Health Policy

To the Editor:

I read with interest the article by Sosa and colleagues¹ in which they present some stimulating analyses pertaining to a topic that we have been discussing at my institution for several years. Part of this discussion deals with the complexity of our hospital and how complexity is affected by comorbidity coding.

In 2013, we implemented the International Refined-DRGs (IR-DRGs) system to measure complexity at our hospital in Bogotá, Colombia. Our perception at that time was that the case mix index (CMI) was very low (0.7566), even for a general hospital with a high volume of pathologies with low relative weight (RW). Two medical auditors were assigned to review the medical records in order to improve the quality, quantity, and order of diagnoses. Emphasis was placed on patients with stays longer than 5 days and with only 1 diagnosis coded at admission. Additionally, International Classification of Diseases 10th Revision (World Health Organization version) diagnoses from chapters R (Symptoms and Signs Not Elsewhere Classified) and V through Y (External Causes) were blocked in the electronic health record. With these measures, our CMI increased 74%, reaching 1.3151 by the end of 2021, with a maximum peak of 1.6743 in May 2021, which coincided with the third peak of COVID-19 in Colombia.

However, the article by Sosa and colleagues draws my attention to the following: why do the authors state that their CMI is low and the patient acuity was under-represented? Is this due to a comparison with similar hospitals, or to a recommendation from a regulatory agency? We have found our CMI remains low because of a high volume of nonsurgical care (60%), deliveries, and digestive, respiratory, and urinary pathologies of low RW.

Also, was the perceived low CMI causing problems with payers? And further, how did the authors avoid the risk of artificially increasing the CMI through overdiagnosis of patients, and were there audit mechanisms to avoid this? While there was a clear change in expected mortality, did the observed mortality also change with the strategies implemented? This last question is relevant because, if the observed mortality were maintained, this would provide evidence that a coding problem was the cause of their hospital’s low CMI.

I reiterate my congratulations to the authors for presenting analyses that are very useful to other providers and researchers worldwide interested in addressing management issues related to the correct identification and classification of patients.

Carlos Kerguelen, MD, MA
Fundacion Santa Fe de Bogotá, Bogotá, Colombia
[email protected]

Disclosures: None reported.

To the Editor:

I read with interest the article by Sosa and colleagues¹ in which they present some stimulating analyses pertaining to a topic that we have been discussing at my institution for several years. Part of this discussion deals with the complexity of our hospital and how complexity is affected by comorbidity coding.

In 2013, we implemented the International Refined-DRGs (IR-DRGs) system to measure complexity at our hospital in Bogotá, Colombia. Our perception at that time was that the case mix index (CMI) was very low (0.7566), even for a general hospital with a high volume of pathologies with low relative weight (RW). Two medical auditors were assigned to review the medical records in order to improve the quality, quantity, and order of diagnoses. Emphasis was placed on patients with stays longer than 5 days and with only 1 diagnosis coded at admission. Additionally, International Classification of Diseases 10th Revision (World Health Organization version) diagnoses from chapters R (Symptoms and Signs Not Elsewhere Classified) and V through Y (External Causes) were blocked in the electronic health record. With these measures, our CMI increased 74%, reaching 1.3151 by the end of 2021, with a maximum peak of 1.6743 in May 2021, which coincided with the third peak of COVID-19 in Colombia.

However, the article by Sosa and colleagues draws my attention to the following: why do the authors state that their CMI is low and the patient acuity was under-represented? Is this due to a comparison with similar hospitals, or to a recommendation from a regulatory agency? We have found our CMI remains low because of a high volume of nonsurgical care (60%), deliveries, and digestive, respiratory, and urinary pathologies of low RW.

Also, was the perceived low CMI causing problems with payers? And further, how did the authors avoid the risk of artificially increasing the CMI through overdiagnosis of patients, and were there audit mechanisms to avoid this? While there was a clear change in expected mortality, did the observed mortality also change with the strategies implemented? This last question is relevant because, if the observed mortality were maintained, this would provide evidence that a coding problem was the cause of their hospital’s low CMI.

I reiterate my congratulations to the authors for presenting analyses that are very useful to other providers and researchers worldwide interested in addressing management issues related to the correct identification and classification of patients.

Carlos Kerguelen, MD, MA
Fundacion Santa Fe de Bogotá, Bogotá, Colombia
[email protected]

Disclosures: None reported.

To the Editor:

I read with interest the article by Sosa and colleagues¹ in which they present some stimulating analyses pertaining to a topic that we have been discussing at my institution for several years. Part of this discussion deals with the complexity of our hospital and how complexity is affected by comorbidity coding.

In 2013, we implemented the International Refined-DRGs (IR-DRGs) system to measure complexity at our hospital in Bogotá, Colombia. Our perception at that time was that the case mix index (CMI) was very low (0.7566), even for a general hospital with a high volume of pathologies with low relative weight (RW). Two medical auditors were assigned to review the medical records in order to improve the quality, quantity, and order of diagnoses. Emphasis was placed on patients with stays longer than 5 days and with only 1 diagnosis coded at admission. Additionally, International Classification of Diseases 10th Revision (World Health Organization version) diagnoses from chapters R (Symptoms and Signs Not Elsewhere Classified) and V through Y (External Causes) were blocked in the electronic health record. With these measures, our CMI increased 74%, reaching 1.3151 by the end of 2021, with a maximum peak of 1.6743 in May 2021, which coincided with the third peak of COVID-19 in Colombia.

However, the article by Sosa and colleagues draws my attention to the following: why do the authors state that their CMI is low and the patient acuity was under-represented? Is this due to a comparison with similar hospitals, or to a recommendation from a regulatory agency? We have found our CMI remains low because of a high volume of nonsurgical care (60%), deliveries, and digestive, respiratory, and urinary pathologies of low RW.

Also, was the perceived low CMI causing problems with payers? And further, how did the authors avoid the risk of artificially increasing the CMI through overdiagnosis of patients, and were there audit mechanisms to avoid this? While there was a clear change in expected mortality, did the observed mortality also change with the strategies implemented? This last question is relevant because, if the observed mortality were maintained, this would provide evidence that a coding problem was the cause of their hospital’s low CMI.

I reiterate my congratulations to the authors for presenting analyses that are very useful to other providers and researchers worldwide interested in addressing management issues related to the correct identification and classification of patients.

Carlos Kerguelen, MD, MA
Fundacion Santa Fe de Bogotá, Bogotá, Colombia
[email protected]

Disclosures: None reported.

From Memora Health (Dr. Flyckt and Dr. Colbert), San Francisco, CA; and Harvard Medical School (Dr. Colbert), Boston, MA.

A close relative was recently diagnosed with follicular lymphoma. He was cared for at a high-ranked cancer center by physicians with demonstrated expertise, and even had the support of a care navigator. Still, he was often left feeling overwhelmed and confused, holding an inch-thick stack of papers, instructions, and pamphlets. As he left his treatment planning visit, reeling from the emotional burden of his diagnosis and all the unfamiliar terminology, he didn’t know what to do or what to expect. Later, when he experienced early signs of tumor lysis syndrome, he struggled to reach his care team for triage and guidance. When he went to the emergency room, his oncologist was never informed.

This scenario is unfortunately common, and versions of this scenario play out thousands of times each day across the US health system. Within the clinic and hospital setting, patients receive excellent care from their providers, but a disconnect emerges once the patient leaves these medical settings: patients at home struggle to find guidance and support, while care teams lack the tools to engage patients between visits or monitor their health across care settings, providers, or episodes of care.

Leveraging Technology to Move From Episodes of Care to Complex Care Journeys

The use of automated messaging, artificial intelligence and natural language processing–driven chat experiences, and text-based support is becoming more common. However, health care lags behind other industries in the adoption of these technologies.^1,2 The slow pace can be warranted, given that health care is more complicated and higher risk than inquiring about a lost package, ordering groceries, or applying for a mortgage. At the same time, many of the consumer engagement tools used to guide an applicant through the multiple steps and complexities of their home loan process or to prompt viewers to select new shows to binge have applications in health care.

Over the past few years, technologies have emerged that guide patients through complex care journeys and allow care teams to monitor and engage patients between visits. These solutions come in different formats, but generally patients can receive messages on their phones that contain disease-specific educational content, prompts to fill prescriptions and take medications, and reminders and guidance on how to prepare for appointments and procedures. These programs also collect relevant data from patients through survey and electronic patient-reported outcomes instruments, as well as connected patient monitoring devices, that help track patient progress and identify issues as they arise. Many programs also incorporate symptom triage pathways and use natural language processing to respond automatically to patient questions and concerns.^3,4

These technology solutions can automate many tasks that in the past required a care team member to spend hours on the phone. Newly freed from such repetitive tasks, care teams can now focus on more in-depth interactions with those patients who are most in need—the types of interactions that are more satisfying and rewarding. Such assistance is particularly needed today with the staffing shortages faced by most health systems.⁵

In addition, technology allows teams to see the panel of patients they are caring for and to quickly identify and take action on any specific needs or issues. Care teams can focus on any patient and see where they are in their journey. When appropriate, some solutions also allow care teams to engage directly with patients through text-messaging, creating a seamless experience and unified communication channel. Ideally, these solutions should be linked or embedded within the electronic health record or other primary system of record, so that teams can easily access these tools through their existing workflows and avoid creating yet another interface to navigate.

The Impact of Low-Tech Solutions to Deliver High-Touch Support

There is evidence showing that digital patient navigation tools impact patient care. In the oncology setting, patients with a digital navigator have achieved over 95% adherence rates with complex oral chemotherapy regimens (Memora Health Unpublished Data. 2022.). In the postpartum setting, a text message–based program improved screening rates for postpartum depression and did so with very high patient satisfaction ratings.⁶ Particularly notable is the fact that this depression screening program achieved these results in a population that was predominantly low income, with more than half belonging to underrepresented minority populations.⁶

We believe these digital patient navigation technologies, specifically low-tech solutions that don’t require app downloads, portal log-ins, or high-speed internet, will transform care delivery over the next 5 to 10 years. Successful management of complex conditions like diabetes or cancer requires more than 3 hours of care each day,⁷ yet most patients spend only 1 or 2 hours per month directly interacting with their health care providers. However, most patients carry their phones with them at all times, and artificial intelligence–enabled text support is “always on” to provide support, monitoring, and guidance, wherever a patient happens to be when assistance is needed.

Shifting the Model to Support a Lifetime of Care

While still in the early stages of development, these tools have the potential to radically alter the practice of medicine, shifting the focus from episodic interactions to continuous journey-based care delivery. Outside of an acute event bringing a patient into the clinic or emergency room, many patients go a year or more without seeing their primary care providers.⁸ During that time, an immense amount of information is underreported or completely lost. Capturing this information in real-time and more holistically over a person’s lifetime of care could provide physicians better insight to both better manage and more fully evaluate the success of treatment plans by tracking patient symptoms, pain, and functional status over time. With this more longitudinal view of the patient, we see a pathway towards achieving the Quadruple Aim: patients who are more supported will achieve better outcomes at lower cost, they will have a better experience, and care teams will be empowered to focus their time on more satisfying activities rather than repetitive administrative tasks.

Corresponding author: James A. Colbert, MD, MBA; [email protected]

Disclosures: Dr. Flyckt and Dr. Colbert are employed by Memora Health, an organization that helps health care systems digitize and automate care journeys.

From Memora Health (Dr. Flyckt and Dr. Colbert), San Francisco, CA; and Harvard Medical School (Dr. Colbert), Boston, MA.

A close relative was recently diagnosed with follicular lymphoma. He was cared for at a high-ranked cancer center by physicians with demonstrated expertise, and even had the support of a care navigator. Still, he was often left feeling overwhelmed and confused, holding an inch-thick stack of papers, instructions, and pamphlets. As he left his treatment planning visit, reeling from the emotional burden of his diagnosis and all the unfamiliar terminology, he didn’t know what to do or what to expect. Later, when he experienced early signs of tumor lysis syndrome, he struggled to reach his care team for triage and guidance. When he went to the emergency room, his oncologist was never informed.

This scenario is unfortunately common, and versions of this scenario play out thousands of times each day across the US health system. Within the clinic and hospital setting, patients receive excellent care from their providers, but a disconnect emerges once the patient leaves these medical settings: patients at home struggle to find guidance and support, while care teams lack the tools to engage patients between visits or monitor their health across care settings, providers, or episodes of care.

Leveraging Technology to Move From Episodes of Care to Complex Care Journeys

The use of automated messaging, artificial intelligence and natural language processing–driven chat experiences, and text-based support is becoming more common. However, health care lags behind other industries in the adoption of these technologies.^1,2 The slow pace can be warranted, given that health care is more complicated and higher risk than inquiring about a lost package, ordering groceries, or applying for a mortgage. At the same time, many of the consumer engagement tools used to guide an applicant through the multiple steps and complexities of their home loan process or to prompt viewers to select new shows to binge have applications in health care.

Over the past few years, technologies have emerged that guide patients through complex care journeys and allow care teams to monitor and engage patients between visits. These solutions come in different formats, but generally patients can receive messages on their phones that contain disease-specific educational content, prompts to fill prescriptions and take medications, and reminders and guidance on how to prepare for appointments and procedures. These programs also collect relevant data from patients through survey and electronic patient-reported outcomes instruments, as well as connected patient monitoring devices, that help track patient progress and identify issues as they arise. Many programs also incorporate symptom triage pathways and use natural language processing to respond automatically to patient questions and concerns.^3,4

These technology solutions can automate many tasks that in the past required a care team member to spend hours on the phone. Newly freed from such repetitive tasks, care teams can now focus on more in-depth interactions with those patients who are most in need—the types of interactions that are more satisfying and rewarding. Such assistance is particularly needed today with the staffing shortages faced by most health systems.⁵

In addition, technology allows teams to see the panel of patients they are caring for and to quickly identify and take action on any specific needs or issues. Care teams can focus on any patient and see where they are in their journey. When appropriate, some solutions also allow care teams to engage directly with patients through text-messaging, creating a seamless experience and unified communication channel. Ideally, these solutions should be linked or embedded within the electronic health record or other primary system of record, so that teams can easily access these tools through their existing workflows and avoid creating yet another interface to navigate.

The Impact of Low-Tech Solutions to Deliver High-Touch Support

There is evidence showing that digital patient navigation tools impact patient care. In the oncology setting, patients with a digital navigator have achieved over 95% adherence rates with complex oral chemotherapy regimens (Memora Health Unpublished Data. 2022.). In the postpartum setting, a text message–based program improved screening rates for postpartum depression and did so with very high patient satisfaction ratings.⁶ Particularly notable is the fact that this depression screening program achieved these results in a population that was predominantly low income, with more than half belonging to underrepresented minority populations.⁶

We believe these digital patient navigation technologies, specifically low-tech solutions that don’t require app downloads, portal log-ins, or high-speed internet, will transform care delivery over the next 5 to 10 years. Successful management of complex conditions like diabetes or cancer requires more than 3 hours of care each day,⁷ yet most patients spend only 1 or 2 hours per month directly interacting with their health care providers. However, most patients carry their phones with them at all times, and artificial intelligence–enabled text support is “always on” to provide support, monitoring, and guidance, wherever a patient happens to be when assistance is needed.

Shifting the Model to Support a Lifetime of Care

While still in the early stages of development, these tools have the potential to radically alter the practice of medicine, shifting the focus from episodic interactions to continuous journey-based care delivery. Outside of an acute event bringing a patient into the clinic or emergency room, many patients go a year or more without seeing their primary care providers.⁸ During that time, an immense amount of information is underreported or completely lost. Capturing this information in real-time and more holistically over a person’s lifetime of care could provide physicians better insight to both better manage and more fully evaluate the success of treatment plans by tracking patient symptoms, pain, and functional status over time. With this more longitudinal view of the patient, we see a pathway towards achieving the Quadruple Aim: patients who are more supported will achieve better outcomes at lower cost, they will have a better experience, and care teams will be empowered to focus their time on more satisfying activities rather than repetitive administrative tasks.

Corresponding author: James A. Colbert, MD, MBA; [email protected]

Disclosures: Dr. Flyckt and Dr. Colbert are employed by Memora Health, an organization that helps health care systems digitize and automate care journeys.

From Memora Health (Dr. Flyckt and Dr. Colbert), San Francisco, CA; and Harvard Medical School (Dr. Colbert), Boston, MA.

A close relative was recently diagnosed with follicular lymphoma. He was cared for at a high-ranked cancer center by physicians with demonstrated expertise, and even had the support of a care navigator. Still, he was often left feeling overwhelmed and confused, holding an inch-thick stack of papers, instructions, and pamphlets. As he left his treatment planning visit, reeling from the emotional burden of his diagnosis and all the unfamiliar terminology, he didn’t know what to do or what to expect. Later, when he experienced early signs of tumor lysis syndrome, he struggled to reach his care team for triage and guidance. When he went to the emergency room, his oncologist was never informed.

This scenario is unfortunately common, and versions of this scenario play out thousands of times each day across the US health system. Within the clinic and hospital setting, patients receive excellent care from their providers, but a disconnect emerges once the patient leaves these medical settings: patients at home struggle to find guidance and support, while care teams lack the tools to engage patients between visits or monitor their health across care settings, providers, or episodes of care.

Leveraging Technology to Move From Episodes of Care to Complex Care Journeys

The use of automated messaging, artificial intelligence and natural language processing–driven chat experiences, and text-based support is becoming more common. However, health care lags behind other industries in the adoption of these technologies.^1,2 The slow pace can be warranted, given that health care is more complicated and higher risk than inquiring about a lost package, ordering groceries, or applying for a mortgage. At the same time, many of the consumer engagement tools used to guide an applicant through the multiple steps and complexities of their home loan process or to prompt viewers to select new shows to binge have applications in health care.

Over the past few years, technologies have emerged that guide patients through complex care journeys and allow care teams to monitor and engage patients between visits. These solutions come in different formats, but generally patients can receive messages on their phones that contain disease-specific educational content, prompts to fill prescriptions and take medications, and reminders and guidance on how to prepare for appointments and procedures. These programs also collect relevant data from patients through survey and electronic patient-reported outcomes instruments, as well as connected patient monitoring devices, that help track patient progress and identify issues as they arise. Many programs also incorporate symptom triage pathways and use natural language processing to respond automatically to patient questions and concerns.^3,4

These technology solutions can automate many tasks that in the past required a care team member to spend hours on the phone. Newly freed from such repetitive tasks, care teams can now focus on more in-depth interactions with those patients who are most in need—the types of interactions that are more satisfying and rewarding. Such assistance is particularly needed today with the staffing shortages faced by most health systems.⁵

In addition, technology allows teams to see the panel of patients they are caring for and to quickly identify and take action on any specific needs or issues. Care teams can focus on any patient and see where they are in their journey. When appropriate, some solutions also allow care teams to engage directly with patients through text-messaging, creating a seamless experience and unified communication channel. Ideally, these solutions should be linked or embedded within the electronic health record or other primary system of record, so that teams can easily access these tools through their existing workflows and avoid creating yet another interface to navigate.

The Impact of Low-Tech Solutions to Deliver High-Touch Support

There is evidence showing that digital patient navigation tools impact patient care. In the oncology setting, patients with a digital navigator have achieved over 95% adherence rates with complex oral chemotherapy regimens (Memora Health Unpublished Data. 2022.). In the postpartum setting, a text message–based program improved screening rates for postpartum depression and did so with very high patient satisfaction ratings.⁶ Particularly notable is the fact that this depression screening program achieved these results in a population that was predominantly low income, with more than half belonging to underrepresented minority populations.⁶

We believe these digital patient navigation technologies, specifically low-tech solutions that don’t require app downloads, portal log-ins, or high-speed internet, will transform care delivery over the next 5 to 10 years. Successful management of complex conditions like diabetes or cancer requires more than 3 hours of care each day,⁷ yet most patients spend only 1 or 2 hours per month directly interacting with their health care providers. However, most patients carry their phones with them at all times, and artificial intelligence–enabled text support is “always on” to provide support, monitoring, and guidance, wherever a patient happens to be when assistance is needed.

Shifting the Model to Support a Lifetime of Care

While still in the early stages of development, these tools have the potential to radically alter the practice of medicine, shifting the focus from episodic interactions to continuous journey-based care delivery. Outside of an acute event bringing a patient into the clinic or emergency room, many patients go a year or more without seeing their primary care providers.⁸ During that time, an immense amount of information is underreported or completely lost. Capturing this information in real-time and more holistically over a person’s lifetime of care could provide physicians better insight to both better manage and more fully evaluate the success of treatment plans by tracking patient symptoms, pain, and functional status over time. With this more longitudinal view of the patient, we see a pathway towards achieving the Quadruple Aim: patients who are more supported will achieve better outcomes at lower cost, they will have a better experience, and care teams will be empowered to focus their time on more satisfying activities rather than repetitive administrative tasks.

Corresponding author: James A. Colbert, MD, MBA; [email protected]

Disclosures: Dr. Flyckt and Dr. Colbert are employed by Memora Health, an organization that helps health care systems digitize and automate care journeys.

This issue of the Journal of Clinical Outcomes (JCOM) debuts a new cover design that brings forward the articles and features in each issue. Although the Journal’s cover has a new look, JCOM’s goals remain the same—improving care by disseminating evidence of quality improvement in health care and sharing access to the medical literature with our readers. We continue our mission to promote the best medical practice by providing clinicians with updates and communicating advances that lead to measurable improvement in health care delivery, quality, and outcomes.

As we continue the work of improving health care quality, knowledge gaps and unmet needs in the literature remain. These unmet needs are evident throughout all phases of health care delivery. Moreover, the Institutes of Medicine report that centered on efforts to build a safer health care environment by redesigning health care processes remains salient.¹ The journey to continuous improvement in health care, where we achieve threshold change in the quality of each process and across the entire health care system, requires collective effort. Such efforts include establishing clear metrics and measurements for improvement goals throughout the patient’s journey through diagnosis, treatment, transitions of care, and disease management.^2,3 To address evidence and knowledge gaps in the literature, JCOM publishes reports of original studies and quality improvement projects as well as reviews, providing its 30,000 readers with new evidence to implement in daily practice. We welcome submissions of original research reports, reports of quality improvement projects that follow the SQUIRE 2.0 standards,⁴ and perspectives on developments and innovations in health care delivery.

The next chapter in health care delivery improvement will encompass value-based care.⁵ This new era of clinical outcomes management will dictate the metrics and outcomes reporting⁶ and how to plan future investments. The value-based phase will increase innovation and shape policies that advance population health, transforming every step in the care delivery journey.⁷ The next phase in health care delivery will also create a viable financial structure while implementing effective performance measures for optimal outcomes through patient-centered care and optimization of cost and care strategies. In light of health care’s evolution toward a value-based model, JCOM welcomes submissions of manuscripts that explore themes central to this model, including patient-centered care, implementation of best practices, system design, safety, cost-effectiveness, and the balance between cost optimization and quality. For JCOM’s authors and readers, our editorial team remains commited to the highest standards in timely publishing to support our community through our collective expertise and dedication to quality improvement.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; [email protected]

This issue of the Journal of Clinical Outcomes (JCOM) debuts a new cover design that brings forward the articles and features in each issue. Although the Journal’s cover has a new look, JCOM’s goals remain the same—improving care by disseminating evidence of quality improvement in health care and sharing access to the medical literature with our readers. We continue our mission to promote the best medical practice by providing clinicians with updates and communicating advances that lead to measurable improvement in health care delivery, quality, and outcomes.

As we continue the work of improving health care quality, knowledge gaps and unmet needs in the literature remain. These unmet needs are evident throughout all phases of health care delivery. Moreover, the Institutes of Medicine report that centered on efforts to build a safer health care environment by redesigning health care processes remains salient.¹ The journey to continuous improvement in health care, where we achieve threshold change in the quality of each process and across the entire health care system, requires collective effort. Such efforts include establishing clear metrics and measurements for improvement goals throughout the patient’s journey through diagnosis, treatment, transitions of care, and disease management.^2,3 To address evidence and knowledge gaps in the literature, JCOM publishes reports of original studies and quality improvement projects as well as reviews, providing its 30,000 readers with new evidence to implement in daily practice. We welcome submissions of original research reports, reports of quality improvement projects that follow the SQUIRE 2.0 standards,⁴ and perspectives on developments and innovations in health care delivery.

The next chapter in health care delivery improvement will encompass value-based care.⁵ This new era of clinical outcomes management will dictate the metrics and outcomes reporting⁶ and how to plan future investments. The value-based phase will increase innovation and shape policies that advance population health, transforming every step in the care delivery journey.⁷ The next phase in health care delivery will also create a viable financial structure while implementing effective performance measures for optimal outcomes through patient-centered care and optimization of cost and care strategies. In light of health care’s evolution toward a value-based model, JCOM welcomes submissions of manuscripts that explore themes central to this model, including patient-centered care, implementation of best practices, system design, safety, cost-effectiveness, and the balance between cost optimization and quality. For JCOM’s authors and readers, our editorial team remains commited to the highest standards in timely publishing to support our community through our collective expertise and dedication to quality improvement.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; [email protected]

This issue of the Journal of Clinical Outcomes (JCOM) debuts a new cover design that brings forward the articles and features in each issue. Although the Journal’s cover has a new look, JCOM’s goals remain the same—improving care by disseminating evidence of quality improvement in health care and sharing access to the medical literature with our readers. We continue our mission to promote the best medical practice by providing clinicians with updates and communicating advances that lead to measurable improvement in health care delivery, quality, and outcomes.

As we continue the work of improving health care quality, knowledge gaps and unmet needs in the literature remain. These unmet needs are evident throughout all phases of health care delivery. Moreover, the Institutes of Medicine report that centered on efforts to build a safer health care environment by redesigning health care processes remains salient.¹ The journey to continuous improvement in health care, where we achieve threshold change in the quality of each process and across the entire health care system, requires collective effort. Such efforts include establishing clear metrics and measurements for improvement goals throughout the patient’s journey through diagnosis, treatment, transitions of care, and disease management.^2,3 To address evidence and knowledge gaps in the literature, JCOM publishes reports of original studies and quality improvement projects as well as reviews, providing its 30,000 readers with new evidence to implement in daily practice. We welcome submissions of original research reports, reports of quality improvement projects that follow the SQUIRE 2.0 standards,⁴ and perspectives on developments and innovations in health care delivery.

The next chapter in health care delivery improvement will encompass value-based care.⁵ This new era of clinical outcomes management will dictate the metrics and outcomes reporting⁶ and how to plan future investments. The value-based phase will increase innovation and shape policies that advance population health, transforming every step in the care delivery journey.⁷ The next phase in health care delivery will also create a viable financial structure while implementing effective performance measures for optimal outcomes through patient-centered care and optimization of cost and care strategies. In light of health care’s evolution toward a value-based model, JCOM welcomes submissions of manuscripts that explore themes central to this model, including patient-centered care, implementation of best practices, system design, safety, cost-effectiveness, and the balance between cost optimization and quality. For JCOM’s authors and readers, our editorial team remains commited to the highest standards in timely publishing to support our community through our collective expertise and dedication to quality improvement.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; [email protected]

Susan Snead used to live in an apartment complex for older adults. The complex had a nice dayroom, and neighbors would knock on her door every now and then to check in.

But despite not being lonely, Ms. Snead, 89, did live alone in downtown Charleston, S.C. Eventually, that became dangerous.

“I fell a few times,” she says. “I had to call somebody to come and get me up.”

Sometimes help would come from the apartment complex’s office. Sometimes it came with a police escort.

Over time, needing to make those calls became a burden. Making and keeping appointments with her doctor, something she had to do regularly, as she has diabetes, got harder, too.

“It kind of wore me out,” she says. “Like you’re going up a hill.”

As she was beginning to accept she could no longer live alone, Ms. Snead, an Air Force veteran, learned about a program run by the Department of Veterans Affairs called Medical Foster Home.

Medical foster homes are privately owned homes in which a licensed caregiver lives with and supervises residents around the clock. Caregivers help aging veterans with activities of daily living like bathing, cooking, making and getting to appointments, getting dressed, and taking daily medication.

Caregivers can take care of up to three residents in their home at a time. While most residents are veterans, caregivers sometimes care for non-veteran residents, such as a veteran’s spouse or a caregiver’s family member.

Veterans typically pay about $1,500 to $3,000 out-of-pocket per month for the service, depending on location.

According to the VA, the concept of medical foster homes has been around since 1999, when VA hospitals across the country began reaching out to people willing to provide live-in care for veterans. The option is led by local VA hospitals, which approve caregivers and provide administrative services. There are now 517 medical foster homes, the VA says.

Much like other residential care facilities, medical foster homes get regular inspections for safety, nutrition, and more.

In 2019, Ms. Snead signed up for the program. She expected to be cared for, but she found a sense of family with her caregiver, Wilhelmina Brown, and another veteran in the home.

Ms. Brown started taking care of people – but not necessarily veterans – in 1997 when her grandmother was unable to care for herself, she says.

“My grandmama carried me to church every Sunday, she carried me to the beach – everywhere she went, she took me with her,” Ms. Brown says. As her grandmother got older, “I said, ‘I’m going to take care of her in my home.’ ”

Caring for others must come from the heart, Ms. Brown says.

She cooks her residents’ meals three times a day with dietary restrictions in mind, washes their dishes, does their laundry, remembers birthdays, and plans little parties.

“That’s my family,” Ms. Brown says.

In 2020, the COVID-19 pandemic upended the world – but at the same time, it highlighted the advantages of the medical foster home model.

Home-based primary care keeps veterans out of nursing homes – something that became particularly important as COVID-19 hit nursing homes and long-term care facilities.

Caregivers in the system were also able to help veterans, often living in rural areas, pivot and adapt to telehealth during a time of crisis.

One study, published in the journal Geriatrics, set out to identify how medical foster homes were able to deliver safe, effective health care during the early stages of the pandemic.

Researchers interviewed 37 VA care providers at 16 rural medical foster home programs across the country. The interviews took place between December 2020 and February 2021. They found medical foster home caregivers, coordinators, and health care providers communicated to move office visits to the home, helped veterans navigate telehealth, advocated to get veterans vaccinated in-home, and relied on each other to fight social isolation.

Caregivers also adapted quickly to telehealth, according to Leah Haverhals, PhD, a health research scientist and communications director for the Seattle-Denver Center of Innovation for Veteran Centered and Value Driven Care, who led the study.

Most veterans in the foster home program are older and find new technology difficult to use.

Caregivers, coordinators, and health care providers were largely new to the technology, too.

While the study found that most veterans and caregivers preferred in-person care, they were able to work together to make the best of telehealth.

“That speaks to the nature of the care being given, being able to pivot in a crisis like that,” Dr. Haverhals says.

If caregivers didn’t already have computers or telehealth-compatible devices, the VA provided iPads that would connect to the internet using cellular signals. According to the study, this helped to overcome connectivity issues that may have caused problems in rural areas.

Ms. Snead says Ms. Brown helped a lot with her telehealth calls.

“If we had to do things over the phone or with video, she was able to set that up to work with the person on the other end. She knows a lot about that stuff – about computers and things like that,” Ms. Snead says, adding that she hadn’t worked with computers since retirement in 1998.

Telehealth helped health care providers identify infections and quickly prescribe antibiotics to veterans in rural areas and provide other care that was more safely delivered in private homes.

“The findings from our study highlighted that when working together for the common goal of keeping vulnerable populations like veterans in MFHs [medical foster homes] safe during times of crisis, adaptation and collaboration facilitated the ongoing provision of high-quality care,” Dr. Haverhals’s group wrote. “Such collaboration has been shown to be critical in recent research in the United States on supporting older adults during the pandemic.”

Cari Levy, MD, PhD, a professor at the University of Colorado at Denver, Aurora, and a co-author of the study, specializes in palliative and telenursing home care for the VA.

Dr. Levy, who has worked for the VA for about 20 years, says how medical foster homes provided care during the pandemic carries lessons for civilian clinics. One of the most important lessons, she says, is that medical professionals will need to provide more care where people are, especially in populations that are too sick to get to the clinic.

“For years, there was all this hope that telehealth would expand,” but it took a pandemic to authorize approval from federal agencies to explode, she says. “I shudder to think what would have happened if we didn’t have telehealth. Fortunately, it was the right time to be able to flip a switch.”

Crisis aside, Dr. Levy says her dream would be for health care providers to do more home-based care. The model allows people to preserve the relational aspects of medicine, which can counteract a lot of the moral injury and burnout in the field, she says, adding:

“I see this as the kind of medicine many people intended to do when they got into medicine.”

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

Susan Snead used to live in an apartment complex for older adults. The complex had a nice dayroom, and neighbors would knock on her door every now and then to check in.

But despite not being lonely, Ms. Snead, 89, did live alone in downtown Charleston, S.C. Eventually, that became dangerous.

“I fell a few times,” she says. “I had to call somebody to come and get me up.”

Sometimes help would come from the apartment complex’s office. Sometimes it came with a police escort.

Over time, needing to make those calls became a burden. Making and keeping appointments with her doctor, something she had to do regularly, as she has diabetes, got harder, too.

“It kind of wore me out,” she says. “Like you’re going up a hill.”

As she was beginning to accept she could no longer live alone, Ms. Snead, an Air Force veteran, learned about a program run by the Department of Veterans Affairs called Medical Foster Home.

Medical foster homes are privately owned homes in which a licensed caregiver lives with and supervises residents around the clock. Caregivers help aging veterans with activities of daily living like bathing, cooking, making and getting to appointments, getting dressed, and taking daily medication.

Caregivers can take care of up to three residents in their home at a time. While most residents are veterans, caregivers sometimes care for non-veteran residents, such as a veteran’s spouse or a caregiver’s family member.

Veterans typically pay about $1,500 to $3,000 out-of-pocket per month for the service, depending on location.

According to the VA, the concept of medical foster homes has been around since 1999, when VA hospitals across the country began reaching out to people willing to provide live-in care for veterans. The option is led by local VA hospitals, which approve caregivers and provide administrative services. There are now 517 medical foster homes, the VA says.

Much like other residential care facilities, medical foster homes get regular inspections for safety, nutrition, and more.

In 2019, Ms. Snead signed up for the program. She expected to be cared for, but she found a sense of family with her caregiver, Wilhelmina Brown, and another veteran in the home.

Ms. Brown started taking care of people – but not necessarily veterans – in 1997 when her grandmother was unable to care for herself, she says.

“My grandmama carried me to church every Sunday, she carried me to the beach – everywhere she went, she took me with her,” Ms. Brown says. As her grandmother got older, “I said, ‘I’m going to take care of her in my home.’ ”

Caring for others must come from the heart, Ms. Brown says.

She cooks her residents’ meals three times a day with dietary restrictions in mind, washes their dishes, does their laundry, remembers birthdays, and plans little parties.

“That’s my family,” Ms. Brown says.

In 2020, the COVID-19 pandemic upended the world – but at the same time, it highlighted the advantages of the medical foster home model.

Home-based primary care keeps veterans out of nursing homes – something that became particularly important as COVID-19 hit nursing homes and long-term care facilities.

Caregivers in the system were also able to help veterans, often living in rural areas, pivot and adapt to telehealth during a time of crisis.

One study, published in the journal Geriatrics, set out to identify how medical foster homes were able to deliver safe, effective health care during the early stages of the pandemic.

Researchers interviewed 37 VA care providers at 16 rural medical foster home programs across the country. The interviews took place between December 2020 and February 2021. They found medical foster home caregivers, coordinators, and health care providers communicated to move office visits to the home, helped veterans navigate telehealth, advocated to get veterans vaccinated in-home, and relied on each other to fight social isolation.

Caregivers also adapted quickly to telehealth, according to Leah Haverhals, PhD, a health research scientist and communications director for the Seattle-Denver Center of Innovation for Veteran Centered and Value Driven Care, who led the study.

Most veterans in the foster home program are older and find new technology difficult to use.

Caregivers, coordinators, and health care providers were largely new to the technology, too.

While the study found that most veterans and caregivers preferred in-person care, they were able to work together to make the best of telehealth.

“That speaks to the nature of the care being given, being able to pivot in a crisis like that,” Dr. Haverhals says.

If caregivers didn’t already have computers or telehealth-compatible devices, the VA provided iPads that would connect to the internet using cellular signals. According to the study, this helped to overcome connectivity issues that may have caused problems in rural areas.

Ms. Snead says Ms. Brown helped a lot with her telehealth calls.

“If we had to do things over the phone or with video, she was able to set that up to work with the person on the other end. She knows a lot about that stuff – about computers and things like that,” Ms. Snead says, adding that she hadn’t worked with computers since retirement in 1998.

Telehealth helped health care providers identify infections and quickly prescribe antibiotics to veterans in rural areas and provide other care that was more safely delivered in private homes.

“The findings from our study highlighted that when working together for the common goal of keeping vulnerable populations like veterans in MFHs [medical foster homes] safe during times of crisis, adaptation and collaboration facilitated the ongoing provision of high-quality care,” Dr. Haverhals’s group wrote. “Such collaboration has been shown to be critical in recent research in the United States on supporting older adults during the pandemic.”

Cari Levy, MD, PhD, a professor at the University of Colorado at Denver, Aurora, and a co-author of the study, specializes in palliative and telenursing home care for the VA.

Dr. Levy, who has worked for the VA for about 20 years, says how medical foster homes provided care during the pandemic carries lessons for civilian clinics. One of the most important lessons, she says, is that medical professionals will need to provide more care where people are, especially in populations that are too sick to get to the clinic.

“For years, there was all this hope that telehealth would expand,” but it took a pandemic to authorize approval from federal agencies to explode, she says. “I shudder to think what would have happened if we didn’t have telehealth. Fortunately, it was the right time to be able to flip a switch.”

Crisis aside, Dr. Levy says her dream would be for health care providers to do more home-based care. The model allows people to preserve the relational aspects of medicine, which can counteract a lot of the moral injury and burnout in the field, she says, adding:

“I see this as the kind of medicine many people intended to do when they got into medicine.”

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

Susan Snead used to live in an apartment complex for older adults. The complex had a nice dayroom, and neighbors would knock on her door every now and then to check in.

But despite not being lonely, Ms. Snead, 89, did live alone in downtown Charleston, S.C. Eventually, that became dangerous.

“I fell a few times,” she says. “I had to call somebody to come and get me up.”

Sometimes help would come from the apartment complex’s office. Sometimes it came with a police escort.

Over time, needing to make those calls became a burden. Making and keeping appointments with her doctor, something she had to do regularly, as she has diabetes, got harder, too.

“It kind of wore me out,” she says. “Like you’re going up a hill.”

As she was beginning to accept she could no longer live alone, Ms. Snead, an Air Force veteran, learned about a program run by the Department of Veterans Affairs called Medical Foster Home.

Medical foster homes are privately owned homes in which a licensed caregiver lives with and supervises residents around the clock. Caregivers help aging veterans with activities of daily living like bathing, cooking, making and getting to appointments, getting dressed, and taking daily medication.

Caregivers can take care of up to three residents in their home at a time. While most residents are veterans, caregivers sometimes care for non-veteran residents, such as a veteran’s spouse or a caregiver’s family member.

Veterans typically pay about $1,500 to $3,000 out-of-pocket per month for the service, depending on location.

According to the VA, the concept of medical foster homes has been around since 1999, when VA hospitals across the country began reaching out to people willing to provide live-in care for veterans. The option is led by local VA hospitals, which approve caregivers and provide administrative services. There are now 517 medical foster homes, the VA says.

Much like other residential care facilities, medical foster homes get regular inspections for safety, nutrition, and more.

In 2019, Ms. Snead signed up for the program. She expected to be cared for, but she found a sense of family with her caregiver, Wilhelmina Brown, and another veteran in the home.

Ms. Brown started taking care of people – but not necessarily veterans – in 1997 when her grandmother was unable to care for herself, she says.

“My grandmama carried me to church every Sunday, she carried me to the beach – everywhere she went, she took me with her,” Ms. Brown says. As her grandmother got older, “I said, ‘I’m going to take care of her in my home.’ ”

Caring for others must come from the heart, Ms. Brown says.

She cooks her residents’ meals three times a day with dietary restrictions in mind, washes their dishes, does their laundry, remembers birthdays, and plans little parties.

“That’s my family,” Ms. Brown says.

In 2020, the COVID-19 pandemic upended the world – but at the same time, it highlighted the advantages of the medical foster home model.

Home-based primary care keeps veterans out of nursing homes – something that became particularly important as COVID-19 hit nursing homes and long-term care facilities.

Caregivers in the system were also able to help veterans, often living in rural areas, pivot and adapt to telehealth during a time of crisis.

One study, published in the journal Geriatrics, set out to identify how medical foster homes were able to deliver safe, effective health care during the early stages of the pandemic.

Researchers interviewed 37 VA care providers at 16 rural medical foster home programs across the country. The interviews took place between December 2020 and February 2021. They found medical foster home caregivers, coordinators, and health care providers communicated to move office visits to the home, helped veterans navigate telehealth, advocated to get veterans vaccinated in-home, and relied on each other to fight social isolation.

Caregivers also adapted quickly to telehealth, according to Leah Haverhals, PhD, a health research scientist and communications director for the Seattle-Denver Center of Innovation for Veteran Centered and Value Driven Care, who led the study.

Most veterans in the foster home program are older and find new technology difficult to use.

Caregivers, coordinators, and health care providers were largely new to the technology, too.

While the study found that most veterans and caregivers preferred in-person care, they were able to work together to make the best of telehealth.

“That speaks to the nature of the care being given, being able to pivot in a crisis like that,” Dr. Haverhals says.

If caregivers didn’t already have computers or telehealth-compatible devices, the VA provided iPads that would connect to the internet using cellular signals. According to the study, this helped to overcome connectivity issues that may have caused problems in rural areas.

Ms. Snead says Ms. Brown helped a lot with her telehealth calls.

“If we had to do things over the phone or with video, she was able to set that up to work with the person on the other end. She knows a lot about that stuff – about computers and things like that,” Ms. Snead says, adding that she hadn’t worked with computers since retirement in 1998.

Telehealth helped health care providers identify infections and quickly prescribe antibiotics to veterans in rural areas and provide other care that was more safely delivered in private homes.

“The findings from our study highlighted that when working together for the common goal of keeping vulnerable populations like veterans in MFHs [medical foster homes] safe during times of crisis, adaptation and collaboration facilitated the ongoing provision of high-quality care,” Dr. Haverhals’s group wrote. “Such collaboration has been shown to be critical in recent research in the United States on supporting older adults during the pandemic.”

Cari Levy, MD, PhD, a professor at the University of Colorado at Denver, Aurora, and a co-author of the study, specializes in palliative and telenursing home care for the VA.

Dr. Levy, who has worked for the VA for about 20 years, says how medical foster homes provided care during the pandemic carries lessons for civilian clinics. One of the most important lessons, she says, is that medical professionals will need to provide more care where people are, especially in populations that are too sick to get to the clinic.

“For years, there was all this hope that telehealth would expand,” but it took a pandemic to authorize approval from federal agencies to explode, she says. “I shudder to think what would have happened if we didn’t have telehealth. Fortunately, it was the right time to be able to flip a switch.”

Crisis aside, Dr. Levy says her dream would be for health care providers to do more home-based care. The model allows people to preserve the relational aspects of medicine, which can counteract a lot of the moral injury and burnout in the field, she says, adding:

“I see this as the kind of medicine many people intended to do when they got into medicine.”

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

To the Editor:

There is increasing demand for medical care in the United States due to expanded health care coverage; an aging population; and advancements in diagnostics, treatment, and technology.¹ It is predicted that by 2050 the number of dermatologists will be 24.4% short of the expected estimate of demand.²

Accordingly, dermatologists are increasingly practicing in team-based care delivery models that incorporate nonphysician clinicians (NPCs), including nurse practitioners and physician assistants.¹ Despite recognition that NPCs are taking a larger role in medical teams, there is, to our knowledge, limited training for dermatologists and dermatologists in-training to optimize this professional alliance.

The objectives of this study included (1) determining whether residency programs adequately prepare residents to work with or supervise NPCs and (2) understanding the relationship between NPCs and dermatology residents across residency programs in the United States.

An anonymous cross-sectional, Internet-based survey designed using Google Forms survey creation and administration software was distributed to 117 dermatology residency program directors through email, with a request for further dissemination to residents through self-maintained listserves. Four email reminders about completing and disseminating the survey were sent to program directors between August and November 2020. The study was approved by the Emory University institutional review board. All respondents consented to participate in this survey prior to completing it.

The survey included questions pertaining to demographic information, residents’ experiences working with NPCs, residency program training specific to working with NPCs, and residents’ and residency program directors’ opinions on NPCs’ impact on education and patient care. Program directors were asked to respond N/A to 6 questions on the survey because data from those questions represented residents’ opinions only. Questions relating to residents’ and residency program directors’ opinions were based on a 5-point scale of impact (1=strongly impact in a negative way; 5=strongly impact in a positive way) or importance (1=not at all important; 5=extremely important). The survey was not previously validated.

Descriptive analysis and a paired t test were conducted when appropriate. Missing data were excluded.

There were 81 respondents to the survey. Demographic information is shown Table 1. Thirty-five dermatology residency program directors (29.9% of 117 programs) responded. Of the 45 residents or recent graduates, 29 (64.4%) reported that they foresaw the need to work with or supervise NPCs in the future (Table 2). Currently, 29 (64.4%) residents also reported that (1) they do not feel adequately trained to provide supervision of or to work with NPCs or (2) were uncertain whether they could do so. Sixty-five (80.2%) respondents stated that there was no formalized training in their program for supervising or working with NPCs; 45 (55.6%) respondents noted that they do not think that their program provided adequate training in supervising NPCs.

Regarding NPCs impact on care, residency program directors who completed the survey were more likely to rank NPCs as having a more significant positive impact on patient care than residents (mean score, 3.43 vs 2.78; P=.043; 95% CI, –1.28 to –0.20)(Table 3).

This study demonstrated a lack of dermatology training related to working with NPCs in a professional setting and highlighted residents’ perception that formal education in working with and supervising NPCs could be of benefit to their education. Furthermore, residency directors perceived NPCs as having a greater positive impact on patient care than residents did, underscoring the importance of the continued need to educate residents on working synergistically with NPCs to optimize patient care. Ultimately, these results suggest a potential area for further development of residency curricula.

There are approximately 360,000 NPCs serving as integral members of interdisciplinary medical teams across the United States.^3,4 In a 2014 survey, 46% of 2001 dermatologists noted that they already employed 1 or more NPCs, a number that has increased over time and is likely to continue to do so.⁵ Although the number of NPCs in dermatology has increased, there remain limited formal training and certificate programs for these providers.^1,6

Furthermore, the American Academy of Dermatology recommends that “[w]hen practicing in a dermatological setting, non-dermatologist physicians and non-physician clinicians . . . should be directly supervised by a board-certified dermatologist.”⁷ Therefore, the responsibility for a dermatology-specific education can fall on the dermatologist, necessitating adequate supervision and training of NPCs.

The findings of this study were limited by a small sample size; response bias because distribution of the survey relied on program directors disseminating the instrument to their residents, thereby limiting generalizability; and a lack of predissemination validation of the survey. Additional research in this area should focus on survey validation and distribution directly to dermatology residents, instead of relying on dermatology program directors to disseminate the survey.

To the Editor:

There is increasing demand for medical care in the United States due to expanded health care coverage; an aging population; and advancements in diagnostics, treatment, and technology.¹ It is predicted that by 2050 the number of dermatologists will be 24.4% short of the expected estimate of demand.²

Accordingly, dermatologists are increasingly practicing in team-based care delivery models that incorporate nonphysician clinicians (NPCs), including nurse practitioners and physician assistants.¹ Despite recognition that NPCs are taking a larger role in medical teams, there is, to our knowledge, limited training for dermatologists and dermatologists in-training to optimize this professional alliance.

The objectives of this study included (1) determining whether residency programs adequately prepare residents to work with or supervise NPCs and (2) understanding the relationship between NPCs and dermatology residents across residency programs in the United States.

An anonymous cross-sectional, Internet-based survey designed using Google Forms survey creation and administration software was distributed to 117 dermatology residency program directors through email, with a request for further dissemination to residents through self-maintained listserves. Four email reminders about completing and disseminating the survey were sent to program directors between August and November 2020. The study was approved by the Emory University institutional review board. All respondents consented to participate in this survey prior to completing it.

The survey included questions pertaining to demographic information, residents’ experiences working with NPCs, residency program training specific to working with NPCs, and residents’ and residency program directors’ opinions on NPCs’ impact on education and patient care. Program directors were asked to respond N/A to 6 questions on the survey because data from those questions represented residents’ opinions only. Questions relating to residents’ and residency program directors’ opinions were based on a 5-point scale of impact (1=strongly impact in a negative way; 5=strongly impact in a positive way) or importance (1=not at all important; 5=extremely important). The survey was not previously validated.

Descriptive analysis and a paired t test were conducted when appropriate. Missing data were excluded.

There were 81 respondents to the survey. Demographic information is shown Table 1. Thirty-five dermatology residency program directors (29.9% of 117 programs) responded. Of the 45 residents or recent graduates, 29 (64.4%) reported that they foresaw the need to work with or supervise NPCs in the future (Table 2). Currently, 29 (64.4%) residents also reported that (1) they do not feel adequately trained to provide supervision of or to work with NPCs or (2) were uncertain whether they could do so. Sixty-five (80.2%) respondents stated that there was no formalized training in their program for supervising or working with NPCs; 45 (55.6%) respondents noted that they do not think that their program provided adequate training in supervising NPCs.

Regarding NPCs impact on care, residency program directors who completed the survey were more likely to rank NPCs as having a more significant positive impact on patient care than residents (mean score, 3.43 vs 2.78; P=.043; 95% CI, –1.28 to –0.20)(Table 3).

This study demonstrated a lack of dermatology training related to working with NPCs in a professional setting and highlighted residents’ perception that formal education in working with and supervising NPCs could be of benefit to their education. Furthermore, residency directors perceived NPCs as having a greater positive impact on patient care than residents did, underscoring the importance of the continued need to educate residents on working synergistically with NPCs to optimize patient care. Ultimately, these results suggest a potential area for further development of residency curricula.

There are approximately 360,000 NPCs serving as integral members of interdisciplinary medical teams across the United States.^3,4 In a 2014 survey, 46% of 2001 dermatologists noted that they already employed 1 or more NPCs, a number that has increased over time and is likely to continue to do so.⁵ Although the number of NPCs in dermatology has increased, there remain limited formal training and certificate programs for these providers.^1,6

Furthermore, the American Academy of Dermatology recommends that “[w]hen practicing in a dermatological setting, non-dermatologist physicians and non-physician clinicians . . . should be directly supervised by a board-certified dermatologist.”⁷ Therefore, the responsibility for a dermatology-specific education can fall on the dermatologist, necessitating adequate supervision and training of NPCs.

The findings of this study were limited by a small sample size; response bias because distribution of the survey relied on program directors disseminating the instrument to their residents, thereby limiting generalizability; and a lack of predissemination validation of the survey. Additional research in this area should focus on survey validation and distribution directly to dermatology residents, instead of relying on dermatology program directors to disseminate the survey.

To the Editor:

There is increasing demand for medical care in the United States due to expanded health care coverage; an aging population; and advancements in diagnostics, treatment, and technology.¹ It is predicted that by 2050 the number of dermatologists will be 24.4% short of the expected estimate of demand.²

Accordingly, dermatologists are increasingly practicing in team-based care delivery models that incorporate nonphysician clinicians (NPCs), including nurse practitioners and physician assistants.¹ Despite recognition that NPCs are taking a larger role in medical teams, there is, to our knowledge, limited training for dermatologists and dermatologists in-training to optimize this professional alliance.

The objectives of this study included (1) determining whether residency programs adequately prepare residents to work with or supervise NPCs and (2) understanding the relationship between NPCs and dermatology residents across residency programs in the United States.

An anonymous cross-sectional, Internet-based survey designed using Google Forms survey creation and administration software was distributed to 117 dermatology residency program directors through email, with a request for further dissemination to residents through self-maintained listserves. Four email reminders about completing and disseminating the survey were sent to program directors between August and November 2020. The study was approved by the Emory University institutional review board. All respondents consented to participate in this survey prior to completing it.

The survey included questions pertaining to demographic information, residents’ experiences working with NPCs, residency program training specific to working with NPCs, and residents’ and residency program directors’ opinions on NPCs’ impact on education and patient care. Program directors were asked to respond N/A to 6 questions on the survey because data from those questions represented residents’ opinions only. Questions relating to residents’ and residency program directors’ opinions were based on a 5-point scale of impact (1=strongly impact in a negative way; 5=strongly impact in a positive way) or importance (1=not at all important; 5=extremely important). The survey was not previously validated.

Descriptive analysis and a paired t test were conducted when appropriate. Missing data were excluded.

There were 81 respondents to the survey. Demographic information is shown Table 1. Thirty-five dermatology residency program directors (29.9% of 117 programs) responded. Of the 45 residents or recent graduates, 29 (64.4%) reported that they foresaw the need to work with or supervise NPCs in the future (Table 2). Currently, 29 (64.4%) residents also reported that (1) they do not feel adequately trained to provide supervision of or to work with NPCs or (2) were uncertain whether they could do so. Sixty-five (80.2%) respondents stated that there was no formalized training in their program for supervising or working with NPCs; 45 (55.6%) respondents noted that they do not think that their program provided adequate training in supervising NPCs.

Regarding NPCs impact on care, residency program directors who completed the survey were more likely to rank NPCs as having a more significant positive impact on patient care than residents (mean score, 3.43 vs 2.78; P=.043; 95% CI, –1.28 to –0.20)(Table 3).

This study demonstrated a lack of dermatology training related to working with NPCs in a professional setting and highlighted residents’ perception that formal education in working with and supervising NPCs could be of benefit to their education. Furthermore, residency directors perceived NPCs as having a greater positive impact on patient care than residents did, underscoring the importance of the continued need to educate residents on working synergistically with NPCs to optimize patient care. Ultimately, these results suggest a potential area for further development of residency curricula.

There are approximately 360,000 NPCs serving as integral members of interdisciplinary medical teams across the United States.^3,4 In a 2014 survey, 46% of 2001 dermatologists noted that they already employed 1 or more NPCs, a number that has increased over time and is likely to continue to do so.⁵ Although the number of NPCs in dermatology has increased, there remain limited formal training and certificate programs for these providers.^1,6

Furthermore, the American Academy of Dermatology recommends that “[w]hen practicing in a dermatological setting, non-dermatologist physicians and non-physician clinicians . . . should be directly supervised by a board-certified dermatologist.”⁷ Therefore, the responsibility for a dermatology-specific education can fall on the dermatologist, necessitating adequate supervision and training of NPCs.

The findings of this study were limited by a small sample size; response bias because distribution of the survey relied on program directors disseminating the instrument to their residents, thereby limiting generalizability; and a lack of predissemination validation of the survey. Additional research in this area should focus on survey validation and distribution directly to dermatology residents, instead of relying on dermatology program directors to disseminate the survey.

Pharmacists can now prescribe Paxlovid, Pfizer’s COVID-19 antiviral pill, directly to patients.

The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.

Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.

“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.

Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”

“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.

But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”

“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.

After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.

Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.

If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.

In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.

Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.

Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.

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

Pharmacists can now prescribe Paxlovid, Pfizer’s COVID-19 antiviral pill, directly to patients.

The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.

Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.

“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.

Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”

“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.

But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”

“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.

After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.

Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.

If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.

In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.

Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.

Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.

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

Pharmacists can now prescribe Paxlovid, Pfizer’s COVID-19 antiviral pill, directly to patients.

The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.

Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.

“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.

Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”

“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.

But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”

“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.

After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.

Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.

If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.

In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.

Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.

Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.

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

World Health Organization officials announced July 6 that they’re tracking a new subvariant of Omicron, which is becoming more common in India.

The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.

“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.

The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.

“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.

The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.

Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.

BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.

Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.

The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.

BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.

“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.

“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.

Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.

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

World Health Organization officials announced July 6 that they’re tracking a new subvariant of Omicron, which is becoming more common in India.

The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.

“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.

The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.

“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.

The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.

Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.

BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.

Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.

The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.

BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.

“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.

“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.

Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.

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

World Health Organization officials announced July 6 that they’re tracking a new subvariant of Omicron, which is becoming more common in India.

The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.

“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.

The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.

“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.

The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.

Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.

BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.

Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.

The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.

BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.

“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.

“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.

Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.

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

To the Editor:

A 47-year-old man presented at the dermatology clinic with a growing lesion on the left medial thigh. The patient traveled frequently for work. Although asymptomatic, the lesion was interfering with the patient’s ability to get through security because it routinely was getting detected by airport full-body scanners. These scanners use high-frequency radio waves or x-rays to detect nonmetallic objects under a traveler’s clothing. The patient would be frisked by security and had to explain that he had a growth in that location. He thankfully would be released by security on those occasions, but the delay in getting through security was becoming a nuisance.

Physical examination revealed a 5-cm, pedunculated, fatty nodule on the left medial thigh that was clinically consistent with nevus lipomatosis (NL)(Figure). Although benign, trouble traveling through airport security prompted the patient to request shave removal, which subsequently was performed. Histology showed a large pedunculated nodule with prominent adipose tissue, consistent with NL. At 3-month follow-up, the patient reported getting through airport security multiple times without incident.

Nevus lipomatosis is a benign fatty lesion most commonly found on the medial thighs or trunk of adults. The lesion usually is asymptomatic but can become irritated by rubbing or catching on clothing. Our patient had symptomatic NL that caused delays getting through airport security; he experienced full resolution after simple shave removal. In rare instances, both benign and malignant skin conditions have been seen on airport scanning devices since the introduction of increased security measures following September 11, 2001. In 2016, Heymann¹ reported a man with a 1.5-cm epidermal inclusion cyst detected by airport security scanners, prompting the traveler to request and carry a medically explanatory letter used to get through security. In 2015 Mayer and Adams² described a case of nodular melanoma that was detected 20 times over a period of 2 months by airport scanners, and in 2016, Caine et al³ reported a case of desmoplastic melanoma that was detected by airport security, but after its removal was not identified by security for the next 40 flights. Noncutaneous pathology also can be detected by airport scanners. In 2013, Naraynsingh et al⁴ reported a man with a large left reducible inguinal hernia who was stopped by airport security and subjected to an invasive physical examination of the area. These instances demonstrate the breadth of conditions that can be cumbersome when individuals are traveling by airplane in our current security climate.

Our patient had to go through the trouble of having the benign NL lesion removed to avoid the hassle of repeatedly being stopped by airport security. The patient had the lesion removed and is doing well, but the procedure could have been avoided if systems existed to help patients with dermatologic and medical conditions at airport security. Our patient likely will never be stopped again for the suspicious lump on the left inner thigh, but many others will be stopped for similar reasons.

To the Editor:

A 47-year-old man presented at the dermatology clinic with a growing lesion on the left medial thigh. The patient traveled frequently for work. Although asymptomatic, the lesion was interfering with the patient’s ability to get through security because it routinely was getting detected by airport full-body scanners. These scanners use high-frequency radio waves or x-rays to detect nonmetallic objects under a traveler’s clothing. The patient would be frisked by security and had to explain that he had a growth in that location. He thankfully would be released by security on those occasions, but the delay in getting through security was becoming a nuisance.

Physical examination revealed a 5-cm, pedunculated, fatty nodule on the left medial thigh that was clinically consistent with nevus lipomatosis (NL)(Figure). Although benign, trouble traveling through airport security prompted the patient to request shave removal, which subsequently was performed. Histology showed a large pedunculated nodule with prominent adipose tissue, consistent with NL. At 3-month follow-up, the patient reported getting through airport security multiple times without incident.

Nevus lipomatosis is a benign fatty lesion most commonly found on the medial thighs or trunk of adults. The lesion usually is asymptomatic but can become irritated by rubbing or catching on clothing. Our patient had symptomatic NL that caused delays getting through airport security; he experienced full resolution after simple shave removal. In rare instances, both benign and malignant skin conditions have been seen on airport scanning devices since the introduction of increased security measures following September 11, 2001. In 2016, Heymann¹ reported a man with a 1.5-cm epidermal inclusion cyst detected by airport security scanners, prompting the traveler to request and carry a medically explanatory letter used to get through security. In 2015 Mayer and Adams² described a case of nodular melanoma that was detected 20 times over a period of 2 months by airport scanners, and in 2016, Caine et al³ reported a case of desmoplastic melanoma that was detected by airport security, but after its removal was not identified by security for the next 40 flights. Noncutaneous pathology also can be detected by airport scanners. In 2013, Naraynsingh et al⁴ reported a man with a large left reducible inguinal hernia who was stopped by airport security and subjected to an invasive physical examination of the area. These instances demonstrate the breadth of conditions that can be cumbersome when individuals are traveling by airplane in our current security climate.

Our patient had to go through the trouble of having the benign NL lesion removed to avoid the hassle of repeatedly being stopped by airport security. The patient had the lesion removed and is doing well, but the procedure could have been avoided if systems existed to help patients with dermatologic and medical conditions at airport security. Our patient likely will never be stopped again for the suspicious lump on the left inner thigh, but many others will be stopped for similar reasons.

To the Editor:

A 47-year-old man presented at the dermatology clinic with a growing lesion on the left medial thigh. The patient traveled frequently for work. Although asymptomatic, the lesion was interfering with the patient’s ability to get through security because it routinely was getting detected by airport full-body scanners. These scanners use high-frequency radio waves or x-rays to detect nonmetallic objects under a traveler’s clothing. The patient would be frisked by security and had to explain that he had a growth in that location. He thankfully would be released by security on those occasions, but the delay in getting through security was becoming a nuisance.

Physical examination revealed a 5-cm, pedunculated, fatty nodule on the left medial thigh that was clinically consistent with nevus lipomatosis (NL)(Figure). Although benign, trouble traveling through airport security prompted the patient to request shave removal, which subsequently was performed. Histology showed a large pedunculated nodule with prominent adipose tissue, consistent with NL. At 3-month follow-up, the patient reported getting through airport security multiple times without incident.

Nevus lipomatosis is a benign fatty lesion most commonly found on the medial thighs or trunk of adults. The lesion usually is asymptomatic but can become irritated by rubbing or catching on clothing. Our patient had symptomatic NL that caused delays getting through airport security; he experienced full resolution after simple shave removal. In rare instances, both benign and malignant skin conditions have been seen on airport scanning devices since the introduction of increased security measures following September 11, 2001. In 2016, Heymann¹ reported a man with a 1.5-cm epidermal inclusion cyst detected by airport security scanners, prompting the traveler to request and carry a medically explanatory letter used to get through security. In 2015 Mayer and Adams² described a case of nodular melanoma that was detected 20 times over a period of 2 months by airport scanners, and in 2016, Caine et al³ reported a case of desmoplastic melanoma that was detected by airport security, but after its removal was not identified by security for the next 40 flights. Noncutaneous pathology also can be detected by airport scanners. In 2013, Naraynsingh et al⁴ reported a man with a large left reducible inguinal hernia who was stopped by airport security and subjected to an invasive physical examination of the area. These instances demonstrate the breadth of conditions that can be cumbersome when individuals are traveling by airplane in our current security climate.

Our patient had to go through the trouble of having the benign NL lesion removed to avoid the hassle of repeatedly being stopped by airport security. The patient had the lesion removed and is doing well, but the procedure could have been avoided if systems existed to help patients with dermatologic and medical conditions at airport security. Our patient likely will never be stopped again for the suspicious lump on the left inner thigh, but many others will be stopped for similar reasons.

Republican and Democratic members of the House called for changes in how insurer-run Medicare plans manage the prior authorization process, following testimony from a federal watchdog organization about improper denials of payment for care.

About 18% of payment denials in a sample examined by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) either met Medicare coverage rules or the rules of the insurance plan.

As such, they should not have been denied, according to the OIG. That was the finding of an April OIG report, based on a sample of 2019 denials from large insurer-run Medicare plans.

Erin Bliss, an assistant inspector general with the OIG, appeared as a witness at a June 28 Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss this investigation and other issues with prior authorization and insurer-run Medicare, also known as the Advantage plans.

Most of these payment denials of appropriate services were due to human error during manual claims-processing reviews, Ms. Bliss told the subcommittee, such as overlooking a document, and to system processing errors, such as a Medicare insurance plan failing to program or update a system correctly.

In many cases, these denials were reversed, but patient care was still disrupted and clinicians lost time chasing clearances for services that plans already had covered, Ms. Bliss said in her testimony.

The April report was not the OIG’s first look into concerns about insurer-run plans inappropriately denying care through prior authorizations. The OIG in 2018 reported that insurer-run Medicare plans overturned 75% of their own denials during 2014-2016 when patients and clinicians appealed these decisions, overturning approximately 216,000 denials each year.

‘Numerous hoops’ unnecessary for doctors, patients

Lawmakers at the hearing supported the idea of the need for prior authorization as a screening tool to prevent unneeded care.

But they chided insurance companies for their execution of this process, with clinicians and patients often frustrated by complex steps needed. Medicare Advantage plans sometimes require prior authorization for “relatively standard medical services,” said Subcommittee on Oversight and Investigations Chair Diana DeGette (D-Colo.).

“Our seniors and their doctors should not be required to jump through numerous hoops to ensure coverage for straightforward and medically necessary procedures,” Rep. DeGette said.

Several lawmakers spoke at the hearing about the need for changes to prior authorization, including calling for action on a pending bill intended to compel insurers to streamline the review process. The Improving Seniors’ Timely Access to Care Act of 2021 already has attracted more than 300 bipartisan sponsors. A companion Senate bill has more than 30 sponsors.

The bill’s aim is to shift this process away from faxes and phone calls while also encouraging plans to adhere to evidence-based medical guidelines in consultation with physicians. The bill calls for the establishment of an electronic prior authorization program that could issue real-time decisions.

“The result will be less administrative burden for providers and more information in the hands of patients. It will allow more patients to receive care when they need it, reducing the likelihood of additional, often more severe complications,” said Rep. Larry Bucshon, MD, (R-Ind.) who is among the active sponsors of the bill.

“In the long term, I believe it would also result in cost savings for the health care system at large by identifying problems earlier and getting them treated before their patients have more complications,” Rep. Bucshon added.
 

Finding ‘room for improvement’ for prior authorizations

There’s strong bipartisan support in Congress for insurer-run Medicare, which has grown by 10% per year over the last several years and has doubled since 2010, according to the Medicare Payment Advisory Commission (MedPAC). About 27 million people are now enrolled in these plans.

But for that reason, insurer-run Medicare may also need more careful watching, lawmakers made clear at the hearing.

“We’ve heard quite a bit of evidence today that there is room for improvement,” said Rep. Bucshon, a strong supporter of insurer-run Medicare, which can offer patients added benefits such as dental coverage.

Rep. Ann Kuster (D-N.H.) said simplifying prior authorization would reduce stress on clinicians already dealing with burnout.

“They’re just so tired of all this paperwork and red tape,” Rep. Kuster said. “In 2022 can’t we at least consider electronic prior authorization?”

At the hearing, Rep. Michael C. Burgess, MD, (R-Tex.) noted that his home state already has taken a step toward reducing the burden of prior authorization with its “gold card” program.

In 2021, a new Texas law called on the state department of insurance to develop rules to require health plans to provide an exemption from preauthorization requirements for a particular health care service if the issuer has approved, or would have approved, at least 90% of the preauthorization requests submitted by the physician or provider for that service. The law also mandates that a physician participating in a peer-to-peer review on behalf of a health benefit plan issuer must be a Texas-licensed physician who has the same or similar specialty as the physician or clinician requesting the service, according to the state insurance department.

Separately, Rep. Suzan DelBene (D-Wash.), the sponsor of the Improving Seniors’ Timely Access to Care Act, told the American Medical Association in a recent interview that she expects the House Ways and Means Committee, on which she serves, to mark up her bill in July. (A mark-up is the process by which a House or Senate committee considers and often amends a bill and then sends it to the chamber’s leadership for a floor vote.)

In a statement issued about the hearing, America’s Health Insurance Plans (AHIP) noted that there has been work in recent years toward streamlining prior authorization. AHIP said it launched the Fast Prior Authorization Technology Highway (Fast PATH) initiative in 2020 to study electronic procedures for handling these reviews.

“The findings of this study showed that ePA delivered improvements with a strong majority of experienced providers reporting faster time to patient care, fewer phone calls and faxes, better understanding of [prior authorization] requirements, and faster time to decisions,” AHIP said.

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

Republican and Democratic members of the House called for changes in how insurer-run Medicare plans manage the prior authorization process, following testimony from a federal watchdog organization about improper denials of payment for care.

About 18% of payment denials in a sample examined by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) either met Medicare coverage rules or the rules of the insurance plan.

As such, they should not have been denied, according to the OIG. That was the finding of an April OIG report, based on a sample of 2019 denials from large insurer-run Medicare plans.

Erin Bliss, an assistant inspector general with the OIG, appeared as a witness at a June 28 Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss this investigation and other issues with prior authorization and insurer-run Medicare, also known as the Advantage plans.

Most of these payment denials of appropriate services were due to human error during manual claims-processing reviews, Ms. Bliss told the subcommittee, such as overlooking a document, and to system processing errors, such as a Medicare insurance plan failing to program or update a system correctly.

In many cases, these denials were reversed, but patient care was still disrupted and clinicians lost time chasing clearances for services that plans already had covered, Ms. Bliss said in her testimony.

The April report was not the OIG’s first look into concerns about insurer-run plans inappropriately denying care through prior authorizations. The OIG in 2018 reported that insurer-run Medicare plans overturned 75% of their own denials during 2014-2016 when patients and clinicians appealed these decisions, overturning approximately 216,000 denials each year.

‘Numerous hoops’ unnecessary for doctors, patients

Lawmakers at the hearing supported the idea of the need for prior authorization as a screening tool to prevent unneeded care.

But they chided insurance companies for their execution of this process, with clinicians and patients often frustrated by complex steps needed. Medicare Advantage plans sometimes require prior authorization for “relatively standard medical services,” said Subcommittee on Oversight and Investigations Chair Diana DeGette (D-Colo.).

“Our seniors and their doctors should not be required to jump through numerous hoops to ensure coverage for straightforward and medically necessary procedures,” Rep. DeGette said.

Several lawmakers spoke at the hearing about the need for changes to prior authorization, including calling for action on a pending bill intended to compel insurers to streamline the review process. The Improving Seniors’ Timely Access to Care Act of 2021 already has attracted more than 300 bipartisan sponsors. A companion Senate bill has more than 30 sponsors.

The bill’s aim is to shift this process away from faxes and phone calls while also encouraging plans to adhere to evidence-based medical guidelines in consultation with physicians. The bill calls for the establishment of an electronic prior authorization program that could issue real-time decisions.

“The result will be less administrative burden for providers and more information in the hands of patients. It will allow more patients to receive care when they need it, reducing the likelihood of additional, often more severe complications,” said Rep. Larry Bucshon, MD, (R-Ind.) who is among the active sponsors of the bill.

“In the long term, I believe it would also result in cost savings for the health care system at large by identifying problems earlier and getting them treated before their patients have more complications,” Rep. Bucshon added.
 

Finding ‘room for improvement’ for prior authorizations

There’s strong bipartisan support in Congress for insurer-run Medicare, which has grown by 10% per year over the last several years and has doubled since 2010, according to the Medicare Payment Advisory Commission (MedPAC). About 27 million people are now enrolled in these plans.

But for that reason, insurer-run Medicare may also need more careful watching, lawmakers made clear at the hearing.

“We’ve heard quite a bit of evidence today that there is room for improvement,” said Rep. Bucshon, a strong supporter of insurer-run Medicare, which can offer patients added benefits such as dental coverage.

Rep. Ann Kuster (D-N.H.) said simplifying prior authorization would reduce stress on clinicians already dealing with burnout.

“They’re just so tired of all this paperwork and red tape,” Rep. Kuster said. “In 2022 can’t we at least consider electronic prior authorization?”

At the hearing, Rep. Michael C. Burgess, MD, (R-Tex.) noted that his home state already has taken a step toward reducing the burden of prior authorization with its “gold card” program.

In 2021, a new Texas law called on the state department of insurance to develop rules to require health plans to provide an exemption from preauthorization requirements for a particular health care service if the issuer has approved, or would have approved, at least 90% of the preauthorization requests submitted by the physician or provider for that service. The law also mandates that a physician participating in a peer-to-peer review on behalf of a health benefit plan issuer must be a Texas-licensed physician who has the same or similar specialty as the physician or clinician requesting the service, according to the state insurance department.

Separately, Rep. Suzan DelBene (D-Wash.), the sponsor of the Improving Seniors’ Timely Access to Care Act, told the American Medical Association in a recent interview that she expects the House Ways and Means Committee, on which she serves, to mark up her bill in July. (A mark-up is the process by which a House or Senate committee considers and often amends a bill and then sends it to the chamber’s leadership for a floor vote.)

In a statement issued about the hearing, America’s Health Insurance Plans (AHIP) noted that there has been work in recent years toward streamlining prior authorization. AHIP said it launched the Fast Prior Authorization Technology Highway (Fast PATH) initiative in 2020 to study electronic procedures for handling these reviews.

“The findings of this study showed that ePA delivered improvements with a strong majority of experienced providers reporting faster time to patient care, fewer phone calls and faxes, better understanding of [prior authorization] requirements, and faster time to decisions,” AHIP said.

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

Republican and Democratic members of the House called for changes in how insurer-run Medicare plans manage the prior authorization process, following testimony from a federal watchdog organization about improper denials of payment for care.

About 18% of payment denials in a sample examined by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) either met Medicare coverage rules or the rules of the insurance plan.

As such, they should not have been denied, according to the OIG. That was the finding of an April OIG report, based on a sample of 2019 denials from large insurer-run Medicare plans.

Erin Bliss, an assistant inspector general with the OIG, appeared as a witness at a June 28 Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss this investigation and other issues with prior authorization and insurer-run Medicare, also known as the Advantage plans.

Most of these payment denials of appropriate services were due to human error during manual claims-processing reviews, Ms. Bliss told the subcommittee, such as overlooking a document, and to system processing errors, such as a Medicare insurance plan failing to program or update a system correctly.

In many cases, these denials were reversed, but patient care was still disrupted and clinicians lost time chasing clearances for services that plans already had covered, Ms. Bliss said in her testimony.

The April report was not the OIG’s first look into concerns about insurer-run plans inappropriately denying care through prior authorizations. The OIG in 2018 reported that insurer-run Medicare plans overturned 75% of their own denials during 2014-2016 when patients and clinicians appealed these decisions, overturning approximately 216,000 denials each year.

‘Numerous hoops’ unnecessary for doctors, patients

Lawmakers at the hearing supported the idea of the need for prior authorization as a screening tool to prevent unneeded care.

But they chided insurance companies for their execution of this process, with clinicians and patients often frustrated by complex steps needed. Medicare Advantage plans sometimes require prior authorization for “relatively standard medical services,” said Subcommittee on Oversight and Investigations Chair Diana DeGette (D-Colo.).

“Our seniors and their doctors should not be required to jump through numerous hoops to ensure coverage for straightforward and medically necessary procedures,” Rep. DeGette said.

Several lawmakers spoke at the hearing about the need for changes to prior authorization, including calling for action on a pending bill intended to compel insurers to streamline the review process. The Improving Seniors’ Timely Access to Care Act of 2021 already has attracted more than 300 bipartisan sponsors. A companion Senate bill has more than 30 sponsors.

The bill’s aim is to shift this process away from faxes and phone calls while also encouraging plans to adhere to evidence-based medical guidelines in consultation with physicians. The bill calls for the establishment of an electronic prior authorization program that could issue real-time decisions.

“The result will be less administrative burden for providers and more information in the hands of patients. It will allow more patients to receive care when they need it, reducing the likelihood of additional, often more severe complications,” said Rep. Larry Bucshon, MD, (R-Ind.) who is among the active sponsors of the bill.

“In the long term, I believe it would also result in cost savings for the health care system at large by identifying problems earlier and getting them treated before their patients have more complications,” Rep. Bucshon added.
 

Finding ‘room for improvement’ for prior authorizations

There’s strong bipartisan support in Congress for insurer-run Medicare, which has grown by 10% per year over the last several years and has doubled since 2010, according to the Medicare Payment Advisory Commission (MedPAC). About 27 million people are now enrolled in these plans.

But for that reason, insurer-run Medicare may also need more careful watching, lawmakers made clear at the hearing.

“We’ve heard quite a bit of evidence today that there is room for improvement,” said Rep. Bucshon, a strong supporter of insurer-run Medicare, which can offer patients added benefits such as dental coverage.

Rep. Ann Kuster (D-N.H.) said simplifying prior authorization would reduce stress on clinicians already dealing with burnout.

“They’re just so tired of all this paperwork and red tape,” Rep. Kuster said. “In 2022 can’t we at least consider electronic prior authorization?”

At the hearing, Rep. Michael C. Burgess, MD, (R-Tex.) noted that his home state already has taken a step toward reducing the burden of prior authorization with its “gold card” program.

In 2021, a new Texas law called on the state department of insurance to develop rules to require health plans to provide an exemption from preauthorization requirements for a particular health care service if the issuer has approved, or would have approved, at least 90% of the preauthorization requests submitted by the physician or provider for that service. The law also mandates that a physician participating in a peer-to-peer review on behalf of a health benefit plan issuer must be a Texas-licensed physician who has the same or similar specialty as the physician or clinician requesting the service, according to the state insurance department.

Separately, Rep. Suzan DelBene (D-Wash.), the sponsor of the Improving Seniors’ Timely Access to Care Act, told the American Medical Association in a recent interview that she expects the House Ways and Means Committee, on which she serves, to mark up her bill in July. (A mark-up is the process by which a House or Senate committee considers and often amends a bill and then sends it to the chamber’s leadership for a floor vote.)

In a statement issued about the hearing, America’s Health Insurance Plans (AHIP) noted that there has been work in recent years toward streamlining prior authorization. AHIP said it launched the Fast Prior Authorization Technology Highway (Fast PATH) initiative in 2020 to study electronic procedures for handling these reviews.

“The findings of this study showed that ePA delivered improvements with a strong majority of experienced providers reporting faster time to patient care, fewer phone calls and faxes, better understanding of [prior authorization] requirements, and faster time to decisions,” AHIP said.

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

The U.S. Food and Drug Administration has unveiled a 5-year strategy aimed at improving and extending the lives of people with rare neurodegenerative diseases.

The agency’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) aims to advance the development of safe and effective medical products and facilitate patient access to novel treatments.

“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” FDA Commissioner Robert M. Califf, MD, said in a news release.

“To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities,” Dr. Califf acknowledged.

“This action plan, especially including the use of public-private partnerships and direct involvement of patients, will ensure the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies,” Dr. Califf added.
 

Blueprint to ‘aggressively’ move forward

The action plan represents a “blueprint” for how the agency will “aggressively” move forward to address challenges in drug development for rare neurodegenerative diseases to improve patient health, the FDA said.

The plan was created in accordance with provisions in the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) that President Biden signed into law in late 2021.

Targeted activities include establishing the FDA Rare Neurodegenerative Diseases Task Force and the public-private partnership for rare neurodegenerative diseases, developing disease-specific science strategies over the next 5 years, and leveraging ongoing FDA regulatory science efforts.

The ALS Science Strategy is part of the plan focused specifically on ALS. It provides a “forward-leaning” framework for FDA activities, which include efforts to improve characterization of disease pathogenesis and natural history, boost clinical trial infrastructure and agility to enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.

The FDA says patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health will be key to the success of implementation of the ALS Science Strategy.

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

The U.S. Food and Drug Administration has unveiled a 5-year strategy aimed at improving and extending the lives of people with rare neurodegenerative diseases.

The agency’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) aims to advance the development of safe and effective medical products and facilitate patient access to novel treatments.

“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” FDA Commissioner Robert M. Califf, MD, said in a news release.

“To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities,” Dr. Califf acknowledged.

“This action plan, especially including the use of public-private partnerships and direct involvement of patients, will ensure the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies,” Dr. Califf added.
 

Blueprint to ‘aggressively’ move forward

The action plan represents a “blueprint” for how the agency will “aggressively” move forward to address challenges in drug development for rare neurodegenerative diseases to improve patient health, the FDA said.

The plan was created in accordance with provisions in the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) that President Biden signed into law in late 2021.

Targeted activities include establishing the FDA Rare Neurodegenerative Diseases Task Force and the public-private partnership for rare neurodegenerative diseases, developing disease-specific science strategies over the next 5 years, and leveraging ongoing FDA regulatory science efforts.

The ALS Science Strategy is part of the plan focused specifically on ALS. It provides a “forward-leaning” framework for FDA activities, which include efforts to improve characterization of disease pathogenesis and natural history, boost clinical trial infrastructure and agility to enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.

The FDA says patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health will be key to the success of implementation of the ALS Science Strategy.

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

The U.S. Food and Drug Administration has unveiled a 5-year strategy aimed at improving and extending the lives of people with rare neurodegenerative diseases.

The agency’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) aims to advance the development of safe and effective medical products and facilitate patient access to novel treatments.

“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” FDA Commissioner Robert M. Califf, MD, said in a news release.

“To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities,” Dr. Califf acknowledged.

“This action plan, especially including the use of public-private partnerships and direct involvement of patients, will ensure the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies,” Dr. Califf added.
 

Blueprint to ‘aggressively’ move forward

The action plan represents a “blueprint” for how the agency will “aggressively” move forward to address challenges in drug development for rare neurodegenerative diseases to improve patient health, the FDA said.

The plan was created in accordance with provisions in the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) that President Biden signed into law in late 2021.

Targeted activities include establishing the FDA Rare Neurodegenerative Diseases Task Force and the public-private partnership for rare neurodegenerative diseases, developing disease-specific science strategies over the next 5 years, and leveraging ongoing FDA regulatory science efforts.

The ALS Science Strategy is part of the plan focused specifically on ALS. It provides a “forward-leaning” framework for FDA activities, which include efforts to improve characterization of disease pathogenesis and natural history, boost clinical trial infrastructure and agility to enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.

The FDA says patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health will be key to the success of implementation of the ALS Science Strategy.

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