect mental health,” Ms. Ettman said.
 

Four groups most affected

In this latest research, a longitudinal panel study of a nationally representative group of U.S. adults, the researchers surveyed participants in March and April 2020 (n = 1,414) and the same group again in March and April 2021 (n = 1,161). The participants completed the Patient Health Questionnaire–9 (PHQ-9) and were enrolled in the COVID-19 and Life Stressors Impact on Mental Health and Well-Being study.

The study found that elevated depressive symptoms were most prevalent in four groups:

• Younger patients, with 43.9% of patients aged 18-39 years self-reporting elevated depressive symptoms, compared with 32.4% of those aged 40-59, and 19.1% of patients aged 60 and older.
• People with lower incomes, with 58.1% of people making $19,999 or less reporting elevated symptoms, compared with 41.3% of those making $20,000-$44,999, 31.4% of people making $45,000-$74,999, and 14.1% of those making $75,000 or more.
• People with less than $5,000 in family savings, with a rate of 51.1%, compared with 24.2% of those with more than that.
• People never married, with a rate of 39.8% versus 37.7% of those living with a partner; 31.5% widowed, divorced, or separated; and 18.3% married.

The study also found correlations between the number of self-reported stressors and elevated depression symptoms: a rate of 51.1% in people with four or more stressors; 25.8% in those with two or three stressors; and 17% in people with one or no stressors.

Among the groups reporting the lowest rates of depressive symptoms in 2021 were people making more than $75,000 a year; those with one or no COVID-19 stressors; and non-Hispanic Asian persons.

“Stressors such as difficulties finding childcare, difficulties paying for housing, and job loss were associated with greater depression 12 months into the COVID-19 pandemic,” Ms. Ettman said. “Efforts to address stressors and improve access to childcare, housing, employment, and fair wages can improve mental health.”

The duration of the pandemic is another explanation for the significant rise in depressive symptoms, senior author Sandro Galea, MD, MPH, DrPH, said in an interview. “The COVID-19 pandemic is different from other traumatic events in its ongoing length, in its widespread reach, and in its inequities,” Dr. Galea added. “Unlike acute traumatic events, the COVID-19 pandemic has been ongoing.”

He said clinicians, public health officials, and policy makers need to be aware of the impact COVID-19 has had on mental health. “We can take steps as a society to treat and prevent depression and create conditions that allow all populations to be healthy,” said Dr. Galea, who is dean and a professor of family medicine at Boston University.
 

Age of sample cited as limitation

The study builds on existing evidence linking depression trends and the COVID-19 pandemic, David Puder, MD, a medical director at Loma Linda (Calif.) University, said in an interview. However, he noted it had some limitations. “The age range is only 18 and older, so we don’t get to see what is happening with a highly impacted group of students who have not been able to go to school and be with their friends during COVID,” said Dr. Puder, who also hosts the podcast “Psychiatry & Psychotherapy.” “Further, the PHQ-9 is often a screening tool for depression and is not best used for changes in mental health over time.”

At the same time, Dr. Puder said, one of the study’s strengths was that it showed how depressive symptoms increased during the COVID lockdown. “It shows certain groups are at higher risk, including those with less financial resources and those with higher amounts of stress,” Dr. Puder said.

Ms. Ettman, Dr. Galea, and Dr. Puder reported no relevant disclosures.

A year into the COVID-19 pandemic, the share of the U.S. adult population reporting symptoms of elevated depression had more than tripled from prepandemic levels and worsened significantly since restrictions went into effect, a study of more than 1,000 adults surveyed at the start of the pandemic and 1 year into it has reported.

The study also found that younger adults, people with lower incomes and savings, unmarried people, and those exposed to multiple stress factors were most vulnerable to elevated levels of depression through the first year of the pandemic.

“The pandemic has been an ongoing exposure,” lead author Catherine K. Ettman, a PhD candidate at Brown University, Providence, R.I., said in an interview. “Mental health is sensitive to economic and social conditions. While living conditions have improved for some people over the last 12 months, the pandemic has been disruptive to life and economic well-being for many,” said Ms. Ettman, who is also chief of staff and director of strategic initiatives in the office of the dean at Boston University. Her study was published in Lancet Regional Health – Americas.

Ms. Ettman and coauthors reported that 32.8% (95% confidence interval, 29.1%-36.8%) of surveyed adults had elevated depressive symptoms in 2021, compared with 27.8% (95% CI, 24.9%-30.9%) in the early months of the pandemic in 2020 (P = .0016). That compares with a rate of 8.5% before the pandemic, a figure based on a prepandemic sample of 5,065 patients from the National Health and Nutrition Examination Survey reported previously by Ms. Ettman and associates.

“The COVID-19 pandemic and its economic consequences have displaced social networks, created ongoing stressors, and reduced access to the resources that protect mental health,” Ms. Ettman said.
 

Four groups most affected

In this latest research, a longitudinal panel study of a nationally representative group of U.S. adults, the researchers surveyed participants in March and April 2020 (n = 1,414) and the same group again in March and April 2021 (n = 1,161). The participants completed the Patient Health Questionnaire–9 (PHQ-9) and were enrolled in the COVID-19 and Life Stressors Impact on Mental Health and Well-Being study.

The study found that elevated depressive symptoms were most prevalent in four groups:

• Younger patients, with 43.9% of patients aged 18-39 years self-reporting elevated depressive symptoms, compared with 32.4% of those aged 40-59, and 19.1% of patients aged 60 and older.
• People with lower incomes, with 58.1% of people making $19,999 or less reporting elevated symptoms, compared with 41.3% of those making $20,000-$44,999, 31.4% of people making $45,000-$74,999, and 14.1% of those making $75,000 or more.
• People with less than $5,000 in family savings, with a rate of 51.1%, compared with 24.2% of those with more than that.
• People never married, with a rate of 39.8% versus 37.7% of those living with a partner; 31.5% widowed, divorced, or separated; and 18.3% married.

The study also found correlations between the number of self-reported stressors and elevated depression symptoms: a rate of 51.1% in people with four or more stressors; 25.8% in those with two or three stressors; and 17% in people with one or no stressors.

Among the groups reporting the lowest rates of depressive symptoms in 2021 were people making more than $75,000 a year; those with one or no COVID-19 stressors; and non-Hispanic Asian persons.

“Stressors such as difficulties finding childcare, difficulties paying for housing, and job loss were associated with greater depression 12 months into the COVID-19 pandemic,” Ms. Ettman said. “Efforts to address stressors and improve access to childcare, housing, employment, and fair wages can improve mental health.”

The duration of the pandemic is another explanation for the significant rise in depressive symptoms, senior author Sandro Galea, MD, MPH, DrPH, said in an interview. “The COVID-19 pandemic is different from other traumatic events in its ongoing length, in its widespread reach, and in its inequities,” Dr. Galea added. “Unlike acute traumatic events, the COVID-19 pandemic has been ongoing.”

He said clinicians, public health officials, and policy makers need to be aware of the impact COVID-19 has had on mental health. “We can take steps as a society to treat and prevent depression and create conditions that allow all populations to be healthy,” said Dr. Galea, who is dean and a professor of family medicine at Boston University.
 

Age of sample cited as limitation

The study builds on existing evidence linking depression trends and the COVID-19 pandemic, David Puder, MD, a medical director at Loma Linda (Calif.) University, said in an interview. However, he noted it had some limitations. “The age range is only 18 and older, so we don’t get to see what is happening with a highly impacted group of students who have not been able to go to school and be with their friends during COVID,” said Dr. Puder, who also hosts the podcast “Psychiatry & Psychotherapy.” “Further, the PHQ-9 is often a screening tool for depression and is not best used for changes in mental health over time.”

At the same time, Dr. Puder said, one of the study’s strengths was that it showed how depressive symptoms increased during the COVID lockdown. “It shows certain groups are at higher risk, including those with less financial resources and those with higher amounts of stress,” Dr. Puder said.

Ms. Ettman, Dr. Galea, and Dr. Puder reported no relevant disclosures.

The presence of benzene has prompted voluntary company recalls of antifungal foot sprays and sunscreen products, all aerosol spray products.

mark wragg/iStockphoto.com

Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.

Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.

The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.

Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.

In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.

“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.

In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.

In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.

Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.

The presence of benzene has prompted voluntary company recalls of antifungal foot sprays and sunscreen products, all aerosol spray products.

mark wragg/iStockphoto.com

Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.

Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.

The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.

Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.

In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.

“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.

In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.

In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.

Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.

The presence of benzene has prompted voluntary company recalls of antifungal foot sprays and sunscreen products, all aerosol spray products.

mark wragg/iStockphoto.com

Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.

Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.

The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.

Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.

In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.

“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.

In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.

In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.

Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.

James Taylor, MD, a former physician director of coding and medical director of revenue cycle at Kaiser’s Colorado Permanente Medical Group, just wanted Kaiser to do the right thing and stop submitting false claims to Medicare Advantage.

Dr. Taylor, who describes himself as tenacious to a fault, says he waited 7 years to file his lawsuit because he thought he could convince Kaiser to fix the coding problems on their end. He alternated between optimism and despair as Kaiser’s management supported some solutions only to shut them down later.

Finally, Dr. Taylor had had enough – the stress was getting to him, and his job was on the line.

As a last resort, he consulted a law firm that specializes in whistle-blower cases. Soon afterward, they filed a civil lawsuit in Colorado.

“My wife says that I have a justice gene – she can tell when it’s vibrating because I get amazed, not because people do wrong things, which they do all the time, but to that scale where it’s millions of dollars, and they’re being smug and acting like a bully. They thought they would never get caught and just kept going and even ramped it up in some situations,” says Dr. Taylor.

Several other whistle-blowers filed five lawsuits also alleging that Kaiser knew it was committing Medicare Advantage fraud amounting to tens of millions of dollars. The U.S. Department of Justice (DoJ) announced in July that it will join the six lawsuits and that it would file its complaint by late October.

Martin Mansukhani, a former regional CFO for Prime Health Care, was out of the country when the CEO signed a multimillion dollar contract with a cardiologist that went into effect immediately. At first, he tried to make the agreement work financially but then realized there were serious problems with the contract. He consulted a law firm, which confirmed that this was a kickback scheme in which the cardiologist was being overpaid in exchange for referring patients to Prime hospitals. The attorneys filed his whistle-blower lawsuit in 2017.

“My goal in filing the lawsuit was to get the company to stop these business practices,” says Mr. Mansukhani.

For being a whistle-blower, Mr. Mansukhani will receive nearly $10 million from the $37 settlement the DoJ negotiated. The False Claims Act entitles whistle-blowers to receive a higher reward (25% to 30%) when the DoJ doesn’t join a case than when it does (15% to 25%).

His lawsuit alleges that Prime Health Care, a hospital chain in California, its CEO, Prem Reddy, MD, and cardiologist Siva Arunasalam, MD, violated the federal Anti-Kickback Statute and the Stark Law, which generally make it illegal for anyone to offer or to provide something of value in exchange for a referral for a federal health care service. The suit also alleges that Prime had engaged in fraudulent billing practices.

The most challenging aspect was the decision to file the case. “It was a big-time commitment to pull together the evidence and to spend time interviewing law firms to determine who would best represent me, before I chose Phillips & Cohen,” says Mr. Mansukhani.
 

When management fails to listen

Dr. Taylor loved working at Kaiser Colorado and used to joke that he had job security as director of revenue cycle because doctors don’t like mixing business with medicine. He earned less money than when he was a family physician but “loved the lifestyle because it gave me time to spend with my wife and two young children.”

He was well thought of by the medical group – they elected him to serve on its board of directors for 4 years (2009-2013), during which time he served 2 years as chairman. They also sent him to Harvard’s executive leadership program.

As a certified risk adjustment coder and EPIC (the electronic medical records system that Kaiser used at that time) certified physician builder, Dr. Taylor had the expertise to recognize problems and fix them.

The audits that Kaiser and Dr. Taylor conducted showed high rates of errors for conditions related to cancer, stroke, and vascular disease.

“I hired a physician to review thousands of stroke codes and catch the false ones and created a filter in EPIC that weeded out incorrect codes before they were submitted,” Dr. Taylor says.

But these changes didn’t last because Kaiser managers would cancel or defund them, says Dr. Taylor. “That’s why I stayed for so many years. I would make one change and it would go very well and then they would shut it down. I would think, ‘This is great, they’re listening,’ but then it was gone. If all that had happened at once, I would have left immediately, but it was over time,” says Dr. Taylor.

He informed Kaiser Colorado’s upper management and its national organization about the problems, but he got nowhere.
 

Becoming a target

Dr. Taylor’s efforts to stop Kaiser from submitting false diagnosis codes didn’t sit well with the CFO.

Things came to a head in 2014 when Dr. Taylor discovered that a board meeting had been called to push him out of the company. “They said I failed a work improvement plan and that was why they needed to get me out.

“When they started saying that I was part of the problem after all the work I had done to keep their noses clean, I couldn’t tolerate it any longer. That’s when I filed the lawsuit,” says Dr. Taylor.

The stress from the “chaos and craziness” was also starting to affect his health, and he was worried that Kaiser would damage his reputation further.

He resigned in 2015. “I left 14 months before being fully vested in their retirement program.”
 

Employer retaliation?

Prime first sidelined and then fired Mr. Mansukhani (not for cause) in 2017 just before he filed his lawsuit. It offered him only 30 days of severance pay, which he didn’t accept. He didn’t think his firing was in retaliation for being a whistle-blower because his relationship with the chief operating officer had soured long before, in 2013, and the lawsuit was sealed.

At the time, he owned a nursing home in England that was doing well financially. He worried whether “Prime would try to retaliate against me in the U.K. I was a senior executive in a fairly high-profile position in the health care sector, and lots of informal networks exist,” says Mr. Mansukhani. But that never happened.

He found a new job right away. “At that stage of my life, I was 53 years old, and I wasn’t looking for another job. But College Healthcare in California offered me one as the CFO, which I accepted,” says Mr. Mansukhani.
 

Did it ruin his career?

Dr. Taylor also found a new job right away as chief medical officer of Colorado Access, where he trained practitioners on the Medicare Advantage model and documentation standards required by the Centers for Medicare & Medicaid Services (CMS). He is now an independent consultant with Principled Advantage.

Dr. Taylor’s lawsuit was filed under the False Claims Act, which requires that court documents be kept confidential (“sealed”) for at least 60 days while the DoJ investigates the case. Judges often extend that time frame.

In Dr. Taylor’s case, it took 7 years for the DoJ to unseal the documents. “The bad news is the wheels of justice turned really slowly. The good news was that I could seek employment and not have them worry about hiring a whistle-blower. As much as I didn’t like it, it was truly a blessing in disguise,” he says.

Dr. Taylor doesn’t know what the outcome of his case against Kaiser will be. When it was unsealed recently, he worried that local TV stations would show up at his doorstep and hound him or that Kaiser’s administrators would try to dig up dirt on him, which hasn’t happened.

He has no regrets about filing the lawsuit and feels vindicated because the managers/administrators who didn’t support him have been fired, including the CFO “who threw the biggest obstacles at me and defunded my work,” says Dr. Taylor.

The DoJ’s recent decision to join the consolidated whistle-blower case “was an indication that I was correct that Kaiser wasn’t doing what they should have been doing. You can’t have dishonest scales – if you’re purposely cheating the government to get promotions, more bonuses, that’s just wrong.”

Kaiser Permanente declined to comment on Dr. Taylor’s allegations and referred to its statement. “We are confident that Kaiser Permanente is compliant with Medicare Advantage program requirements, and we intend to strongly defend against the lawsuits alleging otherwise.”

“Our medical record documentation and risk adjustment diagnosis data submitted to the Centers for Medicare & Medicaid Services comply with applicable laws and Medicare Advantage program requirements. Our policies and practices represent well-reasoned and good-faith interpretations of sometimes vague and incomplete guidance from CMS,” according to the statement.
 

Did it make a difference?

When the government settles whistle-blower cases, the defendants usually admit no liability or wrongdoing, which some whistle-blowers find frustrating.

“I think the company was hurt by the lawsuit. It may make them think twice about doing this again,” says Mr. Mansukhani. However, he is cynical about whether the culture will change.

As part of its settlement, Prime agreed to amend its current corporate integrity agreement (CIA) from a previous 2018 settlement to include testing on physician compensation arrangements.

CIAs are standard monitoring agreements in the health care industry, and Prime asserts that it remains in full compliance, according to its statement.

Prime Health Care and Arunasalam did not respond to several interview requests. A statement from Prime in July says, “The settled matters related to an isolated, single physician practice in Southern California between 2015-2017 and billing of forty-five implantable device claims. The allegations did not involve patient care, but instead related to the valuation of a physician practice and the appropriate documentation for a limited number of implant claims totaling approximately $200,000. As soon as these matters were identified, Prime conducted an exhaustive internal review, fully cooperated with the DOJ, and negotiated a mutually acceptable resolution.”

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

James Taylor, MD, a former physician director of coding and medical director of revenue cycle at Kaiser’s Colorado Permanente Medical Group, just wanted Kaiser to do the right thing and stop submitting false claims to Medicare Advantage.

Dr. Taylor, who describes himself as tenacious to a fault, says he waited 7 years to file his lawsuit because he thought he could convince Kaiser to fix the coding problems on their end. He alternated between optimism and despair as Kaiser’s management supported some solutions only to shut them down later.

Finally, Dr. Taylor had had enough – the stress was getting to him, and his job was on the line.

As a last resort, he consulted a law firm that specializes in whistle-blower cases. Soon afterward, they filed a civil lawsuit in Colorado.

“My wife says that I have a justice gene – she can tell when it’s vibrating because I get amazed, not because people do wrong things, which they do all the time, but to that scale where it’s millions of dollars, and they’re being smug and acting like a bully. They thought they would never get caught and just kept going and even ramped it up in some situations,” says Dr. Taylor.

Several other whistle-blowers filed five lawsuits also alleging that Kaiser knew it was committing Medicare Advantage fraud amounting to tens of millions of dollars. The U.S. Department of Justice (DoJ) announced in July that it will join the six lawsuits and that it would file its complaint by late October.

Martin Mansukhani, a former regional CFO for Prime Health Care, was out of the country when the CEO signed a multimillion dollar contract with a cardiologist that went into effect immediately. At first, he tried to make the agreement work financially but then realized there were serious problems with the contract. He consulted a law firm, which confirmed that this was a kickback scheme in which the cardiologist was being overpaid in exchange for referring patients to Prime hospitals. The attorneys filed his whistle-blower lawsuit in 2017.

“My goal in filing the lawsuit was to get the company to stop these business practices,” says Mr. Mansukhani.

For being a whistle-blower, Mr. Mansukhani will receive nearly $10 million from the $37 settlement the DoJ negotiated. The False Claims Act entitles whistle-blowers to receive a higher reward (25% to 30%) when the DoJ doesn’t join a case than when it does (15% to 25%).

His lawsuit alleges that Prime Health Care, a hospital chain in California, its CEO, Prem Reddy, MD, and cardiologist Siva Arunasalam, MD, violated the federal Anti-Kickback Statute and the Stark Law, which generally make it illegal for anyone to offer or to provide something of value in exchange for a referral for a federal health care service. The suit also alleges that Prime had engaged in fraudulent billing practices.

The most challenging aspect was the decision to file the case. “It was a big-time commitment to pull together the evidence and to spend time interviewing law firms to determine who would best represent me, before I chose Phillips & Cohen,” says Mr. Mansukhani.
 

When management fails to listen

Dr. Taylor loved working at Kaiser Colorado and used to joke that he had job security as director of revenue cycle because doctors don’t like mixing business with medicine. He earned less money than when he was a family physician but “loved the lifestyle because it gave me time to spend with my wife and two young children.”

He was well thought of by the medical group – they elected him to serve on its board of directors for 4 years (2009-2013), during which time he served 2 years as chairman. They also sent him to Harvard’s executive leadership program.

As a certified risk adjustment coder and EPIC (the electronic medical records system that Kaiser used at that time) certified physician builder, Dr. Taylor had the expertise to recognize problems and fix them.

The audits that Kaiser and Dr. Taylor conducted showed high rates of errors for conditions related to cancer, stroke, and vascular disease.

“I hired a physician to review thousands of stroke codes and catch the false ones and created a filter in EPIC that weeded out incorrect codes before they were submitted,” Dr. Taylor says.

But these changes didn’t last because Kaiser managers would cancel or defund them, says Dr. Taylor. “That’s why I stayed for so many years. I would make one change and it would go very well and then they would shut it down. I would think, ‘This is great, they’re listening,’ but then it was gone. If all that had happened at once, I would have left immediately, but it was over time,” says Dr. Taylor.

He informed Kaiser Colorado’s upper management and its national organization about the problems, but he got nowhere.
 

Becoming a target

Dr. Taylor’s efforts to stop Kaiser from submitting false diagnosis codes didn’t sit well with the CFO.

Things came to a head in 2014 when Dr. Taylor discovered that a board meeting had been called to push him out of the company. “They said I failed a work improvement plan and that was why they needed to get me out.

“When they started saying that I was part of the problem after all the work I had done to keep their noses clean, I couldn’t tolerate it any longer. That’s when I filed the lawsuit,” says Dr. Taylor.

The stress from the “chaos and craziness” was also starting to affect his health, and he was worried that Kaiser would damage his reputation further.

He resigned in 2015. “I left 14 months before being fully vested in their retirement program.”
 

Employer retaliation?

Prime first sidelined and then fired Mr. Mansukhani (not for cause) in 2017 just before he filed his lawsuit. It offered him only 30 days of severance pay, which he didn’t accept. He didn’t think his firing was in retaliation for being a whistle-blower because his relationship with the chief operating officer had soured long before, in 2013, and the lawsuit was sealed.

At the time, he owned a nursing home in England that was doing well financially. He worried whether “Prime would try to retaliate against me in the U.K. I was a senior executive in a fairly high-profile position in the health care sector, and lots of informal networks exist,” says Mr. Mansukhani. But that never happened.

He found a new job right away. “At that stage of my life, I was 53 years old, and I wasn’t looking for another job. But College Healthcare in California offered me one as the CFO, which I accepted,” says Mr. Mansukhani.
 

Did it ruin his career?

Dr. Taylor also found a new job right away as chief medical officer of Colorado Access, where he trained practitioners on the Medicare Advantage model and documentation standards required by the Centers for Medicare & Medicaid Services (CMS). He is now an independent consultant with Principled Advantage.

Dr. Taylor’s lawsuit was filed under the False Claims Act, which requires that court documents be kept confidential (“sealed”) for at least 60 days while the DoJ investigates the case. Judges often extend that time frame.

In Dr. Taylor’s case, it took 7 years for the DoJ to unseal the documents. “The bad news is the wheels of justice turned really slowly. The good news was that I could seek employment and not have them worry about hiring a whistle-blower. As much as I didn’t like it, it was truly a blessing in disguise,” he says.

Dr. Taylor doesn’t know what the outcome of his case against Kaiser will be. When it was unsealed recently, he worried that local TV stations would show up at his doorstep and hound him or that Kaiser’s administrators would try to dig up dirt on him, which hasn’t happened.

He has no regrets about filing the lawsuit and feels vindicated because the managers/administrators who didn’t support him have been fired, including the CFO “who threw the biggest obstacles at me and defunded my work,” says Dr. Taylor.

The DoJ’s recent decision to join the consolidated whistle-blower case “was an indication that I was correct that Kaiser wasn’t doing what they should have been doing. You can’t have dishonest scales – if you’re purposely cheating the government to get promotions, more bonuses, that’s just wrong.”

Kaiser Permanente declined to comment on Dr. Taylor’s allegations and referred to its statement. “We are confident that Kaiser Permanente is compliant with Medicare Advantage program requirements, and we intend to strongly defend against the lawsuits alleging otherwise.”

“Our medical record documentation and risk adjustment diagnosis data submitted to the Centers for Medicare & Medicaid Services comply with applicable laws and Medicare Advantage program requirements. Our policies and practices represent well-reasoned and good-faith interpretations of sometimes vague and incomplete guidance from CMS,” according to the statement.
 

Did it make a difference?

When the government settles whistle-blower cases, the defendants usually admit no liability or wrongdoing, which some whistle-blowers find frustrating.

“I think the company was hurt by the lawsuit. It may make them think twice about doing this again,” says Mr. Mansukhani. However, he is cynical about whether the culture will change.

As part of its settlement, Prime agreed to amend its current corporate integrity agreement (CIA) from a previous 2018 settlement to include testing on physician compensation arrangements.

CIAs are standard monitoring agreements in the health care industry, and Prime asserts that it remains in full compliance, according to its statement.

Prime Health Care and Arunasalam did not respond to several interview requests. A statement from Prime in July says, “The settled matters related to an isolated, single physician practice in Southern California between 2015-2017 and billing of forty-five implantable device claims. The allegations did not involve patient care, but instead related to the valuation of a physician practice and the appropriate documentation for a limited number of implant claims totaling approximately $200,000. As soon as these matters were identified, Prime conducted an exhaustive internal review, fully cooperated with the DOJ, and negotiated a mutually acceptable resolution.”

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

James Taylor, MD, a former physician director of coding and medical director of revenue cycle at Kaiser’s Colorado Permanente Medical Group, just wanted Kaiser to do the right thing and stop submitting false claims to Medicare Advantage.

Dr. Taylor, who describes himself as tenacious to a fault, says he waited 7 years to file his lawsuit because he thought he could convince Kaiser to fix the coding problems on their end. He alternated between optimism and despair as Kaiser’s management supported some solutions only to shut them down later.

Finally, Dr. Taylor had had enough – the stress was getting to him, and his job was on the line.

As a last resort, he consulted a law firm that specializes in whistle-blower cases. Soon afterward, they filed a civil lawsuit in Colorado.

“My wife says that I have a justice gene – she can tell when it’s vibrating because I get amazed, not because people do wrong things, which they do all the time, but to that scale where it’s millions of dollars, and they’re being smug and acting like a bully. They thought they would never get caught and just kept going and even ramped it up in some situations,” says Dr. Taylor.

Several other whistle-blowers filed five lawsuits also alleging that Kaiser knew it was committing Medicare Advantage fraud amounting to tens of millions of dollars. The U.S. Department of Justice (DoJ) announced in July that it will join the six lawsuits and that it would file its complaint by late October.

Martin Mansukhani, a former regional CFO for Prime Health Care, was out of the country when the CEO signed a multimillion dollar contract with a cardiologist that went into effect immediately. At first, he tried to make the agreement work financially but then realized there were serious problems with the contract. He consulted a law firm, which confirmed that this was a kickback scheme in which the cardiologist was being overpaid in exchange for referring patients to Prime hospitals. The attorneys filed his whistle-blower lawsuit in 2017.

“My goal in filing the lawsuit was to get the company to stop these business practices,” says Mr. Mansukhani.

For being a whistle-blower, Mr. Mansukhani will receive nearly $10 million from the $37 settlement the DoJ negotiated. The False Claims Act entitles whistle-blowers to receive a higher reward (25% to 30%) when the DoJ doesn’t join a case than when it does (15% to 25%).

His lawsuit alleges that Prime Health Care, a hospital chain in California, its CEO, Prem Reddy, MD, and cardiologist Siva Arunasalam, MD, violated the federal Anti-Kickback Statute and the Stark Law, which generally make it illegal for anyone to offer or to provide something of value in exchange for a referral for a federal health care service. The suit also alleges that Prime had engaged in fraudulent billing practices.

The most challenging aspect was the decision to file the case. “It was a big-time commitment to pull together the evidence and to spend time interviewing law firms to determine who would best represent me, before I chose Phillips & Cohen,” says Mr. Mansukhani.
 

When management fails to listen

Dr. Taylor loved working at Kaiser Colorado and used to joke that he had job security as director of revenue cycle because doctors don’t like mixing business with medicine. He earned less money than when he was a family physician but “loved the lifestyle because it gave me time to spend with my wife and two young children.”

He was well thought of by the medical group – they elected him to serve on its board of directors for 4 years (2009-2013), during which time he served 2 years as chairman. They also sent him to Harvard’s executive leadership program.

As a certified risk adjustment coder and EPIC (the electronic medical records system that Kaiser used at that time) certified physician builder, Dr. Taylor had the expertise to recognize problems and fix them.

The audits that Kaiser and Dr. Taylor conducted showed high rates of errors for conditions related to cancer, stroke, and vascular disease.

“I hired a physician to review thousands of stroke codes and catch the false ones and created a filter in EPIC that weeded out incorrect codes before they were submitted,” Dr. Taylor says.

But these changes didn’t last because Kaiser managers would cancel or defund them, says Dr. Taylor. “That’s why I stayed for so many years. I would make one change and it would go very well and then they would shut it down. I would think, ‘This is great, they’re listening,’ but then it was gone. If all that had happened at once, I would have left immediately, but it was over time,” says Dr. Taylor.

He informed Kaiser Colorado’s upper management and its national organization about the problems, but he got nowhere.
 

Becoming a target

Dr. Taylor’s efforts to stop Kaiser from submitting false diagnosis codes didn’t sit well with the CFO.

Things came to a head in 2014 when Dr. Taylor discovered that a board meeting had been called to push him out of the company. “They said I failed a work improvement plan and that was why they needed to get me out.

“When they started saying that I was part of the problem after all the work I had done to keep their noses clean, I couldn’t tolerate it any longer. That’s when I filed the lawsuit,” says Dr. Taylor.

The stress from the “chaos and craziness” was also starting to affect his health, and he was worried that Kaiser would damage his reputation further.

He resigned in 2015. “I left 14 months before being fully vested in their retirement program.”
 

Employer retaliation?

Prime first sidelined and then fired Mr. Mansukhani (not for cause) in 2017 just before he filed his lawsuit. It offered him only 30 days of severance pay, which he didn’t accept. He didn’t think his firing was in retaliation for being a whistle-blower because his relationship with the chief operating officer had soured long before, in 2013, and the lawsuit was sealed.

At the time, he owned a nursing home in England that was doing well financially. He worried whether “Prime would try to retaliate against me in the U.K. I was a senior executive in a fairly high-profile position in the health care sector, and lots of informal networks exist,” says Mr. Mansukhani. But that never happened.

He found a new job right away. “At that stage of my life, I was 53 years old, and I wasn’t looking for another job. But College Healthcare in California offered me one as the CFO, which I accepted,” says Mr. Mansukhani.
 

Did it ruin his career?

Dr. Taylor also found a new job right away as chief medical officer of Colorado Access, where he trained practitioners on the Medicare Advantage model and documentation standards required by the Centers for Medicare & Medicaid Services (CMS). He is now an independent consultant with Principled Advantage.

Dr. Taylor’s lawsuit was filed under the False Claims Act, which requires that court documents be kept confidential (“sealed”) for at least 60 days while the DoJ investigates the case. Judges often extend that time frame.

In Dr. Taylor’s case, it took 7 years for the DoJ to unseal the documents. “The bad news is the wheels of justice turned really slowly. The good news was that I could seek employment and not have them worry about hiring a whistle-blower. As much as I didn’t like it, it was truly a blessing in disguise,” he says.

Dr. Taylor doesn’t know what the outcome of his case against Kaiser will be. When it was unsealed recently, he worried that local TV stations would show up at his doorstep and hound him or that Kaiser’s administrators would try to dig up dirt on him, which hasn’t happened.

He has no regrets about filing the lawsuit and feels vindicated because the managers/administrators who didn’t support him have been fired, including the CFO “who threw the biggest obstacles at me and defunded my work,” says Dr. Taylor.

The DoJ’s recent decision to join the consolidated whistle-blower case “was an indication that I was correct that Kaiser wasn’t doing what they should have been doing. You can’t have dishonest scales – if you’re purposely cheating the government to get promotions, more bonuses, that’s just wrong.”

Kaiser Permanente declined to comment on Dr. Taylor’s allegations and referred to its statement. “We are confident that Kaiser Permanente is compliant with Medicare Advantage program requirements, and we intend to strongly defend against the lawsuits alleging otherwise.”

“Our medical record documentation and risk adjustment diagnosis data submitted to the Centers for Medicare & Medicaid Services comply with applicable laws and Medicare Advantage program requirements. Our policies and practices represent well-reasoned and good-faith interpretations of sometimes vague and incomplete guidance from CMS,” according to the statement.
 

Did it make a difference?

When the government settles whistle-blower cases, the defendants usually admit no liability or wrongdoing, which some whistle-blowers find frustrating.

“I think the company was hurt by the lawsuit. It may make them think twice about doing this again,” says Mr. Mansukhani. However, he is cynical about whether the culture will change.

As part of its settlement, Prime agreed to amend its current corporate integrity agreement (CIA) from a previous 2018 settlement to include testing on physician compensation arrangements.

CIAs are standard monitoring agreements in the health care industry, and Prime asserts that it remains in full compliance, according to its statement.

Prime Health Care and Arunasalam did not respond to several interview requests. A statement from Prime in July says, “The settled matters related to an isolated, single physician practice in Southern California between 2015-2017 and billing of forty-five implantable device claims. The allegations did not involve patient care, but instead related to the valuation of a physician practice and the appropriate documentation for a limited number of implant claims totaling approximately $200,000. As soon as these matters were identified, Prime conducted an exhaustive internal review, fully cooperated with the DOJ, and negotiated a mutually acceptable resolution.”

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

Anthem Blue Cross, the country’s second-biggest health insurance company, is behind on billions of dollars in payments owed to hospitals and doctors because of onerous new reimbursement rules, computer problems and mishandled claims, say hospital officials in multiple states.

Anthem, like other big insurers, is using the COVID-19 crisis as cover to institute “egregious” policies that harm patients and pinch hospital finances, said Molly Smith, group vice president at the American Hospital Association. “There’s this sense of ‘Everyone’s distracted. We can get this through.’ ”

Hospitals are also dealing with a spike in retroactive claims denials by UnitedHealthcare, the biggest health insurer, for ED care, the AHA said.

Disputes between insurers and hospitals are nothing new. But this fight sticks more patients in the middle, worried they’ll have to pay unresolved claims. Hospitals say it is hurting their finances as many cope with COVID surges – even after the industry has received tens of billions of dollars in emergency assistance from the federal government.

“We recognize there have been some challenges” to prompt payments caused by claims-processing changes and “a new set of dynamics” amid the pandemic, Anthem spokesperson Colin Manning said in an email. “We apologize for any delays or inconvenience this may have caused.”

Virginia law requires insurers to pay claims within 40 days. In a Sept. 24 letter to state insurance regulators, VCU Health, a system that operates a large teaching hospital in Richmond associated with Virginia Commonwealth University, said Anthem owes it $385 million. More than 40% of the claims are more than 90 days old, VCU said.

For all Virginia hospitals, Anthem’s late, unpaid claims amount to “hundreds of millions of dollars,” the Virginia Hospital and Healthcare Association said in a June 23 letter to state regulators.

Nationwide, the payment delays “are creating an untenable situation,” the American Hospital Association said in a Sept. 9 letter to Anthem CEO Gail Boudreaux. “Patients are facing greater hurdles to accessing care; clinicians are burning out on unnecessary administrative tasks; and the system is straining to finance the personnel and supplies” needed to fight Covid.

Complaints about Anthem extend “from sea to shining sea, from New Hampshire to California,” AHA CEO Rick Pollack told KHN.

Substantial payment delays can be seen on Anthem’s books. On June 30, 2019, before the pandemic, 43% of the insurer’s medical bills for that quarter were unpaid, according to regulatory filings. Two years later that figure had risen to 53% – a difference of $2.5 billion.

Anthem profits were $4.6 billion in 2020 and $3.5 billion in the first half of 2021.

Alexis Thurber, who lives near Seattle, was insured by Anthem when she got an $18,192 hospital bill in May for radiation therapy that doctors said was essential to treat her breast cancer.

The treatments were “experimental” and “not medically necessary,” Anthem said, according to Ms. Thurber. She spent much of the summer trying to get the insurer to pay up – placing two dozen phone calls, spending hours on hold, sending multiple emails and enduring unmeasurable stress and worry. It finally covered the claim months later.

“It’s so egregious. It’s a game they’re playing,” said Ms. Thurber, 51, whose cancer was diagnosed in November. “Trying to get true help was impossible.”

Privacy rules prevent Anthem from commenting on Ms. Thurber’s case, said Anthem spokesperson Colin Manning.

When insurers fail to promptly pay medical bills, patients are left in the lurch. They might first get a notice saying payment is pending or denied. A hospital might bill them for treatment they thought would be covered. Hospitals and doctors often sue patients whose insurance didn’t pay up.

Hospitals point to a variety of Anthem practices contributing to payment delays or denials, including new layers of document requirements, prior-authorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers. “This requires providers to literally leave the patient[’s] bedside to get on the phone with Anthem,” AHA said in its letter.

Anthem often hinders coverage for outpatient surgery, specialty pharmacy and other services in health systems listed as in network, amounting to a “bait and switch” on Anthem members, AHA officials said.

“Demanding that patients be treated outside of the hospital setting, against the advice of the patient’s in-network treating physician, appears to be motivated by a desire to drive up Empire’s profits,” the Greater New York Hospital Association wrote in an April letter to Empire Blue Cross, which is owned by Anthem.

Anthem officials pushed back in a recent letter to the AHA, saying the insurer’s changing rules are intended partly to control excessive prices charged by hospitals for specialty drugs and nonemergency surgery, screening and diagnostic procedures.

Severe problems with Anthem’s new claims management system surfaced months ago and “persist without meaningful improvement,” AHA said in its letter.

Claims have gotten lost in Anthem’s computers, and in some cases VCU Health has had to print medical records and mail them to get paid, VCU said in its letter. The cash slowdown imposes “an unmanageable disruption that threatens to undermine our financial footing,” VCU said.

United denied $31,557 in claims for Emily Long’s care after she was struck in June by a motorcycle in New York City. She needed surgery to repair a fractured cheekbone. United said there was a lack of documentation for “medical necessity” – an “incredibly aggravating” response on top of the distress of the accident, Ms. Long said.

The Brooklyn hospital that treated Ms. Long was “paid appropriately under her plan and within the required time frame,” said United spokesperson Maria Gordon Shydlo. “The facility has the right to appeal the decision.”

United’s unpaid claims came to 54% as of June 30, about the same level as 2 years previously.

When Erin Conlisk initially had trouble gaining approval for a piece of medical equipment for her elderly father this summer, United employees told her the insurer’s entire prior-authorization database had gone down for weeks, said Ms. Conlisk, who lives in California.

“There was a brief issue with our prior-authorization process in mid-July, which was resolved quickly,” Gordon Shydlo said.

When asked by Wall Street analysts about the payment backups, Anthem executives said it partly reflects their decision to increase financial reserves amid the health crisis.

“Really a ton of uncertainty associated with this environment,” John Gallina, the company’s chief financial officer, said on a conference call in July. “We’ve tried to be extremely prudent and conservative in our approach.”

During the pandemic, hospitals have benefited from two extraordinary cash infusions. They and other medical providers have received more than $100 billion through the CARES Act of 2020 and the American Rescue Plan of 2021. Last year United, Anthem and other insurers accelerated billions in hospital reimbursements.

The federal payments enriched many of the biggest, wealthiest systems while poorer hospitals serving low-income patients and rural areas struggled.

Those are the systems most hurt now by insurer payment delays, hospital officials said. Federal relief funds “have been a lifeline, but they don’t make people whole in terms of the losses from increased expenses and lost revenue as a result of the COVID experience,” Mr. Pollack said.

Several health systems declined to comment about claims payment delays or didn’t respond to a reporter’s queries. Among individual hospitals “there is a deep fear of talking on the record about your largest business partner,” AHA’s Ms. Smith said.

Alexis Thurber worried she might have to pay her $18,192 radiation bill herself, and she’s not confident her Anthem policy will do a better job next time of covering the cost of her care.

“It makes me not want to go to the doctor anymore,” she said. “I’m scared to get another mammogram because you can’t rely on it.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Anthem Blue Cross, the country’s second-biggest health insurance company, is behind on billions of dollars in payments owed to hospitals and doctors because of onerous new reimbursement rules, computer problems and mishandled claims, say hospital officials in multiple states.

Anthem, like other big insurers, is using the COVID-19 crisis as cover to institute “egregious” policies that harm patients and pinch hospital finances, said Molly Smith, group vice president at the American Hospital Association. “There’s this sense of ‘Everyone’s distracted. We can get this through.’ ”

Hospitals are also dealing with a spike in retroactive claims denials by UnitedHealthcare, the biggest health insurer, for ED care, the AHA said.

Disputes between insurers and hospitals are nothing new. But this fight sticks more patients in the middle, worried they’ll have to pay unresolved claims. Hospitals say it is hurting their finances as many cope with COVID surges – even after the industry has received tens of billions of dollars in emergency assistance from the federal government.

“We recognize there have been some challenges” to prompt payments caused by claims-processing changes and “a new set of dynamics” amid the pandemic, Anthem spokesperson Colin Manning said in an email. “We apologize for any delays or inconvenience this may have caused.”

Virginia law requires insurers to pay claims within 40 days. In a Sept. 24 letter to state insurance regulators, VCU Health, a system that operates a large teaching hospital in Richmond associated with Virginia Commonwealth University, said Anthem owes it $385 million. More than 40% of the claims are more than 90 days old, VCU said.

For all Virginia hospitals, Anthem’s late, unpaid claims amount to “hundreds of millions of dollars,” the Virginia Hospital and Healthcare Association said in a June 23 letter to state regulators.

Nationwide, the payment delays “are creating an untenable situation,” the American Hospital Association said in a Sept. 9 letter to Anthem CEO Gail Boudreaux. “Patients are facing greater hurdles to accessing care; clinicians are burning out on unnecessary administrative tasks; and the system is straining to finance the personnel and supplies” needed to fight Covid.

Complaints about Anthem extend “from sea to shining sea, from New Hampshire to California,” AHA CEO Rick Pollack told KHN.

Substantial payment delays can be seen on Anthem’s books. On June 30, 2019, before the pandemic, 43% of the insurer’s medical bills for that quarter were unpaid, according to regulatory filings. Two years later that figure had risen to 53% – a difference of $2.5 billion.

Anthem profits were $4.6 billion in 2020 and $3.5 billion in the first half of 2021.

Alexis Thurber, who lives near Seattle, was insured by Anthem when she got an $18,192 hospital bill in May for radiation therapy that doctors said was essential to treat her breast cancer.

The treatments were “experimental” and “not medically necessary,” Anthem said, according to Ms. Thurber. She spent much of the summer trying to get the insurer to pay up – placing two dozen phone calls, spending hours on hold, sending multiple emails and enduring unmeasurable stress and worry. It finally covered the claim months later.

“It’s so egregious. It’s a game they’re playing,” said Ms. Thurber, 51, whose cancer was diagnosed in November. “Trying to get true help was impossible.”

Privacy rules prevent Anthem from commenting on Ms. Thurber’s case, said Anthem spokesperson Colin Manning.

When insurers fail to promptly pay medical bills, patients are left in the lurch. They might first get a notice saying payment is pending or denied. A hospital might bill them for treatment they thought would be covered. Hospitals and doctors often sue patients whose insurance didn’t pay up.

Hospitals point to a variety of Anthem practices contributing to payment delays or denials, including new layers of document requirements, prior-authorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers. “This requires providers to literally leave the patient[’s] bedside to get on the phone with Anthem,” AHA said in its letter.

Anthem often hinders coverage for outpatient surgery, specialty pharmacy and other services in health systems listed as in network, amounting to a “bait and switch” on Anthem members, AHA officials said.

“Demanding that patients be treated outside of the hospital setting, against the advice of the patient’s in-network treating physician, appears to be motivated by a desire to drive up Empire’s profits,” the Greater New York Hospital Association wrote in an April letter to Empire Blue Cross, which is owned by Anthem.

Anthem officials pushed back in a recent letter to the AHA, saying the insurer’s changing rules are intended partly to control excessive prices charged by hospitals for specialty drugs and nonemergency surgery, screening and diagnostic procedures.

Severe problems with Anthem’s new claims management system surfaced months ago and “persist without meaningful improvement,” AHA said in its letter.

Claims have gotten lost in Anthem’s computers, and in some cases VCU Health has had to print medical records and mail them to get paid, VCU said in its letter. The cash slowdown imposes “an unmanageable disruption that threatens to undermine our financial footing,” VCU said.

United denied $31,557 in claims for Emily Long’s care after she was struck in June by a motorcycle in New York City. She needed surgery to repair a fractured cheekbone. United said there was a lack of documentation for “medical necessity” – an “incredibly aggravating” response on top of the distress of the accident, Ms. Long said.

The Brooklyn hospital that treated Ms. Long was “paid appropriately under her plan and within the required time frame,” said United spokesperson Maria Gordon Shydlo. “The facility has the right to appeal the decision.”

United’s unpaid claims came to 54% as of June 30, about the same level as 2 years previously.

When Erin Conlisk initially had trouble gaining approval for a piece of medical equipment for her elderly father this summer, United employees told her the insurer’s entire prior-authorization database had gone down for weeks, said Ms. Conlisk, who lives in California.

“There was a brief issue with our prior-authorization process in mid-July, which was resolved quickly,” Gordon Shydlo said.

When asked by Wall Street analysts about the payment backups, Anthem executives said it partly reflects their decision to increase financial reserves amid the health crisis.

“Really a ton of uncertainty associated with this environment,” John Gallina, the company’s chief financial officer, said on a conference call in July. “We’ve tried to be extremely prudent and conservative in our approach.”

During the pandemic, hospitals have benefited from two extraordinary cash infusions. They and other medical providers have received more than $100 billion through the CARES Act of 2020 and the American Rescue Plan of 2021. Last year United, Anthem and other insurers accelerated billions in hospital reimbursements.

The federal payments enriched many of the biggest, wealthiest systems while poorer hospitals serving low-income patients and rural areas struggled.

Those are the systems most hurt now by insurer payment delays, hospital officials said. Federal relief funds “have been a lifeline, but they don’t make people whole in terms of the losses from increased expenses and lost revenue as a result of the COVID experience,” Mr. Pollack said.

Several health systems declined to comment about claims payment delays or didn’t respond to a reporter’s queries. Among individual hospitals “there is a deep fear of talking on the record about your largest business partner,” AHA’s Ms. Smith said.

Alexis Thurber worried she might have to pay her $18,192 radiation bill herself, and she’s not confident her Anthem policy will do a better job next time of covering the cost of her care.

“It makes me not want to go to the doctor anymore,” she said. “I’m scared to get another mammogram because you can’t rely on it.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Anthem Blue Cross, the country’s second-biggest health insurance company, is behind on billions of dollars in payments owed to hospitals and doctors because of onerous new reimbursement rules, computer problems and mishandled claims, say hospital officials in multiple states.

Anthem, like other big insurers, is using the COVID-19 crisis as cover to institute “egregious” policies that harm patients and pinch hospital finances, said Molly Smith, group vice president at the American Hospital Association. “There’s this sense of ‘Everyone’s distracted. We can get this through.’ ”

Hospitals are also dealing with a spike in retroactive claims denials by UnitedHealthcare, the biggest health insurer, for ED care, the AHA said.

Disputes between insurers and hospitals are nothing new. But this fight sticks more patients in the middle, worried they’ll have to pay unresolved claims. Hospitals say it is hurting their finances as many cope with COVID surges – even after the industry has received tens of billions of dollars in emergency assistance from the federal government.

“We recognize there have been some challenges” to prompt payments caused by claims-processing changes and “a new set of dynamics” amid the pandemic, Anthem spokesperson Colin Manning said in an email. “We apologize for any delays or inconvenience this may have caused.”

Virginia law requires insurers to pay claims within 40 days. In a Sept. 24 letter to state insurance regulators, VCU Health, a system that operates a large teaching hospital in Richmond associated with Virginia Commonwealth University, said Anthem owes it $385 million. More than 40% of the claims are more than 90 days old, VCU said.

For all Virginia hospitals, Anthem’s late, unpaid claims amount to “hundreds of millions of dollars,” the Virginia Hospital and Healthcare Association said in a June 23 letter to state regulators.

Nationwide, the payment delays “are creating an untenable situation,” the American Hospital Association said in a Sept. 9 letter to Anthem CEO Gail Boudreaux. “Patients are facing greater hurdles to accessing care; clinicians are burning out on unnecessary administrative tasks; and the system is straining to finance the personnel and supplies” needed to fight Covid.

Complaints about Anthem extend “from sea to shining sea, from New Hampshire to California,” AHA CEO Rick Pollack told KHN.

Substantial payment delays can be seen on Anthem’s books. On June 30, 2019, before the pandemic, 43% of the insurer’s medical bills for that quarter were unpaid, according to regulatory filings. Two years later that figure had risen to 53% – a difference of $2.5 billion.

Anthem profits were $4.6 billion in 2020 and $3.5 billion in the first half of 2021.

Alexis Thurber, who lives near Seattle, was insured by Anthem when she got an $18,192 hospital bill in May for radiation therapy that doctors said was essential to treat her breast cancer.

The treatments were “experimental” and “not medically necessary,” Anthem said, according to Ms. Thurber. She spent much of the summer trying to get the insurer to pay up – placing two dozen phone calls, spending hours on hold, sending multiple emails and enduring unmeasurable stress and worry. It finally covered the claim months later.

“It’s so egregious. It’s a game they’re playing,” said Ms. Thurber, 51, whose cancer was diagnosed in November. “Trying to get true help was impossible.”

Privacy rules prevent Anthem from commenting on Ms. Thurber’s case, said Anthem spokesperson Colin Manning.

When insurers fail to promptly pay medical bills, patients are left in the lurch. They might first get a notice saying payment is pending or denied. A hospital might bill them for treatment they thought would be covered. Hospitals and doctors often sue patients whose insurance didn’t pay up.

Hospitals point to a variety of Anthem practices contributing to payment delays or denials, including new layers of document requirements, prior-authorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers. “This requires providers to literally leave the patient[’s] bedside to get on the phone with Anthem,” AHA said in its letter.

Anthem often hinders coverage for outpatient surgery, specialty pharmacy and other services in health systems listed as in network, amounting to a “bait and switch” on Anthem members, AHA officials said.

“Demanding that patients be treated outside of the hospital setting, against the advice of the patient’s in-network treating physician, appears to be motivated by a desire to drive up Empire’s profits,” the Greater New York Hospital Association wrote in an April letter to Empire Blue Cross, which is owned by Anthem.

Anthem officials pushed back in a recent letter to the AHA, saying the insurer’s changing rules are intended partly to control excessive prices charged by hospitals for specialty drugs and nonemergency surgery, screening and diagnostic procedures.

Severe problems with Anthem’s new claims management system surfaced months ago and “persist without meaningful improvement,” AHA said in its letter.

Claims have gotten lost in Anthem’s computers, and in some cases VCU Health has had to print medical records and mail them to get paid, VCU said in its letter. The cash slowdown imposes “an unmanageable disruption that threatens to undermine our financial footing,” VCU said.

United denied $31,557 in claims for Emily Long’s care after she was struck in June by a motorcycle in New York City. She needed surgery to repair a fractured cheekbone. United said there was a lack of documentation for “medical necessity” – an “incredibly aggravating” response on top of the distress of the accident, Ms. Long said.

The Brooklyn hospital that treated Ms. Long was “paid appropriately under her plan and within the required time frame,” said United spokesperson Maria Gordon Shydlo. “The facility has the right to appeal the decision.”

United’s unpaid claims came to 54% as of June 30, about the same level as 2 years previously.

When Erin Conlisk initially had trouble gaining approval for a piece of medical equipment for her elderly father this summer, United employees told her the insurer’s entire prior-authorization database had gone down for weeks, said Ms. Conlisk, who lives in California.

“There was a brief issue with our prior-authorization process in mid-July, which was resolved quickly,” Gordon Shydlo said.

When asked by Wall Street analysts about the payment backups, Anthem executives said it partly reflects their decision to increase financial reserves amid the health crisis.

“Really a ton of uncertainty associated with this environment,” John Gallina, the company’s chief financial officer, said on a conference call in July. “We’ve tried to be extremely prudent and conservative in our approach.”

During the pandemic, hospitals have benefited from two extraordinary cash infusions. They and other medical providers have received more than $100 billion through the CARES Act of 2020 and the American Rescue Plan of 2021. Last year United, Anthem and other insurers accelerated billions in hospital reimbursements.

The federal payments enriched many of the biggest, wealthiest systems while poorer hospitals serving low-income patients and rural areas struggled.

Those are the systems most hurt now by insurer payment delays, hospital officials said. Federal relief funds “have been a lifeline, but they don’t make people whole in terms of the losses from increased expenses and lost revenue as a result of the COVID experience,” Mr. Pollack said.

Several health systems declined to comment about claims payment delays or didn’t respond to a reporter’s queries. Among individual hospitals “there is a deep fear of talking on the record about your largest business partner,” AHA’s Ms. Smith said.

Alexis Thurber worried she might have to pay her $18,192 radiation bill herself, and she’s not confident her Anthem policy will do a better job next time of covering the cost of her care.

“It makes me not want to go to the doctor anymore,” she said. “I’m scared to get another mammogram because you can’t rely on it.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.