Health Policy

Study Overview

Objective: This study evaluated whether a clinical-decision-support (CDS) tool that utilizes a real-time algorithm incorporating patient vital sign data can identify hospitalized patients who can forgo overnight vital sign checks and thus reduce delirium incidence.

Design: This was a parallel randomized clinical trial of adult inpatients admitted to the general medical service of a tertiary care academic medical center in the United States. The trial intervention consisted of a CDS notification in the electronic health record (EHR) that informed the physician if a patient had a high likelihood of nighttime vital signs within the reference ranges based on a logistic regression model of real-time patient data input. This notification provided the physician an opportunity to discontinue nighttime vital sign checks, dismiss the notification for 1 hour, or dismiss the notification until the next day.

Setting and participants: This clinical trial was conducted at the University of California, San Francisco Medical Center from March 11 to November 24, 2019. Participants included physicians who served on the primary team (eg, attending, resident) of 1699 patients on the general medical service who were outside of the intensive care unit (ICU). The hospital encounters were randomized (allocation ratio of 1:1) to sleep promotion vitals CDS (SPV CDS) intervention or usual care.

Main outcome and measures: The primary outcome was delirium as determined by bedside nurse assessment using the Nursing Delirium Screening Scale (Nu-DESC) recorded once per nursing shift. The Nu-DESC is a standardized delirium screening tool that defines delirium with a score ≥2. Secondary outcomes included sleep opportunity (ie, EHR-based sleep metrics that reflected the maximum time between iatrogenic interruptions, such as nighttime vital sign checks) and patient satisfaction (ie, patient satisfaction measured by standardized Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS] survey). Potential balancing outcomes were assessed to ensure that reduced vital sign checks were not causing harms; these included ICU transfers, rapid response calls, and code blue alarms. All analyses were conducted on the basis of intention-to-treat.

Main results: A total of 3025 inpatient encounters were screened and 1930 encounters were randomized (966 SPV CDS intervention; 964 usual care). The randomized encounters consisted of 1699 patients; demographic factors between the 2 trial arms were similar. Specifically, the intervention arm included 566 men (59%) and mean (SD) age was 53 (15) years. The incidence of delirium was similar between the intervention and usual care arms: 108 (11%) vs 123 (13%) (P = .32). Compared to the usual care arm, the intervention arm had a higher mean (SD) number of sleep opportunity hours per night (4.95 [1.45] vs 4.57 [1.30], P < .001) and fewer nighttime vital sign checks (0.97 [0.95] vs 1.41 [0.86], P < .001). The post-discharge HCAHPS survey measuring patient satisfaction was completed by only 5% of patients (53 intervention, 49 usual care), and survey results were similar between the 2 arms (P = .86). In addition, safety outcomes including ICU transfers (49 [5%] vs 47 [5%], P = .92), rapid response calls (68 [7%] vs 55 [6%], P = .27), and code blue alarms (2 [0.2%] vs 9 [0.9%], P = .07) were similar between the study arms.

Conclusion: In this randomized clinical trial, a CDS tool utilizing a real-time prediction algorithm embedded in EHR did not reduce the incidence of delirium in hospitalized patients. However, this SPV CDS intervention helped physicians identify clinically stable patients who can forgo routine nighttime vital sign checks and facilitated greater opportunity for patients to sleep. These findings suggest that augmenting physician judgment using a real-time prediction algorithm can help to improve sleep opportunity without an accompanying increased risk of clinical decompensation during acute care.

Commentary

High-quality sleep is fundamental to health and well-being. Sleep deprivation and disorders are associated with many adverse health outcomes, including increased risks for obesity, diabetes, hypertension, myocardial infarction, and depression.¹ In hospitalized patients who are acutely ill, restorative sleep is critical to facilitating recovery. However, poor sleep is exceedingly common in hospitalized patients and is associated with deleterious outcomes, such as high blood pressure, hyperglycemia, and delirium.^2,3 Moreover, some of these adverse sleep-induced cardiometabolic outcomes, as well as sleep disruption itself, may persist after hospital discharge.⁴ Factors that precipitate interrupted sleep during hospitalization include iatrogenic causes such as frequent vital sign checks, nighttime procedures or early morning blood draws, and environmental factors such as loud ambient noise.³ Thus, a potential intervention to improve sleep quality in the hospital is to reduce nighttime interruptions such as frequent vital sign checks.

In the current study, Najafi and colleagues conducted a randomized trial to evaluate whether a CDS tool embedded in EHR, powered by a real-time prediction algorithm of patient data, can be utilized to identify patients in whom vital sign checks can be safely discontinued at nighttime. The authors found a modest but statistically significant reduction in the number of nighttime vital sign checks in patients who underwent the SPV CDS intervention, and a corresponding higher sleep opportunity per night in those who received the intervention. Importantly, this reduction in nighttime vital sign checks did not cause a higher risk of clinical decompensation as measured by ICU transfers, rapid response calls, or code blue alarms. Thus, the results demonstrated the feasibility of using a real-time, patient data-driven CDS tool to augment physician judgment in managing sleep disruption, an important hospital-associated stressor and a common hazard of hospitalization in older patients.

Delirium is a common clinical problem in hospitalized older patients that is associated with prolonged hospitalization, functional and cognitive decline, institutionalization, death, and increased health care costs.⁵ Despite a potential benefit of SPV CDS intervention in reducing vital sign checks and increasing sleep opportunity, this intervention did not reduce the incidence of delirium in hospitalized patients. This finding is not surprising given that delirium has a multifactorial etiology (eg, metabolic derangements, infections, medication side effects and drug toxicity, hospital environment). A small modification in nighttime vital sign checks and sleep opportunity may have limited impact on optimizing sleep quality and does not address other risk factors for delirium. As such, a multicomponent nonpharmacologic approach that includes sleep enhancement, early mobilization, feeding assistance, fluid repletion, infection prevention, and other interventions should guide delirium prevention in the hospital setting. The SPV CDS intervention may play a role in the delivery of a multifaceted, nonpharmacologic delirium prevention intervention in high-risk individuals.

Sleep disruption is one of the multiple hazards of hospitalization frequently experience by hospitalized older patients. Other hazards, or hospital-associated stressors, include mobility restriction (eg, physical restraints such as urinary catheters and intravenous lines, bed elevation and rails), malnourishment and dehydration (eg, frequent use of no-food-by-mouth order, lack of easy access to hydration), and pain (eg, poor pain control). Extended exposures to these stressors may lead to a maladaptive state called allostatic overload that transiently increases vulnerability to post-hospitalization adverse events, including emergency department use, hospital readmission, or death (ie, post-hospital syndrome).⁶ Thus, the optimization of sleep during hospitalization in vulnerable patients may have benefits that extend beyond delirium prevention. It is perceivable that a CDS tool embedded in EHR, powered by a real-time prediction algorithm of patient data, may be applied to reduce some of these hazards of hospitalization in addition to improving sleep opportunity.

Applications for Clinical Practice

Findings from the current study indicate that a CDS tool embedded in EHR that utilizes a real-time prediction algorithm of patient data may help to safely improve sleep opportunity in hospitalized patients. The participants in the current study were relatively young (53 [15] years). Given that age is a risk factor for delirium, the effects of this intervention on delirium prevention in the most susceptible population (ie, those over the age of 65) remain unknown and further investigation is warranted. Additional studies are needed to determine whether this approach yields similar results in geriatric patients and improves clinical outcomes.

—Fred Ko, MD

Study Overview

Objective: This study evaluated whether a clinical-decision-support (CDS) tool that utilizes a real-time algorithm incorporating patient vital sign data can identify hospitalized patients who can forgo overnight vital sign checks and thus reduce delirium incidence.

Design: This was a parallel randomized clinical trial of adult inpatients admitted to the general medical service of a tertiary care academic medical center in the United States. The trial intervention consisted of a CDS notification in the electronic health record (EHR) that informed the physician if a patient had a high likelihood of nighttime vital signs within the reference ranges based on a logistic regression model of real-time patient data input. This notification provided the physician an opportunity to discontinue nighttime vital sign checks, dismiss the notification for 1 hour, or dismiss the notification until the next day.

Setting and participants: This clinical trial was conducted at the University of California, San Francisco Medical Center from March 11 to November 24, 2019. Participants included physicians who served on the primary team (eg, attending, resident) of 1699 patients on the general medical service who were outside of the intensive care unit (ICU). The hospital encounters were randomized (allocation ratio of 1:1) to sleep promotion vitals CDS (SPV CDS) intervention or usual care.

Main outcome and measures: The primary outcome was delirium as determined by bedside nurse assessment using the Nursing Delirium Screening Scale (Nu-DESC) recorded once per nursing shift. The Nu-DESC is a standardized delirium screening tool that defines delirium with a score ≥2. Secondary outcomes included sleep opportunity (ie, EHR-based sleep metrics that reflected the maximum time between iatrogenic interruptions, such as nighttime vital sign checks) and patient satisfaction (ie, patient satisfaction measured by standardized Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS] survey). Potential balancing outcomes were assessed to ensure that reduced vital sign checks were not causing harms; these included ICU transfers, rapid response calls, and code blue alarms. All analyses were conducted on the basis of intention-to-treat.

Main results: A total of 3025 inpatient encounters were screened and 1930 encounters were randomized (966 SPV CDS intervention; 964 usual care). The randomized encounters consisted of 1699 patients; demographic factors between the 2 trial arms were similar. Specifically, the intervention arm included 566 men (59%) and mean (SD) age was 53 (15) years. The incidence of delirium was similar between the intervention and usual care arms: 108 (11%) vs 123 (13%) (P = .32). Compared to the usual care arm, the intervention arm had a higher mean (SD) number of sleep opportunity hours per night (4.95 [1.45] vs 4.57 [1.30], P < .001) and fewer nighttime vital sign checks (0.97 [0.95] vs 1.41 [0.86], P < .001). The post-discharge HCAHPS survey measuring patient satisfaction was completed by only 5% of patients (53 intervention, 49 usual care), and survey results were similar between the 2 arms (P = .86). In addition, safety outcomes including ICU transfers (49 [5%] vs 47 [5%], P = .92), rapid response calls (68 [7%] vs 55 [6%], P = .27), and code blue alarms (2 [0.2%] vs 9 [0.9%], P = .07) were similar between the study arms.

Conclusion: In this randomized clinical trial, a CDS tool utilizing a real-time prediction algorithm embedded in EHR did not reduce the incidence of delirium in hospitalized patients. However, this SPV CDS intervention helped physicians identify clinically stable patients who can forgo routine nighttime vital sign checks and facilitated greater opportunity for patients to sleep. These findings suggest that augmenting physician judgment using a real-time prediction algorithm can help to improve sleep opportunity without an accompanying increased risk of clinical decompensation during acute care.

Commentary

High-quality sleep is fundamental to health and well-being. Sleep deprivation and disorders are associated with many adverse health outcomes, including increased risks for obesity, diabetes, hypertension, myocardial infarction, and depression.¹ In hospitalized patients who are acutely ill, restorative sleep is critical to facilitating recovery. However, poor sleep is exceedingly common in hospitalized patients and is associated with deleterious outcomes, such as high blood pressure, hyperglycemia, and delirium.^2,3 Moreover, some of these adverse sleep-induced cardiometabolic outcomes, as well as sleep disruption itself, may persist after hospital discharge.⁴ Factors that precipitate interrupted sleep during hospitalization include iatrogenic causes such as frequent vital sign checks, nighttime procedures or early morning blood draws, and environmental factors such as loud ambient noise.³ Thus, a potential intervention to improve sleep quality in the hospital is to reduce nighttime interruptions such as frequent vital sign checks.

In the current study, Najafi and colleagues conducted a randomized trial to evaluate whether a CDS tool embedded in EHR, powered by a real-time prediction algorithm of patient data, can be utilized to identify patients in whom vital sign checks can be safely discontinued at nighttime. The authors found a modest but statistically significant reduction in the number of nighttime vital sign checks in patients who underwent the SPV CDS intervention, and a corresponding higher sleep opportunity per night in those who received the intervention. Importantly, this reduction in nighttime vital sign checks did not cause a higher risk of clinical decompensation as measured by ICU transfers, rapid response calls, or code blue alarms. Thus, the results demonstrated the feasibility of using a real-time, patient data-driven CDS tool to augment physician judgment in managing sleep disruption, an important hospital-associated stressor and a common hazard of hospitalization in older patients.

Delirium is a common clinical problem in hospitalized older patients that is associated with prolonged hospitalization, functional and cognitive decline, institutionalization, death, and increased health care costs.⁵ Despite a potential benefit of SPV CDS intervention in reducing vital sign checks and increasing sleep opportunity, this intervention did not reduce the incidence of delirium in hospitalized patients. This finding is not surprising given that delirium has a multifactorial etiology (eg, metabolic derangements, infections, medication side effects and drug toxicity, hospital environment). A small modification in nighttime vital sign checks and sleep opportunity may have limited impact on optimizing sleep quality and does not address other risk factors for delirium. As such, a multicomponent nonpharmacologic approach that includes sleep enhancement, early mobilization, feeding assistance, fluid repletion, infection prevention, and other interventions should guide delirium prevention in the hospital setting. The SPV CDS intervention may play a role in the delivery of a multifaceted, nonpharmacologic delirium prevention intervention in high-risk individuals.

Sleep disruption is one of the multiple hazards of hospitalization frequently experience by hospitalized older patients. Other hazards, or hospital-associated stressors, include mobility restriction (eg, physical restraints such as urinary catheters and intravenous lines, bed elevation and rails), malnourishment and dehydration (eg, frequent use of no-food-by-mouth order, lack of easy access to hydration), and pain (eg, poor pain control). Extended exposures to these stressors may lead to a maladaptive state called allostatic overload that transiently increases vulnerability to post-hospitalization adverse events, including emergency department use, hospital readmission, or death (ie, post-hospital syndrome).⁶ Thus, the optimization of sleep during hospitalization in vulnerable patients may have benefits that extend beyond delirium prevention. It is perceivable that a CDS tool embedded in EHR, powered by a real-time prediction algorithm of patient data, may be applied to reduce some of these hazards of hospitalization in addition to improving sleep opportunity.

Applications for Clinical Practice

Findings from the current study indicate that a CDS tool embedded in EHR that utilizes a real-time prediction algorithm of patient data may help to safely improve sleep opportunity in hospitalized patients. The participants in the current study were relatively young (53 [15] years). Given that age is a risk factor for delirium, the effects of this intervention on delirium prevention in the most susceptible population (ie, those over the age of 65) remain unknown and further investigation is warranted. Additional studies are needed to determine whether this approach yields similar results in geriatric patients and improves clinical outcomes.

—Fred Ko, MD

Study Overview

Objective: This study evaluated whether a clinical-decision-support (CDS) tool that utilizes a real-time algorithm incorporating patient vital sign data can identify hospitalized patients who can forgo overnight vital sign checks and thus reduce delirium incidence.

Design: This was a parallel randomized clinical trial of adult inpatients admitted to the general medical service of a tertiary care academic medical center in the United States. The trial intervention consisted of a CDS notification in the electronic health record (EHR) that informed the physician if a patient had a high likelihood of nighttime vital signs within the reference ranges based on a logistic regression model of real-time patient data input. This notification provided the physician an opportunity to discontinue nighttime vital sign checks, dismiss the notification for 1 hour, or dismiss the notification until the next day.

Setting and participants: This clinical trial was conducted at the University of California, San Francisco Medical Center from March 11 to November 24, 2019. Participants included physicians who served on the primary team (eg, attending, resident) of 1699 patients on the general medical service who were outside of the intensive care unit (ICU). The hospital encounters were randomized (allocation ratio of 1:1) to sleep promotion vitals CDS (SPV CDS) intervention or usual care.

Main outcome and measures: The primary outcome was delirium as determined by bedside nurse assessment using the Nursing Delirium Screening Scale (Nu-DESC) recorded once per nursing shift. The Nu-DESC is a standardized delirium screening tool that defines delirium with a score ≥2. Secondary outcomes included sleep opportunity (ie, EHR-based sleep metrics that reflected the maximum time between iatrogenic interruptions, such as nighttime vital sign checks) and patient satisfaction (ie, patient satisfaction measured by standardized Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS] survey). Potential balancing outcomes were assessed to ensure that reduced vital sign checks were not causing harms; these included ICU transfers, rapid response calls, and code blue alarms. All analyses were conducted on the basis of intention-to-treat.

Main results: A total of 3025 inpatient encounters were screened and 1930 encounters were randomized (966 SPV CDS intervention; 964 usual care). The randomized encounters consisted of 1699 patients; demographic factors between the 2 trial arms were similar. Specifically, the intervention arm included 566 men (59%) and mean (SD) age was 53 (15) years. The incidence of delirium was similar between the intervention and usual care arms: 108 (11%) vs 123 (13%) (P = .32). Compared to the usual care arm, the intervention arm had a higher mean (SD) number of sleep opportunity hours per night (4.95 [1.45] vs 4.57 [1.30], P < .001) and fewer nighttime vital sign checks (0.97 [0.95] vs 1.41 [0.86], P < .001). The post-discharge HCAHPS survey measuring patient satisfaction was completed by only 5% of patients (53 intervention, 49 usual care), and survey results were similar between the 2 arms (P = .86). In addition, safety outcomes including ICU transfers (49 [5%] vs 47 [5%], P = .92), rapid response calls (68 [7%] vs 55 [6%], P = .27), and code blue alarms (2 [0.2%] vs 9 [0.9%], P = .07) were similar between the study arms.

Conclusion: In this randomized clinical trial, a CDS tool utilizing a real-time prediction algorithm embedded in EHR did not reduce the incidence of delirium in hospitalized patients. However, this SPV CDS intervention helped physicians identify clinically stable patients who can forgo routine nighttime vital sign checks and facilitated greater opportunity for patients to sleep. These findings suggest that augmenting physician judgment using a real-time prediction algorithm can help to improve sleep opportunity without an accompanying increased risk of clinical decompensation during acute care.

Commentary

High-quality sleep is fundamental to health and well-being. Sleep deprivation and disorders are associated with many adverse health outcomes, including increased risks for obesity, diabetes, hypertension, myocardial infarction, and depression.¹ In hospitalized patients who are acutely ill, restorative sleep is critical to facilitating recovery. However, poor sleep is exceedingly common in hospitalized patients and is associated with deleterious outcomes, such as high blood pressure, hyperglycemia, and delirium.^2,3 Moreover, some of these adverse sleep-induced cardiometabolic outcomes, as well as sleep disruption itself, may persist after hospital discharge.⁴ Factors that precipitate interrupted sleep during hospitalization include iatrogenic causes such as frequent vital sign checks, nighttime procedures or early morning blood draws, and environmental factors such as loud ambient noise.³ Thus, a potential intervention to improve sleep quality in the hospital is to reduce nighttime interruptions such as frequent vital sign checks.

In the current study, Najafi and colleagues conducted a randomized trial to evaluate whether a CDS tool embedded in EHR, powered by a real-time prediction algorithm of patient data, can be utilized to identify patients in whom vital sign checks can be safely discontinued at nighttime. The authors found a modest but statistically significant reduction in the number of nighttime vital sign checks in patients who underwent the SPV CDS intervention, and a corresponding higher sleep opportunity per night in those who received the intervention. Importantly, this reduction in nighttime vital sign checks did not cause a higher risk of clinical decompensation as measured by ICU transfers, rapid response calls, or code blue alarms. Thus, the results demonstrated the feasibility of using a real-time, patient data-driven CDS tool to augment physician judgment in managing sleep disruption, an important hospital-associated stressor and a common hazard of hospitalization in older patients.

Delirium is a common clinical problem in hospitalized older patients that is associated with prolonged hospitalization, functional and cognitive decline, institutionalization, death, and increased health care costs.⁵ Despite a potential benefit of SPV CDS intervention in reducing vital sign checks and increasing sleep opportunity, this intervention did not reduce the incidence of delirium in hospitalized patients. This finding is not surprising given that delirium has a multifactorial etiology (eg, metabolic derangements, infections, medication side effects and drug toxicity, hospital environment). A small modification in nighttime vital sign checks and sleep opportunity may have limited impact on optimizing sleep quality and does not address other risk factors for delirium. As such, a multicomponent nonpharmacologic approach that includes sleep enhancement, early mobilization, feeding assistance, fluid repletion, infection prevention, and other interventions should guide delirium prevention in the hospital setting. The SPV CDS intervention may play a role in the delivery of a multifaceted, nonpharmacologic delirium prevention intervention in high-risk individuals.

Sleep disruption is one of the multiple hazards of hospitalization frequently experience by hospitalized older patients. Other hazards, or hospital-associated stressors, include mobility restriction (eg, physical restraints such as urinary catheters and intravenous lines, bed elevation and rails), malnourishment and dehydration (eg, frequent use of no-food-by-mouth order, lack of easy access to hydration), and pain (eg, poor pain control). Extended exposures to these stressors may lead to a maladaptive state called allostatic overload that transiently increases vulnerability to post-hospitalization adverse events, including emergency department use, hospital readmission, or death (ie, post-hospital syndrome).⁶ Thus, the optimization of sleep during hospitalization in vulnerable patients may have benefits that extend beyond delirium prevention. It is perceivable that a CDS tool embedded in EHR, powered by a real-time prediction algorithm of patient data, may be applied to reduce some of these hazards of hospitalization in addition to improving sleep opportunity.

Applications for Clinical Practice

Findings from the current study indicate that a CDS tool embedded in EHR that utilizes a real-time prediction algorithm of patient data may help to safely improve sleep opportunity in hospitalized patients. The participants in the current study were relatively young (53 [15] years). Given that age is a risk factor for delirium, the effects of this intervention on delirium prevention in the most susceptible population (ie, those over the age of 65) remain unknown and further investigation is warranted. Additional studies are needed to determine whether this approach yields similar results in geriatric patients and improves clinical outcomes.

—Fred Ko, MD

On Feb. 15, Robert Califf, MD, narrowly won Senate confirmation to once again serve as the commissioner of the Food and Drug Administration, overcoming protest votes from lawmakers about abortion and opioid issues.

FDA photo by Michael J. Ermarth

The Senate voted 50-46 in favor of Dr. Califf’s nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Dr. Califf also led the FDA from February 2016 through January 2017.

In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned that Dr. Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.

Sen. Manchin also objected to Dr. Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Feb. 15 vote, Sen. Markey said he has “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”

“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Sen. Markey said. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”

This time, Dr. Califf lost support among Republican senators due to objections raised by groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Dr. Califf’s nomination, citing their objections to how the FDA handled reporting of adverse events from abortions by medication during Dr. Califf’s Tenure.

But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor.

On Feb. 14, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Education, Labor, and Pensions Committee, urged her colleagues to vote for Dr. Califf to give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in health care.

“At this critical moment, we need a trusted hand to lead the FDA,” she said in a floor speech. Dr. Califf’s previous service at the FDA and his years spent as a research scientist “give him the experience to take on this challenge.”

Separately, three former FDA commissioners on Feb. 15 published an opinion article that appeared in The Hill. Republican presidents nominated two of these former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Dr. Califf for his first time as FDA chief.

There’s an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.

Dr. Califf “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals, and public health organizations,” Dr. Gottlieb, Dr. Hamburg, and Dr. McClellan wrote.

The article also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.
 

Support of medical community

The American Heart Association issued a statement on Feb.15, congratulating Dr. Califf on his second confirmation after the Senate vote.

“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policymaking.”

Dr. Califf was also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.

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

On Feb. 15, Robert Califf, MD, narrowly won Senate confirmation to once again serve as the commissioner of the Food and Drug Administration, overcoming protest votes from lawmakers about abortion and opioid issues.

FDA photo by Michael J. Ermarth

The Senate voted 50-46 in favor of Dr. Califf’s nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Dr. Califf also led the FDA from February 2016 through January 2017.

In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned that Dr. Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.

Sen. Manchin also objected to Dr. Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Feb. 15 vote, Sen. Markey said he has “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”

“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Sen. Markey said. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”

This time, Dr. Califf lost support among Republican senators due to objections raised by groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Dr. Califf’s nomination, citing their objections to how the FDA handled reporting of adverse events from abortions by medication during Dr. Califf’s Tenure.

But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor.

On Feb. 14, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Education, Labor, and Pensions Committee, urged her colleagues to vote for Dr. Califf to give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in health care.

“At this critical moment, we need a trusted hand to lead the FDA,” she said in a floor speech. Dr. Califf’s previous service at the FDA and his years spent as a research scientist “give him the experience to take on this challenge.”

Separately, three former FDA commissioners on Feb. 15 published an opinion article that appeared in The Hill. Republican presidents nominated two of these former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Dr. Califf for his first time as FDA chief.

There’s an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.

Dr. Califf “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals, and public health organizations,” Dr. Gottlieb, Dr. Hamburg, and Dr. McClellan wrote.

The article also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.
 

Support of medical community

The American Heart Association issued a statement on Feb.15, congratulating Dr. Califf on his second confirmation after the Senate vote.

“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policymaking.”

Dr. Califf was also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.

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

On Feb. 15, Robert Califf, MD, narrowly won Senate confirmation to once again serve as the commissioner of the Food and Drug Administration, overcoming protest votes from lawmakers about abortion and opioid issues.

FDA photo by Michael J. Ermarth

The Senate voted 50-46 in favor of Dr. Califf’s nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Dr. Califf also led the FDA from February 2016 through January 2017.

In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned that Dr. Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.

Sen. Manchin also objected to Dr. Califf’s second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Feb. 15 vote, Sen. Markey said he has “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”

“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Sen. Markey said. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”

This time, Dr. Califf lost support among Republican senators due to objections raised by groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Dr. Califf’s nomination, citing their objections to how the FDA handled reporting of adverse events from abortions by medication during Dr. Califf’s Tenure.

But some Republicans supported Califf in the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor.

On Feb. 14, Sen. Patty Murray, D-WA, chairwoman of the Senate Health, Education, Labor, and Pensions Committee, urged her colleagues to vote for Dr. Califf to give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in health care.

“At this critical moment, we need a trusted hand to lead the FDA,” she said in a floor speech. Dr. Califf’s previous service at the FDA and his years spent as a research scientist “give him the experience to take on this challenge.”

Separately, three former FDA commissioners on Feb. 15 published an opinion article that appeared in The Hill. Republican presidents nominated two of these former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Dr. Califf for his first time as FDA chief.

There’s an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.

Dr. Califf “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals, and public health organizations,” Dr. Gottlieb, Dr. Hamburg, and Dr. McClellan wrote.

The article also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.
 

Support of medical community

The American Heart Association issued a statement on Feb.15, congratulating Dr. Califf on his second confirmation after the Senate vote.

“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policymaking.”

Dr. Califf was also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.

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

The CDC will soon update its COVID-19 guidance – including masking recommendations – as cases continue to drop, CDC Director Rochelle P. Walensky, MD, said on Feb. 16.

“As we consider future metrics, which will be updated soon, we recognize the importance of not just cases … but critically, medically severe disease that leads to hospitalizations,” Dr. Walensky said at a White House news briefing. “We must consider hospital capacity as an additional important barometer.”

She later added, “We are looking at an overview of much of our guidance, and masking in all settings will be a part of that.”

Coronavirus cases continue to drop nationwide. This week’s 7-day daily average of cases is 147,000, a decrease of 40%. Hospitalizations have dropped 28% to 9,500, and daily deaths are 2,200, a decrease of 9%.

“Omicron cases are declining, and we are all cautiously optimistic about the trajectory we’re on,” Dr. Walensky said. “Things are moving in the right direction, but we want to remain vigilant to do all we can so this trajectory continues.”

Dr. Walensky said public masking remains especially important if someone is symptomatic or not feeling well, or if there has been a COVID-19 exposure. Those who are within 10 days of being diagnosed with the virus should also remain masked in public.

“We all share the same goal: to get to a point where COVID-19 is no longer disrupting our daily lives. A time when it won’t be a constant crisis,” Dr. Walensky said. “Moving from this pandemic will be a process led by science and epidemiological trends, and one that relies on the powerful tools we already have.”
 

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

The CDC will soon update its COVID-19 guidance – including masking recommendations – as cases continue to drop, CDC Director Rochelle P. Walensky, MD, said on Feb. 16.

“As we consider future metrics, which will be updated soon, we recognize the importance of not just cases … but critically, medically severe disease that leads to hospitalizations,” Dr. Walensky said at a White House news briefing. “We must consider hospital capacity as an additional important barometer.”

She later added, “We are looking at an overview of much of our guidance, and masking in all settings will be a part of that.”

Coronavirus cases continue to drop nationwide. This week’s 7-day daily average of cases is 147,000, a decrease of 40%. Hospitalizations have dropped 28% to 9,500, and daily deaths are 2,200, a decrease of 9%.

“Omicron cases are declining, and we are all cautiously optimistic about the trajectory we’re on,” Dr. Walensky said. “Things are moving in the right direction, but we want to remain vigilant to do all we can so this trajectory continues.”

Dr. Walensky said public masking remains especially important if someone is symptomatic or not feeling well, or if there has been a COVID-19 exposure. Those who are within 10 days of being diagnosed with the virus should also remain masked in public.

“We all share the same goal: to get to a point where COVID-19 is no longer disrupting our daily lives. A time when it won’t be a constant crisis,” Dr. Walensky said. “Moving from this pandemic will be a process led by science and epidemiological trends, and one that relies on the powerful tools we already have.”
 

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

The CDC will soon update its COVID-19 guidance – including masking recommendations – as cases continue to drop, CDC Director Rochelle P. Walensky, MD, said on Feb. 16.

“As we consider future metrics, which will be updated soon, we recognize the importance of not just cases … but critically, medically severe disease that leads to hospitalizations,” Dr. Walensky said at a White House news briefing. “We must consider hospital capacity as an additional important barometer.”

She later added, “We are looking at an overview of much of our guidance, and masking in all settings will be a part of that.”

Coronavirus cases continue to drop nationwide. This week’s 7-day daily average of cases is 147,000, a decrease of 40%. Hospitalizations have dropped 28% to 9,500, and daily deaths are 2,200, a decrease of 9%.

“Omicron cases are declining, and we are all cautiously optimistic about the trajectory we’re on,” Dr. Walensky said. “Things are moving in the right direction, but we want to remain vigilant to do all we can so this trajectory continues.”

Dr. Walensky said public masking remains especially important if someone is symptomatic or not feeling well, or if there has been a COVID-19 exposure. Those who are within 10 days of being diagnosed with the virus should also remain masked in public.

“We all share the same goal: to get to a point where COVID-19 is no longer disrupting our daily lives. A time when it won’t be a constant crisis,” Dr. Walensky said. “Moving from this pandemic will be a process led by science and epidemiological trends, and one that relies on the powerful tools we already have.”
 

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

In mid-November, Kevin Billingsley, MD, MBA, chief medical officer at Yale Cancer Center, New Haven, Conn., was keeping a close eye on the new COVID variant sweeping across South Africa. Six weeks later, the Omicron variant had become the dominant strain in the U.S. – and the Yale health system was no exception.

“As we entered January, we had a breathtaking rate of infection in our hospital,” said Dr. Billingsley, who also leads clinical care at the Smilow Cancer Hospital. “Some of the newly authorized COVID agents were available but not widely enough to make a clinically meaningful impact to protect all high-risk individuals during this surge.”

That left the team at Yale with difficult decisions about who would receive these treatments and who wouldn’t.

The health system convened a COVID-19 immunocompromised working group to identify which patients should get priority access to one of the promising drugs authorized to treat the infection – the monoclonal antibody sotrovimab and antiviral pills Paxlovid and molnupiravir – or the sole available option to prevent it, Evusheld.

“Although clinically sound, none of these decisions have been easy,” Dr. Billingsley told this news organization. “We have done a lot of case-by-case reviewing and a lot of handwringing. Omicron has been a wild ride for us all, and we have been doing the best we can with limited resources.”
 

‘We’re seeing incredible variability’

The team at Yale is not alone. The restricted supply of COVID-19 treatments has led many oncologists and other experts across the U.S. to create carefully curated lists of their most vulnerable patients.

In late December, the National Institutes of Health published broad criteria to help clinicians prioritize patients most likely to benefit from these therapies. A handful of state health departments, including those in Michigan and Minnesota, established their own standards. Patients with cancer – specifically those with hematologic malignancies and receiving oncology therapies that compromise the immune system – appeared at the top of everyone’s list.

But ultimately individual decisions about who receives these drugs and how they’re allocated fell to institutions.

“Overall, what we’re seeing is incredible variability across the country, because there’s no uniform agreement on what comprises best practices on allocating scarce resources,” said Matthew Wynia, MD, MPH, professor of medicine and director of the Center for Bioethics and Humanities at the University of Colorado, Aurora. “There are so many people at the top of most lists, and the drugs are in such short supply, that there’s no guarantee even those in the top tier will get it.”

This news organization spoke to experts across the country about their experiences accessing these treatments during the Omicron surge and their strategies prioritizing patients with cancer.
 

Dealing with limited supply

Overall, the limited supply of COVID-19 drugs means not every patient who’s eligible to receive a treatment will get one.

A snapshot of the past 2 weeks, for instance, shows that the count of new infections hit almost 4.3 million, while distribution of the two antiviral pills Paxlovid and molnupiravir and the monoclonal antibody sotrovimab reached just over 600,000 courses.

Since receiving emergency use authorization in early December, almost 500,000 courses of the pre-exposure prophylactic agent Evusheld – which offers about 6 months of protection for immunocompromised individuals – have been distributed; however, about 7 million adults in the U.S. could potentially benefit from it.

In addition, the distribution of drugs is uneven. The federal government manages the overall distribution to states, but states then decide how to divvy up these allocations to hospitals, pharmacies, and medical centers. In Ohio, for instance, the antivirals go to providers who already receive monoclonal antibodies, while in Tennessee, the supply of antiviral agents only goes to Walmart pharmacies.

This strategy, Dr. Wynia explained, can leave clinicians at the mercy of where and how much states decide to allocate to each location. “I’ve heard of some hospitals and health systems in Colorado that aren’t using all they’ve got, but most don’t have nearly enough,” Dr. Wynia said. However, he noted, “some of that is inevitable. We will never get a perfect distribution of these drugs when there is such variable need and demand.”

And, according to Nicolette Louissaint, PhD, MBA, senior vice president of policy and strategic planning at the Healthcare Distribution Alliance in Arlington, Virginia, “we can take some comfort that the federal government is actively looking at cases from week to week and working with state and local health departments to see who needs these products, which means the process is constantly being reviewed and adjusted.”

Plus, not every positive COVID-19 case, even among immunocompromised individuals, necessarily warrants treatment. “If, for instance, an individual with cancer has a mild case of COVID-19, their provider may not deem it necessary for them to receive treatment,” Dr. Louissaint noted.

Still, given the limited and unpredictable supply, “we have had to be thoughtful about who gets these drugs,” said Derek Raghavan, MD, PhD, president of the Levine Cancer Institute, part of the 40-hospital Atrium Health system in Charlotte, North Carolina.

Dr. Raghavan said the highest priority goes to patients with hematologic malignancies, those receiving or coming off chemotherapy or experiencing myelosuppression and immune paresis, as well as those who have undergone organ transplants. Age and other comorbidities, such as diabetes or obesity, play into the lineup as well.

To further hone their priority list, the Levine Cancer Institute has implemented a cancer-centered Hospital at Home initiative. The program includes 40 oncology nurse navigators who routinely screen and score all cancer patients who test positive for COVID-19 by their symptoms and risk factors. For a time-sensitive treatment like Paxlovid, this close monitoring allows patients with COVID to access the pills within 5 days of symptom onset.

Ultimately, “the decision regarding who gets these drugs is [made] by a team to overcome any risk of personal bias, and some of it just comes down to the interface between clinical judgment and available data,” Dr. Raghavan told this news organization. “Although we’d like to have more COVID drugs available and fewer patients with COVID, we have been able to get adequate supplies for our most at-risk patients.”

Like Dr. Raghavan, Karen Bloch, MD, MPH, the medical director for the COVID Infusion Clinic at Vanderbilt University Medical Center (VUMC), said the clinic has had to be highly selective about which patients would benefit most from the COVID monoclonal antibodies. For patients with cancer, her team prioritizes individuals who would be least able to develop antibodies through vaccination or natural infection – which includes patients with B cell malignancies, acute myeloid leukemia, or multiple myeloma receiving active treatment, as well as those who recently received an allogeneic or autologous stem cell transplant.

“Since our criteria for treatment with therapies such as sotrovimab and Evusheld are pretty stringent, we have had sufficient supply to treat those who meet our internal ‘category 1’ predetermined criteria,” said Dr. Bloch, professor of medicine and associate division director for clinical affairs at VUMC, Nashville. “More recently, as the supply chain has begun to open up, we’ve been able to loosen our criteria for sotrovimab, though not for Evusheld yet.”

The Yale team described a similar evolution. “Initially, only a small subset of oncology patients could get these drugs,” said Osama (Sam) Abdelghany, PharmD, MHA, associate director of Oncology Pharmacy Services at Smilow Cancer Hospital. But as the caseload has diminished, Dr. Abdelghany noted, “we have been able to reach many more patients with COVID-19.”
 

An equitable system?

Dr. Wynia, who has written many reports on crisis standards of care, has spent thousands of hours delving into the ethics of allocating scarce resources during a disaster.

A core problem arises when there are too many people who need a scarce resource and no way of differentiating among them.

In response to the limited supply of COVID-19 treatments, some institutions, such as the University of Pittsburgh Medical Center and Massachusetts General Hospital, have created a lottery system. Others, such as Johns Hopkins Medicine, have opted for first come, first served. Each strategy comes with caveats.

“First come, first served prioritization may be quicker, but it gives more well-resourced people an advantage and lends itself to people abusing the system or exacerbating existing disparities,” Dr. Wynia said.

While a lottery system may be more equitable, this strategy often comes at the price of efficiency. “The practicality of doing a lottery when you have to make a decision about whether or not to treat the patient sitting in front of you comes with its own challenges,” Dr. Wynia said.

At the University of Colorado, he explained, the health center constantly scans medical records for patients who have been diagnosed with COVID and fall into a high-risk group. That way clinicians can call or email those most likely to benefit from these drugs.

“It ends up being a bit of a first come, first served strategy,” Dr. Wynia said. “But we also do not have a huge supply coming in each week, so reaching out to the most eligible people when we have the drugs in hand means more privileged patients are less likely to game the system.”

To manage the supply of Evusheld, Timothy Kubal, MD, MBA, and colleagues also reach out to patients most likely to benefit – specifically, those who can’t mount an adequate antibody response after vaccination.

“We screen all of our patients who have been receiving anti-CD20 agents and other chemotherapy agents known to suppress antibody response,” Dr. Kubal, a medical oncologist/hematologist at the Moffitt Institute in Tampa, Florida, said in an interview. “We then test those patients for antibodies and deliver Evusheld if they have no evidence of antibodies.”

Fortunately, in the coming months, distribution of these drugs should improve significantly. Pfizer says it expects to deliver 10 million courses of Paxlovid by the end of June, and another 10 million by the end of September. More than 1 million courses of sotrovimab should be distributed by GlaxoSmithKline through the end of March. And, recently, the Biden administration announced it purchased 1.2 million courses of Evusheld from AstraZeneca.

“Every few weeks, because the COVID picture changes, the demand changes,” said Dr. Louissaint. “With vaccination rates going up and cases going down, fewer patients will need these products.”

Still, the constant barrage of supply shortages over the past 2 years – from COVID tests, ventilators, and personal protective equipment early on to COVID vaccines a year later and more recently health care staff and COVID tests once again – has taken its toll.

“We have faced supply challenge after challenge and have had to be creative in each situation,” said Lisa Barbarotta, MSN, APRN, program director of Oncology Education and Clinical Practice at Smilow Cancer Hospital. “Nothing has been easy about this.”

And, Dr. Bloch cautioned, even with broader access to COVID-19 drugs on the horizon, there is still no substitute for vaccination. “Getting vaccinated is the best and first line of defense for most people,” she said.

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

In mid-November, Kevin Billingsley, MD, MBA, chief medical officer at Yale Cancer Center, New Haven, Conn., was keeping a close eye on the new COVID variant sweeping across South Africa. Six weeks later, the Omicron variant had become the dominant strain in the U.S. – and the Yale health system was no exception.

“As we entered January, we had a breathtaking rate of infection in our hospital,” said Dr. Billingsley, who also leads clinical care at the Smilow Cancer Hospital. “Some of the newly authorized COVID agents were available but not widely enough to make a clinically meaningful impact to protect all high-risk individuals during this surge.”

That left the team at Yale with difficult decisions about who would receive these treatments and who wouldn’t.

The health system convened a COVID-19 immunocompromised working group to identify which patients should get priority access to one of the promising drugs authorized to treat the infection – the monoclonal antibody sotrovimab and antiviral pills Paxlovid and molnupiravir – or the sole available option to prevent it, Evusheld.

“Although clinically sound, none of these decisions have been easy,” Dr. Billingsley told this news organization. “We have done a lot of case-by-case reviewing and a lot of handwringing. Omicron has been a wild ride for us all, and we have been doing the best we can with limited resources.”
 

‘We’re seeing incredible variability’

The team at Yale is not alone. The restricted supply of COVID-19 treatments has led many oncologists and other experts across the U.S. to create carefully curated lists of their most vulnerable patients.

In late December, the National Institutes of Health published broad criteria to help clinicians prioritize patients most likely to benefit from these therapies. A handful of state health departments, including those in Michigan and Minnesota, established their own standards. Patients with cancer – specifically those with hematologic malignancies and receiving oncology therapies that compromise the immune system – appeared at the top of everyone’s list.

But ultimately individual decisions about who receives these drugs and how they’re allocated fell to institutions.

“Overall, what we’re seeing is incredible variability across the country, because there’s no uniform agreement on what comprises best practices on allocating scarce resources,” said Matthew Wynia, MD, MPH, professor of medicine and director of the Center for Bioethics and Humanities at the University of Colorado, Aurora. “There are so many people at the top of most lists, and the drugs are in such short supply, that there’s no guarantee even those in the top tier will get it.”

This news organization spoke to experts across the country about their experiences accessing these treatments during the Omicron surge and their strategies prioritizing patients with cancer.
 

Dealing with limited supply

Overall, the limited supply of COVID-19 drugs means not every patient who’s eligible to receive a treatment will get one.

A snapshot of the past 2 weeks, for instance, shows that the count of new infections hit almost 4.3 million, while distribution of the two antiviral pills Paxlovid and molnupiravir and the monoclonal antibody sotrovimab reached just over 600,000 courses.

Since receiving emergency use authorization in early December, almost 500,000 courses of the pre-exposure prophylactic agent Evusheld – which offers about 6 months of protection for immunocompromised individuals – have been distributed; however, about 7 million adults in the U.S. could potentially benefit from it.

In addition, the distribution of drugs is uneven. The federal government manages the overall distribution to states, but states then decide how to divvy up these allocations to hospitals, pharmacies, and medical centers. In Ohio, for instance, the antivirals go to providers who already receive monoclonal antibodies, while in Tennessee, the supply of antiviral agents only goes to Walmart pharmacies.

This strategy, Dr. Wynia explained, can leave clinicians at the mercy of where and how much states decide to allocate to each location. “I’ve heard of some hospitals and health systems in Colorado that aren’t using all they’ve got, but most don’t have nearly enough,” Dr. Wynia said. However, he noted, “some of that is inevitable. We will never get a perfect distribution of these drugs when there is such variable need and demand.”

And, according to Nicolette Louissaint, PhD, MBA, senior vice president of policy and strategic planning at the Healthcare Distribution Alliance in Arlington, Virginia, “we can take some comfort that the federal government is actively looking at cases from week to week and working with state and local health departments to see who needs these products, which means the process is constantly being reviewed and adjusted.”

Plus, not every positive COVID-19 case, even among immunocompromised individuals, necessarily warrants treatment. “If, for instance, an individual with cancer has a mild case of COVID-19, their provider may not deem it necessary for them to receive treatment,” Dr. Louissaint noted.

Still, given the limited and unpredictable supply, “we have had to be thoughtful about who gets these drugs,” said Derek Raghavan, MD, PhD, president of the Levine Cancer Institute, part of the 40-hospital Atrium Health system in Charlotte, North Carolina.

Dr. Raghavan said the highest priority goes to patients with hematologic malignancies, those receiving or coming off chemotherapy or experiencing myelosuppression and immune paresis, as well as those who have undergone organ transplants. Age and other comorbidities, such as diabetes or obesity, play into the lineup as well.

To further hone their priority list, the Levine Cancer Institute has implemented a cancer-centered Hospital at Home initiative. The program includes 40 oncology nurse navigators who routinely screen and score all cancer patients who test positive for COVID-19 by their symptoms and risk factors. For a time-sensitive treatment like Paxlovid, this close monitoring allows patients with COVID to access the pills within 5 days of symptom onset.

Ultimately, “the decision regarding who gets these drugs is [made] by a team to overcome any risk of personal bias, and some of it just comes down to the interface between clinical judgment and available data,” Dr. Raghavan told this news organization. “Although we’d like to have more COVID drugs available and fewer patients with COVID, we have been able to get adequate supplies for our most at-risk patients.”

Like Dr. Raghavan, Karen Bloch, MD, MPH, the medical director for the COVID Infusion Clinic at Vanderbilt University Medical Center (VUMC), said the clinic has had to be highly selective about which patients would benefit most from the COVID monoclonal antibodies. For patients with cancer, her team prioritizes individuals who would be least able to develop antibodies through vaccination or natural infection – which includes patients with B cell malignancies, acute myeloid leukemia, or multiple myeloma receiving active treatment, as well as those who recently received an allogeneic or autologous stem cell transplant.

“Since our criteria for treatment with therapies such as sotrovimab and Evusheld are pretty stringent, we have had sufficient supply to treat those who meet our internal ‘category 1’ predetermined criteria,” said Dr. Bloch, professor of medicine and associate division director for clinical affairs at VUMC, Nashville. “More recently, as the supply chain has begun to open up, we’ve been able to loosen our criteria for sotrovimab, though not for Evusheld yet.”

The Yale team described a similar evolution. “Initially, only a small subset of oncology patients could get these drugs,” said Osama (Sam) Abdelghany, PharmD, MHA, associate director of Oncology Pharmacy Services at Smilow Cancer Hospital. But as the caseload has diminished, Dr. Abdelghany noted, “we have been able to reach many more patients with COVID-19.”
 

An equitable system?

Dr. Wynia, who has written many reports on crisis standards of care, has spent thousands of hours delving into the ethics of allocating scarce resources during a disaster.

A core problem arises when there are too many people who need a scarce resource and no way of differentiating among them.

In response to the limited supply of COVID-19 treatments, some institutions, such as the University of Pittsburgh Medical Center and Massachusetts General Hospital, have created a lottery system. Others, such as Johns Hopkins Medicine, have opted for first come, first served. Each strategy comes with caveats.

“First come, first served prioritization may be quicker, but it gives more well-resourced people an advantage and lends itself to people abusing the system or exacerbating existing disparities,” Dr. Wynia said.

While a lottery system may be more equitable, this strategy often comes at the price of efficiency. “The practicality of doing a lottery when you have to make a decision about whether or not to treat the patient sitting in front of you comes with its own challenges,” Dr. Wynia said.

At the University of Colorado, he explained, the health center constantly scans medical records for patients who have been diagnosed with COVID and fall into a high-risk group. That way clinicians can call or email those most likely to benefit from these drugs.

“It ends up being a bit of a first come, first served strategy,” Dr. Wynia said. “But we also do not have a huge supply coming in each week, so reaching out to the most eligible people when we have the drugs in hand means more privileged patients are less likely to game the system.”

To manage the supply of Evusheld, Timothy Kubal, MD, MBA, and colleagues also reach out to patients most likely to benefit – specifically, those who can’t mount an adequate antibody response after vaccination.

“We screen all of our patients who have been receiving anti-CD20 agents and other chemotherapy agents known to suppress antibody response,” Dr. Kubal, a medical oncologist/hematologist at the Moffitt Institute in Tampa, Florida, said in an interview. “We then test those patients for antibodies and deliver Evusheld if they have no evidence of antibodies.”

Fortunately, in the coming months, distribution of these drugs should improve significantly. Pfizer says it expects to deliver 10 million courses of Paxlovid by the end of June, and another 10 million by the end of September. More than 1 million courses of sotrovimab should be distributed by GlaxoSmithKline through the end of March. And, recently, the Biden administration announced it purchased 1.2 million courses of Evusheld from AstraZeneca.

“Every few weeks, because the COVID picture changes, the demand changes,” said Dr. Louissaint. “With vaccination rates going up and cases going down, fewer patients will need these products.”

Still, the constant barrage of supply shortages over the past 2 years – from COVID tests, ventilators, and personal protective equipment early on to COVID vaccines a year later and more recently health care staff and COVID tests once again – has taken its toll.

“We have faced supply challenge after challenge and have had to be creative in each situation,” said Lisa Barbarotta, MSN, APRN, program director of Oncology Education and Clinical Practice at Smilow Cancer Hospital. “Nothing has been easy about this.”

And, Dr. Bloch cautioned, even with broader access to COVID-19 drugs on the horizon, there is still no substitute for vaccination. “Getting vaccinated is the best and first line of defense for most people,” she said.

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

In mid-November, Kevin Billingsley, MD, MBA, chief medical officer at Yale Cancer Center, New Haven, Conn., was keeping a close eye on the new COVID variant sweeping across South Africa. Six weeks later, the Omicron variant had become the dominant strain in the U.S. – and the Yale health system was no exception.

“As we entered January, we had a breathtaking rate of infection in our hospital,” said Dr. Billingsley, who also leads clinical care at the Smilow Cancer Hospital. “Some of the newly authorized COVID agents were available but not widely enough to make a clinically meaningful impact to protect all high-risk individuals during this surge.”

That left the team at Yale with difficult decisions about who would receive these treatments and who wouldn’t.

The health system convened a COVID-19 immunocompromised working group to identify which patients should get priority access to one of the promising drugs authorized to treat the infection – the monoclonal antibody sotrovimab and antiviral pills Paxlovid and molnupiravir – or the sole available option to prevent it, Evusheld.

“Although clinically sound, none of these decisions have been easy,” Dr. Billingsley told this news organization. “We have done a lot of case-by-case reviewing and a lot of handwringing. Omicron has been a wild ride for us all, and we have been doing the best we can with limited resources.”
 

‘We’re seeing incredible variability’

The team at Yale is not alone. The restricted supply of COVID-19 treatments has led many oncologists and other experts across the U.S. to create carefully curated lists of their most vulnerable patients.

In late December, the National Institutes of Health published broad criteria to help clinicians prioritize patients most likely to benefit from these therapies. A handful of state health departments, including those in Michigan and Minnesota, established their own standards. Patients with cancer – specifically those with hematologic malignancies and receiving oncology therapies that compromise the immune system – appeared at the top of everyone’s list.

But ultimately individual decisions about who receives these drugs and how they’re allocated fell to institutions.

“Overall, what we’re seeing is incredible variability across the country, because there’s no uniform agreement on what comprises best practices on allocating scarce resources,” said Matthew Wynia, MD, MPH, professor of medicine and director of the Center for Bioethics and Humanities at the University of Colorado, Aurora. “There are so many people at the top of most lists, and the drugs are in such short supply, that there’s no guarantee even those in the top tier will get it.”

This news organization spoke to experts across the country about their experiences accessing these treatments during the Omicron surge and their strategies prioritizing patients with cancer.
 

Dealing with limited supply

Overall, the limited supply of COVID-19 drugs means not every patient who’s eligible to receive a treatment will get one.

A snapshot of the past 2 weeks, for instance, shows that the count of new infections hit almost 4.3 million, while distribution of the two antiviral pills Paxlovid and molnupiravir and the monoclonal antibody sotrovimab reached just over 600,000 courses.

Since receiving emergency use authorization in early December, almost 500,000 courses of the pre-exposure prophylactic agent Evusheld – which offers about 6 months of protection for immunocompromised individuals – have been distributed; however, about 7 million adults in the U.S. could potentially benefit from it.

In addition, the distribution of drugs is uneven. The federal government manages the overall distribution to states, but states then decide how to divvy up these allocations to hospitals, pharmacies, and medical centers. In Ohio, for instance, the antivirals go to providers who already receive monoclonal antibodies, while in Tennessee, the supply of antiviral agents only goes to Walmart pharmacies.

This strategy, Dr. Wynia explained, can leave clinicians at the mercy of where and how much states decide to allocate to each location. “I’ve heard of some hospitals and health systems in Colorado that aren’t using all they’ve got, but most don’t have nearly enough,” Dr. Wynia said. However, he noted, “some of that is inevitable. We will never get a perfect distribution of these drugs when there is such variable need and demand.”

And, according to Nicolette Louissaint, PhD, MBA, senior vice president of policy and strategic planning at the Healthcare Distribution Alliance in Arlington, Virginia, “we can take some comfort that the federal government is actively looking at cases from week to week and working with state and local health departments to see who needs these products, which means the process is constantly being reviewed and adjusted.”

Plus, not every positive COVID-19 case, even among immunocompromised individuals, necessarily warrants treatment. “If, for instance, an individual with cancer has a mild case of COVID-19, their provider may not deem it necessary for them to receive treatment,” Dr. Louissaint noted.

Still, given the limited and unpredictable supply, “we have had to be thoughtful about who gets these drugs,” said Derek Raghavan, MD, PhD, president of the Levine Cancer Institute, part of the 40-hospital Atrium Health system in Charlotte, North Carolina.

Dr. Raghavan said the highest priority goes to patients with hematologic malignancies, those receiving or coming off chemotherapy or experiencing myelosuppression and immune paresis, as well as those who have undergone organ transplants. Age and other comorbidities, such as diabetes or obesity, play into the lineup as well.

To further hone their priority list, the Levine Cancer Institute has implemented a cancer-centered Hospital at Home initiative. The program includes 40 oncology nurse navigators who routinely screen and score all cancer patients who test positive for COVID-19 by their symptoms and risk factors. For a time-sensitive treatment like Paxlovid, this close monitoring allows patients with COVID to access the pills within 5 days of symptom onset.

Ultimately, “the decision regarding who gets these drugs is [made] by a team to overcome any risk of personal bias, and some of it just comes down to the interface between clinical judgment and available data,” Dr. Raghavan told this news organization. “Although we’d like to have more COVID drugs available and fewer patients with COVID, we have been able to get adequate supplies for our most at-risk patients.”

Like Dr. Raghavan, Karen Bloch, MD, MPH, the medical director for the COVID Infusion Clinic at Vanderbilt University Medical Center (VUMC), said the clinic has had to be highly selective about which patients would benefit most from the COVID monoclonal antibodies. For patients with cancer, her team prioritizes individuals who would be least able to develop antibodies through vaccination or natural infection – which includes patients with B cell malignancies, acute myeloid leukemia, or multiple myeloma receiving active treatment, as well as those who recently received an allogeneic or autologous stem cell transplant.

“Since our criteria for treatment with therapies such as sotrovimab and Evusheld are pretty stringent, we have had sufficient supply to treat those who meet our internal ‘category 1’ predetermined criteria,” said Dr. Bloch, professor of medicine and associate division director for clinical affairs at VUMC, Nashville. “More recently, as the supply chain has begun to open up, we’ve been able to loosen our criteria for sotrovimab, though not for Evusheld yet.”

The Yale team described a similar evolution. “Initially, only a small subset of oncology patients could get these drugs,” said Osama (Sam) Abdelghany, PharmD, MHA, associate director of Oncology Pharmacy Services at Smilow Cancer Hospital. But as the caseload has diminished, Dr. Abdelghany noted, “we have been able to reach many more patients with COVID-19.”
 

An equitable system?

Dr. Wynia, who has written many reports on crisis standards of care, has spent thousands of hours delving into the ethics of allocating scarce resources during a disaster.

A core problem arises when there are too many people who need a scarce resource and no way of differentiating among them.

In response to the limited supply of COVID-19 treatments, some institutions, such as the University of Pittsburgh Medical Center and Massachusetts General Hospital, have created a lottery system. Others, such as Johns Hopkins Medicine, have opted for first come, first served. Each strategy comes with caveats.

“First come, first served prioritization may be quicker, but it gives more well-resourced people an advantage and lends itself to people abusing the system or exacerbating existing disparities,” Dr. Wynia said.

While a lottery system may be more equitable, this strategy often comes at the price of efficiency. “The practicality of doing a lottery when you have to make a decision about whether or not to treat the patient sitting in front of you comes with its own challenges,” Dr. Wynia said.

At the University of Colorado, he explained, the health center constantly scans medical records for patients who have been diagnosed with COVID and fall into a high-risk group. That way clinicians can call or email those most likely to benefit from these drugs.

“It ends up being a bit of a first come, first served strategy,” Dr. Wynia said. “But we also do not have a huge supply coming in each week, so reaching out to the most eligible people when we have the drugs in hand means more privileged patients are less likely to game the system.”

To manage the supply of Evusheld, Timothy Kubal, MD, MBA, and colleagues also reach out to patients most likely to benefit – specifically, those who can’t mount an adequate antibody response after vaccination.

“We screen all of our patients who have been receiving anti-CD20 agents and other chemotherapy agents known to suppress antibody response,” Dr. Kubal, a medical oncologist/hematologist at the Moffitt Institute in Tampa, Florida, said in an interview. “We then test those patients for antibodies and deliver Evusheld if they have no evidence of antibodies.”

Fortunately, in the coming months, distribution of these drugs should improve significantly. Pfizer says it expects to deliver 10 million courses of Paxlovid by the end of June, and another 10 million by the end of September. More than 1 million courses of sotrovimab should be distributed by GlaxoSmithKline through the end of March. And, recently, the Biden administration announced it purchased 1.2 million courses of Evusheld from AstraZeneca.

“Every few weeks, because the COVID picture changes, the demand changes,” said Dr. Louissaint. “With vaccination rates going up and cases going down, fewer patients will need these products.”

Still, the constant barrage of supply shortages over the past 2 years – from COVID tests, ventilators, and personal protective equipment early on to COVID vaccines a year later and more recently health care staff and COVID tests once again – has taken its toll.

“We have faced supply challenge after challenge and have had to be creative in each situation,” said Lisa Barbarotta, MSN, APRN, program director of Oncology Education and Clinical Practice at Smilow Cancer Hospital. “Nothing has been easy about this.”

And, Dr. Bloch cautioned, even with broader access to COVID-19 drugs on the horizon, there is still no substitute for vaccination. “Getting vaccinated is the best and first line of defense for most people,” she said.

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

The “Cancer Moonshot” is about to be relaunched.

In a White House briefing, President Joe Biden announced that he is “reigniting” the initiative he spearheaded when he was vice president during the Obama administration.

During the livestreamed event, the president discussed his plans to bring a “fierce sense of urgency” to the fight against cancer and better support patients with cancer and their families.

He emphasized that cancer is one of the truly bipartisan issues. There is strong support from both “sides of the aisle,” he said, and he sees it as an issue that can bring the country together.

“We can do this. I promise you, we can do this. For all those we lost, for all those we miss. We can end cancer as we know it,” he said. “This is a presidential White House priority.”

The aim is to reduce the death rate from cancer by at least 50% over the next 25 years.

One of the efforts will be directed to get people back to routine cancer screenings, such as mammograms and colonoscopies, with a special focus on ensuring equitable access.

There is also a proposal to create the Advanced Research Projects Agency for Health, which would focus on driving cutting-edge innovation in health research.

Part of the plan is to assemble a “cancer cabinet” that includes 18 federal departments, agencies, and offices, including leaders from the departments of Health & Human Services, Veterans Affairs, Defense, Energy, and Agriculture.

At present, there are few details about the new program or how it will be funded.

Presumably more will be revealed at the Cancer Moonshot Summit being planned, as well as on a planned new website where people can track its progress.
 

President priority

Cancer Moonshot began back in 2016, when during his last State of the Union Address, former President Barack Obama announced the ambitious initiative. A few days later, Obama asked Congress for $1 billion to send cancer to the moon, and he put Biden, then vice president, in charge of “mission control” in the remaining months of the administration.

The new initiative will be headed by Danielle Carnival, PhD, who serves in the White House Office of Science and Technology Policy and has been appointed as White House Cancer Moonshot coordinator.

At the briefing, Mr. Biden and Vice President Kamala Harris spoke about losing family members to cancer. The president spoke about his eldest son, Beau, who died from brain cancer when he was 46 years old, while Ms. Harris spoke about her mother, Shyamala Gopalan, a breast cancer researcher who died of colon cancer in 2009.
 

Accolades but a bit of caution

The president’s speech was applauded by many cancer groups, both professional organizations and patient advocacy groups.

Karen E. Knudsen, PhD, chief executive officer of the American Cancer Society and its advocacy affiliate, the American Cancer Society Cancer Action Network, commended Mr. Biden for reigniting Cancer Moonshot.

“In 2022 alone, there will be an estimated 1.9 million people diagnosed with cancer and more than 600,000 people in the U.S. will die. Marshaling the resources of the federal government will be critical in our ability to reduce death and suffering from this disease,” she said.

The American Society for Radiation Oncology issued a press release, saying: “On behalf of radiation oncologists who treat people with cancer every day, we support the Biden-Harris administration’s move to drastically reduce the number of cancer deaths in the United States and improve the lives of people diagnosed with this disease.

“We believe the administration’s commitment to expand cancer prevention efforts and to increase equitable access to screenings and treatments will help mitigate some of the negative impact of the COVID-19 pandemic,” the society added.

At the American Association for Cancer Research, Chief Executive Officer Margaret Foti, MD, PhD, said she was thrilled to hear the announcement after the devastating interruptions in cancer research and patient care over the past 2 years.

“The reignited Cancer Moonshot will provide an important framework to help improve cancer prevention strategies, increase cancer screenings and early detection, reduce cancer disparities, and propel new lifesaving cures for patients with cancer,” she said.

However, increased funding from Congress will be needed for these goals to be achieved, she emphasized.

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

The “Cancer Moonshot” is about to be relaunched.

In a White House briefing, President Joe Biden announced that he is “reigniting” the initiative he spearheaded when he was vice president during the Obama administration.

During the livestreamed event, the president discussed his plans to bring a “fierce sense of urgency” to the fight against cancer and better support patients with cancer and their families.

He emphasized that cancer is one of the truly bipartisan issues. There is strong support from both “sides of the aisle,” he said, and he sees it as an issue that can bring the country together.

“We can do this. I promise you, we can do this. For all those we lost, for all those we miss. We can end cancer as we know it,” he said. “This is a presidential White House priority.”

The aim is to reduce the death rate from cancer by at least 50% over the next 25 years.

One of the efforts will be directed to get people back to routine cancer screenings, such as mammograms and colonoscopies, with a special focus on ensuring equitable access.

There is also a proposal to create the Advanced Research Projects Agency for Health, which would focus on driving cutting-edge innovation in health research.

Part of the plan is to assemble a “cancer cabinet” that includes 18 federal departments, agencies, and offices, including leaders from the departments of Health & Human Services, Veterans Affairs, Defense, Energy, and Agriculture.

At present, there are few details about the new program or how it will be funded.

Presumably more will be revealed at the Cancer Moonshot Summit being planned, as well as on a planned new website where people can track its progress.
 

President priority

Cancer Moonshot began back in 2016, when during his last State of the Union Address, former President Barack Obama announced the ambitious initiative. A few days later, Obama asked Congress for $1 billion to send cancer to the moon, and he put Biden, then vice president, in charge of “mission control” in the remaining months of the administration.

The new initiative will be headed by Danielle Carnival, PhD, who serves in the White House Office of Science and Technology Policy and has been appointed as White House Cancer Moonshot coordinator.

At the briefing, Mr. Biden and Vice President Kamala Harris spoke about losing family members to cancer. The president spoke about his eldest son, Beau, who died from brain cancer when he was 46 years old, while Ms. Harris spoke about her mother, Shyamala Gopalan, a breast cancer researcher who died of colon cancer in 2009.
 

Accolades but a bit of caution

The president’s speech was applauded by many cancer groups, both professional organizations and patient advocacy groups.

Karen E. Knudsen, PhD, chief executive officer of the American Cancer Society and its advocacy affiliate, the American Cancer Society Cancer Action Network, commended Mr. Biden for reigniting Cancer Moonshot.

“In 2022 alone, there will be an estimated 1.9 million people diagnosed with cancer and more than 600,000 people in the U.S. will die. Marshaling the resources of the federal government will be critical in our ability to reduce death and suffering from this disease,” she said.

The American Society for Radiation Oncology issued a press release, saying: “On behalf of radiation oncologists who treat people with cancer every day, we support the Biden-Harris administration’s move to drastically reduce the number of cancer deaths in the United States and improve the lives of people diagnosed with this disease.

“We believe the administration’s commitment to expand cancer prevention efforts and to increase equitable access to screenings and treatments will help mitigate some of the negative impact of the COVID-19 pandemic,” the society added.

At the American Association for Cancer Research, Chief Executive Officer Margaret Foti, MD, PhD, said she was thrilled to hear the announcement after the devastating interruptions in cancer research and patient care over the past 2 years.

“The reignited Cancer Moonshot will provide an important framework to help improve cancer prevention strategies, increase cancer screenings and early detection, reduce cancer disparities, and propel new lifesaving cures for patients with cancer,” she said.

However, increased funding from Congress will be needed for these goals to be achieved, she emphasized.

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

The “Cancer Moonshot” is about to be relaunched.

In a White House briefing, President Joe Biden announced that he is “reigniting” the initiative he spearheaded when he was vice president during the Obama administration.

During the livestreamed event, the president discussed his plans to bring a “fierce sense of urgency” to the fight against cancer and better support patients with cancer and their families.

He emphasized that cancer is one of the truly bipartisan issues. There is strong support from both “sides of the aisle,” he said, and he sees it as an issue that can bring the country together.

“We can do this. I promise you, we can do this. For all those we lost, for all those we miss. We can end cancer as we know it,” he said. “This is a presidential White House priority.”

The aim is to reduce the death rate from cancer by at least 50% over the next 25 years.

One of the efforts will be directed to get people back to routine cancer screenings, such as mammograms and colonoscopies, with a special focus on ensuring equitable access.

There is also a proposal to create the Advanced Research Projects Agency for Health, which would focus on driving cutting-edge innovation in health research.

Part of the plan is to assemble a “cancer cabinet” that includes 18 federal departments, agencies, and offices, including leaders from the departments of Health & Human Services, Veterans Affairs, Defense, Energy, and Agriculture.

At present, there are few details about the new program or how it will be funded.

Presumably more will be revealed at the Cancer Moonshot Summit being planned, as well as on a planned new website where people can track its progress.
 

President priority

Cancer Moonshot began back in 2016, when during his last State of the Union Address, former President Barack Obama announced the ambitious initiative. A few days later, Obama asked Congress for $1 billion to send cancer to the moon, and he put Biden, then vice president, in charge of “mission control” in the remaining months of the administration.

The new initiative will be headed by Danielle Carnival, PhD, who serves in the White House Office of Science and Technology Policy and has been appointed as White House Cancer Moonshot coordinator.

At the briefing, Mr. Biden and Vice President Kamala Harris spoke about losing family members to cancer. The president spoke about his eldest son, Beau, who died from brain cancer when he was 46 years old, while Ms. Harris spoke about her mother, Shyamala Gopalan, a breast cancer researcher who died of colon cancer in 2009.
 

Accolades but a bit of caution

The president’s speech was applauded by many cancer groups, both professional organizations and patient advocacy groups.

Karen E. Knudsen, PhD, chief executive officer of the American Cancer Society and its advocacy affiliate, the American Cancer Society Cancer Action Network, commended Mr. Biden for reigniting Cancer Moonshot.

“In 2022 alone, there will be an estimated 1.9 million people diagnosed with cancer and more than 600,000 people in the U.S. will die. Marshaling the resources of the federal government will be critical in our ability to reduce death and suffering from this disease,” she said.

The American Society for Radiation Oncology issued a press release, saying: “On behalf of radiation oncologists who treat people with cancer every day, we support the Biden-Harris administration’s move to drastically reduce the number of cancer deaths in the United States and improve the lives of people diagnosed with this disease.

“We believe the administration’s commitment to expand cancer prevention efforts and to increase equitable access to screenings and treatments will help mitigate some of the negative impact of the COVID-19 pandemic,” the society added.

At the American Association for Cancer Research, Chief Executive Officer Margaret Foti, MD, PhD, said she was thrilled to hear the announcement after the devastating interruptions in cancer research and patient care over the past 2 years.

“The reignited Cancer Moonshot will provide an important framework to help improve cancer prevention strategies, increase cancer screenings and early detection, reduce cancer disparities, and propel new lifesaving cures for patients with cancer,” she said.

However, increased funding from Congress will be needed for these goals to be achieved, she emphasized.

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

The Endocrine Society is among several organizations and individuals petitioning the Food and Drug Administration to remove its approvals of bisphenol A (BPA), citing recent evidence that exposure to it is unsafe.

The chemical is used to make plastics in items such as food containers, pitchers, and inner linings of metal products. Small amounts of BPA can leak into food and beverages.

tezzstock/Thinkstock

The petition points to a December 2021 report by the European Food Safety Authority titled: “Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs,” which summarizes evidence gathered since 2013.

It concludes that “there is a health concern from BPA exposure for all age groups.” Specific concerns include harm to the immune system and male and female reproductive systems.
 

Average American exposed to 5,000 times the safe level of BPA

The EFSA established a new “tolerable daily intake” of BPA of 0.04 ng/kg of body weight per day. By contrast, in 2014 the FDA estimated that the mean BPA intake for the U.S. population older than 2 years was 200 ng/kg bw/day and that the 90th percentile for BPA intake was 500 ng/kg of body weight per day.

“Using FDA’s own exposure estimates, the average American is exposed to more than 5000 times the safe level of 0.04 ng BPA/kg [body weight per day] set by the EFSA expert panel. Without a doubt, these values constitute a high health risk and support the conclusion that uses of BPA are not safe ... Given the magnitude of the overexposure, we request an expedited review by FDA,” the petition reads.

In addition to the Endocrine Society, which has long warned about the dangers of endocrine-disrupting chemicals, other signatories to the petition include the Environmental Defense Fund, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Environmental Working Group, Healthy Babies Bright Futures, and the former director of the National Institute of Environmental Health Sciences and National Toxicology Program.

In a statement, Endocrine Society BPA expert Heather Patisaul, PhD, of North Carolina University, Raleigh, said the report’s findings “are extremely concerning and prove the point that even very low levels of BPA exposure can be harmful and lead to issues with reproductive health, breast cancer risk, behavior, and metabolism.”

“The FDA needs to acknowledge the science behind endocrine-disrupting chemicals and act accordingly to protect public health,” she urged.

The FDA is expected to decide within the next few days whether to open a docket to accept comments.

A final decision could take 6 months or longer, an Endocrine Society spokesperson told this news organization.

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

The Endocrine Society is among several organizations and individuals petitioning the Food and Drug Administration to remove its approvals of bisphenol A (BPA), citing recent evidence that exposure to it is unsafe.

The chemical is used to make plastics in items such as food containers, pitchers, and inner linings of metal products. Small amounts of BPA can leak into food and beverages.

tezzstock/Thinkstock

The petition points to a December 2021 report by the European Food Safety Authority titled: “Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs,” which summarizes evidence gathered since 2013.

It concludes that “there is a health concern from BPA exposure for all age groups.” Specific concerns include harm to the immune system and male and female reproductive systems.
 

Average American exposed to 5,000 times the safe level of BPA

The EFSA established a new “tolerable daily intake” of BPA of 0.04 ng/kg of body weight per day. By contrast, in 2014 the FDA estimated that the mean BPA intake for the U.S. population older than 2 years was 200 ng/kg bw/day and that the 90th percentile for BPA intake was 500 ng/kg of body weight per day.

“Using FDA’s own exposure estimates, the average American is exposed to more than 5000 times the safe level of 0.04 ng BPA/kg [body weight per day] set by the EFSA expert panel. Without a doubt, these values constitute a high health risk and support the conclusion that uses of BPA are not safe ... Given the magnitude of the overexposure, we request an expedited review by FDA,” the petition reads.

In addition to the Endocrine Society, which has long warned about the dangers of endocrine-disrupting chemicals, other signatories to the petition include the Environmental Defense Fund, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Environmental Working Group, Healthy Babies Bright Futures, and the former director of the National Institute of Environmental Health Sciences and National Toxicology Program.

In a statement, Endocrine Society BPA expert Heather Patisaul, PhD, of North Carolina University, Raleigh, said the report’s findings “are extremely concerning and prove the point that even very low levels of BPA exposure can be harmful and lead to issues with reproductive health, breast cancer risk, behavior, and metabolism.”

“The FDA needs to acknowledge the science behind endocrine-disrupting chemicals and act accordingly to protect public health,” she urged.

The FDA is expected to decide within the next few days whether to open a docket to accept comments.

A final decision could take 6 months or longer, an Endocrine Society spokesperson told this news organization.

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

The Endocrine Society is among several organizations and individuals petitioning the Food and Drug Administration to remove its approvals of bisphenol A (BPA), citing recent evidence that exposure to it is unsafe.

The chemical is used to make plastics in items such as food containers, pitchers, and inner linings of metal products. Small amounts of BPA can leak into food and beverages.

tezzstock/Thinkstock

The petition points to a December 2021 report by the European Food Safety Authority titled: “Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs,” which summarizes evidence gathered since 2013.

It concludes that “there is a health concern from BPA exposure for all age groups.” Specific concerns include harm to the immune system and male and female reproductive systems.
 

Average American exposed to 5,000 times the safe level of BPA

The EFSA established a new “tolerable daily intake” of BPA of 0.04 ng/kg of body weight per day. By contrast, in 2014 the FDA estimated that the mean BPA intake for the U.S. population older than 2 years was 200 ng/kg bw/day and that the 90th percentile for BPA intake was 500 ng/kg of body weight per day.

“Using FDA’s own exposure estimates, the average American is exposed to more than 5000 times the safe level of 0.04 ng BPA/kg [body weight per day] set by the EFSA expert panel. Without a doubt, these values constitute a high health risk and support the conclusion that uses of BPA are not safe ... Given the magnitude of the overexposure, we request an expedited review by FDA,” the petition reads.

In addition to the Endocrine Society, which has long warned about the dangers of endocrine-disrupting chemicals, other signatories to the petition include the Environmental Defense Fund, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Environmental Working Group, Healthy Babies Bright Futures, and the former director of the National Institute of Environmental Health Sciences and National Toxicology Program.

In a statement, Endocrine Society BPA expert Heather Patisaul, PhD, of North Carolina University, Raleigh, said the report’s findings “are extremely concerning and prove the point that even very low levels of BPA exposure can be harmful and lead to issues with reproductive health, breast cancer risk, behavior, and metabolism.”

“The FDA needs to acknowledge the science behind endocrine-disrupting chemicals and act accordingly to protect public health,” she urged.

The FDA is expected to decide within the next few days whether to open a docket to accept comments.

A final decision could take 6 months or longer, an Endocrine Society spokesperson told this news organization.

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

Hundreds of Native American tribes have tentatively settled in what one of the lead attorneys describes as “an epic deal”: The top 3 pharmaceutical distributors in the US and Johnson & Johnson have agreed to pay $665 million for deceptive marketing practices and overdistribution of opioids. Native Americans were among those hardest hit by the opioid epidemic. Between 2006 and 2014, Native Americans were nearly 50% more likely than non-Natives to die of an opioid overdose. In 2014, they ranked number 1 for death by opioid overdose.

Overprescribing was rampant. In some areas, such as southwestern Virginia, eastern Kentucky, and Alabama, prescriptions were 5 to 6 times higher than the national average. The overprescribing was largely due to massive and aggressive billion-dollar marketing campaigns, which misrepresented the safety of opioid medications. Purdue Pharma, for instance, trained sales representatives to claim that the risk of addiction was “less than 1 percent.” In an interview with Smithsonian Magazine, Caleb Alexander, MD, codirector of Johns Hopkins’ Center for Drug Safety and Effectiveness, said, “When I was in residency training, we were taught that one needn’t worry about the addictive potential of opioids if a patient had true pain.” He said it was no accident that physicians were cultivated to overestimate the effectiveness for chronic, noncancer pain while underestimating the risks.

Native Americans were not only in the target group for prescriptions, but also apparently singularly targeted. “We were preyed upon,” said Chickasaw Nation Governor Bill Anoatubby in the Washington Post. “It was unconscionable.” A Washington Post analysis found that, between 2006 and 2014, opioid distributors shipped an average of 36 pills per person in the US. States in the so-called opioid belt (mostly Southern states), received an average of 60 to 66 pills per person. The distributors shipped 57 pills per person to Oklahoma, home to nearly 322,000 Native Americans. (The opioid death rate for Native Americans in Oklahoma from 2006 to 2014 was more than triple the nationwide rate for non-Natives.) In South Dakota as recently as 2015, enough opioids were prescribed to medicate every adult around-the-clock for 19 consecutive days. Native Americans comprise 9% of South Dakota’s population; however, almost 30% of the patients are being treated for opioid use disorder.

In the settlement, which is a first for tribes, McKesson, Cardinal Health, and AmerisourceBergen would pay $515 million over 7 years. Johnson & Johnson would contribute $150 million in 2 years to the federally recognized tribes. “This settlement is a real turning point in history,” said Lloyd Miller, one of the attorneys representing one-third of the litigating tribes.

But the money is still small compensation for ravaging millions of lives. “Flooding the Native community with Western medicine—sedating a population rather than seeking to understand its needs and challenges—is not an acceptable means of handling its trauma,” the Lakota People’s Law Project says in an article on its website. Thus, the money dispersal will be overseen by a panel of tribal health experts, to go toward programs that aid drug users and their communities.

The funds will be managed in a way that will consider the long-term damage, Native American leaders vow. Children, for instance, have not been exempt from the sequelae of the overprescribing. Foster care systems are “overrun” with children of addicted parents, the Law Project says, and the children are placed in homes outside the tribe. “In the long run, this has the potential to curtail tribal membership, break down familial lines, and degrade cultural values.”

Dealing with the problem has drained tribal resources—doubly strained by the COVID-19 epidemic. Chairman Douglas Yankton, of the Spirit Lake Nation in North Dakota, said in a statement, “The dollars that will flow to Tribes under this initial settlement will help fund crucial, on-reservation, culturally appropriate opioid treatment services.”

However, Chairman Kristopher Peters, of the Squaxin Island Tribe in Washington State, told the Washington Post, “There is no amount of money that’s going to solve the generational issues that have been created from this. Our hope is that we can use these funds to help revitalize our culture and help heal our people.”

Johnson & Johnson says it no longer sells prescription opioids in the US

Hundreds of Native American tribes have tentatively settled in what one of the lead attorneys describes as “an epic deal”: The top 3 pharmaceutical distributors in the US and Johnson & Johnson have agreed to pay $665 million for deceptive marketing practices and overdistribution of opioids. Native Americans were among those hardest hit by the opioid epidemic. Between 2006 and 2014, Native Americans were nearly 50% more likely than non-Natives to die of an opioid overdose. In 2014, they ranked number 1 for death by opioid overdose.

Overprescribing was rampant. In some areas, such as southwestern Virginia, eastern Kentucky, and Alabama, prescriptions were 5 to 6 times higher than the national average. The overprescribing was largely due to massive and aggressive billion-dollar marketing campaigns, which misrepresented the safety of opioid medications. Purdue Pharma, for instance, trained sales representatives to claim that the risk of addiction was “less than 1 percent.” In an interview with Smithsonian Magazine, Caleb Alexander, MD, codirector of Johns Hopkins’ Center for Drug Safety and Effectiveness, said, “When I was in residency training, we were taught that one needn’t worry about the addictive potential of opioids if a patient had true pain.” He said it was no accident that physicians were cultivated to overestimate the effectiveness for chronic, noncancer pain while underestimating the risks.

Native Americans were not only in the target group for prescriptions, but also apparently singularly targeted. “We were preyed upon,” said Chickasaw Nation Governor Bill Anoatubby in the Washington Post. “It was unconscionable.” A Washington Post analysis found that, between 2006 and 2014, opioid distributors shipped an average of 36 pills per person in the US. States in the so-called opioid belt (mostly Southern states), received an average of 60 to 66 pills per person. The distributors shipped 57 pills per person to Oklahoma, home to nearly 322,000 Native Americans. (The opioid death rate for Native Americans in Oklahoma from 2006 to 2014 was more than triple the nationwide rate for non-Natives.) In South Dakota as recently as 2015, enough opioids were prescribed to medicate every adult around-the-clock for 19 consecutive days. Native Americans comprise 9% of South Dakota’s population; however, almost 30% of the patients are being treated for opioid use disorder.

In the settlement, which is a first for tribes, McKesson, Cardinal Health, and AmerisourceBergen would pay $515 million over 7 years. Johnson & Johnson would contribute $150 million in 2 years to the federally recognized tribes. “This settlement is a real turning point in history,” said Lloyd Miller, one of the attorneys representing one-third of the litigating tribes.

But the money is still small compensation for ravaging millions of lives. “Flooding the Native community with Western medicine—sedating a population rather than seeking to understand its needs and challenges—is not an acceptable means of handling its trauma,” the Lakota People’s Law Project says in an article on its website. Thus, the money dispersal will be overseen by a panel of tribal health experts, to go toward programs that aid drug users and their communities.

The funds will be managed in a way that will consider the long-term damage, Native American leaders vow. Children, for instance, have not been exempt from the sequelae of the overprescribing. Foster care systems are “overrun” with children of addicted parents, the Law Project says, and the children are placed in homes outside the tribe. “In the long run, this has the potential to curtail tribal membership, break down familial lines, and degrade cultural values.”

Dealing with the problem has drained tribal resources—doubly strained by the COVID-19 epidemic. Chairman Douglas Yankton, of the Spirit Lake Nation in North Dakota, said in a statement, “The dollars that will flow to Tribes under this initial settlement will help fund crucial, on-reservation, culturally appropriate opioid treatment services.”

However, Chairman Kristopher Peters, of the Squaxin Island Tribe in Washington State, told the Washington Post, “There is no amount of money that’s going to solve the generational issues that have been created from this. Our hope is that we can use these funds to help revitalize our culture and help heal our people.”

Johnson & Johnson says it no longer sells prescription opioids in the US

Hundreds of Native American tribes have tentatively settled in what one of the lead attorneys describes as “an epic deal”: The top 3 pharmaceutical distributors in the US and Johnson & Johnson have agreed to pay $665 million for deceptive marketing practices and overdistribution of opioids. Native Americans were among those hardest hit by the opioid epidemic. Between 2006 and 2014, Native Americans were nearly 50% more likely than non-Natives to die of an opioid overdose. In 2014, they ranked number 1 for death by opioid overdose.

Overprescribing was rampant. In some areas, such as southwestern Virginia, eastern Kentucky, and Alabama, prescriptions were 5 to 6 times higher than the national average. The overprescribing was largely due to massive and aggressive billion-dollar marketing campaigns, which misrepresented the safety of opioid medications. Purdue Pharma, for instance, trained sales representatives to claim that the risk of addiction was “less than 1 percent.” In an interview with Smithsonian Magazine, Caleb Alexander, MD, codirector of Johns Hopkins’ Center for Drug Safety and Effectiveness, said, “When I was in residency training, we were taught that one needn’t worry about the addictive potential of opioids if a patient had true pain.” He said it was no accident that physicians were cultivated to overestimate the effectiveness for chronic, noncancer pain while underestimating the risks.

Native Americans were not only in the target group for prescriptions, but also apparently singularly targeted. “We were preyed upon,” said Chickasaw Nation Governor Bill Anoatubby in the Washington Post. “It was unconscionable.” A Washington Post analysis found that, between 2006 and 2014, opioid distributors shipped an average of 36 pills per person in the US. States in the so-called opioid belt (mostly Southern states), received an average of 60 to 66 pills per person. The distributors shipped 57 pills per person to Oklahoma, home to nearly 322,000 Native Americans. (The opioid death rate for Native Americans in Oklahoma from 2006 to 2014 was more than triple the nationwide rate for non-Natives.) In South Dakota as recently as 2015, enough opioids were prescribed to medicate every adult around-the-clock for 19 consecutive days. Native Americans comprise 9% of South Dakota’s population; however, almost 30% of the patients are being treated for opioid use disorder.

In the settlement, which is a first for tribes, McKesson, Cardinal Health, and AmerisourceBergen would pay $515 million over 7 years. Johnson & Johnson would contribute $150 million in 2 years to the federally recognized tribes. “This settlement is a real turning point in history,” said Lloyd Miller, one of the attorneys representing one-third of the litigating tribes.

But the money is still small compensation for ravaging millions of lives. “Flooding the Native community with Western medicine—sedating a population rather than seeking to understand its needs and challenges—is not an acceptable means of handling its trauma,” the Lakota People’s Law Project says in an article on its website. Thus, the money dispersal will be overseen by a panel of tribal health experts, to go toward programs that aid drug users and their communities.

The funds will be managed in a way that will consider the long-term damage, Native American leaders vow. Children, for instance, have not been exempt from the sequelae of the overprescribing. Foster care systems are “overrun” with children of addicted parents, the Law Project says, and the children are placed in homes outside the tribe. “In the long run, this has the potential to curtail tribal membership, break down familial lines, and degrade cultural values.”

Dealing with the problem has drained tribal resources—doubly strained by the COVID-19 epidemic. Chairman Douglas Yankton, of the Spirit Lake Nation in North Dakota, said in a statement, “The dollars that will flow to Tribes under this initial settlement will help fund crucial, on-reservation, culturally appropriate opioid treatment services.”

However, Chairman Kristopher Peters, of the Squaxin Island Tribe in Washington State, told the Washington Post, “There is no amount of money that’s going to solve the generational issues that have been created from this. Our hope is that we can use these funds to help revitalize our culture and help heal our people.”

Johnson & Johnson says it no longer sells prescription opioids in the US

In 2014, amidst stories of delays at Veterans Health Administration facilities, Congress established the Veterans Choice Program, which expanded access to private sector health care practitioners. When the program expired in 2018, lawmakers replaced it with the Veterans Community Care Program (VCCP) as part of the US Department of Veterans Affairs (VA) Maintaining Internal Systems and Strengthening Integrated Outside Networks Act (38 USC § 1703 MISSION Act). Since then, the VCCP has grown exponentially; 34% of current veteran health care visits are with private clinicians.

Along with broader private sector access, the MISSION Act also mandated the creation of quality-of-care standards for both VA and VCCP, and stipulated that data be compiled and made available to “provide covered veterans relevant comparative information to make informed decisions regarding their health care.” Two-and-a-half years later, data about the quality of VCCP care remains largely unknown.

Access to Care Website  

In the lead up to the MISSION Act, the VA launched its Access to Care website, an online tool that publishes institutional performance data on key metrics so that veterans can make “more informed choices about where, when, and how they receive their health care.” Following the bill’s passage, the VA added a MISSION Act Quality Standards section, which includes results of 27 conventional quality measures for every VA facility. These scores are posted alongside data of regional facilities.

This trailblazing tool is exceedingly comprehensive. Yet, multiple website gaps compromise its utility for veterans deliberating whether to obtain VCCP care, including:

1. Data isn’t about VCCP care. The hospitals are selected because they are local, not whether they participate in VCCP.  Further, it appears that aggregate scores include non-VCCP facilities.
2. Missing conditions/treatments. While the website contains quality scores for an ample range of procedures, it lacks information for many conditions that disproportionately affect veterans. A veteran with posttraumatic stress disorder (PTSD) or traumatic brain injury (TBI), for example, has no data to check.
3. Skewed comparison population. Private sector practitioners primarily treat nonveteran patients, a population that is, on average, healthier and of higher socioeconomic status when compared with VA patients. Outcomes differ, for example, when patients have coexisting mental illness or homelessness. For VCCP scores to be beneficial for comparisons, they should derive from treated veterans or be accurately risk-adjusted.
4. Tangential measures. The Institute of Medicine defined health care quality as “improvement of outcomes.” Patients considering health care options benefit from information about treatment effectiveness and symptom reduction. But because obtaining that quality data is labor intensive, proxy measures are substituted. For example, the measure advising smokers to quit is the closest the website comes to reporting on the quality of mental health care.

High-Performers

The VA initiated a second means to inform veterans about the quality of furnished care. Specifically, they guided third-party administrators (TPAs)—TriWest Healthcare Alliance and Optum—in creating algorithms designating that VCCP individual clinicians, practice groups, and hospitals can be deemed high performing providers (HPPs). The algorithms are calculated using a mix of Healthcare Effectiveness Data and Information Set (HEDIS), Physician Quality Reporting System (PQRS), and Blue Health Intelligence (BHI) primary and specialty care measures. The designations are intended to be accessible to local VA community care schedulers to connect veterans with HPPs.

Many aspects of the HPP system are not yet public, including the measures that comprise the algorithms and when the designations will become operational. From what is publicly discoverable about HPP designations, there are crucial gaps like those on the Access to Care website. Behavioral and mental health conditions, for instance, are intentionally excluded in HPP monitoring. HPP algorithms draw from care provided to the general population; an HPP’s patient panel may contain no veterans (with their common comorbidities) at all. Most limiting, there’s no expectation that VCCP clinicians be high performing. Of the 1.2 million program clinicians treating veterans as of November 2020, only a nominal 13.4% were HPP.

After studying the HPP system, VA Partnered Evidence-based Policy Resource Center acknowledged that “it remains unclear whether the quality metrics and referral system result in higher quality of care for VA patients or whether the program improves veteran health.”

Quality of VCCP Mental Health Treatment

The MISSION Act mandated the VA to “establish standards and requirements for the provision of care by non-VA health care practitioners in clinical areas for which the Department of Veterans Affairs has special expertise, including PTSD, military sexual trauma-related conditions (MST), and TBI.” This requirement arose from a recognition that mental health care provided in the private sector pales in comparison to the VA’s rigorous evidence-based training, consultation, case review and care delivery. For example, over 8500 VA clinicians have received training in evidence-based cognitive processing therapy and/or prolonged exposure therapy for PTSD.

The MISSION Act also mandated that VCCP providers must “fulfill training requirements established by the Secretary on how to deliver evidence-based treatments in the clinical areas for which the Department of Veterans Affairs has special expertise” before furnishing care pursuant to a contract with the VA. However, the VA elected to disregard the directive, and left it up to VCCP clinician’s discretion whether to obtain training or proficiency.

Two bills introduced in Congress in 2021 aim to uphold these vital mandates for the VCCP program. The Veterans’ Culturally Competent Care Act requires VCCP mental health practitioners to take courses on the evaluation and management of suicide, PTSD, TBI, and MST. The Lethal Means Safety Training Act aligns VCCP clinicians suicide prevention training with existing VA standards.

Recommendations to Assure the Quality of VCCP Care

With review and revision of VCCP quality standards now underway, the following remedial actions are recommended:

1. VCCP metrics must be compiled using data on veterans’ care, not the general population, and be published on the Access to Care website. This indispensable information is published on the website for VA care but not for VCCP. Unless VCCP is required to track their veterans, apples-to-apples comparisons of quality of care will remain difficult to attain. Supplemental research that directly contrasts quality of VA to VCCP care should be posted. For example, a 2021 study of enrolled veterans brought by ambulance to VA or community emergency rooms found that all 170 VA medical centers had lower comparative death rates.
2. VCCP providers should be held to the same quality standards as those applied to VA clinicians. In a 2020 critical issue update on implementation of the MISSION Act, major veterans service organizations (VSOs) recommended that competency, training, and quality standards for non-VA community clinicians must be equivalent to benchmarks expected of VA clinicians. That includes credentials, initial and follow-up training, diagnostic screening, care-delivery, and documentation standards. Enacting the Veterans’ Culturally Competent Care Act and the Lethal Means Safety Training Act would begin to meet the MISSION Act’s clear statutory language.
3. The VA and VCCP should add quality information about major diagnostic categories. This will allow veterans to make informed decisions about their personal condition. For most health diagnoses, there is no searchable listing by disorder. 
4. Quality assessments should be realigned to focus on outcome measures. For prospective patients, outcome results provide the most meaningful basis for comparing and selecting clinicians. Proxy measures may have little bearing on whether veterans receive effective care. (As Albert Einstein’s famously observed, “Not everything that can be counted counts.”). Also, the specific measures used for a clinician’s HPP designation should be delineated.
5. The VA must enforce the MISSION Act’s instruction to renew or cancel contracts based on demonstrated quality of care. As VSOs emphasized, “if the private sector is unwilling or unable to match the VA’s access and quality standards, the VA must consider whether it needs to find new community partners.”  

Seventeen billion dollars is spent yearly on purchased health care whose quality remains indeterminate. Ironclad commitments are needed from Congress and the VA to ensure that the effectiveness of, and standards for, veterans care options in the private sector match that in the VA.

In 2014, amidst stories of delays at Veterans Health Administration facilities, Congress established the Veterans Choice Program, which expanded access to private sector health care practitioners. When the program expired in 2018, lawmakers replaced it with the Veterans Community Care Program (VCCP) as part of the US Department of Veterans Affairs (VA) Maintaining Internal Systems and Strengthening Integrated Outside Networks Act (38 USC § 1703 MISSION Act). Since then, the VCCP has grown exponentially; 34% of current veteran health care visits are with private clinicians.

Along with broader private sector access, the MISSION Act also mandated the creation of quality-of-care standards for both VA and VCCP, and stipulated that data be compiled and made available to “provide covered veterans relevant comparative information to make informed decisions regarding their health care.” Two-and-a-half years later, data about the quality of VCCP care remains largely unknown.

Access to Care Website  

In the lead up to the MISSION Act, the VA launched its Access to Care website, an online tool that publishes institutional performance data on key metrics so that veterans can make “more informed choices about where, when, and how they receive their health care.” Following the bill’s passage, the VA added a MISSION Act Quality Standards section, which includes results of 27 conventional quality measures for every VA facility. These scores are posted alongside data of regional facilities.

This trailblazing tool is exceedingly comprehensive. Yet, multiple website gaps compromise its utility for veterans deliberating whether to obtain VCCP care, including:

1. Data isn’t about VCCP care. The hospitals are selected because they are local, not whether they participate in VCCP.  Further, it appears that aggregate scores include non-VCCP facilities.
2. Missing conditions/treatments. While the website contains quality scores for an ample range of procedures, it lacks information for many conditions that disproportionately affect veterans. A veteran with posttraumatic stress disorder (PTSD) or traumatic brain injury (TBI), for example, has no data to check.
3. Skewed comparison population. Private sector practitioners primarily treat nonveteran patients, a population that is, on average, healthier and of higher socioeconomic status when compared with VA patients. Outcomes differ, for example, when patients have coexisting mental illness or homelessness. For VCCP scores to be beneficial for comparisons, they should derive from treated veterans or be accurately risk-adjusted.
4. Tangential measures. The Institute of Medicine defined health care quality as “improvement of outcomes.” Patients considering health care options benefit from information about treatment effectiveness and symptom reduction. But because obtaining that quality data is labor intensive, proxy measures are substituted. For example, the measure advising smokers to quit is the closest the website comes to reporting on the quality of mental health care.

High-Performers

The VA initiated a second means to inform veterans about the quality of furnished care. Specifically, they guided third-party administrators (TPAs)—TriWest Healthcare Alliance and Optum—in creating algorithms designating that VCCP individual clinicians, practice groups, and hospitals can be deemed high performing providers (HPPs). The algorithms are calculated using a mix of Healthcare Effectiveness Data and Information Set (HEDIS), Physician Quality Reporting System (PQRS), and Blue Health Intelligence (BHI) primary and specialty care measures. The designations are intended to be accessible to local VA community care schedulers to connect veterans with HPPs.

Many aspects of the HPP system are not yet public, including the measures that comprise the algorithms and when the designations will become operational. From what is publicly discoverable about HPP designations, there are crucial gaps like those on the Access to Care website. Behavioral and mental health conditions, for instance, are intentionally excluded in HPP monitoring. HPP algorithms draw from care provided to the general population; an HPP’s patient panel may contain no veterans (with their common comorbidities) at all. Most limiting, there’s no expectation that VCCP clinicians be high performing. Of the 1.2 million program clinicians treating veterans as of November 2020, only a nominal 13.4% were HPP.

After studying the HPP system, VA Partnered Evidence-based Policy Resource Center acknowledged that “it remains unclear whether the quality metrics and referral system result in higher quality of care for VA patients or whether the program improves veteran health.”

Quality of VCCP Mental Health Treatment

The MISSION Act mandated the VA to “establish standards and requirements for the provision of care by non-VA health care practitioners in clinical areas for which the Department of Veterans Affairs has special expertise, including PTSD, military sexual trauma-related conditions (MST), and TBI.” This requirement arose from a recognition that mental health care provided in the private sector pales in comparison to the VA’s rigorous evidence-based training, consultation, case review and care delivery. For example, over 8500 VA clinicians have received training in evidence-based cognitive processing therapy and/or prolonged exposure therapy for PTSD.

The MISSION Act also mandated that VCCP providers must “fulfill training requirements established by the Secretary on how to deliver evidence-based treatments in the clinical areas for which the Department of Veterans Affairs has special expertise” before furnishing care pursuant to a contract with the VA. However, the VA elected to disregard the directive, and left it up to VCCP clinician’s discretion whether to obtain training or proficiency.

Two bills introduced in Congress in 2021 aim to uphold these vital mandates for the VCCP program. The Veterans’ Culturally Competent Care Act requires VCCP mental health practitioners to take courses on the evaluation and management of suicide, PTSD, TBI, and MST. The Lethal Means Safety Training Act aligns VCCP clinicians suicide prevention training with existing VA standards.

Recommendations to Assure the Quality of VCCP Care

With review and revision of VCCP quality standards now underway, the following remedial actions are recommended:

1. VCCP metrics must be compiled using data on veterans’ care, not the general population, and be published on the Access to Care website. This indispensable information is published on the website for VA care but not for VCCP. Unless VCCP is required to track their veterans, apples-to-apples comparisons of quality of care will remain difficult to attain. Supplemental research that directly contrasts quality of VA to VCCP care should be posted. For example, a 2021 study of enrolled veterans brought by ambulance to VA or community emergency rooms found that all 170 VA medical centers had lower comparative death rates.
2. VCCP providers should be held to the same quality standards as those applied to VA clinicians. In a 2020 critical issue update on implementation of the MISSION Act, major veterans service organizations (VSOs) recommended that competency, training, and quality standards for non-VA community clinicians must be equivalent to benchmarks expected of VA clinicians. That includes credentials, initial and follow-up training, diagnostic screening, care-delivery, and documentation standards. Enacting the Veterans’ Culturally Competent Care Act and the Lethal Means Safety Training Act would begin to meet the MISSION Act’s clear statutory language.
3. The VA and VCCP should add quality information about major diagnostic categories. This will allow veterans to make informed decisions about their personal condition. For most health diagnoses, there is no searchable listing by disorder. 
4. Quality assessments should be realigned to focus on outcome measures. For prospective patients, outcome results provide the most meaningful basis for comparing and selecting clinicians. Proxy measures may have little bearing on whether veterans receive effective care. (As Albert Einstein’s famously observed, “Not everything that can be counted counts.”). Also, the specific measures used for a clinician’s HPP designation should be delineated.
5. The VA must enforce the MISSION Act’s instruction to renew or cancel contracts based on demonstrated quality of care. As VSOs emphasized, “if the private sector is unwilling or unable to match the VA’s access and quality standards, the VA must consider whether it needs to find new community partners.”  

Seventeen billion dollars is spent yearly on purchased health care whose quality remains indeterminate. Ironclad commitments are needed from Congress and the VA to ensure that the effectiveness of, and standards for, veterans care options in the private sector match that in the VA.

In 2014, amidst stories of delays at Veterans Health Administration facilities, Congress established the Veterans Choice Program, which expanded access to private sector health care practitioners. When the program expired in 2018, lawmakers replaced it with the Veterans Community Care Program (VCCP) as part of the US Department of Veterans Affairs (VA) Maintaining Internal Systems and Strengthening Integrated Outside Networks Act (38 USC § 1703 MISSION Act). Since then, the VCCP has grown exponentially; 34% of current veteran health care visits are with private clinicians.

Along with broader private sector access, the MISSION Act also mandated the creation of quality-of-care standards for both VA and VCCP, and stipulated that data be compiled and made available to “provide covered veterans relevant comparative information to make informed decisions regarding their health care.” Two-and-a-half years later, data about the quality of VCCP care remains largely unknown.

Access to Care Website  

In the lead up to the MISSION Act, the VA launched its Access to Care website, an online tool that publishes institutional performance data on key metrics so that veterans can make “more informed choices about where, when, and how they receive their health care.” Following the bill’s passage, the VA added a MISSION Act Quality Standards section, which includes results of 27 conventional quality measures for every VA facility. These scores are posted alongside data of regional facilities.

This trailblazing tool is exceedingly comprehensive. Yet, multiple website gaps compromise its utility for veterans deliberating whether to obtain VCCP care, including:

1. Data isn’t about VCCP care. The hospitals are selected because they are local, not whether they participate in VCCP.  Further, it appears that aggregate scores include non-VCCP facilities.
2. Missing conditions/treatments. While the website contains quality scores for an ample range of procedures, it lacks information for many conditions that disproportionately affect veterans. A veteran with posttraumatic stress disorder (PTSD) or traumatic brain injury (TBI), for example, has no data to check.
3. Skewed comparison population. Private sector practitioners primarily treat nonveteran patients, a population that is, on average, healthier and of higher socioeconomic status when compared with VA patients. Outcomes differ, for example, when patients have coexisting mental illness or homelessness. For VCCP scores to be beneficial for comparisons, they should derive from treated veterans or be accurately risk-adjusted.
4. Tangential measures. The Institute of Medicine defined health care quality as “improvement of outcomes.” Patients considering health care options benefit from information about treatment effectiveness and symptom reduction. But because obtaining that quality data is labor intensive, proxy measures are substituted. For example, the measure advising smokers to quit is the closest the website comes to reporting on the quality of mental health care.

High-Performers

The VA initiated a second means to inform veterans about the quality of furnished care. Specifically, they guided third-party administrators (TPAs)—TriWest Healthcare Alliance and Optum—in creating algorithms designating that VCCP individual clinicians, practice groups, and hospitals can be deemed high performing providers (HPPs). The algorithms are calculated using a mix of Healthcare Effectiveness Data and Information Set (HEDIS), Physician Quality Reporting System (PQRS), and Blue Health Intelligence (BHI) primary and specialty care measures. The designations are intended to be accessible to local VA community care schedulers to connect veterans with HPPs.

Many aspects of the HPP system are not yet public, including the measures that comprise the algorithms and when the designations will become operational. From what is publicly discoverable about HPP designations, there are crucial gaps like those on the Access to Care website. Behavioral and mental health conditions, for instance, are intentionally excluded in HPP monitoring. HPP algorithms draw from care provided to the general population; an HPP’s patient panel may contain no veterans (with their common comorbidities) at all. Most limiting, there’s no expectation that VCCP clinicians be high performing. Of the 1.2 million program clinicians treating veterans as of November 2020, only a nominal 13.4% were HPP.

After studying the HPP system, VA Partnered Evidence-based Policy Resource Center acknowledged that “it remains unclear whether the quality metrics and referral system result in higher quality of care for VA patients or whether the program improves veteran health.”

Quality of VCCP Mental Health Treatment

The MISSION Act mandated the VA to “establish standards and requirements for the provision of care by non-VA health care practitioners in clinical areas for which the Department of Veterans Affairs has special expertise, including PTSD, military sexual trauma-related conditions (MST), and TBI.” This requirement arose from a recognition that mental health care provided in the private sector pales in comparison to the VA’s rigorous evidence-based training, consultation, case review and care delivery. For example, over 8500 VA clinicians have received training in evidence-based cognitive processing therapy and/or prolonged exposure therapy for PTSD.

The MISSION Act also mandated that VCCP providers must “fulfill training requirements established by the Secretary on how to deliver evidence-based treatments in the clinical areas for which the Department of Veterans Affairs has special expertise” before furnishing care pursuant to a contract with the VA. However, the VA elected to disregard the directive, and left it up to VCCP clinician’s discretion whether to obtain training or proficiency.

Two bills introduced in Congress in 2021 aim to uphold these vital mandates for the VCCP program. The Veterans’ Culturally Competent Care Act requires VCCP mental health practitioners to take courses on the evaluation and management of suicide, PTSD, TBI, and MST. The Lethal Means Safety Training Act aligns VCCP clinicians suicide prevention training with existing VA standards.

Recommendations to Assure the Quality of VCCP Care

With review and revision of VCCP quality standards now underway, the following remedial actions are recommended:

1. VCCP metrics must be compiled using data on veterans’ care, not the general population, and be published on the Access to Care website. This indispensable information is published on the website for VA care but not for VCCP. Unless VCCP is required to track their veterans, apples-to-apples comparisons of quality of care will remain difficult to attain. Supplemental research that directly contrasts quality of VA to VCCP care should be posted. For example, a 2021 study of enrolled veterans brought by ambulance to VA or community emergency rooms found that all 170 VA medical centers had lower comparative death rates.
2. VCCP providers should be held to the same quality standards as those applied to VA clinicians. In a 2020 critical issue update on implementation of the MISSION Act, major veterans service organizations (VSOs) recommended that competency, training, and quality standards for non-VA community clinicians must be equivalent to benchmarks expected of VA clinicians. That includes credentials, initial and follow-up training, diagnostic screening, care-delivery, and documentation standards. Enacting the Veterans’ Culturally Competent Care Act and the Lethal Means Safety Training Act would begin to meet the MISSION Act’s clear statutory language.
3. The VA and VCCP should add quality information about major diagnostic categories. This will allow veterans to make informed decisions about their personal condition. For most health diagnoses, there is no searchable listing by disorder. 
4. Quality assessments should be realigned to focus on outcome measures. For prospective patients, outcome results provide the most meaningful basis for comparing and selecting clinicians. Proxy measures may have little bearing on whether veterans receive effective care. (As Albert Einstein’s famously observed, “Not everything that can be counted counts.”). Also, the specific measures used for a clinician’s HPP designation should be delineated.
5. The VA must enforce the MISSION Act’s instruction to renew or cancel contracts based on demonstrated quality of care. As VSOs emphasized, “if the private sector is unwilling or unable to match the VA’s access and quality standards, the VA must consider whether it needs to find new community partners.”  

Seventeen billion dollars is spent yearly on purchased health care whose quality remains indeterminate. Ironclad commitments are needed from Congress and the VA to ensure that the effectiveness of, and standards for, veterans care options in the private sector match that in the VA.

Not all federal practitioners know about the National Practitioner Data Bank (NPDB), a federal web-based repository of reports containing information on medical malpractice payments and certain adverse actions related to health care practitioners, providers, and suppliers. This article explains how NPDB statutes and regulations specifically affect federal health care practitioners, which may differ from how the rules affect practitioners in the private sector.¹

National Practitioner Data Bank

Established by Congress in 1986, the NPDB contains information health care organizations need to make informed decisions about the health care practitionerss they license, credential, and hire. Federal regulations authorize eligible entities, including government agencies, to report to and query the NPDB. Individuals and organizations that are subjects of these reports have access to their own information. The reports are confidential and not available to the public. The NPDB currently contains > 1.6 million reports.²

Federal Agencies Queries

A query is a search for information in the NPDB regarding a health care practitioners or organization. Some federal agencies are permitted to query the NPDB, and all hospitals, including federal hospitals, are required to query. Agencies administering government health care programs (including private entities administering such programs under contract), federal law enforcement officials and agencies, and federal agencies responsible for the licensing or certification of health care practitioners, health care providers, or health care suppliers may query NPDB. Information received in response to queries includes, among other actions, licensure and certification actions taken by states, medical malpractice payment information, federal licensing and certification actions, and adverse privileging actions.³

Federal Reporting Requirements

Federal government agencies must report exclusions (described below), adjudicated actions, civil judgments, and criminal convictions concerning health care practitioners, providers, or suppliers. The following provides detailed information about the actions federal government agencies are required to report.

Adjudicated Actions or Decisions

Adjudicated actions or decisions are formal or official final actions.³ They include, but are not limited to, personnel-related actions such as suspensions without pay, reductions in pay, reductions in grade for cause, terminations, or other comparable actions. To be reportable, adjudicated actions or decisions must include due process mechanisms. Whether the subject of a report elects not to use the due process mechanism is immaterial as long as such a process is available to the subject before the adjudicated action or decision is made final. In general, if an adjudicated action or decision follows an agency’s established administrative procedures and those procedures ensure that due process is available to the subject, the due process requirement is satisfied. This definition specifically excludes clinical privileging actions taken by federal government agencies, which are described in appropriate memorandums of understanding.

Exclusions

An exclusion is a temporary or permanent debarment of an individual or organization from participation in a federal health-related program, such that items or services furnished by the individual or organization will not be reimbursed under the federal program.³

Civil Judgments and Criminal Convictions

Health care–related civil judgments and settlements must be reported.However, settlements in which no findings of liability have been made are not reportable.³ Health care–related criminal convictions prosecuted by federal government agencies in federal court must be reported to the NPDB. Pleas of guilt and nolo contendere, or no contest, by individuals or organizations also are reportable.³

In addition, final adverse licensure and certification actions are those taken against health care practitioners, providers, or suppliers, regardless of whether the final adverse action is the subject of a pending appeal.³ These must be reported.

Additional Reporting Requirements

Federal hospitals or federal government agencies administering health care services may have additional reporting requirements besides reporting adjudicated actions, exclusions, civil judgments, and criminal convictions. They may include submitting reports under a memorandum of understanding on clinical privileges actions and medical malpractice payments.³ The US Department of Health and Human Services (HHS) has entered into memorandums of understanding with the US Department of Defense and the US Department of Veteran Affairs to ensure their participation in the NPDB system. Federal hospitals should refer to applicable memorandums of understanding and agency-specific policies for guidance on carrying out their reporting responsibilities.⁴

Responding to a Report

The NPDB sends a letter to health care practitioners when an organization submits a report about the practitioner. The letter has the report number and a password is required to view the report.² Health care practitioners also can order a self-query online to view any reports on them in the NPDB.

The subject of the report can also add a statement and dispute the report. The statement is an opportunity to provide additional information the subject would like to have included in the report. If the subject disagrees with the accuracy of a report or believes it does not meet NPDB reporting requirements, it can be disputed. The dispute will become part of the report. When the subject adds a statement or dispute, the NPDB notifies the reporting organization and all organizations that received the report within the previous 3 years of the report activity.

Health care practitioners must contact the reporting organization to try to resolve their dispute. If the subject of the report has contacted or tried to contact the reporting organization and could not resolve the dispute after 60 days, or if, within the 60-day period, the organization informs the subject that it will not modify the report, that individual may request dispute resolution.Requesting dispute resolution does not remove the report from the NPDB.

Dispute Resolution

Dispute resolution is a request for the HHS secretary to review the report. The secretary authorizes the Division of Practitioner Data Bank (DPDB) to conduct this review. The DPDB is responsible for oversight of the NPDB. The subject of the report will need to submit relevant supporting documentation to request dispute resolution. This documentation should show that the information in the report is not accurate or that the action is not reportable. Also, proof should be included that the subject contacted or attempted to contact the reporting organization. Submitting large volumes or extraneous documentation can delay the review process.

A dispute resolution manager will review the case and send the reporting organization a request for information if needed. The DPDB will send the subject of the report a courtesy copy of all correspondence. The dispute resolution timeline varies, as the DPDB reviews disputes in the order they are received. It completes a fair and thorough review based on the unique circumstances of each case and will review the case as soon as possible. Once the DPDB receives documentation from the subject and the reporting organization, it reviews the documentation to determine whether the report accurately reflects the record.

The DPDB decides to either maintain the report as is, correct it, or remove it from the NPDB. Once the process is complete, the dispute resolution manager sends a decision letter to the subject of the report and the reporting organization. The dispute resolution decision will appear in the report.

Not all federal practitioners know about the National Practitioner Data Bank (NPDB), a federal web-based repository of reports containing information on medical malpractice payments and certain adverse actions related to health care practitioners, providers, and suppliers. This article explains how NPDB statutes and regulations specifically affect federal health care practitioners, which may differ from how the rules affect practitioners in the private sector.¹

National Practitioner Data Bank

Established by Congress in 1986, the NPDB contains information health care organizations need to make informed decisions about the health care practitionerss they license, credential, and hire. Federal regulations authorize eligible entities, including government agencies, to report to and query the NPDB. Individuals and organizations that are subjects of these reports have access to their own information. The reports are confidential and not available to the public. The NPDB currently contains > 1.6 million reports.²

Federal Agencies Queries

A query is a search for information in the NPDB regarding a health care practitioners or organization. Some federal agencies are permitted to query the NPDB, and all hospitals, including federal hospitals, are required to query. Agencies administering government health care programs (including private entities administering such programs under contract), federal law enforcement officials and agencies, and federal agencies responsible for the licensing or certification of health care practitioners, health care providers, or health care suppliers may query NPDB. Information received in response to queries includes, among other actions, licensure and certification actions taken by states, medical malpractice payment information, federal licensing and certification actions, and adverse privileging actions.³

Federal Reporting Requirements

Federal government agencies must report exclusions (described below), adjudicated actions, civil judgments, and criminal convictions concerning health care practitioners, providers, or suppliers. The following provides detailed information about the actions federal government agencies are required to report.

Adjudicated Actions or Decisions

Adjudicated actions or decisions are formal or official final actions.³ They include, but are not limited to, personnel-related actions such as suspensions without pay, reductions in pay, reductions in grade for cause, terminations, or other comparable actions. To be reportable, adjudicated actions or decisions must include due process mechanisms. Whether the subject of a report elects not to use the due process mechanism is immaterial as long as such a process is available to the subject before the adjudicated action or decision is made final. In general, if an adjudicated action or decision follows an agency’s established administrative procedures and those procedures ensure that due process is available to the subject, the due process requirement is satisfied. This definition specifically excludes clinical privileging actions taken by federal government agencies, which are described in appropriate memorandums of understanding.

Exclusions

An exclusion is a temporary or permanent debarment of an individual or organization from participation in a federal health-related program, such that items or services furnished by the individual or organization will not be reimbursed under the federal program.³

Civil Judgments and Criminal Convictions

Health care–related civil judgments and settlements must be reported.However, settlements in which no findings of liability have been made are not reportable.³ Health care–related criminal convictions prosecuted by federal government agencies in federal court must be reported to the NPDB. Pleas of guilt and nolo contendere, or no contest, by individuals or organizations also are reportable.³

In addition, final adverse licensure and certification actions are those taken against health care practitioners, providers, or suppliers, regardless of whether the final adverse action is the subject of a pending appeal.³ These must be reported.

Additional Reporting Requirements

Federal hospitals or federal government agencies administering health care services may have additional reporting requirements besides reporting adjudicated actions, exclusions, civil judgments, and criminal convictions. They may include submitting reports under a memorandum of understanding on clinical privileges actions and medical malpractice payments.³ The US Department of Health and Human Services (HHS) has entered into memorandums of understanding with the US Department of Defense and the US Department of Veteran Affairs to ensure their participation in the NPDB system. Federal hospitals should refer to applicable memorandums of understanding and agency-specific policies for guidance on carrying out their reporting responsibilities.⁴

Responding to a Report

The NPDB sends a letter to health care practitioners when an organization submits a report about the practitioner. The letter has the report number and a password is required to view the report.² Health care practitioners also can order a self-query online to view any reports on them in the NPDB.

The subject of the report can also add a statement and dispute the report. The statement is an opportunity to provide additional information the subject would like to have included in the report. If the subject disagrees with the accuracy of a report or believes it does not meet NPDB reporting requirements, it can be disputed. The dispute will become part of the report. When the subject adds a statement or dispute, the NPDB notifies the reporting organization and all organizations that received the report within the previous 3 years of the report activity.

Health care practitioners must contact the reporting organization to try to resolve their dispute. If the subject of the report has contacted or tried to contact the reporting organization and could not resolve the dispute after 60 days, or if, within the 60-day period, the organization informs the subject that it will not modify the report, that individual may request dispute resolution.Requesting dispute resolution does not remove the report from the NPDB.

Dispute Resolution

Dispute resolution is a request for the HHS secretary to review the report. The secretary authorizes the Division of Practitioner Data Bank (DPDB) to conduct this review. The DPDB is responsible for oversight of the NPDB. The subject of the report will need to submit relevant supporting documentation to request dispute resolution. This documentation should show that the information in the report is not accurate or that the action is not reportable. Also, proof should be included that the subject contacted or attempted to contact the reporting organization. Submitting large volumes or extraneous documentation can delay the review process.

A dispute resolution manager will review the case and send the reporting organization a request for information if needed. The DPDB will send the subject of the report a courtesy copy of all correspondence. The dispute resolution timeline varies, as the DPDB reviews disputes in the order they are received. It completes a fair and thorough review based on the unique circumstances of each case and will review the case as soon as possible. Once the DPDB receives documentation from the subject and the reporting organization, it reviews the documentation to determine whether the report accurately reflects the record.

The DPDB decides to either maintain the report as is, correct it, or remove it from the NPDB. Once the process is complete, the dispute resolution manager sends a decision letter to the subject of the report and the reporting organization. The dispute resolution decision will appear in the report.

Not all federal practitioners know about the National Practitioner Data Bank (NPDB), a federal web-based repository of reports containing information on medical malpractice payments and certain adverse actions related to health care practitioners, providers, and suppliers. This article explains how NPDB statutes and regulations specifically affect federal health care practitioners, which may differ from how the rules affect practitioners in the private sector.¹

National Practitioner Data Bank

Established by Congress in 1986, the NPDB contains information health care organizations need to make informed decisions about the health care practitionerss they license, credential, and hire. Federal regulations authorize eligible entities, including government agencies, to report to and query the NPDB. Individuals and organizations that are subjects of these reports have access to their own information. The reports are confidential and not available to the public. The NPDB currently contains > 1.6 million reports.²

Federal Agencies Queries

A query is a search for information in the NPDB regarding a health care practitioners or organization. Some federal agencies are permitted to query the NPDB, and all hospitals, including federal hospitals, are required to query. Agencies administering government health care programs (including private entities administering such programs under contract), federal law enforcement officials and agencies, and federal agencies responsible for the licensing or certification of health care practitioners, health care providers, or health care suppliers may query NPDB. Information received in response to queries includes, among other actions, licensure and certification actions taken by states, medical malpractice payment information, federal licensing and certification actions, and adverse privileging actions.³

Federal Reporting Requirements

Federal government agencies must report exclusions (described below), adjudicated actions, civil judgments, and criminal convictions concerning health care practitioners, providers, or suppliers. The following provides detailed information about the actions federal government agencies are required to report.

Adjudicated Actions or Decisions

Adjudicated actions or decisions are formal or official final actions.³ They include, but are not limited to, personnel-related actions such as suspensions without pay, reductions in pay, reductions in grade for cause, terminations, or other comparable actions. To be reportable, adjudicated actions or decisions must include due process mechanisms. Whether the subject of a report elects not to use the due process mechanism is immaterial as long as such a process is available to the subject before the adjudicated action or decision is made final. In general, if an adjudicated action or decision follows an agency’s established administrative procedures and those procedures ensure that due process is available to the subject, the due process requirement is satisfied. This definition specifically excludes clinical privileging actions taken by federal government agencies, which are described in appropriate memorandums of understanding.

Exclusions

An exclusion is a temporary or permanent debarment of an individual or organization from participation in a federal health-related program, such that items or services furnished by the individual or organization will not be reimbursed under the federal program.³

Civil Judgments and Criminal Convictions

Health care–related civil judgments and settlements must be reported.However, settlements in which no findings of liability have been made are not reportable.³ Health care–related criminal convictions prosecuted by federal government agencies in federal court must be reported to the NPDB. Pleas of guilt and nolo contendere, or no contest, by individuals or organizations also are reportable.³

In addition, final adverse licensure and certification actions are those taken against health care practitioners, providers, or suppliers, regardless of whether the final adverse action is the subject of a pending appeal.³ These must be reported.

Additional Reporting Requirements

Federal hospitals or federal government agencies administering health care services may have additional reporting requirements besides reporting adjudicated actions, exclusions, civil judgments, and criminal convictions. They may include submitting reports under a memorandum of understanding on clinical privileges actions and medical malpractice payments.³ The US Department of Health and Human Services (HHS) has entered into memorandums of understanding with the US Department of Defense and the US Department of Veteran Affairs to ensure their participation in the NPDB system. Federal hospitals should refer to applicable memorandums of understanding and agency-specific policies for guidance on carrying out their reporting responsibilities.⁴

Responding to a Report

The NPDB sends a letter to health care practitioners when an organization submits a report about the practitioner. The letter has the report number and a password is required to view the report.² Health care practitioners also can order a self-query online to view any reports on them in the NPDB.

The subject of the report can also add a statement and dispute the report. The statement is an opportunity to provide additional information the subject would like to have included in the report. If the subject disagrees with the accuracy of a report or believes it does not meet NPDB reporting requirements, it can be disputed. The dispute will become part of the report. When the subject adds a statement or dispute, the NPDB notifies the reporting organization and all organizations that received the report within the previous 3 years of the report activity.

Health care practitioners must contact the reporting organization to try to resolve their dispute. If the subject of the report has contacted or tried to contact the reporting organization and could not resolve the dispute after 60 days, or if, within the 60-day period, the organization informs the subject that it will not modify the report, that individual may request dispute resolution.Requesting dispute resolution does not remove the report from the NPDB.

Dispute Resolution

Dispute resolution is a request for the HHS secretary to review the report. The secretary authorizes the Division of Practitioner Data Bank (DPDB) to conduct this review. The DPDB is responsible for oversight of the NPDB. The subject of the report will need to submit relevant supporting documentation to request dispute resolution. This documentation should show that the information in the report is not accurate or that the action is not reportable. Also, proof should be included that the subject contacted or attempted to contact the reporting organization. Submitting large volumes or extraneous documentation can delay the review process.

A dispute resolution manager will review the case and send the reporting organization a request for information if needed. The DPDB will send the subject of the report a courtesy copy of all correspondence. The dispute resolution timeline varies, as the DPDB reviews disputes in the order they are received. It completes a fair and thorough review based on the unique circumstances of each case and will review the case as soon as possible. Once the DPDB receives documentation from the subject and the reporting organization, it reviews the documentation to determine whether the report accurately reflects the record.

The DPDB decides to either maintain the report as is, correct it, or remove it from the NPDB. Once the process is complete, the dispute resolution manager sends a decision letter to the subject of the report and the reporting organization. The dispute resolution decision will appear in the report.

Medical case reports are as old as the healing profession itself.¹ These ancient medical stories have a modern definition: “A case report is a narrative that describes, for medical, scientific or educational purposes, a medical problem experienced by one or more patients.”² Case report experts describe the 3-fold purposes of this type of research: as a mainstay of education; a harbinger of emerging illnesses; and an appraiser of new interventions. Case-based education has long been a pillar of health professions education: Nurses, doctors, and allied health professionals are taught and learn through reading and discussing with their teachers and each other about cases of their own patients and of those in the literature.³ Case reports also have helped identify and raise awareness of new diseases and rare conditions, such as HIV.⁴ Finally, case reports have alerted regulatory agencies and the medical community about medication adverse effects, such as birth defects from thalidomide.⁵

Case reports also have been criticized on both scientific and ethical grounds. Critics argue that many case reports often lack the rigor and consistency of other types of research.⁶ Three recent trends in medical publication have strengthened the validity of these criticisms: the increase in the popularity of case reports; the corresponding increase in submissions to journals, including Federal Practitioner; and the rise of predatory publishers.^7,8

The ethical scrutiny of case reports discussed in this column focuses on the tension between providing readers with adequate, accurate information to fulfil the goals of case reports while also protecting patient confidentiality. The latter issue during most of the history of medicine was not considered by health care professionals when the prevailing paternalism supported a professional-oriented approach to health care. The rise of bioethics in the 1960s and 1970s began the shift toward patient autonomy in medical decision making and patient rights to control their protected health information that rendered case reports ethically problematic.

To address both changes in ethical standards and scientific limitations, a committee of clinicians, researchers, and journal editors formed the Case Report (CARE) group.^2,8 The group undertook an effort to improve the quality of case reports. From 2011 to 2012, they developed the CARE guidelines for clinical case reporting. The guidance took the form of a Statement and Checklist presented at the 2013 International Congress on Peer Review and Biomedical Publication. Since their presentation, multiple prestigious medical journals in many countries have implemented these recommendations.

As part of an overall effort to raise the ethical caliber of our own journal, Federal Practitioner will begin to implement the CARE guidelines for case reports for all future submissions. Use of the CARE recommendations will help prospective authors enhance the scientific value and ethical caliber of case reports submitted to the journal as well as assist the Federal Practitioner editorial team, editorial board, and peer reviewers to evaluate submissions more judiciously.

An essential part of the CARE guidelines is that the patient who is the subject of the case report provide informed consent for the publication of their personal narrative. The CARE group considers this an “ethical duty” of authors and editors alike. In “exceptional circumstances” such as if the patient is a minor or permanently incapacitated, a guardian or relative may grant consent. In the rare event that even with exhaustive attempts, if informed consent cannot be obtained from a patient or their representative, then the authors of the case report must submit a statement to this effect.⁴ Some journals may require that the authors obtain the approval of an institutional review board or the permission of an ethics or other institutional committee or a privacy officer.²

Requesting the patient’s consent is an extension of the shared decision making that is now a best practice in clinical care into the arena of research, making the patient or their representative a partner in the work. Ethicists have recommended inviting patients or relatives to read a draft of the case report and agree to its publication or request specific modifications to the manuscript. The CARE group rightly points out that with the rise of open notes in medical documentation, patients increasingly have access to their charts in near or real time.² Gone are the days of Sir William Osler when only doctors read medical journals and all of these technical developments as well as standards of research and social changes in the practitioner-patient relationship make it imperative that writers and editors join together to make case reports more transparent, accurate, and consistent.⁷

An additional step to protect patient privacy is the requirement that authors either de-identify potentially identifiable health information, such as age, birth, death, admission, and discharge dates, or in some instances obtain separate consent for the release of that protected data.⁸ These restrictions constitute a challenge to case report authors who in some instances may consider these same facts critical to the integrity of the case presentation that have made some scholars doubt their continued viability. After all, the contribution of the case to the medical literature often lies in its very particularity. Conversely, no matter how frustrated we might become during writing a case report, we would not want to see our own protected health information or that of our family on a website or in print without our knowledge or approval. Indeed, the International Committee of Medical Journal Editors states that “If identifying characteristics are de-identified, authors should provide assurance, and editors should so note, that such changes do not distort scientific meaning.”⁹

However, the exponential growth of the internet, the spread of social media, and the ubiquity of a plethora of electronic devices, which prior generations of writers and readers could not even imagine, make these limitations necessary to protect patient privacy and the public’s trust in health care professionals. The CARE guidelines can help authors of case reports hone the art of anonymizing the protected health information of subjects of case reports, such as ethnicity and occupation, while accurately conveying the clinical specifics of the case that make it valuable to students and colleagues.

We at Federal Practitioner recognize there is a real tension between truth-telling in case report publication and respect for patient confidentiality that will never be perfectly achieved, but is one that is important for medical knowledge, making it worthy of the continuous efforts of authors and editors to negotiate.

Medical case reports are as old as the healing profession itself.¹ These ancient medical stories have a modern definition: “A case report is a narrative that describes, for medical, scientific or educational purposes, a medical problem experienced by one or more patients.”² Case report experts describe the 3-fold purposes of this type of research: as a mainstay of education; a harbinger of emerging illnesses; and an appraiser of new interventions. Case-based education has long been a pillar of health professions education: Nurses, doctors, and allied health professionals are taught and learn through reading and discussing with their teachers and each other about cases of their own patients and of those in the literature.³ Case reports also have helped identify and raise awareness of new diseases and rare conditions, such as HIV.⁴ Finally, case reports have alerted regulatory agencies and the medical community about medication adverse effects, such as birth defects from thalidomide.⁵

Case reports also have been criticized on both scientific and ethical grounds. Critics argue that many case reports often lack the rigor and consistency of other types of research.⁶ Three recent trends in medical publication have strengthened the validity of these criticisms: the increase in the popularity of case reports; the corresponding increase in submissions to journals, including Federal Practitioner; and the rise of predatory publishers.^7,8

The ethical scrutiny of case reports discussed in this column focuses on the tension between providing readers with adequate, accurate information to fulfil the goals of case reports while also protecting patient confidentiality. The latter issue during most of the history of medicine was not considered by health care professionals when the prevailing paternalism supported a professional-oriented approach to health care. The rise of bioethics in the 1960s and 1970s began the shift toward patient autonomy in medical decision making and patient rights to control their protected health information that rendered case reports ethically problematic.

To address both changes in ethical standards and scientific limitations, a committee of clinicians, researchers, and journal editors formed the Case Report (CARE) group.^2,8 The group undertook an effort to improve the quality of case reports. From 2011 to 2012, they developed the CARE guidelines for clinical case reporting. The guidance took the form of a Statement and Checklist presented at the 2013 International Congress on Peer Review and Biomedical Publication. Since their presentation, multiple prestigious medical journals in many countries have implemented these recommendations.

As part of an overall effort to raise the ethical caliber of our own journal, Federal Practitioner will begin to implement the CARE guidelines for case reports for all future submissions. Use of the CARE recommendations will help prospective authors enhance the scientific value and ethical caliber of case reports submitted to the journal as well as assist the Federal Practitioner editorial team, editorial board, and peer reviewers to evaluate submissions more judiciously.

An essential part of the CARE guidelines is that the patient who is the subject of the case report provide informed consent for the publication of their personal narrative. The CARE group considers this an “ethical duty” of authors and editors alike. In “exceptional circumstances” such as if the patient is a minor or permanently incapacitated, a guardian or relative may grant consent. In the rare event that even with exhaustive attempts, if informed consent cannot be obtained from a patient or their representative, then the authors of the case report must submit a statement to this effect.⁴ Some journals may require that the authors obtain the approval of an institutional review board or the permission of an ethics or other institutional committee or a privacy officer.²

Requesting the patient’s consent is an extension of the shared decision making that is now a best practice in clinical care into the arena of research, making the patient or their representative a partner in the work. Ethicists have recommended inviting patients or relatives to read a draft of the case report and agree to its publication or request specific modifications to the manuscript. The CARE group rightly points out that with the rise of open notes in medical documentation, patients increasingly have access to their charts in near or real time.² Gone are the days of Sir William Osler when only doctors read medical journals and all of these technical developments as well as standards of research and social changes in the practitioner-patient relationship make it imperative that writers and editors join together to make case reports more transparent, accurate, and consistent.⁷

An additional step to protect patient privacy is the requirement that authors either de-identify potentially identifiable health information, such as age, birth, death, admission, and discharge dates, or in some instances obtain separate consent for the release of that protected data.⁸ These restrictions constitute a challenge to case report authors who in some instances may consider these same facts critical to the integrity of the case presentation that have made some scholars doubt their continued viability. After all, the contribution of the case to the medical literature often lies in its very particularity. Conversely, no matter how frustrated we might become during writing a case report, we would not want to see our own protected health information or that of our family on a website or in print without our knowledge or approval. Indeed, the International Committee of Medical Journal Editors states that “If identifying characteristics are de-identified, authors should provide assurance, and editors should so note, that such changes do not distort scientific meaning.”⁹

However, the exponential growth of the internet, the spread of social media, and the ubiquity of a plethora of electronic devices, which prior generations of writers and readers could not even imagine, make these limitations necessary to protect patient privacy and the public’s trust in health care professionals. The CARE guidelines can help authors of case reports hone the art of anonymizing the protected health information of subjects of case reports, such as ethnicity and occupation, while accurately conveying the clinical specifics of the case that make it valuable to students and colleagues.

We at Federal Practitioner recognize there is a real tension between truth-telling in case report publication and respect for patient confidentiality that will never be perfectly achieved, but is one that is important for medical knowledge, making it worthy of the continuous efforts of authors and editors to negotiate.

Medical case reports are as old as the healing profession itself.¹ These ancient medical stories have a modern definition: “A case report is a narrative that describes, for medical, scientific or educational purposes, a medical problem experienced by one or more patients.”² Case report experts describe the 3-fold purposes of this type of research: as a mainstay of education; a harbinger of emerging illnesses; and an appraiser of new interventions. Case-based education has long been a pillar of health professions education: Nurses, doctors, and allied health professionals are taught and learn through reading and discussing with their teachers and each other about cases of their own patients and of those in the literature.³ Case reports also have helped identify and raise awareness of new diseases and rare conditions, such as HIV.⁴ Finally, case reports have alerted regulatory agencies and the medical community about medication adverse effects, such as birth defects from thalidomide.⁵

Case reports also have been criticized on both scientific and ethical grounds. Critics argue that many case reports often lack the rigor and consistency of other types of research.⁶ Three recent trends in medical publication have strengthened the validity of these criticisms: the increase in the popularity of case reports; the corresponding increase in submissions to journals, including Federal Practitioner; and the rise of predatory publishers.^7,8

The ethical scrutiny of case reports discussed in this column focuses on the tension between providing readers with adequate, accurate information to fulfil the goals of case reports while also protecting patient confidentiality. The latter issue during most of the history of medicine was not considered by health care professionals when the prevailing paternalism supported a professional-oriented approach to health care. The rise of bioethics in the 1960s and 1970s began the shift toward patient autonomy in medical decision making and patient rights to control their protected health information that rendered case reports ethically problematic.

To address both changes in ethical standards and scientific limitations, a committee of clinicians, researchers, and journal editors formed the Case Report (CARE) group.^2,8 The group undertook an effort to improve the quality of case reports. From 2011 to 2012, they developed the CARE guidelines for clinical case reporting. The guidance took the form of a Statement and Checklist presented at the 2013 International Congress on Peer Review and Biomedical Publication. Since their presentation, multiple prestigious medical journals in many countries have implemented these recommendations.

As part of an overall effort to raise the ethical caliber of our own journal, Federal Practitioner will begin to implement the CARE guidelines for case reports for all future submissions. Use of the CARE recommendations will help prospective authors enhance the scientific value and ethical caliber of case reports submitted to the journal as well as assist the Federal Practitioner editorial team, editorial board, and peer reviewers to evaluate submissions more judiciously.

An essential part of the CARE guidelines is that the patient who is the subject of the case report provide informed consent for the publication of their personal narrative. The CARE group considers this an “ethical duty” of authors and editors alike. In “exceptional circumstances” such as if the patient is a minor or permanently incapacitated, a guardian or relative may grant consent. In the rare event that even with exhaustive attempts, if informed consent cannot be obtained from a patient or their representative, then the authors of the case report must submit a statement to this effect.⁴ Some journals may require that the authors obtain the approval of an institutional review board or the permission of an ethics or other institutional committee or a privacy officer.²

Requesting the patient’s consent is an extension of the shared decision making that is now a best practice in clinical care into the arena of research, making the patient or their representative a partner in the work. Ethicists have recommended inviting patients or relatives to read a draft of the case report and agree to its publication or request specific modifications to the manuscript. The CARE group rightly points out that with the rise of open notes in medical documentation, patients increasingly have access to their charts in near or real time.² Gone are the days of Sir William Osler when only doctors read medical journals and all of these technical developments as well as standards of research and social changes in the practitioner-patient relationship make it imperative that writers and editors join together to make case reports more transparent, accurate, and consistent.⁷

An additional step to protect patient privacy is the requirement that authors either de-identify potentially identifiable health information, such as age, birth, death, admission, and discharge dates, or in some instances obtain separate consent for the release of that protected data.⁸ These restrictions constitute a challenge to case report authors who in some instances may consider these same facts critical to the integrity of the case presentation that have made some scholars doubt their continued viability. After all, the contribution of the case to the medical literature often lies in its very particularity. Conversely, no matter how frustrated we might become during writing a case report, we would not want to see our own protected health information or that of our family on a website or in print without our knowledge or approval. Indeed, the International Committee of Medical Journal Editors states that “If identifying characteristics are de-identified, authors should provide assurance, and editors should so note, that such changes do not distort scientific meaning.”⁹

However, the exponential growth of the internet, the spread of social media, and the ubiquity of a plethora of electronic devices, which prior generations of writers and readers could not even imagine, make these limitations necessary to protect patient privacy and the public’s trust in health care professionals. The CARE guidelines can help authors of case reports hone the art of anonymizing the protected health information of subjects of case reports, such as ethnicity and occupation, while accurately conveying the clinical specifics of the case that make it valuable to students and colleagues.

We at Federal Practitioner recognize there is a real tension between truth-telling in case report publication and respect for patient confidentiality that will never be perfectly achieved, but is one that is important for medical knowledge, making it worthy of the continuous efforts of authors and editors to negotiate.